tag:theconversation.com,2011:/nz/topics/pfizer-biontech-vaccine-99165/articlesPfizer-BioNTech vaccine – The Conversation2023-01-25T13:25:09Ztag:theconversation.com,2011:article/1978782023-01-25T13:25:09Z2023-01-25T13:25:09ZEven bivalent updated COVID-19 boosters struggle to prevent omicron subvariant transmission – an immunologist discusses why new approaches are necessary<figure><img src="https://images.theconversation.com/files/506017/original/file-20230124-17-uye0hb.jpg?ixlib=rb-1.1.0&rect=61%2C51%2C6816%2C3434&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The FDA is proposing an annual shot against COVID-19, signaling that a new approach is needed.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/antibodies-background-royalty-free-image/1358868801?phrase=antibodies&adppopup=true">wildpixel/iStock via Getty Images Plus</a></span></figcaption></figure><p>By almost any measure, the vaccination campaign against SARS-CoV-2, the virus that causes COVID-19, has been <a href="https://www.unicef.org/coronavirus/the-covid-19-vaccine-success-stories">a global success</a>. </p>
<p>As of January 2023, more than <a href="https://www.bloomberg.com/graphics/covid-vaccine-tracker-global-distribution/">12 billion</a> vaccines against SARS-CoV-2 have been administered in an effort that has saved countless lives – more than <a href="https://doi.org/10.1016/S1473-3099(22)00320-6">14 million</a> in the first year of vaccine availability alone. With a <a href="https://doi.org/10.1056/NEJMoa2034577">95% efficacy</a> in the prevention of severe infection and death, and better safety profiles than similar <a href="https://doi.org/10.1001/jama.294.21.2734">historically effective vaccines</a>, the biomedical community hoped that a combination of vaccination and natural immunity might bring the pandemic to a relatively quick end.</p>
<p>But the emergence of new viral variants, <a href="https://theconversation.com/will-omicron-the-new-coronavirus-variant-of-concern-be-more-contagious-than-delta-a-virus-evolution-expert-explains-what-researchers-know-and-what-they-dont-169020">particularly omicron</a> and its <a href="https://theconversation.com/how-the-omicron-subvariant-ba-5-became-a-master-of-disguise-and-what-it-means-for-the-current-covid-19-surge-187132">array of subvariants</a>, upended those expectations. The latest omicron strain, XBB.1.5. – dubbed “Kraken”, after a mythical sea creature – has rapidly become the dominant subvariant in the U.S. The World Health Organization is calling it <a href="https://www.washingtonpost.com/health/2023/01/05/new-omicron-variant-xbb15-covid-who/">the most contagious strain so far</a>, with its success almost certainly attributable to an ability to dodge immunity from previous vaccines or infections.</p>
<p>The effort to get ahead of these ever-changing variants is also in part what has led the Food and Drug Administration to <a href="https://www.statnews.com/2023/01/23/fda-scientists-propose-an-annual-covid-shot-matched-to-current-strains/?utm_campaign=daily">reconsider its approach</a> to COVID-19 vaccination. On Jan. 23, 2023, the agency proposed that current guidelines for a series of shots followed by a booster be replaced by an annual COVID-19 vaccine that is updated each year to combat current strains. The proposal is set to be reviewed by the FDA’s science advisory committee on Jan. 26.</p>
<h2>Limitations of current mRNA vaccination strategies</h2>
<p>Unfortunately, the new bivalent shots, which include components from both the original SARS-CoV-2 strain as well as a recent omicron variant, have <a href="https://doi.org/10.1056/NEJMp2215780">not performed as well</a> as some scientists had hoped. Although there is no question that the updated jabs are capable of <a href="https://doi.org/10.1056/NEJMc2214293">boosting antibody levels</a> against SARS-CoV-2 and <a href="http://dx.doi.org/10.2139/ssrn.4314067">helping to prevent severe illness and hospitalization</a>, <a href="https://doi.org/10.1101/2022.10.22.513349">several</a> <a href="https://doi.org/10.1101/2022.10.24.513619">studies</a> have suggested that they are not necessarily more capable of preventing omicron infections than their predecessors.</p>
<p>As <a href="https://scholar.google.com/citations?user=-oDHlFYAAAAJ&hl=en">an immunologist</a> who studies how the immune system <a href="https://doi.org/10.1016/j.celrep.2018.09.029">selects which antibodies to produce</a> and <a href="https://doi.org/10.1038/s41586-022-05273-0">immune responses to COVID-19</a>, these new results are disappointing. But they are not entirely unexpected. </p>
<p>When COVID-19 vaccines were being rolled out in early 2021, immunologists began having <a href="https://theconversation.com/immune-interference-why-even-updated-vaccines-could-struggle-to-keep-up-with-emerging-coronavirus-strains-156465">public discussions</a> about the potential obstacles to rapidly generating updated vaccines to emerging viral strains. At the time, there was no hard data. But researchers have known for a <a href="https://www.jstor.org/stable/985534">very long time</a> that immunological memory, the very thing that offers continued protection against a virus long after vaccination, can sometimes negatively interfere with the development of slightly <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2138235/pdf/331.pdf">updated immune responses</a>. </p>
<p>The failure of these new bivalent vaccines in widely preventing omicron infections suggests that our current approach is simply not sufficient to interrupt the viral transmission cycle driving the COVID-19 pandemic. In my view, it’s clear that innovative vaccine designs capable of producing a broader immunity are badly needed. </p>
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<figcaption><span class="caption">The latest COVID-19 subvariant, XBB.1.5, accounts for a large portion of new cases.</span></figcaption>
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<h2>Vaccines are designed to generate immune memory</h2>
<p>In simplest terms, vaccines are a way to give your immune system a sneak peek at a pathogen. <a href="https://www.vaccines.gov/basics/types">There are several different ways to do this</a>. One way is to inject inactivated versions of a virus, as has been <a href="https://www.vaccines.gov/diseases/polio">done with polio</a>. Another is to use noninfectious viral components, such as the proteins used for <a href="https://www.cdc.gov/flu/prevent/different-flu-vaccines.htm">flu vaccines</a>. </p>
<p>And most recently, scientists have found ways to deliver mRNA <a href="https://theconversation.com/what-happens-when-the-covid-19-vaccines-enter-the-body-a-road-map-for-kids-and-grown-ups-164624">“instructions” that tell your body</a> how to make those noninfectious viral components. This is the approach used with the <a href="https://www.nytimes.com/interactive/2020/health/moderna-covid-19-vaccine.html">Moderna and Pfizer vaccines</a> targeted against COVID-19.</p>
<p>The mRNA-based vaccines all train your immune system to identify and respond against critical components of a potential invader. An important part of that response is to get your body to produce antibodies that will hopefully prevent future infections, helping to break the cycle of person-to-person transmission. </p>
<p>In a successful response, the immune system will not only produce antibodies that are specific to the pathogen, but will also remember how to make them in case you encounter that same pathogen again in the future.</p>
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<a href="https://images.theconversation.com/files/506020/original/file-20230124-11-xb1ovk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Vials and syringes containing COVID-19 vaccine are displayed on a tray." src="https://images.theconversation.com/files/506020/original/file-20230124-11-xb1ovk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/506020/original/file-20230124-11-xb1ovk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/506020/original/file-20230124-11-xb1ovk.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/506020/original/file-20230124-11-xb1ovk.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/506020/original/file-20230124-11-xb1ovk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/506020/original/file-20230124-11-xb1ovk.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/506020/original/file-20230124-11-xb1ovk.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">The existing approach to COVID-19 vaccines has proved effective at preventing serious illness and death, but it has not prevented infections as well as scientists had hoped.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/vials-with-the-covid-19-vaccine-and-syringes-are-royalty-free-image/1303457369?phrase=immune%20system%20concept&adppopup=true">Morsa Images/DigitalVision via Getty Images</a></span>
</figcaption>
</figure>
<h2>The specter of ‘original antigenic sin’</h2>
<p>But what happens when the virus evolves and that memory becomes obsolete?</p>
<p>Immunologists have wondered this <a href="https://theconversation.com/immune-interference-why-even-updated-vaccines-could-struggle-to-keep-up-with-emerging-coronavirus-strains-156465">since the initial COVID-19 vaccine rollout</a>. Recently, it has found new relevance in light of the <a href="https://www.statnews.com/2023/01/23/fda-scientists-propose-an-annual-covid-shot-matched-to-current-strains/?utm_campaign=daily">FDA’s proposal</a> for an updated annual COVID-19 shot. </p>
<p>While it is possible that immune responses to updated vaccines will <a href="https://doi.org/10.1016/j.it.2022.02.009">simply replace the old ones</a>, that has not been true for influenza. With flu, researchers have learned that preexisting immunity to one strain <a href="https://doi.org/10.4049/jimmunol.0900398">can actively inhibit</a> the ability to respond well against another.</p>
<p>Put in everyday language, think of a virus as a car trying to run you over. You might produce one kind of antibody against the hood, one against the bumper and one against the hubcaps that prevents the wheels from turning. You have produced three kinds of antibodies specific to the car, but it turns out that only the hubcap antibodies effectively slow it down.</p>
<p>Now the car mutates, like SARS-CoV-2 has. It changes the shape of the hubcaps or it removes them altogether. Your immune system still recognizes the car, but not the hubcaps. The system doesn’t know that the hubcap was the only effective target, so it ignores the hubcaps and ramps up its attack on the hood and bumper. </p>
<p>In ignoring the new hubcap response, the immune system’s memory of the original car is not only obsolete, but it is also actively interfering with the response necessary to target the new car’s wheels. This is what immunologists call “<a href="https://doi.org/10.4049/jimmunol.1801149">original antigenic sin</a>” – ineffective immune memory that hampers desired responses to new pathogen strains.</p>
<p>This sort of interference has been extremely difficult to quantify and study in humans, although it may become easier with the <a href="https://www.washingtonpost.com/health/2023/01/23/covid-vaccine-once-a-year/">FDA’s proposal</a>. A once-yearly approach to COVID-19 vaccination opens the door for more straightforward studies on how memory to each vaccine influences the next.</p>
<h2>Multi-strain vaccinations offer hope</h2>
<p>Simultaneously, <a href="https://www.niaidcivics.org/">significant efforts</a> are being made to prioritize the pursuit of a single-shot or “universal” vaccine. One approach has been to take advantage of emerging research showing that if your immune system is presented with multiple versions of the same pathogen, it will tend to <a href="https://doi.org/10.1016/j.celrep.2018.09.029">choose targets that are shared between them</a>. </p>
<p>Presented with a Model T, Ford F-150 and electric Mustang all at once, your immune system will often choose to ignore differences like the hubcaps in favor of similarities like the shape and rubber on the tires. Not only would this interfere with the function of all three vehicles, but it could theoretically interfere with most road-based vehicles – or viral threats such as variants.</p>
<p>Researchers have begun making rapid headway using this approach with the development of <a href="https://doi.org/10.1038/s41591-020-1118-7">complex multi-strain flu vaccines</a> that are performing well in early clinical trials. New studies focused on SARS-CoV-2 <a href="https://doi.org/10.1016/j.ebiom.2022.104341">hope to do the same</a>. Persistent pathogens including <a href="https://doi.org/10.1186/s12985-017-0918-y">influenza</a> and <a href="https://doi.org/10.1038/ni.3158">HIV</a> all suffer from versions of the same antibody-targeting issues. It is possible that this pandemic may serve as a crucible of innovation that leads to the next generation of infectious disease prevention.</p>
<p><em>This is an updated version of an article <a href="https://theconversation.com/immune-interference-why-even-updated-vaccines-could-struggle-to-keep-up-with-emerging-coronavirus-strains-156465">originally published on March 8, 2021</a>.</em></p><img src="https://counter.theconversation.com/content/197878/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Matthew Woodruff does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The new bivalent boosters against COVID-19 have failed to halt omicron infections. However, new technologies are being developed that pave a way forward.Matthew Woodruff, Instructor of Human Immunology, Emory UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1896102022-09-01T12:25:45Z2022-09-01T12:25:45ZWill omicron-specific booster shots be more effective at combating COVID-19? 5 questions answered<figure><img src="https://images.theconversation.com/files/482134/original/file-20220831-4878-mt0k59.jpg?ixlib=rb-1.1.0&rect=53%2C116%2C6000%2C3853&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">In a matter of days, eligible people will be lining up to receive the newly formulated booster shot.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/vaccination-center-royalty-free-image/1358994941?adppopup=true">filadendron/E+ via Getty Images</a></span></figcaption></figure><p><em>On Sept. 1, 2022, the Centers for Disease Control and Prevention <a href="https://www.cdc.gov/media/releases/2022/s0901-covid-19-booster.html">endorsed the use of updated COVID-19 booster shots</a> that are specifically tailored to combat the two most prevalent <a href="https://doi.org/10.1136/bmj.o1969">omicron subvariants, BA.4 and BA.5</a>. The decision comes just a day after the <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use">Food and Drug Administration’s emergency use authorization of the shots</a>. The CDC’s backing will enable a full roll-out of the reformulated vaccines to begin within days.</em> </p>
<p><em>The new booster shots – one by Moderna and another from Pfizer-BioNTech – come as more than <a href="https://www.nytimes.com/interactive/2021/us/covid-cases.html">450 people are still dying of COVID-19 every day in the U.S</a>.</em> </p>
<p><em>As of Aug. 31, 2022, only <a href="https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-additional-dose-totalpop">48.5% of booster-eligible people in the U.S. have received their first booster shot</a>, and just under 34% of those eligible have received their second. These low numbers may in part be influenced by <a href="https://theconversation.com/should-you-get-a-covid-19-booster-shot-now-or-wait-until-fall-two-immunologists-help-weigh-the-options-184809">people waiting for the newer versions of the vaccines</a> to provide better protection. But booster shots have proven to be an <a href="https://theconversation.com/low-vaccine-booster-rates-are-now-a-key-factor-in-covid-19-deaths-and-racial-disparities-in-booster-rates-persist-187272">essential layer of protection against COVID-19</a>.</em> </p>
<p><em><a href="https://scholar.google.com/citations?user=jJVj3sUAAAAJ&hl=en">Prakash Nagarkatti</a> and <a href="https://scholar.google.com/citations?user=af7TahQAAAAJ&hl=en">Mitzi Nagarkatti</a> are immunologists who study infectious disorders and how vaccines trigger different aspects of the immune system to fight infection. They weigh in on how the updated booster shots train the immune system and how protective they might be against COVID-19.</em> </p>
<h2>1. What is different about the updated booster shots?</h2>
<p>The newly authorized shots are the first updates to the original COVID-19 vaccines that were introduced in late 2020. They use the same <a href="https://theconversation.com/how-mrna-vaccines-from-pfizer-and-moderna-work-why-theyre-a-breakthrough-and-why-they-need-to-be-kept-so-cold-150238">mRNA technology as the original vaccines</a>. The key difference between the original COVID-19 shots and the new “bivalent” version is that the latter consists of a mixture of mRNA that encodes the <a href="https://doi.org/10.1038/s41401-020-0485-4">spike proteins</a> of both the original SARS-CoV-2 virus and the more <a href="https://doi.org/10.1136/bmj.o1969">recent omicron subvariants, BA.4 and BA.5</a>.</p>
<p>As of late August 2022, the BA.4 and BA.5 omicron subvariants are dominant worldwide. <a href="https://covid.cdc.gov/covid-data-tracker/#variant-proportions">In the U.S., currently</a> 89% of COVID-19 infections are caused by BA.5 and 11% are caused by BA.4.</p>
<p>The inability of the original vaccine strains to prevent reinfection and <a href="https://theconversation.com/how-long-does-protective-immunity-against-covid-19-last-after-infection-or-vaccination-two-immunologists-explain-177309">to trigger long-term protective immunity</a> prompted the need for the reformulated vaccines.</p>
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<figcaption><span class="caption">The booster shots target the BA.4 and BA.5 subvariants of the omicron variant, as well as the original version of SARS-CoV-2, the virus that causes COVID-19.</span></figcaption>
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<h2>2. How does a bivalent vaccine trigger an immune response?</h2>
<p>In an actual COVID-19 infection, the SARS-CoV-2 virus uses its protruding <a href="https://doi.org/10.1073/pnas.2003138117">spike protein to latch onto human cells</a> and gain entry into cells. The spike protein triggers the production of so-called <a href="https://doi.org/10.1126/science.abd7728">neutralizing antibodies</a>, which bind to the spike protein and prevent the virus from invading other cells.</p>
<p>But <a href="https://doi.org/10.3390%2Fv14030640">when the virus mutates</a>, as we know that it does, the antibodies that were previously produced in response to the virus can no longer effectively bind to the newly mutated spike protein. In this respect, the SARS-CoV-2 virus acts like a chameleon – a master of disguise – by changing its body configuration and escaping recognition by the immune system. </p>
<p>The ongoing viral mutations are why antibodies produced in response to the original vaccine strains have over time become less effective at fending off infections by new variants.</p>
<p>The concept of bivalent vaccines aimed at protecting against two different strains of a virus is not new. For instance, <a href="https://www.fda.gov/vaccines-blood-biologics/vaccines/cervarix">Cervarix is an FDA-approved bivalent vaccine</a> that provides protection against two different types of human papillomaviruses that cause cancer.</p>
<h2>3. How protective will the new shots be against infection?</h2>
<p>There are as of yet no human studies on the efficacy of the new bivalent vaccine at preventing reinfections and providing long-term immune protection.</p>
<p>However, in human clinical trials and laboratory studies, <a href="https://doi.org/10.1126/science.ade6584">both Pfizer-BioNTech and Moderna found</a> that their initial version of the bivalent vaccine, which was directed against the original SARS-CoV-2 virus and an earlier omicron strain, BA.1, induced a strong immune response and longer protection against both the original strain and the BA.1 variant. In addition, the companies reported that the same early combination generated a significant antibody response against the newest omicron subvariants, BA.4 and BA.5, though this antibody response was lower than that seen against subvariant BA.1.</p>
<p>Based on those results, in spring 2022 the <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-recommends-inclusion-omicron-ba45-component-covid-19-vaccine-booster">FDA rejected</a> the BA.1 bivalent boosters because the agency felt the boosters may fall short of providing sufficient protection against the newest strains, BA.4 and BA.5, which were by then spreading quickly throughout the U.S. and the world. So the FDA asked Pfizer-BioNTech and Moderna <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/fda-recommends-inclusion-ba4-ba5-subvariants-covid-boosters-2022-06-30/">to develop bivalent vaccines specifically targeting BA.4 and BA.5</a>, instead of BA.1. </p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1561732830211735553"}"></div></p>
<p>Because clinical trials are time-consuming, the <a href="https://www.npr.org/sections/health-shots/2022/08/18/1117778748/whats-behind-the-fdas-controversial-strategy-for-evaluating-new-covid-boosters">FDA was willing to consider animal studies</a> and other laboratory findings, such as the ability of antibodies to neutralize the virus, to decide whether to authorize the bivalent boosters. </p>
<p>This decision <a href="https://www.npr.org/sections/health-shots/2022/08/18/1117778748/whats-behind-the-fdas-controversial-strategy-for-evaluating-new-covid-boosters">has stirred up controversy</a> over whether it is appropriate for the FDA to approve a booster without direct human data to support it. However, the FDA has stated that millions of people have safely received the mRNA vaccines – which were originally tested in humans – and that the changes in the mRNA sequences in the vaccines <a href="https://abcnews.go.com/Health/fall-covid-19-boosters-roll-pending-green-light/story?id=88973334">do not affect vaccine safety</a>. Thus, it concluded that the bivalent vaccines are safe and that there is no need to wait for human clinical trials.</p>
<p>It is also noteworthy that influenza vaccines are introduced each year based on prediction of the strain that is likely to be dominant, <a href="https://doi.org/10.1126/science.ade6584">and such formulations do not undergo new clinical trials</a>. </p>
<p>Based on available evidence from the previous COVID-19 vaccines, we believe it is very likely that the new boosters will continue to offer strong protection from <a href="https://www.cdc.gov/media/releases/2022/s0318-COVID-19-vaccines-protect.html">severe COVID-19 leading to hospitalization and death</a>.
But whether they will protect against reinfection and breakthrough infections remains to be seen. </p>
<h2>4. Will it only be a booster shot?</h2>
<p>The bivalent vaccines <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use">can only be used</a> as a booster shot at least two months after the completion of the primary series – or initial required shots – or following a previous booster shot. The Moderna bivalent vaccine is authorized for use in people 18 years of age, while the Pfizer bivalent vaccine is authorized for those 12 years of age and older. </p>
<p>Because of the superiority of the bivalent vaccines, the FDA has also removed the use authorization for the original monovalent Moderna and Pfizer COVID-19 vaccines for booster purposes in individuals 18 years of age and older and 12 years of age and older, respectively. </p>
<p>The new <a href="https://doi.org/10.1126/science.ade6584">bivalent vaccines contain a lower dose of mRNA</a>, and as such are meant to be used only as boosters and not in people who have never received a COVID-19 vaccination. </p>
<h2>5. Will the new shots protect against future variants?</h2>
<p>How well the bivalent vaccines will perform in the face of new variants that might arise will depend on the nature of future spike protein mutations. </p>
<p>If it is a minor mutation or set of mutations when compared to the original strain or to omicron variants BA.4 and BA.5, the new shots will provide good protection. However, if a hypothetical new strain were to possess highly unique mutations in its spike protein, then it’s likely that it could once again dodge immune protection. </p>
<p>On the flip side, the successful development of the updated vaccines demonstrates that the mRNA vaccine technology is nimble and innovative enough that – within a couple of months of the emergence of a new variant – it is now likely possible to develop and distribute new vaccines that are tailor-made to fight an emerging variant.</p>
<p><em>This article has been updated to reflect the CDC’s endorsement of the reformulated shots.</em></p><img src="https://counter.theconversation.com/content/189610/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Prakash Nagarkatti receives funding from the National Institutes of Health and the National Science Foundation.</span></em></p><p class="fine-print"><em><span>Mitzi Nagarkatti receives funding from the National Institutes of Health.</span></em></p>The CDC’s endorsement of the reformulated COVID-19 booster shots represents a major step in the effort to get more Americans boosted.Prakash Nagarkatti, Professor of Pathology, Microbiology and Immunology, University of South CarolinaMitzi Nagarkatti, Professor of Pathology, Microbiology and Immunology, University of South CarolinaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1872722022-08-30T12:19:19Z2022-08-30T12:19:19ZLow vaccine booster rates are now a key factor in COVID-19 deaths – and racial disparities in booster rates persist<figure><img src="https://images.theconversation.com/files/480642/original/file-20220823-11-gs3akm.jpg?ixlib=rb-1.1.0&rect=77%2C0%2C8660%2C5691&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">As of August 2022, COVID-19 vaccination rates in Black and Hispanic people exceeded those of white Americans nationally, but only for the initial shots.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/getting-vaccinated-royalty-free-image/1363894755?adppopup=true">FatCamera/E+ via Getty Images</a></span></figcaption></figure><p>More than 450 people are <a href="https://www.nytimes.com/interactive/2021/us/covid-cases.html">dying of COVID-19 in the U.S. each day</a> as of late August 2022.</p>
<p>When COVID-19 vaccines first became available, public officials, community organizations and policymakers mobilized to get shots into arms. These efforts included <a href="https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/vaccine-equity.html">significant investments</a> in making vaccines accessible to <a href="https://www.whitehouse.gov/briefing-room/statements-releases/2021/03/25/fact-sheet-biden-administration-announces-historic-10-billion-investment-to-expand-access-to-covid-19-vaccines-and-build-vaccine-confidence-in-hardest-hit-and-highest-risk-communities/">Black, Hispanic, American Indian and Alaska Native populations</a>. These groups experienced exceptionally high <a href="https://www.cdc.gov/mmwr/volumes/71/wr/mm7117e2.htm">COVID-19 death rates early in the pandemic</a> and had <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7006e3.htm?s_cid=mm7006e3_w">low initial vaccine rates</a>.</p>
<p>The <a href="https://www.cdc.gov/mmwr/volumes/71/wr/mm7123a2.htm">efforts worked</a>. As of August 2022, vaccination rates for the <a href="https://covid.cdc.gov/covid-data-tracker/#vaccination-demographics-trends">primary series – or required initial doses of COVID-19 vaccines – for Black and Hispanic people</a> exceeded those of white Americans.</p>
<p>But boosters are a different story. Comparable booster vaccine promotion efforts <a href="https://theconversation.com/should-you-get-a-covid-19-booster-shot-now-or-wait-until-fall-two-immunologists-help-weigh-the-options-184809">have been lacking</a>. <a href="https://www.theatlantic.com/health/archive/2022/04/cdc-covid-vaccine-booster-campaign/629536/">Confusion</a> in the public health messaging surrounding boosters and <a href="https://www.theguardian.com/us-news/2022/mar/27/us-second-covid-booster-delays-funding">limited federal funding</a> for rolling out vaccination campaigns have resulted in <a href="https://www.washingtonpost.com/politics/2022/04/18/us-booster-gap/">slow booster uptake</a> across the country. </p>
<p>As a result, divides have once again emerged. A recent <a href="https://doi.org/10.1001/jamanetworkopen.2022.27680">study of COVID-19 booster rates</a> found that 45% of white adults and 52% of Asian American adults had received boosters by January 2022. But only 29% of Black adults and 31% of adults who reported another racial or ethnic identity, such as American Indian, Alaska Native, Native Hawaiian, Pacific Islander or multiracial, were boosted. </p>
<p>As of late August 2022, the U.S. <a href="https://covid.cdc.gov/covid-data-tracker/#vaccination-demographics-trends">Centers for Disease Control and Prevention reported</a> that 36.3% of white adults in the U.S. 50 years or older and eligible for a second booster shot had received one. This is compared to only 28.4% for the Black population, 31.3% for American Indian or Alaska Native populations, and 25.1% for the Hispanic population. </p>
<p>New boosters aimed at the <a href="https://www.nytimes.com/article/covid-omicron-booster.html?">currently dominant omicron subvariant</a> are expected to become available <a href="https://www.nytimes.com/2022/08/23/us/politics/covid-booster-shots-biden.html">in early September 2022</a>. But the benefits of this new booster will be limited if it is not widely used. </p>
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<figcaption><span class="caption">The new variant-specific boosters are expected to be available in September 2022.</span></figcaption>
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<h2>Booster rates predict mortality rates across counties</h2>
<p>We are a team of population health researchers at <a href="https://www.bu.edu/sph/profile/andrew-stokes/">Boston University</a> and the <a href="https://cla.umn.edu/about/directory/profile/ewf">University of Minnesota</a>. We have been <a href="https://doi.org/10.1371/journal.pmed.1003571">tracking COVID-19 mortality rates</a> since the <a href="https://doi.org/10.1177%2F2378023120980918">beginning of the pandemic</a>. Our team uses demographic methods to identify social and structural factors that influence health and <a href="https://ajph.aphapublications.org/doi/full/10.2105/AJPH.2021.306331">contribute to evidence-based reforms</a> of <a href="https://thehill.com/opinion/healthcare/3572982-hidden-covid-fatalities-show-us-death-investigations-need-reform/">public health and health care systems</a>.</p>
<p>Vaccine studies suggest that adults age 50 and older who receive a booster shot have <a href="https://doi.org/10.1056/NEJMoa2115624">90% lower death rates</a> from COVID-19 than those who receive only the initial vaccine regimen. But the extent to which boosters have translated into health gains at the population level remains unclear. </p>
<p>Preliminary analyses by our team indicate that people in the U.S. living in counties with low booster uptake are dying from COVID-19 at higher rates than people living in counties with high booster uptake. In particular, in comparing the counties in the bottom 10% of booster rates with those in the top 10%, the COVID-19 death rates for residents of the bottom 10% of counties were 64% higher. Our analysis applies to the period from January to June 2022. It also adjusts for residents’ ages.</p>
<p>This difference in death rates may in part reflect the fact that counties with greater booster protection also tend to have higher rates of primary-series vaccination. Nonetheless, these findings suggest that at the population level, booster rates are now a key factor behind COVID-19 deaths. </p>
<p><iframe id="oENt5" class="tc-infographic-datawrapper" src="https://datawrapper.dwcdn.net/oENt5/14/" height="400px" width="100%" style="border: none" frameborder="0"></iframe></p>
<p>A prior study found that vaccination strategies that target high-risk geographical areas <a href="https://doi.org/10.1126/sciadv.abj2099">save more lives than strategies based on age alone</a>. Thus, the evidence suggests that limited federal funding for COVID-19 booster promotion should be sent to geographical areas that are currently reporting high rates of COVID-19 deaths. </p>
<h2>Learning from the community</h2>
<p>An effective booster campaign could build on lessons learned from prior vaccination campaigns. Specifically, this involves <a href="https://time.com/6204470/innovation-covid-19/">bringing vaccines directly to people</a>. From the earliest days of vaccine distribution during the pandemic, partnerships with faith-based organizations, housing communities and trusted community organizations have been <a href="https://doi.org/10.1007%2Fs11524-021-00594-3">successful in reaching populations with low vaccination rates</a>. </p>
<p>Other strategies to make boosters <a href="https://www.cdc.gov/vaccines/covid-19/downloads/vaccination-strategies.pdf">more accessible</a> include increasing access to vaccine centers via public transit and outside of typical working hours. In rural areas, <a href="https://doi.org/10.1093%2Fofid%2Fofab152">evidence-based strategies</a> to promote vaccination include education of community ambassadors, use of social media and operation of mobile vaccination sites. </p>
<p>In the absence of federal funding, community efforts have aimed to make boosters more accessible. A New Yorker documentary filmed in 2021 explored the <a href="https://www.newyorker.com/culture/the-new-yorker-documentary/an-alabama-womans-neighborly-vaccination-campaign">challenges that one rural community in Alabama</a> – Panola – has faced with vaccination. It highlights community leader Dorothy Oliver as she promotes vaccination with little to no support from the government. Her efforts included door-to-door campaigns, discussions with residents about their fears and concerns and coordination of vaccination logistics, including scheduling and transport. </p>
<p>In a similar way, Minneapolis’ Seward Vaccine Equity Project <a href="https://www.healthaffairs.org/do/10.1377/forefront.20220518.186581/">increased booster shots among East African immigrant families</a> by having volunteers call members of their own communities and offer them a booster appointment and a ride. The volunteers were also available to answer residents’ questions and address any concerns. Successful efforts like those could be carried out by health departments on a much wider scale.</p><img src="https://counter.theconversation.com/content/187272/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Andrew Stokes receives funding from the Robert Wood Johnson Foundation, the W.K. Kellogg Foundation, and the National Institute on Aging. </span></em></p><p class="fine-print"><em><span>Elizabeth Wrigley-Field is a member of the Seward Vaccine Equity Project, discussed in the article. She receives funding from the Eunice Kennedy Shriver National Institute on Child Health and Human Development via the Minnesota Population Center and from the National Institute on Aging via the Life Course Center, both at the University of Minnesota.</span></em></p><p class="fine-print"><em><span>Dielle Lundberg and Rafeya Raquib do not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Early on, public health messaging focused on the need for vaccines to combat COVID-19. But far less attention has been given to the role of boosters in preventing deaths and reducing inequities.Andrew Stokes, Assistant Professor of Global Health, Boston UniversityDielle Lundberg, Research Fellow in Global Health, Boston UniversityElizabeth Wrigley-Field, Assistant Professor of Sociology, University of MinnesotaRafeya Raquib, Research Fellow in Global Health, Boston UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1852152022-07-19T02:56:18Z2022-07-19T02:56:18ZCOVID vaccines for children under 5 are almost here. Here’s what parents need to know<figure><img src="https://images.theconversation.com/files/470496/original/file-20220623-51812-40p93u.jpg?ixlib=rb-1.1.0&rect=2%2C1%2C995%2C661&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/portrait-cute-happy-8-month-old-213114688">Shutterstock</a></span></figcaption></figure><p>COVID vaccines for children as young as six months look set to be available in the coming months, now the Therapeutic Goods Administration has <a href="https://www.tga.gov.au/media-release/tga-provisionally-approves-moderna-covid-19-vaccine-spikevax-use-children-6-months">approved</a> the Moderna vaccine for babies and young children.</p>
<p>The vaccine has been approved for children aged six months to five years. However, we need to wait for advice from the Australian Technical Advisory Group on Immunisation (ATAGI) to provide further scientific advice and recommendations around an immunisation program. Given no vaccines are currently manufactured in Australia, we will also need to wait for availability of supply before the program can commence.</p>
<p>Australia’s approval of the Moderna vaccine for this age group follows a <a href="https://www.cdc.gov/media/releases/2022/s0618-children-vaccine.html">similar move</a> in the United States in June.</p>
<p>Here’s what parents need to know ahead of Australia’s rollout of the Moderna vaccine to these younger children, the last remaining age group to receive COVID vaccines.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/covid-19-in-babies-heres-what-to-expect-181940">COVID-19 in babies – here's what to expect</a>
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</em>
</p>
<hr>
<h2>Why vaccinate this age group?</h2>
<p>COVID case numbers are still high. So with the threat of <a href="https://theconversation.com/why-are-there-so-many-new-omicron-sub-variants-like-ba-4-and-ba-5-will-i-be-reinfected-is-the-virus-mutating-faster-182274">Omicron sub-variants</a> and other potential variants, expansion of COVID vaccines to young children will be a welcome relief for many concerned parents and families.</p>
<p>Children are less likely to have severe outcomes or complications from COVID compared with adults. However, they continue to experience <a href="https://www.health.gov.au/health-alerts/covid-19/case-numbers-and-statistics">high levels of infection</a>. This disrupts their schooling, childcare and other activities. When they are sick, their parents need to take time off work to care for them.</p>
<p>Severe disease can also happen in <a href="https://www.nature.com/articles/s41467-022-29951-9">previously healthy children</a>, and not just in children at higher risk because of underlying medical conditions.</p>
<p>While the total number of admissions to hospital from COVID infection in children is small, <a href="https://www.ncirs.org.au/covid-19-in-schools">a large proportion</a> of these have been children under five years. </p>
<p>That’s because they are more likely to need supportive care, such as observation and hydration, than older children.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/470494/original/file-20220623-51865-ah9l7b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Preschoolers playing at daycare with blocks at table" src="https://images.theconversation.com/files/470494/original/file-20220623-51865-ah9l7b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/470494/original/file-20220623-51865-ah9l7b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=443&fit=crop&dpr=1 600w, https://images.theconversation.com/files/470494/original/file-20220623-51865-ah9l7b.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=443&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/470494/original/file-20220623-51865-ah9l7b.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=443&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/470494/original/file-20220623-51865-ah9l7b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=557&fit=crop&dpr=1 754w, https://images.theconversation.com/files/470494/original/file-20220623-51865-ah9l7b.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=557&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/470494/original/file-20220623-51865-ah9l7b.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=557&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">When preschoolers are sick, they lose opportunities to learn and play with their friends.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/nursery-children-playing-teacher-classroom-1241605294">Shutterstock</a></span>
</figcaption>
</figure>
<p>Children are also at risk of a severe COVID complication known as <a href="https://theconversation.com/more-than-100-australian-kids-have-had-multisystem-inflammatory-syndrome-after-covid-what-should-parents-watch-for-183533">multi-system inflammatory syndrome</a>. This requires admission to hospital and possibly the intensive care unit. We know <a href="https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-05-19/02-COVID-Link-Gelles-508.pdf">vaccination protects</a> children from this life-threatening condition.</p>
<p>The long-term effects and implications of COVID in children are also still not fully understood. Long COVID appears to be much less common in children than in adults, occurring in <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8575095/">less than 2–3%</a> of children. So, prevention of infection in children is still a priority.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/do-kids-get-long-covid-and-how-often-a-paediatrician-looks-at-the-data-166277">Do kids get long COVID? And how often? A paediatrician looks at the data</a>
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<hr>
<h2>My child’s had COVID. Do they still need a shot?</h2>
<p>Many parents may be unsure of the benefit of vaccines if their child has already had COVID, especially if they weren’t that unwell. </p>
<p>However, the World Health Organization <a href="https://www.who.int/news/item/01-06-2022-interim-statement-on-hybrid-immunity-and-increasing-population-seroprevalence-rates">says</a> protection from vaccinating someone who has already caught COVID (known as providing hybrid immunity) is stronger than that provided by either vaccination or infection alone.</p>
<p>Importantly, hybrid immunity offers <a href="https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(22)00143-8/fulltext">superior protection</a> against severe COVID compared with infection-induced or vaccine-induced immunity alone. However, it is unclear whether this hybrid immunity will persist with new variants.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/if-ive-already-had-covid-do-i-need-a-vaccine-and-how-does-the-immune-system-respond-an-expert-explains-164236">If I've already had COVID, do I need a vaccine? And how does the immune system respond? An expert explains</a>
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<h2>The wider family and community benefit too</h2>
<p>The benefits of vaccination extend beyond direct protection. The mRNA vaccines (Moderna, Pfizer) <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2116597">reduce transmission</a> of SARS-CoV-2, the virus that causes COVID, although less so with the Omicron variant.</p>
<p>Nevertheless, the vaccines remain an important way to protect both young children and those around them.</p>
<p>They can help to ensure young kids can still go to kindergarten, play with their friends, travel and visit their grandparents.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/471745/original/file-20220630-14-3x0m57.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Grandmother cuddling young grandson, nose to cheek" src="https://images.theconversation.com/files/471745/original/file-20220630-14-3x0m57.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/471745/original/file-20220630-14-3x0m57.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/471745/original/file-20220630-14-3x0m57.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/471745/original/file-20220630-14-3x0m57.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/471745/original/file-20220630-14-3x0m57.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/471745/original/file-20220630-14-3x0m57.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/471745/original/file-20220630-14-3x0m57.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Vaccinated young children protects vulnerable people around them.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/happy-loving-family-grandmother-grandson-having-1987660103">Shutterstock</a></span>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/should-my-child-have-a-covid-vaccine-heres-what-can-happen-when-parents-disagree-174395">Should my child have a COVID vaccine? Here's what can happen when parents disagree</a>
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</em>
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<hr>
<h2>Does the vaccine work?</h2>
<p>The Moderna vaccine is available for children from six months to five years, with two doses needed to complete the course. </p>
<p>The dose is one-quarter of the adult dose (25 micrograms instead of 100 micrograms), and should be given at least four weeks apart. </p>
<p>The Moderna clinical trials demonstrated adequate vaccine effectiveness in younger infants and children. <a href="https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-06-17-18/04-COVID-Das-508.pdf">It showed</a> a 51% effectiveness against COVID infection in children between six months to two years, and 37% effectiveness in children between two and five years.</p>
<p>It’s too soon to say how much protection vaccination will protect preschoolers against multi-system inflammatory syndrome, but we do expect some protection.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/more-than-100-australian-kids-have-had-multisystem-inflammatory-syndrome-after-covid-what-should-parents-watch-for-183533">More than 100 Australian kids have had multisystem inflammatory syndrome after COVID. What should parents watch for?</a>
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<hr>
<h2>Is the vaccine safe?</h2>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/471749/original/file-20220630-22-f3ya3j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Health worker putting on bandaid on upper arm of young child after vaccination" src="https://images.theconversation.com/files/471749/original/file-20220630-22-f3ya3j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/471749/original/file-20220630-22-f3ya3j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/471749/original/file-20220630-22-f3ya3j.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/471749/original/file-20220630-22-f3ya3j.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/471749/original/file-20220630-22-f3ya3j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/471749/original/file-20220630-22-f3ya3j.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/471749/original/file-20220630-22-f3ya3j.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">The most common side effects include a painful arm, mild fever, headache and tiredness.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/doctor-puts-patch-on-childs-shoulder-2094936937">Shutterstock</a></span>
</figcaption>
</figure>
<p>Of course, we need to balance the benefits with any risks, and all vaccines have side effects. </p>
<p>In both <a href="https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-06-22-23/03-COVID-Shimabukuro-508.pdf">real-world data and clinical trials</a>, the number and rate of reports of side effects from COVID vaccines in young children are lower than for adults.</p>
<p>Most of the common and expected side effects in young children occur in the first 24–48 hours and include a fever, painful arm, headache and tiredness.</p>
<p>There were <a href="https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-06-17-18/06-COVID-Oliver-508.pdf">no serious adverse events</a> such as myocarditis (heart inflammation), anaphylaxis (life-threatening immune reaction) or multi-system inflammatory syndrome detected during the clinical trials for this age group for either vaccine.</p>
<p>There are also no currently detected longer-term safety concerns with mRNA vaccines in the paediatric age group.</p>
<p>Once the COVID vaccines are available for this age group, side effects will be monitored and documented through <a href="https://ausvaxsafety.org.au">AusVaxSafety</a> and other surveillance systems, as they have been for <a href="https://ausvaxsafety.org.au/covid-19-vaccines/pfizer-covid-19-vaccine-paediatric-formulation-5-11-years">other age groups</a>, and other childhood vaccines.</p>
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<p><em>Reliable information about COVID vaccines for children is available from the <a href="https://mvec.mcri.edu.au/references/covid-19-vaccination-in-children/">Melbourne Vaccine Education Centre</a>, the Australian <a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/who-can-get-vaccinated">department of health</a> and your child’s GP.</em></p><img src="https://counter.theconversation.com/content/185215/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Margie Danchin receives funding from Commonwealth and State Governments, NHMRC, DFAT and WHO. She is chair, Collaboration in Social Science and Immunisation (COSSI). </span></em></p><p class="fine-print"><em><span>Daryl Cheng does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>It’s natural to have questions about the risks and benefits of COVID vaccines in young children. Here’s what you need to know ahead of Australia’s rollout.Daryl Cheng, Consultant Paediatrician & Medical Lead, Melbourne Vaccine Education Centre, Murdoch Children's Research InstituteMargie Danchin, Paediatrician at the Royal Childrens Hospital and Associate Professor and Clinician Scientist, University of Melbourne and MCRI, Murdoch Children's Research InstituteLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1848092022-06-27T12:24:39Z2022-06-27T12:24:39ZShould you get a COVID-19 booster shot now or wait until fall? Two immunologists help weigh the options<figure><img src="https://images.theconversation.com/files/470339/original/file-20220622-11-hea4if.jpg?ixlib=rb-1.1.0&rect=58%2C0%2C6562%2C4312&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Clinical studies show that mixing and matching booster vaccines can lead to a more robust immune response.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/doctor-prepares-the-syringe-royalty-free-image/1379312638?adppopup=true">SDI Productions/E+ via Getty Images</a></span></figcaption></figure><p>While COVID-19 vaccines continue to be <a href="https://www.commonwealthfund.org/blog/2022/impact-us-covid-19-vaccination-efforts-march-update">highly effective</a> at preventing hospitalization and death, it has become clear that the protection offered by the current vaccines <a href="https://theconversation.com/how-long-does-protective-immunity-against-covid-19-last-after-infection-or-vaccination-two-immunologists-explain-177309">wanes over time</a>. This necessitates the use of <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html#">booster shots</a> that are safe and effective in enhancing the immune response against the virus and extending protection.</p>
<p>But when to get a first or second booster, and which shot to choose, are open questions. Many people find themselves unsure whether to wait on new, updated formulations of the COVID-19 vaccines or to mix and match combinations of the original vaccine strains. </p>
<p>SARS-CoV-2, the virus that causes COVID-19, uses <a href="https://doi.org/10.1038/s41580-021-00418-x">its knob-shaped spike protein</a> to gain entry into cells and to cause infection. Each of the existing and upcoming vaccines relies on emulating the spike protein to trigger the immune response. However, each vaccine type presents the spike protein to the immune system in different ways. </p>
<p>As <a href="https://scholar.google.com/citations?user=jJVj3sUAAAAJ&hl=en">immunologists</a> studying inflammatory and <a href="https://sc.edu/study/colleges_schools/medicine/about_the_school/faculty-staff/nagarkatti_mitzi.php">infectious diseases</a>, including COVID-19, we are interested in understanding how the COVID-19 vaccine designs differ in the type of immunity they trigger and the protection that results.</p>
<h2>New bivalent vaccines</h2>
<p>Moderna and Pfizer-BioNTech, the two companies whose mRNA vaccines have been the primary options for COVID-19 vaccination across all age groups, both have new vaccine formulations on the way. An advisory committee of the Food and Drug Administration is set to meet on June 28, 2022, to <a href="https://www.statnews.com/2022/06/25/pfizer-says-its-omicron-containing-boosters-outperform-current-vaccine/">evaluate the newest versions</a> and to decide on which are likely to be recommended for use in this fall’s booster shots.</p>
<p>Moderna’s new bivalent vaccine mixes mRNA that encodes for the spike proteins of the original SARS-CoV-2 virus as well as the slightly different spike protein of the <a href="https://www.sciencenews.org/article/covid-coronavirus-omicron-variant-mutation-infectious">more infectious omicron variant</a>. </p>
<p>In early June 2022, Moderna said that in clinical trials, <a href="https://www.npr.org/2022/06/08/1103659340/moderna-vaccine-booster-omicron">its bivalent vaccine outcompetes the original vaccine strain</a>, inducing a stronger immune response and longer protection against the original SARS-CoV-2 and <a href="https://investors.modernatx.com/news/news-details/2022/Moderna-Announces-Omicron-Containing-Bivalent-Booster-Candidate-mRNA-1273.214-Demonstrates-Superior-Antibody-Response-Against-Omicron/default.aspx">its variants, including omicron</a>. </p>
<p>Moderna later announced that its newest formulation also <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-booster-candidate-produces-strong-antibodies-against-omicron-subvariants-2022-06-22/">performs well against the newest omicron subvariants, BA.4 and BA.5</a>, which are quickly becoming the dominant strains in the U.S. Because of the significantly stronger immune response that the new shot induces, Moderna predicts that <a href="https://www.npr.org/2022/06/08/1103659340/moderna-vaccine-booster-omicron">such protection may last a year</a> and plans to <a href="https://www.cbsnews.com/news/covid-vaccine-moderna-omicron-variant-booster-shot-august/">introduce its new vaccine in August</a>. </p>
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<figcaption><span class="caption">The new Moderna booster could be available by fall 2022.</span></figcaption>
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<p>And most recently, <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-omicron-adapted-covid-19">on June 25, Pfizer-BioNTech also announced</a> results for its two new COVID-19 vaccine formulations: a bivalent formulation consisting of mRNA that encodes for the spike proteins of the original SARS-CoV-2 strain and the original BA.1 omicron subvariant, and a “monovalent” version that is only directed at the spike protein of BA.1. </p>
<p>The company’s preliminary studies demonstrated that both the monovalent and the bivalent vaccines triggered antibodies that neutralized the newer omicron BA.4 and BA.5 subvariants, although to a lesser degree than the BA.1 subvariant. However, Pfizer’s monovalent vaccine <a href="https://www.statnews.com/2022/06/25/pfizer-says-its-omicron-containing-boosters-outperform-current-vaccine/">triggered better virus-neutralizing antibodies</a> against the omicron BA.1 subvariant than did the bivalent vaccine.</p>
<p>However, whether the differences in the levels of such antibodies seen with the monovalent versus bivalent vaccines translate into different levels of protection against newer omicron variants remains to be established in clinical trials. </p>
<h2>Progress on the Novavax vaccine</h2>
<p>Another vaccine formulation that is working its way toward authorization is Novavax, a vaccine built using the spike protein of the original SARS-CoV-2 virus. The Novavax vaccine has the advantage of being <a href="https://www.science.org/content/blog-post/novavax-vaccine-finally">similar to traditional vaccines</a>, such as the <a href="https://www.cdc.gov/vaccines/hcp/vis/vis-statements/dtap.html">DTaP vaccines against diphtheria, tetanus and pertussis</a>, or the vaccines against other viral infections such as hepatitis and shingles. The Novavax vaccine has been clinically tested in South Africa, the United Kingdom and the U.S. and found to be <a href="https://doi.org/10.1056/NEJMoa2116185">safe and highly effective</a> with <a href="https://www.who.int/news-room/feature-stories/detail/the-novavax-vaccine-against-covid-19-what-you-need-to-know">90% efficacy</a> against mild, moderate and severe forms of COVID-19. </p>
<p>An advisory committee to the Food and Drug Administration <a href="https://www.science.org/content/article/fda-advisers-greenlight-novavax-covid-19-vaccine">endorsed the Novavax vaccine</a> in early June 2022. Now, the FDA is reviewing changes that Novavax made during its manufacturing process before making its decision to authorize the shot.</p>
<p>In Australia, the Novavax vaccine was recently registered provisionally as a booster for individuals aged 18 years and over. The company is <a href="https://ir.novavax.com/Novavax-Initiates-Phase-3-Trial-of-its-COVID-19-Omicron-Strain-Vaccine-as-a-Booster">performing phase 3 clinical trials</a> to determine if its vaccine can be used safely and effectively as a booster in people who have previously taken mRNA vaccines.</p>
<p>When these new vaccines become available in the coming months, people will have significantly more options for mixing and matching vaccines in order to enhance the duration and quality of their immune protection against COVID-19. </p>
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<figcaption><span class="caption">Novavax does not need to be frozen, so storage and delivery of the vaccine is much easier.</span></figcaption>
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<h2>Mixing and matching</h2>
<p>Until then, clinical studies have shown that even <a href="https://theconversation.com/a-mix-and-match-approach-to-covid-19-vaccines-could-provide-logistical-and-immunological-benefits-161974">mixing and matching</a> the existing vaccine types is an effective strategy for boosting. For example, <a href="https://covid19.nih.gov/news-and-stories/mixing-matching-covid-19-vaccine-booster-doses">recent studies</a> suggest that when adults who were fully vaccinated with any of the original three COVID-19 vaccines – Pfizer-BioNTech, Moderna or Johnson & Johnson – received a booster dose with a different vaccine brand from the one they received in their initial series, they had a similar or more robust immune response compared to boosting with the same brand of vaccine.</p>
<p>Vaccine mixing has been <a href="https://doi.org/10.1056/NEJMoa2116414">found to be safe</a> <a href="https://doi.org/10.1016/S0140-6736(21)02717-3">and effective</a> in various studies. The reason why mixing vaccines might produce a more robust immune response goes back to how each one presents the spike protein of the virus to the immune system. </p>
<p>When the SARS-CoV-2 virus mutates in regions of the spike protein, as has been the case with each of the variants and subvariants, and tries to evade the immune cells, antibodies that recognize different parts of the spike protein can stop it in its tracks and prevent the virus from infecting the body’s cells.</p>
<p>So whether you decide to get a booster shot now or wait until the fall, for many it’s heartening to know that more options are on the way.</p><img src="https://counter.theconversation.com/content/184809/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Prakash Nagarkatti receives funding from the National Institutes of Health and the National Science Foundation.</span></em></p><p class="fine-print"><em><span>Mitzi Nagarkatti receives funding from National Institutes of Health</span></em></p>On the horizon: A new omicron-focused version of the Moderna vaccine that may offer longer protection and a stronger immune response.Prakash Nagarkatti, Professor of Pathology, Microbiology and Immunology, University of South CarolinaMitzi Nagarkatti, Professor of Pathology, Microbiology and Immunology, University of South CarolinaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1850072022-06-17T18:38:51Z2022-06-17T18:38:51ZAt last, COVID-19 shots for little kids – 5 essential reads<figure><img src="https://images.theconversation.com/files/468928/original/file-20220615-24-8k5pqs.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Millions of U.S. children between the ages of 6 months and 4 years will soon be eligible for COVID-19 shots. </span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/getting-a-bandage-after-a-vaccine-royalty-free-image/1358496301?adppopup=true">FatCamera/E+ via Getty Images</a></span></figcaption></figure><p>For many parents of kids under age 5, a safe and effective COVID-19 vaccine could not come soon enough. A full year and a half after shots first became available for adults, their wait is nearly over. </p>
<p>On June 17, 2022, the Food and Drug Administration <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-covid-19-vaccines-children">authorized both the Pfizer-BioNTech and Moderna COVID-19 shots</a> for the nearly 20 million U.S. children between the ages of 6 months and 4 years. The widely anticipated decision follows <a href="https://www.statnews.com/2022/06/15/tracking-an-fda-advisory-panel-meeting-on-covid-vaccines-in-young-children/">a unanimous recommendation in favor of the shots</a> by the FDA’s independent advisory panel. </p>
<p>The remaining critical step is for the <a href="https://www.nytimes.com/2022/06/17/health/cdc-kids-vaccines.html">Centers for Disease Control and Prevention to sign off on the shots</a>, which is expected to take place within days. </p>
<p>The following collection of articles from The Conversation’s archives traces the winding path of the development of COVID-19 vaccines for the youngest children, from the early days of clinical trials to the practical challenges of how to help kids overcome their fears and anxieties over getting a shot.</p>
<h2>1. ‘Kids aren’t just littler adults’</h2>
<p>As the delta variant raged across the country in the summer of 2021, parents of kids under age 12 were anxiously awaiting the availability of a safe and effective COVID-19 shot for that age group. The FDA’s authorization for ages 5 to 11 finally came in October 2021. But that still left the preschool and younger kids waiting for their own version of the vaccine.</p>
<p>In July 2021, Judy Martin, <a href="https://www.cvr.pitt.edu/people/judy-martin-md">a professor of pediatrics</a> at the University of Pittsburgh Health Sciences, <a href="https://theconversation.com/kids-arent-just-littler-adults-heres-why-they-need-their-own-clinical-trials-for-a-covid-19-vaccine-162821">helped pull back the curtain</a> for our readers on the often mysterious and slow-going clinical research studies that must take place before vaccines are authorized for children. Martin explained how the developing brains, bodies and immune systems of infants and young children differ from those of older children, and how that is taken into account during vaccine development, clinical trials and safety assessment.</p>
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<a href="https://theconversation.com/kids-arent-just-littler-adults-heres-why-they-need-their-own-clinical-trials-for-a-covid-19-vaccine-162821">Kids aren't just littler adults – here's why they need their own clinical trials for a COVID-19 vaccine</a>
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<h2>2. So you get a shot, then what?</h2>
<p>The COVID-19 pandemic has turned a lot of once-obscure biology terms such as <a href="https://theconversation.com/what-is-mrna-the-messenger-molecule-thats-been-in-every-living-cell-for-billions-of-years-is-the-key-ingredient-in-some-covid-19-vaccines-158511">mRNA</a>, <a href="https://www.sciencenewsforstudents.org/article/explainer-what-is-a-spike-protein">spike proteins</a> and “waning antibodies” into household words. Yet for all the talk of vaccines and immunology, few people have a deep understanding of just what exactly happens once a vaccine is injected into the body. </p>
<p>One curious 12-year-old posed that very question to The Conversation: “How does a COVID-19 vaccine work in the body?” So we asked Glenn J. Rapsinski, a <a href="https://www.pediatrics.pitt.edu/people/glenn-j-rapsinski-md-phd">pediatric infectious diseases expert</a> at the University of Pittsburgh Health Sciences, <a href="https://theconversation.com/what-happens-when-the-covid-19-vaccines-enter-the-body-a-road-map-for-kids-and-grown-ups-164624">to tackle that question</a> for our <a href="https://theconversation.com/us/topics/curious-kids-us-74795">Curious Kids series</a> – at a level that young kids and adults alike can appreciate. </p>
<p>When the body encounters the molecules in a COVID-19 vaccine – which mimics the SARS-CoV-2 virus – it activates an intricate and coordinated set of cells and processes. It’s a lot like an elaborate construction zone. Some of these cells alert the body to the invader and recruit helpers, flagging the invader with signals akin to “flashing neon yellow signs.” </p>
<p>“As all of these important processes are happening inside your body, you might see some physical signs that there’s a struggle going on underneath the skin,” Rapsinski explained. “If your arm gets sore after you get the shot, it’s because immune cells like the dendritic cells, T-cells and B-cells are racing to the arm to inspect the threat.”</p>
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Read more:
<a href="https://theconversation.com/what-happens-when-the-covid-19-vaccines-enter-the-body-a-road-map-for-kids-and-grown-ups-164624">What happens when the COVID-19 vaccines enter the body – a road map for kids and grown-ups</a>
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<span class="caption">When the body encounters a perceived threat, such as an actual SARS-CoV-2 virus or a vaccine that mimics it, B-cells and T-cells spring into action alongside a sophisticated chorus of other cells.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/illustration/cells-and-t-cells-schematic-diagram-vector-royalty-free-illustration/907993572?adppopup=true">VectorMine/iStock via Getty Images Plus</a></span>
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<h2>3. Training the immune system</h2>
<p>As clinical trials of COVID-19 shots for children under age 5 crawled along in early 2022, the omicron variant gained a firm foothold in the U.S. While serious cases of COVID-19 remain relatively rare in children, hospitalizations in kids under 5 increased dramatically due to the heightened transmissibility of omicron, highlighting the urgent need for a safe vaccine in that age group.</p>
<p>Debbie-Ann Shirley, a <a href="https://uvahealth.com/findadoctor/profile/debbie-ann-shirley">pediatrician specializing in infectious diseases</a> at the University of Virginia, wrote in March 2022 about the <a href="https://theconversation.com/covid-19-vaccines-for-the-youngest-children-may-be-inching-closer-to-authorization-a-pediatrician-explains-how-theyre-being-tested-176774">painstaking process of performing clinical trials</a> sequentially for each descending age group. </p>
<p>“Several factors determine how our bodies respond to vaccines, and one of these variables is age,” Shirley explained. “Testing by age groups helps to account for these differences in how the maturing immune system responds to different types of vaccines. It is common for childhood vaccines to be given in series to help train the young immune response to make better and stronger antibody responses with each subsequent dose.” </p>
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<a href="https://theconversation.com/covid-19-vaccines-for-the-youngest-children-may-be-inching-closer-to-authorization-a-pediatrician-explains-how-theyre-being-tested-176774">COVID-19 vaccines for the youngest children may be inching closer to authorization – a pediatrician explains how they're being tested</a>
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<h2>4. The inevitable booster shot question</h2>
<p>In the fall of 2021, a mounting body of data from adults and adolescents found that immunity from COVID-19 vaccines and infections was waning over time, suggesting that booster shots would be needed – especially in the face of omicron. The same trends proved true for the 5 to 11 age group, though vaccination continued to provide strong protection against severe COVID-19 that leads to hospitalization. So in May 2022, the CDC recommended a booster dose for 5- to 11-year-olds.</p>
<p>COVID-19 shots for infants and preschoolers are expected to follow a similar trajectory; Pfizer’s COVID-19 shots for kids under age 5 are intended to be a three-dose series. Moderna’s testing of the third dose is still underway. In May 2022, Shirley provided a <a href="https://theconversation.com/how-important-is-the-covid-19-booster-shot-for-5-to-11-year-olds-5-questions-answered-183427">snapshot of those studies</a> and explained how researchers were determining that the third shots were safe and effective. </p>
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Read more:
<a href="https://theconversation.com/how-important-is-the-covid-19-booster-shot-for-5-to-11-year-olds-5-questions-answered-183427">How important is the COVID-19 booster shot for 5-to-11-year-olds? 5 questions answered</a>
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<h2>5. Helping kids overcome fear of shots</h2>
<p>While the wait for COVID-19 vaccines for young children has undoubtedly been excruciating for some parents, so might be their conversations with children who have serious anxiety over getting a shot. Lynn Gardner, an <a href="https://msm.edu/about_us/FacultyDirectory/Pediatrics/LynnGardner/index.php">associate professor of pediatrics</a> at Morehouse School of Medicine and a primary care pediatrician, has helped thousands of parents and their children cope with the very real fears that can surface in the doctor’s office.</p>
<p>Gardner wrote about <a href="https://theconversation.com/kids-afraid-of-getting-shots-here-are-3-easy-ways-for-parents-to-help-them-177025">what she calls the “Three P’s</a>” – preparation, proximity and praise – that parents and caregivers can use to lessen their children’s anxiety around shots and help them have a more positive experience. </p>
<p>“It is essential that you ask your child how they are feeling about receiving a shot,” she explained. “Giving them the opportunity to express their feelings can decrease the amount of stress and anxiety they feel about it. Validate their feelings by telling them you know needles can be a bit scary, but then reassure them that they can handle it. Explain why they’re receiving vaccines and emphasize it is for their overall good.”</p>
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Read more:
<a href="https://theconversation.com/kids-afraid-of-getting-shots-here-are-3-easy-ways-for-parents-to-help-them-177025">Kids afraid of getting shots? Here are 3 easy ways for parents to help them</a>
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<p><em>Editor’s note: This story is a roundup of articles from The Conversation’s archives.</em></p><img src="https://counter.theconversation.com/content/185007/count.gif" alt="The Conversation" width="1" height="1" />
The FDA’s authorization of COVID-19 shots for children ages 6 months to 4 years will bring relief for millions of parents. Pending CDC endorsement, shots for this group will be available within days.Amanda Mascarelli, Senior Health and Medicine EditorLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1839942022-06-01T15:33:15Z2022-06-01T15:33:15ZCOVID vaccines for children under five: what parents need to know<figure><img src="https://images.theconversation.com/files/466317/original/file-20220531-14-dy1xga.jpg?ixlib=rb-1.1.0&rect=16%2C8%2C5591%2C3725&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/portrait-adorable-little-boy-being-vaccinate-1756653812">Kamil Macniak/Shutterstock</a></span></figcaption></figure><p>Pfizer’s COVID-19 vaccine became available for children aged five to 11 in the UK <a href="https://www.england.nhs.uk/2022/04/nhs-rolls-out-covid-vaccine-to-five-million-5-to-11-year-olds/">in April 2022</a>. Those <a href="https://www.england.nhs.uk/2021/09/nhs-rolls-out-covid-19-jab-to-children-aged-12-to-15/">aged 12 and up</a> had already been eligible since 2021.</p>
<p>But if you have a child aged under five, you might be wondering, when will they be able to be vaccinated against COVID-19? Children under five represent the only age group yet to have a COVID-19 vaccine approved for use. There could be a number of <a href="https://adc.bmj.com/content/archdischild/early/2021/11/01/archdischild-2021-323040.full.pdf">reasons for this</a>, including the fact children don’t tend to be as seriously affected if they contract COVID-19, so other groups have possibly been prioritised.</p>
<p>But both Pfizer and Moderna have been testing their COVID-19 vaccines in this age group and, based on these results, it’s possible there will be one or more COVID-19 vaccines approved for young children in the coming months. </p>
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<img alt="Quarter life, a series by The Conversation" src="https://images.theconversation.com/files/451343/original/file-20220310-13-1bj6csd.png?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/451343/original/file-20220310-13-1bj6csd.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=600&fit=crop&dpr=1 600w, https://images.theconversation.com/files/451343/original/file-20220310-13-1bj6csd.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=600&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/451343/original/file-20220310-13-1bj6csd.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=600&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/451343/original/file-20220310-13-1bj6csd.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=754&fit=crop&dpr=1 754w, https://images.theconversation.com/files/451343/original/file-20220310-13-1bj6csd.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=754&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/451343/original/file-20220310-13-1bj6csd.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=754&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<p><em><strong><a href="https://theconversation.com/uk/topics/quarter-life-117947?utm_source=TCUK&utm_medium=linkback&utm_campaign=UK+YP2022&utm_content=InArticleTop">This article is part of Quarter Life</a></strong>, a series about issues affecting those of us in our twenties and thirties. From the challenges of beginning a career and taking care of our mental health, to the excitement of starting a family, adopting a pet or just making friends as an adult. The articles in this series explore the questions and bring answers as we navigate this turbulent period of life.</em></p>
<p><em>You may be interested in:</em></p>
<p><em><a href="https://theconversation.com/long-social-distancing-how-young-adults-habits-have-changed-since-covid-183837?utm_source=TCUK&utm_medium=linkback&utm_campaign=UK+YP2022&utm_content=InArticleTop">Long social distancing: how young adults’ habits have changed since COVID</a></em></p>
<p><em><a href="https://theconversation.com/my-five-year-old-is-now-eligible-for-a-covid-vaccine-should-i-get-them-immunised-180269?utm_source=TCUK&utm_medium=linkback&utm_campaign=UK+YP2022&utm_content=InArticleTop">My five-year-old is now eligible for a COVID vaccine – should I get them immunised?</a></em></p>
<p><em><a href="https://theconversation.com/five-tips-for-young-people-dealing-with-long-covid-from-a-gp-180464?utm_source=TCUK&utm_medium=linkback&utm_campaign=UK+YP2022&utm_content=InArticleTop">Five tips for young people dealing with long COVID – from a GP</a></em></p>
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<p>Pfizer/BioNTech has been trialling their vaccine in children aged six months up to five years. Children in this age group receive three doses of three micrograms each. For comparison, <a href="https://www.gov.uk/government/publications/national-protocol-for-comirnaty-10-microgramdose-covid-19-mrna-vaccine">the vaccine schedule</a> approved for five- to 11-year-olds consists of two doses of ten micrograms each, while older children and adults receive <a href="https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html">30 micrograms</a> per dose of the Pfizer vaccine.</p>
<p>In May 2022, Pfizer <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-covid-19-vaccine-demonstrates-strong-immune">released results</a> based on administering three doses to 1,678 young children. They reported the vaccine was well tolerated in this age group, with a safety profile similar to the placebo. </p>
<p>The three-dose regimen <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-provide-update-ongoing-studies-covid-19">was introduced</a> after initial studies on the two-dose regimen showed that the immune response wasn’t strong enough. The immune response is a separate, though related, measure to efficacy. It can be measured by determining the concentration of antibodies that neutralise infection, or through the cellular immune response, including the number of immune cells called T cells. Pfizer has reported that three doses generated a strong immune response.</p>
<p>Their results stated the vaccine had an efficacy of 80%, meaning those children who were vaccinated had an 80% lower risk of developing COVID-19 compared to the placebo group. The data was collected during a time when omicron was the main circulating variant. </p>
<p>While these results are encouraging, it’s important to note that they’re in the form of a press release from Pfizer with limited detail and have not yet been published in a peer-reviewed journal article.</p>
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<p>Moderna has tested its vaccine in a similar age group as part of the <a href="https://trials.modernatx.com/study/?id=mRNA-1273-P204">KidCOVE study</a>, which included roughly 2,500 children aged six months to two years, and 4,200 children aged two up to six. The regimen comprised two doses of 25 micrograms each – <a href="https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html">one-quarter of the dose</a> given to adults.</p>
<p>In March 2022, also in a <a href="https://investors.modernatx.com/news/news-details/2022/Moderna-Announces-its-COVID-19-Vaccine-Phase-23-Study-in-Children-6-Months-to-Under-6-Years-Has-Successfully-Met-Its-Primary-Endpoint/default.aspx">press release</a>, Moderna reported two doses were able to induce neutralising antibodies without any serious adverse events. Vaccine efficacy in preventing COVID-19 in children six months to two years was 43.7%, and 37.5% in the two to six age group. </p>
<p>According to Moderna, efficacy could not be measured with respect to severe illness, hospitalisation or death, as none of these events occurred in the study. Pfizer’s press release doesn’t mention whether or not its trial measured these outcomes.</p>
<p>Moderna has reportedly applied to the relevant regulatory bodies in the US and the EU for <a href="https://www.ft.com/content/48c88652-502c-4b33-9866-589eeafcf302">emergency authorisation</a> of its vaccine for this age group. Pfizer was similarly expected to request emergency authorisation in the US following the release of its results.</p>
<h2>How important is COVID-19 vaccination for young children?</h2>
<p>COVID-19 has generally been found to be <a href="https://www.who.int/publications/i/item/WHO-2019-nCoV-Sci_Brief-Children_and_adolescents-2021.1">milder in children</a> compared to adults, with significantly <a href="https://www.thelancet.com/journals/lanchi/article/PIIS2352-4642(21)00066-3/fulltext">lower mortality</a>. </p>
<p>In a study of <a href="https://journals.lww.com/pidj/Fulltext/2020/12000/Children_and_Adolescents_With_SARS_CoV_2.1.aspx">203 children</a> aged six days up to 18 years, who were infected before vaccination was available for any age group, 54.7% were asymptomatic. Symptomatic disease was found to be more likely in infants aged under one. While most of the cases were mild, of the 92 children who did develop symptoms in this study, 26% were admitted to hospital.</p>
<p>Another study found <a href="https://journals.lww.com/pidj/Fulltext/9900/COVID_19_in_Children__Correlation_Between.71.aspx">401 out of 419 children</a> with COVID-19 had mild or no symptoms.</p>
<p>However, children with COVID-19 can occasionally present with severe illness up to six to eight weeks afterwards – the rare complication referred to as “multi-system inflammatory syndrome”. The causes are not fully understood, although it may be related to altered levels of <a href="https://onlinelibrary.wiley.com/doi/10.1002/jmv.26951">inflammatory markers</a>. The condition is <a href="https://www.frontiersin.org/articles/10.3389/fped.2020.626182/full">associated with</a> myocarditis (inflammation of the heart muscle), vasculopathy (disease of the blood vessels), and can also be linked to <a href="https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.31526">hepatitis</a> (inflammation of the liver). </p>
<p>Further, some children who contract COVID-19 will continue to experience symptoms after the infection has passed, known as <a href="https://www.thelancet.com/journals/lanchi/article/PIIS2352-4642(21)00342-4/fulltext">long COVID</a>. Studies on how commonly this occurs have reported <a href="https://www.mdpi.com/2075-1729/12/2/285">mixed results</a>.</p>
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<img alt="A young girl lies in bed. An adult feels her forehead." src="https://images.theconversation.com/files/466326/original/file-20220531-26162-gyxdlu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/466326/original/file-20220531-26162-gyxdlu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/466326/original/file-20220531-26162-gyxdlu.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/466326/original/file-20220531-26162-gyxdlu.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/466326/original/file-20220531-26162-gyxdlu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/466326/original/file-20220531-26162-gyxdlu.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/466326/original/file-20220531-26162-gyxdlu.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">COVID-19 is generally more mild in children.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/woman-checking-temperature-hand-little-ill-1820118677">Rido/Shutterstock</a></span>
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<h2>Where to from here?</h2>
<p>In the UK, COVID-19 vaccination rates are fairly low in the five to 12 age group. The data for England show recent <a href="https://coronavirus.data.gov.uk/details/vaccinations?areaType=nation&areaName=England">uptake just above 8%</a>, suggesting there’s a reluctance to have children vaccinated. It’s important we understand and address the source of this reluctance. Possible reasons may include concerns around the vaccine, or the perception that children are not severely affected by COVID-19.</p>
<p>While for the most part the latter is true, we know some children are affected more seriously. There is therefore a basis for vaccinating children even as young as six months to reduce the risks of infection. </p>
<p>Although there were no serious adverse events reported in Pfizer’s or Moderna’s trials, we have seen serious incidents <a href="https://www.ejcrim.com/index.php/EJCRIM/article/view/2681/2722">such as myocarditis</a> reported on occasion in older age groups. So it is possible that as more young children are vaccinated, we would see rare instances of serious side effects. </p>
<p>That said, the mRNA vaccines have a good safety profile. The fact that there could be a low risk of adverse events from the vaccine should not deter parents from vaccinating when compared with the risks of illness, hospitalisation and complications such as multi-system inflammatory syndrome due to the virus itself.</p>
<p>One <a href="https://www.thelancet.com/action/showPdf?pii=S2352-4642%2822%2900100-6">Danish study</a> found the incidence of multi-system inflammatory syndrome in unvaccinated children to be one in 3,400, compared with one in 9,900 in vaccinated children.</p>
<p>Vaccinating younger children could also limit community spread of COVID-19, although the extent to which children contribute to <a href="https://www.science.org/doi/10.1126/science.abj2042?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed">transmission of the virus</a> has been subject to debate.</p>
<p>Before we can start vaccinating the youngest children, we will need to wait for peer-reviewed data to confirm safety and efficacy, and for approval from the relevant regulatory bodies. But we may see this fairly soon.</p><img src="https://counter.theconversation.com/content/183994/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Tara Hurst does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Pfizer and Moderna have both recently reported results for their COVID-19 vaccines in the youngest children.Tara Hurst, Lecturer, Biomedical Science, Birmingham City UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1834272022-05-26T12:27:33Z2022-05-26T12:27:33ZHow important is the COVID-19 booster shot for 5-to-11-year-olds? 5 questions answered<figure><img src="https://images.theconversation.com/files/464830/original/file-20220523-16-fzudrg.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">About 8 million U.S. children have received two shots of COVID-19 vaccine and are now eligible for a third.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/young-girl-watching-her-being-injected-with-covid-royalty-free-image/1339290664?adppopup=true">KoldoyChris/Moment via Getty Images</a></span></figcaption></figure><p><em>COVID-19 case numbers are rising again in the U.S. – including <a href="https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-state-level-data-report/">among children</a>. In mid-May 2022, the Food and Drug Administration authorized a booster shot of the COVID-19 vaccine for <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-expands-eligibility-pfizer-biontech-covid-19-vaccine-booster-dose">U.S. children ages 5 to 11</a>, and the Centers for Disease Control and Prevention followed by <a href="https://www.cdc.gov/media/releases/2022/s0519-covid-booster-acip.html#">recommending a booster shot</a> for this age group.</em> </p>
<p><em>Naturally, many parents are wondering about the importance and safety of a booster shot for their school-age children. <a href="https://uvahealth.com/findadoctor/profile/debbie-ann-shirley">Debbie-Ann Shirley</a>, a <a href="https://scholar.google.com/citations?user=M6zP_sMAAAAJ&hl=en">pediatric infectious disease specialist</a> at the University of Virginia, answers some common questions about COVID-19 and booster shots in kids that she hears in her practice and explains the research behind why booster shots are recommended for children ages 5 to 11.</em> </p>
<h2>1. How important is a booster shot for children?</h2>
<p>COVID-19 is generally milder in children than adults, but severe disease can occur.
As of late May 2022, more than 15,000 children ages 5 to 11 <a href="https://www.cdc.gov/media/releases/2022/s0519-covid-booster-acip.html#">have been hospitalized</a> with COVID-19 and <a href="https://data.cdc.gov/d/3apk-4u4f/visualization">180 children</a> have died. During the height of the recent winter surge of <a href="https://theconversation.com/will-omicron-the-new-coronavirus-variant-of-concern-be-more-contagious-than-delta-a-virus-evolution-expert-explains-what-researchers-know-and-what-they-dont-169020">the highly transmissible omicron variant</a>, 87% of the children in the 5-to-11 age group <a href="https://www.cdc.gov/mmwr/volumes/71/wr/mm7116e1.htm?s_cid=mm7116e1_w">who became hospitalized with COVID-19 were unvaccinated</a>. </p>
<p>In addition, the rare but serious condition that can follow in the weeks after COVID-19 infection, known as <a href="https://www.cdc.gov/mis/mis-c.html">Multisystem Inflammatory Syndrome in Children</a>, or MIS-C, most commonly occurs among children ages 5 to 11. Over <a href="https://covid.cdc.gov/covid-data-tracker/#mis-national-surveillance">3,800 cases of MIS-C have been reported</a> in that 5-to-11 age group, and <a href="https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-05-19/06-COVID-Oliver-508.pdf">93% of the children</a> who developed this complication were unvaccinated. </p>
<p>For some vaccines – including those for COVID-19 – effectiveness wanes over time. <a href="https://theconversation.com/why-its-normal-for-covid-19-vaccine-immunity-to-wane-and-how-booster-shots-can-help-171786">Booster shots</a> help to bolster the immune response. Several <a href="https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html#note-dtap">childhood vaccines</a>, such as the tetanus and diphtheria vaccines, require booster shots. </p>
<p>COVID-19 boosters have been shown to improve waning protection <a href="https://www.cdc.gov/mmwr/volumes/71/wr/mm7109e3.htm?s_cid=mm7109e3_w">in adolescents</a> and <a href="https://doi.org/10.1001/jama.2022.0470">adults</a>. Side effects are similar to those reported with the initial series. The risk of myocarditis, or heart inflammation – a rare side effect that can occur following COVID-19 vaccination – seems to be less after a third dose than <a href="https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-05-19/06-COVID-Oliver-508.pdf">after the second</a>. </p>
<h2>2. How well is immunity holding up from the initial COVID-19 shots?</h2>
<p>When administered to children 5 to 11 years old, the Pfizer-BioNTech vaccine generated levels of antibody response similar to that in 16-to-25-year-olds in <a href="https://doi.org/10.1056/NEJMoa2116298">a clinical trial</a>, which was the basis for the <a href="https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use-children-5-through-11-years-age">FDA’s initial authorization of the shots</a> in October 2021. But <a href="https://doi.org/10.1001/jama.2022.7493">studies after the shots were authorized</a> found that <a href="https://doi.org/10.1001/jama.2022.7319">vaccine effectiveness rapidly waned</a> in the 5-to-11 age group during the omicron surge. Despite that, the shots continued to be <a href="https://www.cdc.gov/mmwr/volumes/71/wr/mm7109e3.htm?s_cid=mm7109e3_w">protective against severe disease and hospitalization</a>. </p>
<p>Vaccination has also <a href="https://www.cdc.gov/mmwr/volumes/71/wr/mm7102e1.htm#">been shown to be be highly protective</a> against Multisystem Inflammatory Syndrome in Children.</p>
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<figcaption><span class="caption">How to talk to kids about getting vaccinated.</span></figcaption>
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<h2>3. Does a third dose make a difference in children?</h2>
<p>In a clinical trial, researchers tested the Pfizer vaccine in children 5 to 11 using a 10-microgram booster dose, which is the same dose children received for the primary series and is one-third the dose used for adolescents and adults. When tested among 401 children, <a href="https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-05-19/05-COVID-Sabharwal-508.pdf">no new safety concerns arose</a>, and in the smaller subset of children in which the immune response was tested, the third shot <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-data-demonstrating-high-immune">significantly increased antibody responses</a>, including against the omicron variant. Hence, a third dose seems beneficial for boosting immunity in this age group, similar to older age groups. </p>
<p>The booster dose can be given <a href="https://www.cdc.gov/media/releases/2022/s0519-covid-booster-acip.html#">five months or more</a> after the second shot. But as of late May 2022, fewer than <a href="https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-vaccination-trends/#">one-third</a> of children ages 5 to 11 had received two shots, meaning that only <a href="https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-vaccination-trends/">about 8 million</a> school-age children were eligible to start receiving the booster. This could prove an important layer of protection for them and <a href="https://cai.burbio.com/school-opening-tracker/">help limit disruptions</a> on schooling and summer activities, particularly as <a href="https://www.nytimes.com/explain/2022/03/01/us/mask-mandates-us">mask mandates have gone by the wayside</a>.</p>
<p>Children with <a href="https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html#immunocompromised">weakened immune systems</a> who were at first authorized to receive three initial doses of COVID-19 vaccine may now also receive a booster shot – or a fourth dose – <a href="https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html#immunocompromised">as soon as three months</a> after their third dose.</p>
<h2>4. Is the COVID-19 vaccine safe for kids?</h2>
<p>As of late May 2022, more than <a href="https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total">18.5 million</a> doses of the COVID-19 vaccine had been administered to children in the 5-to-11 age group. Most <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm705152a1.htm?s_cid=mm705152a1_w">COVID-19 vaccine side effects</a> – such as pain at the injection site – have been mild and short-lived in children. Fatigue, headache and muscle aches are other common side effects. </p>
<p>Reports suggest that most cases of myocarditis that follow vaccination typically <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myocarditis.html">improve quickly with medicine and rest</a>. Rates of myocarditis <a href="https://www.cdc.gov/mmwr/volumes/71/wr/mm7114e1.htm?s_cid=mm7114e1_w">have been lower</a> in children ages 5 to 11 than in teens. In any age group, myocarditis is more likely to occur <a href="https://www.cdc.gov/mmwr/volumes/71/wr/mm7114e1.htm?s_cid=mm7114e1_w">after infection</a> than vaccination. </p>
<h2>5. What about the kids under 5?</h2>
<p>For parents of kids ages 6 months to 5 years, COVID-19 vaccines are also finally within sight. On May 23, 2022, Pfizer <a href="https://investors.pfizer.com/Investors/News/news-details/2022/Pfizer-BioNTech-COVID-19-Vaccine-Demonstrates-Strong-Immune-Response-High-Efficacy-and-Favorable-Safety-in-Children-6-Months-to-Under-5-Years-of-Age-Following-Third-Dose/default.aspx">released new data for this age group</a>, stating that three shots generated strong antibody responses, were well tolerated with no new safety concerns and, based on preliminary data, the series was 80% effective at preventing COVID-19 infection. In late April 2022, <a href="https://investors.modernatx.com/news/news-details/2022/Moderna-Files-for-Authorization-of-Its-COVID-19-Vaccine-in-Young-Children-Six-Months-to-Under-Six-Years-of-Age/default.aspx">Moderna</a> released similar data showing that two doses of its vaccine stimulated good antibody responses and were tolerated well by kids under age 6.</p>
<p>The FDA is <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-announces-tentative-advisory-committee-meeting-schedule-regarding">set to meet in June 2022</a> to discuss new low-dose formulations of the <a href="https://investors.modernatx.com/news/news-details/2022/Moderna-Files-for-Authorization-of-Its-COVID-19-Vaccine-in-Young-Children-Six-Months-to-Under-Six-Years-of-Age/default.aspx">Moderna</a> and <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-provide-update-rolling-submission">Pfizer</a> vaccines for this group. </p>
<p>If it is authorized by the FDA, the CDC will then provide recommendations on its use for the more than 20 million children ages 6 months to 5 years in the U.S.</p><img src="https://counter.theconversation.com/content/183427/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Debbie-Ann Shirley does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The COVID-19 vaccines continue to be effective against severe illness leading to hospitalization and death in all age groups, including children ages 5 to 11.Debbie-Ann Shirley, Associate Professor of Pediatrics, University of VirginiaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1767742022-03-30T12:39:53Z2022-03-30T12:39:53ZCOVID-19 vaccines for the youngest children may be inching closer to authorization – a pediatrician explains how they’re being tested<figure><img src="https://images.theconversation.com/files/451453/original/file-20220310-13-cntwts.jpg?ixlib=rb-1.1.0&rect=0%2C34%2C7633%2C4715&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Millions of U.S. children ages 5-11 have already received at least one dose of the COVID-19 vaccine.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/year-old-max-lahoda-receives-his-shot-from-shirley-alfonso-news-photo/1236345904?adppopup=true">Keith Birmingham/MediaNews Group/Pasadena Star-News via Getty Images</a></span></figcaption></figure><p>For some parents of young children, the wait for COVID-19 vaccines has been long and agonizing. </p>
<p>Throughout 2021, vaccines against COVID-19 emerged as the most effective way to prevent severe forms of the disease. Vaccines are <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html">currently recommended</a> for everyone 5 years and older in the United States but are not yet available for younger age groups. Though more rare in young children, <a href="https://doi.org/10.1001/jamanetworkopen.2021.5298">severe disease</a> leading to <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm705152a3.htm?s_cid=mm705152a3_w">hospitalization</a> and <a href="https://covid.cdc.gov/covid-data-tracker/?ACSTrackingID=USCDC_2145-DM67940&ACSTrackingLabel=10.15.2021%20-%20COVID-19%20Data%20Tracker%20Weekly%20Review&deliveryName=USCDC_2145-DM67940#demographics">even death</a> from COVID-19 can occur. </p>
<p>Recent U.S. <a href="https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html">rates of COVID-19-associated hospitalization</a> in those under 5 have been the highest on record, as a result of the surge in cases from <a href="https://theconversation.com/will-omicron-the-new-coronavirus-variant-of-concern-be-more-contagious-than-delta-a-virus-evolution-expert-explains-what-researchers-know-and-what-they-dont-169020">the highly transmissible omicron variant</a>. Hospitalizations escalated to 14.8 per 100,000 people during January 2022, <a href="https://www.cdc.gov/mmwr/volumes/71/wr/mm7111e2.htm?s_cid=mm7111e2_e&ACSTrackingID=USCDC_921-DM77802&ACSTrackingLabel=MMWR%20Early%20Release%20-%20Vol.%2071%2C%20March%2015%2C%202022&deliveryName=USCDC_921-DM77802">five times higher</a> than during the delta variant surge in September 2021. Safe and effective vaccines for young children offer the prospect of protection as well as limitation to disruptions in child care and early childhood educational opportunities. </p>
<p>As a <a href="https://uvahealth.com/findadoctor/profile/debbie-ann-shirley">pediatrician specializing in infectious diseases</a>, I have cared for many children with COVID-19 at our medical center. I have also had the opportunity to frequently spend time talking with parents about how to make the best choices to protect their young children from COVID-19. </p>
<p>Here’s the latest on the clinical trials and formal review process for vaccines for this important group of patients.</p>
<h2>COVID-19 vaccine timeline for the youngest children</h2>
<p>On March 23, 2022, Moderna released <a href="https://investors.modernatx.com/news/news-details/2022/Moderna-Announces-its-COVID-19-Vaccine-Phase-23-Study-in-Children-6-Months-to-Under-6-Years-Has-Successfully-Met-Its-Primary-Endpoint/default.aspx">interim results</a> of its trial for young children, which included enrollment of 6,700 children in the 6 month to under 6 year age group. Moderna administered the vaccine as two doses in children, giving the kids in this age group one-fourth the adult dose. </p>
<p>The company reported robust antibody responses comparable to what they saw in young adults between 18 and 25 years old. During the omicron surge, however, efficacy against infection was 44% in children 6 months to under 2 years and 38% in children between 2 and 6, the company said. On the same day, Moderna announced it is moving ahead with <a href="https://www.nytimes.com/2022/03/23/us/politics/moderna-coronavirus-vaccine-young-children.html">seeking emergency use authorization</a> from the Food and Drug Administration for use of the vaccine.</p>
<p>Shortly before, during the height of the omicron surge, Pfizer-BioNTech, the company whose COVID-19 vaccine is the only one currently available for U.S. children and adolescents over 5 years, applied to the FDA to expand <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-initiate-rolling-submission-emergency">emergency use authorization</a> of its COVID-19 vaccine for use in children under age 5. The kids in this part of their trial were given one-tenth the dose given to adults and teens.</p>
<p>Pfizer <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-provide-update-ongoing-studies-covid-19">had previously announced</a> that while two shots of this low dose of its vaccine generated antibody responses comparable to older groups in children ages 6 months to 2 years, adequate antibody responses did not develop in children ages 2 to 5 years. A three-dose series for all young children is now being tested. The <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-provide-update-rolling-submission">FDA has deferred</a> its review of Pfizer’s emergency use authorization request until the third-dose data is available, which is expected in early April.</p>
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<figcaption><span class="caption">Vaccine advice for parents of children under age 5.</span></figcaption>
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<h2>COVID-19 vaccines for young immune systems</h2>
<p>COVID-19 vaccines have proved highly effective in the prevention of <a href="https://www.cdc.gov/mmwr/volumes/71/wr/mm7104e3.htm">severe COVID-19 in adults</a> and <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7042e1.htm?s_cid=mm7042e1_w">older children</a>. </p>
<p>Prior to use, all vaccines go through rigorous testing in clinical trials, first in adults and then <a href="https://theconversation.com/kids-arent-just-littler-adults-heres-why-they-need-their-own-clinical-trials-for-a-covid-19-vaccine-162821">in children</a>, recognizing that there may be biological differences in immune response for different age groups. Going down sequentially in age allows investigators and regulators to evaluate the optimal dose with the least number of side effects.</p>
<p>Both Moderna and Pfizer have tested their vaccines by age groups. The ongoing Pfizer trial for those under 12 years began in March 2021, following evaluation in <a href="https://doi.org/10.1056/NEJMoa2034577">adults and older teens</a> and then <a href="https://doi.org/10.1056/NEJMoa2107456">12- to 15-year-olds</a>, for example. <a href="https://doi.org/10.1056/NEJMoa2116298">Children 5 to 11</a> next received one-third the dose given to adults and teens as two doses, which produced similarly high levels of protective antibody responses compared to 16-to-25-year-olds. Based on the robust immune response and safety established in this trial, the FDA expanded its <a href="https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use-children-5-through-11-years-age">emergency use authorization for children 5 to 11</a> in October 2021.</p>
<p>However, more recent work, including a <a href="https://doi.org/10.1101/2022.02.25.22271454">study that is not yet peer-reviewed</a>, suggests waning vaccine effectiveness during the omicron variant surge, with more pronounced decline over time in children ages 5 to 11. Reassuringly, protection against hospitalization remained strong, and boosters <a href="https://www.cdc.gov/mmwr/volumes/71/wr/mm7109e3.htm?s_cid=mm7109e3_w">improved protection</a> among eligible older teens. Pfizer and Moderna are planning to evaluate booster doses in children. Optimization of doses and intervals in all age groups may help maintain higher levels of protection in the face of the omicron variant. </p>
<h2>How immune responses may differ in children by age</h2>
<p>Vaccines work by <a href="https://theconversation.com/what-happens-when-the-covid-19-vaccines-enter-the-body-a-road-map-for-kids-and-grown-ups-164624">teaching the immune system</a> <a href="https://theconversation.com/how-long-does-protective-immunity-against-covid-19-last-after-infection-or-vaccination-two-immunologists-explain-177309">to make disease-fighting antibodies</a>. Several factors determine how our bodies respond to vaccines, and one of these variables is age. Vaccine responses in particular may differ in <a href="https://doi.org/10.1038/s41577-020-00479-7">the very young</a> when immune systems may have less memory.</p>
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<p>Testing by age groups helps to account for these differences in how the <a href="https://theconversation.com/why-vaccine-doses-differ-for-babies-kids-teens-and-adults-an-immunologist-explains-how-your-immune-system-changes-as-you-mature-168708">maturing immune system</a> responds to different types of vaccines. It is common for <a href="https://www.cdc.gov/vaccines/schedules/easy-to-read/child-easyread.html">childhood vaccines</a> to be given in series to help train the young immune response to make better and stronger antibody responses with each subsequent dose. </p>
<h2>Vaccine safety</h2>
<p>Trials also evaluate vaccine reactions by age. Most COVID-19 vaccine side effects have been mild and short-lived, such as pain at the injection site. <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-provide-update-rolling-submission">Pfizer</a> and <a href="https://investors.modernatx.com/news/news-details/2022/Moderna-Announces-its-COVID-19-Vaccine-Phase-23-Study-in-Children-6-Months-to-Under-6-Years-Has-Successfully-Met-Its-Primary-Endpoint/default.aspx">Moderna</a> both report that their COVID-19 vaccines are similarly well-tolerated in the youngest age groups. Moderna reports the frequency of fever in keeping with other pediatric vaccines.</p>
<p>Even after trials are complete and vaccines are authorized or approved, safety monitoring continues. This allows even very rare side effects to be detected. One such example is that of <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myocarditis.html">myocarditis</a>, or inflammation of the heart, which can occur in rare cases following COVID-19 vaccination. Reports indicate that these cases typically responded well to supportive care and resolved rapidly. </p>
<p><a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm705152a1.htm?s_cid=mm705152a1_w">Few adverse events</a> were reported among nearly 8 million vaccine doses given in those age 5 to 11, indicating even lower rates in this age group compared to in ages <a href="https://doi.org/10.1001/jama.2021.24110">12 and above</a>. <a href="https://doi.org/10.1016/j.amjcard.2021.03.019">Outside of infancy</a>, when babies may be born with congenital heart problems, myocarditis is generally uncommon in younger age groups, so it may prove to be rare following vaccination in young children.</p>
<h2>Looking ahead</h2>
<p>If the FDA grants emergency use authorization of a COVID-19 shot for children under 5 years of age following its upcoming review, it will clear the way for the vaccine to be <a href="https://www.whitehouse.gov/covidplan/">distributed nationwide</a>. The next step will be for the Centers for Disease Control and Prevention to endorse its use for the 18 million U.S. children in this age group – a decision that has usually come within days of FDA authorization for COVID-19 vaccines.</p>
<p>Young infants under the age of 6 months are not currently included in the vaccine clinical trials, but antibodies produced by mothers from <a href="https://www.cdc.gov/mmwr/volumes/71/wr/mm7107e3.htm?s_cid=mm7107e3_x">vaccination in pregnancy</a> can be passed on through the placenta to provide protection from COVID-19 during the first few months of life.</p><img src="https://counter.theconversation.com/content/176774/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Debbie-Ann Shirley does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Moderna will ask the FDA to allow emergency use for its vaccine in children as young as 6 months, a step many parents have been anticipating.Debbie-Ann Shirley, Associate Professor of Pediatrics, University of VirginiaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1790602022-03-17T12:10:24Z2022-03-17T12:10:24ZHow does the immune system mobilize in response to a COVID-19 infection or a vaccine? 5 essential reads<figure><img src="https://images.theconversation.com/files/452348/original/file-20220316-16-12d1gnq.jpg?ixlib=rb-1.1.0&rect=231%2C52%2C6774%2C4810&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The COVID-19 pandemic has taught most people more than they ever expected to know about immunology.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/coronavirus-structural-morphology-royalty-free-image/1215480593">Membio/iStock via Getty Images Plus</a></span></figcaption></figure><p>Heading into the third year of the COVID-19 pandemic, many of us have become amateur immunologists, having conversations at the dinner table and in the grocery store aisle about <a href="https://theconversation.com/how-mrna-vaccines-from-pfizer-and-moderna-work-why-theyre-a-breakthrough-and-why-they-need-to-be-kept-so-cold-150238">mRNA vaccines</a>, <a href="https://theconversation.com/will-omicron-the-new-coronavirus-variant-of-concern-be-more-contagious-than-delta-a-virus-evolution-expert-explains-what-researchers-know-and-what-they-dont-169020">variants</a>, <a href="https://theconversation.com/what-is-a-breakthrough-infection-6-questions-answered-about-catching-covid-19-after-vaccination-164909">breakthrough infections</a>, <a href="https://theconversation.com/how-long-does-protective-immunity-against-covid-19-last-after-infection-or-vaccination-two-immunologists-explain-177309">“waning” immunity</a>, <a href="https://theconversation.com/what-is-herd-immunity-a-public-health-expert-and-a-medical-laboratory-scientist-explain-170520">herd immunity</a>, <a href="https://theconversation.com/is-covid-19-here-to-stay-a-team-of-biologists-explains-what-it-means-for-a-virus-to-become-endemic-168462">endemic viruses</a>, <a href="https://theconversation.com/tense-decision-making-as-cdc-joins-fda-in-recommending-pfizer-booster-shot-for-65-and-up-people-at-high-risk-and-those-with-occupational-exposure-to-covid-19-168703">booster shots</a> and much more. </p>
<p>Many of the stories that we’ve published over the past two years here at The Conversation have stemmed from our own head-scratching questions that came up in our morning news meetings or were posed to us directly by curious readers. We sought out scholars who could take our readers on deep dives into immunology and virology to help demystify these sometimes confusing, conflicting and taxing science-based questions.</p>
<p>Here are five stories from The Conversation’s archives that highlight critical insights that we as editors and readers have gained thanks to COVID-19, and that will no doubt continue to be an important part of our pandemic lexicon. </p>
<h2>1. COVID-19 vaccines explained</h2>
<p>Understanding how vaccines can “trick” the body into mounting an effective immune response against a perceived or actual threat is one of the most fascinating aspects of immunology. “The most important thing to understand about vaccines is that they <a href="https://theconversation.com/what-happens-when-the-covid-19-vaccines-enter-the-body-a-road-map-for-kids-and-grown-ups-164624">teach your body how to gear up to fight an infection</a>, without your body having to deal with the infection itself,” writes <a href="https://scholar.google.com/citations?user=YpknwWcAAAAJ&hl=en">Glenn J. Rapsinski</a>, a pediatric infectious diseases fellow at the University of Pittsburgh Health Sciences. “In this way, vaccines help your body be prepared for invasions by germs that could otherwise make you very sick.”</p>
<p>Rapsinski explains how the COVID-19 vaccines available in the U.S. emulate the spike protein of SARS-CoV-2, the virus that causes COVID-19. “SARS-CoV-2 is a round virus, with bumps all over it – sort of like a baseball covered in golf tees. The bumps are the spike proteins.”</p>
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<a href="https://theconversation.com/what-happens-when-the-covid-19-vaccines-enter-the-body-a-road-map-for-kids-and-grown-ups-164624">What happens when the COVID-19 vaccines enter the body – a road map for kids and grown-ups</a>
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<figcaption><span class="caption">How mRNA COVID-19 vaccines work.</span></figcaption>
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<h2>2. And then came breakthrough infections</h2>
<p>Soon after the relief that came with the widespread availability of vaccines in the spring of 2021, we were introduced to the idea of “breakthrough infections,” which were the rare cases in which fully vaccinated people got infected with COVID-19. </p>
<p>“<a href="https://theconversation.com/what-is-a-breakthrough-infection-6-questions-answered-about-catching-covid-19-after-vaccination-164909">Breakthrough infections</a> are a little more frequent than previously expected and are probably increasing because of growing dominance of the delta variant,” <a href="https://scholar.google.com/citations?user=F8vQ9xIAAAAJ&hl=en">Sanjay Mishra</a>, a cancer and vaccine researcher from Vanderbilt University, wrote in July 2021. “But infections in vaccinated people are still very rare and usually cause mild or no symptoms.” </p>
<p>Although breakthrough infections became far more common late in 2021, in part because of the emergence of the highly transmissible omicron variant – more on that down below – COVID-19 vaccines still continue to provide robust protection against the most severe forms of COVID-19 that lead to hospitalization and death.</p>
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<a href="https://theconversation.com/what-is-a-breakthrough-infection-6-questions-answered-about-catching-covid-19-after-vaccination-164909">What is a breakthrough infection? 6 questions answered about catching COVID-19 after vaccination</a>
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<h2>3. The growing list of variants</h2>
<p>In 2020 and 2021, new strains of SARS-CoV-2 seemed to emerge faster than people could keep up with their Greek names. But by mid-2021, the highly transmissible delta variant had become the dominant strain in the U.S. and was responsible for the growing number of breakthrough infections. The continual emergence of variants was and is concerning, because it raises questions about how robust one’s immune protection will be from prior infections or from the COVID-19 vaccines, which were based on the original strain of the virus. </p>
<p>The delta variant was between 40% and 60% more transmissible than the alpha variant that it replaced and nearly <a href="https://theconversation.com/will-omicron-the-new-coronavirus-variant-of-concern-be-more-contagious-than-delta-a-virus-evolution-expert-explains-what-researchers-know-and-what-they-dont-169020">twice as transmissible as the original SARS-CoV-2</a> virus, wrote <a href="https://scholar.google.com/citations?user=dqahf8oAAAAJ&hl=en">Suresh V. Kuchipudi</a>, a professor of emerging infectious diseases at Penn State. </p>
<p>But then, of course, came omicron, which was even more contagious than delta, thanks in part to its high number of mutations. “Omicron is very unusual in that it is by far the most heavily mutated variant yet of SARS-CoV-2, the virus that causes COVID-19,” Kuchipudi explained. “The omicron variant has 50 mutations overall, with 32 mutations on the spike protein alone. The spike protein – which forms protruding knobs on the outside of the SARS-CoV-2 virus – helps the virus adhere to cells so that it can gain entry.”</p>
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Read more:
<a href="https://theconversation.com/will-omicron-the-new-coronavirus-variant-of-concern-be-more-contagious-than-delta-a-virus-evolution-expert-explains-what-researchers-know-and-what-they-dont-169020">Will omicron – the new coronavirus variant of concern – be more contagious than delta? A virus evolution expert explains what researchers know and what they don't</a>
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<h2>4. Putting ‘endemic’ viruses into context</h2>
<p>At some point in 2021 – the year is one big blur – we entered a phase of the pandemic where it became clear that we were stuck with COVID-19 for the foreseeable future. For many people, there was a mental shift from the assumption that we could eradicate the coronavirus that causes COVID-19 through vaccination, into the slow realization that it just wasn’t going away. Virologists and other researchers began using the term “endemic” to describe the way that some viruses can fade away but still maintain a low level of transmission in a community. </p>
<p><a href="https://scholar.google.com/citations?user=XY7DNtgAAAAJ&hl=en">Sara Sawyer</a>, <a href="https://experts.colorado.edu/display/fisid_166880">Arturo Barbachano-Guerrero</a> and <a href="https://scholar.google.com/citations?user=l2lpnYkAAAAJ&hl=en">Cody Warren</a>, a team of virologists and immunologists <a href="https://theconversation.com/is-covid-19-here-to-stay-a-team-of-biologists-explains-what-it-means-for-a-virus-to-become-endemic-168462">from the University of Colorado Boulder explain</a> that SARS-CoV, the coronavirus that set off the SARS pandemic in 2003, was less contagious than SARS-CoV-2 and was brought under control relatively quickly by speedy public health measures that ultimately drove the virus extinct. </p>
<p>On the other hand, they wrote, “pandemic viruses may also gradually settle into a relatively stable rate of occurrence, maintaining a constant pool of infected hosts capable of spreading the virus to others.” Such viruses are said to be “endemic” – as will likely become the case with the coronavirus that causes COVID-19.</p>
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Read more:
<a href="https://theconversation.com/is-covid-19-here-to-stay-a-team-of-biologists-explains-what-it-means-for-a-virus-to-become-endemic-168462">Is COVID-19 here to stay? A team of biologists explains what it means for a virus to become endemic</a>
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<h2>5. Immune defenses shift over time</h2>
<p>As 2021 waned, so – apparently – did protective antibodies against COVID-19. Researchers began to learn more about how the immune response shifts in the months following COVID-19 infection or vaccination. And it became clear that over time, people became more vulnerable to getting reinfected or having a breakthrough infection following vaccination – in part because of the emergence of variants.</p>
<p>But antibodies are only <a href="https://theconversation.com/how-long-does-protective-immunity-against-covid-19-last-after-infection-or-vaccination-two-immunologists-explain-177309">part of the immune system’s protective defense</a>, explain <a href="https://scholar.google.com/citations?user=jJVj3sUAAAAJ&hl=en">Prakash Nagarkatti</a> and <a href="https://scholar.google.com/citations?user=af7TahQAAAAJ&hl=en">Mitzi Nagarkatti</a>, a husband-and-wife team of immunologists from the University of South Carolina. </p>
<p>“Throughout the COVID-19 pandemic, the public has widely and mistakenly believed that antibodies provide the bulk of protective immunity, while not recognizing the important role of killer T cells,” they write. “This is in part because antibodies are easy to detect, whereas killer T-cell detection is complex and involves advanced technology. When antibodies fail, it is the killer T cells that are responsible for preventing the more severe outcomes of COVID-19, such as hospitalization and death.”</p>
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Read more:
<a href="https://theconversation.com/how-long-does-protective-immunity-against-covid-19-last-after-infection-or-vaccination-two-immunologists-explain-177309">How long does protective immunity against COVID-19 last after infection or vaccination? Two immunologists explain</a>
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<p><em>Editor’s note: This story is a roundup of articles from The Conversation’s archives.</em></p><img src="https://counter.theconversation.com/content/179060/count.gif" alt="The Conversation" width="1" height="1" />
The COVID-19 pandemic has brought immunology terms that are typically relegated to textbooks into our everyday vernacular. These stories helped us make sense of the ever-evolving science.Amanda Mascarelli, Senior Health and Medicine EditorLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1774162022-02-28T22:32:22Z2022-02-28T22:32:22ZA South African company addresses vaccine supply inequity, despite Canada’s lack of support<figure><img src="https://images.theconversation.com/files/448942/original/file-20220228-27-6k9j7.jpg?ixlib=rb-1.1.0&rect=0%2C11%2C3894%2C2510&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">South Africans wait for access to a COVID-19 vaccine.</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><iframe style="width: 100%; height: 175px; border: none; position: relative; z-index: 1;" allowtransparency="" src="https://narrations.ad-auris.com/widget/the-conversation-canada/a-south-african-company-addresses-vaccine-supply-inequity--despite-canada-s-lack-of-support" width="100%" height="400"></iframe>
<p>Since late 2020, <a href="https://doi.org/10.1136/bmj.n2027">the inequitable access across the globe to COVID-19 vaccines has been a glaring problem</a>. But a remarkable achievement earlier this month offers hope that the supply of vaccines to developing countries will improve: Afrigen Biologics, a South African based company, produced its <a href="https://doi.org/10.1038/d41586-022-00293-2">own version</a> of Moderna’s mRNA COVID-19 vaccine. This was achieved with no support from Moderna or Pfizer-BioNTech, the manufacturer of the other mRNA vaccine.</p>
<p>What many don’t realize is that two Canadian companies control a key component of the mRNA vaccines. Busy fighting over their lucrative <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/arbutus-files-patent-infringement-lawsuit-against-moderna-2022-02-28/">patent rights</a>, there is no sign they shared their technology with Afrigen either. </p>
<p>The two companies in question — <a href="https://nrc.canada.ca/index.php/en/stories/producing-lipid-nanoparticle-technology-vaccine-delivery-acuitas-therapeutics">Acuitas Therapeutics</a> and Arbutus Biopharma — are based in Vancouver, B.C., and have strong ties to the <a href="https://lsi.ubc.ca/2020/11/13/lsi-spinoff-company-the-source-of-technology-pfizers-mrna-covid-19-vaccine-cant-work-without/">University of British Columbia</a>. They have been lauded for their positive “<a href="https://www.nanomedicines.ca/2021/10/07/acuitas-wins-global-impact-award/">global impact</a>” in combating the pandemic.</p>
<p>But that impact seems to stop short of sharing their technology with Afrigen and other would-be suppliers of COVID-19 vaccines in the Global South.</p>
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<figcaption><span class="caption">Afrigen uses Moderna data to make a COVID-19 vaccine.</span></figcaption>
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<h2>Protecting patents and profits</h2>
<p>The mRNA vaccines are incredible innovations and the culmination of <a href="https://www.nytimes.com/2022/01/15/health/mrna-vaccine.html">decades of research</a>. They work because of something called “lipid nanoparticles,” (LNPs) which deliver the mRNA to its target. LNPs are also the result of <a href="https://doi.org/10.1080/1061186x.2016.1221955">many years</a> of publicly funded research, spearheaded by scientists at the University of British Columbia and further developed by companies like Arbutus and Acuitas. </p>
<p>As we show in <a href="https://www.longwoods.com/content/26724/healthcare-policy/university-technology-transfer-has-failed-to-improve-access-to-global-health-products-during-the-cov">our research</a>, the long road to developing LNPs is littered with <a href="https://www.canlii.org/en/bc/bcsc/doc/2017/2017bcsc199/2017bcsc199.pdf">lawsuits over patent rights and allegations of scientific theft</a>. In the 1990s, Pieter Cullis, a biochemist at UBC, worked alongside Ian MacLachlan, <a href="https://www.forbes.com/sites/nathanvardi/2021/08/17/covids-forgotten-hero-the-untold-story-of-the-scientist-whose-breakthrough-made-the-vaccines-possible/">another one of the inventors of the LNP delivery system</a>, and Thomas Madden at a company called Inex. </p>
<p>Years later, they split up. In 2008, Madden was pushed out. He then formed a new outfit with Cullis, which became Acuitas. This precipitated <a href="https://www.longwoods.com/content/26724/healthcare-policy/university-technology-transfer-has-failed-to-improve-access-to-global-health-products-during-the-cov">a series of lawsuits</a> between Acuitas and the company now known as Arbutus, UBC and various commercial partners, including Moderna. </p>
<p>Through the pandemic, Moderna and Arbutus have continued to fight over several LNP patents, with <a href="https://www.bloomberg.com/news/articles/2021-12-01/moderna-drops-after-losing-appeal-in-drug-delivery-patents-case">Moderna suffering a major blow in December 2021</a>, when its appeal was rejected by the U.S. Federal Court of Appeals. Arbutus has since turned around and <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/arbutus-files-patent-infringement-lawsuit-against-moderna-2022-02-28/">sued Moderna anew</a>. Meanwhile Pfizer just inked a <a href="https://acuitastx.com/wp-content/uploads/2022/01/Acuitas-Pfizer-Agreement-Release.pdf">new deal with Acuitas for its vaccine technology</a>.</p>
<h2>Vaccine inequities</h2>
<p>Lost in all of this corporate wheeling, dealing and litigating are a number of important questions: Given the scale of the ongoing pandemic, why wasn’t the LNP technology shared with Afrigen? Why didn’t the scientists who developed this foundational technology rise to that same task? Why didn’t Canada, which funded much of the foundational research, have the ability to ensure equitable access? And why didn’t UBC, <a href="https://doi.org/10.1002/jps.21495">lauded for prioritizing global health when commercializing technology</a>, require that the research was made more broadly available? </p>
<p>In short, in the face of vaccine inequity, why not try to help?</p>
<p>The obvious answer is that it’s not in the companies’ financial interests. A new investigation by the <em>British Medical Journal</em> showed <a href="https://doi.org/10.1136/bmj.o304">just how far industry will go to protect its profits</a> by working surreptitiously through a foundation to undermine the World Health Organization’s newly created “<a href="https://www.who.int/initiatives/the-mrna-vaccine-technology-transfer-hub">technology transfer hub</a>” in South Africa. </p>
<p>The Canadian companies likewise appear to have determined that it is not in their financial interests to assist vaccine makers in low- and middle-income countries. For its part, Acuitas might have been worried that if it shared the LNP technology it would breach its agreements with Pfizer-BioNTech. Having warded off Moderna’s challenge to its patents, Arbutus is positioned to license its LNP technology to additional partners. Transferring the know-how to Afrigen would diminish the asset’s value.</p>
<p>Lying beneath these calculations lies a troubling truth: this is exactly how the drug and vaccine innovation system was designed to work. Discover a technology, patent it and then — regardless of how much public funding supported its discovery — let the market decide how, and on what terms, its development should proceed.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/448944/original/file-20220228-13-1rkalz2.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A worker wearing a surgical mask surveys a stack of boxes with the sign COVAX affixed to them" src="https://images.theconversation.com/files/448944/original/file-20220228-13-1rkalz2.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/448944/original/file-20220228-13-1rkalz2.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/448944/original/file-20220228-13-1rkalz2.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/448944/original/file-20220228-13-1rkalz2.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/448944/original/file-20220228-13-1rkalz2.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/448944/original/file-20220228-13-1rkalz2.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/448944/original/file-20220228-13-1rkalz2.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Kenya received its first shipment of 880,460 doses of the Moderna vaccine in August 2021, donated by the United States through the COVAX program.</span>
<span class="attribution"><span class="source">(AP Photo/Brian Inganga)</span></span>
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<p>This system does produce innovations like the mRNA vaccines. But in the ongoing pandemic, firms with innovative technologies use patents and other forms of intellectual property to triple dip: they retain the benefit of public dollars that went into the underlying research, they receive revenues for their product from that same public and they extort poorer countries to pay through the nose for that product. </p>
<p>Meanwhile, would-be producers of public health interventions such as COVID-19 vaccines not only face delays due to limited access to the underlying knowledge, but they also run the risk of being sued for patent infringement.</p>
<h2>Fundamental changes to innovation</h2>
<p>More details about how Afrigen overcame these challenges to produce its first doses of an mRNA vaccine are apt to emerge in the weeks ahead. Perhaps some scientists, aghast at the abject level of vaccine inequity globally, rebelled and gave Afrigen a helping hand. </p>
<p>However, we doubt that any of these publicly supported Canadian scientists — who possess the needed know-how — were among them. Sadly, that is not what our <a href="https://doi.org/10.1080/23299460.2019.1608615">system teaches</a> them to do.</p>
<p>In the end, Canada has not been a helpful partner in the global fight against COVID-19. It has failed to mobilize production of COVID-19 vaccines under Canada’s <a href="https://www.theglobeandmail.com/canada/article-bolivia-calls-on-canada-to-waive-patent-and-export-covid-19-vaccines-2/">Access to Medicines Regime</a>. It has failed to support a <a href="https://www.policyalternatives.ca/newsroom/updates/trips-covid-19-waiver">waiver of certain international trade rules to allow developing countries to manufacture their own vaccines without fear of trade-related reprisals</a>. And Canadian companies, as best we can tell, have failed to help Afrigen scale up production of mRNA vaccines. </p>
<p>If we truly want out of this pandemic, and more equitable outcomes in the next, our innovation laws, policies and practices require fundamental change.</p><img src="https://counter.theconversation.com/content/177416/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Matthew Herder receives funding from the Canadian Institutes of Health Research, the Public Health Agency of Canada, and The Commonwealth Fund. He is also a member of the Patented Medicine Prices Review Board, Canada's national drug pricing regualtor, and receives honoraria for his part-time public service. </span></em></p><p class="fine-print"><em><span>E. Richard Gold receives funding from Genome Canada, Genome Quebec, and Fonds de recherche-Société et culture.</span></em></p>New research sheds light on how Canadian researchers developed a key component of the mRNA COVID-19 vaccines but failed to share it with the worldMatthew Herder, Director of the Health Law Institute at the Schulich School of Law, Dalhousie UniversityE. Richard Gold, Professor of intellectual property and innovation, Faculty of Law and Faculty of Medicine and Health Sciences, McGill UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1754962022-01-27T13:28:42Z2022-01-27T13:28:42ZIs the omicron variant Mother Nature’s way of vaccinating the masses and curbing the pandemic?<figure><img src="https://images.theconversation.com/files/442657/original/file-20220126-17-75f6ee.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C7592%2C3940&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Preliminary research suggests that the omicron variant may potentially induce a robust immune response.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/coronavirus-royalty-free-image/1357650209?adppopup=true">Olga Siletskaya/Moment via Getty Images</a></span></figcaption></figure><p>In the short time since the omicron variant was <a href="https://www.cnn.com/2021/12/02/world/south-africa-omicron-origins-covid-cmd-intl/index.html">identified in South Africa</a> in November 2021, <a href="https://doi.org/10.12998/wjcc.v10.i1.1">researchers have quickly learned</a> that it has three unique characteristics: It spreads efficiently and quickly, it generally causes milder disease than previous variants and it may confer strong protection against other variants such as delta. </p>
<p>This has many people wondering whether omicron could act as a vaccine of sorts, inoculating enough people to effectively bring about <a href="https://theconversation.com/what-is-herd-immunity-a-public-health-expert-and-a-medical-laboratory-scientist-explain-170520">herd immunity</a> – the threshold at which enough of the population is immune to the virus to stop its spread – and end the COVID-19 pandemic.</p>
<p>As <a href="https://sc.edu/study/colleges_schools/medicine/about_the_school/faculty-staff/nagarkatti_mitzi.php">immunology researchers</a> at the University of South Carolina who are <a href="https://pubmed.ncbi.nlm.nih.gov/?term=nagarkatti+p&sort=date&size=200&show_snippets=off">working on inflammatory and infectious diseases</a>, including COVID-19, we find the characteristics of omicron in the pandemic setting particularly intriguing. And it is these characteristics that can help answer that question. </p>
<p>Some 4.73 billion people across the globe – about 61.6% of the world’s population – have received at least <a href="https://www.nytimes.com/interactive/2021/world/covid-vaccinations-tracker.html">one dose of a COVID-19 vaccine</a>. In the United States, 63.4% of the population <a href="https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total">is fully vaccinated with two doses</a> as of late January 2022, while only 39.9% of Americans have received the booster dose. Such low levels of vaccination resulting from <a href="https://data.cdc.gov/stories/s/Vaccine-Hesitancy-for-COVID-19/cnd2-a6zw/">vaccine hesitancy</a> and the complexities of the <a href="https://dx.doi.org/10.1016%2Fj.ijpe.2021.108193">global vaccine supply chain</a> cast doubt on reaching <a href="https://theconversation.com/what-is-herd-immunity-a-public-health-expert-and-a-medical-laboratory-scientist-explain-170520">herd immunity</a> through vaccination anytime soon. </p>
<h2>How does omicron mimic a vaccine?</h2>
<p><a href="https://www.hhs.gov/immunization/basics/types/index.html">All vaccines</a> work on the principle of training the immune system to fight against an infectious agent. Each vaccine, regardless of how it is made, exposes the human or animal host to the critical molecules used by the infectious agent – in this case, the SARS-CoV-2 virus – to gain entry into the host’s cells.</p>
<p>Some vaccines expose the host only to select portions of the virus. For example, the Pfizer-BioNTech and Moderna vaccines use a <a href="https://theconversation.com/how-mrna-vaccines-from-pfizer-and-moderna-work-why-theyre-a-breakthrough-and-why-they-need-to-be-kept-so-cold-150238">molecule called messenger RNA</a>, or mRNA, to encode and produce a fragment of the “spike protein” – the knobby protrusion that is expressed on the outside of SARS-CoV-2 viruses – inside a person’s body. These spike proteins are the key way that <a href="https://theconversation.com/what-happens-when-the-covid-19-vaccines-enter-the-body-a-road-map-for-kids-and-grown-ups-164624">the coronavirus invades cells</a>, so the mRNA vaccines are designed to mimic that protein and trigger an immune response against it. </p>
<p>In contrast, some vaccines against other infections, <a href="https://theconversation.com/the-chickenpox-virus-has-a-fascinating-evolutionary-history-that-continues-to-affect-peoples-health-today-168636">such as chickenpox</a> and <a href="https://www.cdc.gov/vaccines/hcp/vis/vis-statements/mmr.html">measles, mumps and rubella (MMR)</a>, expose the host to a “live attenuated” form of the virus. These vaccines use small amounts of a weakened form of the live virus. They mimic a natural infection, trigger a strong immune response and afford lasting resistance to infection. </p>
<p>In some respects, omicron mimics these live attenuated vaccines because it causes milder infection and trains the body to trigger a strong immune response against the delta variant, as shown in a recent <a href="https://doi.org/10.1101/2021.12.27.21268439">study that is not yet peer-reviewed</a> from South Africa. </p>
<h2>Deliberate infection with omicron is not the answer</h2>
<p>While omicron may share certain characteristics with a vaccine, it should not be considered a viable alternative to the existing vaccines. For one, COVID-19 infection can result in <a href="https://www.nytimes.com/live/2022/01/10/world/omicron-covid-testing-vaccines">severe illness, hospitalization or death</a>, especially in <a href="https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html">vulnerable individuals with underlying conditions</a>. It can also cause long-term health effects in some people, called <a href="https://theconversation.com/deciphering-the-symptoms-of-long-covid-19-is-slow-and-painstaking-for-both-sufferers-and-their-physicians-164754">long COVID</a>. In contrast, vaccines currently available against COVID-19 have been tested for safety and efficacy. </p>
<p>The high transmission of omicron combined with ongoing vaccination efforts could help attain herd immunity soon and end the most acute phase of the pandemic. However, there is little chance of it eradicating COVID-19, since all signs point to the likelihood that the virus <a href="https://theconversation.com/is-covid-19-here-to-stay-a-team-of-biologists-explains-what-it-means-for-a-virus-to-become-endemic-168462">will become endemic</a> – meaning SARS-CoV-2 will be in circulation but will likely not be as disruptive to society.</p>
<p>Thus far, smallpox is the only infectious disease that <a href="https://www.cdc.gov/smallpox/index.html#">has been eradicated globally</a>, which shows how difficult it is to fully eliminate a disease. However, it is easier to control an infection effectively. One example is <a href="https://www.cdc.gov/polio/what-is-polio/polio-us.html">polio</a>, which has been reduced or eliminated in most countries through vaccination. </p>
<h2>What happens when the body meets a virus or vaccine</h2>
<p>Both viral infections or the mimicking of a virus through vaccination activate a critical component of the immune system, called B cells, in the body. These cells produce antibodies that bind to the virus, preventing it from infecting cells. These antibodies act much like anti-ballistic missiles that shoot down an incoming virus missile. However, once a virus manages to get inside the body’s cells, antibodies are less effective. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/442658/original/file-20220126-13-ngm9rq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A 3-D illustration of antibody proteins attacking a coronavirus pathogen cell." src="https://images.theconversation.com/files/442658/original/file-20220126-13-ngm9rq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/442658/original/file-20220126-13-ngm9rq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=300&fit=crop&dpr=1 600w, https://images.theconversation.com/files/442658/original/file-20220126-13-ngm9rq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=300&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/442658/original/file-20220126-13-ngm9rq.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=300&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/442658/original/file-20220126-13-ngm9rq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=377&fit=crop&dpr=1 754w, https://images.theconversation.com/files/442658/original/file-20220126-13-ngm9rq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=377&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/442658/original/file-20220126-13-ngm9rq.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=377&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Antibodies behave similarly to anti-ballistic missiles, shooting down their target – in this case, the SARS-CoV-2 virus.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/immunoglobulin-or-antibody-proteins-attack-a-corona-royalty-free-image/1299604801?adppopup=true">Christoph Burgstedt/iStock via Getty Images Plus</a></span>
</figcaption>
</figure>
<p>That’s where another key player in the immune system, called killer T cells, come in. These cells can recognize and destroy a cell as soon as it is infected, thereby preventing the virus from multiplying and spreading further. Think of this as an anti-ballistic missile that detects and destroys the factory where missiles are manufactured. </p>
<p>Immunologists believe that antibodies against COVID-19 prevent an individual from catching the infection, while the <a href="https://www.nature.com/articles/d41586-021-00367-7">killer T cells are crucial</a> in preventing severe disease. Despite its numerous mutations, omicron can trigger a <a href="https://www.nature.com/articles/d41586-022-00063-0#">strong killer T cell response</a>. This may explain why the COVID-19 vaccines – by triggering the T cells – have provided strong enough immunity against omicron to, in most cases, <a href="https://doi.org/10.1001/jamanetworkopen.2021.42725">prevent hospitalization and death</a>.</p>
<p>But, critically, the first wave of antibodies and killer T cells produced during infection or vaccination last for only a few months. This is why recurrent infections of COVID-19 have occurred even in the vaccinated population, and it’s also <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html">why booster shots are needed</a>. In contrast, some vaccines – like the one against smallpox – have been shown to trigger immunity that lasts for several years. </p>
<h2>Memory immune response</h2>
<p>So what exactly triggers strong and lasting immunity? The lifelong immunity seen in certain infections such as smallpox can be explained by a phenomenon called “<a href="https://www.ncbi.nlm.nih.gov/books/NBK27158/">immunological memory</a>.”</p>
<p>After the B cells and killer T cells first encounter the virus, some of them get converted into what are called memory cells, which are known to <a href="https://doi.org/10.1038/nm917">live for several decades</a>. As their name suggests, when memory cells “see” a virus again after initial exposure, they recognize it, divide rapidly and mount a robust antibody and killer T cell response, thereby preventing reinfection.</p>
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<p>For this reason, memory cells are critical for establishing strong, long-lasting immunity. This is evidenced from studies with smallpox in which people that were infected or vaccinated were found to have the antibody response <a href="https://dx.doi.org/10.1016%2Fj.amjmed.2008.08.019">even after 88 years</a>! Why some infections or vaccines trigger long-lasting memory and others do not is under active investigation. Because COVID-19 is only two years old, we researchers don’t know yet how long the memory B and T cells last. Based on recurrent infections, it looks like longer-term immunity does not last very long, but that could also in part be due to the evolution of new variants. </p>
<p>All of these considerations leave room for hope that when new variants of SARS-CoV-2 inevitably arise, omicron will have left the population better equipped to fight them. So the COVID-19 vaccines combined with the omicron variant could feasibly move the world to a new stage in the pandemic – one where the virus doesn’t dominate our lives and where hospitalization and death are far less common.</p><img src="https://counter.theconversation.com/content/175496/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Prakash Nagarkatti receives funding from the National Institutes of Health and the National Science Foundation.</span></em></p><p class="fine-print"><em><span>Mitzi Nagarkatti receives funding from the National Institutes of Health.</span></em></p>Some of the omicron variant’s unique properties – such as its ability to spread rapidly while causing milder COVID-19 infections – could usher in a new phase of the pandemic.Prakash Nagarkatti, Professor of Pathology, Microbiology and Immunology, University of South CarolinaMitzi Nagarkatti, Professor of Pathology, Microbiology and Immunology, University of South CarolinaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1746052022-01-10T03:44:56Z2022-01-10T03:44:56ZWhy has my child’s vaccination been cancelled? We’re reliant on overseas supply and a complex logistics network<figure><img src="https://images.theconversation.com/files/439941/original/file-20220110-13-gd4wmt.jpg?ixlib=rb-1.1.0&rect=0%2C22%2C5058%2C2589&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>Reports of GPs <a href="https://www.abc.net.au/radionational/programs/breakfast/child-vaccine-appointments-delayed-or-cancelled/13700424">cancelling</a> or postponing COVID vaccine appointments for 5-11 year olds are piling up, with desperate parents expressing anger and fear about how their as-yet unvaccinated children will fare as Omicron case numbers explode.</p>
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<p>Federal COVID-19 Task Force Commander Lieutenant General John Frewen <a href="https://www.health.gov.au/news/lieutenant-general-john-frewens-interview-on-sunrise-on-10-january-2022">said</a> on Monday:</p>
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<p>Supply isn’t the issue; we’ve got enough vaccines. The real challenge now is just getting the distribution to where the demand is greatest. </p>
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<p>South Australia’s health deputy chief executive Don Frater, however, has reportedly <a href="https://indaily.com.au/news/2022/01/10/sa-health-reveals-shortfall-of-vaccines-for-children/">said</a> that state has “more demand than what we have supply”.</p>
<p>The child’s dose comes in different vials to the adult dose, with <a href="https://www.ncirs.org.au/safety-side-effects-allergies-and-doses-covid-19-pfizer-vaccine-5-11-year-olds-explained">different packaging</a>.</p>
<p>The rollout of the Pfizer vaccine for children has come at a difficult time, from a logistics perspective. Many GPs have said “delivery delays” are behind the need to reschedule appointments.</p>
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Read more:
<a href="https://theconversation.com/australia-may-miss-out-on-several-covid-vaccines-if-it-cant-make-mrna-ones-locally-148996">Australia may miss out on several COVID vaccines if it can't make mRNA ones locally</a>
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<h2>What might be behind the delays?</h2>
<p>This is a specialised product, which needs to be stored in special freezers <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-covid-19-vaccine-stability-data">at -80°C</a>, and obviously needs to be transported in a certain way. </p>
<p>There are a lot of steps in the transport process – from the supplier overseas to the shipping service bringing them to Australia, from their landing spot in the country, to specialised storage, to individual GPs.</p>
<p>Each of those steps require staff on the ground to ensure the system works – and many workers in this system are likely being affected by Omicron.</p>
<p>The same staffing issues resulting in <a href="https://theconversation.com/supermarket-shortages-are-different-this-time-how-to-respond-and-avoid-panic-174529">empty supermarket shelves</a> could be affecting the vaccine distribution network too. </p>
<p>Thousands of drivers, administration staff, packers and logistics planners could be furloughed, off sick or in isolation because a household member is.</p>
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<p>The rollout of the 5-11 year old vaccination program, timed in an effort to get kids vaccinated before school starts, also comes hot on the heels of the Christmas and New Year break; even without Omicron, it’s possible staffing numbers across the supply chain and logistics network are still yet to return to pre-Christmas levels.</p>
<p>There have been <a href="https://twitter.com/Leighma03/status/1479403027517755392">anecdotal reports</a> of <a href="https://twitter.com/Leighma03/status/1479403027517755392">some</a> people having their booster appointments being cancelled too, so it seems it is not only 5-11 year olds who are affected.</p>
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Read more:
<a href="https://theconversation.com/safety-side-effects-allergies-and-doses-the-covid-19-pfizer-vaccine-for-5-11-year-olds-explained-173323">Safety, side effects, allergies and doses. The COVID-19 Pfizer vaccine for 5-11 year olds explained</a>
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<p>It’s hard to know how widespread the issue is. Frewen told Sunrise on Monday</p>
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<p>if you’re having trouble at the moment, maybe with your normal healthcare provider, your GP, then please do try pharmacies, maybe try one of the state and territory clinics as they come online. </p>
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<p>He <a href="https://twitter.com/RNBreakfast/status/1480285219496202240">told</a> RN Breakfast that: </p>
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<p>We will have more than enough vaccines for every kid to have their first dose before the end of the year.</p>
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<p>This must be very frustrating for people who have tried to get in early and are keen to have their children vaccinated as soon as possible.</p>
<p>Clearly, something has fallen over somewhere in the distribution. It would be good to have some clarity from government and industry on exactly where the systemic problems are and what’s being planned to address them.</p>
<h2>Domestic production of mRNA vaccines</h2>
<p>The Therapeutic Goods Administration (TGA) only just provisionally approved the use of Pfizer’s COMINARTY COVID vaccine for people aged 5-11 years on <a href="https://www.tga.gov.au/covid-19-vaccines-undergoing-evaluation">December 3</a>.</p>
<p>Moderna’s application for the use of SPIKEVAX COVID vaccine for children under age 12 is still <a href="https://www.tga.gov.au/covid-19-vaccines-undergoing-evaluation">under evaluation</a>, according to the TGA.</p>
<p>Hopefully, once that is approved, parents of children in the 5-11 year old age bracket will have more choice on where and how they can get their child vaccinated.</p>
<p>Both Pfizer and Moderna’s COVID vaccines are mRNA vaccines, and experts have long called for a boost in domestic mRNA manufacturing capacity so Australia is less reliant on overseas supplies.</p>
<p>Promisingly, Moderna and the Australian government late last year <a href="https://www.biopharma-reporter.com/Article/2021/12/14/Moderna-to-build-mRNA-vaccine-manufacturing-facility-in-Australia">announced</a> an in-principle agreement to build a mRNA manufacturing facility in Victoria. The site will hopefully be up and running by 2024, according to media <a href="https://www.abc.net.au/news/2021-12-14/moderna-to-be-first-mrna-vaccine-made-in-australia/100697324">reports</a>. </p>
<p>That’s something to be celebrated, and domestic manufacturing would hopefully mean a shorter and less complex supply chain with less opportunity for difficulties in future. But it does highlight it would have been good to have something worked out earlier. </p>
<p>It would also be prudent for the government to consider what it might take to lure Pfizer to develop mRNA manufacturing capability in Australia. You could argue, from a market point of view, it could be strategic for Moderna to have a manufacturing competitor here in Australia too. </p>
<p>If we are serious about building our biotechnology sector in Australia, then having monopoly of just one player in the country might not be ideal.</p>
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Read more:
<a href="https://theconversation.com/supermarket-shortages-are-different-this-time-how-to-respond-and-avoid-panic-174529">Supermarket shortages are different this time: how to respond and avoid panic</a>
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<img src="https://counter.theconversation.com/content/174605/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Archa Fox receives funding from the Australian Research Council. She is a member of the Australia New Zealand RNA Production Consortium that has lobbied for establishment of onshore mRNA vaccine manufacturing in Australia</span></em></p>We’re reliant on overseas supply - and the many moving parts of delivery. Each of those parts require staff on the ground – and many workers in this system are likely being affected by Omicron.Archa Fox, Associate Professor and ARC Future Fellow, The University of Western AustraliaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1729432021-12-02T22:03:12Z2021-12-02T22:03:12ZHow can scientists update coronavirus vaccines for omicron? A microbiologist answers 5 questions about how Moderna and Pfizer could rapidly adjust mRNA vaccines<figure><img src="https://images.theconversation.com/files/435121/original/file-20211201-21-17k49im.jpg?ixlib=rb-1.1.0&rect=0%2C23%2C7940%2C5880&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Some vaccines use mRNA to make copies of the triangular red spike proteins to induce immunity.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/covid-19-viruses-attaching-to-cell-illustration-royalty-free-image/1307405789?adppopup=true">Juan Gaertner/Science Photo Library via Getty Images</a></span></figcaption></figure><p><em>If the omicron variant of the coronavirus is different enough from the original variant, it’s possible that existing vaccines won’t be as effective as they have been. If so, it’s likely that companies will need to update their vaccines to better fight omicron. Deborah Fuller is a <a href="https://scholar.google.com/citations?user=eNprtJEAAAAJ&hl=en&oi=ao">microbiologist who has been studying mRNA and DNA vaccines</a> for over two decades. Here she explains why vaccines might need to be updated and what that process would look like.</em></p>
<h2>1. Why might vaccines need to be updated?</h2>
<p>Basically, it’s a question of whether a virus has changed enough so that antibodies created by the original vaccine are no longer able to recognize and fend off the new mutated variant.</p>
<p>Coronaviruses use spike proteins to attach to <a href="https://theconversation.com/what-is-the-ace2-receptor-how-is-it-connected-to-coronavirus-and-why-might-it-be-key-to-treating-covid-19-the-experts-explain-136928">ACE-2 receptors on the surface of human cells and infect them</a>. All mRNA COVID-19 vaccines work by giving instructions in the form of mRNA that direct cells to <a href="https://theconversation.com/how-do-mrna-vaccines-work-and-why-do-you-need-a-second-dose-5-essential-reads-157198">make a harmless version of the spike</a> protein. This spike protein then induces the human body to produce antibodies. If a person is then ever exposed to the coronavirus, these antibodies bind to the coronavirus’s spike protein and thus interfere with its ability to infect that person’s cells. </p>
<p>The omicron variant contains a new <a href="https://www.who.int/news/item/26-11-2021-classification-of-omicron-(b.1.1.529)-sars-cov-2-variant-of-concern">pattern of mutations to its spike protein</a>. These changes could disrupt the ability of some – but probably not all – of the antibodies induced by the current vaccines to <a href="https://doi.org/10.1038/s41586-021-04005-0">bind to the spike protein</a>. If that happens, the vaccines could be less effective at preventing people from getting infected by and transmitting the omicron variant.</p>
<h2>2. How would a new vaccine be different?</h2>
<p>Existing mRNA vaccines, like those made by Moderna or Pfizer, code for a <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html">spike protein from the original strain of coronavirus</a>. In a new or updated vaccine, the mRNA instructions would encode for the omicron spike protein.</p>
<p>By swapping out the genetic code of original spike protein for the one from this new variant, a new vaccine would induce antibodies that more effectively bind the omicron virus and prevent it from infecting cells. </p>
<p>People already vaccinated or previously exposed to COVID-19 would likely need only a single booster dose of a new vaccine to be protected not only from the new strain but <a href="https://doi.org/10.1038/d41586-021-02795-x">also other strains that may be still in circulation</a>. If omicron emerges as the dominant strain over delta, then those who are unvaccinated would only need to receive 2-3 doses of the updated vaccine. If delta and omicron are both in circulation, people would likely get a combination of the current and updated vaccines.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/435122/original/file-20211201-28-lmhzff.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A diagram showing how DNA becomes mRNA which becomes proteins." src="https://images.theconversation.com/files/435122/original/file-20211201-28-lmhzff.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/435122/original/file-20211201-28-lmhzff.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=470&fit=crop&dpr=1 600w, https://images.theconversation.com/files/435122/original/file-20211201-28-lmhzff.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=470&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/435122/original/file-20211201-28-lmhzff.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=470&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/435122/original/file-20211201-28-lmhzff.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=591&fit=crop&dpr=1 754w, https://images.theconversation.com/files/435122/original/file-20211201-28-lmhzff.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=591&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/435122/original/file-20211201-28-lmhzff.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=591&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">By changing the mRNA sequence in a vaccine, researchers can change the antibody producing protein it encodes for to better match new variants.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/illustration/protein-syntesis-schematic-illustration-royalty-free-illustration/1298189974?adppopup=true">Alkov/iStock via Getty Images</a></span>
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<h2>3. How do scientists update a vaccine?</h2>
<p>To make an updated mRNA vaccine, you need two ingredients: the genetic sequence of the spike protein from a new variant of concern and a DNA template that would be used to build the mRNA.</p>
<p>In most organisms, DNA provides the instructions for making mRNA. Since researchers have already <a href="https://covariants.org/variants/21K.Omicron">published the genetic code for the omicron spike protein</a>, all that’s left to do is make a DNA template for the spike protein that would be used to produce the mRNA part of new vaccines. </p>
<p>To do this, researchers mix DNA templates with synthetic enzymes and four molecular building blocks that make mRNA – G, A, U and C for short. The enzymes then build an mRNA copy of the DNA template, a process called transcription. Using this process, it takes only minutes to produce a batch of the mRNA for vaccines. Researchers then place the mRNA transcripts within <a href="https://www.genome.gov/about-genomics/fact-sheets/COVID-19-mRNA-Vaccine-Production">fatty nanoparticles that protect the instructions</a> until they are safely delivered into cells in your arm.</p>
<h2>4. How long until a new vaccine might be ready?</h2>
<p>It takes only three days to generate the DNA template needed to make a new mRNA vaccine. Then it would take about a week to produce sufficient doses of the mRNA vaccine for testing in the lab and another six weeks to perform the pre-clinical tests on human cells in test tubes to make sure a new vaccine works as it should.</p>
<p>So <a href="https://doi.org/10.1038/d41586-021-00241-6">within 52 days</a>, scientists could have an updated mRNA vaccine ready to plug into the manufacturing process and begin producing doses for a human clinical trial. That trial would likely require at least another few weeks for a total of around 100 days to update and test a new vaccine.</p>
<p>While that trial is going on, manufacturers could start switching their current process to making a new vaccine. Ideally, once the clinical trial is complete – and if the vaccine gets authorized or approved – a company could immediately start rolling out doses of a new vaccine.</p>
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<a href="https://images.theconversation.com/files/435124/original/file-20211201-25-9dj61a.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Dozens of vaccine vials on a table." src="https://images.theconversation.com/files/435124/original/file-20211201-25-9dj61a.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/435124/original/file-20211201-25-9dj61a.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/435124/original/file-20211201-25-9dj61a.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/435124/original/file-20211201-25-9dj61a.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/435124/original/file-20211201-25-9dj61a.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/435124/original/file-20211201-25-9dj61a.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/435124/original/file-20211201-25-9dj61a.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Both Moderna and Pfizer have made statements saying that they could have updated vaccines ready for trials in fewer than 100 days.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/APTOPIXVirusOutbreakBrazil/66429176b01146408b7757600b8c55c4/photo?Query=covid%20vaccine%20vials&mediaType=photo&sortBy=&dateRange=Anytime&totalCount=697&currentItemNo=38">AP Photo/Bruna Prado</a></span>
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<h2>5. Does an updated vaccine need full clinical trials?</h2>
<p>It’s currently not clear how much clinical data would be required to get FDA approval or authorization for an updated COVID-19 vaccine. However, all the ingredients would be the same in a new vaccine. The only difference would be a few lines of genetic code that would ever so slightly change the shape of the spike protein. From a safety perspective, an updated vaccine is essentially identical to the already tested vaccines. Because of these similarities, clinical testing may not need to be as extensive as what was needed for the first-generation COVID-19 vaccines.</p>
<p>At a minimum, clinical trials for updated vaccines would likely require safety testing and confirmation that an updated vaccine <a href="https://www.technologyreview.com/2021/01/13/1016098/moderna-variant-coronavirus-vaccine-update/">induces antibody levels</a> on par with the response of the original vaccine against the original, beta and delta strains. If these are the only requirements, then researchers would enroll only hundreds – not tens of thousands – of people to obtain the clinical data needed. </p>
<p>[<em>The Conversation’s science, health and technology editors pick their favorite stories.</em> <a href="https://theconversation.com/us/newsletters/science-editors-picks-71/?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=science-favorite">Weekly on Wednesdays</a>.]</p>
<p>One important thing to note is that if vaccine manufacturers decide to update their vaccines for the omicron variant, it wouldn’t be their first time making this kind of change.</p>
<p>A previous variant, B.1.351, emerged in October 2020 and was <a href="https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/scientific-brief-emerging-variants.html">sufficiently resistant to then-current vaccines to warrant updating them</a>. Manufacturers quickly responded to the potential threat by developing an updated mRNA vaccine to match this variant and performed clinical trials to <a href="https://www.nih.gov/news-events/news-releases/nih-clinical-trial-evaluating-moderna-covid-19-variant-vaccine-begins">test the new vaccine</a>. Fortunately, this variant did not become the dominant variant. But if it had, vaccine manufacturers <a href="https://doi.org/10.1038/d41586-021-02854-3">would have been ready to roll out an updated vaccine</a>.</p>
<p>If it turns out that omicron – or any future variant, for that matter – warrants a new vaccine, companies have already completed the dress rehearsals and are ready to meet the challenge.</p><img src="https://counter.theconversation.com/content/172943/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Deborah Fuller is co-founder of Orlance, Inc, a biotechnology company developing a needle free technology to deliver RNA and DNA vaccines. She also serves as a scientific advisor for HDT Bio, a biotechnology company developing RNA vaccines for COVID19 and other infectious diseases. She receives funding supporting basic and translational research in RNA and DNA vaccines from the National Institutes of Health.</span></em></p>The new omicron variant of coronavirus has a number of mutations that may require manufacturers to update vaccines. The unique attributes of mRNA vaccines make updating them fast and easy.Deborah Fuller, Professor of Microbiology, School of Medicine, University of WashingtonLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1726092021-11-29T04:25:59Z2021-11-29T04:25:59ZDoes AstraZeneca’s COVID vaccine give longer-lasting protection than mRNA shots?<p>Last week, AstraZeneca’s chief executive officer <a href="https://www.bloomberg.com/opinion/articles/2021-11-24/did-astrazeneca-covid-vaccine-really-keep-britain-safer-than-europe-not-so-fast">said</a> the company’s COVID vaccine may provide longer-lasting protection than mRNA vaccines like Pfizer’s, especially in older people.</p>
<p>CEO Pascal Soriot said this might explain the United Kingdom’s <a href="https://www.ft.com/content/92e77bf1-2266-4534-a043-daa6c8bb413f">more stable hospitalisation rate</a> compared to the escalating COVID situation in continental Europe.</p>
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<p>The UK used the AstraZeneca vaccine a lot more widely than other European countries, many of which <a href="https://www.theguardian.com/world/2021/nov/23/astrazeneca-chief-links-europes-covid-surge-to-rejection-of-firms-vaccine">restricted its use</a> to older age groups or <a href="https://www.bbc.com/news/world-europe-56744474">abandoned using it altogether</a> after reports of very rare blood clots.</p>
<p>The theory behind this is the AstraZeneca vaccine may provide more durable “T cell protection”. T cells are a crucial part of our immune system, and differ from antibodies.</p>
<p>There’s not enough evidence yet to support the CEO’s claim. But we do know a lot more about adenovirus vector vaccines, such as AstraZeneca’s, as they’ve been around for decades, while mRNA vaccines are relatively newer.</p>
<p>Theoretically, it is possible adenovirus vector vaccines do give more durable protection against COVID via T cells.</p>
<p>Let me explain.</p>
<h2>What is AstraZeneca’s vaccine again?</h2>
<p>AstraZeneca’s COVID vaccine is an adenovirus vector vaccine.</p>
<p>This means it uses an adenovirus – a common type of virus that affects humans and many other animals. The adenovirus is genetically modified so it doesn’t replicate.</p>
<p>It’s used as a way to deliver the vaccine’s information into our cells.</p>
<p>In this case, the information packaged in the adenovirus tells our body how to make the coronavirus <a href="https://theconversation.com/revealed-the-protein-spike-that-lets-the-2019-ncov-coronavirus-pierce-and-invade-human-cells-132183">spike protein</a>. This teaches our immune system how to deal with the coronavirus if we’re exposed.</p>
<p>Adenovirus vectors have been used in medicine for a few decades in other vaccines and <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4507798/">also cancer therapy</a>. They’re very good at stimulating both antibody production and T cell responses.</p>
<h2>What are T cells?</h2>
<p><a href="http://www.biology.arizona.edu/immunology/tutorials/antibody/structure.html">Antibodies</a> bind tightly to a specific target, locking onto invading viruses and preventing them from entering our cells.</p>
<p>But the immune system is more than just antibodies.</p>
<p>T cells are also really important for our immune response, and have different roles. One type, known as “killer T cells”, attack and destroy virus-infected cells.</p>
<p>Another type, known as “helper T cells”, interpret the nature of the infection and help the immune system respond appropriately. This includes activating killer T cells to destroy virus-infected cells, and also helping B cells make antibodies. </p>
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<p>Antibodies wane over time, which can lead to more breakthrough infections <a href="https://theconversation.com/why-are-we-seeing-more-covid-cases-in-fully-vaccinated-people-an-expert-explains-166741">in fully vaccinated people</a>.</p>
<p>When viruses are not stopped by antibodies, we rely on killer T cells to eradicate the virus. And T cells almost certainly help prevent severe outcomes if you get COVID.</p>
<p>It’s a lot harder for a virus to escape a T cell-based immune response. So a vaccine that generates strong T cell immunity should help retain effectiveness over time against variants including Delta and Omicron.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/why-are-we-seeing-more-covid-cases-in-fully-vaccinated-people-an-expert-explains-166741">Why are we seeing more COVID cases in fully vaccinated people? An expert explains</a>
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<p>All COVID vaccines stimulate our bodies to produce both antibodies and T cells.</p>
<p>So the key questions are: does AstraZeneca’s vaccine produce a longer-lasting T cell response than the mRNA vaccines? And might this be one reason why the UK, which relied heavily on the AstraZeneca vaccine, has a more stable hospitalisation rate than other parts of Europe?</p>
<p>Unfortunately, there are not enough data yet to answer these conclusively.</p>
<p>There are many reasons why hospitalisation rates can vary between countries, so it’s difficult to know how much of a factor the use of AstraZeneca’s vaccine would be.</p>
<p>But we can lean on what we know about adenovirus vector vaccines to break down this theory.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/from-adenoviruses-to-rna-the-pros-and-cons-of-different-covid-vaccine-technologies-145454">From adenoviruses to RNA: the pros and cons of different COVID vaccine technologies</a>
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<h2>It’s plausible</h2>
<p>Adenovirus vector vaccines are very good at stimulating immune responses, <a href="https://ashpublications.org/blood/article/110/6/1916/24190/Adenoviral-vectors-persist-in-vivo-and-maintain">particularly T cell responses</a>.</p>
<p>Current wisdom tells us the mRNA vaccines <a href="https://www.bloomberg.com/news/articles/2021-11-15/pfizer-shot-generated-the-most-antibodies-in-a-comparative-study">provide a stronger antibody response</a> than the viral vector vaccines like AstraZeneca’s.</p>
<p>But this antibody protection seems to <a href="https://theconversation.com/why-its-normal-for-covid-19-vaccine-immunity-to-wane-and-how-booster-shots-can-help-171786">wane relatively quickly</a> over 4-6 months.</p>
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<p>It’s possible immune memory with the mRNA vaccines isn’t as strong, and the AstraZeneca vaccine may produce a longer-lasting T cell response that supports more durable immune memory.</p>
<p>This could slow the loss of antibodies and generate a better killer T cell response.</p>
<h2>Why might AstraZeneca produce a longer-lasting response?</h2>
<p>One reason might be because the RNA in Pfizer’s and Moderna’s vaccines doesn’t last very long in the body, <a href="https://theconversation.com/no-covid-vaccines-dont-stay-in-your-body-for-years-169247">only a week or so</a>, because RNA is very fragile.</p>
<p>But the DNA delivered by adenovirus vector vaccines will likely hang around in the body for a bit longer.</p>
<p>DNA is more stable than RNA, and might allow for a more prolonged, low-level activation of our immune system that provides longer-lasting protection.</p>
<p>This might explain longer-lasting T cell responses with the AstraZeneca vaccine.</p>
<p>But this is only speculative for now as such direct tests haven’t been done yet.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/no-covid-vaccines-dont-stay-in-your-body-for-years-169247">No, COVID vaccines don't stay in your body for years</a>
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<h2>If true, we can learn from this</h2>
<p>This isn’t about which vaccine is “<a href="https://theconversation.com/which-covid-vaccine-is-best-heres-why-thats-really-hard-to-answer-161185">better</a>”, or picking and choosing which vaccine to get. </p>
<p>Both are excellent vaccines that have saved many, many lives already. We shouldn’t <a href="https://theconversation.com/covid-vaccination-has-turned-into-a-battle-of-the-brands-but-not-everyones-buying-it-162181">play a tribal game</a> where we say we’re only going to get one type of vaccine.</p>
<p>It’s important to learn from both types of vaccine, while we continue to learn about immunity to COVID, so we can incorporate the best characteristics of both into next-generation vaccines that help us better fight COVID and future pandemics.</p>
<p>I’m sure mRNA vaccine producers will learn from this and develop new formulas to give a longer-lasting response. </p>
<p>It’s worth remembering Pfizer and Moderna’s vaccines are the first mRNA vaccines ever approved for use in humans.</p>
<p>There was an immediate need to get antibodies against COVID in our bodies as soon as possible, and they’ve done a fantastic job doing that.</p><img src="https://counter.theconversation.com/content/172609/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Nathan Bartlett does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>There’s not enough evidence yet to support the AstraZeneca CEO’s statement. But it is theoretically plausible.Nathan Bartlett, Associate Professor, School of Biomedical Sciences and Pharmacy, University of NewcastleLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1710072021-11-17T13:18:00Z2021-11-17T13:18:00Z‘Off-label’ use is common in medicine – a bioethicist and legal philosopher explain why the COVID-19 vaccines are different<figure><img src="https://images.theconversation.com/files/431765/original/file-20211113-1788-1dxb739.jpg?ixlib=rb-1.1.0&rect=19%2C31%2C2098%2C1308&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Research suggests that about 20% of all prescriptions are administered "off-label."</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/off-label-concept-royalty-free-image/511790452?adppopup=true">Hafakot/iStock via Getty Images Plus</a></span></figcaption></figure><p>Kids ages 5 to 11 can now be vaccinated against COVID-19 following the Food and Drug Administration’s emergency use authorization of the <a href="https://theconversation.com/the-fda-authorizes-pfizers-covid-19-vaccine-for-children-ages-5-to-11-a-pediatrician-explains-how-the-drug-was-tested-for-safety-and-efficacy-169907">Pfizer Bio-NTech vaccine for this age group</a> and the <a href="https://www.cdc.gov/media/releases/2021/s1102-PediatricCOVID-19Vaccine.html">Centers for Disease Control and Prevention’s endorsement</a> in early November 2021.</p>
<p>Some parents <a href="https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-october-2021/">remain hesitant</a> about vaccinating their kids. But many around the country are <a href="https://spectrumlocalnews.com/nys/rochester/coronavirus/2021/11/05/rochester-area-pediatric-vaccination-appointments-filling-up-quickly">enthusiastically signing up</a> and <a href="https://www.fox19.com/2021/11/03/heavy-demand-vaccine-among-kids-5-11-cincinnati-childrens/">lining up</a> to get their elementary schoolers vaccinated. Yet parents of children under 5 are <a href="https://twitter.com/vegforward/status/1455901492284698639?s=20">still left wondering</a> when their children will be vaccinated. <a href="https://www.cnn.com/2021/11/03/health/covid-19-vaccines-children-younger-than-5-wellness/index.html">Experts suggest</a> it may not be before next year.</p>
<p>This wait could prompt parents and doctors alike to consider vaccinating against COVID-19 “<a href="https://doi.org/10.1016/j.vaccine.2017.02.056">off-label</a>.” Off-label refers to the administration of an FDA-approved product for a different population, use or <a href="https://theconversation.com/why-vaccine-doses-differ-for-babies-kids-teens-and-adults-an-immunologist-explains-how-your-immune-system-changes-as-you-mature-168708">dosage</a> than what it was approved for. It is a common practice in health care. </p>
<p>However, <a href="https://www.cnn.com/2021/08/23/health/covid-19-vaccine-off-label-children-fda-bn/index.html">the FDA</a> and the <a href="https://www.aappublications.org/news/2021/08/24/covid-vaccine-off-label-warning-082421">American Academy of Pediatrics</a> have warned against off-label use of COVID-19 vaccines in kids. And the CDC <a href="https://www.cdc.gov/vaccines/covid-19/vaccination-provider-support.html">prohibits it</a> based on the COVID-19 vaccine provider agreement it has with pharmacies, hospitals and clinics that are administering COVID-19 vaccines. </p>
<p>But is it ethical to withhold available vaccines from young kids? </p>
<p>We are philosophers with <a href="https://scholar.google.com/citations?user=AqiUIzAAAAAJ&hl=en">expertise in bioethics</a>, <a href="https://scholar.google.com/citations?user=mbfKbrgAAAAJ&hl=en">legal philosophy</a> and the application of philosophy to <a href="https://www.ippp.gmu.edu/">public policy</a>. <a href="https://doi.org/10.1002/hast.1296">Our newly published analysis</a> explores how prohibiting off-label use of COVID-19 vaccines in kids departs from ethical and legal norms. </p>
<p>Off-label vaccination is not a strategy for mass vaccination. But our research suggests that off-label use of COVID-19 vaccines is an ethically permissible option on a case-by-case basis. This is especially true for children at high risk of severe COVID-19 infection because of underlying conditions, or those at heightened exposure to COVID-19. </p>
<h2>What is off-label use?</h2>
<p>While off-label use may be a new concept to many, in medical practice it is <a href="https://doi.org/10.1001/archinte.166.9.1021">relatively routine</a>. Studies suggest that <a href="https://doi.org/10.7326/0003-4819-150-5-200903030-00108">approximately 20%</a> of all prescriptions are administered off-label. </p>
<p>In pediatrics, off-label use is even <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6677268/">more common</a> because fewer clinical trials of the kind required for the FDA approval process are conducted in children. The American Academy of Pediatrics <a href="https://www.aappublications.org/news/2016/12/26/OffLabel122616">endorses off-label use</a> as an available tool “to benefit the individual patient” based on a pediatrician’s clinical judgment and the best evidence available. A <a href="https://doi.org/10.1542/hpeds.2018-0168">recent study</a> suggests that over half of pediatric hospitalizations involve treatment with at least one off-label medication.</p>
<p><a href="https://doi.org/10.7326/0003-4819-150-5-200903030-00108">Reasons for off-label use</a> vary. Practically, the time and cost to conduct additional clinical trials on an already-approved medication is burdensome. Some products proven to be safe for use for a specific reason are later found to be effective for a new purpose. Off-label use helps make these treatments more accessible to other populations who may benefit from them.</p>
<p>Within medicine, off-label use is an ethically and legally sound practice. The FDA does not permit physicians to conduct experimental research on patients outside of clinical trials. But the <a href="https://doi.org/10.1080/01947649909511094">law does permit</a> physicians to prescribe FDA-approved products off-label for the purpose of enhancing a patient’s well-being. Doctors face no heightened risk of malpractice liability when they follow informed consent processes, when clinical data suggest that the anticipated benefits likely outweigh known risks and when the medication was prescribed for the patient’s benefit rather than for research.</p>
<h2>But what about COVID-19 vaccines?</h2>
<p>Despite the ethical and legal norms supporting off-label use, it’s more complicated when it comes to COVID-19 vaccines. </p>
<p>When the FDA <a href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine">“fully approved</a>” the Pfizer vaccine for people age 16 and older in August 2021, some parents, pediatricians and scientists <a href="https://www.wired.com/story/are-off-label-prescriptions-a-backdoor-to-giving-kids-covid-vaccines/">began debating</a> whether it could be administered “off-label” to younger kids who were not yet eligible.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/432105/original/file-20211116-17-1mjcotf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A child with long hair wearing a mask receives a Pfizer COVID-19 shot." src="https://images.theconversation.com/files/432105/original/file-20211116-17-1mjcotf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/432105/original/file-20211116-17-1mjcotf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/432105/original/file-20211116-17-1mjcotf.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/432105/original/file-20211116-17-1mjcotf.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/432105/original/file-20211116-17-1mjcotf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=502&fit=crop&dpr=1 754w, https://images.theconversation.com/files/432105/original/file-20211116-17-1mjcotf.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=502&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/432105/original/file-20211116-17-1mjcotf.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=502&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Kid ages 5 to 11 are now eligible for the Pfizer COVID-19 shot, but parents of younger children – even those at high risk of severe COVID-19 – still have months to wait for vaccines to be authorized for that age group.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/eight-year-old-child-receives-the-pfizer-biontech-covid-19-news-photo/1236307179?adppopup=true">Joseph Prezioso/AFP via Getty Images</a></span>
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<p>Off-label vaccination is less common than prescribing medication off-label. But other vaccines are at times administered off-label, especially <a href="https://pubmed.ncbi.nlm.nih.gov/9639369/">during outbreaks</a> of diseases like measles. The MMR (measles, mumps and rubella) vaccine is <a href="https://www.fda.gov/vaccines-blood-biologics/vaccines/measles-mumps-and-rubella-virus-vaccine-live">approved for kids older than 12 months only</a>. Yet even the CDC’s Advisory Committee on Immunization Practices <a href="https://health.mil/Reference-Center/Publications/2020/06/23/Standing-Orders-for-Administering-Measles-Mumps-Rubella-Vaccine-Pediatric">recommends</a> administering the MMR vaccine off-label to children between 6 and 12 months old when traveling internationally. </p>
<p>But in the case of COVID-19 vaccines, the CDC <a href="https://www.cdc.gov/vaccines/covid-19/vaccination-provider-support.html">vaccine provider agreement restricts</a> off-label vaccination. The agreement prohibits using federally purchased COVID-19 vaccines outside the ages for which vaccines are authorized or approved. The CDC <a href="https://www.cdc.gov/vaccines/covid-19/vaccination-provider-support.html">has implied</a> that providers who do not follow this agreement risk legal and financial liability and can be removed from the vaccine provider program. As <a href="https://crsreports.congress.gov/product/pdf/IN/IN11560">all COVID-19 vaccines administered in the U.S.</a> are purchased and supplied by the U.S. government, the agreement effectively prohibits any off-label use in children. </p>
<p>This means that medical providers are unable to offer off-label vaccination even to those children for whom it might be most ethically justified, namely those with underlying health conditions that place them at <a href="https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html">increased risk</a> of complications from COVID-19. </p>
<p>[<em>Research into coronavirus and other news from science</em> <a href="https://theconversation.com/us/newsletters/science-editors-picks-71/?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=science-corona-research">Subscribe to The Conversation’s new science newsletter</a>.]</p>
<h2>Looking forward</h2>
<p>The CDC has not explained its departure from ethical and legal norms of off-label use for the COVID-19 vaccines. </p>
<p>When considering emergency use authorization of the Pfizer vaccine for 5-to-11-year-olds, <a href="https://www.youtube.com/watch?v=laaL0_xKmmA">FDA advisory committee members</a> drew attention to the possibility of extremely rare side effects in kids that may arise only once the vaccine is administered more widely. The CDC has stressed that the safety of the vaccines will <a href="https://www.cdc.gov/media/releases/2021/s1102-PediatricCOVID-19Vaccine.html">continue to be closely monitored</a>.</p>
<p>Because of this, some members of the FDA’s vaccine committee <a href="https://www.statnews.com/2021/10/26/pfizer-covid19-vaccine-kids-vrbpac-fda/">expressed concern</a> about authorizing the vaccine for all kids this age, even while stressing its importance for high-risk kids. The committee ultimately <a href="https://www.npr.org/sections/health-shots/2021/10/26/1049372524/fda-panel-recommends-pfizer-vaccine-for-kids-ages-5-to-11">voted to recommend</a> authorization. But had off-label use of COVID-19 vaccines been on the table, some high-risk kids would have already had access to the vaccine. So would kids under 5.</p>
<p>For children under 5 with high-risk medical conditions or those living in communities that continue to have low overall <a href="https://www.nytimes.com/interactive/2020/us/covid-19-vaccine-doses.html">vaccination rates</a>, high community spread <a href="https://districtadministration.com/track-school-mask-rules-requirements-state-by-state/">or prohibitions</a> on other <a href="https://theconversation.com/evidence-shows-that-yes-masks-prevent-covid-19-and-surgical-masks-are-the-way-to-go-167963">evidence-based</a> mitigation strategies like indoor masking, their parents and pediatricians may want to decide that the benefits of off-label vaccination outweigh the risks. But they can’t. </p>
<p>Heightened awareness of off-label use practices might lead parents to wonder – or worry – about its frequent and routine use in pediatric care. One way to reduce off-label use in kids in general is to <a href="https://doi.org/10.1126/scitranslmed.3008043">increase pediatric clinical trials</a>. This requires funding for and interest from researchers and participants – including children and their parents. COVID-19 vaccines sparked an outpouring of interest in enrolling in clinical trials. This broadening of interest may yield more and faster access to “on-label” vaccines and other pharmaceuticals for children in the future.</p><img src="https://counter.theconversation.com/content/171007/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The CDC’s COVID-19 vaccine provider agreement prohibits health care professionals from administering the vaccines in people for whom they are not yet authorized or approved. But this departs from longstanding norms.Elizabeth Lanphier, Assistant Professor of Philosophy and Bioethicist, University of Cincinnati Shannon Fyfe, Assistant Professor of Philosophy and Adjunct Professor of Law, George Mason UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1711642021-11-08T11:14:26Z2021-11-08T11:14:26ZVaccine trial misconduct allegation – could it damage trust in science?<p><em>This article has been updated and certain passages, which are the subject of disagreement between parties referred to in the article, have been removed.</em></p>
<p>The success of medical research has been one of the few positives of the COVID pandemic. The effectiveness of vaccines in preventing deaths (see graph below), is particularly impressive given the <a href="https://theconversation.com/dont-hold-your-breath-for-a-covid-19-vaccine-in-2020-137441">short time</a> in which they were developed. But if <a href="https://www.bmj.com/content/375/bmj.n2635">recent allegations</a> from a whistleblower about a Pfizer vaccine trial can be proven, they would indicate that time and financial pressures may have led to serious misconduct.</p>
<p>The whistleblower is Brook Jackson, previously a regional director at a Texas-based contract research organisation called Ventavia, who supplied an account to the BMJ. She alleges that Ventavia falsified data, “unblinded” patients (that is, researchers could see who was receiving the vaccine and who the placebo), employed inadequately trained vaccinators, and was slow to follow up on adverse events during one of the final trials.</p>
<p>Given the size of the vaccine trial, and the many centres involved, bad data from a few rogue centres is unlikely to fatally undermine the evidence needed for licensing the Pfizer vaccine. But it is important to examine allegations because research misconduct is a serious issue, especially if linked to a vaccine being given to millions of people. If the alleged activity turns out to be true, there must be severe consequences for Ventavia and those involved.</p>
<p><strong>Evidence from the UK that COVID vaccines prevent deaths</strong></p>
<figure class="align-center ">
<img alt="Graph showing that COVID vaccines reduce death rates." src="https://images.theconversation.com/files/430486/original/file-20211105-9897-1kh6rz2.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/430486/original/file-20211105-9897-1kh6rz2.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/430486/original/file-20211105-9897-1kh6rz2.jpeg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/430486/original/file-20211105-9897-1kh6rz2.jpeg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/430486/original/file-20211105-9897-1kh6rz2.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/430486/original/file-20211105-9897-1kh6rz2.jpeg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/430486/original/file-20211105-9897-1kh6rz2.jpeg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=566&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Death rates (blue) in January 2021 are significantly higher compared with November 2021 despite similar infection rates (red). This correlates with vaccine uptake. Note left axis (daily cases) is ten times larger than the right axis (daily deaths as recorded on death certificates). Vaccination rate is not to scale, but data ranges from 0 to 50 million.</span>
<span class="attribution"><a class="source" href="https://coronavirus.data.gov.uk/">Data downloaded from UK government website on November 3, 2021.</a>, <span class="license">Author provided</span></span>
</figcaption>
</figure>
<p>The international rules for conducting clinical trials are described in the World Medical Association’s <a href="https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/">Declaration of Helsinki</a>. This document lays out the conditions and considerations needed for researchers and doctors to act with integrity when conducting research. </p>
<p>Research integrity has two aspects, both of which are alleged to have been a problem at Ventavia. Poor record-keeping, glossing over errors and drugs stored inappropriately are breaches of methodological integrity, while reports of participants waiting in corridors (when they were supposed to be under observation) and delays in following up side-effects are breaches of ethical integrity.</p>
<p>While ethics and safety regulators play an important role in the design and conduct of trials, ethics committees and inspectors cannot be aware of everything that goes on. Ethical conduct in particular is based on trust that researchers will carry out their work under the rules agreed with the ethics committee. Similarly, safety regulators are not in the position of policing all aspects of trials. In this case, while the US regulator (the Food and Drug Administration) was reportedly trying to monitor the trial, it only inspected <a href="https://www.bmj.com/content/375/bmj.n2635">nine out of 153 sites</a>, not including any of the Ventavia sites.</p>
<p>A spokesperson for Ventavia provided the following comment:</p>
<blockquote>
<p>Ventavia is aware of recent accusations in an article written by Paul Thacker [investigative reporter and author of the BMJ article]. Mr. Thacker did not contact Ventavia prior to publication. These same accusations were made a year ago, at which time Ventavia notified the appropriate parties. The allegations were investigated and determined to be unsubstantiated. Ventavia takes research compliance, data integrity, and participant safety very seriously, and we stand behind our work supporting the development of life-saving vaccines.</p>
</blockquote>
<h2>Complicated activity</h2>
<p>Medical research is a complicated activity and the careful work needed to produce reliable results often takes a long time. Indeed, recent problems at a <a href="https://www.bbc.co.uk/news/health-54923641">UK testing centre</a> – where around 43,000 people may have been wrongly told that their COVID test was negative – show that it is easy to make mistakes, even when conducting the same laboratory process tens of thousands of times. For this reason, universities and other research institutions are required to <a href="https://www.universitiesuk.ac.uk/topics/research-and-innovation/concordat-research-integrity">provide training</a> in research integrity, alongside having processes to detect and investigate serious integrity issues. </p>
<p>In parallel, work by <a href="https://www.ukri.org/our-work/supporting-healthy-research-and-innovation-culture/research-integrity/">research funders</a>, <a href="https://royalsociety.org/topics-policy/projects/research-culture/">academic societies</a> and <a href="https://wellcome.org/what-we-do/our-work/research-culture">research charities</a> is continuously trying to identify the pressures that lead to integrity issues. Perhaps unsurprisingly, time and money pressures frequently top the list. As the COVID dust starts to settle, more allegations like this will undoubtedly be made.</p>
<p>While misconduct is always regrettable, it is not unexpected. Sometimes the scientific method can be presented in an almost mythical way as if it is somehow entirely objective. This view is incorrect. </p>
<p>In reality, science is a human activity conducted by people with different motivations. But perhaps the difference between science and other activities is that systematic efforts are made to check and confirm results. This does not stop some worrying that science has a “<a href="https://www.ukrn.org/">reproducibility crisis</a>” (the problem that not all experiments can be repeated), or that there is a great deal of <a href="https://www.thelancet.com/series/research">research waste</a> (research with no societal benefits), or that misconduct <a href="https://retractionwatch.com">requiring retractions</a> does occur, but scientists are aware of these problems and <a href="https://www.ukri.org/news/promoting-research-integrity-across-the-uk/">are trying to address them</a>.</p>
<p>Take, for instance, the former physician Andrew Wakefield’s <a href="https://www.nature.com/articles/d41586-020-02989-9">fraudulent research</a> – published in The Lancet, but subsequently retracted – which claimed a link between the MMR vaccine and autism. This was a clear and serious breach of research integrity, and although it caused a lot of harm, it also led to <a href="https://www.cochrane.org/news/cochrane-review-confirms-effectiveness-mmr-vaccines">thousands of studies</a> both refuting the fraudulent research, but also arguably <a href="https://www.nature.com/articles/s41577-020-00479-7">advancing vaccine science</a> to the point that it was able to contend with SARS-CoV-2 when it arrived. The Wakefield scandal <a href="https://www.bmj.com/content/342/bmj.c7452">also caused</a> a great deal of self-reflection and many positive actions trying to prevent such things from ever happening again.</p>
<p>COVID science has produced some amazing results, but it is still too early to fully assess the overall value of the research efforts. Given the vast amount of funding, and thousands if not millions of researchers working on COVID, alongside the successes there will inevitably be more examples of alleged misconduct – leading, inevitably, to sensationalist headlines. But when this happens, it is important to remember how many lives the vaccines and other treatments have saved. Yes, science is a human activity. Yes, integrity can be a problem. Yes, fraud and misconduct will occasionally occur, but science also produces remarkable results.</p><img src="https://counter.theconversation.com/content/171164/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Simon Kolstoe does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Pfizer contractor Ventavia denies accusations of scientific misconduct on COVID vaccine trial.Simon Kolstoe, Reader in Bioethics and University Ethics Advisor, University of PortsmouthLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1710012021-11-05T15:00:55Z2021-11-05T15:00:55ZI’m an infectious disease doctor. Yes, I’m vaccinating our 5-year-old against COVID-19. Here is why you should too.<figure><img src="https://images.theconversation.com/files/430390/original/file-20211104-25-12ufquc.jpg?ixlib=rb-1.1.0&rect=684%2C14%2C3414%2C2195&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Carter Giglio, 8, joined by service dog Barney of Hero Dogs, shows off the bandage over his injection site after being vaccinated at Children's National Hospital in Washington.
</span> <span class="attribution"><span class="source">(AP Photo/Carolyn Kaster)</span></span></figcaption></figure><iframe style="width: 100%; height: 175px; border: none; position: relative; z-index: 1;" allowtransparency="" src="https://narrations.ad-auris.com/widget/the-conversation-canada/i-m-an-infectious-disease-doctor--yes--i-m-vaccinating-our-5-year-old-against-covid-19--here-is-why-you-should-too-" width="100%" height="400"></iframe>
<p>I am an infectious disease physician. When it is our turn to vaccinate our five-year-old son against COVID-19, I will do so with confidence and without hesitation. I am encouraging every parent with eligible children between ages five and 11 to do the same. Here is why.</p>
<p>The U.S. Food and Drug Administration (FDA) <a href="https://www.cbc.ca/news/world/fda-approves-pfizer-children-1.6229798">recently authorized the Pfizer-BioNTech vaccine for children between five and 11 years of age</a>. Subsequently, <a href="https://www.cbc.ca/news/health/children-covid-19-vaccine-pfizer-cdc-advisory-panel-1.6234568">members of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted unanimously to recommend vaccination for all children ages five to 11</a>, a recommendation quickly endorsed by CDC director Dr. Rochelle Walensky. </p>
<p>The rush to vaccinate children in this age group in the United States has now begun.</p>
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<img alt="" src="https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=600&fit=crop&dpr=1 600w, https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=600&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=600&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=754&fit=crop&dpr=1 754w, https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=754&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=754&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="attribution"><a class="source" href="https://theconversation.com/ca/topics/vaccine-confidence-in-canada-107061">Click here for more articles in our series about vaccine confidence.</a></span>
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<p><a href="https://www.cbc.ca/news/health/pfizer-seeks-kids-covid-vaccine-approval-health-canada-1.6215547">Health Canada</a> is reviewing a similar submission from Pfizer to allow its vaccine to be used in children aged five to 11. Approval is expected in the coming weeks. The National Advisory Committee on Immunization (NACI) will then provide guidance for its use in Canada, after which we expect to have the vaccine authorized for all children in Canada in this age group.</p>
<h2>Reviewing the evidence</h2>
<p><a href="https://www.theglobeandmail.com/canada/article-parents-more-hesitant-to-vaccinate-kids-than-themselves-researcher/">Many parents in Canada have indicated hesitancy to vaccinate their children</a>, and understandably all parents have questions about weighing the risks and benefits. Let’s review the evidence.</p>
<p>Pfizer’s clinical trial conducted in the United States in kids aged five to 11 began early in 2021, and a significant surge of COVID-19 occurred soon after as the highly contagious Delta variant swept across the country. The data reported from the clinical trial thus far is encouraging. </p>
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Read more:
<a href="https://theconversation.com/ethical-decisions-weighing-risks-and-benefits-of-approving-covid-19-vaccination-in-children-ages-5-11-169820">Ethical decisions: Weighing risks and benefits of approving COVID-19 vaccination in children ages 5-11</a>
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<p>The antibody responses <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-results">in children aged five to 11 with two 10-microgram doses, given three weeks apart, were comparable to those in persons aged 16 to 25 who were given two 30-microgram doses three weeks apart</a>. Being fully vaccinated <a href="https://www.npr.org/sections/health-shots/2021/10/22/1048334791/pfizer-biontech-covid-vaccine-appears-more-than-90-effective-in-kids-5-to-11">reduced the chances of being infected with COVID-19 by over 90 per cent, an impressive number especially amidst the Delta surge</a>. </p>
<p>No concerning safety events were identified in over 3,000 children who received the vaccine, although followup intervals were short.</p>
<h2>Why vaccinate kids against COVID-19?</h2>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/430173/original/file-20211104-17-3uuo0i.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A vial of Pfizer-BioNTech COVID-19 vaccine for children, with a tag indicating it is for ages five to 11" src="https://images.theconversation.com/files/430173/original/file-20211104-17-3uuo0i.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/430173/original/file-20211104-17-3uuo0i.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/430173/original/file-20211104-17-3uuo0i.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/430173/original/file-20211104-17-3uuo0i.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/430173/original/file-20211104-17-3uuo0i.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/430173/original/file-20211104-17-3uuo0i.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/430173/original/file-20211104-17-3uuo0i.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Data from Pfizer’s clinical trial in children, conducted in the U.S., is encouraging.</span>
<span class="attribution"><span class="source">(AP Photo/Mary Altaffer)</span></span>
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</figure>
<p>A question commonly asked by parents is this: “Kids don’t generally get very sick or die from COVID-19 compared to adults, right? So why vaccinate them if their risk is so low?”</p>
<p>Yes, the risk of children getting very sick or dying with COVID-19 is low, but the relative risk of severe outcomes and death that kids face when they acquire COVID-19 is extremely high. <a href="https://www.fda.gov/media/153508/download">COVID-19 was the sixth highest cause of death from disease in children ages five to 11 in the U.S. in 2020, comparable to rates of death seen in children with heart or lung disease</a>. If there were a way to prevent death in children with heart or lung disease as simple as a safe two-dose vaccine, there would be very little hesitation from parents to take advantage of it.</p>
<p>Besides hospitalization and death, COVID-19 infection poses other significant risks for children, including the risk of multisystem inflammatory syndrome in children (MIS-C) and longer-term post-COVID-19 complications (“long COVID”) similar to adults. <a href="http://doi.org/10.1001/jama.2021.2091">MIS-C can occur two to six weeks after COVID-19 infection, nearly two-thirds of affected children will require critical care support, and between one and two per cent of affected children will die</a>.</p>
<p><a href="https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/conditionsanddiseases/bulletins/prevalenceofongoingsymptomsfollowingcoronaviruscovid19infectionintheuk/1april2021">About seven per cent of children in the United Kingdom who recovered from COVID-19 infection reported ongoing symptoms 12 weeks after being diagnosed</a>, which affected various aspects of their quality of life: missing school, being less able to perform physical activity and mental health concerns.</p>
<p>MIS-C and long COVID in children are best avoided through prevention of COVID-19 infection by being fully vaccinated.</p>
<h2>Concerns about side-effects</h2>
<p>The primary side-effect of concern in young children receiving the COVID-19 vaccine is myocarditis, or inflammation of the heart muscle. <a href="https://doi.org/10.1056/NEJMoa2110737">In one recent Israeli study</a>, the risk of myocarditis was highest in male patients between ages 16 and 29 after a second dose of an mRNA vaccine, at roughly 11 out of every 100,000 males. <a href="https://doi.org/10.1056/NEJMoa2109730">A second Israeli study identified males between ages 16 and 19 as being at greatest risk</a>. The risk of myocarditis in females across all age groups was negligible in both studies. Deaths due to vaccine-induced myocarditis are extremely rare, and nearly all cases recover fully.</p>
<figure class="align-center ">
<img alt="A Black woman in a face mask holds her son's hand as a health-care worker gives him an injection" src="https://images.theconversation.com/files/430165/original/file-20211104-19-1wgjf9f.jpg?ixlib=rb-1.1.0&rect=216%2C86%2C5483%2C3529&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/430165/original/file-20211104-19-1wgjf9f.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/430165/original/file-20211104-19-1wgjf9f.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/430165/original/file-20211104-19-1wgjf9f.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/430165/original/file-20211104-19-1wgjf9f.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/430165/original/file-20211104-19-1wgjf9f.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/430165/original/file-20211104-19-1wgjf9f.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">A seven-year-old gets the Pfizer-BioNTech COVID-19 vaccine in Bronx, N.Y. The United States has approved the vaccine in children ages five to 11, and Canada is expected to follow suit.</span>
<span class="attribution"><span class="source">(AP Photo/Mary Altaffer)</span></span>
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<p>In Pfizer’s clinical trial of children between ages five and 11, no cases of myocarditis have been detected, but ongoing surveillance will be necessary as cases of myocarditis in children of this age group are expected to be extremely rare, given that myocarditis is typically a post-pubertal phenomenon. Also, since the vaccine dose being given to children aged five to 11 is one-third the dose given to persons over 12, an even greater reduction in vaccine-induced myocarditis is likely in this younger age group.</p>
<p>The risk of <a href="http://doi.org/10.1001/jama.2021.0107">damage to the heart from infection with SARS-CoV-2</a> is statistically much higher than the risk of vaccine-induced myocarditis. COVID-19 infection can lead to a variety of complications of the heart, some serious. Such complications include damage to heart muscle from myocarditis itself, as well as inflammation of blood vessels supplying the heart muscle caused by the virus. </p>
<p>Many parents worry about the possible effects of COVID-19 vaccine on fertility and future pregnancies. No evidence exists right now to demonstrate any concerns with COVID-19 vaccine and fertility, pregnancy or breast-feeding. <a href="https://doi.org/10.1056/NEJMoa2104983">Tens of thousands of women have received vaccine while being pregnant, and no safety signals have been identified</a>. </p>
<p>Parents are concerned about the lack of long-term safety data available for the mRNA vaccines. No reasonable scientific basis exists to indicate that long-term side effects of mRNA vaccination will occur. mRNA is <a href="https://www.nebraskamed.com/COVID/where-mrna-vaccines-and-spike-proteins-go">degraded in the body very quickly</a>, which is why we would typically expect to see vaccine side effects like myocarditis within the first two months of vaccine administration, or not at all. Billions of doses of COVID-19 vaccine have been administered worldwide with no long-term side effects identified, providing further evidence for the long-term safety of mRNA vaccines.</p>
<h2>Benefits of vaccination far exceed potential risks</h2>
<p>Unfortunately, SARS-CoV-2 is not going to ever go away. Our best-case scenario is <a href="https://ottawacitizen.com/news/local-news/what-does-it-mean-if">endemicity</a>, and even that reality is unpredictable given the potential emergence of new viral variants. We cannot expect our children to live in “bubbles” forever. We must prepare them as best as we can to safely navigate this new reality.</p>
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<img alt="A syringe with a label reading 'PEDIATRIC Pfizer' in the foreground, held by a person in a mask, out of focus in the background" src="https://images.theconversation.com/files/430353/original/file-20211104-21-1egyto7.jpg?ixlib=rb-1.1.0&rect=176%2C109%2C4808%2C3623&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/430353/original/file-20211104-21-1egyto7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/430353/original/file-20211104-21-1egyto7.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/430353/original/file-20211104-21-1egyto7.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/430353/original/file-20211104-21-1egyto7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/430353/original/file-20211104-21-1egyto7.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/430353/original/file-20211104-21-1egyto7.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">Based on the scientific evidence at hand, the benefits of vaccination for five-to-11-year-olds far exceed any potential risk.</span>
<span class="attribution"><span class="source">(AP Photo/David Zalubowski)</span></span>
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</figure>
<p>Based on the scientific evidence at hand, the benefits of vaccination for my five-year-old son far exceeds any potential risk. That is why he will be vaccinated as soon as he is eligible, and also why practically every expert group on child health across the world has come out in favour of universal vaccination of children, including the <a href="https://www.aappublications.org/news/2021/10/26/fda-pfizer-covid-vaccine-children-102621">American Academy of Pediatrics</a>. We have not even brought up the significant societal benefit of moving closer toward herd immunity through universal vaccination of eligible children.</p>
<p>Navigating the COVID-19 pandemic has been difficult and disruptive for children and their families. We now give routine childhood vaccines to our kids without hesitation, and they have dramatically improved the quality of life and life expectancy of children worldwide. Getting every child between ages five and 11 fully vaccinated against COVID-19 helps bring us all one step closer towards normalcy and protects our children from severe outcomes of COVID-19 infection. </p>
<p>That is why I am going to vaccinate our five-year-old son with confidence, and why I will strongly encourage all parents to do the same.</p>
<p><em>Do you have a question about COVID-19 vaccines? Email us at <a href="mailto:ca-vaccination@theconversation.com">ca-vaccination@theconversation.com</a> and vaccine experts will answer questions in upcoming articles.</em></p><img src="https://counter.theconversation.com/content/171001/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Dr. Alexander Wong has previously consulted for Pfizer with regards to its vaccines to prevent pneumococcal infection, and received honoraria from Pfizer for leading scientific discussions for healthcare professionals on pneumococcal vaccines.</span></em></p>An infectious diseases doctor reviews the evidence, discusses hesitancy and concerns about side-effects and explains the overwhelming case for vaccinating five-to-11-year-olds, including his own son.Alexander Wong, Associate Professor, Infectious Diseases, University of SaskatchewanLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1698202021-11-01T16:26:59Z2021-11-01T16:26:59ZEthical decisions: Weighing risks and benefits of approving COVID-19 vaccination in children ages 5-11<figure><img src="https://images.theconversation.com/files/429411/original/file-20211029-23-1u7vp0d.jpg?ixlib=rb-1.1.0&rect=257%2C74%2C4082%2C2809&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Ethics are important to vaccination decisions because while science can clarify some of the costs and benefits, it cannot tell us which costs and benefits matter most to us.</span> <span class="attribution"><span class="source">THE CANADIAN PRESS/Frank Gunn </span></span></figcaption></figure><iframe style="width: 100%; height: 175px; border: none; position: relative; z-index: 1;" allowtransparency="" src="https://narrations.ad-auris.com/widget/the-conversation-canada/ethical-decisions--weighing-risks-and-benefits-of-approving-covid-19-vaccination-in-children-ages-5-11" width="100%" height="400"></iframe>
<p>The U.S. Food and Drug Administration has approved <a href="https://www.cbc.ca/news/world/fda-approves-pfizer-children-1.6229798">Pfizer’s COVID-19 vaccine for use in children ages five to 11</a>. Pfizer’s <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-results">clinical trial results</a> indicate the vaccine is safe and effective in this age group. </p>
<p>This is an important development. <a href="https://globalnews.ca/news/8250271/covid-19-bc-modelling-data-children/">COVID-19 infections</a> <a href="https://www.cbc.ca/news/canada/calgary/covid-alberta-kids-1.6208827">are on the rise</a> <a href="https://www.cbc.ca/news/canada/saskatchewan/covid-19-saskatchewan-october-9-1.6206509">in children</a> <a href="https://www.thestar.com/politics/provincial/2021/09/28/ontarios-new-covid-19-cases-could-drop-to-200-a-day-or-rise-to-5000-latest-modelling-projects.html">across</a> <a href="https://www.cbc.ca/news/canada/new-brunswick/new-brunswick-school-covid-19-1.6202893">Canada</a>.</p>
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<img alt="" src="https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=600&fit=crop&dpr=1 600w, https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=600&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=600&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=754&fit=crop&dpr=1 754w, https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=754&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=754&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="attribution"><a class="source" href="https://theconversation.com/ca/topics/vaccine-confidence-in-canada-107061">Click here for more articles in our series about vaccine confidence.</a></span>
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<p>It is now up to <a href="https://www.cbc.ca/news/health/pfizer-seeks-kids-covid-vaccine-approval-health-canada-1.6215547">Health Canada</a> to consider the data and to decide whether to authorize this COVID-19 vaccine for children. Once it is authorized in Canada, the <a href="https://www.canada.ca/en/public-health/services/immunization/national-advisory-committee-on-immunization-naci.html">National Advisory Committee on Immunization</a> (NACI) will have to decide whether to recommend vaccination for all children in this age group. </p>
<p>This raises the question of how this decision ought to be made.</p>
<h2>Making an ethical decision</h2>
<p>As a moral philosopher who has <a href="http://blog.practicalethics.ox.ac.uk/2021/08/we-should-vaccinate-children-in-high-income-countries-against-covid-19-too/">collaboratively researched</a> <a href="https://doi.org/10.1136/bmj.n1687">ethical issues relating to the vaccination of children</a>, I believe it is important to answer this question, for two reasons. </p>
<p>First, whatever the decision, the principles on which it is based — and should be based — must be clear and transparent. </p>
<p>Second, surprisingly little attention has been paid to this issue in Canada, despite the decision to vaccinate children being a matter <a href="https://www.politico.eu/article/coronavirus-vaccine-children-ethics-science/">of science and ethics</a>. Science can clarify some of the costs and benefits of vaccination, but it cannot tell us which costs and benefits matter and when a cost-benefit ratio is favourable.</p>
<p>Fortunately, there is no need to generate a decision-making procedure from scratch. The procedure used by the <a href="https://www.gov.uk/government/groups/joint-committee-on-vaccination-and-immunisation">United Kingdom’s Joint Committee on Vaccination and Immunisation</a> (JCVI) in deciding whether to vaccinate healthy children aged 12-15 in the U.K. can provide important lessons about what not to do.</p>
<h2>Risks and benefits</h2>
<p>The most important factor is whether the benefits of vaccination outweigh its risks, and the degree to which the benefits outweigh the risks. In weighing these, the JCVI relied on what it called the “health perspective.” </p>
<p>Reasoning from this perspective, the JCVI held (in a <a href="https://www.gov.uk/government/publications/covid-19-vaccination-of-children-and-young-people-aged-12-to-17-years-jcvi-statement/jvci-statement-on-covid-19-vaccination-of-children-and-young-people-aged-12-to-17-years-15-july-2021">series</a> of <a href="https://www.gov.uk/government/publications/jcvi-statement-august-2021-covid-19-vaccination-of-children-and-young-people-aged-12-to-17-years/jcvi-statement-on-covid-19-vaccination-of-children-and-young-people-aged-12-to-17-years-4-august-2021">public</a> <a href="https://www.gov.uk/government/publications/jcvi-statement-september-2021-covid-19-vaccination-of-children-aged-12-to-15-years/jcvi-statement-on-covid-19-vaccination-of-children-aged-12-to-15-years-3-september-2021">statements</a>) that the chief benefits of vaccination against COVID-19 were the prevention of death, hospitalization, intensive care unit (ICU) admissions and pediatric inflammatory multisystem syndrome (PIMS) or multisystem inflammatory syndrome (MIS-C). </p>
<p>The chief harms of vaccination were myocarditis, or inflammation of the heart, and pericarditis, inflammation of the thin sack surrounding the heart, though it said these were rare and “typically self-limiting and resolved within a short time.”</p>
<p>The JCVI argued that the benefits of vaccination in this age group are only “marginally greater” than the harms and that therefore vaccination would not be offered to all members of this group.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/429412/original/file-20211029-25-1xe05b5.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A boy wearing a face mask getting an injection" src="https://images.theconversation.com/files/429412/original/file-20211029-25-1xe05b5.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/429412/original/file-20211029-25-1xe05b5.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/429412/original/file-20211029-25-1xe05b5.JPG?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/429412/original/file-20211029-25-1xe05b5.JPG?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/429412/original/file-20211029-25-1xe05b5.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/429412/original/file-20211029-25-1xe05b5.JPG?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/429412/original/file-20211029-25-1xe05b5.JPG?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Twelve-year-old Sam Hallett got his shot at the Aboriginal Health and Wellness Centre in Winnipeg shortly after Health Canada approved COVID-19 vaccination in his age group in May.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Winnipeg Free Press-Mike Deal</span></span>
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<p><a href="https://www.canada.ca/en/public-health/services/immunization/national-advisory-committee-on-immunization-naci/recommendations-use-covid-19-vaccines/mrna-adolescents.html">NACI disagreed</a>, but did not outline the ethical principles it relied on in recommending vaccination for children ages 12-17.</p>
<p>JCVI’s decision not to offer all children vaccination against COVID-19 was flawed in numerous respects. (It was later <a href="https://www.gov.uk/government/publications/universal-vaccination-of-children-and-young-people-aged-12-to-15-years-against-covid-19/universal-vaccination-of-children-and-young-people-aged-12-to-15-years-against-covid-19">overruled by the chief medical officers of the U.K.’s four nations</a>.) NACI will do well to avoid these mistakes in making its decision about vaccinating children ages five to 11.</p>
<p>The Independent Scientific Advisory Group for Emergencies (Independent SAGE, a group of British scientists offering independent scientific advice on the prevention of COVID-19) <a href="https://www.independentsage.org/wp-content/uploads/2021/10/Independent-SAGE-JCVI-statement_transparency_final.pdf">has raised a number of concerns about the JCVI’s decision-making process</a>. </p>
<p>One concern is the way in which the JCVI calculated the benefits of vaccination, basing these calculations on risk to the population of all children of death, hospitalization, ICU admission and so on from COVID-19 infection, rather than the risks of these to children with a confirmed infection of COVID-19.</p>
<p>Another concern Independent SAGE raised was that the JCVI did not state which vaccine it considered when it examined the risks, a relevant concern <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/heart-inflammation-rates-higher-after-moderna-covid-19-shot-than-pfizer-vaccine-2021-10-01/">since heart inflammation rates appear to be higher after the Moderna vaccine than after the Pfizer</a> vaccine.</p>
<h2>Direct and indirect benefits</h2>
<p>Some of JVCI’s other mistakes related to value judgments, relying on the health perspective to make its decision. However, the JCVI was not consistent on what this included. </p>
<p>As noted, the JCVI mentioned the prevention of death, hospitalization, ICU admission and PIMS or MIS-C. These are not the only health benefits of vaccination against COVID-19. Some direct and indirect health benefits of vaccination were not clearly included.</p>
<p>The direct benefits include the prevention of <a href="https://www.who.int/publications/i/item/WHO-2019-nCoV-Post_COVID-19_condition-Clinical_case_definition-2021.1">long COVID</a> — a condition affecting anywhere <a href="https://www.thelancet.com/journals/lanchi/article/PIIS2352-4642(21)00198-X/fulltext">from two</a> <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/english-study-finds-long-covid-affects-up-1-7-children-months-after-infection-2021-09-01/">to 14</a> per cent of children infected with COVID-19 — and potential neurological and cognitive deficits caused by COVID-19 infection. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/429418/original/file-20211029-21-1rwklhi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A group of adolescents near a schoolyard play structure" src="https://images.theconversation.com/files/429418/original/file-20211029-21-1rwklhi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/429418/original/file-20211029-21-1rwklhi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=422&fit=crop&dpr=1 600w, https://images.theconversation.com/files/429418/original/file-20211029-21-1rwklhi.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=422&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/429418/original/file-20211029-21-1rwklhi.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=422&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/429418/original/file-20211029-21-1rwklhi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=530&fit=crop&dpr=1 754w, https://images.theconversation.com/files/429418/original/file-20211029-21-1rwklhi.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=530&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/429418/original/file-20211029-21-1rwklhi.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=530&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Families and youth aged 12 and older line up for a COVID-19 vaccine at a Toronto school in May.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Nathan Denette</span></span>
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<p>Preventing the <a href="https://doi.org/10.1136/bmj.n2052">negative mental and physical health effects</a> associated with school closures, limits on sporting and other such activities and physical distancing requirements are among the indirect benefits (though these were rightly noted by NACI in its recommendation to vaccinate adolescents). These health effects are important when deciding whether to vaccinate.</p>
<p>These are the known risks and benefits. However, the JCVI’s refusal to recommend vaccination to all children aged 12-15 was due to the uncertainties “regarding the magnitude of the potential harms” of vaccination, including myocarditis. </p>
<p>Although it gave considerable weight to unknown harms or uncertainties of vaccination, the JVCI did not consider potential unknown benefits of vaccination, or uncertainties about benefits. There was no reason to rule these out. Uncertainties about benefits seem to be of as much importance in thinking about the risk benefit profile of COVID-19 vaccination as uncertainties about risks. These, again, matter greatly to this decision.</p>
<p>The JCVI made another ethical error when it said the harms of vaccination should be given greater weight (relatively speaking) than the benefits. </p>
<p>There is no good reason to place a higher relative value on harms compared to benefits. Harms caused by vaccines are not worse than harms caused by COVID-19. It does not appear to be true that the rare and typically mild pericarditis or the myocarditis caused by vaccination is any worse than the pericarditis or the myocarditis caused (at <a href="https://www.newscientist.com/article/mg25133462-800-myocarditis-is-more-common-after-covid-19-infection-than-vaccination/">greater</a> <a href="https://www.nytimes.com/2021/10/06/health/covid-vaccine-children-dose.html?smid=tw-share">frequency</a>) by COVID-19 infection. This is not in line with other treatments considered for children, for which harms are not typically weighed more heavily than benefits.</p>
<h2>The well-being perspective</h2>
<p>It was a mistake for JCVI to make the decision about vaccination against COVID-19 in children purely on the basis of the health perspective. Health is important. But it is not the only value in the lives of children. Health is a priority because without it many other important benefits — enjoying friends, connecting with relatives, absorbing oneself in homework or music lessons — become much more difficult, if not impossible.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/429417/original/file-20211029-27-7g7pj5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A 12-year-old girl wearing a face mask with a sticker reading 'I got vaccinated'" src="https://images.theconversation.com/files/429417/original/file-20211029-27-7g7pj5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/429417/original/file-20211029-27-7g7pj5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/429417/original/file-20211029-27-7g7pj5.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/429417/original/file-20211029-27-7g7pj5.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/429417/original/file-20211029-27-7g7pj5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=565&fit=crop&dpr=1 754w, https://images.theconversation.com/files/429417/original/file-20211029-27-7g7pj5.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=565&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/429417/original/file-20211029-27-7g7pj5.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=565&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Sound ethics and sound science show that vaccinating children is, all things considered, beneficial.</span>
<span class="attribution"><span class="source">(AP Photo/Angie Wang)</span></span>
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</figure>
<p>The JCVI mentioned the beneficial effects of vaccination on education. But it did not factor these benefits into the decision relating to vaccinating children against COVID-19. </p>
<p>Educational and other benefits afforded to children by vaccination matter greatly and must be factored into this decision. Moving beyond the health perspective into the well-being perspective encompasses a larger range of benefits and protections from vaccination, including safe and stable learning environments, time with extended family, sport, music performances and the many other things that make life happy and meaningful for children.</p>
<p>When making the decision whether to vaccinate children aged five to 11 against COVID-19, regulators in Canada must rely on both sound science and sound ethics. They must in particular consider all the health and well-being impacts of vaccination more generally; they must consider the uncertain harms and benefits of vaccination; and they must treat benefits and harms symmetrically.</p>
<p>Doing so will show that vaccinating children is, all things considered, beneficial.</p>
<p><em>Do you have a question about COVID-19 vaccines? Email us at <a href="mailto:ca-vaccination@theconversation.com">ca-vaccination@theconversation.com</a> and vaccine experts will answer questions in upcoming articles.</em></p><img src="https://counter.theconversation.com/content/169820/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Anthony Skelton does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>When making the decision whether to vaccinate children aged five to 11 against COVID-19, regulators in Canada must rely on sound ethics as well as sound science.Anthony Skelton, Associate Professor of Philosophy and Core Member of the Rotman Institute of Philosophy, Western UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1699072021-10-29T23:11:21Z2021-10-29T23:11:21ZThe FDA authorizes Pfizer’s COVID-19 vaccine for children ages 5 to 11 – a pediatrician explains how the drug was tested for safety and efficacy<figure><img src="https://images.theconversation.com/files/428434/original/file-20211026-19-1v5f0xs.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">For many parents, the long-awaited COVID-19 vaccine authorization for younger kids can't come soon enough. </span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/little-boy-getting-vaccinated-at-the-pediatricians-royalty-free-image/1300101068?adppopup=true">Vladimir Vladimirov/E+ via Getty Images</a></span></figcaption></figure><p>Elementary school children in the United States will soon have one more layer of protection to keep them safe from COVID-19. </p>
<p>On Oct. 29, 2021, the Food and Drug Administration authorized emergency use of the Pfizer-BioNTech COVID-19 vaccine for children ages 5 to 11. The move came days after a tense and careful deliberation of its key scientific advisory committee, on Oct. 26, 2021, in which members voted 17-0 to authorize the Pfizer shot, with one abstention.</p>
<p>The next necessary step in the process is for the <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations-process.html">Centers for Disease Control and Prevention</a> to issue its guidance on how to use the vaccine in this age group, based on the FDA’s authorization. The CDC’s Advisory Committee on Immunization Practices is scheduled to meet on Nov. 2, 2021, and the agency’s official recommendation is expected as soon as later that day. Rollout of the Pfizer shots for children ages 5 to 11 will likely begin days after.</p>
<p>Once the CDC issues its recommendation, the <a href="https://www.whitehouse.gov/briefing-room/statements-releases/2021/10/20/fact-sheet-biden-administration-announces-update-on-operational-planning-for-covid-19-vaccinations-for-kids-ages-5-11/">28 million eligible U.S. children in this age group</a> will have the opportunity to receive the Pfizer shot through health departments, medical institutions, doctor’s offices and pharmacies, as well as school and community-based sites.</p>
<p>The FDA authorization comes after months of <a href="https://theconversation.com/kids-arent-just-littler-adults-heres-why-they-need-their-own-clinical-trials-for-a-covid-19-vaccine-162821">pediatric clinical trial</a> investigation involving about 4,500 children ages 5 to 11. Pfizer released new data on Oct. 22, 2021, stating that its vaccine is almost <a href="https://www.fda.gov/media/153409/download">91% effective at preventing COVID-19</a> in that age group, with similar tolerability and antibody responses to that seen in older age groups.</p>
<p>Moderna has also <a href="https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-positive-top-line-data-phase-23-study-covid-19">released preliminary results </a> showing that its low-dose vaccine is safe and produces a strong immune response in children ages 6 to 11 years. It plans to submit data to the FDA for review soon.</p>
<p>As a <a href="https://uvahealth.com/findadoctor/profile/debbie-ann-shirley">pediatrician</a> <a href="https://scholar.google.com/citations?user=M6zP_sMAAAAJ&hl=en">specializing in infectious diseases</a>, I have worked closely on many aspects of the COVID-19 response at the University of Virginia. I have helped care for children with severe COVID-19 and also observed the burden of the pandemic on children and their families. Vaccines, which work by <a href="https://theconversation.com/what-happens-when-the-covid-19-vaccines-enter-the-body-a-road-map-for-kids-and-grown-ups-164624">teaching your immune system to make disease-fighting antibodies</a> without giving you the actual disease, have emerged as the most important tool that we currently have to prevent severe COVID-19.</p>
<p>Here’s how the COVID-19 vaccine was tested for efficacy and safety on children and how access to these shots could alter the impact of COVID-19 for American kids.</p>
<h2>The risks of COVID-19 in school-age children</h2>
<p>The FDA advisory committee openly grappled with the risks and benefits of the vaccine and the weightinesss of the decision for younger children. Ultimately, it concluded that parents should be presented with the option to vaccinate their kids against COVID-19. One committee member – Centers for Disease Control and Prevention vaccine expert Amanda Cohn – noted that COVID-19 was the eighth-highest killer of kids in the 5-11 age group over the past year. She pointed out that children are continuing to be hospitalized and to die or otherwise suffer <a href="https://theconversation.com/how-to-help-kids-with-long-covid-thrive-in-school-169076">adverse long-term effects</a> from a largely vaccine-preventable disease. </p>
<p>As of Oct. 21, 2021, more than <a href="https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-state-level-data-report/">6 million</a> American children have tested positive for COVID-19. Cases in children rapidly increased during <a href="https://theconversation.com/delta-variant-makes-it-even-more-important-to-get-a-covid-19-vaccine-even-if-youve-already-had-the-coronavirus-164203">the delta variant surge</a>, which coincided with the opening of in-person school across much of the country. Children now account for a quarter of <a href="https://downloads.aap.org/AAP/PDF/AAP%20and%20CHA%20-%20Children%20and%20COVID-19%20State%20Data%20Report%2010.14%20FINAL.pdf">new weekly cases</a>. </p>
<p>While severe disease and hospitalization from COVID-19 are far more rare in children than in adults, intensive care admission and the need for invasive ventilation do occur in children. There have been over <a href="https://covid.cdc.gov/covid-data-tracker/?ACSTrackingID=USCDC_2145-DM67940&ACSTrackingLabel=10.15.2021%20-%20COVID-19%20Data%20Tracker%20Weekly%20Review&deliveryName=USCDC_2145-DM67940#demographics">1.9 million</a> COVID-19 cases in children ages 5 to 11, with <a href="https://www.fda.gov/media/153508/download">nearly 100 deaths</a>.</p>
<p><a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7036e2.htm">Rates of COVID-19 hospitalization</a> among children and adolescents rose to the highest rates ever in August and September 2021, with <a href="https://www.fda.gov/media/153508/download">over 8,300</a> children in the 5-11 age group hospitalized since the beginning of the pandemic. Many children hospitalized with COVID-19 have underlying medical conditions, but <a href="https://doi.org/10.1001/jamanetworkopen.2021.5298">one-third</a> of them <a href="https://www.fda.gov/media/153409/download">do not</a>. </p>
<p>Additionally, more than <a href="https://covid.cdc.gov/covid-data-tracker/#mis-national-surveillance">5,200 children</a> have been diagnosed with the rare but serious condition called multisystem inflammatory syndrome in children, or MIS-C, in the weeks after COVID-19 infection. MIS-C can cause inflammation of the heart, brain, skin, gut and other organs, requiring hospitalization and often intensive care. The syndrome <a href="https://www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/misc-and-covid19-rare-inflammatory-syndrome-in-kids-and-teens">most commonly occurs in children</a> <a href="https://covid.cdc.gov/covid-data-tracker/#mis-national-surveillance">6 to 11 years</a> of age. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/428440/original/file-20211026-15-fyhs2w.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Doctor providing breathing support for child in operating room." src="https://images.theconversation.com/files/428440/original/file-20211026-15-fyhs2w.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/428440/original/file-20211026-15-fyhs2w.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=401&fit=crop&dpr=1 600w, https://images.theconversation.com/files/428440/original/file-20211026-15-fyhs2w.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=401&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/428440/original/file-20211026-15-fyhs2w.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=401&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/428440/original/file-20211026-15-fyhs2w.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/428440/original/file-20211026-15-fyhs2w.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/428440/original/file-20211026-15-fyhs2w.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Though serious cases of COVID-19 are more rare in children than adults, hospitalizations of children spiked over the summer during the delta variant surge.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/doctor-and-patient-in-operating-theatre-royalty-free-image/532049626?adppopup=true">Simonkr/E+ via Getty Images</a></span>
</figcaption>
</figure>
<p>The pandemic has also harmed children’s <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7024e1.htm">social, emotional</a> and <a href="https://www.aap.org/en/advocacy/child-and-adolescent-healthy-mental-development/aap-aacap-cha-declaration-of-a-national-emergency-in-child-and-adolescent-mental-health/">mental well-being</a> and <a href="https://www.mckinsey.com/industries/public-and-social-sector/our-insights/covid-19-and-education-the-lingering-effects-of-unfinished-learning">delayed their education progress</a>. Safe and effective vaccines are one of the most promising ways that children can be protected from COVID-19, prevent spread and have as little disruption as possible in their schooling and everyday life.</p>
<h2>COVID-19 vaccine development for children</h2>
<p>Before use in the general public, all vaccines go through rigorous phases of testing starting with pre-clinical studies in the laboratory and in animals. Then they must go through three phases of clinical studies in people, allowing investigators and regulators to evaluate the vaccine’s safety at each stage before moving on to test it in larger numbers of people. </p>
<p>Once a vaccine is shown to be safe and effective in adults, <a href="https://theconversation.com/kids-arent-just-littler-adults-heres-why-they-need-their-own-clinical-trials-for-a-covid-19-vaccine-162821">trials move on to children</a>, who may differ in their reactions and immune response to vaccines. Going down stepwise by age, Pfizer studied children <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use">ages 12 to 15</a> before the younger age groups. The FDA expanded its emergency authorization of the Pfizer COVID-19 vaccine to include that age group in May 2021. In adolescents ages 12 to 18, the vaccine was shown to <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7042e1.htm?s_cid=mm7042e1_w">reduce hospitalizations by 93%</a> from June through September 2021.</p>
<p>Even after vaccines are authorized or approved for use, monitoring for safety continues. This allows very rare side effects not seen in large late-phase trials to be detected and investigated. Safety surveillance with the COVID-19 vaccines following authorization in adults and older adolescents ages 16 and up quickly identified a rare increase in inflammation of the heart known as myocarditis following COVID-19 vaccines, particularly in young males. Most patients <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myocarditis.html">responded well</a> to supportive care and rapidly improved. <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7035e5.htm">Myocarditis</a> can also occur with COVID-19 or as a complication of <a href="https://doi.org/10.1001/jama.2021.2091">multisystem inflammatory syndrome</a>. </p>
<p>The Pfizer trial for those under age 12 began with three different doses; ultimately, researchers determined the optimal dosage for children ages 5 to 11 to be <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-results">one-third</a> of the dose given to adults and adolescents and administered as a two-shot regimen three weeks apart. </p>
<p>No serious side effects related to the vaccine, and no cases of myocarditis were reported. The <a href="https://www.fda.gov/media/153447/download">Pfizer data</a> also showed that the vaccine in that age group seems to provide similar high levels of protective antibody responses to those seen in older age groups. And the antibodies produced demonstrated an ability to neutralize the delta variant.</p>
<h2>Next steps</h2>
<p>Ongoing studies will continue to follow vaccinated children closely for safety and to provide more insight into the durability of immunity. The results of the Pfizer vaccine trial for the younger two age cohorts, those 2 to 5 years and 6 months to 2 years, are expected <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-results">later this year</a>. Testing of the Moderna and Johnson & Johnson vaccines in clinical trials in children is also underway. </p>
<p>Given that the pediatric clinical trial data show the overall benefits outweigh risks in this age group, I look forward to being one step closer to offering the COVID-19 vaccine to newly eligible children and their families if the CDC recommendations make this possible.</p>
<p>[<em>Over 115,000 readers rely on The Conversation’s newsletter to understand the world.</em> <a href="https://theconversation.com/us/newsletters/the-daily-3?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=100Ksignup">Sign up today</a>.]</p><img src="https://counter.theconversation.com/content/169907/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Debbie-Ann Shirley does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Pediatric clinical trials for the COVID-19 Pfizer vaccine for children ages 5 to 11 have shown that the Pfizer shot is safe and effective.Debbie-Ann Shirley, Associate Professor of Pediatrics, University of VirginiaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1704222021-10-22T19:38:15Z2021-10-22T19:38:15ZAn infectious disease expert explains new federal rules on ‘mix-and-match’ vaccine booster shots<figure><img src="https://images.theconversation.com/files/427899/original/file-20211021-13-8uxwc7.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C5003%2C3383&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Discuss with your doctor whether or not you need a booster – and if so, which vaccine will work best for you.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/safeway-pharmacist-ashley-mcgee-fills-a-syringe-with-the-news-photo/1344323367?adppopup=true">Justin Sullivan/Getty Images News via Getty Images</a></span></figcaption></figure><p>Many Americans now have the green light to get a COVID-19 vaccine booster – and the flexibility to receive a different brand than the original vaccine they received.</p>
<p>On the heels of the Food and Drug Administration’s Sept. 22, 2021, emergency use authorization of a third dose – or “booster shot” – of the <a href="https://www.fda.gov/news-events/press-announcements/fda-authorizes-booster-dose-pfizer-biontech-covid-19-vaccine-certain-populations">Pfizer-BioNtech</a> vaccine for certain Americans, on Oct. 20, the agency <a href="https://www.nytimes.com/2021/10/20/us/politics/fda-boosters-moderna-johnson-johnson.html">also gave emergency authorization</a> to a third <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-additional-actions-use-booster-dose-covid-19-vaccines">Moderna shot</a> and a second dose of the <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-additional-actions-use-booster-dose-covid-19-vaccines">Johnson & Johnson</a> <a href="https://theconversation.com/new-johnson-and-johnson-data-shows-second-shot-boosts-antibodies-and-protection-against-covid-19-but-one-dose-is-still-strong-against-delta-variant-168463">vaccine</a>. </p>
<p>On Oct. 21, the Centers for Disease Control and Prevention also <a href="https://apnews.com/article/coronavirus-pandemic-science-business-health-centers-for-disease-control-and-prevention-4753c485c75ee34268e1a7de918a7581">recommended these vaccinations</a> in light of the FDA’s authorization. The CDC’s signoff will make the Moderna booster shot available to people 65 and older, younger adults at higher risk of severe COVID-19 due to medical conditions and those who are at increased risk due to their workplace environment. People are now eligible for the Moderna booster six months after completion of their original series – as is already the case for the third Pfizer shot. The authorization made all Johnson & Johnson vaccine recipients eligible for a second shot two months after the initial dose. </p>
<p>Notably, the <a href="https://apnews.com/article/coronavirus-pandemic-science-business-health-coronavirus-vaccine-5ba0ada40600e590fc3ab38bba046a94">FDA and CDC also authorized a “mix-and-match” strategy</a>, enabling eligible Americans to get a booster shot from a brand different from their original vaccine. </p>
<p><a href="https://www.pediatrics.pitt.edu/people/glenn-j-rapsinski-md-phd">As an infectious disease expert</a>, I have closely followed the development of the COVID-19 vaccines and the research on how immunity and vaccine efficacy shift over time. </p>
<p>With the swirling mass of news around how effective the COVID-19 vaccines are and who needs booster shots and when, it can be challenging and confusing to make sense of it all. But understanding how the immune system works can help bring clarity to the reasons some people could benefit from the authorized shots.</p>
<h2>How vaccine efficacy evolves</h2>
<p>The discussion and perceived urgency around booster shots has partially been driven by the occurrence of <a href="https://theconversation.com/what-is-a-breakthrough-infection-6-questions-answered-about-catching-covid-19-after-vaccination-164909">“breakthrough” COVID-19 infections</a> in fully vaccinated people. The term breakthrough misleadingly implies that the vaccines failed, but this is not the case. The intention of the vaccine is to reduce hospitalizations and deaths, a goal that the <a href="https://www.ama-assn.org/delivering-care/public-health/what-doctors-wish-patients-knew-about-breakthrough-covid-infections">COVID-19 vaccines continue to meet</a>. </p>
<p>While the Pfizer mRNA vaccine shows decreasing efficacy against asymptomatic and mild infections over the <a href="https://doi.org/10.1056/NEJMoa2110345">first six months after vaccination</a>, studies show that it continues to be highly effective at <a href="https://doi.org/10.1016/S0140-6736(21)02183-8">preventing hospitalizations and deaths</a>, including <a href="https://doi.org/10.1056/NEJMc2113864">against the delta variant</a>, in the first six months. </p>
<p>A <a href="https://doi.org/10.1056/NEJMc2103916">clinical study of the Moderna vaccine</a> showed that antibody levels remain strong after six months as well. But studies after the six-month mark have been mixed, with reports of <a href="https://www.nature.com/articles/d41586-021-02532-4">waning antibody levels</a> leaving some researchers concerned that a booster shot strategy is essential. However, the <a href="https://theconversation.com/tense-decision-making-as-cdc-joins-fda-in-recommending-pfizer-booster-shot-for-65-and-up-people-at-high-risk-and-those-with-occupational-exposure-to-covid-19-168703">limited data left too many questions</a> for the FDA and CDC to approve a booster shot for all Americans, at least at this time. </p>
<figure class="align-center ">
<img alt="A man wearing a mask receives a COVID-19 vaccine booster." src="https://images.theconversation.com/files/427900/original/file-20211021-14-jvy53b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/427900/original/file-20211021-14-jvy53b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/427900/original/file-20211021-14-jvy53b.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/427900/original/file-20211021-14-jvy53b.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/427900/original/file-20211021-14-jvy53b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/427900/original/file-20211021-14-jvy53b.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/427900/original/file-20211021-14-jvy53b.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Frank Mallone, 71, receives a Pfizer COVID-19 vaccine booster shot in Washington, D.C.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/frank-mallone-receives-a-pfizer-covid-19-vaccine-booster-news-photo/1235695993?adppopup=true">Tom Williams/CQ-Roll Call, Inc. via Getty Images</a></span>
</figcaption>
</figure>
<p>Still, the overwhelming majority of intensive care admissions and deaths from COVID-19 <a href="https://doi.org/10.15585/mmwr.mm7034e5">continue to be in unvaccinated people</a>. The rare deaths from COVID-19 in vaccinated people are mostly in people with <a href="https://www.wistv.com/2021/08/27/vast-majority-hospitalized-covid-breakthrough-cases-sc-among-immunocompromised/">immune systems weakened either by age or underlying conditions</a>, which is why booster shots have been <a href="https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalizations-vaccination">authorized for these groups</a>. While boosters clearly help the individual, it is just as important for everyone to get fully vaccinated to protect vulnerable people by reducing the overall number of cases in the community.</p>
<h2>Vaccines rev up the immune system</h2>
<p>All three of the authorized vaccines in the U.S. work by <a href="https://doi.org/10.1038/s41577-021-00526-x">giving the body instructions</a> for making the spike protein from the SARS-CoV-2 virus that causes COVID-19. The spike protein, which resembles a stem with three buds on the end, is what enables the actual virus to invade cells and cause infection. The mRNA vaccines by Pfizer-BioNTech and Moderna provide the blueprint for the spike protein in the form of mRNA in a drug-delivery system called a <a href="https://doi.org/10.1038/s41578-021-00358-0">lipid nanoparticle</a>. The Johnson & Johnson vaccine gives DNA instructions inside the coat of a <a href="https://www.mayoclinic.org/johnson-johnson-adenovirus-vaccine-explained/vid-20510091">different virus, called a viral vector</a>. </p>
<p>The immune system quickly recognizes that these foreign proteins do not belong, and it generates an <a href="https://theconversation.com/what-happens-when-the-covid-19-vaccines-enter-the-body-a-road-map-for-kids-and-grown-ups-164624">immune response</a> to fight them off. These newfound defenses gear the body up to protect against the real virus. During this <a href="https://doi.org/10.1002/9780470015902.a0029196">primary immune response</a>, immune cells encounter spike proteins and, as a defense, they produce antibodies, “memory” cells and T-cells that can kill infected cells to prevent the virus from multiplying. Some of these antibodies and T-cells from the primary immune response persist over time, though they decrease during the first month after vaccination, while memory cells last much longer.</p>
<p>Then, when someone gets an additional dose of vaccine, the immune system goes through <a href="https://www.ncbi.nlm.nih.gov/books/NBK27158/">a secondary immune response</a>. Thanks to the memory cells, the secondary immune response activates more rapidly, triggering lots of antibody production and T-cell activation. More mature antibodies are produced as well, and they are even better at trapping the spike proteins. And T-cells proliferate, helping to stop the intruder in its tracks. This type of secondary immune response can be activated again and again when repeat exposures to a vaccine – or booster doses – occur. Each time, the immune response mounts a stronger and more effective defense. </p>
<h2>Mix-and-match vaccine boosters</h2>
<p><a href="https://www.nature.com/articles/s41591-021-01464-w">Multiple</a> <a href="https://doi.org/10.1016/S0140-6736(21)01420-3">studies</a>, including <a href="https://doi.org/10.1101/2021.10.10.21264827">preliminary research</a> from the National Institutes of Health that is not yet peer-reviewed, have shown that the <a href="https://doi.org/10.1016/S0140-6736(21)01115-6">mix-and-match</a> strategy is safe and effective at providing a significant immune boost. </p>
<p>Additionally, mixing vaccine types may be most beneficial in those who initially received a non-mRNA vaccine. The NIH data suggests that people who got the single-shot Johnson & Johnson vaccine had a bigger increase and achieved a higher antibody concentration after receiving an mRNA booster than if they received the Johnson & Johnson booster. For people who first received one of the mRNA vaccines, Pfizer or Moderna, followed by a third shot with Johnson & Johnson, the antibody response was similar to that seen in those who got a third, or homologous, mRNA dose. </p>
<p>Studies exploring why the mix-and-match strategy is more effective with some initial vaccines and not others are underway. Understanding this and the effectiveness of different vaccine combinations, including using <a href="https://doi.org/10.1038/s41591-021-01449-9">vaccines that are authorized in other countries</a>, will help improve vaccination strategies all over the world.</p>
<p>Interchanging vaccine types may have greater advantages in some people than in others, which will become clearer as more data is gathered. But the good news is that the immune response seems to get a solid boost from booster shots, regardless of which vaccine combination is used. </p>
<p>[<em><a href="https://theconversation.com/us/newsletters/science-editors-picks-71/?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=science-corona-important">Get The Conversation’s most important coronavirus headlines, weekly in a science newsletter</a></em>]</p><img src="https://counter.theconversation.com/content/170422/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Glenn J. Rapsinski does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>As boosters are authorized for all three COVID-19 shots available in the US, the ability to swap out vaccine types looks to be a boon to the immune system.Glenn J. Rapsinski, Pediatric Infectious Diseases Fellow, University of PittsburghLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1689262021-10-03T23:29:07Z2021-10-03T23:29:07ZNZ needs a more urgent vaccination plan — with nearly 80% now single-dosed, the majority will support it<figure><img src="https://images.theconversation.com/files/424349/original/file-20211003-101695-l48f6.jpg?ixlib=rb-1.1.0&rect=0%2C8%2C5455%2C3579&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">GettyImages</span></span></figcaption></figure><p>With vaccination rates still too low in Auckland and around Aotearoa New Zealand, and with unexpected cases still showing up, there are few options ahead of today’s <a href="https://www.stuff.co.nz/national/health/coronavirus/126568006/covid19-how-likely-is-level-2-for-auckland-pm-says-other-options-on-the-table">government decision</a> on alert levels.</p>
<p>Until there are high levels of immunity, any relaxation of restrictions within Aotearoa when Delta is in the community will dramatically increase the speed at which the virus spreads through the population.</p>
<p>The time has come for a concerted vaccination drive, mandatory vaccination for more workers, and a clear signal that eligible but unvaccinated people will face restricted access to travel and other activities.</p>
<p>With Delta, there is no “herd immunity” — almost everyone who has not been vaccinated will eventually (and sooner rather than later) get infected. Vaccinated people are about 75% less likely than unvaccinated people to develop a COVID infection if exposed, and over 90% less likely to develop severe disease.</p>
<p>In the current Auckland outbreak, only 3% of the more than 1,000 cases were fully vaccinated. There has been only one fully vaccinated patient among the more than 100 hospitalised cases.</p>
<p>With fewer than 10,000 New Zealanders having been infected by COVID-19, unlike most other countries we are completely dependent on high levels of vaccination to provide high levels of immunity.</p>
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<h2>System overload</h2>
<p>Left to its own devices, Delta spreads like wildfire – from 1 person to 6, to 36, to 216, to 1296 and so on – at high speed until there is a high enough vaccination level. This rapid exponential spread is the main threat to health and other essential services.</p>
<p>No hospital system, however many ICU beds per capita, could cope, and no amount of testing would be able to get on top of Delta in an opened-up Aotearoa. Contact tracing systems would be overwhelmed in days.</p>
<p>Without a high vaccination level, increasing hospital capacity or investing in new drugs would be the equivalent of rearranging deck chairs on the Titanic.</p>
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Read more:
<a href="https://theconversation.com/new-zealand-cannot-abandon-its-covid-elimination-strategy-while-maori-and-pasifika-vaccination-rates-are-too-low-168278">New Zealand cannot abandon its COVID elimination strategy while Māori and Pasifika vaccination rates are too low</a>
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<p>Beyond the hospitals, COVID will spread through the unvaccinated 5–11-year-olds at school, who will then infect their teachers, parents and grandparents. Who will be able to care for whom?</p>
<p>Beyond the schools, businesses with clusters of unvaccinated staff will shut down because up to half the unvaccinated infected people will be too sick to work, and up to one in ten could be hospitalised. Asymptomatic infected staff will infect other staff, clients, customers and their families and friends.</p>
<p>Then there is long COVID. A large <a href="https://www.bmj.com/content/373/bmj.n853">British study</a> has reported one in three hospitalised COVID cases needed to be readmitted. </p>
<p>In <a href="https://www.bmj.com/content/372/bmj.n693">another British study</a>, more than half admitted to hospital had long COVID symptoms three months after discharge. Symptoms were worse among those aged under 50, women and those with higher pre-COVID fitness levels.</p>
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<h2>What are the acceptable costs?</h2>
<p>Every national and international health authority has always accepted the only possible sustainable way to deal with COVID is through the development of immunity. </p>
<p>Since the introduction of safe and effective vaccines, every health authority has recommended high levels of vaccination as the only safe and acceptable way to achieve high levels of immunity.</p>
<p>Today, in semi-vaccinated Aotearoa, only two questions are relevant to any plan to open up:</p>
<ul>
<li><p>is there a high target vaccination level and what does the target imply about the numbers of infections, hospitalisations, deaths and cases of long COVID considered an “acceptable cost” of opening up?</p></li>
<li><p>how does the plan propose to achieve the vaccination target required to meet the “acceptable cost”?</p></li>
</ul>
<p>Aotearoa’s most respected COVID-19 modellers, from <a href="https://www.tepunahamatatini.ac.nz/">Te Pūnaha Matatini</a>, have provided robust scenarios of the likely impacts of a one-year outbreak at different vaccination levels.</p>
<p>Their modelling assumes moderate public health measures, including a full testing, tracing, isolation and quarantine system. Their predictions are remarkably similar to equivalent predictions from Australian modelling groups (aside from the one used by the federal government).</p>
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<a href="https://images.theconversation.com/files/424348/original/file-20211003-102804-fmz64f.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/424348/original/file-20211003-102804-fmz64f.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/424348/original/file-20211003-102804-fmz64f.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=532&fit=crop&dpr=1 600w, https://images.theconversation.com/files/424348/original/file-20211003-102804-fmz64f.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=532&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/424348/original/file-20211003-102804-fmz64f.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=532&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/424348/original/file-20211003-102804-fmz64f.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=669&fit=crop&dpr=1 754w, https://images.theconversation.com/files/424348/original/file-20211003-102804-fmz64f.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=669&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/424348/original/file-20211003-102804-fmz64f.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=669&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<h2>More radical plan needed</h2>
<p>The National Party’s recently announced “<a href="https://www.national.org.nz/opening-up">Opening Up</a>” plan was based on nationwide lockdowns no longer being necessary when 70-75% of the population aged 12+ are fully vaccinated.</p>
<p>Based on the Te Pūnaha Matatini models, this suggests the acceptable cost, in the event of a new outbreak, would be somewhere between 1.5 million and 1.8 million cases, 80,000–105,000 hospitalisations and 10,000–13,000 deaths annually.</p>
<p>The plan states international borders would open at a 12+ vaccination level of 85-90%. It’s unclear why there are different thresholds for opening internally and externally. If COVID comes back, whether through an opened border or under the current border restrictions, the consequences will be the same without lockdowns.</p>
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Read more:
<a href="https://theconversation.com/new-zealand-government-takes-a-calculated-risk-to-relax-aucklands-lockdown-while-new-cases-continue-to-appear-168269">New Zealand government takes a calculated risk to relax Auckland's lockdown while new cases continue to appear</a>
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<p>National’s proposals for increasing vaccination rates are excellent, although most are already happening to a greater or lesser extent. If the government hasn’t already done so, however, the proposal to order a supply of booster shots should be adopted immediately, as we are very likely to need these as immunity wanes.</p>
<p>The key problem with the plan is that it’s not sufficiently radical to achieve either the 85-90% target or the more humane target of 95% or higher. Even at 95%, there could be 40,000 cases, 1,000 hospitalisations, over 100 deaths and over 10,000 cases of long COVID.</p>
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<h2>Vaccine ‘passports’ now</h2>
<p>In most countries that have already achieved targets above 90%, the main motivation has been fear due to daily exposure to death and hospitalisations. Fortunately, this does not apply in New Zealand yet, although it might if lockdowns were removed as a strategy at 70–75% vaccination rates.</p>
<p>The most effective intervention now required to convince the last 20% of the eligible population to be vaccinated will be some form of vaccination authentication — a vaccine “passport”.</p>
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Read more:
<a href="https://theconversation.com/new-zealand-has-ramped-up-vaccination-rates-but-too-many-people-remain-concerned-about-vaccine-safety-167984">New Zealand has ramped up vaccination rates, but too many people remain concerned about vaccine safety</a>
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<p>Internationally, this approach has been very successful. It has included mandatory vaccination in many jobs beyond border or healthcare, and restricted access to flying, hospitality and other activities for unvaccinated eligible people.</p>
<p>Both major parties have so far only hinted at many of these options, other than that vaccination should be mandated for healthcare workers. This should have been implemented months ago.</p>
<h2>A non-partisan approach</h2>
<p>It is not surprising politicians are reluctant to make vaccination compulsory for some, restrict activities for the unvaccinated, or allow businesses to exclude workers, clients and customers if they are unvaccinated. But we won’t achieve an acceptable target without it.</p>
<p>Among other international precedents, Victoria will require all school and childcare staff to have their first shot or a booking by October 18. In the US, all federal workers must be vaccinated by November 22. And vaccine “passports” are already required for access to hospitality in much of Western Europe.</p>
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Read more:
<a href="https://theconversation.com/why-a-domestic-nz-covid-passport-raises-hard-questions-about-discrimination-inequality-and-coercion-167703">Why a domestic NZ COVID ‘passport’ raises hard questions about discrimination, inequality and coercion</a>
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<p>New Zealand now needs a unified, non-partisan and radical approach to achieving a minimum 95% of eligible people vaccinated. Ideally this will include 5-11-year-olds if the Pfizer vaccine is approved for this age group.</p>
<p>Mandated vaccination for a wide range of jobs should be introduced, and limits on various activities put in place for unvaccinated eligible people. These may only be required for 12 months, but without them the current restrictions will have to remain.</p>
<p>With almost 80% of all eligible New Zealanders already having had their first vaccination shot, the country will be overwhelmingly behind such a proposal.</p><img src="https://counter.theconversation.com/content/168926/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Rod Jackson does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>With the government decision on alert levels due today, it’s clear a more radical approach to vaccination is needed — including restrictions for eligible but unvaccinated people.Rod Jackson, Professor of Epidemiology, University of Auckland, Waipapa Taumata RauLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1687032021-09-25T11:52:47Z2021-09-25T11:52:47ZTense decision-making as CDC joins FDA in recommending Pfizer booster shot for 65 & up, people at high risk and those with occupational exposure to COVID-19<figure><img src="https://images.theconversation.com/files/423190/original/file-20210924-3841-1shex90.jpg?ixlib=rb-1.1.0&rect=331%2C53%2C4796%2C3172&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The FDA and CDC are recommending use of a third shot, or "booster dose" for certain groups of people in the U.S.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/syringes-wand-vials-of-the-pfizer-biontech-covid-19-vaccine-news-photo/1230186505?adppopup=true"> Patrick T. Fallon/AFP via Getty Images</a></span></figcaption></figure><p>Following the <a href="https://theconversation.com/fda-panel-recommends-limiting-pfizer-booster-shots-to-americans-65-and-older-and-those-at-high-risk-of-severe-covid-19-168224">recommendations of its vaccine advisory committee</a>, the Food and Drug Administration <a href="https://www.fda.gov/news-events/press-announcements/fda-authorizes-booster-dose-pfizer-biontech-covid-19-vaccine-certain-populations">gave emergency use authorization</a> to Pfizer-BioNTech’s COVID-19 vaccine booster dose for certain populations. The single shot is to be administered six months following completion of the original two-dose course.</p>
<p>The FDA’s Sept. 22, 2021, decision to not extend boosters to the general population – at least not yet – was a <a href="https://apnews.com/article/joe-biden-health-coronavirus-pandemic-404cf650431f8aeee17d333180760337">direct rebuke</a> to the Biden administration’s announcement in August that booster shots would be rolled out to all eligible Americans beginning in late September. Biden’s pledge had been widely criticized for <a href="https://www.cnn.com/2021/08/31/health/fda-vaccine-officials-step-down/index.html">getting out in front of the science</a> and the regulatory process.</p>
<p>The FDA instead limited its authorization of the third Pfizer dose to people 65 and older, people ages 18-64 at high risk of severe COVID-19 due to pre-existing conditions, and individuals with frequent risk of exposure to the coronavirus through their work, such as health care workers and teachers. </p>
<p>The Centers for Disease Control and Prevention’s <a href="https://www.cdc.gov/vaccines/acip/index.html">Advisory Committee on Immunization Practices</a> then issued its own booster recommendations on Sept. 23, 2021. Its guidance aligned with the FDA’s authorization of boosters for use in ages 65 and up and people at high risk of severe COVID-19, but stopped short of endorsing booster shots for people with frequent occupational exposure. However, in an effort to realign the two agencies’ recommendations, CDC director Dr. Rochelle Walensky <a href="https://www.nytimes.com/2021/09/24/world/covid-boosters-vaccine-cdc-director.html">overrode the CDC advisory committee</a>, <a href="https://www.cdc.gov/media/releases/2021/p0924-booster-recommendations-.html">providing the go-ahead</a> for all groups listed under the FDA’s emergency use authorizations – including those with increased job-site risk. </p>
<p>Despite the mixed messaging between the agencies, the immediate effect is that millions of Americans will be in line for added protection amid concerns over <a href="https://www.nature.com/articles/d41586-021-02532-4">waning vaccine immunity</a>. An ongoing evaluation of whether COVID-19 boosters should be administered more broadly among vaccine-eligible people is <a href="https://www.statnews.com/2021/09/24/biden-covid-19-boosters-pitting-white-house-against-scientific-advisers/">likely to take place in the coming months</a>, as more data becomes available to inform questions of safety, need and efficacy of boosters.</p>
<h2>Fault lines between the FDA and CDC</h2>
<p>This fraught booster approval process may strike some as strange, as the FDA is solely responsible for drug approval <a href="https://doi.org/10.1001/jama.2021.11558">in most contexts</a>. However, as the body responsible for managing U.S. public vaccination programs, the CDC’s approval is required in order to begin the distribution and administration of vaccines.</p>
<p>The close intersection of the two agencies in approval and distribution of vaccines has recently become a point of contention for some high level officials, with <a href="https://www.cnn.com/2021/08/31/health/fda-vaccine-officials-step-down/index.html">two senior FDA vaccine leaders resigning</a> from their posts in early September 2021. One former FDA leader cited the expanding role of the CDC in vaccine evaluation as <a href="https://endpts.com/breaking-in-a-major-blow-to-vaccine-efforts-senior-fda-leaders-stepping-down-report/">a major reason for their departure</a>.</p>
<p>The tensions between these agencies was on full display when the CDC’s advisory committee excluded high occupational exposure risk as a booster-eligible group, <a href="https://thehill.com/policy/healthcare/573707-cdc-panel-authorizes-covid-19-vaccine-boosters">breaking from the FDA recommendation and authorization</a>. The committee’s vote to not authorize boosters for those with frequent occupational exposures stemmed primarily from concerns that the recommendation was overly broad – potentially leading to confusion as to who counts as a worker at “high risk.” </p>
<p>This, combined with a shared view – <a href="https://doi.org/10.1016/S0140-6736(21)02046-8">including among some public health officials</a> – that critical pieces of data being used to advocate for the booster in the broader population were <a href="https://www.cnbc.com/2021/08/30/booster-shot-cdc-scientist-says-theres-limited-data-to-evaluate-covid-shot-for-general-population.html">incomplete and open to interpretation</a>, resulted in a 9-6 vote from the CDC committee <a href="https://www.statnews.com/2021/09/23/covid19-vaccine-boosters-cdc-acip">against the third dose</a> for those at increased occupational risk. </p>
<h2>Back in alignment</h2>
<p>Ultimately, Walensky’s decision to side with the FDA on extending boosters to those with frequent occupational exposure – such as health care workers and teachers – brings the two agencies into alignment. And while it still falls short of the Biden administration’s pledge of boosters for all vaccine-eligible people in the U.S., the decision will pave the way for millions of third Pfizer doses to be administered in the coming months. </p>
<p>“As CDC Director, it is my job to recognize where our actions can have the greatest impact. At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good,” <a href="https://www.cdc.gov/media/releases/2021/p0924-booster-recommendations-.html">Walensky said in a statement</a>.</p>
<p>More guidance on COVID-19 boosters is expected to be issued soon for people who received the <a href="https://www.nbcchicago.com/news/coronavirus/johnson-johnson-moderna-and-pfizer-what-we-know-about-booster-shots-so-far/2618188/">Moderna</a> and <a href="https://theconversation.com/new-johnson-johnson-data-shows-second-shot-boosts-antibodies-and-protection-but-one-dose-is-still-strong-against-delta-168463">Johnson & Johnson</a> vaccines.</p>
<p>[<em>Research into coronavirus and other news from science</em> <a href="https://theconversation.com/us/newsletters/science-editors-picks-71/?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=science-corona-research">Subscribe to The Conversation’s new science newsletter</a>.]</p><img src="https://counter.theconversation.com/content/168703/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Matthew Woodruff's research is supported by the US National Institute of Health. He is a co-founder of Jefferson's Electorate.</span></em></p>Fault lines between the FDA and CDC regulatory processes have been on full display in the decisions over which groups of Americans should receive the Pfizer booster shot.Matthew Woodruff, Instructor of Human Immunology, Emory UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1676812021-09-15T23:01:00Z2021-09-15T23:01:00ZA researcher’s view on COVID-19 vaccine hesitancy: The scientific process needs to be better explained<figure><img src="https://images.theconversation.com/files/420655/original/file-20210912-27-1x5nmgm.jpg?ixlib=rb-1.1.0&rect=0%2C45%2C3798%2C2644&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">In the reluctance to vaccinate, there is a lack of trust and understanding of the scientific process. Better communication would help rebuild bridges. </span> <span class="attribution"><span class="source">The Canadian Press/Paul Chiasson</span></span></figcaption></figure><iframe style="width: 100%; height: 175px; border: none; position: relative; z-index: 1;" allowtransparency="" src="https://narrations.ad-auris.com/widget/the-conversation-canada/a-researcher’s-view-on-covid-19-vaccine-hesitancy--the-scientific-process-needs-to-be-better-explained" width="100%" height="400"></iframe>
<p><a href="https://theconversation.com/what-scientists-are-doing-to-develop-a-vaccine-for-the-new-coronavirus-131255">When I first wrote about the arrival of SARS-CoV-2</a> in early March 2020, the question was whether or not the new virus would become a pandemic. At the time, most experts believed that we had already reached the point of no return.</p>
<p>Today, 18 months later, the answer is clear. You don’t need to be a scientist to know it. This pandemic is the worst public health emergency of international concern that our modern society has faced. To date, <a href="https://www.who.int/emergencies/diseases/novel-coronavirus-2019?adgroupsurvey=%7Badgroupsurvey%7D&gclid=EAIaIQobChMIyfmOzMHy8gIVkYjICh3I8wo5EAAYAiAAEgKQ3_D_BwE">more than 215 million cases have been confirmed and 4.5 million deaths have been reported globally</a>.</p>
<p>These are just the reported cases. In reality, the number of cases is higher, and for a variety of reasons: lack of diagnostic capacity, infection without symptoms, unwillingness or inability to be tested or to visit a health facility, etc. The number of deaths due to COVID-19 is probably underestimated, both <a href="https://www.cp24.com/mobile/news/death-certificates-don-t-accurately-reflect-the-toll-of-the-pandemic-experts-say-1.5326970?cache=/7.363087">in Canada</a> and <a href="https://www.who.int/data/stories/the-true-death-toll-of-covid-19-estimating-global-excess-mortality">worldwide</a>.</p>
<p>In addition to changing the way we live our daily lives, the pandemic has brought scientific processes to public attention. Researchers, used to working in the shadows, now had to provide solutions — and explanations — to a very real threat, and they have been doing this under the watchful eye of the public.</p>
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<img alt="" src="https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=600&fit=crop&dpr=1 600w, https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=600&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=600&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=754&fit=crop&dpr=1 754w, https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=754&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=754&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="attribution"><a class="source" href="https://theconversation.com/ca/topics/vaccine-confidence-in-canada-107061">Click here for more articles in our series about vaccine confidence.</a></span>
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<p>One of these solutions, vaccination, is far from new. Yet no matter what the context, <a href="https://timesofsandiego.com/opinion/2021/09/08/anti-vax-movement-has-a-long-deadly-history-from-smallpox-to-covid/">it has always generated news</a>. So where are we now?</p>
<p>Still in our laboratories! I recently completed my PhD in microbiology-immunology at Laval University, research that I conducted under the supervision of <a href="https://ipolitics.ca/2020/09/21/leading-vaccine-developer-walks-out-on-federal-vaccine-task-force/">Professor Gary Kobigner</a>, who is known for co-developing an effective vaccine and treatment for Ebola. This fall, I will begin a postdoctoral fellowship at the Galveston National Laboratory in Texas, where I will continue my work on the transmission of, and vaccine development against, severe pathogens.</p>
<h2>Relevant questions</h2>
<p>The World Health Organization (WHO) currently lists <a href="https://www.who.int/news-room/q-a-detail/coronavirus-disease-covid-19">13 available COVID-19 vaccines, based on four different platforms, including mRNA vaccines and viral vector vaccines</a>. Globally, more than five billion doses of vaccines have been administered. In Canada, five of these vaccines are currently approved for use: <a href="https://health-infobase.canada.ca/covid-19/vaccine-administration/">Pfizer-BioNTech, Moderna, AstraZeneca, COVISHIELD and Janssen</a>, with <a href="https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/prevention-risks/covid-19-vaccine-treatment/vaccine-rollout.html#a4">Pfizer-BioNTech, Moderna and AstraZeneca</a> in wide distribution. Combined, these vaccines have been administered to approximately <a href="https://health-infobase.canada.ca/covid-19/vaccination-coverage/">70 per cent</a> of Canadians.</p>
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<img alt="A woman administers a vaccine to another woman, seated, from behind" src="https://images.theconversation.com/files/420137/original/file-20210909-23-1miromd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/420137/original/file-20210909-23-1miromd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=396&fit=crop&dpr=1 600w, https://images.theconversation.com/files/420137/original/file-20210909-23-1miromd.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=396&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/420137/original/file-20210909-23-1miromd.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=396&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/420137/original/file-20210909-23-1miromd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=497&fit=crop&dpr=1 754w, https://images.theconversation.com/files/420137/original/file-20210909-23-1miromd.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=497&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/420137/original/file-20210909-23-1miromd.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=497&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">A woman receives her COVID-19 vaccine at Olympic Stadium in Montréal. Five vaccines have been approved in Canada and about 70 per cent of the population is doubly vaccinated.</span>
<span class="attribution"><span class="source">The Canadian Press/Paul Chiasson</span></span>
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<p>However, <a href="https://theconversation.com/i-work-at-a-covid-19-vaccine-clinic-heres-what-people-ask-me-when-theyre-getting-their-shot-and-what-i-tell-them-167046">many people have raised questions about these vaccines</a>. And it is fair to do so! The unknown has always been a source of anxiety for human beings, it is normal to <a href="https://theconversation.com/astrazeneca-covid-19-vaccine-faq-why-do-the-age-recommendations-keep-changing-does-it-cause-vipit-blood-clots-is-it-effective-against-variants-158302">ask questions</a>.</p>
<p>So, after working tirelessly to develop vaccines against COVID-19, what are scientists and doctors doing now?</p>
<p>They are doing what they have always done: Practising the best science they can within the limits of current knowledge. This scientific practice means continuing to evaluate the effectiveness of these vaccines <a href="https://www.who.int/en/activities/tracking-SARS-CoV-2-variants/">against new variants</a> in labs, as the virus continues to mutate. </p>
<p>It means continuing to record who has experienced side-effects (serious or not) from vaccination and continuing to investigate the potential links between these side-effects and the vaccine. The science they are practising involves studying the virus day and night to understand how it makes people sick, how we can prevent infection and what our options are for getting rid of it as quickly as possible.</p>
<p>The term “current knowledge” is very important here. It is possible that more side-effects related to vaccination will be discovered much later. Here’s why.</p>
<h2>The scientific method</h2>
<p>When vaccines are initially developed in the laboratory and tested on animals, it is normal that <em>not</em> all side-effects are identified. A mouse is not a human, after all, and models cannot account for all the variables that can be found in a human. Humans live in a complex environment and society where individuals each have their own genetics, immunity and lifestyle (exercise, smoking, nutrition).</p>
<p>Furthermore, the more people are vaccinated, the greater the likelihood of detecting a serious side-effect. Clinical trials, where <a href="https://theconversation.com/explainer-how-clinical-trials-test-covid-19-vaccines-146061">drugs and vaccines are evaluated in a small group of individuals</a> before being made available to the general population, are designed to be safe. Volunteers are usually healthy adults, without serious <a href="https://www.inspq.qc.ca/en/publications/3082-impact-comorbidities-risk-death-covid19">pre-existing medical conditions</a>.</p>
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À lire aussi :
<a href="https://theconversation.com/explainer-how-clinical-trials-test-covid-19-vaccines-146061">Explainer: How clinical trials test COVID-19 vaccines</a>
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<p>Vaccination is now widespread in many countries. It is therefore statistically normal that rarer effects (for example, ones that one in a million people develop) are now being observed. These effects are too rare to have been detected in a clinical trial of 10,000 people. This is the case for rare side-effects such as <a href="https://www.forbes.com/sites/siladityaray/2021/09/09/european-medicines-agency-lists-nerve-disorder-as-very-rare-side-effect-of-astrazeneca-covid-19-vaccine/?sh=5fd603e61a7b">Guillain-Barré syndrome</a> and <a href="https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/76203a-eng.php">Bell’s palsy</a>.</p>
<p>The <a href="https://www.sciencebuddies.org/science-fair-projects/science-fair/steps-of-the-scientific-method">scientific method</a> requires that the following process is followed: Observe a problem, formulate a hypothesis about its possible causes, evaluate it experimentally by controlling the variables, interpret the results and draw a conclusion.</p>
<p>It can turn out that our initial hypothesis is wrong, and that is equally acceptable. This is how science was designed. I think that before the pandemic, people considered science infallible. Opening up research to the general public has greatly changed this perception, especially as science quickly became embroiled in politics, particularly over <a href="https://www.who.int/health-topics/coronavirus/origins-of-the-virus">the question of the origin of the pandemic</a>.</p>
<figure class="align-center ">
<img alt="Justin Trudeau is surrounded by scientists, in a lab" src="https://images.theconversation.com/files/420138/original/file-20210909-21-17ccvfk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/420138/original/file-20210909-21-17ccvfk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=436&fit=crop&dpr=1 600w, https://images.theconversation.com/files/420138/original/file-20210909-21-17ccvfk.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=436&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/420138/original/file-20210909-21-17ccvfk.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=436&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/420138/original/file-20210909-21-17ccvfk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=548&fit=crop&dpr=1 754w, https://images.theconversation.com/files/420138/original/file-20210909-21-17ccvfk.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=548&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/420138/original/file-20210909-21-17ccvfk.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=548&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Prime Minister Justin Trudeau with scientists during a visit to the National Research Council of Canada (NRC), in Montréal, August 2020. The scientific method makes it possible to observe a problem, formulate a hypothesis about its causes, evaluate it experimentally by controlling the variables, interpret the results and draw a conclusion.</span>
<span class="attribution"><span class="source">The Canadian Press/Graham Hughes</span></span>
</figcaption>
</figure>
<h2>Knowing how to communicate</h2>
<p>And that’s where the problem comes from, among other things. <a href="https://doi.org/10.1038/d41586-020-00452-3">The key to effective scientific communication is not the science. It’s the communication</a>. The results of laboratory experiments and clinical trials are what they are. Either the vaccine or drug works to reduce mortality, or it doesn’t work, and we go back to the drawing board.</p>
<p>So where does the reluctance about vaccines come from? One of the main problems is not the lack of information about the safety of the vaccine. Almost everyone has access to this information on internet. The problem is the lack of trust in institutions, <a href="https://www.cairn-int.info/journal-revue-internationale-de-politique-comparee-2003-3-page-433.htm">which has been growing globally in recent years</a>.</p>
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À lire aussi :
<a href="https://theconversation.com/how-better-conversations-can-help-reduce-vaccine-hesitancy-for-covid-19-and-other-shots-159321">How better conversations can help reduce vaccine hesitancy for COVID-19 and other shots</a>
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<p>But this trust can be earned — or regained. It just takes time, respect and empathy. A study by researchers at the <a href="https://doi.org/10.1080/21645515.2018.1549451">Centre Hospitalier Universitaire de Sherbrooke</a> shows that an educational session about immunization that used motivational interviewing techniques with parents of infants resulted in a nine per cent increase in immunization rates compared with families who did not receive the sessions.</p>
<h2>Finding the right answer to a question</h2>
<p>Ultimately, the goal of science is to find the right answer to a question.</p>
<p>Of course, human nature being what it is, we are not immune to conflicts of interest. We need to ensure transparency about things like funding and links between scientists and potential investors. This is especially important since we are all responsible for funding research, whether through federal subsidies, which are partly derived from taxes paid by citizens, or through the ordinary purchase of drugs in pharmacies.</p>
<p>Since this concerns everyone, it is high time that the public became more involved. After all, scientific discoveries and health measures are everybody’s business. For example, few citizens are familiar with “<a href="https://www.ncbi.nlm.nih.gov/books/NBK285579/">gain-of-function research</a>.” These studies can involve a level of risk ranging from very low to very high. For example, producing a drug from a bacterium carries little risk and much benefit. However, increasing the virulence or transmissibility of a virus such as Ebola or Influenza could carry a lot of risk if such research were carried out by individuals with bad intentions, or in poorly secured laboratories.</p>
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À lire aussi :
<a href="https://theconversation.com/origins-of-sars-cov-2-why-the-lab-leak-idea-is-being-considered-again-161947">Origins of SARS-CoV-2: Why the lab-leak idea is being considered again</a>
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<p>As with any aspect of science, a risk-benefit analysis must be carried out. Note that in the vast majority of institutions where research is done, the committees assessing whether or not a study is worth doing are not only composed of scientists and students, but also members of the public.</p>
<p>Now each side just has to do its part. Scientists need to do a better job of communicating their results and the interpretation of them, as well as specifically answering questions of interest to the public and regaining their trust. They need to listen and stop hiding behind mountains of data, complicated words and scientific articles that are not easily accessible to the general public.</p>
<p>To those who are hesitant about vaccination, scientists should ask: “What data would make you change your mind?”, “Why do you think the current data are insufficient?”, “Why do you trust this individual, but not another or the institutions?” This is how constructive dialogue can be initiated and more in-depth reflection can begin.</p>
<p>For their part, citizens can adopt better practices when it comes to getting information and not only consider information that fits into their personal narrative. It is also important to avoid falling into a spiral of conspiracy theories and trust in false experts. It is important to not be afraid to doubt, to find other sources to confirm or refute what you have just read and to ask trusted experts around you what they think.</p>
<p><em>Do you have a question about COVID-19 vaccines? Email us at <a href="mailto:ca-vaccination@theconversation.com">ca‑vaccination@theconversation.com</a> and vaccine experts will answer questions in upcoming articles.</em></p><img src="https://counter.theconversation.com/content/167681/count.gif" alt="La Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Marc-Antoine De La Vega ne travaille pas, ne conseille pas, ne possède pas de parts, ne reçoit pas de fonds d'une organisation qui pourrait tirer profit de cet article, et n'a déclaré aucune autre affiliation que son organisme de recherche.</span></em></p>Before the pandemic, the public perceived science as infallible and inaccessible. But the opening up of research to the general public has changed that perception.Marc-Antoine De La Vega, PhD Student in Microbiology-Immunology, Université LavalLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1676012021-09-14T19:08:05Z2021-09-14T19:08:05ZForceful vaccine messages backfire with holdouts – how can it be done better?<figure><img src="https://images.theconversation.com/files/420892/original/file-20210913-21-15zd52e.jpg?ixlib=rb-1.1.0&rect=0%2C44%2C942%2C579&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Protesters gather at Indiana University in June 2021 to demonstrate against mandatory COVID-19 vaccinations for students, staff and faculty. </span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/protesters-holding-placards-gather-at-indiana-universitys-news-photo/1233384399?adppopup=true">SOPA Images/LightRocket via Getty Images</a></span></figcaption></figure><p>With the <a href="https://theconversation.com/what-does-full-fda-approval-of-a-vaccine-do-if-its-already-authorized-for-emergency-use-165654">FDA approval of the Pfizer-BioNTech vaccine</a> and the <a href="https://www.usatoday.com/story/news/health/2021/08/24/covid-vaccines-mandates-masks-biden-fauci/8250548002/">continued surge of the delta variant</a>, governments across the world have renewed their push to increase the number of vaccinated individuals by persuading the holdouts. On Sept. 9, 2021, <a href="https://www.nytimes.com/2021/09/09/us/politics/biden-vaccine-mandates-transcript.html">President Joe Biden announced</a> sweeping vaccine mandates, expressing frustration at the vaccine holdouts: “We’ve been patient, but our patience is wearing thin. And your refusal has cost all of us.”</p>
<p>As a <a href="https://www.bellisario.psu.edu/people/individual/s.-shyam-sundar">communication scientist</a> who has studied the effects of media and health campaigns for the past 30 years, I worry that a fevered pitch in vaccine messaging may make the holdouts even more resistant. The direct, blunt messages to go get vaccinated that worked on three-quarters of Americans may not work for the remaining one-quarter. If anything, they might backfire.</p>
<p>Research has shown that some health communication techniques work more effectively than others depending on the audience. It’s a lesson that not only policymakers can apply but also members of the media, industry and even parents and relatives.</p>
<p>When it comes to embracing new ideas and practices, research has identified <a href="http://scholar.google.com/scholar_lookup?hl=en&publication_year=2003&author=EM+Rogers&title=Diffusion+of+innovations">five categories of people</a>: innovators, early adopters, early majority, late majority and laggards. With COVID-19 vaccination, it’s come down to the last two, and they are the most resistant to change.</p>
<p>This group of <a href="https://fivethirtyeight.com/features/unvaccinated-america-in-5-charts/">unvaccinated people</a> is substantial in number – there are nearly <a href="https://www.advisory.com/daily-briefing/2021/07/21/unvaccinated">80 million people</a> in the U.S. who are vaccine eligible yet remain unvaccinated – and they are the ones who could help the U.S. achieve herd immunity. But, research suggests that they are also the ones who will take offense at forceful exhortations to <a href="https://www.nytimes.com/2021/08/05/opinion/coronavirus-mask-vaccine-mandates.html">go get vaccinated</a>. </p>
<h2>Strong messaging can backfire</h2>
<p>Public health messaging can and does often influence people – but not always in the intended direction. Back in 1999, I <a href="https://books.google.com/books?id=euwjAAAAMAAJ&pg=PA155&lpg=PA155&dq=STATEMENT+BEFORE+THE+SUBCOMMITTEE+ON+CRIMINAL+JUSTICE,+DRUG+POLICY+AND+HUMAN+RESOURCES+OF+THE+UNITED+STATES+HOUSE+OF+REPRESENTATIVES+BY+S.+SHYAM+SUNDAR,+PH.D.&source=bl&ots=QAAzWaL6o7&sig=ACfU3U2zK6uWRtXCmPnOmiU5n8XSRl3tJA&hl=en&sa=X&ved=2ahUKEwirh66dmbvyAhUjEFkFHTziDREQ6AF6BAgCEAM#v=onepage&q&f=false">testified in the U.S. Congress</a> about how powerful anti-drug messages may be turning adolescents on to drugs rather than off of them. Likewise, the strong language of current vaccine messaging may be evoking resistance rather than compliance. </p>
<p>Consider <a href="https://www.nytimes.com/2021/08/05/opinion/coronavirus-mask-vaccine-mandates.html">this headline</a> from a recent New York Times editorial: “Get Masked. Get Vaccinated. It’s the Only Way Out of This.” This follows 18 months of public-health messaging urging people to stay home, wash hands and maintain social distancing.</p>
<p>They may be well intentioned, but research in health communication shows that such directive messages can be perceived as “high threat,” meaning they threaten the free will of the message receiver by dictating what they should do. They are likely to trigger <a href="https://psycnet.apa.org/record/1967-08061-000">what psychologists call “reactance”</a>. In other words, when individuals sense a threat to their freedom of action, they become motivated to restore that freedom, often by attempting to do the very thing that is prohibited or by refusing to adhere to the recommended behavior. </p>
<p><a href="https://doi.org/10.1080/00913367.2021.1927914">Recent research</a> by my communications colleagues at Penn State shows that even advertisements that include directive slogans such as “No Mask, No Ride” – from Uber – and “Socialize Responsibly to Keep Bars Open” – a Heineken message – can irritate consumers and make them less likely to engage in responsible behaviors.</p>
<p>Reactance to COVID-19 messaging is evident in the form of <a href="https://www.nytimes.com/2021/07/24/world/france-protests-covid-health-pass.html?smid=em-share">widespread protests</a> around the world. Many have gone to the streets and social media, <a href="https://www.malheurenterprise.com/posts/8849/covid-surge-malheur-county-goes-back-to-school-local-health-experts-ask-community-to-vaccinate">with slogans</a> such as “my body, my choice,” “let me call my own shots” and “coercion is not consent.” </p>
<p>These responses demonstrate not simply hesitation to get vaccinated, but rather active resistance to vaccine messaging, reflecting an effort to protect personal agency by asserting one’s freedom of action. </p>
<h2>Flipping the script</h2>
<p>Freedom is a critical concept in the anti-vaccination rhetoric. “Freedom, not force” is the battle cry of the protesters. “If we lose medical freedom, we lose all freedom,” <a href="https://www.nytimes.com/2021/08/22/nyregion/staten-island-covid-vaccine-workers.html">reads a poster</a>. “Choose freedom,” urged Sen. Rand Paul in a <a href="https://www.paul.senate.gov/fox-news-op-ed-sen-rand-paul-mask-mandates-and-lockdowns-petty-tyrants-no-not-again-choose-freedom">recent op-ed</a> expressing his resistance to mask mandates and lockdowns. “We will make our own health choices. We will not show you a passport, we will not wear a mask, we will not be forced into random screening and testing.”</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/420895/original/file-20210913-27-kozdbl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Anti-vaccination protester holds a sign and a flag during a rally against COVID-19 vaccines" src="https://images.theconversation.com/files/420895/original/file-20210913-27-kozdbl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/420895/original/file-20210913-27-kozdbl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/420895/original/file-20210913-27-kozdbl.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/420895/original/file-20210913-27-kozdbl.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/420895/original/file-20210913-27-kozdbl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/420895/original/file-20210913-27-kozdbl.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/420895/original/file-20210913-27-kozdbl.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Freedom of choice has been a constant theme throughout the pandemic, whether it be about masking, school and business closures or vaccination.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/an-anti-vaccination-protester-holds-a-sign-and-a-flag-as-news-photo/1234951009?adppopup=true">Ringo Chiu/AFP via Getty Images</a></span>
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<p>One way to counter such reactance is by changing the communication strategy. Health communication researchers have found that simple changes to message wording can make a big difference. In <a href="https://doi.org/10.1080/03637750500111815">one study</a> by my Penn State colleagues who study health persuasion, the researchers tested participants’ responses to sensible health behaviors such as flossing: “If you floss already, don’t stop even for a day. And, if you haven’t been flossing, right now is the time to start. … Flossing: It’s easy. Do it because you have to!” Study participants reacted to such messages by expressing their disagreement through anger and by defying the advocated behavior.</p>
<p>But then the researchers reworded the same advocacy to be less threatening, such as: “If you floss already, keep up the good work. And if you haven’t been flossing, now might be a good time to start.” And “Flossing: It’s easy. Why not give it a try?” They found that the participants’ reactance was significantly lower and their message acceptance higher. </p>
<p>In the same way, softening the message and using less dogmatic language could be the key to persuading some of the unvaccinated. This is because suggestive, rather than directive, messages allow room for people to exercise their own free will. <a href="https://doi.org/10.3389/fcomm.2019.00056">Studies in health communication</a> also suggest several other strategies for reducing reactance, ranging from providing choices to evoking empathy.</p>
<h2>Bandwagon effects</h2>
<p>Perhaps more important – given people’s reliance on smartphones and social networking – is to make better use of the technological features of interactive media, which includes websites, social media, mobile apps and games. Clever use of digital media can help convey strong health messages without triggering reactance.</p>
<p><a href="https://doi.org/10.1016/j.chb.2020.106270">Research in our lab</a> shows that people’s responses to media messages can be influenced by the approval of anonymous others on the internet, in the same way that <a href="https://doi.org/10.1145/1358628.1358873">consumers rely</a> on other people’s opinions and star ratings for making purchasing decisions online. In a <a href="https://doi.org/10.1080/10410236.2021.1888450">recent study</a>, we discovered that freedom-threatening health messages can be made more palatable if they are accompanied by a large number of likes on social media from other people. When a lot of others were seen as supporting the advocacy message, the forceful language did not seem any more threatening to their freedom than the gentler version. </p>
<p>In other words, we found that the number of likes has a strong “bandwagon effect” in reducing reactance. We also discovered that providing an option to comment on the health message imbues a higher sense of personal agency and greater acceptance of the message.</p>
<p>In another <a href="https://doi.org/10.1080/10410236.2021.1885772">recent experiment</a>, we found that customization, or the ability to tailor one’s phone or online site to one’s liking, can also aid health communication. Whether it is a phone app, dating site or social media feed, customizing a digital space allows people to reflect their personality. Seeing a health advocacy message in such a personalized space does not pose as much of a threat in such venues because people feel secure in their identity. We found that customization helps reduce negative reactions to health messages by increasing one’s sense of identity.</p>
<p>A communication strategy that is sensitive to psychological reactance could empower the holdouts to willingly get vaccinated instead of grudgingly comply with a mandate.</p>
<p>[<em>Understand new developments in science, health and technology, each week.</em> <a href="https://theconversation.com/us/newsletters/science-editors-picks-71/?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=science-understand">Subscribe to The Conversation’s science newsletter</a>.]</p><img src="https://counter.theconversation.com/content/167601/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>S. Shyam Sundar receives funding from U. S. National Science Foundation. </span></em></p>Subtly shifting the crafting and delivery of public health messaging on COVID-19 vaccines could go a long way toward persuading many of the unvaccinated to get the shot.S. Shyam Sundar, James P. Jimirro Professor of Media Effects & Co-Director, Media Effects Research Laboratory, Penn StateLicensed as Creative Commons – attribution, no derivatives.