tag:theconversation.com,2011:/us/topics/emergency-use-authorization-86869/articlesEmergency Use Authorization – The Conversation2022-09-01T12:25:45Ztag: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>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/vZeTs9-rgPU?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<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>
</figure>
<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/1804882022-04-13T12:15:43Z2022-04-13T12:15:43ZDo you need a second booster shot? An epidemiologist scoured the latest research and has some answers<figure><img src="https://images.theconversation.com/files/456233/original/file-20220404-30995-ylbsxy.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C5382%2C3591&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The CDC recommends the second booster for those over 50 who received their initial booster shot at least four months earlier.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/shana-alesi-administers-a-second-covid-19-booster-shot-to-news-photo/1388972345?adppopup=true">Scott Olson via Getty Images News</a></span></figcaption></figure><p>In late March 2022, the U.S. Food and Drug Administration <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-second-booster-dose-two-covid-19-vaccines-older-and">authorized a second booster shot</a> of COVID-19 vaccines for vulnerable populations in the U.S., a move that was <a href="https://www.cdc.gov/media/releases/2022/s0328-covid-19-boosters.html#">soon after endorsed</a> by the Centers for Disease Control and Prevention. People ages 50 years and older and certain immunocompromised individuals who are at higher risk for severe disease, hospitalization and death are eligible four months after receiving the initial booster shot.</p>
<p>A second booster shot is equivalent to a fourth dose for people who received a <a href="https://theconversation.com/how-effective-is-the-first-shot-of-the-pfizer-or-moderna-vaccine-156615">Pfizer-BioNTech or Moderna mRNA series</a> or a third dose for those who received the <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">single-shot Johnson & Johnson vaccine</a>.</p>
<p>In Israel, people in these same vulnerable categories <a href="https://doi.org/10.1038/d41586-022-00200-9">began receiving fourth doses</a> in January 2022. The U.K. recently started administering a fourth dose for people <a href="https://www.bbc.com/news/health-55045639">75 years and older</a> and coined it a “<a href="https://www.gov.uk/government/publications/covid-19-vaccination-spring-booster-resources/a-guide-to-the-spring-booster-for-those-aged-75-years-and-older-residents-in-care-homes">spring booster</a>.” In Germany, those <a href="https://www.dw.com/en/coronavirus-german-health-minister-calls-for-4th-covid-19-shot/a-61294978">over 60 years old</a> are now eligible for a fourth shot of the mRNA series. </p>
<p>I am an epidemiologist at the <a href="https://scholar.google.com/citations?user=t3nqdNQAAAAJ">University of Texas Health Science Center</a> School of Public Health and founder and author of <a href="https://yourlocalepidemiologist.substack.com/">Your Local Epidemiologist</a>, a newsletter translating the latest public health science for everyday use. </p>
<p>The latest recommendations have left many wondering about the importance of boosters for protection against COVID-19. Does the third shot wane over time? Is a fourth dose necessary? What if you’ve had a previous infection? </p>
<p>After reviewing the mounting body of research on how the immune system shifts over time following each dose, it is clear that another booster for vulnerable populations has meaningful benefit with very little risk. </p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/ZEjJsVeEMWI?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">The FDA’s authorization provides the option of a second booster shot for vulnerable populations, but the agency stopped short of making it a broad recommendation.</span></figcaption>
</figure>
<h2>Vaccine effectiveness following the first booster dose</h2>
<p><a href="https://doi.org/10.1038/s41591-022-01727-0">There is clear evidence</a> that a third dose of the mRNA series – or the first booster dose – was and still is critical for ensuring a robust immune response against <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 omicron variant</a> for all age groups. This is in part because the immune response <a href="https://doi.org/10.1038/s41591-022-01727-0">wanes over time</a> and also in part because omicron has proved to be partially effective at evading immunity from the existing COVID-19 vaccines and from prior infections.</p>
<p>But then the question becomes: How well is immunity from the first booster holding up over time? </p>
<p>The best real-time data to follow on vaccine effectiveness over time is in the U.K. The U.K. Health Security Agency currently has follow-up data for 15 weeks after the third dose, or first booster shot. <a href="https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1063023/Vaccine-surveillance-report-week-12.pdf">In its latest report</a>, the effectiveness of vaccines against infection wanes significantly after a third dose. In the U.K. report, vaccine effectiveness against hospitalization is holding up much better compared to effectiveness against infection. But even protection against hospitalization is slightly decreasing over time. While this data is insightful, 15 weeks of follow-up data isn’t very helpful in the U.S. because many Americans got their third dose up to 24 weeks ago.</p>
<p>A <a href="https://doi.org/10.1056/NEJMc2119912">recent study</a> assessed the durability of a Moderna third dose after six months. Researchers found waning levels of neutralizing antibodies six months after the booster. The CDC <a href="https://www.cdc.gov/mmwr/volumes/71/wr/mm7107e2.htm?s_cid=mm7107e2_w">also found significant waning protection</a> against emergency department and urgent care visits five months after the first booster. Vaccine effectiveness against hospitalization decreased a little but largely held up five months after the booster.</p>
<p>The studies mentioned above pooled all age groups. But researchers know that older adults don’t mount as durable an immune response as younger people. This explains why breakthrough infections have occurred at a much <a href="https://www.kff.org/coronavirus-covid-19/press-release/breakthrough-covid-19-hospitalizations-among-fully-vaccinated-patients-occur-most-often-among-older-adults-and-involve-people-with-chronic-health-conditions/">higher rate</a> among people ages 65 and up. A recent study in the Lancet <a href="https://doi.org/10.1016/S1473-3099(22)00135-9">assessed the durability of a third dose</a> among people ages 76 to 96 years old. Researchers found that the third dose improved neutralizing antibodies, but in the face of omicron, antibodies still dropped substantially following a booster.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/njzyLwbpYIY?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">President Biden gets his second booster shot on camera, and Dr. Anthony Fauci discusses the benefits of a booster.</span></figcaption>
</figure>
<h2>Data on the second booster dose/fourth shot</h2>
<p>Now that Israel has been delivering a fourth dose for several months, researchers have some data to rely on to assess its effectiveness. There are three studies that have been released so far, one which has not yet been peer-reviewed. </p>
<p>In one study published in the New England Journal of Medicine, scientists assessed the <a href="https://doi.org/10.1056/NEJMoa2201570">rates of infection and severe illness after a fourth dose</a> – or second booster – among more than a million people ages 60 and older in Israel. The researchers found that after a fourth dose, the rate of COVID-19 infection was two times lower than after a third dose. However, this protection quickly waned after six weeks. They also found the rate of severe disease was four times lower compared to those who received only three doses. It’s important to note, though, that hospitalizations among both groups were very low. </p>
<p>Importantly, <a href="https://doi.org/10.1056/NEJMc2202542">another study</a> assessed the effectiveness of a fourth dose among younger health care workers in Israel. The results confirmed that antibody levels dropped significantly five months after the third dose. Unfortunately, the effectiveness of the fourth dose was no different from the effectiveness of a third dose in this population of younger health care workers. In other words, there may not be meaningful benefit of a second booster of the same formula for young, healthy populations. </p>
<p>Researchers carried out a third study, <a href="https://doi.org/10.21203/rs.3.rs-1478439/v1">one that has not yet been peer-reviewed</a>, at a large health care system in Israel among people aged 60 to 100 years. Among 563,465 patients in the health care system, 58% received a second booster. During the study period, 92 people who received the second booster died compared to 232 people who had only the first booster. In other words, the second booster equated to a 78% reduction in death compared to the first booster alone. </p>
<h2>What if you had a COVID-19 infection with omicron?</h2>
<p>The combination of being both vaccinated and having experienced a COVID-19 infection is called “<a href="https://theconversation.com/how-long-does-protective-immunity-against-covid-19-last-after-infection-or-vaccination-two-immunologists-explain-177309">hybrid immunity</a>.” More than <a href="https://doi.org/10.1126/science.abj2258">35 studies</a> have shown that hybrid immunity offers complimentary and broad protection. This is because immunity from the vaccines targets the spike protein – after which the <a href="https://theconversation.com/how-can-scientists-update-coronavirus-vaccines-for-omicron-a-microbiologist-answers-5-questions-about-how-moderna-and-pfizer-could-rapidly-adjust-mrna-vaccines-172943">COVID-19 vaccines were designed</a> – and infection-induced immunity aims more broadly at the whole virus. </p>
<p>[<em>Over 150,000 readers rely on The Conversation’s newsletters to understand the world.</em> <a href="https://memberservices.theconversation.com/newsletters/?source=inline-150ksignup">Sign up today</a>.]</p>
<p>So, it is not unreasonable to skip a second booster with a confirmed infection of omicron. This doesn’t mean that people should purposefully get SARS-CoV-2, the virus that causes COVID-19. But it is clear that hybrid immunity is a viable path to protection.</p>
<p>In short, there is strong evidence that a fourth dose – or second booster – provides meaningful protection among vulnerable populations, including people over 60. So another booster is reasonable for some groups. And while a fourth dose may benefit a select group, it is far more important that people receive their first, second and third doses.</p><img src="https://counter.theconversation.com/content/180488/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Katelyn Jetelina receives research funding from the NIH, CDC, DOJ, NIOSH, and several non-profit organizations. She sole founder, owner, and author of Your Local Epidemiologist newsletter. She is senior scientific advisor to Judge Lina Hidalgo in Harris County. </span></em></p>New data on the second booster suggests the older you are, the more you need it.Katelyn Jetelina, Assistant Professor of Epidemiology, University of Texas Health Science Center at HoustonLicensed 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>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/4XvBKsKGABM?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Vaccine advice for parents of children under age 5.</span></figcaption>
</figure>
<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>
<p>[<em>Research into coronavirus and other news from science</em> <a href="https://memberservices.theconversation.com/newsletters/?nl=science&source=inline-science-corona-research">Subscribe to The Conversation’s new science newsletter</a>.]</p>
<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/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/1646242021-08-30T12:33:16Z2021-08-30T12:33:16ZWhat happens when the COVID-19 vaccines enter the body – a road map for kids and grown-ups<figure><img src="https://images.theconversation.com/files/417889/original/file-20210825-21-2seocg.jpg?ixlib=rb-1.1.0&rect=352%2C24%2C4997%2C3385&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">COVID-19 vaccines have been proved safe and effective. But it's understandable to have questions.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/child-with-face-mask-getting-vaccinated-coronavirus-royalty-free-image/1278968456?adppopup=true"> Halfpoint/iStock via Getty Images Plus</a></span></figcaption></figure><figure class="align-left ">
<img alt="" src="https://images.theconversation.com/files/281719/original/file-20190628-76743-26slbc.png?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/281719/original/file-20190628-76743-26slbc.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=293&fit=crop&dpr=1 600w, https://images.theconversation.com/files/281719/original/file-20190628-76743-26slbc.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=293&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/281719/original/file-20190628-76743-26slbc.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=293&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/281719/original/file-20190628-76743-26slbc.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=368&fit=crop&dpr=1 754w, https://images.theconversation.com/files/281719/original/file-20190628-76743-26slbc.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=368&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/281719/original/file-20190628-76743-26slbc.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=368&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption"></span>
</figcaption>
</figure>
<p><em><a href="https://theconversation.com/us/topics/curious-kids-us-74795">Curious Kids</a> is a series for children of all ages. If you have a question you’d like an expert to answer, send it to <a href="mailto:curiouskidsus@theconversation.com">curiouskidsus@theconversation.com</a>.</em></p>
<hr>
<blockquote>
<p><strong>How does a COVID-19 vaccine work in the body? – Wixy, age 12, New York</strong></p>
</blockquote>
<hr>
<p>The COVID-19 pandemic, caused by the SARS-CoV-2 virus, has changed the way people live around the world. As of late August 2021, more than <a href="https://covid.cdc.gov/covid-data-tracker/#datatracker-home">630,000 people have died</a> in the United States alone. Health experts agree that <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits.html">COVID-19 vaccines are one important way</a> to help bring an end to the pandemic. </p>
<p>But getting a vaccine can be scary for both kids and adults. Plus, there is lot of information about how the COVID-19 vaccines work, but some of it can be hard to understand. </p>
<p>As a pediatrician, <a href="https://www.pediatrics.pitt.edu/people/glenn-j-rapsinski-md-phd">infectious disease doctor</a> <a href="https://scholar.google.com/citations?user=YpknwWcAAAAJ&hl=en">and scientist</a> who studies germs like bacteria and viruses, I have devoted close attention to the pandemic and the development of the COVID-19 vaccines.</p>
<h2>Vaccines are made to resemble invaders</h2>
<p>The most important thing to understand about vaccines is that they teach your body how to gear up to fight an infection, without your body having to deal with the infection itself. In this way, vaccines help your body be prepared for invasions by germs that could otherwise make you very sick.</p>
<p>All three of the <a href="https://theconversation.com/what-does-full-fda-approval-of-a-vaccine-do-if-its-already-authorized-for-emergency-use-165654">COVID-19 vaccines available in the U.S.</a> focus on what is called the spike protein of the SARS-CoV-2 virus, or coronavirus. 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>
<p>On an actual coronavirus, spike proteins allow the COVID-19 virus to get into cells so the virus can make more copies of itself. It does this by <a href="https://doi.org/10.1073/pnas.2003138117">sticking to certain kinds of proteins</a>, called receptors, on human cells – particularly lung cells. In this way, the virus can break into healthy cells and infect them. </p>
<p>The Pfizer-BioNTech, Moderna and Johnson & Johnson vaccines all work similarly by giving the body’s cells the instructions to make the spike protein. The Pfizer and Moderna vaccines carry these instructions on <a href="https://doi.org/10.1038/s41577-021-00526-x">a molecule called mRNA</a>. This single-stranded molecule looks like a long piece of tape with the instructions to make a protein coded on one side. </p>
<p>The Johnson & Johnson vaccine, on the other hand, passes the instructions to cells through DNA molecules. It uses a virus <a href="https://www.mayoclinic.org/johnson-johnson-adenovirus-vaccine-explained/vid-20510091">called an adenovirus</a>, which cannot make copies of itself, to carry the spike proteins’ DNA into human cells. This DNA gets copied into mRNA, which then translates the instructions into proteins – in this case, the spike protein of the coronavirus. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/417906/original/file-20210825-25-1v6sgao.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Diagram shows encapsulated mRNA that codes for spike protein of coronavirus" src="https://images.theconversation.com/files/417906/original/file-20210825-25-1v6sgao.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/417906/original/file-20210825-25-1v6sgao.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=424&fit=crop&dpr=1 600w, https://images.theconversation.com/files/417906/original/file-20210825-25-1v6sgao.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=424&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/417906/original/file-20210825-25-1v6sgao.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=424&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/417906/original/file-20210825-25-1v6sgao.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=533&fit=crop&dpr=1 754w, https://images.theconversation.com/files/417906/original/file-20210825-25-1v6sgao.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=533&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/417906/original/file-20210825-25-1v6sgao.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=533&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 three COVID-19 vaccines code for the spike protein of the coronavirus – two using mRNA as a template (Pfizer and Moderna) and one using DNA as a template (J&J).</span>
<span class="attribution"><span class="source">Trinset/iStock via Getty Images Plus</span></span>
</figcaption>
</figure>
<p>So the main difference between the three vaccines is that the Pfizer and Moderna shots give your body instructions for the spike protein through mRNA, while the Johnson & Johnson shot directs it via DNA. After that, all three vaccines work the same way.</p>
<h2>What happens when the vaccine enters your body?</h2>
<p>Once a COVID-19 vaccine is injected, the mRNA or DNA gets swallowed up by tissue cells and special immune cells that live in muscles, skin and organs called <a href="https://www.immunology.org/public-information/bitesized-immunology/cells/dendritic-cells">dendritic cells</a>. Dendritic cells keep watch over all parts of the body like sentinels, searching for signs of invading germs – like the coronavirus.</p>
<p>As soon as the DNA or mRNA is inside the dendritic or tissue cells, the cells use the instructions to create spike proteins. This process <a href="https://doi.org/10.1038/gt.2010.52">usually takes</a> less than 12 hours. After the spike proteins are made and ready to “show” to the immune system, the mRNA or DNA is broken down by the cell and eliminated. </p>
<p>It’s important to know that even though your cells have made their own spike proteins, they don’t have enough information to make copies of the full virus. But the spike proteins can trigger the body’s immune system to amp up its defense so it is ready if the whole coronavirus invades. </p>
<p>When the tissue cells and dendritic cells recognize the spike proteins as unwelcome visitors, the cells place sections of the spike proteins on their exterior for other cells to see. The dendritic cells also release “danger” signals at the same time to let other cells know that the spike protein presents a threat. The danger signals are like flashing neon yellow signs pointing to the displayed spike protein piece saying, “This does not belong!” </p>
<p>These warning signals then fire up your body’s immune response.</p>
<h2>What happens once the immune system gets revved up?</h2>
<p>Thanks to that process, the body is now on high alert and ready to learn to fight invaders – in this case, the spike proteins made after injection with the COVID-19 vaccine.</p>
<p>Immune cells in the body, called B-cells and T-cells, recognize the warning signs of an outside invader. Thousands of these cells rush to the area to learn about this new threat so they can help provide protection. </p>
<p>B-cells are specialists at building “traps,” called antibodies, that will take down any invading spike proteins. Different B-cells make lots of specialized antibodies that recognize different parts of a virus or bacteria. And B-cells will act like a factory, continuing to make antibodies against the perceived threat even after it’s gone in order to protect the body for a long time to come. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/417895/original/file-20210825-13-1citx3j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Illustration of antibodies attacking coronavirus particle" src="https://images.theconversation.com/files/417895/original/file-20210825-13-1citx3j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/417895/original/file-20210825-13-1citx3j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=300&fit=crop&dpr=1 600w, https://images.theconversation.com/files/417895/original/file-20210825-13-1citx3j.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=300&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/417895/original/file-20210825-13-1citx3j.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=300&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/417895/original/file-20210825-13-1citx3j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=377&fit=crop&dpr=1 754w, https://images.theconversation.com/files/417895/original/file-20210825-13-1citx3j.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=377&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/417895/original/file-20210825-13-1citx3j.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">This artistic depiction shows an antibody (on right) attacking a coronavirus particle, with golf-tee shaped spike proteins (in hot pink) on outer surface.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/antibodies-attacking-coronavirus-particle-royalty-free-image/1307403039?adppopup=true">Christoph Burgstedt/Science Photo Library via Getty Images</a></span>
</figcaption>
</figure>
<p>One type of <a href="https://www.ncbi.nlm.nih.gov/books/NBK10762/">T-cell</a>, called helper T-cells, assist the B-cells in making antibodies when danger signals are present. Another kind of T-cell is there to check if other cells in the body are infected by the virus. If that type of T-cell spots an infected cell, it removes the infected cell so it cannot create more copies and pass on the infection to other cells.</p>
<h2>Why is my arm sore?</h2>
<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. 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>
<p>You might also experience <a href="https://doi.org/10.1001/jama.2021.5374">a fever</a> or other <a href="https://doi.org/10.1056/NEJMoa2107456">signs of sickness</a>. All of these mean that your body is doing exactly what it’s supposed to. This is a safe and natural process that happens when the body is learning how to fight the spike proteins. That way, if you do come into contact with the real coronavirus, your body has learned how to protect you from it. </p>
<hr>
<p><em>Hello, curious kids! Do you have a question you’d like an expert to answer? Ask an adult to send your question to <a href="mailto:curiouskidsus@theconversation.com">CuriousKidsUS@theconversation.com</a>. Please tell us your name, age and the city where you live.</em></p>
<p><em>And since curiosity has no age limit – adults, let us know what you’re wondering, too. We won’t be able to answer every question, but we will do our best.</em></p><img src="https://counter.theconversation.com/content/164624/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>An infectious disease doctor explains the science behind COVID-19 vaccines at a level that children – and adults – of all ages can understand.Glenn J. Rapsinski, Pediatric Infectious Diseases Fellow, University of PittsburghLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1656542021-08-11T19:21:25Z2021-08-11T19:21:25ZWhat does full FDA approval of a vaccine do if it’s already authorized for emergency use?<figure><img src="https://images.theconversation.com/files/415300/original/file-20210809-17-gip7po.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C1022%2C703&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Full FDA approval of the COVID-19 vaccines may help people feel more secure in its safety and effectiveness.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/people-arrive-at-the-fema-supported-covid-19-vaccination-news-photo/1232533616">SOPA Images/LightRocket via Getty Images</a></span></figcaption></figure><p><a href="https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-june-2021/">Thirty percent of unvaccinated American adults</a> say they’re waiting for the COVID-19 vaccines currently authorized for emergency use to be officially approved by the U.S. Food and Drug Administration. The FDA has since <a href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine">granted that approval</a> for those age 16 and older for the Pfizer-BioNTech vaccine on Aug. 23, 2021. What had to happen for the FDA to advance from <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization">emergency use authorization</a>, or EUA, to full approval?</p>
<p>I’m a <a href="https://scholar.google.com/citations?hl=en&user=G2EkJJ0AAAAJ&view_op=list_works&sortby=pubdate">pharmacist</a> who trains other pharmacists, health care providers and students on why, when and how to administer vaccines. Emergency use authorization, while streamlining the regulatory process so the vaccine is more quickly available to the public, still follows a <a href="https://www.fda.gov/drugs/information-consumers-and-patients-drugs/fdas-drug-review-process-continued">rigorous process</a> the FDA requires to ensure vaccine safety and effectiveness. The difference is that more time has passed and more data is available for review when a company applies for full approval.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/JVNDgfCT1pg?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">All vaccines undergo five stages to ensure their safety and efficacy before approval.</span></figcaption>
</figure>
<h2>EUA and full approval share similar first steps</h2>
<p>For both emergency authorization and full approval, for COVID-19 vaccines, the FDA first requires <a href="https://www.fda.gov/patients/drug-development-process/step-3-clinical-research">initial safety studies</a> on a small number of people. Here, researchers document potential adverse events, or side effects, that the vaccine may cause. Researchers also determine the safest and most effective dose of the vaccine.</p>
<p>Once the vaccine is determined to be safe and an optimal dose identified, researchers will create larger studies to ascertain how well it works in a controlled setting where some people are given the vaccine while others are given a placebo.</p>
<p>It is important to note that the number of people who participated in the initial COVID-19 safety studies was similar to that in the safety studies of other commonly used vaccines, including vaccines for <a href="https://doi.org/10.4161/hv.20506">tetanus, diphtheria, whooping cough and meningitis</a>. Over 43,000 adults participated in the early phases of the <a href="https://doi.org/10.1056/NEJMoa2034577">Pfizer-BioNTech</a> clinical trial, over 30,400 in <a href="https://doi.org/10.1056/NEJMoa2035389">Moderna’s</a> and over 44,000 in <a href="https://doi.org/10.1056/NEJMoa2101544">Johnson and Johnson’s</a>. Half the participants in each study were given a vaccine, while the other half were given a placebo.</p>
<h2>Where EUA and full approval differ</h2>
<p>From this point on, emergency use authorization and full FDA approval for COVID-19 vaccines follow different clinical study requirements.</p>
<p>For the <a href="https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained">emergency use authorization</a>, the FDA requires at least half of the participants of the original studies to be followed for at least two months post-vaccination. This is because the vast majority of vaccine-related side effects <a href="https://www.verywellhealth.com/when-to-expect-covid-19-vaccination-side-effects-5176621">occur right after vaccination</a>.</p>
<p>Full FDA approval, on the other hand, requires participants in the original studies to be <a href="https://www.fda.gov/media/139638/download">followed for at least six months</a>. Reviewers look at data from the same study participants but collected over a longer period of time. All adverse events are examined. The manufacturer must also provide more detailed manufacturing plans and processes, as well as a higher level of oversight and inspections. All of this adds significantly more time to the review process.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/415027/original/file-20210806-13508-12j9c4o.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Vaccine vials lined up in front of the FDA and Pfizer BioNTech logos" src="https://images.theconversation.com/files/415027/original/file-20210806-13508-12j9c4o.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/415027/original/file-20210806-13508-12j9c4o.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=372&fit=crop&dpr=1 600w, https://images.theconversation.com/files/415027/original/file-20210806-13508-12j9c4o.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=372&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/415027/original/file-20210806-13508-12j9c4o.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=372&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/415027/original/file-20210806-13508-12j9c4o.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=468&fit=crop&dpr=1 754w, https://images.theconversation.com/files/415027/original/file-20210806-13508-12j9c4o.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=468&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/415027/original/file-20210806-13508-12j9c4o.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=468&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Full FDA approval involves reviewing more data after a longer observational period.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/in-this-photo-illustration-vials-are-seen-in-front-of-the-news-photo/1230084410">SOPA Images/LightRocket via Getty Images</a></span>
</figcaption>
</figure>
<p>Both <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-initiate-rolling-submission-biologics">Pfizer</a> and <a href="https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-initiation-rolling-submission-biologics">Moderna</a> began their rolling submission for approval in the FDA’s <a href="https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track">“Fast Track” process</a>, designed to speed up review. This allows the companies to submit portions of their approval application to the FDA for review as they’re completed.</p>
<p>Full FDA approval will initially apply to only the same age groups that were tested in the original emergency use authorization. This means that the vaccine has been approved first for people ages 16 and up for Pfizer, and will likely be approved for those 18 and up for Moderna. Rolling submission will allow approval of the vaccine for younger groups as more data becomes available.</p>
<h2>Different timelines, same rigorous requirements</h2>
<p>Full FDA approval is a milestone that may help build confidence among the vaccine hesitant about the safety of the vaccines. But the true test of the vaccine came when it first gained emergency use authorization. Then, researchers identified the majority of its potential side effects and proved its ability to protect against severe disease.</p>
<p><em>Article updated on Aug. 23, 2021 to reflect FDA approval of Pfizer BioNTech vaccine for those ages 16 and older.</em></p>
<p>[<em>Like what you’ve read? Want more?</em> <a href="https://theconversation.com/us/newsletters/the-daily-3?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=likethis">Sign up for The Conversation’s daily newsletter</a>.]</p><img src="https://counter.theconversation.com/content/165654/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jennifer Girotto 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>While emergency use authorization gets vaccines out to the public more quickly, it doesn’t skip any steps that full approval requires.Jennifer Girotto, Associate Clinical Professor of Pharmacy Practice, University of ConnecticutLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1644552021-07-19T12:11:41Z2021-07-19T12:11:41ZNew COVID-19 vaccine warnings don’t mean it’s unsafe – they mean the system to report side effects is working<figure><img src="https://images.theconversation.com/files/411706/original/file-20210716-21-lunh2y.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C5000%2C3366&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Put into context, the benefits of vaccination still far outweigh the risks of rare adverse events.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/illustration/vaccine-vial-over-squared-board-with-its-royalty-free-illustration/1263990592">PenWin/iStock via Getty Images Plus</a></span></figcaption></figure><p>While the COVID-19 vaccines currently available in the U.S. have been <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html">proved to be safe and effective</a>, recent reports of rare <a href="https://www.cancer.gov/publications/dictionaries/cancer-terms/def/adverse-event">adverse events</a>, or side effects, have raised concerns. On July 12, 2021, the Food and Drug Administration approved an update to the Johnson & Johnson COVID-19 vaccine <a href="https://www.fda.gov/media/150723/download">fact sheet</a> to include an increased risk of the rare nerve condition <a href="https://www.cdc.gov/campylobacter/guillain-barre.html">Guillain-Barré syndrome</a>. This follows previous reports linking the J&J vaccine with a <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/JJUpdate.html">rare blood clot</a>. </p>
<p>While reports like these can be scary, they’re a sign that the vaccine safety reporting system is working. They also highlight how the relative risks of rare side effects like these need to be put into context.</p>
<p>As a pharmacist who has been managing operations for the University of Virginia Health System’s COVID-19 vaccine program for the past seven months, I’ve seen how uncertainty and fear over potential side effects can drive vaccine hesitancy. Understanding how information about adverse events is collected and what it means for vaccine safety may help people make informed decisions about their health.</p>
<h2>Tracking safety before, during and after approval</h2>
<p>The FDA enforces rigorous testing and approval processes that manufacturers must follow before a new vaccine can be made available to the public. Regardless of whether a vaccine is approved through the <a href="https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/vaccine-development-101">typical FDA approval process</a> or an <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization">Emergency Use Authorization (EUA)</a>, the steps required to test a new drug for safety and effectiveness are the same. An EUA can get a vaccine to the public more quickly by <a href="https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained">streamlining the regulatory process</a>, but no shortcuts are taken. Every step is taken to ensure the vaccine is both safe and effective.</p>
<p>Vaccine clinical trials occur in <a href="https://www.fda.gov/patients/drug-development-process/step-3-clinical-research">four sequential phases</a>. In the first three phases, study investigators are the ones who identify, quantify and document safety issues. Phase 1 typically introduces the vaccine to fewer than 100 people over several months under controlled conditions. Typically, the majority of potential adverse events are identified in this stage. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/411711/original/file-20210716-19-ggc6p6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="People getting vaccinated at various vaccine stations in a clinic." src="https://images.theconversation.com/files/411711/original/file-20210716-19-ggc6p6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/411711/original/file-20210716-19-ggc6p6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=347&fit=crop&dpr=1 600w, https://images.theconversation.com/files/411711/original/file-20210716-19-ggc6p6.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=347&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/411711/original/file-20210716-19-ggc6p6.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=347&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/411711/original/file-20210716-19-ggc6p6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=436&fit=crop&dpr=1 754w, https://images.theconversation.com/files/411711/original/file-20210716-19-ggc6p6.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=436&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/411711/original/file-20210716-19-ggc6p6.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=436&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Everyday people can contribute to vaccine safety monitoring even after it is approved by the FDA.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/people-get-vaccinated-at-a-vaccination-clinic-at-save-max-news-photo/1233919589">Xinhua News Agency via Getty Images</a></span>
</figcaption>
</figure>
<p>After the FDA reviews phase 1 data and deems the vaccine safe enough to be studied further, the vaccine moves on to phases 2 and 3, where it will be given to larger numbers of people over longer periods of time. Here, investigators determine optimal dosage and screen for rare side effects. </p>
<p>If phase 2 and 3 data meets FDA approval standards, the vaccine will then move on to phase 4 and become available to the public. The vaccine is observed over much larger populations and extended periods of time, and manufacturers are required to regularly check and report potential safety concerns to the FDA.</p>
<p>What’s different about this final phase is that the public can also contribute to safety reporting. The <a href="https://vaers.hhs.gov/about.html">Vaccine Adverse Event Reporting System (VAERS)</a> is a national safety monitoring system run by the FDA and Centers for Disease Control and Prevention. While certain types of adverse events, such as injuries during vaccine administration and serious complications, are <a href="https://vaers.hhs.gov/docs/VAERS_Table_of_Reportable_Events_Following_Vaccination.pdf">mandatory for health care providers to report</a>, anyone can submit a report. Recent adverse events associated with the COVID-19 vaccine, including <a href="https://theconversation.com/rare-neurological-disorder-guillain-barre-syndrome-linked-to-covid-19-141511">Guillain-Barré</a> and thrombosis for Johnson & Johnson and <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-june-25-2021">myocarditis</a> for Pfizer, were identified through VAERS.</p>
<h2>Serious adverse event risk from vaccines is small</h2>
<p>A rare adverse event may take months or years to identify for a simple reason: It’s rare. For some drugs that are less commonly used, new safety data takes longer to discover because a relatively small number of patients use the drug. For example, though the shingles vaccine Shingrix was approved 2017, it wasn’t until <a href="https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-requires-warning-about-guillain-barre-syndrome-gbs-be-included-prescribing-information-shingrix">March 2021</a> after over 3.7 million patients had gotten the shot that the FDA announced a potential increased risk of Guillain-Barré. And it still hasn’t been confirmed that the Shringrix vaccine causes the nerve condition.</p>
<p>For cases like the COVID-19 vaccine, however, millions of people will receive the drug shortly after it’s released to the public, and new issues or patterns often emerge more quickly. </p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/zBkVCpbNnkU?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Adverse events that occur closely following vaccination may not be caused by or even related to the vaccine.</span></figcaption>
</figure>
<p>This can lead to two problems.</p>
<p>First, <a href="https://doi.org/10.1038/d41586-021-00880-9">not every reported adverse event is directly related to the vaccine</a>. For example, many of the tens of millions of people who have received the Pfizer vaccine have likely experienced a sunburn. People might report that they experienced a sunburn to VAERS, but the vaccine has no effect on your skin’s ability to protect against the sun. <a href="https://vaers.hhs.gov/about.html">VAERS is very clear</a> that it “is not designed to determine if a vaccine caused a health problem, but is especially useful for detecting unusual or unexpected patterns of adverse event reporting.” Correlation does not imply causation.</p>
<p>Second, a plausibly identified adverse event does not necessarily make the vaccine unsafe. According to CDC, there have been <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-july-13-2021">100 preliminary reports</a> of Guillain–Barré out of 12.5 million J&J doses, or 0.0008% of people who received the vaccine. Administering one vaccine to a huge sample of people can make it easier to identify a possible connection between the shot and a side effect. But that doesn’t mean the risk of getting that side effect is very likely, or that it outweighs the benefit of getting vaccinated.</p>
<p>These risks, while real and potentially life-threatening, must be viewed in context with the much larger risk of negative outcomes from the diseases vaccines protect people from. For example, <a href="https://doi.org/10.2165/00002018-200022060-00003">1%-7% of patients</a> who take cholesterol drugs called statins are likely to experience potentially harmful muscle injury. However, these drugs are still taken by millions of people because they are highly effective at <a href="https://doi.org/10.1002/14651858.CD004816.pub4">preventing heart disease and stroke</a>. And in the case of Guillain–Barré, about <a href="https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Guillain-Barr%C3%A9-Syndrome-Fact-Sheet">one in 100,000</a> people, or 0.001%, develop this condition yearly in the U.S. from any cause. By comparison, the U.S. has had more than <a href="https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days">33 million cases of COVID-19, and over 600,000 deaths</a> caused by this disease.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/411712/original/file-20210716-15-kgvj71.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Close-up of three Johnson & Johnson vaccine vials." src="https://images.theconversation.com/files/411712/original/file-20210716-15-kgvj71.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/411712/original/file-20210716-15-kgvj71.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=395&fit=crop&dpr=1 600w, https://images.theconversation.com/files/411712/original/file-20210716-15-kgvj71.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=395&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/411712/original/file-20210716-15-kgvj71.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=395&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/411712/original/file-20210716-15-kgvj71.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=497&fit=crop&dpr=1 754w, https://images.theconversation.com/files/411712/original/file-20210716-15-kgvj71.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=497&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/411712/original/file-20210716-15-kgvj71.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"></a>
<figcaption>
<span class="caption">While the Johnson & Johnson vaccine has been linked to a possible increased risk of certain rare adverse events, the vaccine is still safe to use.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/this-picture-taken-on-april-24-shows-vials-of-the-single-news-photo/1232493543">Ramon Van Flymen/AFP via Getty Images</a></span>
</figcaption>
</figure>
<h2>COVID-19 is a bigger risk than vaccine side effects</h2>
<p>In such extraordinary times as during a pandemic, it’s understandable that people may be hesitant to take on any more risk than they have to. But there are safety nets in place to monitor the COVID-19 vaccines, and they are still working as they should.</p>
<p>The COVID-19 vaccines are proven to be overwhelmingly safe for most people. <a href="https://clinicaltrials.gov/ct2/show/record/NCT04505722">More than 40,000</a> patients participated in J&J’s clinical trials before the company applied for emergency use authorization, mirroring <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine">Pfizer’s</a> and <a href="https://www.modernatx.com/covid19vaccine-eua/providers/clinical-trial-data">Moderna’s</a> study sample sizes. Some <a href="https://doi.org/10.1056/NEJMoa2101544">0.4% of participants</a> in the J&J trial experienced serious adverse events unrelated to COVID-19 infection. In contrast, the trial demonstrated that people who get the vaccine are <a href="https://doi.org/10.1056/NEJMoa2101544">85% less likely to get severe COVID-19</a> than those who remain unvaccinated.</p>
<p>The extremely rare side effects associated with the COVID-19 vaccines were discovered because safety reporting tools were used appropriately. Being aware of the risks of a treatment, however rare, can help people make health decisions that work best for them. However, these risks must be viewed in context. And in the case of the COVID-19 vaccines, they must be weighed against the consequences of remaining unvaccinated and letting the pandemic rage on.</p>
<p><em>Article updated to correct a typo in the percentage of Guillain-Barré cases identified among recipients of Johnson & Johnson COVID-19 vaccine.</em></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">The Conversation’s most important coronavirus headlines, weekly in a science newsletter</a></em>]</p><img src="https://counter.theconversation.com/content/164455/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Justin Vesser 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>Ongoing tracking is meant to spot very rare risks – like the connection between the Johnson & Johnson shot and Guillain-Barré syndrome. And it relies on public reporting.Justin Vesser, Manager of Ambulatory Pharmacy Services, University of VirginiaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1628212021-07-16T13:04:19Z2021-07-16T13:04:19ZKids aren’t just littler adults – here’s why they need their own clinical trials for a COVID-19 vaccine<figure><img src="https://images.theconversation.com/files/411505/original/file-20210715-32722-7lpsnj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The freedom of going mask-free is still a ways off for kids under age 12.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/american-little-caucasian-boy-posing-with-a-royalty-free-image/1216273821"> Juan Monino/E+ via Getty Images</a></span></figcaption></figure><p>Now that <a href="https://covid.cdc.gov/covid-data-tracker/#vaccinations">two-thirds of all adults</a> in the United States have received at least one dose of a SARS-CoV-2 vaccine as of mid-July 2021, life seems to be returning to some semblance of pre-pandemic times. People are again traveling, eating in restaurants with friends, attending in-person gatherings and flocking to <a href="https://www.forbes.com/sites/jonathanberr/2021/05/31/people-are-returning-to-the-movies-as-mask-requirements-end/?sh=12693670115f">movie theaters</a> and <a href="https://www.sportstravelmagazine.com/how-many-fans-will-be-allowed-at-major-league-baseball-games-this-season-capacity/">Major League baseball games</a>. </p>
<p>Yet for parents of children under the age of 12, who are not yet eligible for COVID-19 vaccines, there is still no collective sigh of relief. Many parents have concerns about <a href="https://www.nature.com/articles/d41586-021-01826-x">the upcoming school year</a> and the uncertainty surrounding the <a href="https://theconversation.com/whats-the-delta-plus-variant-and-can-it-escape-vaccines-an-expert-explains-163644">delta variant</a>. </p>
<p>Clinical research studies of the mRNA-based vaccines for children under 12 are ongoing, and authorization of a vaccine for this younger age group is still at least several months away. These trials are necessary because children have important differences in physiology and <a href="https://doi.org/10.1016/j.vaccine.2015.07.085">responses to vaccines</a> from those of adults. Conducting separate studies in children under age 12 is a vital step toward ending the pandemic.</p>
<p>As a <a href="https://www.pediatrics.pitt.edu/people/judith-m-martin-md">specialist in pediatric infectious diseases</a>, I have been conducting research on common infections in children and related vaccines for over 20 years. Here at the University of Pittsburgh, our <a href="https://covid19research.pitt.edu/pvtu/">Pittsburgh Vaccine Trials Unit</a> has carried out both adult and pediatric clinical trials for vaccines to fight COVID-19. </p>
<p>Ours was one of two COVID-19 vaccine clinical research trial sites in the Pittsburgh area and one of more than 100 sites across the U.S. that have participated in this effort through the <a href="https://www.coronaviruspreventionnetwork.org/about-covpn">COVID-19 Prevention Network</a>, which was formed by the National Institutes of Health to combat the spread of the coronavirus. Our team is about to begin the next phase of trials with the 6-11 year-old age group, which relies on volunteer participants. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/411517/original/file-20210715-25-er3g5n.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A boy receives a shot" src="https://images.theconversation.com/files/411517/original/file-20210715-25-er3g5n.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/411517/original/file-20210715-25-er3g5n.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/411517/original/file-20210715-25-er3g5n.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/411517/original/file-20210715-25-er3g5n.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/411517/original/file-20210715-25-er3g5n.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/411517/original/file-20210715-25-er3g5n.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/411517/original/file-20210715-25-er3g5n.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 FDA authorized the use of the Pfizer COVID-19 vaccine for 12-to-15-year-olds in May.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/aiden-arthurs-receives-the-pfizer-biontech-covid-19-vaccine-news-photo/1232867623?adppopup=true">Jeff Kowalsky/AFP via Getty Images</a></span>
</figcaption>
</figure>
<h2>Testing a vaccine for safety and efficacy</h2>
<p>Vaccines work by tricking the body’s immune system into making proteins, called antibodies, that fight disease – but without giving a person the disease. </p>
<p>Before a vaccine can be approved for use in the general public, it usually goes through clinical safety trials that can take anywhere from <a href="https://www.businessinsider.com/how-long-it-took-to-develop-other-vaccines-in-history-2020-7#measles-mumps-and-rubella-mmr-8">2 to 15 years</a>. The U.S. goverment’s <a href="https://doi.org/10.1016/S2214-109X(21)00140-6">Operation Warp Speed</a> accelerated this process in an unprecedented way, largely because it invested US$18 billion up front to help create lab spaces, build infrastructure, make research investments and pre-purchase vaccines. In December 2020, health care workers in the U.S. <a href="https://www.washingtonpost.com/nation/2020/12/14/first-covid-vaccines-new-york/">began receiving</a> the first COVID-19 vaccines authorized for adults.</p>
<p>Vaccine studies begin with experiments in the laboratory, where candidate vaccines are developed and tested in animals. After pharmaceutical companies and government labs perform initial testing on vaccine candidates, they then turn to research groups throughout the country and world to run <a href="https://theconversation.com/from-the-research-lab-to-your-doctors-office-heres-what-happens-in-phase-1-2-3-drug-trials-138197">several phases of clinical trials</a> in people. </p>
<p>In phase 1 trials, the primary goal is to establish the safety of the vaccine in humans. During phase 2, researchers continue to evaluate the safety of the vaccine, but with an eye to determining the exact dosage needed to achieve the necessary immune response to confer protection. Once a vaccine candidate enters phase 3 trials, the primary goal is to study how well people are protected from the infection or disease, while continuing to assess safety and monitor for potential side effects. </p>
<p>Once clinical trials are complete, vaccines must still undergo a <a href="https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/vaccine-development-101">rigorous evaluation process</a> through the U.S. Food and Drug Administration, the regulatory body that oversees vaccine safety and effectiveness.</p>
<p>After <a href="https://www.nejm.org/doi/full/10.1056/nejmoa2034577">tens</a> <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2107659?">of thousands</a> <a href="https://www.statnews.com/2020/12/09/johnson-johnson-cuts-size-of-covid-19-vaccine-study-due-to-prevalence-of-disease-in-u-s/">of adults</a> participated in phase 3 clinical research studies of COVID-19 vaccines over several months in 2020 and early 2021, the U.S. now has <a href="https://covid19.trackvaccines.org/country/united-states-of-america/">three vaccines</a> <a href="https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained">authorized for emergency use</a> by the FDA for people 18 years of age and older and one vaccine, Pfizer, authorized for use in children age 12 and older. </p>
<h2>How kids’ bodies differ from grown-ups’</h2>
<p>Children are not just littler grownups; their bodies differ from adults’ in important ways. </p>
<p>Their <a href="https://doi.org/10.1016/j.cobeha.2016.05.015">brains are developing rapidly</a>, and their immune systems have important differences too, particularly in toddlers and babies. For the first few months of life, infants’ immune systems still possess the <a href="https://doi.org/10.1016/j.vaccine.2015.07.085">antibodies they received from their mothers</a> across the placenta during late pregnancy. This changes how newborns respond to pathogens and makes them less able to mount an immune response to some vaccines. Young children’s bodies gradually ramp up their own immune systems as their protection from mom wears off.</p>
<p>So vaccines often need to be tailored specifically for young children. For instance, the <a href="https://www.cdc.gov/vaccines/vpd/pneumo/hcp/about-vaccine.html">Pneumococcal vaccine that prevents infections</a> like pneumonia in adults is made from sugar molecules called polysaccharides, which coat the outside of pneumococcal bacteria. But infants can’t mount an effective immune response to these sugar molecules. So researchers had to develop a <a href="https://www.chop.edu/centers-programs/vaccine-education-center/vaccine-details/pneumococcal-vaccine">unique version of the vaccine</a> for babies. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/411525/original/file-20210715-38837-1biu235.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Masked student receives temperature check on way in to school" src="https://images.theconversation.com/files/411525/original/file-20210715-38837-1biu235.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/411525/original/file-20210715-38837-1biu235.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=404&fit=crop&dpr=1 600w, https://images.theconversation.com/files/411525/original/file-20210715-38837-1biu235.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=404&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/411525/original/file-20210715-38837-1biu235.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=404&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/411525/original/file-20210715-38837-1biu235.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=507&fit=crop&dpr=1 754w, https://images.theconversation.com/files/411525/original/file-20210715-38837-1biu235.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=507&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/411525/original/file-20210715-38837-1biu235.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=507&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Masks and temperature checks will likely be the norm for many U.S. school-going kids until a COVID-19 vaccine is authorized for children under age 12.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/school-employee-checks-the-temperature-of-a-student-as-she-news-photo/1228142942?adppopup=true">NurPhoto/Getty Images</a></span>
</figcaption>
</figure>
<p>Even when a vaccine for adults is proven safe in children, there can be important differences in how their bodies respond to it. The vaccine dose that works best in adults might cause a high fever in children, for instance. So one key goal of the COVID-19 vaccine clinical trials in children will be to determine the optimal dosage for each age group.</p>
<p>Researchers need to be on alert for side effects that might only occur in youngsters and didn’t appear during vaccine tests on adults. Safety is critical and each study has many layers of safety mechanisms in place to ensure that researchers like us proceed cautiously and evaluate all of the data and information at every step along the way. </p>
<p>For example, trial participants keep daily diaries and report any side effects or changes. Vaccine clinical trials include frequent safety checks with participants, and unusual reactions are reported immediately to the study sponsor so that any problems can be identified quickly. Researchers also adhere to strict “pause” rules if a serious safety concern arises.</p>
<h2>Clinical trials for kids</h2>
<p>After setting up a new clinical trials space and gathering all the staff and necessary equipment, the Trials Unit here at the University of Pittsburgh was ready to host phase 3 clinical trials with volunteer participants.</p>
<p>Beginning in August 2020 and into the fall, we ran phase 3 adult clinical trials for both the Moderna and Johnson & Johnson vaccines. We recently enrolled kids ages 6-11 as well as 6 to 24 months of age in phase 2 of the pediatric Moderna trials, focusing on whether the vaccine is safe to use in these kids and at what dosages. </p>
<p>Our site is now set to move to phase 3 of the pediatric trials, currently slated to begin in mid-August for children age 6-11, throughout the U.S. and Canada. This final stage of the clinical trials will determine how well the vaccine really works to keep kids from getting COVID-19. We expect early results of these studies by this fall, after which they will be reviewed by the FDA.</p>
<p>[<em>Like what you’ve read? Want more?</em> <a href="https://theconversation.com/us/newsletters/the-daily-3?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=likethis">Sign up for The Conversation’s daily newsletter</a>.]</p>
<p>The FDA said on July 15 that emergency authorization for <a href="https://www.nbcnews.com/health/health-news/vaccines-kids-under-age-12-expected-mid-winter-fda-official-n1274057">vaccines for children under 12</a> is likely to come by early to mid-winter.</p>
<h2>The vital role of volunteers in ending the pandemic</h2>
<p>Volunteering for a research study is not for everyone. </p>
<p>When a family volunteers to enroll in a vaccine study, our research team has an in-depth discussion with them about the requirements, as well as the potential risks and benefits. We try to answer all of their questions so that they can decide if a study is a good fit for them. Ultimately, parents are trying to make a decision that is in the best interest of their child.</p>
<p>Often we hear from our volunteers that they wanted to help bring the pandemic to an end or felt it was their personal responsibility to help others. Their willingness to participate is crucial to finding a safe and effective vaccine that will hopefully help end the pandemic and to help parents – and kids – return to the freedoms of pre-pandemic life.</p><img src="https://counter.theconversation.com/content/162821/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Judy Martin works for the University of Pittsburgh which receives funding from the National Institutes of Health. The University of Pittsburgh receives funding from the National Institutes of Health to conduct the research studies of SARS-CoV-2 vaccines. </span></em></p>As many teens and adults in the US restart their social lives, parents of children under the age of 12 wonder when their kids will also be able to experience the freedom that comes with vaccination.Judy Martin, Professor of Pediatrics, University of PittsburghLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1571982021-03-16T12:09:36Z2021-03-16T12:09:36ZHow do mRNA vaccines work – and why do you need a second dose? 5 essential reads<figure><img src="https://images.theconversation.com/files/389685/original/file-20210315-21-6lsrd2.jpg?ixlib=rb-1.1.0&rect=188%2C179%2C5775%2C4014&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">New mRNA vaccines use genes from the coronavirus to produce immunity.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/covid-19-vaccine-royalty-free-image/1287361510"> Andriy Onufriyenko/Moment via Getty Images</a></span></figcaption></figure><p><a href="https://www.nytimes.com/interactive/2021/world/covid-vaccinations-tracker.html">Tens of millions of people</a> across the U.S. have received a coronavirus vaccine. So far, the <a href="https://abc7chicago.com/covid-vaccine-moderna-pfizer-coronavirus-how-many-people-in-the-us-have-been-vaccinated-who-is-eligible-for/10380767/">majority of doses have been either the Moderna or Pfizer vaccine</a>, both of which use mRNA to generate an immune response. These gene-based vaccines have been in the works for decades, but this is the first time they have been used widely in people.</p>
<p>MRNA vaccines are proving to be <a href="https://www.statnews.com/2021/02/02/comparing-the-covid-19-vaccines-developed-by-pfizer-moderna-and-johnson-johnson/">more effective than anyone had hoped</a>, but as with any new medical advancement, people have a lot of questions. How do they work? Are they safe? Do I really need two shots? Why do they need to be kept so cold? And will this be the vaccine technology of the future? Below, we highlight five articles from The Conversation that will help answer your questions about mRNA vaccines.</p>
<h2>1. A vaccine revolution</h2>
<p>“DNA and mRNA vaccines <a href="https://theconversation.com/3-medical-innovations-fueled-by-covid-19-that-will-outlast-the-pandemic-156464">offer huge advantages over traditional types of vaccines</a>, since they use only genetic code from a pathogen – rather than the entire virus or bacteria,” writes <a href="https://scholar.google.com/citations?hl=en&user=eNprtJEAAAAJ">Deborah Fuller, a microbiologist</a> at the University of Washington who has been working on gene-based vaccines for decades.</p>
<p>The Moderna and Pfizer vaccines are proof that mRNA vaccines are ready for prime time – and far surpass their predecessors. “The hopes that gene-based vaccines could one day provide a vaccine for malaria or HIV, cure cancer, replace less effective traditional vaccines or be ready to stop the next pandemic before it gets started are no longer far-fetched,” explains Fuller.</p>
<h2>2. How does an mRNA vaccine work?</h2>
<p>These vaccines are not only effective, they work in a fundamentally different way from traditional vaccines, explains <a href="https://scholar.google.com/citations?hl=en&user=F8vQ9xIAAAAJ">Sanjay Mishra</a>, a staff scientist at the Vanderbilt University Medical Center. </p>
<p>Traditional vaccines use an entire dead virus – or just a piece of one – to generate immunity. “But an <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 vaccine is different</a>,” writes Mishra, “because rather than having the viral protein injected, a person receives genetic material – mRNA – that encodes the viral protein. When these genetic instructions are injected into the upper arm, the muscle cells translate them to make the viral protein directly in the body.”</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/389686/original/file-20210315-21-jqmjnt.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A drawing of the coronavirus." src="https://images.theconversation.com/files/389686/original/file-20210315-21-jqmjnt.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/389686/original/file-20210315-21-jqmjnt.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=337&fit=crop&dpr=1 600w, https://images.theconversation.com/files/389686/original/file-20210315-21-jqmjnt.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=337&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/389686/original/file-20210315-21-jqmjnt.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=337&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/389686/original/file-20210315-21-jqmjnt.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=423&fit=crop&dpr=1 754w, https://images.theconversation.com/files/389686/original/file-20210315-21-jqmjnt.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=423&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/389686/original/file-20210315-21-jqmjnt.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=423&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Just as the pandemic hit, mRNA vaccine research had reached a tipping point.</span>
<span class="attribution"><a class="source" href="https://phil.cdc.gov/Details.aspx?pid=23312">CDC/Alissa Eckert, MSMI; Dan Higgins, MAMS</a></span>
</figcaption>
</figure>
<h2>3. Quick to market, but still safe</h2>
<p>“Safety is the first and foremost goal for a vaccine,” says <a href="https://scholar.google.com/citations?hl=en&user=6yMIM1MAAAAJ">William Petri</a>, a Professor of Medicine at the University of Virginia. A lot of people have expressed safety concerns based on how fast these vaccines were developed, approved and distributed. </p>
<p>According to Petri, the vaccines still went through every normal step – they just did them simultaneously.</p>
<blockquote>
<p>“In my opinion, <a href="https://theconversation.com/covid-19-vaccines-were-developed-in-record-time-but-are-these-game-changers-safe-150249">safety is not compromised by the speed of vaccine development</a> and emergency use authorization. The reason that vaccines may be approved so quickly is that the large clinical trials to assess vaccine efficacy and safety are happening at the same time as the large-scale manufacturing preparation, funded by the federal government’s Operation Warp Speed program.”</p>
</blockquote>
<h2>4. Why it’s important to get your second shot</h2>
<p>You got your first vaccine shot. But with shortages and supply problems, getting the second dose might be becoming a hassle. Does it really matter? Yes, explains William Petri in another article. </p>
<p>“The first dose primes the immune system and introduces the body to the germ of interest. This allows the immune system to prepare its defense. The second dose, or booster, provides the opportunity for the immune system to ramp up the quality and quantity of the antibodies used to fight the virus.”</p>
<p>Immunity is a complex process, and “if the booster isn’t given within the appropriate window, lower quantities of antibodies will be produced that <a href="https://theconversation.com/why-it-takes-2-shots-to-make-mrna-vaccines-do-their-antibody-creating-best-and-what-the-data-shows-on-delaying-the-booster-dose-153956">may not provide as powerful protection from the virus</a>,” writes Petri. So go get your second shot if you can, even if you have to get it a bit later than expected.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/389687/original/file-20210315-15-5cwqys.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A person getting the coronavirus vaccine." src="https://images.theconversation.com/files/389687/original/file-20210315-15-5cwqys.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/389687/original/file-20210315-15-5cwqys.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/389687/original/file-20210315-15-5cwqys.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/389687/original/file-20210315-15-5cwqys.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/389687/original/file-20210315-15-5cwqys.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/389687/original/file-20210315-15-5cwqys.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/389687/original/file-20210315-15-5cwqys.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">Both doses are important for full immunity.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/VirusOutbreakPfizerVaccineMichigan/4956f368c5ce455795c5891b82a7b5b8/photo?Query=vaccine%20shot%20covid&mediaType=photo&sortBy=&dateRange=Anytime&totalCount=1632&currentItemNo=12">AP Photo/Paul Sancya</a></span>
</figcaption>
</figure>
<h2>5. Subzero storage makes distribution a challenge</h2>
<p>For all of their amazing attributes, mRNA vaccines do have at least one weakness: “If they get too warm or too cold they spoil. And, just like fish, a spoiled vaccine must be thrown away,” explains <a href="https://scholar.google.com/citations?user=ecFsBp0AAAAJ&hl=en&oi=ao">Anna Nagurney</a>, Professor of Operations Management at the University of Massachusetts, Amherst, who studies medical supply chains. </p>
<p>The mRNA molecule is very fragile, so vaccines need to be kept at extremely cold, very specific temperatures – a challenge for distribution. “The answer is something called <a href="https://theconversation.com/keeping-coronavirus-vaccines-at-subzero-temperatures-during-distribution-will-be-hard-but-likely-key-to-ending-pandemic-146071">the vaccine cold chain</a> – a supply chain that can keep vaccines in tightly controlled temperatures from the moment they are made to the moment that they are administered to a person,” explains Nagurney. This cold supply chain is critical to getting vaccines where they need to go, and without it, no matter how good the vaccines are, they can’t make much of a difference.</p>
<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/157198/count.gif" alt="The Conversation" width="1" height="1" />
So far, most vaccines in the US are mRNA vaccines. These represent a new technology and are likely to take over the vaccine world. But how do they work? What are their weaknesses? Five experts explain.Daniel Merino, Associate Breaking News Editor and Co-Host of The Conversation Weekly PodcastLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1524342020-12-22T20:51:51Z2020-12-22T20:51:51ZCan employers require workers to take the COVID-19 vaccine? 6 questions answered<figure><img src="https://images.theconversation.com/files/376437/original/file-20201222-19-nwqzra.jpg?ixlib=rb-1.1.0&rect=99%2C130%2C3395%2C2200&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">A patient care director in New York receives the coronavirus vaccine. </span> <span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/VirusOutbreakModernaVaccine/d0133089b2b3408f86b6cdd2370b53d6/photo?Query=vaccine&mediaType=photo&sortBy=arrivaldatetime:desc&dateRange=Anytime&totalCount=5869&currentItemNo=49">Eduardo Munoz/Pool via AP</a></span></figcaption></figure><p><em>The Equal Employment Opportunity Commission, the <a href="https://www.eeoc.gov/overview">federal agency</a> in charge of enforcing laws prohibiting discrimination in the workplace, on Dec. 16 said that <a href="https://www.cbsnews.com/news/eeoc-covid-19-vaccine-employers-exclude-unvaccinated-workers/">employers can require employees</a> to get vaccinated before entering the workplace. Now that <a href="https://theconversation.com/why-should-i-trust-the-coronavirus-vaccine-when-it-was-developed-so-fast-a-doctor-answers-that-and-other-reader-questions-152429">two COVID-19 vaccines</a> have received emergency use authorization in the U.S., some people are concerned they could be fired if they don’t want to take the vaccine. We asked legal scholar <a href="https://www.slu.edu/law/faculty/ana-santos-rutschman.php">Ana Santos Rutschman</a>, who teaches a course on vaccine law at Saint Louis University, to explain the decision and the rights employees and employers have.</em></p>
<h2>1. Can employers require employees to get a vaccine?</h2>
<p>The general rule is yes – with some exceptions. </p>
<p>Under U.S. law, private employers have the ability to define general working conditions, including the adoption of <a href="https://www.osha.gov/as/opa/worker/employer-responsibility.html">health and safety</a> within the workspace. Requiring employees to get vaccinated against diseases that could compromise health and safety in the workplace is viewed as part of that ability.</p>
<h2>2. Does the rule apply to COVID-19 vaccines?</h2>
<p>Earlier in the pandemic, there were <a href="https://blog.petrieflom.law.harvard.edu/category/contributors/dorit-reiss/">some doubts</a> about whether the general rule would apply to COVID-19 vaccines because the first vaccines that became available in the U.S. have <a href="https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained">not been fully approved</a> by the Food and Drug Administration. They have received an <a href="https://theconversation.com/what-are-emergency-use-authorizations-and-do-they-guarantee-that-a-vaccine-or-drug-is-safe-151178">emergency use authorization</a>, which is temporary permission to commercialize the vaccines because of the public health crisis the U.S. is facing. This is the first time emergency use authorization has been granted to a new vaccine. For this reason, some <a href="https://blog.petrieflom.law.harvard.edu/category/contributors/dorit-reiss/">legal scholars</a> questioned whether existing laws applied to temporarily authorized vaccines.</p>
<p>That question was addressed when the Equal Employment Opportunity Commission issued guidelines that said <a href="https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws">employers have the right</a> to impose a mandatory COVID-19 vaccination policy. </p>
<p>From a legal perspective, this view is based on the fact that the law allows employers to impose requirements to make sure that employees don’t pose threats to the “health or safety of other individuals in the workplace.” The EEOC treated emergency use vaccines as part of the sets of measures that employers are able to mandate in order to accomplish this goal.</p>
<p>Therefore, the general rule applies and employers should be able to require that employees get vaccinated against COVID-19, within certain limits. These limits – including the exceptions below – are the same as the general exemptions applicable to any employer-mandated vaccination. </p>
<h2>3. Are there religious exemptions?</h2>
<p>Title VII of the Civil Rights Act established that if an employee has a sincerely held <a href="https://www.eeoc.gov/laws/guidance/questions-and-answers-religious-discrimination-workplace">religious belief</a> incompatible with vaccination, the employer cannot require that employee to be vaccinated. The EEOC has traditionally interpreted the concept of “religious belief” <a href="https://www.eeoc.gov/foia/eeoc-informal-discussion-letter-250">very broadly</a>. Vaccine refusal cannot, however, be a personal or politically motivated belief.</p>
<p>If an employee qualifies for a religious exemption, the employer must then try to reasonably accommodate the employee. An example of an accommodation would be for the employer to have the employee switch from in-person to remote work while COVID-19 poses risks to public health.</p>
<p>However, the employer does not have to grant an accommodation if doing so would result in “<a href="https://www.law.cornell.edu/cfr/text/29/1605.2">undue hardship</a>.” Typical cases of undue hardship include situations in which the accommodation would compromise the health and safety of other employees or in which implementing the accommodation is too costly or logistically burdensome. In case of a dispute over what constitutes an undue hardship for the employer, a <a href="https://scholarship.law.missouri.edu/cgi/viewcontent.cgi?article=4367&context=mlr">court would typically</a> be asked to resolve it based on the cost of offering the accommodation, as well as how difficult it is for the employer to implement it.</p>
<h2>4. How about disability-related exemptions?</h2>
<p>The balance of rights between an employee with a disability and her employer is similar to the one described above. Under the Americans with Disabilities Act, if an employee <a href="https://www.govinfo.gov/content/pkg/CFR-2012-title29-vol4/xml/CFR-2012-title29-vol4-sec1630-2.xml">has a disability</a> and cannot safely receive a vaccine, that employee qualifies for an exemption and the employer has to provide <a href="https://adata.org/factsheet/reasonable-accommodations-workplace">reasonable accommodations</a>. But the act also establishes that employers do not have to provide an accommodation that would result in undue hardship.</p>
<p>The technical question here was whether employers could impose COVID-19 vaccination because the Americans with Disabilities Act severely limits the ability of employers to require medical examinations. In its Dec. 16 guidance, the EEOC clearly stated that COVID-19 vaccines <a href="https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws">do not fall in the “medical examination” category</a>. </p>
<p>Therefore, requiring employee vaccination does not violate federal disability law.</p>
<h2>5. What if the employer cannot provide an accommodation?</h2>
<p>If an employee qualifies for either a religious or disability-related exemption but the employer is unable to provide an accommodation because of undue hardship, then the employer has the right to <a href="https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws">exclude the employee</a> from going to the workplace.</p>
<p>Given the broad set of rights that the law gives employers in order to promote health and safety, in some cases it is possible for an organization to go even further and terminate employment if a worker refuses vaccination and there is no reasonable way to provide an accommodation. For example, if there is no reasonable accommodation that an employer can provide a barista that would allow her to continue make lattes at the coffee shop where she works, the employer may be able to terminate her employment.</p>
<p>However, the EEOC guidelines <a href="https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws">explicitly say</a> that the inability to reasonably accommodate an employee does not automatically give the employer the right to fire her. Finding out whether the coffee shop could indeed terminate its unvaccinated barista would depend on a variety of factors, including state law, union agreements and any other potentially applicable requirements at the federal level. </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/152434/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ana Santos Rutschman 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 federal agency in charge of enforcing discrimination laws in the workplace said ‘yes,’ but there are some important exceptions and limitations.Ana Santos Rutschman, Assistant Professor of Law, Saint Louis UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1524292020-12-22T13:36:26Z2020-12-22T13:36:26ZWhy should I trust the coronavirus vaccine when it was developed so fast? A doctor answers that and other reader questions<figure><img src="https://images.theconversation.com/files/376268/original/file-20201221-21-25j20e.jpg?ixlib=rb-1.1.0&rect=5%2C0%2C3982%2C2664&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Pharmacist Jessica Sahni prepares a Pfizer COVID-19 vaccine in New York City. </span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/walgreens-pharmacist-jessica-sahni-prepares-a-pfizer-covid-news-photo/1230249071?adppopup=true">Bryan R. Smith/AFP via Getty Images</a></span></figcaption></figure><p><em>Editor’s Note: With a coronavirus vaccination effort now underway, you might have questions about what this means for you and your family. If you do, <a href="mailto:lynne.anderson@theconversation.com">send them to The Conversation,</a> and we will find a physician or researcher to answer them. Here, <a href="https://medicine.iu.edu/faculty/4406/dbeibo-lana">Dr. Lana Dbeibo</a>, a clinical assistant professor of medicine at Indiana University School of Medicine, answers reader questions about the vaccine and compromised immune systems and whether to get the vaccine if a person has had previous adverse reactions to a vaccine.</em></p>
<p><strong>I fully support the use of vaccines, but I worry about possible long-term side effects with the new vaccines. How can anyone say with any confidence there will be no long-term consequences with vaccines that have been developed so rapidly?</strong></p>
<p>There are reasons the <a href="https://theconversation.com/covid-19-vaccines-were-developed-in-record-time-but-are-these-game-changers-safe-150249">vaccines were developed rapidly</a>: First, the production started before the end of <a href="https://www.nccn.org/patients/resources/clinical_trials/phases.aspx">phase 3 clinical trials</a>. Second, there was a lot of interest in volunteering for the trials that tested the vaccines’ effectiveness, which expedited the process. Researchers often wait many months and sometimes even years to get people to volunteer to be part of trials. </p>
<p>Last, there was a lot of disease in the community which made it faster to see whether the vaccine was effective. The coronavirus has caused disease in millions of people in the U.S. alone, while <a href="https://www.cdc.gov/vhf/ebola/index.html">Ebola</a> and <a href="https://www.cdc.gov/zika/index.html">Zika </a>viruses, while extremely serious, affected far fewer.</p>
<p>I worry much more about the <a href="https://www.nature.com/articles/d41586-020-02598-6">long-term effects of the virus</a>, which can be very debilitating and start soon after the infection. We have not seen reports of major effects of the vaccine in the past few months that it was studied; if there were major effects, I believe we should have started to see them by now. This could can change, however, and scientists would update recommendations accordingly.</p>
<p><strong>My husband is 72 and undergoing chemo treatment for metastasized cancer in his lymph nodes. So far, treatment is showing shrinkage of tumors and no new spread.
I’m 73. Should I get the vaccine?</strong></p>
<p>There are two issues to address here. First, there is a question of <a href="https://www.nytimes.com/2020/12/08/health/covid-vaccine-mask.html">whether someone who has been vaccinated could spread the disease to someone else</a>. There is very limited data on whether the vaccine effectively limits spread of the disease, but we are waiting on studies to answer this question. </p>
<p>The second issue you raise is about people with compromised immune systems and whether they should get the vaccine. While the efficacy of the COVID-19 vaccines was not studied in immunocompromised people, the <a href="https://www.ajmc.com/view/taking-immunosuppressants-fauci-says-get-the-covid-19-vaccine">danger of COVID-19 to patients with a weaker immune system like your husband’s is very high</a>. Because the benefit may exceed the risk, the Centers for Disease Control and Prevention <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations-process.html">did not list being immunocompromised</a> as a contraindication to receive the COVID vaccine. Please consult with your physician to have a conversation about this.</p>
<p><strong>I have rheumatoid/psoriatic arthritis. I am taking the <a href="https://www.medicinenet.com/biologics_biologic_drug_class/article.htm">biologic</a> <a href="https://www.actemra.com">Actemra</a> and <a href="https://www.rxlist.com/solu-medrol-drug.htm">Solu Medrol</a> as an infusion, monthly. I also take <a href="https://medlineplus.gov/druginfo/meds/a682019.html">methotrexate</a> twice a week. Is the vaccine considered safe for people with compromised immune systems?</strong></p>
<p>The answer to this is very similar to the answer above. The CDC did not list having a weakened immune system as a reason not to get the vaccine, or what we doctors call a <a href="https://www.medicinenet.com/contraindication/definition.htm">contraindication</a>. Still, it is important for you to talk to your physician about your particular case. </p>
<figure class="align-center ">
<img alt="A man receiving the COVID-19 vaccine." src="https://images.theconversation.com/files/376270/original/file-20201221-15-51zgwb.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/376270/original/file-20201221-15-51zgwb.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=399&fit=crop&dpr=1 600w, https://images.theconversation.com/files/376270/original/file-20201221-15-51zgwb.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=399&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/376270/original/file-20201221-15-51zgwb.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=399&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/376270/original/file-20201221-15-51zgwb.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=502&fit=crop&dpr=1 754w, https://images.theconversation.com/files/376270/original/file-20201221-15-51zgwb.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=502&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/376270/original/file-20201221-15-51zgwb.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">
<figcaption>
<span class="caption">Herbie Severe receives Moderna’s COVID-19 vaccine at Hartford Hospital in Hartford, Connecticut, on Dec. 21.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/herbie-severe-recieves-the-covid-19-vaccine-with-the-first-news-photo/1230250350?adppopup=true">Joseph Prezioso/AFP via Getty Images</a></span>
</figcaption>
</figure>
<p><strong>My 22-year-old son had a reaction to the <a href="https://www.cdc.gov/vaccines/vpd/mmr/public/index.html">MMR vaccine</a> when he was approximately 6 years old. He ran a fever for several days and developed <a href="https://medlineplus.gov/ency/article/000535.htm#:%7E:text=Immune%20thrombocytopenic%20purpura%20(ITP)%20is,few%20platelets%20in%20the%20blood.">the bleeding disorder ITP</a> within a month or two after receiving the MMR vaccine. Should he be concerned about receiving the coronavirus vaccine?</strong></p>
<p>Having any type of allergy other than <a href="https://www.mayoclinic.org/diseases-conditions/anaphylaxis/symptoms-causes/syc-20351468">anaphylaxis</a>, which is a severe and sometimes life-threatening allergic reaction, to vaccines or components of the COVID vaccine <a href="https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/covid-19/clinical-considerations.html">is not a contraindication to receive the COVID vaccine</a>. Everyone who receives either one of the drugs that have received emergency use authorization will be monitored for 15-30 minutes in the clinic after the vaccine dose because serious reactions will happen in the first few minutes after the vaccine is given. </p>
<p><strong>At age 7 or 8, I received tetanus antitoxin (horse serum) and quickly lost consciousness for about four days. Subsequently, I remember having hives a few times in childhood and mild asthma until I was about 25. I do not now have significant allergies. I have had several cardiac procedures, including open thoracotomy for mitral and aortic bovine valve replacement in 2010 and a <a href="https://www.watchman.com/en-us/how-watchman-device-works.html">“Watchman”</a> procedure. I have a pacemaker and daily take <a href="https://www.medicalnewstoday.com/articles/metoprolol-oral-tablet">Metoprolol</a>, <a href="https://medlineplus.gov/druginfo/meds/a601212.html">Torsemide</a> and <a href="https://pubchem.ncbi.nlm.nih.gov/compound/Penicillin-g">penicillin g</a> (after two episodes of <a href="https://www.mayoclinic.org/diseases-conditions/endocarditis/symptoms-causes/syc-20352576">endocarditis</a>. Also a <a href="https://www.healthline.com/health/hemicolectomy">hemicolectomy </a>for cancer. No problem with flu shots. Generally I am feeling better than I have in the past several years. I drive without difficulty. Should I get the vaccine?</strong> </p>
<p>My answer here would be similar to one answered above – having any allergy other than anaphylaxis to vaccines or components of the COVID vaccine is not a contraindication to receive the COVID vaccine. Similarly, having asthma or seasonal allergies is not a contraindication. I would recommend you consult with your doctor for specifics related to your other health issues.</p>
<p>And remember that scientific observations of the vaccine are ongoing. The CDC, FDA and other government agencies will update the public on significant changes if they occur.</p><img src="https://counter.theconversation.com/content/152429/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Lana Dbeibo 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>Now that two COVID vaccines have been authorized by the FDA, questions arise. Today, a physician from Indiana University School of Medicine answers five reader questions.Lana Dbeibo, Assistant professor of clinical medicine, Indiana University School of MedicineLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1521582020-12-18T19:15:14Z2020-12-18T19:15:14ZIf I have allergies, should I get the coronavirus vaccine? An expert answers this and other questions<figure><img src="https://images.theconversation.com/files/375789/original/file-20201217-15-qqrmbk.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C5391%2C3597&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Sandra Lindsay, left, a nurse at Long Island Jewish Medical Center, is inoculated with the COVID-19 vaccine by Dr. Michelle Chester. </span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/sandra-lindsay-left-a-nurse-at-long-island-jewish-medical-news-photo/1230125095?adppopup=true">Mark Lennihan/Pool via Getty Images</a></span></figcaption></figure><p><em>Editor’s Note: With a coronavirus vaccination effort now underway, you might have questions about what this means for you and your family. If you do, <a href="mailto:lynne.anderson@theconversation.com">send them to The Conversation,</a> and we will find a physician or researcher to answer them. Here, Dr. Mona Hanna-Attisha, a public health pediatrician whose research exposed the Flint, Michigan, water crisis, answers questions about the vaccine and allergies, and when kids might be able to get the vaccine.</em></p>
<h2>If I have allergies, should I still get the vaccine?</h2>
<p>If you have a history of allergies to food, pets, insects or other things, the Centers for Disease Control and Prevention recommends <a href="https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/clinical-considerations.html#contraindications-precautions">that you proceed with vaccination, with an observation period</a>. If you have a history of severe allergic reaction, or what is called <a href="https://www.mayoclinic.org/diseases-conditions/anaphylaxis/symptoms-causes/syc-20351468">anaphylaxis</a>, to another vaccine or injectable therapy, your doctor can do a risk assessment, defer your vaccination, or proceed and then observe you after vaccination. The only reason to avoid vaccination is a severe allergic reaction to any component of the COVID-19 vaccine. The CDC has <a href="https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/clinical-considerations.html#contraindications-precautions">specific recommendations for post-vaccine observation</a>.</p>
<h2>As the vaccine goes out to a broader population, how will adverse events be tracked?</h2>
<p>The CDC and Food and Drug Administration encourage the public to report possible adverse events to the <a href="https://vaers.hhs.gov">Vaccine Adverse Event Reporting System</a>, or VAERS. This national system collects these data to look for adverse events that are unexpected, appear to happen more often than expected or have unusual patterns of occurrence. Anyone who has experienced an adverse event should report it to the system.</p>
<p>Reporting an adverse event is a crucial step to ensuring safety and to help the CDC monitor the vaccines. <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety.html">Safety is a top priority</a>, and scientists and public health officials need to know about adverse reactions.</p>
<p>An adverse event is different in most cases from a typical vaccine side effect. Vaccines may cause a <a href="https://theconversation.com/vaccines-against-sars-cov-2-will-have-side-effects-thats-a-good-thing-151090">side effect</a>, such as soreness at the injection site or redness. <a href="https://vaers.hhs.gov/index">Adverse events</a> are more serious and can sometimes be life-threatening. If you are unsure whether you have experienced a side effect or adverse event, you can still report the event. </p>
<p>Participants are given a <a href="https://www.fda.gov/media/144414/download">fact sheet</a> when they are vaccinated. Health care providers who vaccinate people will be required to report to VAERS certain adverse events following vaccination. In addition, under the terms of the emergency use authorization, health care providers also must follow any revised safety reporting requirements that may arise.</p>
<p>The CDC is also implementing a new smartphone-based tool called <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html">v-safe</a> to check in on people’s health after they receive a COVID-19 vaccine. When you receive your vaccine, you should also receive an information sheet telling you how to enroll in v-safe. If you enroll, you will receive regular text messages directing you to surveys where you can report any problems or adverse reactions you have after receiving a COVID-19 vaccine.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/375805/original/file-20201217-17-q5777b.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Triage guidelines from CDC for administering the Pfizer-BioNTech COVID-19 vaccine." src="https://images.theconversation.com/files/375805/original/file-20201217-17-q5777b.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/375805/original/file-20201217-17-q5777b.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=419&fit=crop&dpr=1 600w, https://images.theconversation.com/files/375805/original/file-20201217-17-q5777b.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=419&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/375805/original/file-20201217-17-q5777b.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=419&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/375805/original/file-20201217-17-q5777b.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=527&fit=crop&dpr=1 754w, https://images.theconversation.com/files/375805/original/file-20201217-17-q5777b.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=527&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/375805/original/file-20201217-17-q5777b.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=527&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Clinical guidelines from the Centers for Disease Control and Prevention for determining which patients should receive the Pfizer-BioNTech COVID-19 vaccination.</span>
<span class="attribution"><a class="source" href="https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/clinical-considerations.html">CDC</a></span>
</figcaption>
</figure>
<h2>When might kids younger than 16 be vaccinated?</h2>
<p>It is likely to be <a href="https://theconversation.com/when-can-children-get-the-covid-19-vaccine-5-questions-parents-are-asking-150721">several months</a>. The currently authorized Pfizer and soon-to-be-authorized <a href="https://www.nytimes.com/2020/12/17/health/covid-vaccine-fda-moderna.html?action=click&module=Top%20Stories&pgtype=Homepage">Moderna vaccine</a> are not applicable for children. More research and clinical trials need to be done to include younger children in COVID-19 vaccine trials. </p>
<p>According to the <a href="https://services.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/covid-19-vaccine-frequently-asked-questions">American Academy of Pediatrics</a>, Pfizer has enrolled children down to age 12 and submitted a request for emergency use authorization for vaccination down to age 16. <a href="https://www.nytimes.com/2020/12/17/health/covid-vaccine-fda-moderna.html?action=click&module=Top%20Stories&pgtype=Homepage">Moderna</a>, whose vaccine is expected to receive emergency use authorization from the FDA any day, is about to start a similar study. </p>
<p>In the United Kingdom, AstraZeneca has approval to enroll children ages 5 to 12 in clinical trials, but the pharmaceutical company has not yet enrolled any children in trials in the U.S.</p><img src="https://counter.theconversation.com/content/152158/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Mona Hanna-Attisha 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>A serious allergic reaction was reported in a health care worker in Alaska after she received the COVID-19 vaccine. Does this mean that people with allergies need to be concerned? An expert answers.Mona Hanna-Attisha, Professor of Medicine, Michigan State UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1522082020-12-17T19:54:50Z2020-12-17T19:54:50ZFDA authorized first over-the-counter COVID-19 test – useful but not a game changer<figure><img src="https://images.theconversation.com/files/375614/original/file-20201217-17-13f8w1f.png?ixlib=rb-1.1.0&rect=161%2C877%2C5344%2C3267&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The new rapid test is available without a prescription, but only 20 million are set to be sold by the middle of next year. </span> <span class="attribution"><a class="source" href="https://apnews.com/press-release/globenewswire-mobile/business-technology-pandemics-public-health-alabama-539d72db8cbf0f5666bcd58223a537a1">Ellume/AP</a></span></figcaption></figure><p>Soon, people in the U.S. will be able to pick up a <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-antigen-test-first-over-counter-fully-home-diagnostic">rapid antigen test</a> for COVID-19 from their local drugstore without a prescription, test themselves and process the results at home. </p>
<p>The Ellume COVID-19 Home Test that was granted an <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization">emergency use authorization</a> from the Food and Drug Administration is expected <a href="https://www.nytimes.com/2020/12/15/health/rapid-covid-test-ellume.html">to cost US$30</a>, is easy to use and produces results within 20 minutes. </p>
<h2>How does the test work?</h2>
<p>The Ellume test is currently the most versatile rapid antigen test because it is authorized for testing anyone age 2 or over, <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-antigen-test-first-over-counter-fully-home-diagnostic">whether they have symptoms or not</a>. It is an antigen test that detects viral proteins, as opposed to the gold-standard PCR tests that detect viral genetic material.</p>
<p>The Ellume test includes a <a href="https://www.ellumehealth.com/2020/12/15/fda-authorizes-ellume-covid-19-home-test-as-first-over-the-counter-fully-at-home-diagnostic-test/">smartphone app</a> that provides step-by-step instructions explaining how to take a nasal swab and place it into the small analyzer that processes the sample. The app connects to the analyzer via Bluetooth to display the test results on the user’s phone. It is also possible to <a href="https://www.nytimes.com/2020/12/15/health/rapid-covid-test-ellume.html">transmit test results</a> securely and anonymously to public health authorities via the app, which helps provide data to guide COVID-19 policy decisions.</p>
<h2>How does the Ellume test compare to other rapid tests?</h2>
<p>Independent testing by the National Institutes of Health confirmed that the Ellume COVID-19 Home Test <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-antigen-test-first-over-counter-fully-home-diagnostic">successfully identified 96%</a> of PCR-confirmed COVID-19 positive cases in people with symptoms and <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-antigen-test-first-over-counter-fully-home-diagnostic">91% of PCR-confirmed cases</a> in <a href="https://theconversation.com/can-people-spread-the-coronavirus-if-they-dont-have-symptoms-5-questions-answered-about-asymptomatic-covid-19-140531">people without symptoms</a>. This is comparable to the <a href="https://theconversation.com/will-the-new-15-minute-covid-19-test-solve-us-testing-problems-145285">Abbott BinaxNOW rapid test</a>, another commonly used rapid antigen test, that reported agreement with PCR testing for 97.1% of COVID-19 positive cases with symptoms. </p>
<p>Health care providers have been using the <a href="https://theconversation.com/will-the-new-15-minute-covid-19-test-solve-us-testing-problems-145285">Abbott BinaxNOW</a> test for months, and it was <a href="https://www.forbes.com/sites/brucejapsen/2020/12/16/fda-clears-abbott-25-rapid-test-for-use-at-home/?sh=3748ab495210">also authorized for home use this week</a>. However, it is less versatile than the Ellume test since the Abbot test requires a prescription and is currently only authorized for home use in people within seven days of the onset of COVID-19 symptoms.</p>
<p>[<em>Get the best of The Conversation, every weekend.</em> <a href="https://theconversation.com/us/newsletters/weekly-highlights-61?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=weeklybest">Sign up for our weekly newsletter</a>.]</p>
<h2>How can this test be useful?</h2>
<p><a href="https://theconversation.com/rapid-screening-tests-that-prioritize-speed-over-accuracy-could-be-key-to-ending-the-coronavirus-pandemic-143882">Widespread rapid antigen testing</a> to slow COVID-19 transmission remains an important goal even though the FDA has already authorized a COVID-19 vaccine. At-home tests could boost testing rates by offering a quick and convenient alternative to testing at a doctor’s office or public testing site. Since the Ellume test is authorized for everyone, it should help identify COVID-19 cases in people without symptoms, which might otherwise go undetected.</p>
<h2>Are there enough tests to make a difference?</h2>
<p>Home-based antigen testing is one way to improve access to testing. While this test will help identify COVID-19 cases, the planned production of <a href="https://www.nytimes.com/2020/12/15/health/rapid-covid-test-ellume.html">20 million Ellume tests by mid-2021</a> still falls <a href="https://theconversation.com/rapid-covid-19-tests-can-be-useful-but-there-are-far-too-few-to-put-a-dent-in-the-pandemic-148429">far short of meeting the overall need</a> for testing in the U.S. to bring the pandemic under control. Some experts estimate that number could be as high as <a href="https://www.npr.org/sections/health-shots/2020/10/01/915793729/can-the-u-s-use-its-growing-supply-of-rapid-tests-to-stop-the-virus">14 million tests per day</a>.</p>
<p>Additionally, the $30 cost of the test poses a potential barrier to widespread and frequent use. Ideally, screening tests should <a href="https://theconversation.com/rapid-screening-tests-that-prioritize-speed-over-accuracy-could-be-key-to-ending-the-coronavirus-pandemic-143882">cost $1-$5 to achieve the high testing rates</a> needed to control the spread of the virus. Ultimately, the FDA may need to authorize more rapid screening tests if the U.S. is to meet the demand for testing.</p>
<p>Even though there <a href="https://theconversation.com/rapid-covid-19-tests-can-be-useful-but-there-are-far-too-few-to-put-a-dent-in-the-pandemic-148429">aren’t enough of these tests</a> to dramatically change the testing landscape, rapid testing can still help identify contagious cases early so infected people can avoid spreading the virus. This type of easy-to-use rapid antigen testing could also be used to screen travelers entering the U.S.</p>
<p>It will take months for the U.S. to reach the <a href="https://www.jhsph.edu/covid-19/articles/achieving-herd-immunity-with-covid19.html">vaccine-driven herd immunity threshold</a>. In the meantime, rising vaccination rates and rapid antigen testing can work together to slow transmission and suppress the virus. The Ellume test is not a game changer, but every little bit helps.</p><img src="https://counter.theconversation.com/content/152208/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Zoë McLaren 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>A new over-the-counter COVID-19 test has been authorized by the FDA. Though it can be used to test people with and without symptoms, moderate cost and limited production mean it isn’t a game-changer.Zoë McLaren, Associate Professor of Public Policy, University of Maryland, Baltimore CountyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1515422020-12-11T19:34:07Z2020-12-11T19:34:07ZMy university will be getting COVID-19 vaccines soon – here’s how my team will get doses into arms<figure><img src="https://images.theconversation.com/files/374295/original/file-20201210-14-1s886kq.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C5109%2C3361&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">After receiving the vaccine, health systems have a complicated job ahead of them.</span> <span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/APTOPIXChinaVaccine/464310a7f13944838c96d2a241352ac9/photo?Query=covid%20AND%20vaccine&mediaType=photo&sortBy=&dateRange=Anytime&totalCount=1272&currentItemNo=15">AP Photo/Ng Han Guan</a></span></figcaption></figure><p>In late October, I received an email from a member of the California Department of Public Health. I called the number in the email and a bright happy voice answered and asked if the University of California, San Francisco would be interested in the early release and distribution of the Pfizer COVID-19 vaccine. Of course, I said yes.</p>
<p>I am the <a href="https://pharmacy.ucsf.edu/desi-kotis">chief pharmacy executive at UCSF Health</a> and associate dean and clinical professor at the School of Pharmacy. My team and I are responsible for the distribution of all medications and vaccines throughout the health system, and I am also the person running much of the COVID-19 vaccine distribution for UCSF.</p>
<p>UCSF will be receiving our first allocation of the Pfizer vaccine around Dec. 15 and the Moderna vaccine sometime soon after that. We project that by the end of 2020, we will receive enough vaccine for all our staff, students, faculty and most of our high-risk patient populations. This news is incredibly exciting, but will take a lot of work to pull off smoothly. My colleagues and I are working to make sure that critical data tracking, complicated storage and the intricacies of actually administering doses all run smoothly so that these vaccines are distributed as equitably and efficiently as possible. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/374297/original/file-20201210-14-1iparuy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Workers handling a shipment of vaccines in a large cold storage container." src="https://images.theconversation.com/files/374297/original/file-20201210-14-1iparuy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/374297/original/file-20201210-14-1iparuy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=367&fit=crop&dpr=1 600w, https://images.theconversation.com/files/374297/original/file-20201210-14-1iparuy.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=367&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/374297/original/file-20201210-14-1iparuy.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=367&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/374297/original/file-20201210-14-1iparuy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=462&fit=crop&dpr=1 754w, https://images.theconversation.com/files/374297/original/file-20201210-14-1iparuy.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=462&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/374297/original/file-20201210-14-1iparuy.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=462&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Once a health system receives the vaccine, every dose is tracked closely.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/VirusOutbreakEuropeVaccinesLogistics/36d7cd9eec274b4b9810227e598e7a2a/photo?Query=covid%20vaccine%20shipment&mediaType=photo&sortBy=&dateRange=Anytime&totalCount=27&currentItemNo=14">AP Photo/Virginia Mayo</a></span>
</figcaption>
</figure>
<h2>Tracking, storage and preparation</h2>
<p>Before the CDC would give us any vaccine, the first thing I needed to do was register the UCSF health system with the California Department of Public Health. I give them information on everything from the number of our medical workers who are qualified to administer the vaccine to the serial numbers of our freezers.</p>
<p>As a precaution, since many are considering this vaccine “liquid gold,” our team needs to account for every dose at every step of the process due to the potential of diversion. We also aren’t yet sure how much vaccine UCSF will be allocated in these first rounds, so we need to be prepared to store either a small or large supply. </p>
<p>The pharmacies storing the vaccine are highly regulated, monitored and secured spaces. The vaccines will not only be on a secure and backup power supply in case of electrical power outage but also electronically monitored for temperature.</p>
<p>Unlike the flu vaccine, both the Pfizer and Moderna COVID-19 vaccines have <a href="https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf">unique storage requirements</a>, last at room temperature for only a <a href="https://www.pfizer.com/news/hot-topics/covid_19_vaccine_u_s_distribution_fact_sheet">short amount of time</a> and require a lot of preparation.</p>
<p>First, you can’t store either the Pfizer or Moderna vaccine on a refrigerator shelf. The Pfizer vaccine comes in a frozen liquid form that <a href="https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf">needs ultra-cold storage</a> at minus 70 C. In this deep freeze, it is <a href="https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf">stable for six months</a>, but it takes specific preparation before it is ready to give to people.</p>
<p>Pharmacists and technicians have to thaw the frozen liquid and then mix it into a solution of sterile, preservative-free saline. Each Pfizer vaccine vial contains <a href="https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf">five doses and is stable for only six hours at room temperature</a>. The Moderna vaccine is supplied in liquid form with 10 doses per vial.</p>
<p>When it is time to give people the vaccine, each dose has to be prepared and labeled in a ready-to-use syringe. At each step of this process, our staff will document and track every dose. Once we begin vaccinating people, we will send the California Department of Public Health and the Centers for Disease Control and Prevention an accountability log of how many doses we administer each day.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/374298/original/file-20201210-24-mqqpa4.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A healthcare worker receiving a COVID-19 vaccine." src="https://images.theconversation.com/files/374298/original/file-20201210-24-mqqpa4.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/374298/original/file-20201210-24-mqqpa4.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=436&fit=crop&dpr=1 600w, https://images.theconversation.com/files/374298/original/file-20201210-24-mqqpa4.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=436&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/374298/original/file-20201210-24-mqqpa4.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=436&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/374298/original/file-20201210-24-mqqpa4.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=548&fit=crop&dpr=1 754w, https://images.theconversation.com/files/374298/original/file-20201210-24-mqqpa4.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=548&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/374298/original/file-20201210-24-mqqpa4.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"></a>
<figcaption>
<span class="caption">The CDC has given some guidance on who should get vaccinated first, but the specifics are left up to individual health systems.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/APTOPIXVirusOutbreakVaccineRace/d06c92f7015c4ce591617e45f495666f/photo?Query=covid%20AND%20vaccine&mediaType=photo&sortBy=&dateRange=Anytime&totalCount=1272&currentItemNo=23">AP Photo/Hans Pennink</a></span>
</figcaption>
</figure>
<h2>Who gets vaccinated first?</h2>
<p>Once UCSF receives our first vaccine shipment, we face the task of deciding who gets these precious vaccines first. Our team has utilized national guidelines from <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations-process.html">the CDC</a> and the <a href="https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/covid-19.html">Advisory Committee on Immunization Practices</a> as well as state guidance from the <a href="https://www.cdph.ca.gov/Programs/OPA/Pages/NR20-281.aspx">California Department of Public Health</a> to follow the phased prioritization roll out. Right now, we are focusing on <a href="https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-12/COVID-02-Dooling.pdf">phase 1a</a>, which broadly includes <a href="https://www.nytimes.com/2020/12/01/health/covid-vaccine-distribution-first.html">health care workers</a> and first responders as well as high-risk patients and <a href="https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-12/COVID-02-Dooling.pdf">long-term care facility residents</a>.</p>
<p>While the guidance says which groups should be prioritized, there is no way it could cover every decision. Our team has been working with doctors, ethicists and experts in health equity to further prioritize the most vulnerable first responders, high-risk staff and high-risk patients within the University of California system. We are looking at not only clinical health care workers, clinical students and patients, but anyone who could have prolonged, repeated potential exposure to body fluids and aerosols. That includes critical staff like medical transporters who get patients where they need to be, food service workers, police officers and environmental services workers in our hospitals and clinics.</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>Going forward</h2>
<p>On Dec. 3, California Governor Gavin Newsom announced that the state will receive 327,000 doses of the Pfizer vaccine by the middle of December and <a href="https://www.nbcbayarea.com/news/local/race-for-a-vaccine/californias-first-wave-of-coronavirus-vaccine-will-include-2-million-doses/2417075/">2.2 million doses by the New Year</a>. </p>
<p>Giving this vaccine to millions of Californians is going to be a massive undertaking. But our team and health systems throughout the country have been preparing so that this roll out is as effective, efficient and fair as possible.</p><img src="https://counter.theconversation.com/content/151542/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Desi Kotis 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>Health systems around the US are on the cusp of receiving COVID-19 vaccines. At the end of this months-long effort are the nitty-gritty details of how health care providers are giving people the vaccine.Desi Kotis, Associate Dean and Professor of Pharmacy, University of California, San FranciscoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1515322020-12-11T05:39:45Z2020-12-11T05:39:45ZWhy paying people to get the coronavirus vaccine won’t work<figure><img src="https://images.theconversation.com/files/374294/original/file-20201210-17-zgm14s.jpg?ixlib=rb-1.1.0&rect=12%2C0%2C8167%2C5457&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Although monetary incentives work, there are potential drawbacks.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/this-illustration-picture-shows-a-vial-reading-covid-19-news-photo/1229810611?adppopup=true">Joel Saget/AFP via Getty Images</a></span></figcaption></figure><p>The first COVID-19 vaccine to gain <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization">emergency use authorization</a> in the U.S. could roll out within days, as Pfizer and BioNTech’s candidate was <a href="https://www.statnews.com/2020/12/10/tracking-the-fda-advisory-panel-meeting-on-the-pfizer-biontech-covid-19-vaccine/">endorsed</a> by an external advisory panel to the Food and Drug Administration on Dec. 10. Two days earlier, an internal FDA panel endorsed the vaccine. These were the last required steps before the FDA authorizes the vaccine, which will soon be administered to health care workers across the country.</p>
<p>But while health care workers, who will be first to receive the vaccine, appear eager to get the shot, others are not so convinced. In fact, recent <a href="https://www.statnews.com/pharmalot/2020/10/19/covid19-coronavirus-pandemic-vaccine-racial-disparities/">studies</a> indicate that many Americans do not plan to get a COVID-19 vaccine, even if one is available at no cost. </p>
<p>If levels of vaccination are not robust, it will take longer to reach <a href="https://www.vaccines.gov/basics/work/protection">herd immunity</a>, or widespread protection within a population. In response to these concerns, <a href="https://www.brookings.edu/opinions/want-herd-immunity-pay-people-to-take-the-vaccine/">several</a> <a href="https://www.forbes.com/sites/shaharziv/2020/12/01/proposal-pay-americans-1000-to-get-covid-vaccine/?sh=4febd39564bf">people</a> have suggested that the government should provide a monetary incentive to COVID-19 vaccination.</p>
<p><a href="https://www.slu.edu/law/faculty/ana-santos-rutschman.php">We</a> <a href="https://www.slu.edu/law/faculty/robert-gatter.php">are</a> health law professors and, in our view, it is important to understand how these monetary incentives work as COVID-19 vaccines become available, why payment for vaccination may exacerbate vaccine mistrust, and how this incentive fits into the broader history of monetary incentives in public health.</p>
<h2>The idea behind monetary awards for COVID-19 vaccination</h2>
<p>In summer and early fall of 2020, <a href="https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&ved=2ahUKEwjys_nc5L_tAhWFK80KHaTpAloQFjAOegQIDxAC&url=https%3A%2F%2Fwww.pewresearch.org%2Fscience%2F2020%2F09%2F17%2Fu-s-public-now-divided-over-whether-to-get-covid-19-vaccine%2F&usg=AOvVaw3_cbTsdDtJG6-DwdMdHdbS">several</a> <a href="https://news.gallup.com/poll/325208/americans-willing-covid-vaccine.aspx">surveys</a> indicated that the number of Americans planning to get vaccinated against COVID-19 was <a href="https://www.pewresearch.org/science/2020/09/17/u-s-public-now-divided-over-whether-to-get-covid-19-vaccine/">lower</a> than desirable. Experts estimate that achieving herd immunity require anywhere from <a href="https://www.wusa9.com/article/news/verify/reaching-herd-immunity-america-covid-19-vaccine-fact-check-when-will-the-vaccine-roll-out-who-will-get-covid-vaccine-first-explainer-latest-cdc/65-6c2d3fb7-1d93-4a43-bea5-f2e22656dbe2">67% to 85% of Americans to be vaccinated</a>. A recent survey by the Pew Research Center <a href="https://www.businessinsider.com/60-of-americans-say-would-get-covid-19-vaccine-data-2020-12">showed</a> that only 60% of American were considering getting a COVID-19 vaccine.</p>
<p>If vaccination rates are indeed low once vaccines become available on a large scale, it will take the U.S. longer to curb the pandemic. Moreover, many Americans expressing COVID-19 vaccine mistrust are part of are members of <a href="https://www.washingtonpost.com/health/2020/11/23/covid-vaccine-hesitancy/">racial minorities</a>, which are precisely among the groups <a href="https://www.cdc.gov/coronavirus/2019-ncov/covid-data/investigations-discovery/hospitalization-death-by-race-ethnicity.html">hit the hardest</a> by the pandemic.</p>
<p>The idea of monetary incentives seems straightforward: Pay people to get vaccinated. One of the earliest proponents, economist Robert Litan, <a href="https://www.brookings.edu/opinions/want-herd-immunity-pay-people-to-take-the-vaccine/">called</a> the idea an “adult version of the doctor handing out candy to children.”</p>
<p>Litan suggested that the government should pay US$1,000 to each person who receives a COVID-19 vaccine. He <a href="https://www.brookings.edu/opinions/want-herd-immunity-pay-people-to-take-the-vaccine/">admitted</a> in his proposal that he had not relied on any studies or data to get to this number, explaining that the proposed payment amount was a “hunch.” </p>
<p>His idea has since been endorsed by prominent commentators. These include economist <a href="https://www.nytimes.com/2020/09/09/business/pay-people-vaccine-coronavirus.html">Gregory Mankiw</a> and politician <a href="https://www.washingtonpost.com/">John Delaney</a>, who <a href="https://www.washingtonpost.com/">suggested</a> that the incentive should be increased to $1,500. </p>
<figure class="align-center ">
<img alt="A woman receiving a vaccination." src="https://images.theconversation.com/files/374296/original/file-20201210-17-1vp4dd5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/374296/original/file-20201210-17-1vp4dd5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/374296/original/file-20201210-17-1vp4dd5.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/374296/original/file-20201210-17-1vp4dd5.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/374296/original/file-20201210-17-1vp4dd5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/374296/original/file-20201210-17-1vp4dd5.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/374296/original/file-20201210-17-1vp4dd5.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">Some lawmakers and economists are suggesting payments as high as $1,000 to $1,500 for a COVID-19 vaccination.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/heather-lieberman-receives-a-covid-19-vaccination-from-news-photo/1228042322?adppopup=true">Chandan Khanna/AFP via Getty Images</a></span>
</figcaption>
</figure>
<h2>When money works and when it doesn’t</h2>
<p><a href="https://doi.org/10.1186/s12889-019-7407-8">Paying incentives</a> to people who take on health risks to help others is not new. The most common example is clinical trials. Participants in these trials often <a href="http://apps.olin.wustl.edu/faculty/cryder/socialscienceandmedicine.pdf">receive set payments</a> typically ranging from $25 to $1,000, to cover the costs of participation and perhaps to compensate for participants’ time. </p>
<p>Researchers don’t intend for these payments to induce subjects to take risks they would otherwise refuse. But there is a concern that, if clinical researchers pay potential subjects for risk-taking, their clinical trials will prey on poorer people for whom the payment would make the most difference. The <a href="https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/regulations-good-clinical-practice-and-clinical-trials">law</a> withholds authorization for clinical trials where there is reason to suspect that large payments were inducing people to take risks against their better judgment.</p>
<p>While a number of studies demonstrate that nominal payments rarely cause a person to consent to clinical research the person believes is <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7059779/">risky</a>, data show that payments as high as $1,000 cause potential participants to <a href="https://pubmed.ncbi.nlm.nih.gov/19926187/">perceive the proposed research as highly risky.</a> Those individuals seek out risk information and review it more closely than others who were offered significantly smaller payments. </p>
<p>Monetary compensation is also available in other cases. For instance, payments for the donation of <a href="https://www.magnifymoney.com/blog/banking/selling-plasma/">plasma</a> currently ranges from $30 to $60. Compensation for the donation of gametes is also possible, with <a href="https://www.vox.com/the-goods/2019/5/21/18634371/sperm-donor-pay-process-price">$35-$125</a> being the range for <a href="https://www.businessinsider.com/ways-to-make-money-from-medical-research-and-donations-2013-12">sperm</a> donations, and <a href="https://www.businessinsider.com/ways-to-make-money-from-medical-research-and-donations-2013-12">$5,000-$10,000</a> the range for <a href="https://www.brightexpectationsagency.com/blog/how-much-money-egg-donors-paid/#:%7E:text=Compensation%20can%20vary%20quite%20a,%248000%20to%20%2410%2C000%20per%20cycle.">egg</a> donations.</p>
<p>There are also cases in which it’s been effective to nudge people to stop unhealthy behaviors. <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5108450/">Studies</a> have shown that paying people to stop smoking can be a <a href="https://theconversation.com/why-we-should-pay-people-to-stop-smoking-84058">powerful incentive</a>. These studies offered smokers rewards that <a href="https://www.psychologytoday.com/us/blog/evidence-based-living/201907/paying-smokers-quit-really-works">ranged</a> from $45 to $700. People who received a reward were <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5108450/">less likely</a> to restart smoking, even after the monetary incentive ended.</p>
<p>Conversely, the <a href="https://www.uniformlaws.org/committees/community-home?CommunityKey=015e18ad-4806-4dff-b011-8e1ebc0d1d0f">Uniform Anatomical Gift Act</a> expressly prohibits payment for organ donations. Here, the concern is that allowing payments would undermine the altruism underlying the current system such that nobody would give their organs for free if there is a market for them. And where there is a market, it will exploit the poorest among us, who are the most <a href="https://pubmed.ncbi.nlm.nih.gov/12042884/">vulnerable</a>. </p>
<p>In countries that do not prohibit payment for human organs, there is anecdotal <a href="https://www.researchgate.net/publication/7298708_Bulgarian_hospital_admits_role_in_illegal_transplants">evidence</a> of unscrupulous brokers and health care providers who profit from the desperation of wealthy recipients at the expense of impoverished and vulnerable donors. </p>
<figure class="align-center ">
<img alt="Two men in front of Pfizer headquarters in New York City." src="https://images.theconversation.com/files/374299/original/file-20201210-22-1na5473.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/374299/original/file-20201210-22-1na5473.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/374299/original/file-20201210-22-1na5473.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/374299/original/file-20201210-22-1na5473.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/374299/original/file-20201210-22-1na5473.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/374299/original/file-20201210-22-1na5473.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/374299/original/file-20201210-22-1na5473.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">With the FDA’s emergency use authorization, the COVID-19 vaccine developed by Pfizer will soon be in use across the U.S.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/people-walk-by-the-pfizer-world-headquarters-in-new-york-on-news-photo/1229551804?adppopup=true">Kena Betancur/AFP via Getty Images</a></span>
</figcaption>
</figure>
<h2>Why money for COVID-19 vaccination is different</h2>
<p>In the medical context, monetary incentives are typically not available when participants take a health risk that nonetheless provides them with some likely personal benefit. Instead, payment is more likely for people who agree to participate in clinical trials where the participants are unlikely to benefit medically from their participation. This also applies to payments for donations of plasma and gametes given that donors do not benefit medically from their participation.</p>
<p>[<em>Get our best science, health and technology 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-best">Sign up for The Conversation’s science newsletter</a>.]</p>
<p>A massive payment plan designed to promote COVID-19 vaccination would be very different from current monetary incentives. In addition to its novelty, our concern is that such a scheme would have unintended consequences.</p>
<p>First, we have no actual behavioral studies in this area – as opposed to the case of smoking cessation rewards. Similarly, as the proponents of vaccination rewards admit, there is no data on how to set the appropriate reward.</p>
<p>Second, the proposal might backfire. People who already do not trust vaccines may consider the mere availability of payment as confirmation that vaccination is especially risky or undesirable. And people or organizations interested in promoting <a href="https://theconversation.com/malicious-bots-and-trolls-spread-vaccine-misinformation-now-social-media-companies-are-fighting-back-123430">disinformation about vaccines</a> may portray payment originating from the government as “proof” of deep-state or hidden agendas associated with vaccination. If people perceive the monetary incentive in this way, that could contribute to increased vaccine hesitancy – precisely the opposite of what it is intended to do.</p>
<p>Third, we worry about the socioeconomic underpinnings of this proposal. An amount close to $1,000 is supposed to prompt a person to change attitudes toward vaccination. In practice, this means that richer individuals, who might not be moved by $1,000, can just ignore the reward. Poorer people, however, are expected to change their behaviors in exchange for money. This is a paternalistic approach that does not help build trust in the government and public health authorities among poorer communities.</p>
<p>For these reasons, we urge caution to regulators and legislators in this area. We all want the pandemic to come to an end as soon as possible. But we need to get the incentives right, which entails relying on data, and not just on unstudied theories.</p><img src="https://counter.theconversation.com/content/151532/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>Millions of Americans say they won’t get the vaccine. Will money change their minds? And is luring them with cash the right approach?Ana Santos Rutschman, Assistant Professor of Law, Saint Louis UniversityRobert Gatter, Professor of Law, Saint Louis UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1511782020-12-03T13:36:15Z2020-12-03T13:36:15ZWhat are emergency use authorizations, and do they guarantee that a vaccine or drug is safe?<figure><img src="https://images.theconversation.com/files/372613/original/file-20201202-21-832gvy.jpg?ixlib=rb-1.1.0&rect=18%2C0%2C4174%2C2665&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Tony Potts, a 69-year-old retiree, removes his face mask for a temperature check just before receiving his first injection in a phase 3 COVID-19 vaccine clinical trial sponsored by Moderna. Potts is one of 30,000 participants in the Moderna trial. </span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/tony-potts-a-69-year-old-retiree-living-in-ormond-beach-news-photo/1227916339?adppopup=true">Paul Hennessy/NurPhoto via Getty ImageS</a></span></figcaption></figure><p>In coming days, the Food and Drug Administration is <a href="https://abcnews.go.com/Health/moderna-seek-fda-emergency-authorization-covid-19-vaccine/story?id=74454936">likely to authorize new COVID-19 vaccines</a> based on applications submitted by two companies. These authorizations have happened very fast in a process called “emergency use authorizations,” or EUAs.</p>
<p>Does this swift action mean that products are proven safe and effective? Not exactly. But it suggests that they may present a reasonable balance of risks and benefits.</p>
<p>We are a <a href="https://hopkinshistoryofmedicine.org/people/jeremy-a-greene-md-phd/">physician</a> and a <a href="https://www.bu.edu/law/profile/christopher-robertson/">lawyer</a>, and we also study drug development from the perspectives of history and philosophy. The longer view is helpful to understand the differences between full FDA approval and EUAs.</p>
<h2>The peculiar nature of medical products</h2>
<p>When you decide whether to buy a television, you can tell whether it turns on and you can assess its visual clarity. But for a medical product, without the FDA, it would be impossible for you or even your doctor to discern whether it is safe and effective. For that, the American public needs clinical trials, with thousands of patients randomized to receive the treatment or placebo. </p>
<p>Accordingly, for more than a half-century, the <a href="https://theconversation.com/in-the-rush-to-innovate-for-covid-19-drugs-sound-science-is-still-essential-134638">principle</a> guiding access to the pharmaceutical marketplace is: proof before profits. In 1938, Congress required companies to submit <a href="https://www.fda.gov/about-fda/fdas-evolving-regulatory-powers/part-ii-1938-food-drug-cosmetic-act">proof of safety</a> data to the FDA, and in 1962 it extended the principle to <a href="https://www.fda.gov/drugs/enforcement-activities-fda/drug-efficacy-study-implementation-desi">proof of efficacy, or the ability to produce a desired effect</a>. Yet this process of sorting good medical products from bad ones can take five years or more. </p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1333547639917457411"}"></div></p>
<h2>A short history of EUAs</h2>
<p>Emergency use authorizations are a relatively new pathway that the FDA can utilize when there is a declared public health emergency, like a pandemic or bioterrorism attack. </p>
<p>The first time the FDA issued an EUA was in 2005 for an <a href="https://www.federalregister.gov/documents/2005/02/02/05-2028/authorization-of-emergency-use-of-anthrax-vaccine-adsorbed-for-prevention-of-inhalation-anthrax-by">anthrax vaccine</a>, but just for military personnel. In 2009, the FDA issued the first EUA for civilians, so that <a href="https://www.jhsph.edu/covid-19/articles/what-is-emergency-use-authorization.html">Tamiflu</a> could be given to infants during the H1N1 pandemic. </p>
<p>The basic principle behind the EUA, however, originates from an earlier pandemic: HIV/AIDS, which first became visible in North America in 1981. The approval of the first treatment regimens that successfully transformed HIV/AIDS from a uniformly fatal disease into a manageable chronic condition, however, did not occur until the late 1990s. Instead, the first two decades of the HIV/AIDS pandemic were characterized by the urgent need for new drugs on the one hand, and the FDA’s slow pace of evaluating them on the other. </p>
<p>AIDS activist groups staged <a href="https://actupny.com/actions/">“die-in” events</a> at the FDA’s headquarters, and they threw fake blood on government officials to protest the delay in access to potentially lifesaving drugs. Their actions made visible the human cost of delay in the middle of an epidemic and fundamentally altered the role of patients in FDA regulatory processes as well. </p>
<p>AIDS activists successfully secured a new “parallel track,” which helped lead to the approval of <a href="https://www.ncbi.nlm.nih.gov/books/NBK234216/">ddI</a>, or <a href="https://clinicaltrials.gov/ct2/show/NCT00000963">dideoxyinosine</a>, in 1991. This same sense of urgency also led to accelerated approval of another drug, ddC, or <a href="https://www.nlm.nih.gov/databases/alerts/ddi_ddc.html">zalcitabine</a>, which turned out to be “rotten” in the <a href="https://www.treatmentactiongroup.org/publication/access-versus-answers/">words</a> of AIDS activist and researcher Mark Harrington. Patients had “no data” that the drug “in fact saved lives,” but it was “expensive, inconvenient and toxic.” </p>
<p>Emergency use authorizations can be seen as a form of scaling up these earlier pathways to accelerate approval. Since 2009, the FDA has since issued <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-information">dozens</a> of EUAs for drugs, devices and diagnostics based on the best available evidence for prevailing public health crises.</p>
<h2>Different standards for different times</h2>
<p>Once an emergency has been declared for a serious or life-threatening disease, <a href="https://www.law.cornell.edu/uscode/text/21/360bbb-3">federal law</a> gives the FDA broad discretion in deciding whether to issue an EUA for a particular product. There are three guideposts. </p>
<p>First, “the totality of scientific evidence” must make it “reasonable to believe that the product may be effective.” As for safety, federal law requires a weighing of risks and benefits, taking into account the “material threat” posed by the emergency. Finally, an EUA can be granted only when “there is no adequate, approved, and available alternative to the product.”</p>
<p>In contrast, traditional drug approvals require <a href="https://www.fda.gov/media/110437/download">proof of safety</a> and <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=314.126">“substantial evidence” of efficacy</a>, typically based on two well-controlled trials. </p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/iZYiS05FmiQ?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">In a July 28, 2020 news conference, President Trump stresses his support for hydroxychloroquine, which received an EUA that was later revoked.</span></figcaption>
</figure>
<h2>Public perceptions matter</h2>
<p>An EUA is less reassuring than the standard FDA approval, but at the same time it takes into context the increased risk, during a public health crisis, of not making a given product available for use. </p>
<p>The FDA is a science-based regulatory agency that wields its strongest power <a href="https://press.princeton.edu/books/paperback/9780691141800/reputation-and-power">not as a gatekeeper but as a standard-bearer</a>. The FDA can persuade scientists, physicians and consumers worldwide because its assessments carry the weight of careful scientific deliberation. This form of power is based on reputation. And with reputation, every present act affects credibility in the future.</p>
<p>The FDA’s reputation has suffered during the pandemic. Americans saw the FDA provide an emergency approval for President Trump’s pet drug <a href="https://www.fda.gov/media/136534/download">hydroxychloroquine</a>, and then <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chloroquine-and">withdraw</a> it a couple months later, once efficacy and safety claims had been debunked. Similarly, in August, the FDA <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-information">revoked</a> an April 2020 EUA for a coronavirus antibodies test, in part because of false test results. </p>
<p>Now only <a href="https://news.gallup.com/poll/325208/americans-willing-covid-vaccine.aspx#:%7E:text=Fifty%2Deight%20percent%20of%20Americans,42%25%20say%20they%20would%20not">six in 10</a> Americans say they will take a new vaccine if is authorized by EUA. Of those resisting, those in the largest group <a href="https://news.gallup.com/poll/325208/americans-willing-covid-vaccine.aspx#:%7E:text=Fifty%2Deight%20percent%20of%20Americans,42%25%20say%20they%20would%20not">say</a> they lack confidence because of the accelerated time line. Indeed, even the word “emergency” <a href="https://www.liebertpub.com/doi/10.1089/hs.2016.0074">can be misread to suggest</a> that the product may be “risky,” “suspicious” and “desperate.” </p>
<h2>A trade-off between continued testing and access</h2>
<p>EUAs present another problem if they <a href="https://www.statnews.com/2020/11/09/expanded-access-not-eua-for-distributing-preapproval-covid-19-vaccines/">short-circuit</a> the clinical trial process. Why sign up for a 50% chance of receiving a placebo if you can have a 100% chance of receiving the same product through an EUA? Thus, an overly broad EUA can stymie ongoing participation in vaccine trials such that we may never really learn whether the product is safe and effective. </p>
<p>These fears are not new, and can be seen in the earliest debates around parallel-track designations for AIDS drugs. But they weigh more heavily in the scalar logic of pandemic-issued EUAs. Pandemics drive massive shifts in consumer demand that cause enormous supply and logistic problems (remember back when you had a hard time getting toilet paper?). In the short run, we will not have sufficient amounts of vaccine manufactured to support broad access to meet the full demand for new vaccines. </p>
<p>Traditionally, the FDA has restricted its judgments to the evaluation of safety, efficacy and quality, and left broader questions of pricing, allocation and access to other private and public actors, like the <a href="https://www.cnn.com/2020/11/30/health/covid-vaccine-questions-when/index.html">Centers for Disease Control and Prevention</a> and <a href="https://www.cms.gov/covidvax-provider">Centers for Medicare & Medicaid Services</a>. But for an EUA, allocation is a critical question for the FDA to consider when weighing the balance of risks and benefits, which vary from person to person. </p>
<p>Accordingly, the FDA could initially issue a narrow EUA, allowing access only to those, like health care workers and nursing home residents, whose elevated risk merits earlier (and riskier) use of a plausible intervention. The FDA could subsequently issue a somewhat broader EUA for older Americans with comorbid conditions and others at elevated risk. For everyone else, trials would continue in the meantime. </p>
<p>The EUA plays an important role in mobilizing COVID-19 vaccines as promising new tools in a rapidly unfolding public crisis, but it is only one step in making a safe and effective vaccine supply available to the broader population. Hopefully by early summer there will be both sufficient knowledge and sufficient supply to support a traditional FDA approval of the vaccines, based on the best available evidence. We are hopeful about the new vaccines, and confident in the FDA’s ability to engender trust in those vaccines, when it is deserved.</p><img src="https://counter.theconversation.com/content/151178/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Christopher Robertson is author of Exposed: Why our Health Insurance is Incomplete and What Can Be Done About It (2019, Harvard University Press).</span></em></p><p class="fine-print"><em><span>Jeremy Greene is the author of Generic: The Unbranding of Modern Medicine (2015, Johns Hopkins University Press). His research is currently supported by the Jacobs-Rosenthal Fellowship at the Center for Innovative Medicine, the National Library of Medicine, the Mellon Foundation, the Laura and John Arnold Foundation, and the Norwegian Science Foundation.</span></em></p>The vaccines that will first be used to prevent the spread of COVID-19 will have gone through a special approval process with the FDA. but just what is this expedited process?Christopher Robertson, Professor of Law, Boston UniversityJeremy Greene, Professor of Medicine, Johns Hopkins UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1484292020-12-01T13:24:23Z2020-12-01T13:24:23ZRapid COVID-19 tests can be useful – but there are far too few to put a dent in the pandemic<figure><img src="https://images.theconversation.com/files/372068/original/file-20201130-17-1elf41t.jpg?ixlib=rb-1.1.0&rect=254%2C0%2C3354%2C2223&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Rapid tests for COVID-19 are easy to administer and give fast results. </span> <span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/ExchangeCollaborativeTestingStrategy/cd621b49cd784744a268b9e648ecccdf/photo?Query=covid%20rapid%20test&mediaType=photo&sortBy=&dateRange=Anytime&totalCount=463&currentItemNo=28">AP Photo/Julio Cortez, File</a></span></figcaption></figure><p>Since September, the Food and Drug Administration has <a href="https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas#individual-antigen">approved seven COVID-19 tests</a> that yield results in 30 minutes or less, offering hope for vast improvements in test access and efficiency throughout the U.S. Most of these are <a href="https://theconversation.com/antigen-tests-for-covid-19-are-fast-and-easy-and-could-solve-the-coronavirus-testing-problem-despite-being-somewhat-inaccurate-137977">antigen tests</a> that look for viral proteins and can be processed on portable machines or cards. </p>
<p>The idea behind these rapid tests is to detect symptomatic, pre-symptomatic and asymptomatic infectious people before they can spread the coronavirus. But despite massive distribution of these tests by federal officials – including <a href="https://www.hhs.gov/coronavirus/testing/rapid-test-distribution/index.html">to date over 40 million</a> of <a href="https://www.cbsnews.com/news/covid-rapid-test-abbott-labs-150-million/">150 million rapid tests ordered from the medical company Abbott</a> – COVID-19 transmission has been surging in every state since early November. </p>
<p>This calls into question whether the current influx of rapid tests can actually slow the spread of COVID-19. </p>
<p>In some targeted applications – and if people take other precautions including mask wearing and social distancing – rapid tests can be a valuable tool. But the current state of availability and accuracy of these tests greatly limit how effective they are at slowing the spread of the virus in communities.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/372069/original/file-20201130-13-1q24h4i.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A healthcare worker placing a sample into a the small Abbott ID Now processing machine." src="https://images.theconversation.com/files/372069/original/file-20201130-13-1q24h4i.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/372069/original/file-20201130-13-1q24h4i.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/372069/original/file-20201130-13-1q24h4i.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/372069/original/file-20201130-13-1q24h4i.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/372069/original/file-20201130-13-1q24h4i.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/372069/original/file-20201130-13-1q24h4i.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/372069/original/file-20201130-13-1q24h4i.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">Rapid tests like the Abbott ID Now require only small, portable machines and can give results in 15 minutes, but they sacrifice accuracy.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/VirusOutbreakCalifornia/2b7302f66ad440708223cfdb75dc12e9/photo?Query=covid%20rapid%20test&mediaType=photo&sortBy=&dateRange=Anytime&totalCount=463&currentItemNo=53">AP Photo/Jeff Chiu</a></span>
</figcaption>
</figure>
<h2>Speed over accuracy</h2>
<p>Rapid antigen tests are an attractive option because in addition to their speed, they are <a href="https://theconversation.com/rapid-screening-tests-that-prioritize-speed-over-accuracy-could-be-key-to-ending-the-coronavirus-pandemic-143882">cheap and easy to produce</a> and therefore more broadly available than the <a href="https://theconversation.com/how-does-the-coronavirus-test-work-5-questions-answered-133118">more commonly used gold-standard PCR tests</a> in theory. But these attributes come with a trade-off: <a href="https://www.theatlantic.com/health/archive/2020/10/do-rapid-antigen-tests-have-accuracy-problem/616681/">less diagnostic accuracy</a>. This makes them an excellent candidate for <a href="https://theconversation.com/will-the-new-15-minute-covid-19-test-solve-us-testing-problems-145285">use as a screening tool</a>, though less useful for accurately diagnosing SARS-CoV-2 infection. </p>
<p>One-time testing does not mean that a person can <a href="https://www.nytimes.com/2020/11/21/upshot/coronavirus-test-thanksgiving-plans.html">safely travel or mingle without precautions</a>. And while no test is perfectly accurate, there are real questions about the performance of the new rapid tests. </p>
<p>A few test manufacturers <a href="https://www.quidel.com/sites/default/files/product/documents/EF1438903EN00.pdf">reported accuracy</a> between 84.0% and 97.6% in individuals who are tested within five days after developing COVID-19 symptoms. There is, however, an apparent gap between the reported performance of these tests and <a href="https://www.nytimes.com/2020/11/02/health/coronavirus-testing-quidel-sofia.html">what is achieved in the real world</a>. Anecdotally, these tests seem to <a href="https://www.nytimes.com/2020/11/02/health/coronavirus-testing-quidel-sofia.html">miss recent, mild and asymptomatic infections</a> – in fact, rapid tests are authorized by the U.S. Centers for Disease Control and Prevention only for <a href="https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html">use in symptomatic COVID-19 patients</a>. And of course, people can still be infected soon after getting tested. </p>
<p>For rapid tests to effectively limit spread of the coronavirus, experts suggest that they must be <a href="http://doi.org/10.1001/jamanetworkopen.2020.16818">conducted with high frequency</a> – you might miss some cases, but if everyone were getting tested all the time, you would catch a lot of cases too. But even frequent testing is not a panacea. It’s only one part of an approach that must also include social distancing, mask wearing and other precautions.</p>
<p>A highly publicized example of how a rapid testing strategy can go wrong occurred when President Trump and many in his inner circle contracted COVID-19, likely stemming from a single superspreading event. Everyone was reportedly getting daily rapid tests, but they were largely ignoring other measures like face masks and social distancing. It is likely that someone was <a href="https://www.technologyreview.com/2020/10/07/1009636/rapid-covid-tests-can-work-white-houses-mistakes-trump-abbott/">infected and asymptomatic, tested negative, and then started the outbreak</a>. </p>
<h2>Widespread, repeat testing</h2>
<p>Detecting pre-symptomatic and asymptomatic individuals who are infectious is critical to controlling the coronavirus. <a href="https://dx.doi.org/10.1101%2F2020.06.22.20136309">Rapid tests can do this</a>, but only if people are screened repeatedly on a schedule – much as what has been <a href="https://www.bostonglobe.com/2020/11/02/sports/with-careful-planning-total-commitment-nba-constructed-safest-place-earth/">happening in some professional</a> and intercollegiate sports. </p>
<p>The idea is that by testing people early and often – perhaps even <a href="https://www.nytimes.com/2020/07/03/opinion/coronavirus-tests.html">as much as every day</a> – rapid tests <a href="https://theconversation.com/will-the-new-15-minute-covid-19-test-solve-us-testing-problems-145285">can catch infected people before they spread the coronavirus to others</a>. But on a national scale, that is a huge number of tests.</p>
<p>Researchers have estimated that the U.S. would need to perform at least 20 million rapid tests per day to <a href="https://www.rapidtests.org/">drive down infections</a>. The 150 million rapid tests ordered by the government in late August were earmarked for high-risk populations, but would barely cover one week for the population at large. And don’t forget that logistic capabilities, compliance to frequent testing and the infrastructure to act quickly on results all need to happen as well.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/372071/original/file-20201130-17-b1ufyk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A healthcare worker administering a rapid test to an elderly man." src="https://images.theconversation.com/files/372071/original/file-20201130-17-b1ufyk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/372071/original/file-20201130-17-b1ufyk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/372071/original/file-20201130-17-b1ufyk.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/372071/original/file-20201130-17-b1ufyk.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/372071/original/file-20201130-17-b1ufyk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/372071/original/file-20201130-17-b1ufyk.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/372071/original/file-20201130-17-b1ufyk.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">Nursing homes were some of the first places to receive rapid tests.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/VirusOutbreakNursingHomeTesting/92040888c49f470bac9c060c1a90a047/photo?Query=nursing%20home%20covid&mediaType=photo&sortBy=&dateRange=Anytime&totalCount=617&currentItemNo=33">AP Photo/Ted S. Warren</a></span>
</figcaption>
</figure>
<h2>A targeted approach</h2>
<p>There simply aren’t enough rapid tests being produced for the general public to get repeat testing, so the federal government has <a href="https://www.kff.org/coronavirus-covid-19/issue-brief/state-reporting-of-cases-and-deaths-due-to-covid-19-in-long-term-care-facilities/">prioritized deployment of rapid tests to the high-risk population of nursing homes</a>. Federal guidelines for rapid test use in long-term care facilities are a great example of what a testing program might look like – but also illustrate the <a href="https://www.nytimes.com/2020/10/07/health/nevada-covid-testing-nursing-homes.html">current challenges in the use of rapid tests</a>.</p>
<p>If even one person in a nursing home tests positive, all staff and residents must be <a href="https://www.cdc.gov/coronavirus/2019-ncov/hcp/nursing-homes-antigen-testing.html">tested every three to seven days</a> until the facility has been free of COVID–19 for 14 days. When a facility has no cases, all staff are required to get tested <a href="https://www.cdc.gov/coronavirus/2019-ncov/downloads/hcp/nursing-home-testing-algorithm-508.pdf">according to their county’s test-positivity rate</a> – the <a href="https://www.cms.gov/files/document/qso-20-38-nh.pdf">higher the rate, the more testing is needed</a>.</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>Yet nursing homes have had problems with <a href="https://www.nytimes.com/2020/09/29/health/covid-nursing-homes-testing.html">accuracy, staffing and costs</a> while using these tests and find themselves <a href="https://khn.org/news/article/nursing-homes-still-see-dangerously-long-waits-for-covid-test-results/">again in crisis during the current surge</a>. While the rapid tests certainly helped catch many cases and should be used in these settings, they cannot single-handedly overcome <a href="https://www.npr.org/sections/health-shots/2020/10/26/927841874/they-work-in-several-nursing-homes-to-eke-out-a-living-and-that-spreads-the-virus">larger issues that contribute to spread in these settings</a>. </p>
<p>Rapid tests can be effective in highly controlled settings where people are tested frequently and other mitigation measures are in place. Look to the <a href="https://www.latimes.com/science/newsletter/2020-10-12/coronavirus-today-nba-bubble-success-covid-lakers-coronavirus-today">success of the NBA bubble</a> as proof. But in other settings where isolation, mask wearing and social distancing are hard to implement or not followed – like nursing homes or the White House – rapid tests have not kept the virus at bay. </p>
<p>Current testing capacity is nowhere near the hundreds of millions of tests per week required to protect the general population. To date, the promise of cheap and convenient COVID-19 tests being the sole means of controlling disease transmission has not been realized.</p><img src="https://counter.theconversation.com/content/148429/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Dr. Bonnie LaFleur receives funding from NIH, NCI, NIA. She is affiliated with Cofactor Genomics as a consultant. </span></em></p><p class="fine-print"><em><span><a href="mailto:kellingson@arizona.edu">kellingson@arizona.edu</a> receives funding from Centers for Disease Control and Prevention, Arizona Biomedical Research Commission, Arizona Area Health Education Centers, National Association for City and County Health Officials. </span></em></p>In September, production of rapid tests really ramped up in the US. But due to low accuracy and massive numbers needed, these tests alone are unlikely to have much of an effect on the pandemic.Bonnie LaFleur, Professor of Biostatistics, University of ArizonaKatherine Ellingson, Assistant Professor of Epidemiology and Biostatistics, University of ArizonaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1502492020-11-20T13:22:14Z2020-11-20T13:22:14ZCOVID-19 vaccines were developed in record time – but are these game-changers safe?<figure><img src="https://images.theconversation.com/files/370126/original/file-20201118-19-c5f8an.jpg?ixlib=rb-1.1.0&rect=7%2C7%2C4925%2C3255&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The pandemic rages as the world waits for COVID-19 vaccines.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/coronavirus-covid-19-vaccination-with-world-map-in-royalty-free-image/1285321334?adppopup=true&uiloc=thumbnail_same_series_adp">Peter Zelei Images/Getty Images</a></span></figcaption></figure><p>There are now two COVID-19 vaccines that, at least according to preliminary reports, appear to be <a href="https://www.nytimes.com/2020/11/16/health/Covid-moderna-vaccine.html">94.5%</a> and <a href="https://www.nytimes.com/2020/11/18/health/pfizer-covid-vaccine.html?action=click&module=Spotlight&pgtype=Homepage">95% effective</a>. Both were developed in a record-breaking 11 months or so. </p>
<p><a href="https://scholar.google.com/citations?hl=en&user=6yMIM1MAAAAJ&view_op=list_works&sortby=pubdate">I am an infectious diseases specialist</a> and professor at the University of Virginia. I care for patients with COVID-19 and am conducting the local site for a <a href="https://www.fiercebiotech.com/biotech/regeneron-s-covid-19-antibody-cuts-medical-visits-phase-2-3-trial">phase 3 clinical trial of Regeneron’s</a> <a href="https://theconversation.com/what-monoclonal-antibodies-are-and-why-we-need-them-as-well-as-a-vaccine-149356">antibody cocktail</a> as a tool to prevent household transmission of COVID-19. I’m also conducting research on how dysregulation of the immune system during SARS-CoV-2 infection causes lung damage.</p>
<p>Despite the vaccines’ relatively rapid development, the normal safety testing protocols are still in place. </p>
<h2>How long does most vaccine development take?</h2>
<p><a href="https://www.nytimes.com/interactive/2020/04/30/opinion/coronavirus-covid-vaccine.html">Vaccines typically take at least a decade to develop</a>, test and manufacture. Both the <a href="https://www.cdc.gov/vaccines/vpd/varicella/index.html">chickenpox vaccine</a> and <a href="https://www.cdc.gov/flu/prevent/nasalspray.htm">FluMist</a>, which protects against several strains of the influenza virus, took 28 years to develop. It took 15 years to develop a vaccine for <a href="https://www.cdc.gov/hpv/parents/about-hpv.html">human papilloma virus,</a> which can cause six kinds of cancer. It also took 15 years to develop a <a href="https://www.cdc.gov/rotavirus/index.html">vaccine for rotavirus</a>, which commonly causes severe, watery diarrhea. It took Jonas Salk six years to <a href="http://doi.org/10.1126/science.abb8588">develop and test the first polio vaccine</a>, starting with the isolation of the virus. </p>
<p>The <a href="https://theconversation.com/why-we-didnt-get-a-vaccine-by-election-day-but-why-we-may-get-one-soon-149690">Pfizer-BioNTech</a> and the <a href="https://theconversation.com/coronavirus-a-new-type-of-vaccine-using-rna-could-help-defeat-covid-19-133217">Moderna</a> COVID-19 messenger RNA vaccines, by contrast, have been developed in less than a year. That’s a game-changer.</p>
<h2>How was this vaccine developed so quickly?</h2>
<p>The mRNA vaccines produced by Pfizer and Moderna are faster to develop as they do not require companies to produce protein or weakened pathogen for the vaccine. </p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/370350/original/file-20201119-21-gdqun0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/370350/original/file-20201119-21-gdqun0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/370350/original/file-20201119-21-gdqun0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=660&fit=crop&dpr=1 600w, https://images.theconversation.com/files/370350/original/file-20201119-21-gdqun0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=660&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/370350/original/file-20201119-21-gdqun0.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=660&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/370350/original/file-20201119-21-gdqun0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=829&fit=crop&dpr=1 754w, https://images.theconversation.com/files/370350/original/file-20201119-21-gdqun0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=829&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/370350/original/file-20201119-21-gdqun0.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=829&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 spike proteins (red) on the surface of SARS-CoV-2, the virus that causes COVID-19, are essential for infecting human cells.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/illustration/the-structure-of-coronavirus-covid-19-with-royalty-free-illustration/1249231802?adppopup=true">Viktoriia Ilina/iStock/Getty Images Plus</a></span>
</figcaption>
</figure>
<p>Traditional vaccines typically use a weakened version of the pathogen or a protein piece of it, but because these are grown in eggs or cells, developing and manufacturing vaccines takes a long time. By contrast, by using just the genetic material that makes the Spike glycoprotein – the protein on the surface of the coronavirus that is essential for infecting human cells – the design and manufacture of the vaccine is simplified.</p>
<p>The genetic material mRNA is <a href="https://doi.org/10.1038/nrd.2017.243">easy to make in a laboratory</a>. Manufacturing an mRNA vaccine rather than a protein vaccine can save months, if not years. </p>
<p>Another factor that accelerated vaccine development was the swift and efficient recruitment of patients for clinical trials. </p>
<h2>How is safety assured when vaccine development is so fast?</h2>
<p>Safety is the first and foremost goal for a vaccine. </p>
<p>In my opinion, safety is not compromised by the speed of vaccine development and emergency use authorization. The reason that vaccines may be approved so quickly is that the large clinical trials to assess vaccine efficacy and safety are happening at the same time as the large-scale manufacturing preparation, funded by the federal government’s Operation Warp Speed program. </p>
<p>Typically, large-scale manufacturing begins only once the vaccine has been tested in clinical trials. In the case of COVID-19, the U.S. government wanted to be ready to begin distributing the vaccine the moment the results of the phase 3 trials were known and the safety data had been analyzed.</p>
<p>To this end, the pharmaceutical companies launched at-risk manufacturing – which means that the manufactured vaccine doses would be thrown away if the vaccine was ineffective or unsafe – <a href="https://www.npr.org/sections/coronavirus-live-updates/2020/10/23/927015241/former-fda-commissioner-discusses-updates-on-covid-19-vaccine-research-efforts">during the FDA-mandated two-month safety waiting period</a>. </p>
<p>The upside is that if the vaccine is safe and effective, it can be distributed immediately, and vaccination can begin.</p>
<h2>Are these vaccines riskier than others?</h2>
<p>No mRNA vaccines have been approved before because it is <a href="https://www.statnews.com/2020/11/10/the-story-of-mrna-how-a-once-dismissed-idea-became-a-leading-technology-in-the-covid-vaccine-race/">relatively new technology.</a></p>
<p>But these mRNA vaccines appear <a href="https://www.phgfoundation.org/briefing/rna-vaccines">safe and no riskier</a> than other tried and tested ones, like the childhood measles vaccine. To date, no significant side effects have been reported in the interim phase 3 studies of the Moderna and Pfizer vaccines. </p>
<p>[<em>Deep knowledge, daily.</em> <a href="https://theconversation.com/us/newsletters/the-daily-3?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=deepknowledge">Sign up for The Conversation’s newsletter</a>.]</p>
<p><a href="https://www.nih.gov/news-events/news-releases/promising-interim-results-clinical-trial-nih-moderna-covid-19-vaccine">Side effects that have been reported</a> are minor things that one would expect with any vaccine, including soreness at the site of injection and transient fatigue, muscle or joint aches. </p>
<h2>How will EUA work?</h2>
<p>EUA stands for emergency use authorization. </p>
<p>Under EUA, the FDA is requiring that a COVID-19 vaccine be at least 50% effective at preventing symptomatic illness. </p>
<p>It is also requiring a median of two months of follow-up after completion of the vaccination for half of the vaccine recipients (for most of the vaccines this is two doses). This <a href="https://www.fda.gov/media/142749/download">two-month period is to allow detection</a> of an adverse event from the vaccine.</p><img src="https://counter.theconversation.com/content/150249/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>William Petri receives research funding from the NIH, the Bill & Melinda Gates Foundation, and Regeneron, Inc.</span></em></p>Because Pfizer-BioNTech and Moderna vaccines have been developed in record time, many wonder whether companies cut corners or compromised safety.William Petri, Professor of Medicine, University of VirginiaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1496902020-11-10T13:23:24Z2020-11-10T13:23:24ZWhy we didn’t get a vaccine by Election Day – but why we may get one soon<figure><img src="https://images.theconversation.com/files/368378/original/file-20201109-19-1evx3e8.jpg?ixlib=rb-1.1.0&rect=0%2C19%2C2546%2C1672&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Pfizer stock surged higher on Nov. 9 after the company announced its vaccine is "90% effective" against COVID-19 infections. </span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/people-walk-by-the-pfizer-world-headquarters-in-new-york-on-news-photo/1229551804?adppopup=true">KENA BETANCUR/AFP via Getty Images</a></span></figcaption></figure><p>A COVID-19 vaccine was not ready before the general election, as many people, including the president, had hoped. But there are promising signs that one may be available soon. </p>
<p>A sparse <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against">press release</a> issued Nov. 9 by pharmaceutical giant Pfizer suggests that the end is in sight, with preliminary results indicating that its vaccine is 90% effective at preventing symptomatic COVID-19. The company said it intends this month to seek emergency use authorization, or EUA, from the FDA, bringing some encouraging news to the fight against the pandemic. </p>
<p>The Pfizer vaccine is based on <a href="https://theconversation.com/coronavirus-a-new-type-of-vaccine-using-rna-could-help-defeat-covid-19-133217">a new technology in which a molecule called messenger RNA</a> is injected into the body. This mRNA molecule provides the instructions for cells in the body to manufacture a protein, called the spike glycoprotein, that plays an essential role in allowing the SARS-CoV-2 to infect human cells. When the immune system detects the spike glycoprotein, it generates an immune response. If the vaccinated individual is later exposed to the virus that causes COVID-19, the individual’s immune system is prepared to rapidly attack and destroy the coronavirus. </p>
<p><a href="https://scholar.google.com/citations?hl=en&user=6yMIM1MAAAAJ&view_op=list_works&sortby=pubdate">I am an infectious diseases specialist</a> at the University of Virginia who cares for patients with COVID-19. <a href="https://clinicaltrials.gov/ct2/show/NCT04425629">I am conducting a clinical trial of the Regeneron antibodies</a> against the new coronavirus spike glycoprotein to see if it is possible to prevent household transmission. I also do basic research on treatment and prevention of infection by the SARS-CoV-2 virus. The most important tool for preventing further cases is a vaccine. So you might be wondering when we can expect one.</p>
<h2>How big is the problem?</h2>
<p>The U.S. recorded a new record of 117,988 <a href="https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases">daily coronavirus cases in data released Nov. 6</a>. The U.S. has entered a surge of COVID-19 that has surpassed the first and second waves in the number of cases. </p>
<p>As winter weather arrives people spend more time indoors, which increases that chance that the virus will be transmitted. That is especially true if people don’t adhere to common-sense and effective protective measures such as masks and social distancing. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/368406/original/file-20201109-21-ycdr6v.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/368406/original/file-20201109-21-ycdr6v.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/368406/original/file-20201109-21-ycdr6v.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/368406/original/file-20201109-21-ycdr6v.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/368406/original/file-20201109-21-ycdr6v.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/368406/original/file-20201109-21-ycdr6v.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/368406/original/file-20201109-21-ycdr6v.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/368406/original/file-20201109-21-ycdr6v.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">People wait in their cars at a coronavirus testing site in El Paso, Texas, that has reported record numbers of active coronavirus cases.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/an-attendant-talks-to-a-person-waiting-in-their-car-at-a-news-photo/1229386949?adppopup=true">Cengiz Yar/Getty Images</a></span>
</figcaption>
</figure>
<h2>Which vaccines are front-runners for approval?</h2>
<p>Of the six vaccines that the federal government is backing, it is likely that more than one will be available to the public in 2021 – they all missed Election Day because phase 3 trials, which measure safety and efficacy, are still ongoing. One of the advantages of using the messenger RNA approach is speed of development, although no vaccine using that technology has been approved in the U.S. before.</p>
<p><a href="https://pharmaphorum.com/news/scientists-urge-pfizer-to-delay-covid-19-vaccine-filing/">Pfizer, Moderna and AstraZeneca are the front-runners.</a> </p>
<p>New York-based Pfizer, in partnership with the German biotech company BioNTech, <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against">announced in a press release the initial results of their phase 3 study</a> of its two-shot COVID-19 vaccine. </p>
<p>So far 94 cases of COVID-19 infection have been observed in the phase 3 study. Pfizer did not specify how many of these were in the placebo group and how many were in the group that received the vaccine, but the split of cases between the two groups suggests the vaccine is 90% effective at preventing infection in those who have never been exposed. As a comparison, this is almost <a href="https://www.cdc.gov/measles/vaccination.html">as effective as a single dose of the hugely successful measles vaccine,</a> which most infants receive as part of the measles, mumps and rubella vaccine when they are around a year old. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/368414/original/file-20201109-15-324ew0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/368414/original/file-20201109-15-324ew0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/368414/original/file-20201109-15-324ew0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=420&fit=crop&dpr=1 600w, https://images.theconversation.com/files/368414/original/file-20201109-15-324ew0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=420&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/368414/original/file-20201109-15-324ew0.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=420&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/368414/original/file-20201109-15-324ew0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=528&fit=crop&dpr=1 754w, https://images.theconversation.com/files/368414/original/file-20201109-15-324ew0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=528&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/368414/original/file-20201109-15-324ew0.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=528&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Both Pfizer’s and Moderna’s COVID-19 vaccines are molecules called mRNA, the twisted ladder above, that encode a part of the virus called the spike protein.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/illustration/vector-illustration-of-mrna-vaccine-against-royalty-free-illustration/1259026115?adppopup=true">undefined undefined/iStock/Getty Images Plus</a></span>
</figcaption>
</figure>
<p>Pfizer has enrolled almost 44,000 volunteers. Half of these received the vaccine and half the placebo. Of those who received the two-dose vaccine, half of the subjects had received the second vaccine dose a month and a half ago. And the last person received a second dose by Oct. 27. Pfizer can apply for emergency authorization from the FDA as soon as late November. This would be two months after at least half of the subjects completed the second and final dose of the vaccine.</p>
<p>Moderna completed recruitment of 30,000 subjects for its two-dose vaccine on Oct. 22. Of these, 26,000 had received their second dose by that date. Assuming the vaccine is proved effective, the company will also need to monitor volunteers and collect safety data for two months after all the subjects have received their second dose to reach the FDA-mandated safety endpoint. This suggests <a href="https://investors.modernatx.com/news-releases/news-release-details/moderna-completes-enrollment-phase-3-cove-study-mrna-vaccine">the earliest that Moderna could apply for EUA would be late December</a> or early January 2021.</p>
<p>AstraZeneca has enrolled 23,000 subjects in phase 3 studies of its adenovirus-based vaccine. The vaccine uses a common-cold virus from chimpanzees, called adenovirus, to carry instructions to manufacture the coronavirus spike glycoprotein into human cells. The company <a href="https://www.wsj.com/articles/astrazeneca-expects-covid-19-vaccine-trial-results-this-year-11604566767">expects efficacy results in late 2020.</a></p>
<h2>How is Operation Warp Speed helping?</h2>
<p>The major federal-corporate partnership to develop COVID-19 vaccines is called <a href="https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html">Operation Warp Speed</a>. It is co-led by the secretary of Health and Human Services and the secretary of Defense. The goal is to deliver 300 million doses of COVID-19 vaccine starting in January to people in the U.S. Operation Warp Speed is supporting the parallel development of multiple vaccines, each of which is using different technology. </p>
<p>Warp Speed is supporting the research, development and/or manufacture and purchase of vaccines from Johnson & Johnson-Janssen, Moderna, AstraZeneca-Oxford, Novavax, <a href="https://www.hhs.gov/about/news/2020/07/22/us-government-engages-pfizer-produce-millions-doses-covid-19-vaccine.html">Pfizer,</a> and Sanofi-GlaxoSmithKline. </p>
<p>The support for AstraZeneca, Moderna, Johnson & Johnson and Pfizer <a href="https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html">includes investments in manufacturing capabilities and/or prepurchasing of vaccines</a>. Operation Warp Speed is also purchasing syringes and glass vials and is funding a distribution network.</p>
<p>This is a robust approach, in my opinion, as it allows for the best vaccination approaches to win while financially supporting the production of millions of doses of different vaccines in parallel. Vaccines that are approved after having been proved safe and effective therefore will have a jump-start, as doses will be ready for immediate distribution. </p>
<h2>So why wasn’t there a vaccine by Election Day?</h2>
<p>Simply put, not enough time had elapsed since the phase 3 trials started this fall to assess whether the vaccines were effective, and for the two-month safety period after vaccination to have passed. </p>
<p>EUA approval, when it comes, will not be the last hurdle, as the vaccines must be manufactured in tens to hundreds of millions of doses in the highest quality, and must be distributed (for some vaccines on dry ice) and administered. Operation Warp Speed is purchasing needles and vials and funding a distribution network. State and local jurisdictions are now in the planning stages for distribution and administration. </p>
<p>The Centers for Disease Control and Prevention is planning for the vaccine to be administered first to health care professionals, essential workers, national security populations and people aged 65 and older and with underlying illnesses. Vaccination of low-risk individuals in the general population will be later, likely in the summer. <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations-process.html">A vaccine for children likely will not be available until even later</a>. </p>
<p>[<em>Deep knowledge, daily.</em> <a href="https://theconversation.com/us/newsletters/the-daily-3?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=deepknowledge">Sign up for The Conversation’s newsletter</a>.]</p>
<p>While we all want a vaccine as soon as possible so that life can eventually return to what we remember as normal, it is reassuring that the highest standards of safety and efficacy are being applied, and that federal support for the effort extends from research to testing to distribution. </p>
<p>Lots of challenges await us, but as the Chinese proverb states, “A journey of a thousand miles begins with a single step.” We are now many steps into this journey, thanks to the dedicated and collaborative efforts of scientists, physicians and public health care professionals around the world.</p><img src="https://counter.theconversation.com/content/149690/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>William Petri receives funding from the NIH, the Bill & Melinda Gates Foundation and Regeneron for research in infectious diseases.</span></em></p>With COVID-19 cases soaring across the US and worldwide, the need for a vaccine could not be greater. Here’s where we stand on vaccine development, including positive results from Pfizer’s trial.William Petri, Professor of Medicine, University of VirginiaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1452852020-09-01T12:39:29Z2020-09-01T12:39:29ZWill the new 15-minute COVID-19 test solve US testing problems?<figure><img src="https://images.theconversation.com/files/355644/original/file-20200831-22-1tkm5yq.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C4912%2C3551&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Easy, fast coronavirus testing is critical to controlling the virus.</span> <span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Virus-Outbreak-Washington/079818634ad24a938d8488056c56be83/35/0">AP Photo/Elaine Thompson</a></span></figcaption></figure><p>On Aug. 26, the <a href="https://www.fda.gov/home">Food and Drug Administration</a> granted an <a href="https://www.fda.gov/media/141567/download">Emergency Use Authorization</a> to a new rapid <a href="https://theconversation.com/antigen-tests-for-covid-19-are-fast-and-easy-and-could-solve-the-coronavirus-testing-problem-despite-being-somewhat-inaccurate-137977">antigen test</a> for COVID-19 called the <a href="https://abbott.mediaroom.com/2020-08-26-Abbotts-Fast-5-15-Minute-Easy-to-Use-COVID-19-Antigen-Test-Receives-FDA-Emergency-Use-Authorization-Mobile-App-Displays-Test-Results-to-Help-Our-Return-to-Daily-Life-Ramping-Production-to-50-Million-Tests-a-Month">BinaxNOW test</a>.</p>
<p>I <a href="https://scholar.google.com/citations?hl=en&user=t6ZtGJwAAAAJ">study public health policy</a> to combat infectious disease epidemics. Testing is one of the most powerful tools available to fight the spread of COVID-19. The new test is <a href="https://abbott.mediaroom.com/2020-08-26-Abbotts-Fast-5-15-Minute-Easy-to-Use-COVID-19-Antigen-Test-Receives-FDA-Emergency-Use-Authorization-Mobile-App-Displays-Test-Results-to-Help-Our-Return-to-Daily-Life-Ramping-Production-to-50-Million-Tests-a-Month">inexpensive, rapid and easy to use</a>. It will <a href="https://abbott.mediaroom.com/2020-08-26-Abbotts-Fast-5-15-Minute-Easy-to-Use-COVID-19-Antigen-Test-Receives-FDA-Emergency-Use-Authorization-Mobile-App-Displays-Test-Results-to-Help-Our-Return-to-Daily-Life-Ramping-Production-to-50-Million-Tests-a-Month">massively scale up</a> access to testing, but hurdles remain in achieving widespread, frequent COVID-19 testing.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/355579/original/file-20200831-21-vfnu2i.jpeg?ixlib=rb-1.1.0&rect=60%2C80%2C1226%2C916&q=45&auto=format&w=1000&fit=clip"><img alt="A digital results page for the BinaxNOW test." src="https://images.theconversation.com/files/355579/original/file-20200831-21-vfnu2i.jpeg?ixlib=rb-1.1.0&rect=60%2C80%2C1226%2C916&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/355579/original/file-20200831-21-vfnu2i.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/355579/original/file-20200831-21-vfnu2i.jpeg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/355579/original/file-20200831-21-vfnu2i.jpeg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/355579/original/file-20200831-21-vfnu2i.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/355579/original/file-20200831-21-vfnu2i.jpeg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/355579/original/file-20200831-21-vfnu2i.jpeg?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 Abbott BinaxNOW rapid antigen test claims to give results in 15 minutes.</span>
<span class="attribution"><a class="source" href="https://abbott.mediaroom.com/2020-08-26-Abbotts-Fast-5-15-Minute-Easy-to-Use-COVID-19-Antigen-Test-Receives-FDA-Emergency-Use-Authorization-Mobile-App-Displays-Test-Results-to-Help-Our-Return-to-Daily-Life-Ramping-Production-to-50-Million-Tests-a-Month">Abbott</a></span>
</figcaption>
</figure>
<h2>What type of test is BinaxNOW?</h2>
<p>The credit-card-sized test is an antigen test that detects a <a href="https://blogs.sciencemag.org/pipeline/archives/2020/08/27/thoughts-on-a-new-coronavirus-test-and-on-testing">specific viral protein</a> from SARS-CoV-2. It <a href="https://abbott.mediaroom.com/2020-08-26-Abbotts-Fast-5-15-Minute-Easy-to-Use-COVID-19-Antigen-Test-Receives-FDA-Emergency-Use-Authorization-Mobile-App-Displays-Test-Results-to-Help-Our-Return-to-Daily-Life-Ramping-Production-to-50-Million-Tests-a-Month">costs US$5</a> and doesn’t require a lab or a machine for processing. </p>
<p>Performing the test is simple. A health care worker or technician would use a swab to collect a sample from <a href="https://www.fda.gov/media/141570/download">less than 1 inch inside the nostril</a>. They would then combine the sample with a <a href="https://www.fda.gov/media/141570/download">few drops of chemicals</a> inside the test card. Within 15 minutes, the test strip would show a positive or negative result. The <a href="https://www.abbott.com/BinaxNOW-Test-NAVICA-App.html">test is also paired with an app</a> that produces a digital code that can be scanned to show proof of a recent negative COVID-19 test.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/355586/original/file-20200831-18-x9b4ak.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A sign showing the FDA logo with the FDA headquarters in the background." src="https://images.theconversation.com/files/355586/original/file-20200831-18-x9b4ak.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/355586/original/file-20200831-18-x9b4ak.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/355586/original/file-20200831-18-x9b4ak.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/355586/original/file-20200831-18-x9b4ak.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/355586/original/file-20200831-18-x9b4ak.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/355586/original/file-20200831-18-x9b4ak.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/355586/original/file-20200831-18-x9b4ak.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 FDA granted emergency use authorization for the test, but only for use on patients with symptoms of COVID-19.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Right-To-Try-Q-And-A/c43323a9a1a94f8eab13bdb3ec0f95d6/6/0">AP Photo/Andrew Harnik, File</a></span>
</figcaption>
</figure>
<h2>What does the Emergency Use Authorization allow for?</h2>
<p>The BinaxNOW test is currently only authorized for patients who have had <a href="https://abbott.mediaroom.com/2020-08-26-Abbotts-Fast-5-15-Minute-Easy-to-Use-COVID-19-Antigen-Test-Receives-FDA-Emergency-Use-Authorization-Mobile-App-Displays-Test-Results-to-Help-Our-Return-to-Daily-Life-Ramping-Production-to-50-Million-Tests-a-Month">COVID-19 symptoms for seven days or less</a>, which is when virus levels in the body are <a href="https://doi.org/10.1038/s41591-020-0869-5">likely to be high</a>. It must be <a href="https://abbott.mediaroom.com/2020-08-26-Abbotts-Fast-5-15-Minute-Easy-to-Use-COVID-19-Antigen-Test-Receives-FDA-Emergency-Use-Authorization-Mobile-App-Displays-Test-Results-to-Help-Our-Return-to-Daily-Life-Ramping-Production-to-50-Million-Tests-a-Month">prescribed by a physician and performed by a trained technician</a> or other health care worker. </p>
<p>The PCR test for COVID-19 is currently widely used and <a href="https://theconversation.com/coronavirus-tests-are-pretty-accurate-but-far-from-perfect-136671">considered the gold standard</a>, but requires patient samples to be sent to a lab and can <a href="https://theconversation.com/making-coronavirus-testing-easy-accurate-and-fast-is-critical-to-ending-the-pandemic-the-us-response-is-falling-far-short-142366">take days to provide results</a>. The new antigen test is designed to be a <a href="https://www.sciencemag.org/news/2020/08/milestone-fda-oks-simple-accurate-coronavirus-test-could-cost-just-5#">cheap and quick alternative to PCR testing</a> for diagnostic purposes in a medical setting. It would add critical capacity to an <a href="https://theconversation.com/making-coronavirus-testing-easy-accurate-and-fast-is-critical-to-ending-the-pandemic-the-us-response-is-falling-far-short-142366">overstretched testing system</a>.</p>
<p>The emergency use authorization provides <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization">preliminary authorization</a> for doctors to prescribe the antigen test while the full FDA approval process is ongoing. The authorization could be <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chloroquine-and">revoked</a> if the test is not as accurate or reliable as expected.</p>
<p>[<em>Get the best of The Conversation, every weekend.</em> <a href="https://theconversation.com/us/newsletters/weekly-highlights-61?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=weeklybest">Sign up for our weekly newsletter</a>.]</p>
<h2>How accurate is this test?</h2>
<p><a href="https://www.abbott.com/about-abbott.html">Abbott, the health technology company</a> that produces the test, reports that when patients had symptoms the test was in agreement with PCR testing for <a href="https://abbott.mediaroom.com/2020-08-26-Abbotts-Fast-5-15-Minute-Easy-to-Use-COVID-19-Antigen-Test-Receives-FDA-Emergency-Use-Authorization-Mobile-App-Displays-Test-Results-to-Help-Our-Return-to-Daily-Life-Ramping-Production-to-50-Million-Tests-a-Month">97.1% for COVID-19 positive cases and 98.5% for COVID-19 negative cases</a>. This is <a href="https://www.hcplive.com/view/comparing-rt-pcr-and-chest-ct-for-diagnosing-covid19">high enough for diagnostic settings</a> where accuracy is critical. </p>
<p>However, the true accuracy could be lower because the <a href="https://www.fda.gov/media/141570/download">performance testing group was only 102 people</a> and the accuracy hasn’t been validated by the FDA as part of the full approval process. There will inevitably be some false negatives and false positives with the BinaxNOW test since accuracy isn’t 100%, but the <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities#monitoring">FDA will monitor the data</a> to make sure the test meets the reported accuracy.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/355590/original/file-20200831-15-kdff8h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="People waiting in a line of cars with health care workers standing under pop-up shade structures." src="https://images.theconversation.com/files/355590/original/file-20200831-15-kdff8h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/355590/original/file-20200831-15-kdff8h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/355590/original/file-20200831-15-kdff8h.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/355590/original/file-20200831-15-kdff8h.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/355590/original/file-20200831-15-kdff8h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/355590/original/file-20200831-15-kdff8h.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/355590/original/file-20200831-15-kdff8h.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">Long lines and slow turnaround times have limited access to testing, but the new Abbott test should be far easier and faster.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Virus-Outbreak-Nebraska/d964fe543d76489c88a96924b8d02738/72/0">AP Photo/Nati Harnik</a></span>
</figcaption>
</figure>
<h2>Can this test be used for widespread screening?</h2>
<p>The BinaxNOW test is cheap, rapid, able to be mass-produced and easy to use outside a lab. This makes it a promising candidate for <a href="https://theconversation.com/rapid-screening-tests-that-prioritize-speed-over-accuracy-could-be-key-to-ending-the-coronavirus-pandemic-143882">widespread screening</a>. However, the test is currently only authorized for people with COVID-19 symptoms.</p>
<p>This is an obstacle because an estimated <a href="https://theconversation.com/can-people-spread-the-coronavirus-if-they-dont-have-symptoms-5-questions-answered-about-asymptomatic-covid-19-140531">40% of all COVID-19 cases are asymptomatic</a> and these people likely don’t know that they’re contagious. To maximize the effectiveness of any COVID-19 screening program, it is important to test people whether they have symptoms or not.</p>
<p>Health care providers are able to prescribe the BinaxNOW test for asymptomatic patients for <a href="https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-testing-sars-cov-2?utm_campaign=2020-08-14%20August%2014%20Update:%20New%20Information%20on%20Testing%20for%20SARS-CoV-2&utm_medium=email&utm_source=Eloqua#general-screening-asymptomatic">off-label use</a>, but health officials <a href="https://www.cnbc.com/2020/08/28/abbott-has-trial-of-its-rapid-coronavirus-test-for-asymptomatic-people.html">don’t yet know how accurate the test is</a> when performed on asymptomatic people.</p>
<h2>Is this test a game-changer?</h2>
<p>The massive expansion of testing access made possible by the BinaxNOW test will almost surely outweigh the downsides of a small number of inaccurate results. Abbott plans to manufacture <a href="https://abbott.mediaroom.com/2020-08-26-Abbotts-Fast-5-15-Minute-Easy-to-Use-COVID-19-Antigen-Test-Receives-FDA-Emergency-Use-Authorization-Mobile-App-Displays-Test-Results-to-Help-Our-Return-to-Daily-Life-Ramping-Production-to-50-Million-Tests-a-Month">50 million tests per month</a> starting in October. This will quickly exceed the <a href="https://covidtracking.com/data/national/tests">76 million COVID-19 tests</a> the U.S. has performed over the last six months.</p>
<p>Widespread, frequent testing is <a href="https://doi.org/10.1101/2020.06.22.20136309">effective at slowing the spread</a> of the coronavirus. The new testing capacity made possible by the authorization of this rapid antigen test represents a major advance in bringing the pandemic under control.</p><img src="https://counter.theconversation.com/content/145285/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Zoë McLaren 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 BinaxNOW antigen test is quick, easy, accurate and cheap. It could solve the US testing problem, but the emergency use authorization only allows people with COVID-19 symptoms to get tested.Zoë McLaren, Associate Professor of Public Policy, University of Maryland, Baltimore CountyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1450822020-08-27T12:25:14Z2020-08-27T12:25:14ZFDA is departing from long-standing procedures to deal with public health crises, and this may foreshadow problems for COVID-19 vaccines<figure><img src="https://images.theconversation.com/files/354956/original/file-20200826-7028-6mlsaf.jpg?ixlib=rb-1.1.0&rect=6%2C27%2C4650%2C3051&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">FDA Commissioner Stephen Hahn, right, and President Trump at a Coronavirus Task Force meeting March 19, 2020.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/president-donald-trump-listens-to-fda-commissioner-stephen-news-photo/1213540766?adppopup=true">Chip Somodevilla/Getty Images</a></span></figcaption></figure><p>On the eve of the <a href="https://apps.npr.org/liveblogs/20200824-rnc/">Republican National Convention</a>, Food and Drug Administration Commissioner Dr. Stephen Hahn announced that the FDA had <a href="https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-convalescent-plasma-potential-promising-covid-19-treatment">issued emergency use authorization</a> for investigational convalescent plasma as a treatment for COVID-19. </p>
<p>Plasma is the liquid part of blood. Sometimes, for treatment purposes, it is taken from people who have been infected with but recovered from a disease, because it contains antibodies that fought the disease. <a href="https://theconversation.com/im-a-lung-doctor-testing-the-blood-plasma-from-covid-19-survivors-as-a-treatment-for-the-sick-a-century-old-idea-that-could-be-a-fast-track-to-treatment-144105">Doctors then inject this so-called convalescent plasma into patients</a> who currently have a disease in hopes that the antibodies in the plasma can help current patients.</p>
<p>Hahn and several <a href="https://www.commonwealthfund.org/blog/2020/why-we-cant-rely-health-insurance-alone-guarantee-universal-immunization-against-covid-19">members of the administration hailed</a> the authorization as an extraordinary public health achievement. The announcement, however, has drawn <a href="https://www.nytimes.com/2020/08/24/health/fda-blood-plasma.html">extensive criticism</a>. Many scientists have said that both the FDA and the administration greatly overstated and even mischaracterized data on the efficacy of convalescent plasma. </p>
<p>Two days later, <a href="https://apnews.com/a7f0e8aac34a860ad502912564681b7c">Hahn publicly apologized</a> for misrepresenting the benefits of convalescent plasma in connection with COVID-19, but he maintained that the decision to authorize the treatment for emergency use was based upon sound science and data. </p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1298071620414824452"}"></div></p>
<p>Commentators and other <a href="https://www.washingtonpost.com/opinions/the-fda-should-not-have-caved-to-trumps-latest-covid-19-demand/2020/08/24/afc5c97c-e626-11ea-970a-64c73a1c2392_story.html">researchers have questioned</a> whether the decision also reflected extreme political pressure to rush approvals of treatments for COVID-19. </p>
<p>We are law professors and have examined the regulatory posture of the FDA since the beginning of the outbreak. <a href="https://academic.oup.com/jlb/advance-article/doi/10.1093/jlb/lsaa060/5882039">We have studied</a> how the FDA’s decisions have varied with the external pressures that it has faced, comparing it to past emergency decision making by the agency. </p>
<p>We believe that this episode is symptomatic of a larger problem, and we worry that FDA’s repeated departure from evidence-based standards and long-tested and proved procedures will soon translate into a <a href="https://www.bbc.com/news/world-us-canada-53899908">poorly considered</a> authorization of COVID-19 vaccines.</p>
<figure class="align-center ">
<img alt="A young woman lies in a hospital bed donating plasma." src="https://images.theconversation.com/files/354957/original/file-20200826-7216-1fudayh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/354957/original/file-20200826-7216-1fudayh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=421&fit=crop&dpr=1 600w, https://images.theconversation.com/files/354957/original/file-20200826-7216-1fudayh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=421&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/354957/original/file-20200826-7216-1fudayh.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=421&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/354957/original/file-20200826-7216-1fudayh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=529&fit=crop&dpr=1 754w, https://images.theconversation.com/files/354957/original/file-20200826-7216-1fudayh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=529&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/354957/original/file-20200826-7216-1fudayh.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=529&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Former COVID-19 patient Melissa Cruz donates plasma at a hospital in Seattle as part of a study to determine if antibodies in formerly infected patients’ plasma could treat others with the disease.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/melissa-cruz-donates-covid-19-convalescent-plasma-at-news-photo/1210313205?adppopup=true">Karen Ducey/Getty Images</a></span>
</figcaption>
</figure>
<h2>The convalescent plasma decision in context</h2>
<p>Traditional FDA approval takes <a href="https://www.fda.gov/media/82381/download">several years</a> and relies on extensive data. During public health crises, however, the <a href="https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act">law</a> gives FDA the ability to authorize the use of unapproved products on an emergency basis. The agency does so by issuing an emergency authorization, or EUA. </p>
<p>The <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization">EUA pathway</a> gives FDA the flexibility to act faster and green-light worthy products that have otherwise not been sufficiently vetted. An EUA is based on <a href="https://www.law.cornell.edu/uscode/text/21/360bbb-3">much less data</a> than an approval. </p>
<p>A properly issued EUA is balanced by legal and scientific checks. The law directs the FDA to assess whether a specific product considered for an EUA “<a href="https://www.law.cornell.edu/uscode/text/21/360bbb-3">may be effective</a>” in light of the “<a href="https://www.law.cornell.edu/uscode/text/21/360bbb-3">totality of scientific evidence available</a>.” The agency must also determine whether the product’s potential benefits “outweigh the known and potential risks” and that “there is no adequate, approved, and available alternative.”</p>
<p>In the case of convalescent COVID-19 plasma, the FDA justified the EUA by stating that the treatment <a href="https://www.nytimes.com/2020/08/24/health/fda-blood-plasma.html">would save 35 out of every 100 patients</a>. </p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1297662384060981248"}"></div></p>
<p>President Trump <a href="https://www.latimes.com/politics/story/2020-08-23/former-fda-chief-rejects-trump-claim-of-coronavirus-therapy-foot-dragging">called the EUA</a> “a very historic breakthrough.” </p>
<p>However, experts like former FDA Commissioner Robert Califf, were quick to note that the statement of 35 lives saved was not supported by available data. </p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1297694277460299776"}"></div></p>
<p>Moreover, the EUA for convalescent plasma was based on data generated over the course of just <a href="https://www.nytimes.com/2020/08/04/health/trump-plasma.html">a few tests</a> since April. Scientists – including one involved in the <a href="https://www.nytimes.com/2020/08/24/health/fda-blood-plasma.html">Mayo Clinic study</a> used by the FDA to support the EUA – noted that the FDA had <a href="https://www.washingtonpost.com/health/2020/08/24/some-administration-claims-effectiveness-convalescent-plasma-are-wrong-or-dubious-scientists-say/">improperly framed the data</a> to make unsupported efficacy claims. In his apology, Hahn said the criticism was “<a href="https://abcnews.go.com/Health/wireStory/fda-commissioner-overstated-effects-virus-therapy-72595122">entirely justified</a>.”</p>
<h2>Science yields to political pressure</h2>
<p>This is not the first time in the COVID-19 pandemic that the FDA made a controversial decision involving an EUA. In March, <a href="https://www.nytimes.com/2020/06/16/us/politics/trump-hydroxychloroquine-coronavirus.html">under pressure</a> from the Trump Administration, the agency issued an EUA for hydroxychloroquine and chloroquine. Randomized trials, however, <a href="https://www.wired.com/story/the-fda-revokes-its-emergency-use-authorization-for-hydroxychloroquine/">failed to show</a> any benefit associated with these drugs. Three months later, in the face of continued lack of evidence to meet even the lower threshold of an EUA, the FDA <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chloroquine-and">revoked</a> the EUA. </p>
<p>Yet the Trump administration attempted to control the framing of the revocation. It portrayed it as the removal of a barrier to the use of these drugs, when in fact the revocation did exactly <a href="https://www.factcheck.org/2020/06/azar-trump-mislead-on-fdas-hydroxychloroquine-decision/">the opposite</a>.</p>
<p>Recent events like these provide unsettling clues of a deterioration of standards at the FDA. The flexibility that is required to deal with emergency responses creates opportunities for nimbleness. However, it also poses the danger that standards will be displaced. For an agency already overtly yielding to political pressure and short-termism, we are concerned that things are unlikely to improve as the COVID-19 vaccine race accelerates.</p>
<p>[<em>You need to understand the coronavirus pandemic, and we can help.</em> <a href="https://theconversation.com/us/newsletters/the-daily-3?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=coronavirus-help">Read The Conversation’s newsletter</a>.]</p>
<h2>Concerns with emerging COVID-19 vaccines</h2>
<p>There should be absolutely no link between the coming election and the vaccine regulatory process. Yet, there are growing concerns – voiced by experts like <a href="https://thehill.com/changing-america/well-being/prevention-cures/513516-fauci-warns-rushing-a-covid-19-vaccine-to-market">Dr. Anthony Fauci</a> – that there might be a push for a rushed authorization of a COVID-19 vaccine in the U.S. President Trump needs a boost in the polls, and the nation is desperate for a vaccine. The EUA of convalescent plasma, and in particular the misrepresentation of data at FDA level, have fueled these concerns.</p>
<p>Hahn published an op-ed on Aug. 5 <a href="https://www.washingtonpost.com/opinions/fda-commissioner-no-matter-what-only-a-safe-effective-vaccine-will-get-our-approval/2020/08/05/e897d920-d74e-11ea-aff6-220dd3a14741_story.html">saying</a> that he and his agency will not approve a vaccine that is not safe and effective, though previously he had <a href="https://www.forbes.com/sites/brucejapsen/2020/07/30/fda-chief-well-consider-emergency-authorization-for-covid-19-vaccine/#4711b19a574f">stated</a> that the FDA would consider issuing an EUA for a COVID-19 vaccine.</p>
<p>President Trump has <a href="https://www.reuters.com/article/us-health-cornavirus-vaccine-approval-ex/explainer-could-u-s-regulators-authorize-a-covid-19-vaccine-before-the-election-idUSKBN25L2OK">hinted at the possibility</a> of a COVID-19 vaccine being available before the election. Several <a href="https://www.ft.com/content/b053f55b-2a8b-436c-8154-0e93dcdb3c1a">reports</a> suggest that the administration is currently considering fast-tracking a COVID-19 vaccine being developed in the U.K., potentially through an EUA issued by the FDA. </p>
<p>Yet vaccine EUAs can be especially problematic. Because the threshold for an EUA is lower than for full regulatory approval, the FDA must make a risk-benefit assessment based on limited data whenever it uses the EUA pathway. Because of the nature of vaccines, many experts have <a href="https://pharmaintelligence.informa.com/resources/product-content/covid-19-vaccines-ex-fda-leaders-urge-high-bar-for-emergency-use-authorization">argued</a> that this pathway is too risky for vaccines. </p>
<p>One reason that vaccine EUAs would be especially risky is that, unlike treatments for diseases, vaccines are normally administered to healthy people. This makes it much harder to demonstrate their efficacy. When a person is sick and takes a drug, investigators can tell within a fairly short time if the drug works. That is not the case with a preventative like a vaccine. Therefore, to make an informed decision about whether a vaccine is safe and effective, FDA regulators are likely to need significantly more data than an EUA would give them. </p>
<p>Moreover, one of the leading COVID-19 vaccine candidates in the U.S. is an <a href="https://www.modernatx.com/modernas-work-potential-vaccine-against-covid-19">mRNA vaccine</a>, a type of vaccine never before approved anywhere in the world. Using the EUA pathway on such previously untested and unproved technology would be risky. This is even more concerning in light of the FDA’s recent track record of issuing EUAs with little or no data and recasting test results as wholesome without proper support. </p>
<h2>Adhering to its standards</h2>
<p>FDA’s departure from frameworks, scientific parameters and expertise care is contrary to the public interest and breeds distrust that could last for years. Regulatory history shows that the FDA can be flexible in times of crisis without compromising its credibility and its mission to protect the public health. We believe its departures from its standards under political pressure justifiably raises red flags. To be true to its mission, the FDA must stick to its regulatory guns. Right now, that means resisting pressure to further depart from its standards in the approval of COVID-19 vaccines.</p><img src="https://counter.theconversation.com/content/145082/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ana Santos Rutschman has advised the Biden campaign on issues related to intellectual property and health technologies.</span></em></p><p class="fine-print"><em><span>Liza Vertinsky and Yaniv Heled 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 rushed emergency approval for a treatment that might help COVID-19 patients has raised questions: Is the FDA abandoning its own guidelines?Ana Santos Rutschman, Assistant Professor of Law, Saint Louis UniversityLiza Vertinsky, Professor of Law, Emory UniversityYaniv Heled, Associate Professor of Law, Georgia State UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1380642020-05-20T12:13:43Z2020-05-20T12:13:43ZRapid home-based coronavirus tests are coming together in research labs — we’re working on analyzing spit using advanced CRISPR gene editing techniques<figure><img src="https://images.theconversation.com/files/334499/original/file-20200512-82375-1imbmyx.jpg?ixlib=rb-1.1.0&rect=43%2C75%2C7146%2C4710&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">What if you could test yourself for coronavirus with a test in the comfort of your home?</span> <span class="attribution"><a class="source" href="https://media.gettyimages.com/photos/stony-brook-ny-a-digital-sign-directs-people-to-the-drivethrough-picture-id1213723698?s=2048x2048">John Paraskevas/Newsday RM vis Getty Images</a></span></figcaption></figure><p>A desperately needed tool to curb the COVID-19 pandemic is an inexpensive home-based rapid testing kit that can detect the coronavirus without needing to go to the hospital. </p>
<p>The Food and Drug Administration has <a href="https://www.nytimes.com/2020/05/16/health/fda-clears-another-coronavirus-testing-kit-for-use-at-home.html">approved a few home sample collection kits</a> but a <a href="https://www.npr.org/sections/health-shots/2020/04/17/835958797/crispr-and-spit-might-be-keys-to-faster-cheaper-easier-tests-for-the-coronavirus">number of researchers</a>, including myself, are using the gene-editing technique known as CRISPR to make home tests. If they work, these tests could be very accurate and give people an answer in about an hour. </p>
<p><a href="https://www.che.ufl.edu/jain/dr-jain/">I am a biomolecular scientist</a> with training in pharmaceutical sciences and biomedical engineering and <a href="https://www.che.ufl.edu/jain/">my lab</a> focuses on developing next-generation of technologies for detecting and treating cancer, genetic and infectious diseases. </p>
<p>The COVID-19 disease is caused by a coronavirus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Unlike humans which carry their genetic material encoded in DNA, the coronavirus encodes theirs in a related molecule called RNA.</p>
<p>My research group recently engineered a sensitive CRISPR-based technology, that we named CRISPR-ENHANCE, and used it to create a rapid test for SARS-CoV-2 RNA. Our assay works like a pregnancy test and shows two purple colored lines if the sample is positive for the virus. Using our technology, I envision developing a test kit that would allow <a href="https://www.biorxiv.org/content/10.1101/2020.04.13.036079v1">rapid detection of SARS-CoV-2 RNA in saliva within 45-60 minutes</a> at home without needing any expensive equipment. </p>
<h2>Current landscape of coronavirus testing</h2>
<p>The FDA recently gave a green light to a couple of sample collection kits from <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-test-patient-home-sample-collection">LabCorp</a> and <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-standalone-home-sample-collection-kit-can-be-used">Everywell</a> under the Emergency Use Authorization (EUA) that would allow people to ship out the nasal swab samples for analysis. Patients can take a swab of their nose, ship the samples to a lab, and wait for a few days to get the results back. </p>
<p>Although not an at-home testing kit, the test allows the samples to be shipped directly to a lab for detecting SARS-CoV-2 RNA. There they use a <a href="https://theconversation.com/how-does-the-coronavirus-test-work-5-questions-answered-133118">technique</a> called reverse transcription-polymerase chain reaction (RT-PCR), which converts the viral RNA into DNA so that it can be easily multiplied and detected.</p>
<p>Although most FDA-approved tests are based on detecting SARS-CoV-2 RNA at an early stage, before symptoms even appear, such tests can only be performed in a laboratory setting with expensive equipment and can take multiple days to get the results. </p>
<p>Several <a href="https://theconversation.com/coronavirus-how-accurate-are-coronavirus-tests-135972">antibody testing kits</a> have been approved by the FDA that use a paper-based lateral flow strip, also similar to an at-home pregnancy testing strip, for detecting antibodies called IgM and IgG. Almost all SARS-CoV-2 infected patients make antibodies within <a href="https://doi.org/10.1038/s41591-020-0897-1">19 days of onset of symptoms</a> and then the body continues to make detectable antibodies for several weeks to months even after symptoms fades away. Therefore, the <a href="https://www.cdc.gov/coronavirus/2019-ncov/lab/serology-testing.html">Centers for Disease Control and Prevention</a> recommends using antibody tests for detecting past infections. </p>
<p>However, the <a href="https://doi.org/10.1038/s41591-020-0869-5">coronavirus is usually very active and contagious in the first week of infection</a> and peaks on the day of onset of symptoms. Therefore, to prevent the spread of coronavirus, it is extremely important to detect coronavirus early to block the spread. </p>
<p>The antibody testing can be great for detecting past infections but they cannot reliably detect current or early infections. The delayed appearance and patient-to-patient variability of antibodies in a blood test further complicates the COVID-19 diagnosis with antibody testing kits. </p>
<p>In addition, the variability between different antibody testing methods have <a href="https://www.nytimes.com/2020/04/24/health/coronavirus-antibody-tests.html">raised doubts about</a> the reliability of these test kits. </p>
<p>Therefore, the National Institutes of Health recently announced a <a href="https://www.poctrn.org/radx">Rapid Acceleration of Diagnostics (RADx)</a> which offers up to US$500 million in funding for ramping up the technologies that detect the SARS-CoV-2 virus.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/334498/original/file-20200512-82375-a2jkdh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/334498/original/file-20200512-82375-a2jkdh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/334498/original/file-20200512-82375-a2jkdh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/334498/original/file-20200512-82375-a2jkdh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/334498/original/file-20200512-82375-a2jkdh.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/334498/original/file-20200512-82375-a2jkdh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/334498/original/file-20200512-82375-a2jkdh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/334498/original/file-20200512-82375-a2jkdh.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">In the Netherlands, this strip tests blood samples for antibodies against the coronavirus. Right now the test costs 70 euros.</span>
<span class="attribution"><a class="source" href="https://media.gettyimages.com/photos/strip-running-a-test-on-a-blood-samples-at-various-locations-in-picture-id1210092015?s=2048x2048">Robin Utretcht/SOPA Images/LightRocket via Getty Images</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
</figcaption>
</figure>
<h2>How CRISPR-based diagnostics work</h2>
<p>Most people know of CRISPR/Cas systems as a famous gene-editing technology that can precisely edit DNA. Researchers engineer a “guide” RNA molecule with a target genetic sequence that serves like a GPS and zooms in on a location on the DNA where a Cas protein, a pair of molecular scissors, can cut at the desired location. </p>
<p>Scientists in the labs of <a href="https://zlab.bio/">Feng Zhang</a> at <a href="http://www.mit.edu/">MIT</a>, <a href="https://doudnalab.org/">Jennifer Doudna</a> at <a href="https://www.berkeley.edu/">UC Berkeley</a> and others discovered several newer versions of CRISPR/Cas systems, including ones using the proteins <a href="https://www.cell.com/fulltext/S0092-8674%2815%2901200-3">Cas12a</a> and <a href="https://www.ncbi.nlm.nih.gov/pubmed/28408723">Cas13a-d</a>, which <a href="https://science.sciencemag.org/content/360/6387/436">get crazy cutting</a> once they find their match. </p>
<p>My colleagues and I have used this Cas12a-based CRISPR technique to detect the coronavirus.</p>
<p>The coronavirus RNA activates CRISPR/Cas, transforming a pair of controlled molecular scissors into an unstoppable chainsaw. When the the CRISPR/Cas enzyme activates, we know that the genetic sequence of the coronavirus is present in the saliva sample. To make the signal of the coronavirus stronger in the testing kit, we add millions of synthetic “reporter molecules” which are also chopped up by the CRISPR/Cas mechanism. This means that within minutes we can detect detect the presence of coronavirus. </p>
<p>Under EAU, <a href="https://www.washingtonpost.com/health/fda-gives-emergency-authorization-for-crispr-based-diagnostic-tool-for-coronavirus/2020/05/07/f98029bc-9082-11ea-a9c0-73b93422d691_story.html">the FDA recently approved</a> the first CRISPR-based SARS-CoV-2 RNA testing kit from <a href="https://sherlock.bio/">Sherlock Biosciences</a> for testing nasal swabs in a lab. Although not yet approved for at-home testing, this is a big leap toward the development of CRISPR-based diagnostics. </p>
<p>While similar CRISPR-based test kits are in development including one from <a href="https://mammoth.bio/">Mammoth Biosciences</a> and others, our CRISPR-ENHANCE technology relies on engineered CRISPR RNAs that increases the speed of Cas12a “chainsaw” by between three- and four-fold.</p>
<p>This technique dramatically enhances the sensitivity of detection. Our system can detect fewer virus in a clinical sample faster with a clear visual readout. We are in the process of clinically validating the <a href="https://www.biorxiv.org/content/10.1101/2020.04.13.036079v1">CRISPR-ENHANCE</a> technology for SARS-CoV-2 RNA detection. </p>
<h2>Increasing the speed of CRISPR diagnostics</h2>
<p>Standard collection method for detecting respiratory viruses in the clinic is the nasal swab. However, coronaviruses have been detected at comparable levels in saliva so some researchers are now turning to saliva for diagnostic testing.</p>
<p>Collecting saliva is not only less invasive than the nasal swabs but also <a href="https://www.medrxiv.org/content/10.1101/2020.04.16.20067835v1.full.pdf">contains more virus</a>, which makes it easier to detect with RT-PCR. In fact, an <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-diagnostic-test-using-home-collection-saliva">at-home saliva collection kit</a> just received a green light by the FDA on May 8, 2020. In our validation study we will be internally comparing our test between the nasal swabs and saliva for FDA approval. </p>
<p>We are developing a six-step procedure for home-based testing for saliva along with the nasal swabs. Here is how it would work with saliva.</p>
<p>Spit into a sample collection tube that contains dry chemical reagents that will begin to react with your saliva when you drop the closed tube into the warm water for 30 minutes. </p>
<p>The heat helps the chemicals break up the virus particle and expose the virus’s genetic material – RNA. The RT-PCR reagents basically multiply the viral RNA creating billions of copies, which are more easily detected. </p>
<p>After 30 minutes, transfer the contents of the collection tube to a second tube containing dried CRISPR components and leave it at room temperature for 10-15 minutes. </p>
<p>Only if CRISPR/Cas finds the specific coronavirus RNA, will it become active and chop up the synthetic reporter molecules that are engineered and added to this second tube. This part happens in just six minutes.</p>
<p>We then drop a paper strip into the second tube. Within 30 seconds one or two purple bands reveal the results. </p>
<p>The health care provider can then direct the individual to either quarantine, isolate and/or recommend further testing such as antibody-based tests. <a href="https://go.nature.com/3cMAFU8">In our study</a>, currently under peer review, we demonstrated that the ENHANCE technology itself is versatile and can also be adopted for detecting a range of targets including HIV, HCV and prostate cancer.</p>
<p>While there are several labs and companies are rushing to develop similar CRISPR-based coronavirus detection kits for saliva testing, we believe our approach offers the fastest detection. We hope to bring the cost of the kit down to between $1 and $2 so that developing countries can also afford a rapid and reliable coronavirus testing kit.</p>
<p>[<em>You need to understand the coronavirus pandemic, and we can help.</em> <a href="https://theconversation.com/us/newsletters?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=upper-coronavirus-help">Read The Conversation’s newsletter</a>.]</p><img src="https://counter.theconversation.com/content/138064/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Piyush K. Jain 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>Testing for coronavirus has been a fiasco in the US. But now companies are developing super fast tests, including ones that might eventually be as simple as at home pregnancy tests.Piyush K. Jain, Assistant Professor, Department of Chemical Engineering, Herbert Wertheim College of Engineering, UF Health Cancer Center, University of FloridaLicensed as Creative Commons – attribution, no derivatives.