tag:theconversation.com,2011:/nz/topics/pfizer-1708/articlesPfizer – The Conversation2024-03-25T20:27:48Ztag:theconversation.com,2011:article/2261302024-03-25T20:27:48Z2024-03-25T20:27:48ZCardiovascular risks and COVID-19: New research confirms the benefits of vaccination<figure><img src="https://images.theconversation.com/files/584210/original/file-20240325-19-khbs3w.jpg?ixlib=rb-1.1.0&rect=404%2C85%2C2191%2C1576&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Common cardiovascular complications of COVID-19 — including blood clots, stroke, arrhythmias and heart attacks — were substantially reduced in vaccinated patients.</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><p>COVID-19 is a respiratory disease. Yet, from the earliest days of the pandemic, the <a href="https://doi.org/10.1161/CIRCRESAHA.121.317997">cardiovascular risks associated with SARS-CoV-2 infection</a> were clear: individuals with severe cases of COVID-19 often died from cardiovascular complications, and those with pre-existing cardiovascular disease were more likely to have severe illness or die. </p>
<p>In short, the cardiovascular system has played a central role in COVID-19 since the beginning.</p>
<p>It is not surprising that as debate over COVID-19 and vaccines flared that <a href="https://www.ctvnews.ca/health/coronavirus/cardiologists-weigh-in-on-whether-covid-19-or-vaccines-pose-a-greater-risk-of-heart-problems-1.6293061">cardiovascular disease was a central issue</a>. Those opposed to vaccination often make claims of cardiovascular risks that exceed any benefits. But when data on COVID-19, vaccines and cardiovascular health are reviewed, the conclusions are clear: vaccines are safe and effective at reducing the cardiovascular complications that are a hallmark of COVID-19.</p>
<h2>Hot off the presses</h2>
<figure class="align-center ">
<img alt="A person's arm and shoulder, with a small bandage on the upper arm and the other hand holding a heart with a syringe drawn on it" src="https://images.theconversation.com/files/584211/original/file-20240325-20-7px5a5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/584211/original/file-20240325-20-7px5a5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=338&fit=crop&dpr=1 600w, https://images.theconversation.com/files/584211/original/file-20240325-20-7px5a5.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=338&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/584211/original/file-20240325-20-7px5a5.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=338&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/584211/original/file-20240325-20-7px5a5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=424&fit=crop&dpr=1 754w, https://images.theconversation.com/files/584211/original/file-20240325-20-7px5a5.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=424&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/584211/original/file-20240325-20-7px5a5.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=424&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">A new study found that common cardiovascular complications of COVID-19 were substantially reduced in people who were vaccinated, with protective effects lasting up to a year after vaccination.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>A new <a href="https://doi.org/10.1136/heartjnl-2023-323483">study of 20.5 million people</a> in the United Kingdom, Spain and Estonia used electronic health records to determine how COVID-19 vaccines affect cardiovascular complications following SARS-CoV-2 infection. Roughly the same number of vaccinated and unvaccinated subjects were included, and the vaccinated group consisted of people who received at least one of the AstraZeneca, Pfizer, Moderna or Janssen vaccines. </p>
<p>The study found that common cardiovascular complications of COVID-19 — including blood clots, stroke, arrhythmias and heart attacks — were substantially reduced in the vaccinated group, with protective effects lasting up to a year after vaccination.</p>
<h2>Bigger picture</h2>
<p>While this most recent study represents one of the most comprehensive investigations into the cardiovascular benefits of COVID-19 vaccination, its findings are consistent with earlier, smaller studies. </p>
<p>A <a href="https://doi.org/10.1001/jama.2022.12992">2022 study of 231,037 people</a> found two doses of COVID-19 vaccines reduced the risk of stroke and heart attack up to four months after a breakthrough infection. </p>
<p>A subsequent <a href="https://doi.org/10.1016/j.jacc.2022.12.006">study of 1.9 million people</a> found that while two doses of the mRNA vaccines or one dose of the Johnson & Johnson vaccine protected against major cardiovascular events following COVID-19, even a single dose of the mRNA vaccines offered some benefit in reducing the risk of cardiovascular complications.</p>
<p>Health-care decisions require a weighing of the risk and benefits of treatments, and for COVID-19 vaccines the low cardiovascular risks favour vaccination. A <a href="https://doi.org/10.1161/CIRCULATIONAHA.122.063753">study of over four million vaccinated Australians</a> found no increase in sudden cardiac death. Even <a href="https://doi.org/10.1161/CIRCHEARTFAILURE.123.010617">patients with pre-existing heart failure</a> do not have an increased risk of worsening heart failure, myocarditis, or blood clots following vaccination.</p>
<h2>Weighing the risks</h2>
<p>Although the safety of COVID-19 vaccines is well-established, it does not mean there are no risks. A <a href="https://doi.org/10.1016/j.vaccine.2024.01.100">review of 99 million individuals in the Global Vaccine Data Network</a> confirmed earlier studies that found an increased risk of myocarditis and pericarditis, which is seen primarily in young males — historically the group most at risk for myocarditis before COVID-19 emerged. </p>
<p>While individuals at higher risk for these complications should consult with their health-care providers in making decisions about vaccination, it should be noted that the risk for myocarditis and pericarditis is generally higher with COVID-19, even in this cohort.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/myocarditis-covid-19-is-a-much-bigger-risk-to-the-heart-than-vaccination-174580">Myocarditis: COVID-19 is a much bigger risk to the heart than vaccination</a>
</strong>
</em>
</p>
<hr>
<p>Studies have also found that extending the time between first and second doses of the COVID-19 mRNA vaccines beyond the initially recommended three-week interval <a href="https://doi.org/10.1001/jamanetworkopen.2022.18505">decreases the risk of myocarditis</a>. Furthermore, <a href="https://doi.org/10.1016/j.hfc.2022.08.012">post-vaccine myocarditis</a> tends to be transient with very good recovery and is less severe than that associated with COVID-19.</p>
<figure class="align-center ">
<img alt="A health-care provider putting a bandage on a young man's arm" src="https://images.theconversation.com/files/584013/original/file-20240325-28-sqfpke.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/584013/original/file-20240325-28-sqfpke.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/584013/original/file-20240325-28-sqfpke.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/584013/original/file-20240325-28-sqfpke.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/584013/original/file-20240325-28-sqfpke.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/584013/original/file-20240325-28-sqfpke.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/584013/original/file-20240325-28-sqfpke.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">Studies have found that extending the time between first and second doses of the COVID-19 mRNA vaccines beyond the initially recommended three-week interval decreases the risk of myocarditis.</span>
<span class="attribution"><span class="source">(CDC)</span></span>
</figcaption>
</figure>
<p>The risk of myocarditis in young people has led some to claim that the benefits of COVID-19 vaccines are negated when stacked up against the chance of heart inflammation. A <a href="https://doi.org/10.1161/CIR.0000000000001064">statement from the American Heart Association</a> confirms that the risks of cardiovascular complications in young people with more mild cases of COVID-19 (symptoms lasting less than four days) are low, but notes that there are concerning signs for those who experience more severe illness with infection. </p>
<p>Furthermore, other cardiovascular risks associated with infection must be considered in weighing risks and benefits. These include <a href="https://www.cdc.gov/mis/about.html">multisystem inflammatory syndrome</a> or “MIS-C” and cardiac arrhythmias — a far more common risk of COVID-19 than myocarditis. </p>
<p>Finally, <a href="https://www.axios.com/2020/03/20/twitter-lets-musks-coronavirus-misinformation-stand">the claim that COVID-19 is harmless in children</a> is not true: <a href="https://doi.org/10.25318/1310039401-eng">in Canada</a> COVID-19 is the sixth leading cause of death for children aged one to 14 years, and tenth for people 15 to 19 years old. Overall, studies find that <a href="https://www.acc.org/latest-in-cardiology/articles/2022/02/09/12/56/vaccine-associated-myocarditis-risk-in-context">even in young people the benefits of vaccination exceed the risks</a>, particularly when it comes to cardiovascular disease.</p>
<h2>Take to heart</h2>
<p>There are individuals whose health conditions <a href="https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines/advice">preclude COVID-19 vaccination</a>, and others for whom health risks may outweigh the benefits. But, for the vast majority of people — including young and otherwise healthy people — COVID-19 vaccination is not only safe, but the cardiovascular protection it offers could be life-saving.</p><img src="https://counter.theconversation.com/content/226130/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Glen Pyle receives funding from the Heart and Stroke Foundation of Canada, Canadian Institutes of Health Research, and the Natural Sciences and Engineering Research Council of Canada. He is a on the advisory board of "Royal City Science" and "Science Up First".</span></em></p>New research confirms that COVID-19 vaccines are safe and effective at reducing the cardiovascular complications that are a hallmark of COVID-19 infection.Glen Pyle, Member, IMPART (Initiative on Medication Management, Policy Analysis, Research & Training), Dalhousie UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2195412023-12-18T14:48:37Z2023-12-18T14:48:37ZmRNA COVID vaccines make ‘unintended proteins’ – we’ve discovered how to fix this problem<p>MRNA, a type of genetic material that provides the instructions your cells need in order to make proteins, used to be a term mainly used by scientists. But since COVID arrived many of us are now familiar with it thanks to the mRNA-based vaccines.</p>
<p>The people behind the discoveries that made mRNA-based vaccines and treatments a possibility were awarded the <a href="https://theconversation.com/nobel-prize-in-medicine-awarded-to-mrna-pioneers-heres-how-their-discovery-was-integral-to-covid-vaccine-development-214763">Nobel prize</a> earlier this year. That work showed that some of the mRNA’s chemical letters that make up its alphabet need to be switched out for synthetic equivalents for this technology to be viable. </p>
<p>However, these artificial versions are causing <a href="https://www.science.org/content/article/mrna-vaccines-may-make-unintended-proteins-there-s-no-evidence-harm">“unintended proteins”</a> to be made and hence immune responses to these proteins. The question is now: can we prevent this? The answer is yes we can. And it’s a straightforward fix.</p>
<p>Vaccines using all-natural mRNA don’t work. Our immune system recognises them as foreign to the body and mounts a response to remove them, just like it would to any invading germ. </p>
<p>The Nobel prize-winning work of Katalin Karikó and Drew Weissman essentially gave the injected mRNA an invisibility cloak – the synthetic “letters” – preventing its detection and destruction by our immune system. This allows safe delivery of the mRNA to cells to do its job. </p>
<p>In the case of the COVID vaccines, our cells make the spike protein and our immune system makes antibodies against it, protecting us from severe disease.</p>
<p>Micro-protein factories called ribosomes read the mRNA instructions to make proteins. They read the code three chemical letters at a time. Each triplet codes for an amino acid – a single building block of a protein. </p>
<p>The ribosome moves along to the next three letters and identifies which amino acid is next to be added to the growing protein. This repeats until it reaches the end of the mRNA instructions.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/A7gSWqpXRsc?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">How mRNA works.</span></figcaption>
</figure>
<p>So where do the “unintended proteins” come from? They are created in the same way, but errors can occur if the ribosome reaches a string of these synthetic chemical letters in the mRNA. </p>
<p>The ribosome can slip, essentially losing its place in what it is reading. For instance, rather than reading THE CAT ATE THE FAT RAT, it reads the message as THE CAT A TET HEF ATR AT, resulting in the production of a different protein.</p>
<p>In a <a href="https://www.nature.com/articles/s41586-023-06800-3">recent study</a>, published in Nature, my colleagues and I revealed that these unintended proteins were produced in a third of the 21 people who participated in the study and were vaccinated with the Pfizer mRNA vaccine. Also, those people generated an immune response against these proteins.</p>
<p>Beyond the strength of the data from the original clinical trial, the safety of the Pfizer vaccine has been re-established by observing millions of vaccine recipients, and the benefits still outweigh the risks for those still recommended to receive it. So our latest study should not affect the safety assessment of existing mRNA COVID vaccines. </p>
<h2>No evidence of harm</h2>
<p>The data is clear: there is no evidence linking unintended proteins and immune responses with harm. </p>
<p>It’s important to note that humans regularly encounter unintended proteins and generate harmless immune responses, as seen with proteins produced from our food or by harmless gut bacteria. These immune responses, which occur in all of us constantly, are controlled by our immune system to prevent them from causing damage to our bodies.</p>
<p>These unintended proteins arising from mRNA vaccines are not random. We know where errors can occur in the mRNA code and can fix them to prevent issues in future mRNA-based therapies.</p>
<p>Luckily, nature provides a fail-safe we can take advantage of. With only 20 different amino acids, but 64 possible sets of three chemical letters, more than one triplet codes for a given amino acid. When designing new mRNA therapeutics, triplets prone to errors can be identified using a simple algorithm and replaced with an alternative spelling of the same code – similar to “mum” and “mom”.</p>
<p>MRNA therapies will be gamechanging for medicine. They are easy to make, can be produced rapidly and are easily modified. Most excitingly, this technology could be used to treat a wide range of diseases, including cancer. </p>
<p>Cancer treatment has been revolutionised by immunotherapy – which uses the patient’s immune system to fight the cancer, but its effectiveness varies. The main hope for making immunotherapy more successful lies in designing mRNA-based cancer vaccines that are personalised to the patient.</p>
<p>This finding raises the new possibility that unintended proteins could be generated by any mRNA therapeutic. Also, it is not possible to be sure that, in the context of cancer treatment, unintended proteins and the immune responses they trigger will be harmless. However, this discovery gives new insights into how these unintended proteins are generated and, most importantly, how modifications can be made to prevent these from arising.</p><img src="https://counter.theconversation.com/content/219541/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Anne Willis receives funding from Medical Research Council UK and Wellcome Trust LEAP</span></em></p><p class="fine-print"><em><span>James Thaventhiran does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>mRNA vaccines are very safe, but this problem needed to be fixed for future mRNA therapies.James Thaventhiran, MRC Investigator, University of CambridgeAnne Willis, Professor of Toxicology Department of Pharmacology, University of CambridgeLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2178042023-11-20T22:13:55Z2023-11-20T22:13:55ZWhat are the new COVID booster vaccines? Can I get one? Do they work? Are they safe?<figure><img src="https://images.theconversation.com/files/559796/original/file-20231116-15-2n01o.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C1000%2C561&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/happy-senior-laughing-after-vaccinated-ideas-2001444137">Shutterstock</a></span></figcaption></figure><p>As the COVID virus continues to <a href="https://pubmed.ncbi.nlm.nih.gov/36680207/">evolve</a>, so does our vaccine response. From <a href="https://www.health.gov.au/ministers/the-hon-mark-butler-mp/media/new-covid-19-vaccines-available-to-target-current-variants?language=en">December 11</a>, Australians will have access to <a href="https://www.health.gov.au/news/atagi-recommendations-on-use-of-the-moderna-and-pfizer-monovalent-omicron-xbb15-covid-19-vaccines?language=en">new vaccines</a> that offer better protection. </p>
<p>These “monovalent” booster vaccines are expected to be a <a href="https://theconversation.com/cdc-greenlights-two-updated-covid-19-vaccines-but-how-will-they-fare-against-the-latest-variants-5-questions-answered-213341">better match</a> for currently circulating strains of SARS-CoV-2, the virus that causes COVID.</p>
<p>Pfizer’s monovalent vaccine will be <a href="https://www.health.gov.au/ministers/the-hon-mark-butler-mp/media/new-covid-19-vaccines-available-to-target-current-variants?language=en">available</a> to eligible people aged five years and older. The Moderna monovalent vaccine can be used for those aged 12 years and older.</p>
<p>Who is eligible for these new boosters? How do they differ from earlier ones? Do they work? Are they safe?</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/were-in-a-new-covid-wave-what-can-we-expect-this-time-216820">We're in a new COVID wave. What can we expect this time?</a>
</strong>
</em>
</p>
<hr>
<h2>Who’s eligible for the new boosters?</h2>
<p>The federal government has accepted the Australian Technical Advisory Group (ATAGI) recommendation to use the new vaccines, after Australia’s regulator <a href="https://www.tga.gov.au/products/covid-19/covid-19-vaccines/covid-19-vaccines-regulatory-status">approved their use last month</a>. However, vaccine eligibility has remained the same since September. </p>
<p>ATAGI <a href="https://www.health.gov.au/news/atagi-recommendations-on-use-of-the-moderna-and-pfizer-monovalent-omicron-xbb15-covid-19-vaccines?language=en">recommends</a> Australians aged over 75 get vaccinated if it has been six months or more since their last dose. </p>
<p>People aged 65 to 74 are recommended to have a 2023 booster if they haven’t already had one. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/560533/original/file-20231120-21-4igdnx.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/560533/original/file-20231120-21-4igdnx.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/560533/original/file-20231120-21-4igdnx.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=315&fit=crop&dpr=1 600w, https://images.theconversation.com/files/560533/original/file-20231120-21-4igdnx.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=315&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/560533/original/file-20231120-21-4igdnx.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=315&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/560533/original/file-20231120-21-4igdnx.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=396&fit=crop&dpr=1 754w, https://images.theconversation.com/files/560533/original/file-20231120-21-4igdnx.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=396&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/560533/original/file-20231120-21-4igdnx.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=396&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">For people without risk factors.</span>
<span class="attribution"><a class="source" href="https://www.health.gov.au/sites/default/files/2023-10/atagi-recommended-covid-19-vaccine-doses.pdf">Health.gov.au</a></span>
</figcaption>
</figure>
<p>Adults aged 18 to 64 <em>with</em> underlying risk factors that increase their risk of severe COVID are also recommended to have a 2023 booster if they haven’t had one yet. And if they’ve already had a 2023 booster, they can consider an additional dose. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/560532/original/file-20231120-26-70jfyr.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/560532/original/file-20231120-26-70jfyr.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/560532/original/file-20231120-26-70jfyr.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=311&fit=crop&dpr=1 600w, https://images.theconversation.com/files/560532/original/file-20231120-26-70jfyr.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=311&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/560532/original/file-20231120-26-70jfyr.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=311&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/560532/original/file-20231120-26-70jfyr.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=391&fit=crop&dpr=1 754w, https://images.theconversation.com/files/560532/original/file-20231120-26-70jfyr.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=391&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/560532/original/file-20231120-26-70jfyr.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=391&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Advice for people with risk factors.</span>
<span class="attribution"><a class="source" href="https://www.health.gov.au/sites/default/files/2023-10/atagi-recommended-covid-19-vaccine-doses.pdf">Health.gov.au</a></span>
</figcaption>
</figure>
<p>For adults aged 18 to 64 <em>without</em> underlying risk factors who have already received a 2023 booster, an additional dose isn’t recommended. But if you’re aged 18 to 64 and haven’t had a booster in 2023, you can consider an additional dose. </p>
<p>Additional doses aren’t recommended for children <em>without</em> underlying conditions that increase their risk of severe COVID. A primary course is not recommended for children aged six months to five years <em>without</em> additional risk factors. </p>
<h2>Monovalent, bivalent? What’s the difference?</h2>
<p><strong>From monovalent</strong></p>
<p>The initial COVID vaccines were “monovalent”. They had one target – the original viral strain.</p>
<p>But as the virus mutated, we assigned new letters of the Greek alphabet to each variant. This brings us to Omicron. With this significant change, we saw “immune evasion”. The virus had changed so much the original vaccines didn’t provide sufficient immunity.</p>
<p><strong>To bivalent</strong> </p>
<p>So vaccines were updated to target an early Omicron subvariant, BA.1, plus the original ancestral strain. With two targets, these were the first of the “bivalent” vaccines, which were approved in Australia <a href="https://theconversation.com/omicron-specific-vaccines-may-give-slightly-better-covid-protection-but-getting-boosted-promptly-is-the-best-bet-190736">in 2022</a>.</p>
<p>Omicron continued to evolve, leading to more “immune escape”, contributing to repeated waves of transmission.</p>
<p>The vaccines were updated again in <a href="https://theconversation.com/havent-had-covid-or-a-vaccine-dose-in-the-past-six-months-consider-getting-a-booster-199096">early 2023</a>. These newer bivalent vaccines target two strains – the ancestral strain plus the subvariants BA.4 and BA.5.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/a-covid-inquiry-has-been-announced-but-is-covid-still-a-thing-do-i-need-a-booster-213469">A COVID inquiry has been announced. But is COVID still a thing? Do I need a booster?</a>
</strong>
</em>
</p>
<hr>
<p><strong>Back to monovalent</strong></p>
<p>Further changes in the virus have meant our boosters needed to be updated again. This takes us to the recent announcement.</p>
<p>This time the booster targets another subvariant of Omicron known as XBB.1.5 (sometimes known as <a href="https://theconversation.com/the-kraken-subvariant-xbb-1-5-sounds-scary-but-behind-the-headlines-are-clues-to-where-covids-heading-198158">Kraken</a>).</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1621375840284983296"}"></div></p>
<p>This vaccine is monovalent once more, meaning it has only one target. The target against the original viral strain has been removed.</p>
<p>According to advice given to the World Health Organization <a href="https://www.who.int/news/item/18-05-2023-statement-on-the-antigen-composition-of-covid-19-vaccines">in May</a>, this is largely because immunity to this original strain is no longer required (it’s no longer infecting humans). Raising immunity to the original strain may also hamper the immune response to the newer component, but we’re not sure if this is occurring or how important this is.</p>
<p>The United States <a href="https://theconversation.com/cdc-greenlights-two-updated-covid-19-vaccines-but-how-will-they-fare-against-the-latest-variants-5-questions-answered-213341">approved</a> XBB.1.5-specific vaccines from Pfizer and Moderna in <a href="https://www.fda.gov/news-events/press-announcements/fda-takes-action-updated-mrna-covid-19-vaccines-better-protect-against-currently-circulating">mid-September</a>. These updated vaccines have also been <a href="https://www.tga.gov.au/sites/default/files/2023-10/auspar-spikevax-xbb.1.5-231012.pdf">approved in</a> places including Europe, Canada, Japan and Singapore.</p>
<p>In Australia, the Therapeutic Goods Administration (TGA) approved
them <a href="https://www.tga.gov.au/products/covid-19/covid-19-vaccines/covid-19-vaccines-regulatory-status">in October</a>.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/beyond-covid-vaccines-what-else-could-mrna-technology-do-for-our-health-215142">Beyond COVID vaccines: what else could mRNA technology do for our health?</a>
</strong>
</em>
</p>
<hr>
<h2>Do these newer vaccines work?</h2>
<p>Evidence for the efficacy of these new monovalent vaccines comes from the results of research <a href="https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2023-PI-02409-1&d=20231117172310101">Pfizer</a> and <a href="https://www.tga.gov.au/resources/auspar/auspar-spikevax-xbb15">Moderna</a>
submitted to the TGA.</p>
<p>Evidence also comes from a <a href="https://www.medrxiv.org/content/10.1101/2023.08.22.23293434v2">preprint</a> (preliminary research available online that has yet to be independently reviewed) and an update Pfizer <a href="https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-09-12/10-COVID-Modjarrad-508.pdf">presented</a> to the US Centers for Disease Control.</p>
<p>Taken together, the available evidence shows the updated vaccines produce good levels of antibodies in <a href="https://www.tga.gov.au/resources/auspar/auspar-spikevax-xbb15">laboratory studies</a>, <a href="https://www.medrxiv.org/content/10.1101/2023.08.22.23293434v2">in humans</a> and <a href="https://www.tga.gov.au/resources/auspar/auspar-spikevax-xbb15">mice</a> when compared to previous vaccines and when looking at multiple emerging variants, including EG.5 (sometimes known as <a href="https://theconversation.com/the-who-has-declared-eris-a-variant-of-interest-how-is-it-different-from-other-omicron-variants-211276">Eris</a>). This variant is the one causing high numbers of cases around the world currently, including in Australia. It is very similar to the XBB version contained in the updated booster. </p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1689763106791297024"}"></div></p>
<p>The updated vaccines should also cover <a href="https://theconversation.com/how-evasive-and-transmissible-is-the-newest-omicron-offshoot-ba-2-86-that-causes-covid-19-4-questions-answered-212453">BA.2.86 or Pirola</a>, according to <a href="https://www.tga.gov.au/sites/default/files/2023-10/auspar-spikevax-xbb.1.5-231012.pdf">early results</a> from clinical trials and the US <a href="https://www.cdc.gov/respiratory-viruses/whats-new/covid-19-variant.html">Centers for Disease Control</a>. This variant is responsible for a rapidly increasing proportion of cases, with case numbers growing <a href="https://twitter.com/BigBadDenis/status/1725310295596560662?s=19">in Australia</a>.</p>
<p>It’s clear the virus is going to continue to evolve. So performance of these vaccines against new variants will continue to be closely monitored.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/how-evasive-and-transmissible-is-the-newest-omicron-offshoot-ba-2-86-that-causes-covid-19-4-questions-answered-212453">How evasive and transmissible is the newest omicron offshoot, BA.2.86, that causes COVID-19? 4 questions answered</a>
</strong>
</em>
</p>
<hr>
<h2>Are they safe?</h2>
<p>The <a href="https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2023-PI-02409-1&d=20231117172310101">safety</a> of the updated vaccines has also been shown to be similar to previous versions. Studies <a href="https://www.medrxiv.org/content/10.1101/2023.08.22.23293434v2">comparing them</a> found no significant difference in terms of the adverse events reported.</p>
<p>Given the availability of the updated vaccines, some countries have removed their approval for earlier versions. This is because newer versions are a closer match to currently circulating strains, rather than any safety issue with the older vaccines.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/do-covid-boosters-cause-more-or-fewer-side-effects-how-quickly-does-protection-wane-your-questions-answered-176695">Do COVID boosters cause more or fewer side effects? How quickly does protection wane? Your questions answered</a>
</strong>
</em>
</p>
<hr>
<h2>What happens next?</h2>
<p>The availability of updated vaccines is a welcome development, however this is not the end of the story. We need to make sure eligible people get vaccinated.</p>
<p>We also need to acknowledge that vaccination should form part of a comprehensive strategy to limit the impact of COVID from now on. That includes measures such as mask wearing, social distancing, focusing on ventilation and air quality, and to a lesser degree hand hygiene. Rapidly accessing antivirals if eligible is also still important, as is keeping away from others if you are infected.</p><img src="https://counter.theconversation.com/content/217804/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Paul Griffin is a director and scientific advisory board member of the Immunisation Coalition and has previously had roles as an advisory board member for Pfizer, Moderna and Novavax. </span></em></p>As the virus continues to mutate, COVID vaccines are updated. This brings us to the latest announcement about the new ‘monovalent’ vaccines.Paul Griffin, Professor, Infectious Diseases and Microbiology, The University of QueenslandLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2051112023-05-10T12:29:51Z2023-05-10T12:29:51ZFDA’s approval of the world’s first vaccine against RSV will offer a new tool in an old fight – 4 questions answered<figure><img src="https://images.theconversation.com/files/524950/original/file-20230508-244517-v1e63f.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C5397%2C3595&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The long-awaited vaccine is a necessary tool in the fight against the most common respiratory viruses.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/flu-rsv-and-sars-cov-2-coronavirus-vaccine-vials-in-royalty-free-image/1447210141?phrase=RSV+vaccine&adppopup=true">angelp/iStock via Getty Images Plus</a></span></figcaption></figure><p><em>The U.S. Food and Drug Administration approved the world’s <a href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine">first vaccine to prevent the respiratory infection RSV</a>, short for respiratory syncytial virus, on May 3, 2023. The new shot represents six decades of starts and stops in the <a href="https://www.washingtonpost.com/health/2022/10/10/rsv-vaccine/">hunt for a vaccine</a> to curb one of the most common winter respiratory viruses. RSV leads to around <a href="https://www.gsk.com/en-gb/media/press-releases/us-fda-approves-gsk-s-arexvy-the-world-s-first-respiratory-syncytial-virus-rsv-vaccine-for-older-adults/#_RSV3">14,000 deaths in older adults every year</a> and can cause <a href="https://doi.org/10.1016/S2214-109X(21)00518-0">severe illness in infants</a> <a href="https://www.cdc.gov/rsv/high-risk/infants-young-children.html">and children</a> as well.</em></p>
<p><em>The vaccine, called Arexvy, made by the <a href="https://www.gsk.com/en-gb/media/press-releases/us-fda-approves-gsk-s-arexvy-the-world-s-first-respiratory-syncytial-virus-rsv-vaccine-for-older-adults/">biopharmaceutical company GSK</a>, is approved for use in adults ages 60 and over. Now that it is FDA-approved, it must still be endorsed by the Centers for Disease Control and Prevention, a move that’s expected in summer 2023.</em> </p>
<p><em>The Conversation asked Annette Regan, an <a href="https://scholar.google.com/citations?user=Pu3L9HkAAAAJ&hl=en">epidemiologist and vaccine specialist</a>, to discuss the significance of the first vaccine against RSV and the other RSV vaccine candidates that are in the pipeline.</em></p>
<h2>1. How does the new vaccine protect against the virus?</h2>
<p>The vaccine targets a <a href="https://doi.org/10.1126/scitranslmed.ade6422">protein known as RSV F glycoprotein</a>, which is found on the surface of the virus. The F protein enables the RSV virus to enter host cells.</p>
<p>By stimulating antibodies against this protein, the vaccine should protect against infection. Clinical trial data suggests this is the case, since Arexvy was 80% effective at <a href="https://doi.org/10.1056/NEJMoa2209604">protecting against RSV-related disease</a> and 94% effective at protecting against severe disease.</p>
<p>The vaccine also includes an adjuvant, a substance that <a href="https://doi.org/10.3389/fimmu.2013.00114">helps amplify the effect of the vaccine</a> by boosting the immune system’s response.</p>
<h2>2. When and for whom will it be available?</h2>
<p>The RSV vaccine has been developed for and tested in adults age 60 and older. While the FDA has approved the vaccine – which means it has deemed it safe and effective – the shot will not be administered by health care professionals until it is reviewed by an independent expert group coordinated by the CDC called the <a href="https://www.cdc.gov/vaccines/acip/committee/role-vaccine-recommendations.html">Advisory Committee on Immunization Practice</a>, which makes vaccine recommendations to the CDC. </p>
<p>The committee’s recommendations will cover how the vaccine should be used – including the ages at which the vaccine should be given – the number of doses needed, the time between doses and precautions and contraindications.</p>
<p>The <a href="https://www.gsk.com/en-gb/media/press-releases/us-fda-approves-gsk-s-arexvy-the-world-s-first-respiratory-syncytial-virus-rsv-vaccine-for-older-adults/#">committee is expected to meet in June 2023</a> to make a recommendation on the new RSV vaccine, after which the CDC would officially endorse it. The vaccine could be rolled out to the public as soon as late summer 2023, well before the typical RSV season, which usually starts in the fall and peaks in winter.</p>
<p>It’s hard to say what the committee’s recommendation will be. It could recommend the vaccine for all adults 60 and older, or a subset of older adults. While the clinical trial showed the vaccine was 81% effective among adults ages 60 to 69 and 94% effective among adults ages 70 to 79, it was only <a href="https://doi.org/10.1056/NEJMoa2209604">34% effective among adults 80 and older</a>. Given the lower efficacy for adults ages 80 and older, the committee could place an age cap on the recommendations.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/1YdDIK3LYrY?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">More than 14,000 older adults die every year following RSV infection.</span></figcaption>
</figure>
<h2>3. Why has the first RSV vaccine been so long in coming?</h2>
<p>A vaccine against RSV has been in the works for decades. One problem that has plagued vaccine manufacturers is the difficulty of identifying an antigen – the piece of the virus that the vaccine targets – that doesn’t change, or shape-shift. The F protein of the RSV virus is notorious for changing its shape once it fuses with a host’s cell. </p>
<p>In 2013 and 2014, the National Institutes of Health worked out <a href="https://www.nature.com/articles/ncomms9143">how to “freeze” the F protein</a> into a fixed shape before fusing with a cell so that a vaccine could target it well. This was a game-changer that allowed the development of effective vaccines using this target.</p>
<p>In addition to challenges in identifying a good antigen, there were earlier setbacks. Early attempts to create an inactivated RSV vaccine in the 1960s were stalled after they <a href="https://doi.org/10.1128/CVI.00609-15">caused an enhanced form of RSV disease</a>. Children who had never had RSV before and received the vaccine experienced very severe illness when they encountered the virus in the community, and two children died. This tragic outcome sidetracked vaccine development for decades, as researchers needed to investigate the cause and ensure that the problem wouldn’t occur again for future vaccines.</p>
<h2>4. What other RSV vaccine candidates are coming down the line?</h2>
<p>In addition to Arexvy, <a href="https://media.path.org/documents/RSV-Snapshot_03JAN2023_HighResolution.pdf">many other promising RSV candidates</a> are under development, some of which are likely to become available later this year or in early 2024. </p>
<p>The next RSV vaccine under review with the FDA is <a href="https://www.statnews.com/2022/08/25/856828/">Pfizer’s RSV vaccine</a>. It is similar to the recently approved vaccine except that it has no adjuvant and is bivalent, meaning that it targets both RSV A and RSV B – the two strains of RSV. This vaccine is meant not only for adults ages 60 and older, but also for pregnant people – with the aim of protecting young infants through maternal antibodies. </p>
<p>Data from a phase 3 clinical trial – the last stage of clinical trials before a company would apply for a license – shows that when given during pregnancy, the Pfizer vaccine was 82% effective in <a href="https://doi.org/10.1056/NEJMoa2216480">protecting infants less than 3 months old against severe RSV infection</a>. The FDA will be making a determination on <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-grants-priority-review-pfizers-rsv-vaccine-2022-12-07/">the Pfizer vaccine for older adults</a> later in May 2023 and <a href="https://www.pfizer.com/news/press-release/press-release-detail/us-fda-accepts-biologics-license-application-pfizers">for pregnant people</a> in August 2023. The CDC advisory committee is scheduled to discuss vaccine recommendations in October 2023, making this the likely next possible vaccine available.</p>
<p>A few other biopharmaceutical companies have developed alternative RSV vaccines, some of which are in phase 3 clinical trials. For example, Moderna has an mRNA vaccine against RSV with <a href="https://investors.modernatx.com/news/news-details/2023/Moderna-Announces-mRNA-1345-an-Investigational-Respiratory-Syncytial-Virus-RSV-Vaccine-Has-Met-Primary-Efficacy-Endpoints-in-Phase-3-Trial-in-Older-Adults/default.aspx">promising preliminary results</a>. Regardless of which companies make it to the finish line next, it is clear that in the near future there will be a variety of new tools to help protect against RSV infection.</p><img src="https://counter.theconversation.com/content/205111/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Annette Regan receives funding from the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the US Centers for Disease Control and Prevention, and the Pan American Health Organization.</span></em></p>The newly approved RSV vaccine could be rolled out by fall 2023, in time for the typical winter surge in RSV infections.Annette Regan, Associate Professor of Epidemiology, University of San FranciscoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1896102022-09-01T12:25:45Z2022-09-01T12:25:45ZWill omicron-specific booster shots be more effective at combating COVID-19? 5 questions answered<figure><img src="https://images.theconversation.com/files/482134/original/file-20220831-4878-mt0k59.jpg?ixlib=rb-1.1.0&rect=53%2C116%2C6000%2C3853&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">In a matter of days, eligible people will be lining up to receive the newly formulated booster shot.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/vaccination-center-royalty-free-image/1358994941?adppopup=true">filadendron/E+ via Getty Images</a></span></figcaption></figure><p><em>On Sept. 1, 2022, the Centers for Disease Control and Prevention <a href="https://www.cdc.gov/media/releases/2022/s0901-covid-19-booster.html">endorsed the use of updated COVID-19 booster shots</a> that are specifically tailored to combat the two most prevalent <a href="https://doi.org/10.1136/bmj.o1969">omicron subvariants, BA.4 and BA.5</a>. The decision comes just a day after the <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use">Food and Drug Administration’s emergency use authorization of the shots</a>. The CDC’s backing will enable a full roll-out of the reformulated vaccines to begin within days.</em> </p>
<p><em>The new booster shots – one by Moderna and another from Pfizer-BioNTech – come as more than <a href="https://www.nytimes.com/interactive/2021/us/covid-cases.html">450 people are still dying of COVID-19 every day in the U.S</a>.</em> </p>
<p><em>As of Aug. 31, 2022, only <a href="https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-additional-dose-totalpop">48.5% of booster-eligible people in the U.S. have received their first booster shot</a>, and just under 34% of those eligible have received their second. These low numbers may in part be influenced by <a href="https://theconversation.com/should-you-get-a-covid-19-booster-shot-now-or-wait-until-fall-two-immunologists-help-weigh-the-options-184809">people waiting for the newer versions of the vaccines</a> to provide better protection. But booster shots have proven to be an <a href="https://theconversation.com/low-vaccine-booster-rates-are-now-a-key-factor-in-covid-19-deaths-and-racial-disparities-in-booster-rates-persist-187272">essential layer of protection against COVID-19</a>.</em> </p>
<p><em><a href="https://scholar.google.com/citations?user=jJVj3sUAAAAJ&hl=en">Prakash Nagarkatti</a> and <a href="https://scholar.google.com/citations?user=af7TahQAAAAJ&hl=en">Mitzi Nagarkatti</a> are immunologists who study infectious disorders and how vaccines trigger different aspects of the immune system to fight infection. They weigh in on how the updated booster shots train the immune system and how protective they might be against COVID-19.</em> </p>
<h2>1. What is different about the updated booster shots?</h2>
<p>The newly authorized shots are the first updates to the original COVID-19 vaccines that were introduced in late 2020. They use the same <a href="https://theconversation.com/how-mrna-vaccines-from-pfizer-and-moderna-work-why-theyre-a-breakthrough-and-why-they-need-to-be-kept-so-cold-150238">mRNA technology as the original vaccines</a>. The key difference between the original COVID-19 shots and the new “bivalent” version is that the latter consists of a mixture of mRNA that encodes the <a href="https://doi.org/10.1038/s41401-020-0485-4">spike proteins</a> of both the original SARS-CoV-2 virus and the more <a href="https://doi.org/10.1136/bmj.o1969">recent omicron subvariants, BA.4 and BA.5</a>.</p>
<p>As of late August 2022, the BA.4 and BA.5 omicron subvariants are dominant worldwide. <a href="https://covid.cdc.gov/covid-data-tracker/#variant-proportions">In the U.S., currently</a> 89% of COVID-19 infections are caused by BA.5 and 11% are caused by BA.4.</p>
<p>The inability of the original vaccine strains to prevent reinfection and <a href="https://theconversation.com/how-long-does-protective-immunity-against-covid-19-last-after-infection-or-vaccination-two-immunologists-explain-177309">to trigger long-term protective immunity</a> prompted the need for the reformulated vaccines.</p>
<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/1872722022-08-30T12:19:19Z2022-08-30T12:19:19ZLow vaccine booster rates are now a key factor in COVID-19 deaths – and racial disparities in booster rates persist<figure><img src="https://images.theconversation.com/files/480642/original/file-20220823-11-gs3akm.jpg?ixlib=rb-1.1.0&rect=77%2C0%2C8660%2C5691&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">As of August 2022, COVID-19 vaccination rates in Black and Hispanic people exceeded those of white Americans nationally, but only for the initial shots.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/getting-vaccinated-royalty-free-image/1363894755?adppopup=true">FatCamera/E+ via Getty Images</a></span></figcaption></figure><p>More than 450 people are <a href="https://www.nytimes.com/interactive/2021/us/covid-cases.html">dying of COVID-19 in the U.S. each day</a> as of late August 2022.</p>
<p>When COVID-19 vaccines first became available, public officials, community organizations and policymakers mobilized to get shots into arms. These efforts included <a href="https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/vaccine-equity.html">significant investments</a> in making vaccines accessible to <a href="https://www.whitehouse.gov/briefing-room/statements-releases/2021/03/25/fact-sheet-biden-administration-announces-historic-10-billion-investment-to-expand-access-to-covid-19-vaccines-and-build-vaccine-confidence-in-hardest-hit-and-highest-risk-communities/">Black, Hispanic, American Indian and Alaska Native populations</a>. These groups experienced exceptionally high <a href="https://www.cdc.gov/mmwr/volumes/71/wr/mm7117e2.htm">COVID-19 death rates early in the pandemic</a> and had <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7006e3.htm?s_cid=mm7006e3_w">low initial vaccine rates</a>.</p>
<p>The <a href="https://www.cdc.gov/mmwr/volumes/71/wr/mm7123a2.htm">efforts worked</a>. As of August 2022, vaccination rates for the <a href="https://covid.cdc.gov/covid-data-tracker/#vaccination-demographics-trends">primary series – or required initial doses of COVID-19 vaccines – for Black and Hispanic people</a> exceeded those of white Americans.</p>
<p>But boosters are a different story. Comparable booster vaccine promotion efforts <a href="https://theconversation.com/should-you-get-a-covid-19-booster-shot-now-or-wait-until-fall-two-immunologists-help-weigh-the-options-184809">have been lacking</a>. <a href="https://www.theatlantic.com/health/archive/2022/04/cdc-covid-vaccine-booster-campaign/629536/">Confusion</a> in the public health messaging surrounding boosters and <a href="https://www.theguardian.com/us-news/2022/mar/27/us-second-covid-booster-delays-funding">limited federal funding</a> for rolling out vaccination campaigns have resulted in <a href="https://www.washingtonpost.com/politics/2022/04/18/us-booster-gap/">slow booster uptake</a> across the country. </p>
<p>As a result, divides have once again emerged. A recent <a href="https://doi.org/10.1001/jamanetworkopen.2022.27680">study of COVID-19 booster rates</a> found that 45% of white adults and 52% of Asian American adults had received boosters by January 2022. But only 29% of Black adults and 31% of adults who reported another racial or ethnic identity, such as American Indian, Alaska Native, Native Hawaiian, Pacific Islander or multiracial, were boosted. </p>
<p>As of late August 2022, the U.S. <a href="https://covid.cdc.gov/covid-data-tracker/#vaccination-demographics-trends">Centers for Disease Control and Prevention reported</a> that 36.3% of white adults in the U.S. 50 years or older and eligible for a second booster shot had received one. This is compared to only 28.4% for the Black population, 31.3% for American Indian or Alaska Native populations, and 25.1% for the Hispanic population. </p>
<p>New boosters aimed at the <a href="https://www.nytimes.com/article/covid-omicron-booster.html?">currently dominant omicron subvariant</a> are expected to become available <a href="https://www.nytimes.com/2022/08/23/us/politics/covid-booster-shots-biden.html">in early September 2022</a>. But the benefits of this new booster will be limited if it is not widely used. </p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/rRyIDCo0-Rc?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">The new variant-specific boosters are expected to be available in September 2022.</span></figcaption>
</figure>
<h2>Booster rates predict mortality rates across counties</h2>
<p>We are a team of population health researchers at <a href="https://www.bu.edu/sph/profile/andrew-stokes/">Boston University</a> and the <a href="https://cla.umn.edu/about/directory/profile/ewf">University of Minnesota</a>. We have been <a href="https://doi.org/10.1371/journal.pmed.1003571">tracking COVID-19 mortality rates</a> since the <a href="https://doi.org/10.1177%2F2378023120980918">beginning of the pandemic</a>. Our team uses demographic methods to identify social and structural factors that influence health and <a href="https://ajph.aphapublications.org/doi/full/10.2105/AJPH.2021.306331">contribute to evidence-based reforms</a> of <a href="https://thehill.com/opinion/healthcare/3572982-hidden-covid-fatalities-show-us-death-investigations-need-reform/">public health and health care systems</a>.</p>
<p>Vaccine studies suggest that adults age 50 and older who receive a booster shot have <a href="https://doi.org/10.1056/NEJMoa2115624">90% lower death rates</a> from COVID-19 than those who receive only the initial vaccine regimen. But the extent to which boosters have translated into health gains at the population level remains unclear. </p>
<p>Preliminary analyses by our team indicate that people in the U.S. living in counties with low booster uptake are dying from COVID-19 at higher rates than people living in counties with high booster uptake. In particular, in comparing the counties in the bottom 10% of booster rates with those in the top 10%, the COVID-19 death rates for residents of the bottom 10% of counties were 64% higher. Our analysis applies to the period from January to June 2022. It also adjusts for residents’ ages.</p>
<p>This difference in death rates may in part reflect the fact that counties with greater booster protection also tend to have higher rates of primary-series vaccination. Nonetheless, these findings suggest that at the population level, booster rates are now a key factor behind COVID-19 deaths. </p>
<p><iframe id="oENt5" class="tc-infographic-datawrapper" src="https://datawrapper.dwcdn.net/oENt5/14/" height="400px" width="100%" style="border: none" frameborder="0"></iframe></p>
<p>A prior study found that vaccination strategies that target high-risk geographical areas <a href="https://doi.org/10.1126/sciadv.abj2099">save more lives than strategies based on age alone</a>. Thus, the evidence suggests that limited federal funding for COVID-19 booster promotion should be sent to geographical areas that are currently reporting high rates of COVID-19 deaths. </p>
<h2>Learning from the community</h2>
<p>An effective booster campaign could build on lessons learned from prior vaccination campaigns. Specifically, this involves <a href="https://time.com/6204470/innovation-covid-19/">bringing vaccines directly to people</a>. From the earliest days of vaccine distribution during the pandemic, partnerships with faith-based organizations, housing communities and trusted community organizations have been <a href="https://doi.org/10.1007%2Fs11524-021-00594-3">successful in reaching populations with low vaccination rates</a>. </p>
<p>Other strategies to make boosters <a href="https://www.cdc.gov/vaccines/covid-19/downloads/vaccination-strategies.pdf">more accessible</a> include increasing access to vaccine centers via public transit and outside of typical working hours. In rural areas, <a href="https://doi.org/10.1093%2Fofid%2Fofab152">evidence-based strategies</a> to promote vaccination include education of community ambassadors, use of social media and operation of mobile vaccination sites. </p>
<p>In the absence of federal funding, community efforts have aimed to make boosters more accessible. A New Yorker documentary filmed in 2021 explored the <a href="https://www.newyorker.com/culture/the-new-yorker-documentary/an-alabama-womans-neighborly-vaccination-campaign">challenges that one rural community in Alabama</a> – Panola – has faced with vaccination. It highlights community leader Dorothy Oliver as she promotes vaccination with little to no support from the government. Her efforts included door-to-door campaigns, discussions with residents about their fears and concerns and coordination of vaccination logistics, including scheduling and transport. </p>
<p>In a similar way, Minneapolis’ Seward Vaccine Equity Project <a href="https://www.healthaffairs.org/do/10.1377/forefront.20220518.186581/">increased booster shots among East African immigrant families</a> by having volunteers call members of their own communities and offer them a booster appointment and a ride. The volunteers were also available to answer residents’ questions and address any concerns. Successful efforts like those could be carried out by health departments on a much wider scale.</p><img src="https://counter.theconversation.com/content/187272/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Andrew Stokes receives funding from the Robert Wood Johnson Foundation, the W.K. Kellogg Foundation, and the National Institute on Aging. </span></em></p><p class="fine-print"><em><span>Elizabeth Wrigley-Field is a member of the Seward Vaccine Equity Project, discussed in the article. She receives funding from the Eunice Kennedy Shriver National Institute on Child Health and Human Development via the Minnesota Population Center and from the National Institute on Aging via the Life Course Center, both at the University of Minnesota.</span></em></p><p class="fine-print"><em><span>Dielle Lundberg and Rafeya Raquib do not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Early on, public health messaging focused on the need for vaccines to combat COVID-19. But far less attention has been given to the role of boosters in preventing deaths and reducing inequities.Andrew Stokes, Assistant Professor of Global Health, Boston UniversityDielle Lundberg, Research Fellow in Global Health, Boston UniversityElizabeth Wrigley-Field, Assistant Professor of Sociology, University of MinnesotaRafeya Raquib, Research Fellow in Global Health, Boston UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1869592022-08-02T17:03:19Z2022-08-02T17:03:19ZCOVID: antiviral drugs are a vital weapon – but misusing them could backfire<figure><img src="https://images.theconversation.com/files/476314/original/file-20220727-23-hqa3mh.jpg?ixlib=rb-1.1.0&rect=8%2C0%2C5551%2C3700&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/female-taking-paxlovid-prescription-treating-covid19-2161258693">MargJohnsonVA/Shutterstock</a></span></figcaption></figure><p>The “<a href="https://www.gov.uk/government/publications/covid-19-response-living-with-covid-19">living with COVID</a>” strategy being pursued by many countries relies heavily on two key pillars. First, that vaccines continue to protect most people from severe disease. And second, that where they don’t, people will receive antiviral treatments. But are the antivirals currently available sufficiently effective, accessible and durable?</p>
<p>Research advances in the realm of antiviral therapies since the pandemic began have been considerable. At the same time, no medicine is perfect. The concern is that if not deployed properly, the effectiveness and longevity of antiviral treatments may be compromised.</p>
<p>So let’s take a look at what’s in the antivirals arms locker, and how we got to this point.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/covid-who-recommends-two-new-treatments-heres-how-they-work-175004">COVID: WHO recommends two new treatments – here's how they work</a>
</strong>
</em>
</p>
<hr>
<p>In 2020, the priority was <a href="https://www.embopress.org/doi/full/10.15252/emmm.202013105">drug repurposing</a> (identifying medicines for other conditions that might also benefit COVID patients). Success with drugs like <a href="https://www.nejm.org/doi/full/10.1056/nejmoa2021436">dexamethasone</a> followed. This is a steroid which counters the inflammation that occurs as a result of the body’s overactive immune response during severe COVID.</p>
<p>Things didn’t go as smoothly for direct-acting antivirals, a group of drugs that target the virus directly to suppress infection. So desperate was the situation early in the pandemic that agents like <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2022926">hydroxychloroquine</a> and <a href="https://jamanetwork.com/journals/jama/fullarticle/2777389/">ivermectin</a> were tested in clinical trials and, predictably, were found wanting.</p>
<p>One <a href="https://www.sciencedirect.com/science/article/pii/S2211124720309219">promising candidate</a>, however, did emerge during 2020. Remdesivir is a ribonucleotide analogue (or “nuc”) that mimics the building blocks of the virus’ genetic material. It poisons the copying process by not allowing further links to be added to RNA chains. Remdesivir was first developed as a potential cure for <a href="https://journals.sagepub.com/doi/10.1177/13596535221082773">hepatitis C</a>.</p>
<p>Despite working well against SARS-CoV-2 (the virus that causes COVID) in <a href="https://www.sciencedirect.com/science/article/pii/S2211124720309219">pre-clinical settings</a>, <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2007764?query=featured_home">initial trials</a> in patients with severe COVID <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00519-0/fulltext">were conflicted</a>. </p>
<p>We now know that COVID can progress fairly quickly from a virus-driven disease to the severe <a href="https://www.frontiersin.org/articles/10.3389/fimmu.2021.602848/full">sepsis-like</a> <a href="https://jamanetwork.com/journals/jama/fullarticle/2769290">consequences</a> of a misfiring immune response. So direct-acting antivirals must be deployed early. A trial where remdesivir was given to high-risk patients <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2116846">soon after infection</a> found an 87% reduced risk of hospitalisation or death compared with a placebo.</p>
<figure class="align-center ">
<img alt="An illustration of SARS-CoV-2, the coronavirus that causes COVID-19." src="https://images.theconversation.com/files/476542/original/file-20220728-26342-p6nmim.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/476542/original/file-20220728-26342-p6nmim.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=338&fit=crop&dpr=1 600w, https://images.theconversation.com/files/476542/original/file-20220728-26342-p6nmim.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=338&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/476542/original/file-20220728-26342-p6nmim.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=338&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/476542/original/file-20220728-26342-p6nmim.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=424&fit=crop&dpr=1 754w, https://images.theconversation.com/files/476542/original/file-20220728-26342-p6nmim.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=424&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/476542/original/file-20220728-26342-p6nmim.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=424&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Direct-acting antivirals need to be given early to be effective against SARS-CoV-2.</span>
<span class="attribution"><span class="source">Kateryna Kon/Shutterstock</span></span>
</figcaption>
</figure>
<p>Another nuc, molnupiravir, becomes incorporated within RNA chains, generating a drug-laden template that corrupts the next copy. Before the pandemic, <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8277160/">molnupiravir</a> had been explored for <a href="https://www.nature.com/articles/d41573-021-00202-8">influenza and other viruses</a>. Against COVID, it reduced the risk of hospitalisation and death, but only by <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2116044">roughly 30%</a>, despite performing well in <a href="https://www.nature.com/articles/s41586-021-03312-w">lab settings</a>.</p>
<p>Paxlovid, produced by Pfizer, combines two different drugs. Nirmatrelvir, a modified version of an antiviral originally developed <a href="https://www.science.org/doi/10.1126/science.abl4784?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed">for SARS</a>, prevents the virus from replicating. </p>
<p><a href="https://pubmed.ncbi.nlm.nih.gov/25274602/">Ritonavir</a> is not an antiviral, but a <a href="https://pubmed.ncbi.nlm.nih.gov/15523003/">potent inhibitor</a> of the liver metabolism, allowing nirmatrelvir to persist for longer in the body and act more efficiently. In trials, Paxlovid saw <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2118542">a reduction</a> in hospitalisations and deaths similar to remdesivir. </p>
<p>Paxlovid and molnupiravir are taken orally, whereas remdesivir is administered intravenously. The <a href="https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/covid-19-treatments">approval statuses</a> of these direct-acting antivirals varies in different regions, though remdesivir and Paxlovid are available fairly widely. While all three drugs are conditionally approved and currently available in the UK, the availability of molnupiravir is more limited around the world.</p>
<h2>Who can access antivirals?</h2>
<p>Although vaccines have changed things for the better, multiple <a href="https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html">health conditions</a> <a href="https://www.nhs.uk/conditions/coronavirus-covid-19/coronavirus-vaccination/health-conditions/">remain associated</a> with higher risk from COVID, and a suboptimal immune response to vaccination. This is why the UK and other countries are primarily directing antivirals towards people who are vulnerable.</p>
<p>You may be prescribed antivirals if you’re hospitalised with COVID (or catch it in hospital). People in the community can access antiviral treatments if they have a specific medical condition which classifies them as <a href="https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAttachment.aspx?Attachment_id=103996">extremely vulnerable</a>.</p>
<p>Patient groups and charities have raised <a href="https://www.independent.co.uk/news/health/covid-antiviral-nhs-treatment-latest-b2047467.html">concerns</a> about the limited eligibility criteria in the UK, which are narrower than the criteria were for <a href="https://www.nhs.uk/conditions/coronavirus-covid-19/coronavirus-vaccination/coronavirus-vaccine-people-with-severely-weakened-immune-system/">three initial vaccine doses</a> and <a href="https://www.gov.uk/government/publications/guidance-on-shielding-and-protecting-extremely-vulnerable-persons-from-covid-19">shielding</a>.</p>
<p>Alternatively, the <a href="https://www.panoramictrial.org/?92a48870-08d3-11ed-a9c5-0a99519f5684">Panoramic</a> trial, now managed through a network of <a href="https://www.panoramictrial.org/participating-sites">GPs</a>, accepts people over 50, or younger people with certain <a href="https://www.panoramictrial.org/participant-information">medical conditions</a>. However, patients have a 50:50 chance of receiving Paxlovid or molnupiravir versus a placebo.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1489285991928111104"}"></div></p>
<h2>Should we broaden access?</h2>
<p>Increasing eligibility criteria for antivirals would favourably impact upon many vulnerable people’s lives, providing a safety net to allow safer interaction with society. Notwithstanding the results from the <a href="https://www.panoramictrial.org/?92a48870-08d3-11ed-a9c5-0a99519f5684">Panoramic</a> trial, it may also reduce deaths and severe disease.</p>
<p>But viruses, especially RNA viruses, can develop resistance to single-agent drugs. While relatively rare, it can become established. For example, we saw this with HIV when it was treated with the first antiretroviral drug, <a href="https://ccr.cancer.gov/news/landmarks/article/first-aids-drugs">AZT</a>.</p>
<p>Remdesivir, molnupiravir and Paxlovid are all single agents (although Paxlovid is made up of two components, only one is an antiviral).</p>
<p>SARS-CoV-2 has developed <a href="https://journals.plos.org/plospathogens/article?id=10.1371/journal.ppat.1009929">resistance</a> to remdesivir <a href="https://www.science.org/doi/10.1126/scitranslmed.abo0718">in the lab</a>. But at this stage, despite widespread hospital use, real-world resistance <a href="https://pubmed.ncbi.nlm.nih.gov/35033572/">remains low</a>.</p>
<p>We’ve seen reports of viral <a href="https://pharmaceutical-journal.com/article/opinion/sars-cov2-antivirals-are-essential-but-they-are-not-silver-bullets">relapse</a> or <a href="https://emergency.cdc.gov/han/2022/pdf/CDC_HAN_467.pdf">rebound</a> (testing positive to COVID again after direct-acting antiviral treatment) with <a href="https://pubmed.ncbi.nlm.nih.gov/35794889/">Paxlovid and molnupiravir</a>. This could be <a href="https://www.biorxiv.org/content/10.1101/2022.06.07.495116v1">explained by</a> <a href="https://www.biorxiv.org/content/10.1101/2022.06.06.494921v1">transient resistance</a>, or <a href="https://pharmaceutical-journal.com/article/opinion/sars-cov2-antivirals-are-essential-but-they-are-not-silver-bullets">delayed immune responses</a>, but we don’t know. Pfizer has reported that relapse also occurred <a href="https://www.forbes.com/sites/brucelee/2022/05/19/paxlovid-rebound-some-suffering-covid-19-relapses-after-taking-pfizer-antiviral/?sh=7a91bafcb8e4">in control groups</a> (those in the study not taking the drug for comparison) during Paxlovid trials.</p>
<p>Importantly, viruses are significantly <a href="https://journals.asm.org/doi/full/10.1128/mbio.03044-21">less likely</a> to develop resistance to direct-acting antiviral combinations.</p>
<h2>Expanding our antiviral repertoire</h2>
<p>We are fortunate to have safe and effective vaccines and therapeutics that lower individual risks of severe COVID. However, our fruitful repurposing of direct-acting antivirals risks being undermined by overuse.</p>
<p>Other <a href="https://www.nature.com/articles/d41573-021-00202-8">agents</a> including <a href="https://www.ukri.org/about-us/policies-standards-and-data/data-collection/uk-covid-19-therapeutics-advisory-panel/recommended-treatments-for-clinical-trials/">favipiravir</a> (an anti-influenza nuc) and <a href="https://www.nature.com/articles/s41467-021-26760-4#:%7E:text=Remdesivir%20is%20an%20antiviral%20approved,administration%20to%20non%2Dhospitalized%20patients.">oral remdesivir</a> are in the trial pipeline, and may prove useful. Research into new agents should be a priority and <a href="https://journals.asm.org/doi/full/10.1128/mbio.03044-21">combinations of existing agents</a> should be urgently explored. Continuing with just three approved drugs would be short-sighted. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/developing-antiviral-drugs-is-not-easy-heres-why-159512">Developing antiviral drugs is not easy – here's why</a>
</strong>
</em>
</p>
<hr>
<p>The capacity for SARS-CoV-2 evolution is troubling, and will likely blindside us again in the future. Direct-acting antivirals should form an integral part of a <a href="https://www.bmj.com/content/376/bmj.o1">multi-layered mitigation strategy</a> in current and future pandemics.</p><img src="https://counter.theconversation.com/content/186959/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Stephen Griffin is a member of Independent SAGE.</span></em></p>We hear a lot about drug-resistant bacteria. The same thing can happen with viruses.Stephen Griffin, Associate Professor of Viral Oncology, University of LeedsLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1852152022-07-19T02:56:18Z2022-07-19T02:56:18ZCOVID vaccines for children under 5 are almost here. Here’s what parents need to know<figure><img src="https://images.theconversation.com/files/470496/original/file-20220623-51812-40p93u.jpg?ixlib=rb-1.1.0&rect=2%2C1%2C995%2C661&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/portrait-cute-happy-8-month-old-213114688">Shutterstock</a></span></figcaption></figure><p>COVID vaccines for children as young as six months look set to be available in the coming months, now the Therapeutic Goods Administration has <a href="https://www.tga.gov.au/media-release/tga-provisionally-approves-moderna-covid-19-vaccine-spikevax-use-children-6-months">approved</a> the Moderna vaccine for babies and young children.</p>
<p>The vaccine has been approved for children aged six months to five years. However, we need to wait for advice from the Australian Technical Advisory Group on Immunisation (ATAGI) to provide further scientific advice and recommendations around an immunisation program. Given no vaccines are currently manufactured in Australia, we will also need to wait for availability of supply before the program can commence.</p>
<p>Australia’s approval of the Moderna vaccine for this age group follows a <a href="https://www.cdc.gov/media/releases/2022/s0618-children-vaccine.html">similar move</a> in the United States in June.</p>
<p>Here’s what parents need to know ahead of Australia’s rollout of the Moderna vaccine to these younger children, the last remaining age group to receive COVID vaccines.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/covid-19-in-babies-heres-what-to-expect-181940">COVID-19 in babies – here's what to expect</a>
</strong>
</em>
</p>
<hr>
<h2>Why vaccinate this age group?</h2>
<p>COVID case numbers are still high. So with the threat of <a href="https://theconversation.com/why-are-there-so-many-new-omicron-sub-variants-like-ba-4-and-ba-5-will-i-be-reinfected-is-the-virus-mutating-faster-182274">Omicron sub-variants</a> and other potential variants, expansion of COVID vaccines to young children will be a welcome relief for many concerned parents and families.</p>
<p>Children are less likely to have severe outcomes or complications from COVID compared with adults. However, they continue to experience <a href="https://www.health.gov.au/health-alerts/covid-19/case-numbers-and-statistics">high levels of infection</a>. This disrupts their schooling, childcare and other activities. When they are sick, their parents need to take time off work to care for them.</p>
<p>Severe disease can also happen in <a href="https://www.nature.com/articles/s41467-022-29951-9">previously healthy children</a>, and not just in children at higher risk because of underlying medical conditions.</p>
<p>While the total number of admissions to hospital from COVID infection in children is small, <a href="https://www.ncirs.org.au/covid-19-in-schools">a large proportion</a> of these have been children under five years. </p>
<p>That’s because they are more likely to need supportive care, such as observation and hydration, than older children.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/470494/original/file-20220623-51865-ah9l7b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Preschoolers playing at daycare with blocks at table" src="https://images.theconversation.com/files/470494/original/file-20220623-51865-ah9l7b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/470494/original/file-20220623-51865-ah9l7b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=443&fit=crop&dpr=1 600w, https://images.theconversation.com/files/470494/original/file-20220623-51865-ah9l7b.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=443&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/470494/original/file-20220623-51865-ah9l7b.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=443&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/470494/original/file-20220623-51865-ah9l7b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=557&fit=crop&dpr=1 754w, https://images.theconversation.com/files/470494/original/file-20220623-51865-ah9l7b.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=557&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/470494/original/file-20220623-51865-ah9l7b.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=557&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">When preschoolers are sick, they lose opportunities to learn and play with their friends.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/nursery-children-playing-teacher-classroom-1241605294">Shutterstock</a></span>
</figcaption>
</figure>
<p>Children are also at risk of a severe COVID complication known as <a href="https://theconversation.com/more-than-100-australian-kids-have-had-multisystem-inflammatory-syndrome-after-covid-what-should-parents-watch-for-183533">multi-system inflammatory syndrome</a>. This requires admission to hospital and possibly the intensive care unit. We know <a href="https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-05-19/02-COVID-Link-Gelles-508.pdf">vaccination protects</a> children from this life-threatening condition.</p>
<p>The long-term effects and implications of COVID in children are also still not fully understood. Long COVID appears to be much less common in children than in adults, occurring in <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8575095/">less than 2–3%</a> of children. So, prevention of infection in children is still a priority.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/do-kids-get-long-covid-and-how-often-a-paediatrician-looks-at-the-data-166277">Do kids get long COVID? And how often? A paediatrician looks at the data</a>
</strong>
</em>
</p>
<hr>
<h2>My child’s had COVID. Do they still need a shot?</h2>
<p>Many parents may be unsure of the benefit of vaccines if their child has already had COVID, especially if they weren’t that unwell. </p>
<p>However, the World Health Organization <a href="https://www.who.int/news/item/01-06-2022-interim-statement-on-hybrid-immunity-and-increasing-population-seroprevalence-rates">says</a> protection from vaccinating someone who has already caught COVID (known as providing hybrid immunity) is stronger than that provided by either vaccination or infection alone.</p>
<p>Importantly, hybrid immunity offers <a href="https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(22)00143-8/fulltext">superior protection</a> against severe COVID compared with infection-induced or vaccine-induced immunity alone. However, it is unclear whether this hybrid immunity will persist with new variants.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/if-ive-already-had-covid-do-i-need-a-vaccine-and-how-does-the-immune-system-respond-an-expert-explains-164236">If I've already had COVID, do I need a vaccine? And how does the immune system respond? An expert explains</a>
</strong>
</em>
</p>
<hr>
<h2>The wider family and community benefit too</h2>
<p>The benefits of vaccination extend beyond direct protection. The mRNA vaccines (Moderna, Pfizer) <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2116597">reduce transmission</a> of SARS-CoV-2, the virus that causes COVID, although less so with the Omicron variant.</p>
<p>Nevertheless, the vaccines remain an important way to protect both young children and those around them.</p>
<p>They can help to ensure young kids can still go to kindergarten, play with their friends, travel and visit their grandparents.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/471745/original/file-20220630-14-3x0m57.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Grandmother cuddling young grandson, nose to cheek" src="https://images.theconversation.com/files/471745/original/file-20220630-14-3x0m57.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/471745/original/file-20220630-14-3x0m57.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/471745/original/file-20220630-14-3x0m57.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/471745/original/file-20220630-14-3x0m57.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/471745/original/file-20220630-14-3x0m57.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/471745/original/file-20220630-14-3x0m57.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/471745/original/file-20220630-14-3x0m57.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Vaccinated young children protects vulnerable people around them.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/happy-loving-family-grandmother-grandson-having-1987660103">Shutterstock</a></span>
</figcaption>
</figure>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/should-my-child-have-a-covid-vaccine-heres-what-can-happen-when-parents-disagree-174395">Should my child have a COVID vaccine? Here's what can happen when parents disagree</a>
</strong>
</em>
</p>
<hr>
<h2>Does the vaccine work?</h2>
<p>The Moderna vaccine is available for children from six months to five years, with two doses needed to complete the course. </p>
<p>The dose is one-quarter of the adult dose (25 micrograms instead of 100 micrograms), and should be given at least four weeks apart. </p>
<p>The Moderna clinical trials demonstrated adequate vaccine effectiveness in younger infants and children. <a href="https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-06-17-18/04-COVID-Das-508.pdf">It showed</a> a 51% effectiveness against COVID infection in children between six months to two years, and 37% effectiveness in children between two and five years.</p>
<p>It’s too soon to say how much protection vaccination will protect preschoolers against multi-system inflammatory syndrome, but we do expect some protection.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/more-than-100-australian-kids-have-had-multisystem-inflammatory-syndrome-after-covid-what-should-parents-watch-for-183533">More than 100 Australian kids have had multisystem inflammatory syndrome after COVID. What should parents watch for?</a>
</strong>
</em>
</p>
<hr>
<h2>Is the vaccine safe?</h2>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/471749/original/file-20220630-22-f3ya3j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Health worker putting on bandaid on upper arm of young child after vaccination" src="https://images.theconversation.com/files/471749/original/file-20220630-22-f3ya3j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/471749/original/file-20220630-22-f3ya3j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/471749/original/file-20220630-22-f3ya3j.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/471749/original/file-20220630-22-f3ya3j.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/471749/original/file-20220630-22-f3ya3j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/471749/original/file-20220630-22-f3ya3j.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/471749/original/file-20220630-22-f3ya3j.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">The most common side effects include a painful arm, mild fever, headache and tiredness.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/doctor-puts-patch-on-childs-shoulder-2094936937">Shutterstock</a></span>
</figcaption>
</figure>
<p>Of course, we need to balance the benefits with any risks, and all vaccines have side effects. </p>
<p>In both <a href="https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-06-22-23/03-COVID-Shimabukuro-508.pdf">real-world data and clinical trials</a>, the number and rate of reports of side effects from COVID vaccines in young children are lower than for adults.</p>
<p>Most of the common and expected side effects in young children occur in the first 24–48 hours and include a fever, painful arm, headache and tiredness.</p>
<p>There were <a href="https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-06-17-18/06-COVID-Oliver-508.pdf">no serious adverse events</a> such as myocarditis (heart inflammation), anaphylaxis (life-threatening immune reaction) or multi-system inflammatory syndrome detected during the clinical trials for this age group for either vaccine.</p>
<p>There are also no currently detected longer-term safety concerns with mRNA vaccines in the paediatric age group.</p>
<p>Once the COVID vaccines are available for this age group, side effects will be monitored and documented through <a href="https://ausvaxsafety.org.au">AusVaxSafety</a> and other surveillance systems, as they have been for <a href="https://ausvaxsafety.org.au/covid-19-vaccines/pfizer-covid-19-vaccine-paediatric-formulation-5-11-years">other age groups</a>, and other childhood vaccines.</p>
<hr>
<p><em>Reliable information about COVID vaccines for children is available from the <a href="https://mvec.mcri.edu.au/references/covid-19-vaccination-in-children/">Melbourne Vaccine Education Centre</a>, the Australian <a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/who-can-get-vaccinated">department of health</a> and your child’s GP.</em></p><img src="https://counter.theconversation.com/content/185215/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Margie Danchin receives funding from Commonwealth and State Governments, NHMRC, DFAT and WHO. She is chair, Collaboration in Social Science and Immunisation (COSSI). </span></em></p><p class="fine-print"><em><span>Daryl Cheng does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>It’s natural to have questions about the risks and benefits of COVID vaccines in young children. Here’s what you need to know ahead of Australia’s rollout.Daryl Cheng, Consultant Paediatrician & Medical Lead, Melbourne Vaccine Education Centre, Murdoch Children's Research InstituteMargie Danchin, Paediatrician at the Royal Childrens Hospital and Associate Professor and Clinician Scientist, University of Melbourne and MCRI, Murdoch Children's Research InstituteLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1859202022-07-05T14:45:41Z2022-07-05T14:45:41ZCOVID vaccines: our current shots could soon be updated to target new variants – an immunology expert explains<figure><img src="https://images.theconversation.com/files/472492/original/file-20220705-26-7sobc3.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C6243%2C4364&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/coronavirus-prevention-treatment-concept-senior-female-1897703164">Prostock-studio/Shutterstock</a></span></figcaption></figure><p>More than two years into the pandemic, SARS-CoV-2, the virus that causes COVID-19, continues to challenge us. Its ability to rapidly mutate has seen the evolution of increasingly infectious variants that are getting better at hiding from our immune response.</p>
<p>Vaccines are a huge achievement of modern-day science and have played a crucial role in reducing the very worst impacts of COVID. But are the vaccines we currently have able to deal with the newest COVID variants?</p>
<p>The current COVID vaccines are all based on the genetic building blocks, or the <a href="https://virological.org/t/novel-2019-coronavirus-genome/319">DNA sequence</a>, of the original ancestral strain of SARS-CoV-2. The majority of these vaccines target the spike protein – the part of the virus that attaches to our cells to gain entry. </p>
<p>The vaccines work by enabling our immune cells to mount a targeted response to the spike protein, including generating antibodies known as neutralising antibodies. These stop viruses getting into our cells, and help other immune cells find and destroy any viral intruders.</p>
<p>But SARS-CoV-2 is a slippery customer and has been mutating with notable changes to the <a href="https://github.com/cov-lineages/pango-designation/issues/773">spike protein</a>. That means those vaccine-induced neutralising antibodies are less effective than they once were.</p>
<h2>Is it time for a new generation of COVID vaccines?</h2>
<p>The idea to vaccinate against variants rather than the ancestral strain is gaining traction. This is not a new concept in vaccine development. Our annual flu shots, for example, target circulating variants.</p>
<p>One approach is to create what’s called a “bivalent” vaccine that targets the spike protein from omicron (BA.1) as well as the ancestral strain. Moderna is currently testing this option in combined phase 2 and 3 human trials. Data yet to be peer-reviewed suggests this results in around a <a href="https://www.medrxiv.org/content/10.1101/2022.06.24.22276703v1">two-fold increase</a> in neutralising antibodies against BA.1, compared with the original COVID vaccines.</p>
<p>Other Moderna trials are looking at <a href="https://investors.modernatx.com/news/news-details/2022/Moderna-Announces-Clinical-Update-on-Bivalent-COVID-19-Booster-Platform/default.aspx">different bivalent combinations</a>, including vaccines that target the ancestral and beta strains, which look promising. </p>
<p>Pfizer has also released <a href="https://www.statnews.com/2022/06/25/pfizer-says-its-omicron-containing-boosters-outperform-current-vaccine/">trial data</a> on its booster candidate specifically tailored against BA.1. The company says this reformulation induced an immune response to BA.1 superior to that produced by its original COVID vaccine. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/covid-19-vaccine-boosters-is-a-third-dose-really-needed-164125">COVID-19 vaccine boosters: is a third dose really needed?</a>
</strong>
</em>
</p>
<hr>
<p>So should we be investing in these new vaccine candidates? The <a href="https://www.statnews.com/2022/06/29/fda-dont-rush-to-change-covid-19-vaccine-composition/">US Food and Drug Administration</a> seems to think so, having recently approved the use of these omicron-specific shots later this year.</p>
<p>However, investing in and rolling out new vaccines is not cheap, and there are important questions we need to address. As we know, SARS-CoV-2 is ever mutating and changing. It was less than a year ago that the delta strain dominated around the world, and before that we had alpha and beta. So are omicron variants the right ones to be targeting? Will they still be dominant a year from now? We simply don’t know.</p>
<p>Even with omicron strains there is variation. The BA.1 variant that these new vaccine candidates target has recently been outcompeted by <a href="https://twitter.com/Dr_D_Robertson/status/1542854037606961158">BA.4 and BA.5</a>. The BA.4 and BA.5 variants are even more resistant to neutralising antibodies, typically three- or four-fold, than <a href="https://www.gavi.org/vaccineswork/five-things-weve-learned-about-ba4-and-ba5-omicron-variants">BA.1</a>. So the question is, if omicron pervades, would these omicron BA.1 vaccines work better against BA.4 and BA.5 than the original vaccines? Data still to be peer reviewed suggests the bivalent vaccines may be a little <a href="https://www.medrxiv.org/content/10.1101/2022.06.24.22276703v1">better</a> than the original vaccines. </p>
<p>However, omicron may be a poor vaccine candidate as recent data shows that omicron infection doesn’t produce robust immunity and is characterised by low levels of <a href="https://www.science.org/doi/10.1126/science.abq1841">neutralising antibodies</a>, which need to be higher and more persistent to prevent rapid reinfection. This could go a long way to explaining why so many of us are catching COVID multiple times. If we see the same thing with our vaccine-induced immunity to omicron, omicron-specific vaccines may not be a worthwhile investment.</p>
<figure class="align-center ">
<img alt="An illustration of SARS-CoV-2, the coronavirus that causes COVID-19." src="https://images.theconversation.com/files/472498/original/file-20220705-26-k7np96.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/472498/original/file-20220705-26-k7np96.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=338&fit=crop&dpr=1 600w, https://images.theconversation.com/files/472498/original/file-20220705-26-k7np96.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=338&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/472498/original/file-20220705-26-k7np96.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=338&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/472498/original/file-20220705-26-k7np96.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=424&fit=crop&dpr=1 754w, https://images.theconversation.com/files/472498/original/file-20220705-26-k7np96.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=424&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/472498/original/file-20220705-26-k7np96.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=424&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">COVID vaccines target SARS-CoV-2’s spike protein.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-illustration/sarscov2-viruses-binding-ace2-receptors-on-1705841698">Kateryna Kon/Shutterstock</a></span>
</figcaption>
</figure>
<h2>Other strategies</h2>
<p>None of this means we should stop looking for long-term protective vaccines. But perhaps there’s scope to focus on different strategies. Two exciting avenues are emerging. </p>
<p>The first is <a href="https://theconversation.com/covid-why-t-cell-vaccines-could-be-the-key-to-long-term-immunity-174494">vaccines</a> that target other parts of the viral structure that are more stable, or vaccines that target multiple parts of the virus. This might not result in a vaccine that can fully prevent infection, but may be more durable than the current vaccines. </p>
<p>Another avenue involves capitalising on the ability of neutralising antibodies in the nose <a href="https://rupress.org/jem/article/219/7/e20220638/213286/Potent-human-broadly-SARS-CoV-2-neutralizing-IgA">and throat</a> to target SARS-CoV-2 at its point of entry. These antibodies create a barrier that stops the virus getting into the body, so a vaccine that generates neutralising antibodies in the nose and throat could stop the virus in its tracks. Studies trialling <a href="https://www.nature.com/articles/s41577-021-00583-2">nasal vaccines</a> look promising, although these are still at early stages. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/covid-nasal-sprays-could-offer-advantages-over-traditional-vaccines-a-virologist-explains-how-they-work-181371">COVID nasal sprays could offer advantages over traditional vaccines – a virologist explains how they work</a>
</strong>
</em>
</p>
<hr>
<p>Where does this leave us now? An ideal vaccine candidate would elicit long-lived neutralising antibodies and give us life-long immunity. Instead, we’ve learnt that for COVID, our immune system needs boosters to top up those neutralising antibodies and bolster the numbers of memory cells that support immunity.</p>
<p>The last UK-wide booster campaign was in <a href="https://www.gov.uk/government/news/25m-boosters-in-uk-as-public-urged-to-get-boosted-now">December 2021</a>. Studies had shown that COVID vaccination followed by infection lead to <a href="https://www.nature.com/articles/d41586-022-00961-3">months of immunity</a>, but this was before omicron, which we now know doesn’t produce robust <a href="https://www.science.org/doi/10.1126/science.abq1841">immunity</a>. Against omicron, many of us will have minimal neutralising antibodies left.</p>
<p>With the high likelihood of another variant in the <a href="https://www.mrc-bsu.cam.ac.uk/tackling-covid-19/nowcasting-and-forecasting-of-covid-19/">autumn</a>, alongside fears of a <a href="https://www.gov.uk/government/publications/national-flu-immunisation-programme-plan">bad flu season</a>, it would seem prudent to embark on an autumn booster campaign with much wider coverage than the spring campaign. This means not just targeting <a href="https://www.gov.uk/government/news/jcvi-provides-interim-advice-on-an-autumn-covid-19-booster-programme">over 65s and others at higher risk</a> as is currently planned, but extending eligibility to younger age groups. </p>
<p>Crucially we must reach those who are not fully vaccinated, so any campaign should include targeted community education. This should also happen alongside other mitigation strategies like mask-wearing to keep us safe and allow us to live with COVID.</p><img src="https://counter.theconversation.com/content/185920/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Sheena Cruickshank does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Is it time for a new generation of COVID vaccines? Here’s where the research is at.Sheena Cruickshank, Professor in Biomedical Sciences, University of ManchesterLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1848092022-06-27T12:24:39Z2022-06-27T12:24:39ZShould you get a COVID-19 booster shot now or wait until fall? Two immunologists help weigh the options<figure><img src="https://images.theconversation.com/files/470339/original/file-20220622-11-hea4if.jpg?ixlib=rb-1.1.0&rect=58%2C0%2C6562%2C4312&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Clinical studies show that mixing and matching booster vaccines can lead to a more robust immune response.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/doctor-prepares-the-syringe-royalty-free-image/1379312638?adppopup=true">SDI Productions/E+ via Getty Images</a></span></figcaption></figure><p>While COVID-19 vaccines continue to be <a href="https://www.commonwealthfund.org/blog/2022/impact-us-covid-19-vaccination-efforts-march-update">highly effective</a> at preventing hospitalization and death, it has become clear that the protection offered by the current vaccines <a href="https://theconversation.com/how-long-does-protective-immunity-against-covid-19-last-after-infection-or-vaccination-two-immunologists-explain-177309">wanes over time</a>. This necessitates the use of <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html#">booster shots</a> that are safe and effective in enhancing the immune response against the virus and extending protection.</p>
<p>But when to get a first or second booster, and which shot to choose, are open questions. Many people find themselves unsure whether to wait on new, updated formulations of the COVID-19 vaccines or to mix and match combinations of the original vaccine strains. </p>
<p>SARS-CoV-2, the virus that causes COVID-19, uses <a href="https://doi.org/10.1038/s41580-021-00418-x">its knob-shaped spike protein</a> to gain entry into cells and to cause infection. Each of the existing and upcoming vaccines relies on emulating the spike protein to trigger the immune response. However, each vaccine type presents the spike protein to the immune system in different ways. </p>
<p>As <a href="https://scholar.google.com/citations?user=jJVj3sUAAAAJ&hl=en">immunologists</a> studying inflammatory and <a href="https://sc.edu/study/colleges_schools/medicine/about_the_school/faculty-staff/nagarkatti_mitzi.php">infectious diseases</a>, including COVID-19, we are interested in understanding how the COVID-19 vaccine designs differ in the type of immunity they trigger and the protection that results.</p>
<h2>New bivalent vaccines</h2>
<p>Moderna and Pfizer-BioNTech, the two companies whose mRNA vaccines have been the primary options for COVID-19 vaccination across all age groups, both have new vaccine formulations on the way. An advisory committee of the Food and Drug Administration is set to meet on June 28, 2022, to <a href="https://www.statnews.com/2022/06/25/pfizer-says-its-omicron-containing-boosters-outperform-current-vaccine/">evaluate the newest versions</a> and to decide on which are likely to be recommended for use in this fall’s booster shots.</p>
<p>Moderna’s new bivalent vaccine mixes mRNA that encodes for the spike proteins of the original SARS-CoV-2 virus as well as the slightly different spike protein of the <a href="https://www.sciencenews.org/article/covid-coronavirus-omicron-variant-mutation-infectious">more infectious omicron variant</a>. </p>
<p>In early June 2022, Moderna said that in clinical trials, <a href="https://www.npr.org/2022/06/08/1103659340/moderna-vaccine-booster-omicron">its bivalent vaccine outcompetes the original vaccine strain</a>, inducing a stronger immune response and longer protection against the original SARS-CoV-2 and <a href="https://investors.modernatx.com/news/news-details/2022/Moderna-Announces-Omicron-Containing-Bivalent-Booster-Candidate-mRNA-1273.214-Demonstrates-Superior-Antibody-Response-Against-Omicron/default.aspx">its variants, including omicron</a>. </p>
<p>Moderna later announced that its newest formulation also <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-booster-candidate-produces-strong-antibodies-against-omicron-subvariants-2022-06-22/">performs well against the newest omicron subvariants, BA.4 and BA.5</a>, which are quickly becoming the dominant strains in the U.S. Because of the significantly stronger immune response that the new shot induces, Moderna predicts that <a href="https://www.npr.org/2022/06/08/1103659340/moderna-vaccine-booster-omicron">such protection may last a year</a> and plans to <a href="https://www.cbsnews.com/news/covid-vaccine-moderna-omicron-variant-booster-shot-august/">introduce its new vaccine in August</a>. </p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/LXSGUUYAMEo?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">The new Moderna booster could be available by fall 2022.</span></figcaption>
</figure>
<p>And most recently, <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-omicron-adapted-covid-19">on June 25, Pfizer-BioNTech also announced</a> results for its two new COVID-19 vaccine formulations: a bivalent formulation consisting of mRNA that encodes for the spike proteins of the original SARS-CoV-2 strain and the original BA.1 omicron subvariant, and a “monovalent” version that is only directed at the spike protein of BA.1. </p>
<p>The company’s preliminary studies demonstrated that both the monovalent and the bivalent vaccines triggered antibodies that neutralized the newer omicron BA.4 and BA.5 subvariants, although to a lesser degree than the BA.1 subvariant. However, Pfizer’s monovalent vaccine <a href="https://www.statnews.com/2022/06/25/pfizer-says-its-omicron-containing-boosters-outperform-current-vaccine/">triggered better virus-neutralizing antibodies</a> against the omicron BA.1 subvariant than did the bivalent vaccine.</p>
<p>However, whether the differences in the levels of such antibodies seen with the monovalent versus bivalent vaccines translate into different levels of protection against newer omicron variants remains to be established in clinical trials. </p>
<h2>Progress on the Novavax vaccine</h2>
<p>Another vaccine formulation that is working its way toward authorization is Novavax, a vaccine built using the spike protein of the original SARS-CoV-2 virus. The Novavax vaccine has the advantage of being <a href="https://www.science.org/content/blog-post/novavax-vaccine-finally">similar to traditional vaccines</a>, such as the <a href="https://www.cdc.gov/vaccines/hcp/vis/vis-statements/dtap.html">DTaP vaccines against diphtheria, tetanus and pertussis</a>, or the vaccines against other viral infections such as hepatitis and shingles. The Novavax vaccine has been clinically tested in South Africa, the United Kingdom and the U.S. and found to be <a href="https://doi.org/10.1056/NEJMoa2116185">safe and highly effective</a> with <a href="https://www.who.int/news-room/feature-stories/detail/the-novavax-vaccine-against-covid-19-what-you-need-to-know">90% efficacy</a> against mild, moderate and severe forms of COVID-19. </p>
<p>An advisory committee to the Food and Drug Administration <a href="https://www.science.org/content/article/fda-advisers-greenlight-novavax-covid-19-vaccine">endorsed the Novavax vaccine</a> in early June 2022. Now, the FDA is reviewing changes that Novavax made during its manufacturing process before making its decision to authorize the shot.</p>
<p>In Australia, the Novavax vaccine was recently registered provisionally as a booster for individuals aged 18 years and over. The company is <a href="https://ir.novavax.com/Novavax-Initiates-Phase-3-Trial-of-its-COVID-19-Omicron-Strain-Vaccine-as-a-Booster">performing phase 3 clinical trials</a> to determine if its vaccine can be used safely and effectively as a booster in people who have previously taken mRNA vaccines.</p>
<p>When these new vaccines become available in the coming months, people will have significantly more options for mixing and matching vaccines in order to enhance the duration and quality of their immune protection against COVID-19. </p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/WRSStTnrtmw?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Novavax does not need to be frozen, so storage and delivery of the vaccine is much easier.</span></figcaption>
</figure>
<h2>Mixing and matching</h2>
<p>Until then, clinical studies have shown that even <a href="https://theconversation.com/a-mix-and-match-approach-to-covid-19-vaccines-could-provide-logistical-and-immunological-benefits-161974">mixing and matching</a> the existing vaccine types is an effective strategy for boosting. For example, <a href="https://covid19.nih.gov/news-and-stories/mixing-matching-covid-19-vaccine-booster-doses">recent studies</a> suggest that when adults who were fully vaccinated with any of the original three COVID-19 vaccines – Pfizer-BioNTech, Moderna or Johnson & Johnson – received a booster dose with a different vaccine brand from the one they received in their initial series, they had a similar or more robust immune response compared to boosting with the same brand of vaccine.</p>
<p>Vaccine mixing has been <a href="https://doi.org/10.1056/NEJMoa2116414">found to be safe</a> <a href="https://doi.org/10.1016/S0140-6736(21)02717-3">and effective</a> in various studies. The reason why mixing vaccines might produce a more robust immune response goes back to how each one presents the spike protein of the virus to the immune system. </p>
<p>When the SARS-CoV-2 virus mutates in regions of the spike protein, as has been the case with each of the variants and subvariants, and tries to evade the immune cells, antibodies that recognize different parts of the spike protein can stop it in its tracks and prevent the virus from infecting the body’s cells.</p>
<p>So whether you decide to get a booster shot now or wait until the fall, for many it’s heartening to know that more options are on the way.</p><img src="https://counter.theconversation.com/content/184809/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Prakash Nagarkatti receives funding from the National Institutes of Health and the National Science Foundation.</span></em></p><p class="fine-print"><em><span>Mitzi Nagarkatti receives funding from National Institutes of Health</span></em></p>On the horizon: A new omicron-focused version of the Moderna vaccine that may offer longer protection and a stronger immune response.Prakash Nagarkatti, Professor of Pathology, Microbiology and Immunology, University of South CarolinaMitzi Nagarkatti, Professor of Pathology, Microbiology and Immunology, University of South CarolinaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1812352022-06-05T12:22:00Z2022-06-05T12:22:00ZWe still need a vaccine patent waiver, but not the one on offer at the World Trade Organization meeting<figure><img src="https://images.theconversation.com/files/466910/original/file-20220603-17-5nwz4k.jpg?ixlib=rb-1.1.0&rect=382%2C238%2C4930%2C3241&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Global Justice campaigners in London stand by fake coffins to highlight global COVID-19 deaths. If pharma companies waived intellectual property rights, it would be easier for low- and middle-income countries to access COVID-19 vaccines.
</span> <span class="attribution"><span class="source">(AP Photo/Alastair Grant)</span></span></figcaption></figure><p>In mid-June, the <a href="https://www.wto.org/english/thewto_e/minist_e/mc12_e/mc12_e.htm">World Trade Organization (WTO) will meet</a> to finish negotiations to waive certain sections of the agreement on Trade Related Intellectual Property Rights (TRIPS). However, it is not the TRIPS waiver originally proposed 18 months ago by member states South Africa and India, which would have allowed countries to produce lower-cost generic vaccines and other COVID-19 medical tools without the risk of legal trade challenges.</p>
<p>The opposition to the waiver from a few WTO member states — home to the pharma companies holding monopoly patent rights over the vaccines — has resulted in “<a href="https://doi.org/10.1016/S0140-6736(22)00328-2">vaccine apartheid</a>” (rich countries buying up all the early supplies) and “<a href="https://www.thenation.com/article/economy/pfizer-pandemic-profiteering/">vaccine profiteering</a>” (companies making multi-billion-dollar profits and fighting every effort to allow generic competition). </p>
<p>Vaccine supply is no longer the main issue. Pharma companies still holding the vaccine patents can now produce enough for everyone — though not necessarily at affordable prices — and have described the <a href="https://healthpolicy-watch.news/with-covid-vaccine-supply-outstripping-vaccination-rates-pharma-giants-question-pursuit-of-ip-waiver/">idea of a TRIPS waiver now as “insane” and “unproductive</a>.” </p>
<p>But for the scores of WTO member states and thousands of global health researchers still supporting the waiver <a href="https://theconversation.com/covid-19-drug-and-vaccine-patents-are-putting-profit-before-people-149270">(myself included)</a>, getting the WTO to approve one at its upcoming June ministerial meeting remains important. Just not the waiver that’s on the negotiating table. </p>
<h2>Worse than no waiver</h2>
<p><a href="https://www.wto.org/english/news_e/news22_e/trip_06may22_e.htm">The current version</a> is the outcome of discussions involving the two original proposing members, the United States and the European Union. It is restricted to vaccines — a U.S. request — ignoring, for now at least, therapeutics, diagnostics and other essential COVID-19-related health products. </p>
<figure class="align-center ">
<img alt="Hands holding a syringe and vial of vaccine" src="https://images.theconversation.com/files/466905/original/file-20220603-15469-2mn4y6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/466905/original/file-20220603-15469-2mn4y6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/466905/original/file-20220603-15469-2mn4y6.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/466905/original/file-20220603-15469-2mn4y6.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/466905/original/file-20220603-15469-2mn4y6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/466905/original/file-20220603-15469-2mn4y6.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/466905/original/file-20220603-15469-2mn4y6.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">The waiver under negotiation puts a time limit on the waived obligations.</span>
<span class="attribution"><span class="source">(AP Photo/Michel Euler)</span></span>
</figcaption>
</figure>
<p>It requires generic manufacturers to identify all related patents, which is impossible given vaccines’ complex “<a href="https://doi.org/10.1007/s10551-021-04873-6">patent thickets</a>” (overlapping patent rights), and something not required under present TRIPS rules. It puts a time limit on the waived obligations, as though pandemics are calendar-savvy. </p>
<p>While it removes barriers to generic companies exporting to developing countries that lack their own manufacturing capacity, it excludes countries that supplied more than 10 per cent of global vaccine exports in 2021, namely, China. </p>
<p>A shadow of its original intent, the new waiver is <a href="https://twn.my/title2/wto.info/2022/ti220514.htm">endorsed only by the EU, with support from the WTO director-general</a>. </p>
<h2>Why the new waiver proposal should be opposed</h2>
<p>If enacted as currently drafted, the new waiver sets a precedent that will restrict the ability of countries with the capacity to mass produce therapeutics, diagnostics and even personal protective equipment. This would apply to the still-with-us COVID-19 pandemic and for any new zoonotic outbreaks that are <a href="https://theconversation.com/future-infectious-diseases-recent-history-shows-we-can-never-again-be-complacent-about-pathogens-177746">almost certainly on the near horizon</a>. </p>
<p>Without a meaningful waiver, new variant-ready vaccines <a href="https://medicalxpress.com/news/2022-04-pfizer-eyes-covid-vaccine-variants.html">expected later this year</a> are likely to be gobbled up once more by high-paying rich countries, with the poorer ones left with older less-effective versions. </p>
<figure class="align-center ">
<img alt="Vials of vaccine with purple caps shot from above" src="https://images.theconversation.com/files/466908/original/file-20220603-9439-4opry1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/466908/original/file-20220603-9439-4opry1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/466908/original/file-20220603-9439-4opry1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/466908/original/file-20220603-9439-4opry1.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/466908/original/file-20220603-9439-4opry1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/466908/original/file-20220603-9439-4opry1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/466908/original/file-20220603-9439-4opry1.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">Pharma companies holding patents can now produce enough vaccine for everyone, though not necessarily at affordable prices.</span>
<span class="attribution"><span class="source">(AP Photo/Achmad Ibrahim)</span></span>
</figcaption>
</figure>
<p>The same scenario applies to therapeutics such as <a href="https://www.bloomberg.com/news/articles/2022-04-22/covid-antiviral-pills-seen-surging-after-slow-initial-uptake">Pfizer’s antiviral drug, Paxlovid</a>. Most of its current supply will go to wealthy countries that can afford the high prices Pfizer charges. Pfizer will allow licences for generic versions to be produced for distribution to 95 developing countries, but not until 2023. </p>
<p>Moderna, the other mRNA vaccine leader, is busy <a href="https://www.aljazeera.com/opinions/2022/3/16/modernas-profits-show-why-big-pharma-cant-meet-our-health-needs">registering patents for its vaccine in South Africa</a> as that country, with WTO support, is close to copying Moderna’s recipe, the know-how for which it plans to share publicly. Moderna’s new patents could <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-patent-application-raises-fears-africa-covid-vaccine-hub-2022-02-17/">jeopardize this effort</a>. The company meanwhile has plans to create its own mRNA plant in Kenya to supply the African continent <a href="https://socialeurope.eu/control-the-vampire-companies">on its own profitable terms</a>. </p>
<p>On May 25, Pfizer announced that it would eventually provide all “<a href="https://www.weforum.org/agenda/2022/05/pfizer-launches-an-accord-for-a-healthier-world-a-call-for-action-to-improve-health-equity-globally/?utm_source=sfmc&utm_medium=email&utm_campaign=2778051_Am22-AgendaDaily-26May2022&utm_term=&emailType=Agenda%20Week">current and future patent-protected medicines on a not-for-profit basis” to 45 lower-income countries</a>, beginning with five countries in Africa. </p>
<p>The company’s decision is welcome, but questions remain. Will Pfizer forego lucrative sales of its current and future drugs to rich countries in order to supply (eventually) the 1.2 billion people living in the world’s poorest nations? Or will these countries have to wait until the paying world’s 6.7 billion people have had their supply needs met? </p>
<h2>Current property rights not fit for global health purpose</h2>
<p>The bottom line: for-profit companies should not be setting public health policy during global health emergencies. Individual corporate decisions to supply life-saving health innovations at cost in otherwise unprofitable markets is not a sustainable or ethical solution. </p>
<p>Bluntly stated: companies’ intellectual property rights should not be allowed to trump people’s health rights. </p>
<figure class="align-center ">
<img alt="A crowd outdoors with people holding blue signs reading 'Support patent waivers on COVID-19 vaccines'" src="https://images.theconversation.com/files/466911/original/file-20220603-11-mv11bv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/466911/original/file-20220603-11-mv11bv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=417&fit=crop&dpr=1 600w, https://images.theconversation.com/files/466911/original/file-20220603-11-mv11bv.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=417&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/466911/original/file-20220603-11-mv11bv.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=417&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/466911/original/file-20220603-11-mv11bv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=524&fit=crop&dpr=1 754w, https://images.theconversation.com/files/466911/original/file-20220603-11-mv11bv.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=524&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/466911/original/file-20220603-11-mv11bv.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=524&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Activists support patent waivers on COVID-19 vaccines in front of the European Union office during an EU summit in Kyiv, Ukraine, on Oct. 12, 2021.</span>
<span class="attribution"><span class="source">(AP Photo/Efrem Lukatsky)</span></span>
</figcaption>
</figure>
<p>Investment into new health products means taking risks, and it warrants some reward. However, much of the groundwork in pharmaceutical research is publicly funded. </p>
<p>This was certainly the case with COVID-19 vaccines, and one of the reasons why many organizations argued that these discoveries <a href="https://peoplesvaccine.org/">should be considered “people’s vaccines” and treated as public goods</a>. Governments need to place <a href="https://www.who.int/publications/m/item/governing-health-innovation-for-the-common-good">conditions on the financial support they give to health research</a> to ensure that the results are more equitably shared. </p>
<p>In the case of public health emergencies, such as pandemics, this should include requirements that companies forego their monopoly property rights, accept negotiated royalties for their efforts and share their knowledge. </p>
<p>President Joe Biden’s administration recently took a step in this direction. It <a href="https://www.hhs.gov/about/news/2022/05/12/nih-licenses-covid-19-research-tools-early-stage-technologies-who-program.html">licensed 11 COVID-19 inventions</a> that arose from in-house research at the National Institutes of Health, including early-stage development of the stabilized spike protein that forms the base of mRNA vaccines. </p>
<p>Described as “<a href="https://www.science.org/content/article/pretty-big-deal-u-s-makes-covid-19-technologies-available-use-developing-countries">a pretty big deal</a>” by an advocate of shared intellectual property, the licenses will be administered by the non-profit <a href="https://medicinespatentpool.org/">Medicines Patent Pool</a> that negotiates low royalty costs for generic manufacturers, so inventors will still get some reward. </p>
<p>But this early-stage knowledge-sharing is insufficient to enable full development of medical innovations, which requires drug companies holding patents on the finished, commercialized vaccines and COVID-19-related technologies to waive these rights and to share their technical know-how. </p>
<h2>Canada and the June WTO meeting</h2>
<p>As with the rest of the world, Canada’s attention is moving away from COVID-19 to <a href="https://www.cbc.ca/news/business/canada-inflation-april-1.6457520">inflation fears</a> and <a href="https://theconversation.com/why-did-russia-invade-ukraine-faqs-about-the-conflict-that-has-shocked-the-world-177963">Russia’s war against Ukraine</a>. With surprisingly little media coverage, the government began holding <a href="https://www.ourcommons.ca/Committees/en/FAAE/StudyActivity?studyActivityId=11504514">parliamentary committee hearings on vaccine equity</a> this past spring. Still, it remains uncommitted on the waiver, as it has since the original waiver was proposed. </p>
<figure class="align-center ">
<img alt="A globe and a syringe against a blue background" src="https://images.theconversation.com/files/466903/original/file-20220603-26-bpuy54.jpg?ixlib=rb-1.1.0&rect=748%2C30%2C3341%2C2501&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/466903/original/file-20220603-26-bpuy54.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=398&fit=crop&dpr=1 600w, https://images.theconversation.com/files/466903/original/file-20220603-26-bpuy54.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=398&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/466903/original/file-20220603-26-bpuy54.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=398&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/466903/original/file-20220603-26-bpuy54.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=501&fit=crop&dpr=1 754w, https://images.theconversation.com/files/466903/original/file-20220603-26-bpuy54.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=501&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/466903/original/file-20220603-26-bpuy54.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=501&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Companies’ intellectual property rights should not be allowed to trump people’s health rights.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>Health and civil society groups, meanwhile, remain committed to urging the government to make the right ethical and health protective decision. They are calling on Canada to <a href="https://policyalternatives.ca/newsroom/updates/canada-should-reject-compromise-proposal-trips-waiver-its-present-form-civil">use the June WTO meeting to bring the deeply flawed new waiver proposal closer to the original one</a>. </p>
<p>There is still a need for a decent TRIPS waiver to ensure that intellectual property rights do not get in the way of rapid and equitable access to medicines or any other essential health innovations. That must be one of the key lessons we take from our COVID-19 experience.</p><img src="https://counter.theconversation.com/content/181235/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ronald Labonte receives funding from the Canadian Institutes of Health Research, and is a member of the Steering Council of the People's Health Movement, which advocates for global health equity.</span></em></p>Waiving patent rights on COVID-19 vaccines and drugs is still crucial to ensure access globally, but the waiver on the table at the June World Trade Organization meeting doesn’t do the job.Ronald Labonte, Professor and Distinguished Research Chair, Globalization and Health Equity, L’Université d’Ottawa/University of OttawaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1821472022-05-15T20:15:16Z2022-05-15T20:15:16ZAustralia risks relying on Pfizer and Moderna for its COVID vaccines. 3 ways to break free<figure><img src="https://images.theconversation.com/files/460499/original/file-20220429-26-ut9yfa.jpg?ixlib=rb-1.1.0&rect=14%2C0%2C3180%2C1992&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-vector/coronavirus-vaccine-affordability-people-want-buy-1908778336">Shutterstock</a></span></figcaption></figure><p>The rapid development and deployment of COVID vaccines has been one of the greatest achievements of the pandemic.</p>
<p>However, Australia <a href="https://www.mja.com.au/journal/2022/217/2/covid-19-vaccines-boosters-and-mandates-building-mission-economy-not-rentier">risks relying on</a> COVID vaccines from two main companies – Pfizer and Moderna – and that’s a problem.</p>
<p>While the need for COVID vaccines is not going away anytime soon, we need to shape the market to drive more competition for better access to improved vaccines.</p>
<p>Here’s what Australia needs to do to break free from an effective duopoly dominating the local market, especially when many of us are likely to <a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/getting-your-vaccination/booster-doses">need boosters</a>.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/covid-vaccination-recommendations-evolve-over-time-who-is-due-for-which-dose-now-181779">COVID vaccination recommendations evolve over time. Who is due for which dose now?</a>
</strong>
</em>
</p>
<hr>
<h2>How did we get here?</h2>
<p>When COVID finally broke out at scale in Australia late last year, the vaccines (and high levels of adult vaccination) worked extremely well to reduce deaths and severe illness.</p>
<p>Since January 1 this year, there have been <a href="https://ourworldindata.org/coronavirus/country/australia">more than</a> 5.9 million confirmed COVID infections nationwide, but about 5,300 deaths.</p>
<p>Yet current vaccines aren’t 100% effective at protecting against infection; new viral variants (<a href="https://theconversation.com/why-are-there-so-many-new-omicron-sub-variants-like-ba-4-and-ba-5-will-i-be-reinfected-is-the-virus-mutating-faster-182274">and sub-variants</a>) continue to emerge; protection via <a href="https://www1.racgp.org.au/newsgp/clinical/booster-protection-wanes-after-four-months-what-do">vaccination</a> and <a href="https://theconversation.com/how-long-does-protective-immunity-against-covid-19-last-after-infection-or-vaccination-two-immunologists-explain-177309">prior infection wanes</a> quite quickly, meaning reinfection is becoming more common and booster shots may remain part of the landscape for some time to come.</p>
<p>Meanwhile, <a href="https://www.sciencedirect.com/science/article/pii/S0140673622003282?via%3Dihub">vaccine inequity</a> remains an unresolved problem. This has led to a situation where rich countries, such as Australia, are giving booster shots where some <a href="https://www.sciencedirect.com/science/article/pii/S0140673622008170?via%3Dihub">poorer countries</a> don’t even have enough vaccine for first doses.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/how-australias-fickleness-on-covid-vaccines-is-perpetuating-global-vaccine-inequity-165001">How Australia's fickleness on COVID vaccines is perpetuating global vaccine inequity</a>
</strong>
</em>
</p>
<hr>
<h2>Pfizer and Moderna, but not much else</h2>
<p>In <a href="https://www.mja.com.au/journal/2022/217/2/covid-19-vaccines-boosters-and-mandates-building-mission-economy-not-rentier">a recent article</a> in the Medical Journal of Australia, we outline the need to break free from the handful of powerful players still dominating Australia’s COVID vaccine market.</p>
<p>While the number of <a href="https://covid19.trackvaccines.org/agency/who/">approved COVID vaccines</a> <a href="https://en.wikipedia.org/wiki/List_of_COVID-19_vaccine_authorizations">is growing</a> around the world, Australia largely still relies on only two, namely vaccines from Pfizer and Moderna.</p>
<p>The AstraZeneca and Novavax vaccines are only rarely <a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/advice-for-providers/clinical-guidance/clinical-recommendations">used as boosters</a> if <a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/approved-vaccines/novavax">no other vaccines</a> are suitable.</p>
<p>More than <a href="https://www.health.gov.au/sites/default/files/documents/2022/05/covid-19-vaccine-rollout-update-11-may-2022.pdf">95% of Australian adults</a> have received two doses of COVID vaccine already. So future requirements are primarily for boosters and child vaccines. Australia, therefore, continues to face an effective duopoly.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Middle-aged lady smiling with bandaid on upper arm" src="https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.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">Future supplies of COVID vaccines will be used for booster shots and children.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/portrait-mature-female-smiling-after-getting-1927590569">Shutterstock</a></span>
</figcaption>
</figure>
<h2>The power of patents</h2>
<p>This effective duopoly further reinforces the already considerable power these manufacturers hold via the intellectual property rights to their vaccines.</p>
<p>These vaccine patents are protected by the World Trade Organization under the Agreement on Trade-Related Aspects of Intellectual Property Rights (or <a href="https://www.wto.org/english/tratop_e/trips_e/trips_e.htm">TRIPS</a>). This prevents international competitors from replicating patented technologies. </p>
<p>These patent rights allow companies to earn higher profits (or “economic rents”) than if their technologies were freely available to allow open competition.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1523962841178558469"}"></div></p>
<p>The intellectual property dimensions of COVID vaccines have been controversial. </p>
<p>Pfizer and Moderna have continued <a href="https://peoplesvaccine.org/resources/media-releases/pharma-companies-make-1000-dollars-per-second/">to make extraordinary profits</a> from COVID vaccines.</p>
<p>Yet Moderna found itself <a href="https://www.ipwatchdog.com/2022/03/31/nihs-fight-ownership-modernas-covid-19-patent-highlights-hazards-business-collaborations/id=148040/">in dispute</a> with the United States government, conceding <a href="https://www.nytimes.com/2021/12/17/us/moderna-patent-nih.html?msclkid=2baf60f6d0f511ec9526396a701fee1f">US government employees</a> had directly developed several technologies key to the Moderna vaccine (not to mention years of publicly-funded basic research). </p>
<p>Moderna has also <a href="https://www.npr.org/sections/goatsandsoda/2021/10/19/1047411856/the-great-vaccine-bake-off-has-begun">resisted sharing</a> the formulation of its vaccine to allow key middle-income countries to manufacture it.</p>
<p>Meanwhile, Pfizer has negotiated <a href="https://www.citizen.org/article/pfizers-power/?eType=EmailBlastContent&eId=9b708ddb-d34d-4dfa-95e4-d4d672a82a1b">advantageous</a> and <a href="https://www.theguardian.com/uk-news/2021/dec/05/wall-of-secrecy-in-pfizer-contracts-as-company-accused-of-profiteering">secretive</a> vaccine contracts with governments, shifting liability and risk onto governments and controlling nations’ ability to redistribute stock between themselves. </p>
<p>High-income countries have <a href="http://aftinet.org.au/cms/Civil-society-organisations-urge-Australia-to-oppose-ineffective-TRIPS-proposal">consistently resisted</a> or watered down <a href="https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W688.pdf&Open=True">calls for a TRIPS waiver</a>, which would have allowed global sharing of manufacturing technologies. </p>
<p><a href="https://journals.plos.org/globalpublichealth/article?id=10.1371%2Fjournal.pgph.0000427">Critics argue</a> the opponents of a TRIPS waiver are largely concerned about avoiding setting any precedents that might allow the profits of Big Pharma to be limited in future.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/why-a-leaked-wto-solution-for-a-covid-patent-waiver-is-unworkable-and-wont-make-enough-difference-for-developing-countries-179642">Why a leaked WTO 'solution' for a COVID patent waiver is unworkable and won't make enough difference for developing countries</a>
</strong>
</em>
</p>
<hr>
<h2>What should Australia do next?</h2>
<p>In Australia, the reality that current COVID vaccines only partially prevent transmission leaves us dependent on this effective duopoly for ongoing boosters. Boosters also remain mandated for people in <a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/information-for-aged-care-providers-workers-and-residents-about-covid-19-vaccines/residential-aged-care-workers">many occupations</a>.</p>
<p>Australia can escape this captive vaccine market in three steps.</p>
<p><strong>1. Approve more vaccines</strong></p>
<p>Australia needs to expand the supply of new COVID vaccines by actively assisting a wider range of manufacturers to bring their products to the Therapeutic Goods Administration for approval. This would increase competition for boosters and stimulate the development and supply of more effective “sterilising” vaccines (ones that prevent viral transmission).</p>
<p>Meanwhile, Australia must extract maximum value from all existing vaccine contracts, and insist upon full freedom to transfer supplies to our regional neighbours.</p>
<p><strong>2. Push for patent reform</strong></p>
<p>Australia should use its influence to vigorously drive a TRIPS waiver at the World Trade Organization. It should also explore strategic options with a coalition of partners to consider how the current global intellectual property regime could be rapidly reformed or, if necessary, circumvented. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/3-ways-to-vaccinate-the-world-and-make-sure-everyone-benefits-rich-and-poor-155943">3 ways to vaccinate the world and make sure everyone benefits, rich and poor</a>
</strong>
</em>
</p>
<hr>
<p><strong>3. Set up domestic, not-for-profit capability</strong></p>
<p>Australia should institute an economic “mission” to establish publicly-owned, not-for-profit vaccine and essential pharmaceuticals research, development and manufacturing infrastructure and capability in Australia. This would serve domestic and wider regional needs for COVID and beyond. </p>
<p>Sadly, the Australian government’s recent agreement with Moderna for the company to establish <a href="https://theconversation.com/new-facility-to-be-built-in-victoria-to-produce-mrna-vaccines-173674">mRNA manufacturing here</a> is <em>not</em> such an example. It may risk entrenching existing power. The agreement is also <a href="https://www.abc.net.au/radionational/programs/sciencefriction/moderna-mrna-australia-covid-pharmaceutical-profits-business/13849344">still secret</a>. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/new-facility-to-be-built-in-victoria-to-produce-mrna-vaccines-173674">New facility to be built in Victoria to produce mRNA vaccines</a>
</strong>
</em>
</p>
<hr>
<p>In an increasingly insecure world of growing disruptions – ecological and health crises, fracturing supply chains and heightened military tensions – Australia can provide a safe and resilient vaccine and pharmaceutical manufacturing capability to protect the health of Australians and our neighbours. </p>
<p>However, old models that privilege shareholders, via excess profits and intellectual property protection, will not deliver this new vision.</p>
<hr>
<p><em><a href="https://www.deakin.edu.au/about-deakin/people/sithara-wanni-arachchige-dona2">Sithara Dona</a>, an associate research fellow at Deakin University, co-authored the research mentioned in this article.</em></p><img src="https://counter.theconversation.com/content/182147/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Martin Hensher has received an honorarium from Novartis SA (Brazil) for a lecture delivered to the Novartis Access 2021 conference. He is a member of the South Australian Health Performance Council and a board member of Glenview Community Services, Tasmania (a not-for-profit aged care provider).</span></em></p>Boosters and vaccinating children mean we’re relying on two pharmaceutical companies to supply Australia’s COVID vaccines. That needs to change.Martin Hensher, Henry Baldwin Professorial Research Fellow in Health System Sustainability, University of TasmaniaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1790602022-03-17T12:10:24Z2022-03-17T12:10:24ZHow does the immune system mobilize in response to a COVID-19 infection or a vaccine? 5 essential reads<figure><img src="https://images.theconversation.com/files/452348/original/file-20220316-16-12d1gnq.jpg?ixlib=rb-1.1.0&rect=231%2C52%2C6774%2C4810&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The COVID-19 pandemic has taught most people more than they ever expected to know about immunology.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/coronavirus-structural-morphology-royalty-free-image/1215480593">Membio/iStock via Getty Images Plus</a></span></figcaption></figure><p>Heading into the third year of the COVID-19 pandemic, many of us have become amateur immunologists, having conversations at the dinner table and in the grocery store aisle about <a href="https://theconversation.com/how-mrna-vaccines-from-pfizer-and-moderna-work-why-theyre-a-breakthrough-and-why-they-need-to-be-kept-so-cold-150238">mRNA vaccines</a>, <a href="https://theconversation.com/will-omicron-the-new-coronavirus-variant-of-concern-be-more-contagious-than-delta-a-virus-evolution-expert-explains-what-researchers-know-and-what-they-dont-169020">variants</a>, <a href="https://theconversation.com/what-is-a-breakthrough-infection-6-questions-answered-about-catching-covid-19-after-vaccination-164909">breakthrough infections</a>, <a href="https://theconversation.com/how-long-does-protective-immunity-against-covid-19-last-after-infection-or-vaccination-two-immunologists-explain-177309">“waning” immunity</a>, <a href="https://theconversation.com/what-is-herd-immunity-a-public-health-expert-and-a-medical-laboratory-scientist-explain-170520">herd immunity</a>, <a href="https://theconversation.com/is-covid-19-here-to-stay-a-team-of-biologists-explains-what-it-means-for-a-virus-to-become-endemic-168462">endemic viruses</a>, <a href="https://theconversation.com/tense-decision-making-as-cdc-joins-fda-in-recommending-pfizer-booster-shot-for-65-and-up-people-at-high-risk-and-those-with-occupational-exposure-to-covid-19-168703">booster shots</a> and much more. </p>
<p>Many of the stories that we’ve published over the past two years here at The Conversation have stemmed from our own head-scratching questions that came up in our morning news meetings or were posed to us directly by curious readers. We sought out scholars who could take our readers on deep dives into immunology and virology to help demystify these sometimes confusing, conflicting and taxing science-based questions.</p>
<p>Here are five stories from The Conversation’s archives that highlight critical insights that we as editors and readers have gained thanks to COVID-19, and that will no doubt continue to be an important part of our pandemic lexicon. </p>
<h2>1. COVID-19 vaccines explained</h2>
<p>Understanding how vaccines can “trick” the body into mounting an effective immune response against a perceived or actual threat is one of the most fascinating aspects of immunology. “The most important thing to understand about vaccines is that they <a href="https://theconversation.com/what-happens-when-the-covid-19-vaccines-enter-the-body-a-road-map-for-kids-and-grown-ups-164624">teach your body how to gear up to fight an infection</a>, without your body having to deal with the infection itself,” writes <a href="https://scholar.google.com/citations?user=YpknwWcAAAAJ&hl=en">Glenn J. Rapsinski</a>, a pediatric infectious diseases fellow at the University of Pittsburgh Health Sciences. “In this way, vaccines help your body be prepared for invasions by germs that could otherwise make you very sick.”</p>
<p>Rapsinski explains how the COVID-19 vaccines available in the U.S. emulate the spike protein of SARS-CoV-2, the virus that causes COVID-19. “SARS-CoV-2 is a round virus, with bumps all over it – sort of like a baseball covered in golf tees. The bumps are the spike proteins.”</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/what-happens-when-the-covid-19-vaccines-enter-the-body-a-road-map-for-kids-and-grown-ups-164624">What happens when the COVID-19 vaccines enter the body – a road map for kids and grown-ups</a>
</strong>
</em>
</p>
<hr>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/7DlcRSvuvnw?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">How mRNA COVID-19 vaccines work.</span></figcaption>
</figure>
<h2>2. And then came breakthrough infections</h2>
<p>Soon after the relief that came with the widespread availability of vaccines in the spring of 2021, we were introduced to the idea of “breakthrough infections,” which were the rare cases in which fully vaccinated people got infected with COVID-19. </p>
<p>“<a href="https://theconversation.com/what-is-a-breakthrough-infection-6-questions-answered-about-catching-covid-19-after-vaccination-164909">Breakthrough infections</a> are a little more frequent than previously expected and are probably increasing because of growing dominance of the delta variant,” <a href="https://scholar.google.com/citations?user=F8vQ9xIAAAAJ&hl=en">Sanjay Mishra</a>, a cancer and vaccine researcher from Vanderbilt University, wrote in July 2021. “But infections in vaccinated people are still very rare and usually cause mild or no symptoms.” </p>
<p>Although breakthrough infections became far more common late in 2021, in part because of the emergence of the highly transmissible omicron variant – more on that down below – COVID-19 vaccines still continue to provide robust protection against the most severe forms of COVID-19 that lead to hospitalization and death.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/what-is-a-breakthrough-infection-6-questions-answered-about-catching-covid-19-after-vaccination-164909">What is a breakthrough infection? 6 questions answered about catching COVID-19 after vaccination</a>
</strong>
</em>
</p>
<hr>
<h2>3. The growing list of variants</h2>
<p>In 2020 and 2021, new strains of SARS-CoV-2 seemed to emerge faster than people could keep up with their Greek names. But by mid-2021, the highly transmissible delta variant had become the dominant strain in the U.S. and was responsible for the growing number of breakthrough infections. The continual emergence of variants was and is concerning, because it raises questions about how robust one’s immune protection will be from prior infections or from the COVID-19 vaccines, which were based on the original strain of the virus. </p>
<p>The delta variant was between 40% and 60% more transmissible than the alpha variant that it replaced and nearly <a href="https://theconversation.com/will-omicron-the-new-coronavirus-variant-of-concern-be-more-contagious-than-delta-a-virus-evolution-expert-explains-what-researchers-know-and-what-they-dont-169020">twice as transmissible as the original SARS-CoV-2</a> virus, wrote <a href="https://scholar.google.com/citations?user=dqahf8oAAAAJ&hl=en">Suresh V. Kuchipudi</a>, a professor of emerging infectious diseases at Penn State. </p>
<p>But then, of course, came omicron, which was even more contagious than delta, thanks in part to its high number of mutations. “Omicron is very unusual in that it is by far the most heavily mutated variant yet of SARS-CoV-2, the virus that causes COVID-19,” Kuchipudi explained. “The omicron variant has 50 mutations overall, with 32 mutations on the spike protein alone. The spike protein – which forms protruding knobs on the outside of the SARS-CoV-2 virus – helps the virus adhere to cells so that it can gain entry.”</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/will-omicron-the-new-coronavirus-variant-of-concern-be-more-contagious-than-delta-a-virus-evolution-expert-explains-what-researchers-know-and-what-they-dont-169020">Will omicron – the new coronavirus variant of concern – be more contagious than delta? A virus evolution expert explains what researchers know and what they don't</a>
</strong>
</em>
</p>
<hr>
<h2>4. Putting ‘endemic’ viruses into context</h2>
<p>At some point in 2021 – the year is one big blur – we entered a phase of the pandemic where it became clear that we were stuck with COVID-19 for the foreseeable future. For many people, there was a mental shift from the assumption that we could eradicate the coronavirus that causes COVID-19 through vaccination, into the slow realization that it just wasn’t going away. Virologists and other researchers began using the term “endemic” to describe the way that some viruses can fade away but still maintain a low level of transmission in a community. </p>
<p><a href="https://scholar.google.com/citations?user=XY7DNtgAAAAJ&hl=en">Sara Sawyer</a>, <a href="https://experts.colorado.edu/display/fisid_166880">Arturo Barbachano-Guerrero</a> and <a href="https://scholar.google.com/citations?user=l2lpnYkAAAAJ&hl=en">Cody Warren</a>, a team of virologists and immunologists <a href="https://theconversation.com/is-covid-19-here-to-stay-a-team-of-biologists-explains-what-it-means-for-a-virus-to-become-endemic-168462">from the University of Colorado Boulder explain</a> that SARS-CoV, the coronavirus that set off the SARS pandemic in 2003, was less contagious than SARS-CoV-2 and was brought under control relatively quickly by speedy public health measures that ultimately drove the virus extinct. </p>
<p>On the other hand, they wrote, “pandemic viruses may also gradually settle into a relatively stable rate of occurrence, maintaining a constant pool of infected hosts capable of spreading the virus to others.” Such viruses are said to be “endemic” – as will likely become the case with the coronavirus that causes COVID-19.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/is-covid-19-here-to-stay-a-team-of-biologists-explains-what-it-means-for-a-virus-to-become-endemic-168462">Is COVID-19 here to stay? A team of biologists explains what it means for a virus to become endemic</a>
</strong>
</em>
</p>
<hr>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/nclAnJXdgqs?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Epidemics, pandemics and endemic viruses explained.</span></figcaption>
</figure>
<h2>5. Immune defenses shift over time</h2>
<p>As 2021 waned, so – apparently – did protective antibodies against COVID-19. Researchers began to learn more about how the immune response shifts in the months following COVID-19 infection or vaccination. And it became clear that over time, people became more vulnerable to getting reinfected or having a breakthrough infection following vaccination – in part because of the emergence of variants.</p>
<p>But antibodies are only <a href="https://theconversation.com/how-long-does-protective-immunity-against-covid-19-last-after-infection-or-vaccination-two-immunologists-explain-177309">part of the immune system’s protective defense</a>, explain <a href="https://scholar.google.com/citations?user=jJVj3sUAAAAJ&hl=en">Prakash Nagarkatti</a> and <a href="https://scholar.google.com/citations?user=af7TahQAAAAJ&hl=en">Mitzi Nagarkatti</a>, a husband-and-wife team of immunologists from the University of South Carolina. </p>
<p>“Throughout the COVID-19 pandemic, the public has widely and mistakenly believed that antibodies provide the bulk of protective immunity, while not recognizing the important role of killer T cells,” they write. “This is in part because antibodies are easy to detect, whereas killer T-cell detection is complex and involves advanced technology. When antibodies fail, it is the killer T cells that are responsible for preventing the more severe outcomes of COVID-19, such as hospitalization and death.”</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/how-long-does-protective-immunity-against-covid-19-last-after-infection-or-vaccination-two-immunologists-explain-177309">How long does protective immunity against COVID-19 last after infection or vaccination? Two immunologists explain</a>
</strong>
</em>
</p>
<hr>
<p><em>Editor’s note: This story is a roundup of articles from The Conversation’s archives.</em></p><img src="https://counter.theconversation.com/content/179060/count.gif" alt="The Conversation" width="1" height="1" />
The COVID-19 pandemic has brought immunology terms that are typically relegated to textbooks into our everyday vernacular. These stories helped us make sense of the ever-evolving science.Amanda Mascarelli, Senior Health and Medicine EditorLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1766952022-02-22T01:52:19Z2022-02-22T01:52:19ZDo COVID boosters cause more or fewer side effects? How quickly does protection wane? Your questions answered<figure><img src="https://images.theconversation.com/files/447235/original/file-20220218-13-1w2o0nc.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C4968%2C3309&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>The Australian Technical Advisory Group on Immunisation (ATAGI) recommends Australians aged 16 years and older have a COVID booster vaccine <a href="https://www.health.gov.au/news/atagi-statement-on-the-omicron-variant-and-the-timing-of-covid-19-booster-vaccination">three months</a> after receiving their second dose.</p>
<p>You now need a third dose to be <a href="https://www.health.gov.au/news/atagi-statement-on-defining-up-to-date-status-for-covid-19-vaccination">considered</a> “up to date” with COVID vaccination, previously known as “fully vaccinated”.</p>
<p>Despite this, only about <a href="https://www.health.gov.au/sites/default/files/documents/2022/02/covid-19-vaccine-rollout-update-21-february-2022.pdf">half of the eligible population</a> has received a booster dose. </p>
<p>Many people are wondering how booster side effects compare to the first two doses, when they can get a booster dose after COVID infection, and whether we’ll need more than three doses in the future.</p>
<p>Here we answer some of your COVID booster vaccine questions.</p>
<h2>Why have a booster?</h2>
<p>There’s still widespread community transmission of the Omicron variant across Australia and the world.</p>
<p>The protection provided by two doses of a COVID vaccine is <a href="https://theconversation.com/whats-the-difference-in-protection-against-omicron-between-2-doses-and-3-doses-of-vaccine-176447">reduced and more rapidly wanes</a> against Omicron.</p>
<p>Despite this, many eligible Australians aren’t coming forward for their booster, perhaps reassured by reports that <a href="https://theconversation.com/why-does-omicron-appear-to-cause-less-severe-disease-than-previous-variants-174495">Omicron is milder</a>, so therefore not something to be worried about. </p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1491913925348061184"}"></div></p>
<p>Omicron infections continue to cause significant impact in all Australian states and territories, with <a href="https://www.health.gov.au/health-alerts/covid-19/case-numbers-and-statistics#covid19-situation-overview">more than 2,400 Australians</a> currently hospitalised.</p>
<p>There’s now clear evidence getting your booster shot is the best way to restore protection against infection and severe disease.</p>
<p>Having a booster three months following the primary course can provide <a href="https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1052353/Vaccine_surveillance_report_-_week_5.pdf">similar levels of protection against Omicron</a> as the two primary doses did for Delta.</p>
<h2>Which booster can I have?</h2>
<p>Australians over 16 can now have Pfizer or Moderna as a booster, regardless of which vaccines you had for the first two.</p>
<p>Pfizer’s is a full dose just like the first two, while Moderna’s booster dose is <a href="https://www.health.gov.au/news/australian-technical-advisory-group-on-immunisation-atagi-recommendations-on-the-use-of-spikevax-moderna-as-a-covid-19-booster-vaccine">half the dose</a> of the primary vaccine.</p>
<p>AstraZeneca has been approved as a booster dose, but <a href="https://www.health.gov.au/sites/default/files/documents/2021/12/atagi-recommendations-on-the-use-of-a-booster-dose-of-covid-19-vaccine.pdf">Pfizer and Moderna remain preferred</a>, except in a small number people who have had a significant adverse reaction to mRNA vaccines.</p>
<p><a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/approved-vaccines/novavax">Novavax</a>, the new protein-based COVID vaccine, is currently only approved for use in the first two doses. Despite encouraging evidence from <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02717-3/fulltext">clinical trials</a>, it’s not currently approved as a booster. </p>
<p>Boosters aren’t yet recommended in younger adolescents (less than 16 years old) and children.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/havent-yet-been-vaccinated-for-covid-novavax-might-change-your-mind-176694">Haven't yet been vaccinated for COVID? Novavax might change your mind</a>
</strong>
</em>
</p>
<hr>
<h2>What side effects should I expect?</h2>
<p>AusVaxSafety, <a href="https://ausvaxsafety.org.au/covid-19-vaccine-safety-surveillance/what-ausvaxsafety-doing">Australia’s national active vaccine safety surveillance system</a>, found Australians who’ve already had their booster vaccine reported similar side effects as they did after their second dose, for both <a href="https://ausvaxsafety.org.au/all-participants/pfizer-covid-19-vaccine-safety-data-all-participants">Pfizer</a> and <a href="https://ausvaxsafety.org.au/all-participants/moderna-covid-19-vaccine-safety-data-all-participants">Moderna</a> boosters. </p>
<p>The most common side effect following booster vaccines was a local reaction (including pain, redness, swelling and itching over the injection site), followed by fatigue, headache and muscle or joint pain.</p>
<p>Less than 1% of people reported needing to see a doctor as a result of their side effects.</p>
<p>Fewer people also reported needing to miss work, study or their routine duties as a result of booster vaccine side effects compared to their second dose, suggesting they were manageable. </p>
<figure class="align-center ">
<img alt="Person with bandaid on shoulder having just received COVID vaccine" src="https://images.theconversation.com/files/447458/original/file-20220221-19-afhg7f.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/447458/original/file-20220221-19-afhg7f.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/447458/original/file-20220221-19-afhg7f.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/447458/original/file-20220221-19-afhg7f.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/447458/original/file-20220221-19-afhg7f.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/447458/original/file-20220221-19-afhg7f.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/447458/original/file-20220221-19-afhg7f.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">Fewer people needed to miss work and study after their booster, compared to their first two COVID vaccines.</span>
<span class="attribution"><span class="source">Shutterstock</span></span>
</figcaption>
</figure>
<p>It’s not uncommon to experience <a href="https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report/current">swollen lymph nodes</a>,
often in the armpit on the <a href="https://www.abc.net.au/news/science/2022-01-17/lymph-nodes-swollen-sore-covid-booster-immune-system-mrna/100754318">same side as the vaccination shot</a>. This normally occurs within a few days of vaccination and resolves within a week or so without treatment.</p>
<p>Swollen lymph nodes are <a href="https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report-06-01-2022">more common following booster</a> vaccines, with up to 5% of people reporting this following a Pfizer booster, compared to less than 1% of people following dose one or dose two. Swollen lymph nodes were experienced in up to 10% of people following Moderna boosters. </p>
<p>We <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7694388/">don’t know why</a> some people experience side effects such as swollen lymph nodes, and others don’t.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/covid-vaccine-may-lead-to-a-harmless-lump-in-your-armpit-so-women-advised-to-delay-mammograms-for-6-weeks-159529">COVID vaccine may lead to a harmless lump in your armpit, so women advised to delay mammograms for 6 weeks</a>
</strong>
</em>
</p>
<hr>
<h2>What about more serious adverse events?</h2>
<p>There’s a small increased risk of heart inflammation (<a href="https://www.health.gov.au/sites/default/files/documents/2021/11/covid-19-vaccination-guidance-on-myocarditis-and-pericarditis-after-mrna-covid-19-vaccines_1.pdf">pericarditis and/or myocarditis</a>) in people who have received an mRNA COVID vaccine (including Pfizer and Moderna), compared to unvaccinated people.</p>
<p>However, COVID infection is associated with a substantially <a href="https://www.health.gov.au/sites/default/files/documents/2021/12/covid-19-vaccination-guidance-on-myocarditis-and-pericarditis-after-mrna-covid-19-vaccines_0.pdf">higher risk of myocarditis</a>, and other cardiac complications, compared to a COVID vaccination. </p>
<p>As of February 13, approximately 10 million third doses have been administered in Australia. Only six reports of likely myocarditis and 25 reports of likely pericarditis have been <a href="https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report-17-02-2022">reported to the TGA</a> for Pfizer, and four reports of likely myocarditis and eight reports of likely pericarditis for Moderna. </p>
<p>Data from <a href="https://www.fda.gov/media/153086/download">Israel</a> and <a href="https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-01-05/02-covid-su-508.pdf">US</a> are also reassuring, finding lower rates of myocarditis and pericarditis following a third dose compared to a second dose of mRNA vaccines. </p>
<h2>What if you’ve recently had COVID infection?</h2>
<p>As with vaccination, immunity following COVID infection wanes over time. </p>
<p>That’s why, even if you get COVID, we still <a href="https://theconversation.com/if-my-child-or-i-have-covid-when-can-we-get-our-vaccine-or-booster-shot-174690">recommend</a> you get your next dose to ensure you get the best protection.</p>
<p>You can get vaccinated <a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/advice-for-providers/clinical-guidance/clinical-recommendations#people-with-a-past-sarscov2-infection">as soon as you’ve recovered</a> from your COVID infection.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1481063701495316480"}"></div></p>
<p>Having COVID will provide some immunity against reinfection, so you can defer vaccination for up to four months after the start of your infection.</p>
<p>If you’ve received antibody medication or convalescent plasma as part of your treatment for COVID, you should defer future vaccine doses for at least three months after infection. </p>
<h2>Will we need more doses in the future?</h2>
<p>A report published by the US Centers for Disease Control and Prevention (CDC) in February found protection was starting to <a href="https://www.cdc.gov/mmwr/volumes/71/wr/mm7107e2.htm">wane from four months after the third dose</a>. </p>
<p>But it’s <a href="https://www.abc.net.au/news/2022-02-08/how-likely-is-a-further-covid-booster-for-australians/100804380">too early to tell if further booster vaccines are required</a> in the future.</p>
<p>Whether having a single booster is enough to protect ourselves against future infections is still uncertain at this stage, but scientists, health professionals and policy makers are watching these data very closely.</p>
<p>Ahead of these data, it’s more important than ever to get that booster dose as soon as you’re eligible! </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/israel-is-rolling-out-fourth-doses-of-covid-vaccines-should-australia-do-the-same-176145">Israel is rolling out fourth doses of COVID vaccines. Should Australia do the same?</a>
</strong>
</em>
</p>
<hr>
<img src="https://counter.theconversation.com/content/176695/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Chris Blyth receives funding from the National Health and Medical Research Council. He is a member of government advisory committees including the COVID-19 Vaccines and Treatment for Australia - Science and Industry Technical Advisory Group.</span></em></p><p class="fine-print"><em><span>Nicholas Wood has received funding from the NHMRC for a Career Development Fellowship. He holds a Churchill Fellowship awarded in 2019</span></em></p><p class="fine-print"><em><span>Lucy Deng does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Fewer people reported needing to miss work after their booster, compared to their second dose.Christopher Blyth, Paediatrician, Infectious Diseases Physician and Clinical Microbiologist, Telethon Kids Institute, The University of Western AustraliaLucy Deng, Paediatrician, National Centre for Immunisation Research and Surveillance; Clinical Lecturer, Children's Hospital Westmead Clinical School, University of SydneyNicholas Wood, Associate Professor, Discipline of Childhood and Adolescent Health, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1753212022-01-21T05:41:52Z2022-01-21T05:41:52ZAustralia approves two new medicines in the fight against COVID. How can you get them and are they effective against Omicron?<p>On Thursday, health minister Greg Hunt <a href="https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/two-anti-viral-covid-19-treatments-approved">announced</a> Australia’s drug regulator had provisionally approved two new medicines for the treatment of COVID.</p>
<p>These are Lagevrio, made by American pharmaceutical company Merck Sharpe & Dohme, and Paxlovid, by Pfizer.</p>
<p>With the number of hospitalisations and deaths due to the virus continuing to rise, the approval of these drugs comes at a good time.</p>
<p>The federal government has purchased a combined 800,000 courses of the pills, and said the drugs will initially be prioritised for the elderly and other <a href="https://www.health.gov.au/health-alerts/covid-19/advice-for-groups-at-risk">high risk groups</a>.</p>
<p>Both companies say their drugs will work against the Omicron variant, though this is based on preliminary lab-based research.</p>
<h2>What are they and how do they work?</h2>
<p>Merck’s Lagevrio (generic name: <a href="https://theconversation.com/take-at-home-covid-drug-molnupiravir-may-be-on-its-way-but-vaccination-is-still-our-first-line-of-defence-169246">molnupiravir</a>) is an antiviral drug that causes errors to be copied into the COVID virus whenever it replicates. This makes the virus less effective in causing disease. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/take-at-home-covid-drug-molnupiravir-may-be-on-its-way-but-vaccination-is-still-our-first-line-of-defence-169246">Take-at-home COVID drug molnupiravir may be on its way — but vaccination is still our first line of defence</a>
</strong>
</em>
</p>
<hr>
<p>Pfizer’s <a href="https://theconversation.com/pfizers-pill-is-the-latest-covid-treatment-to-show-promise-here-are-some-more-171589">Paxlovid</a> is a two tablet combination of a new drug called nirmatrelvir, and a drug already used to treat HIV called ritonavir.</p>
<p>Nirmatrelvir stops the function of a key protein the virus needs to replicate itself, while ritonavir is there to stop the body from breaking down nirmatrelvir.</p>
<p>According to clinical trial data, <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2116044">Lagevrio</a> and <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-additional-phase-23-study-results">Paxlovid</a> are useful in reducing viral load, the severity of COVID symptoms, and thus, the number of people hospitalised and/or dying from the virus.</p>
<p>Many of Omicron’s concerning mutations are on the “spike protein”, which is what the coronavirus uses to enter our cells. So one reason these drugs are still expected to be effective against variants like Omicron is they don’t target the spike protein. </p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1400135449860096004"}"></div></p>
<h2>Are these medications effective against Omicron?</h2>
<p>This week Pfizer published a media release detailing preliminary results suggesting Paxlovid <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-shares-vitro-efficacy-novel-covid-19-oral-treatment">is still effective against the Omicron variant</a>.</p>
<p>The results of two laboratory <a href="https://www.biorxiv.org/content/10.1101/2022.01.17.476644v1">studies</a> by Pfizer researchers and released as pre-prints (yet to be reviewed by other scientists) shows that the nirmatrelvir can interrupt viral replication across all COVID variants of concern.</p>
<p>One independent <a href="https://www.biorxiv.org/content/10.1101/2021.12.27.474275v1">lab-based study</a> released online as a pre-print looked at both Pfizer and Merck’s drugs.</p>
<p>It found the key drug in Pfizer’s Paxlovid, nirmatrelvir, is still active against its protein target in Omicron, and can still reduce overall viral load. </p>
<p>The study also found Merck’s Lagevrio showed activity against Omicron. The president of Merck Research Laboratories <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/merck-expects-covid-19-pill-molnupiravir-be-effective-against-omicron-2022-01-10/">said</a> the company is very confident Lagevrio will be effective against Omicron. </p>
<p>It’s important to note this research was undetaken in a lab, so we’re still yet to see data on how effective it is in people with Omicron under real world conditions. With both drugs approved in the United States and United Kingdom earlier than Australia, it’s likely we’ll see in-person outcomes data on the effectiveness and safety of these drugs in the near future.</p>
<p>In clinical trials, before Omicron emerged, Paxlovid reduced the risk of hospitalisation and death by <a href="https://www.tga.gov.au/tga-provisionally-approves-pfizer-australia-pty-ltds-covid-19-treatment-nirmatrelvir-ritonavir-paxlovid">88%</a> in high-risk patients, and Lagevrio by <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2116044">31%</a>.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1483975059068919809"}"></div></p>
<h2>What are the side effects?</h2>
<p>It’s important to note no medicine is perfectly safe and side effect free. </p>
<p>From <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2116044">clinical trials</a> so far, we know fewer than 7% of patients taking Lagevrio experienced a serious side effect. Commonly <a href="https://www.tga.gov.au/sites/default/files/lagevrio-cmi.pdf">reported</a> were diarrhoea, nausea, and dizziness.</p>
<p>Different side effects were observed with <a href="https://www.tga.gov.au/sites/default/files/paxlovid-cmi.pdf">Paxlovid</a>, such as vomiting, diarrhoea, and headache, and fewer than 2% of patients in the <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-additional-phase-23-study-results">trials</a> experienced a serious side effect.</p>
<p>The risk of side effects with Paxlovid can be higher if patients are <a href="https://www.tga.gov.au/sites/default/files/paxlovid-cmi.pdf">also taking other medicines at the same time</a>. The list of medications that shouldn’t be taken with Paxlovid includes some anti-cancer, anti-inflammatory and cardiovascular medications, and even some herbal medicines such as St John’s Wort. </p>
<h2>Am I eligible for these treatments?</h2>
<p>Vulnerable people such as the elderly and aged care residents <a href="https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/two-anti-viral-covid-19-treatments-approved">will be prioritised</a> for access to the medication.</p>
<p>The government hasn’t stated when it expects other groups of people may be able to get the medicines, possibly due to the limited number of courses the government has purchased and because of <a href="https://www.washingtonpost.com/health/2022/01/04/antiviral-pills-supply-omicron/">supply difficulties being experienced in other countries</a>.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1478415468981542916"}"></div></p>
<p>Lagevrio and Paxlovid are both oral tablets which may mean you’ll be able take these at home, rather than spending time in hospital.</p>
<p>For both drugs, the tablets must be commenced as soon as possible and within five days of the first symptoms for them to be of any use. </p>
<p>Both medicines have also only been approved for use in adults. There’s no clinical trial data on the safety of Lagevrio or Paxlovid in children so we don’t know how effective and safe they would be in this age group.</p>
<p>There’s also uncertainty as to the potential impact either medicine may have on pregnancy and breastfeeding, so the Therapeutic Goods Administration (TGA) <a href="https://www.tga.gov.au/media-release/tga-provisionally-approves-two-oral-covid-19-treatments-molnupiravir-lagevrio-and-nirmatrelvir-ritonavir-paxlovid">advises</a> patients avoid these medicines in these circumstances. The TGA also recommends avoiding becoming pregnant soon after the use of either medicine.</p>
<h2>How and where can you get them?</h2>
<p>We don’t yet know whether people can obtain a prescription from any general practitioner or whether only specific doctors will be able to prescribe them (for example, geriatric specialists).</p>
<p>The government <a href="https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/two-anti-viral-covid-19-treatments-approved">says</a> the first deliveries of these medicines will arrive “over the coming weeks”.</p>
<p>The health minister also said both medicines will be <a href="https://www.smh.com.au/national/australia-news-live-booster-shot-wait-times-accelerated-in-nsw-victoria-as-covid-19-cases-grow-across-the-nation-2022-australian-open-continues-in-melbourne-20220119-p59pjx.html?post=p5392o#p5392o">free for patients</a>.</p>
<p>Despite the promising treatment opportunity these drugs provide in the fight against COVID, vaccination will still remain the front line of defence against the virus.</p><img src="https://counter.theconversation.com/content/175321/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Elise Schubert is a registered pharmacist and a PhD Candidate receiving scholarship from the University of Sydney and Canngea Pty Ltd.
</span></em></p><p class="fine-print"><em><span>Associate Professor Kellie Charles is a Director of the Board of the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT). She has previously held research grants and provided research advice to Johnson and Johnson (unrelated to the products discussed here). </span></em></p><p class="fine-print"><em><span>Associate Professor Wheate in the past has received funding from the ACT Cancer Council, Tenovus Scotland, Medical Research Scotland, Scottish Crucible, and the Scottish Universities Life Sciences Alliance. He is Fellow of the Royal Australian Chemical Institute and a member of the Australasian Pharmaceutical Science Association. Nial is the science director of Canngea Pty Ltd, chief scientific officer of Vairea Skincare LLC, a board director of the Australian Medicinal Cannabis Association, and a Standards Australia panel member for sunscreen agents.</span></em></p>Both companies say their drugs will work against the Omicron variant, though this is based on preliminary, lab-based research.Elise Schubert, Pharmacist and PhD Candidate, University of SydneyKellie Charles, Head of Pharmacology, Associate Professor in Pharmacology, University of SydneyNial Wheate, Associate Professor of the Sydney Pharmacy School, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1746052022-01-10T03:44:56Z2022-01-10T03:44:56ZWhy has my child’s vaccination been cancelled? We’re reliant on overseas supply and a complex logistics network<figure><img src="https://images.theconversation.com/files/439941/original/file-20220110-13-gd4wmt.jpg?ixlib=rb-1.1.0&rect=0%2C22%2C5058%2C2589&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>Reports of GPs <a href="https://www.abc.net.au/radionational/programs/breakfast/child-vaccine-appointments-delayed-or-cancelled/13700424">cancelling</a> or postponing COVID vaccine appointments for 5-11 year olds are piling up, with desperate parents expressing anger and fear about how their as-yet unvaccinated children will fare as Omicron case numbers explode.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1479256529991651333"}"></div></p>
<p>Federal COVID-19 Task Force Commander Lieutenant General John Frewen <a href="https://www.health.gov.au/news/lieutenant-general-john-frewens-interview-on-sunrise-on-10-january-2022">said</a> on Monday:</p>
<blockquote>
<p>Supply isn’t the issue; we’ve got enough vaccines. The real challenge now is just getting the distribution to where the demand is greatest. </p>
</blockquote>
<p>South Australia’s health deputy chief executive Don Frater, however, has reportedly <a href="https://indaily.com.au/news/2022/01/10/sa-health-reveals-shortfall-of-vaccines-for-children/">said</a> that state has “more demand than what we have supply”.</p>
<p>The child’s dose comes in different vials to the adult dose, with <a href="https://www.ncirs.org.au/safety-side-effects-allergies-and-doses-covid-19-pfizer-vaccine-5-11-year-olds-explained">different packaging</a>.</p>
<p>The rollout of the Pfizer vaccine for children has come at a difficult time, from a logistics perspective. Many GPs have said “delivery delays” are behind the need to reschedule appointments.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/australia-may-miss-out-on-several-covid-vaccines-if-it-cant-make-mrna-ones-locally-148996">Australia may miss out on several COVID vaccines if it can't make mRNA ones locally</a>
</strong>
</em>
</p>
<hr>
<h2>What might be behind the delays?</h2>
<p>This is a specialised product, which needs to be stored in special freezers <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-covid-19-vaccine-stability-data">at -80°C</a>, and obviously needs to be transported in a certain way. </p>
<p>There are a lot of steps in the transport process – from the supplier overseas to the shipping service bringing them to Australia, from their landing spot in the country, to specialised storage, to individual GPs.</p>
<p>Each of those steps require staff on the ground to ensure the system works – and many workers in this system are likely being affected by Omicron.</p>
<p>The same staffing issues resulting in <a href="https://theconversation.com/supermarket-shortages-are-different-this-time-how-to-respond-and-avoid-panic-174529">empty supermarket shelves</a> could be affecting the vaccine distribution network too. </p>
<p>Thousands of drivers, administration staff, packers and logistics planners could be furloughed, off sick or in isolation because a household member is.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1479356503849332738"}"></div></p>
<p>The rollout of the 5-11 year old vaccination program, timed in an effort to get kids vaccinated before school starts, also comes hot on the heels of the Christmas and New Year break; even without Omicron, it’s possible staffing numbers across the supply chain and logistics network are still yet to return to pre-Christmas levels.</p>
<p>There have been <a href="https://twitter.com/Leighma03/status/1479403027517755392">anecdotal reports</a> of <a href="https://twitter.com/Leighma03/status/1479403027517755392">some</a> people having their booster appointments being cancelled too, so it seems it is not only 5-11 year olds who are affected.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/safety-side-effects-allergies-and-doses-the-covid-19-pfizer-vaccine-for-5-11-year-olds-explained-173323">Safety, side effects, allergies and doses. The COVID-19 Pfizer vaccine for 5-11 year olds explained</a>
</strong>
</em>
</p>
<hr>
<p>It’s hard to know how widespread the issue is. Frewen told Sunrise on Monday</p>
<blockquote>
<p>if you’re having trouble at the moment, maybe with your normal healthcare provider, your GP, then please do try pharmacies, maybe try one of the state and territory clinics as they come online. </p>
</blockquote>
<p>He <a href="https://twitter.com/RNBreakfast/status/1480285219496202240">told</a> RN Breakfast that: </p>
<blockquote>
<p>We will have more than enough vaccines for every kid to have their first dose before the end of the year.</p>
</blockquote>
<p>This must be very frustrating for people who have tried to get in early and are keen to have their children vaccinated as soon as possible.</p>
<p>Clearly, something has fallen over somewhere in the distribution. It would be good to have some clarity from government and industry on exactly where the systemic problems are and what’s being planned to address them.</p>
<h2>Domestic production of mRNA vaccines</h2>
<p>The Therapeutic Goods Administration (TGA) only just provisionally approved the use of Pfizer’s COMINARTY COVID vaccine for people aged 5-11 years on <a href="https://www.tga.gov.au/covid-19-vaccines-undergoing-evaluation">December 3</a>.</p>
<p>Moderna’s application for the use of SPIKEVAX COVID vaccine for children under age 12 is still <a href="https://www.tga.gov.au/covid-19-vaccines-undergoing-evaluation">under evaluation</a>, according to the TGA.</p>
<p>Hopefully, once that is approved, parents of children in the 5-11 year old age bracket will have more choice on where and how they can get their child vaccinated.</p>
<p>Both Pfizer and Moderna’s COVID vaccines are mRNA vaccines, and experts have long called for a boost in domestic mRNA manufacturing capacity so Australia is less reliant on overseas supplies.</p>
<p>Promisingly, Moderna and the Australian government late last year <a href="https://www.biopharma-reporter.com/Article/2021/12/14/Moderna-to-build-mRNA-vaccine-manufacturing-facility-in-Australia">announced</a> an in-principle agreement to build a mRNA manufacturing facility in Victoria. The site will hopefully be up and running by 2024, according to media <a href="https://www.abc.net.au/news/2021-12-14/moderna-to-be-first-mrna-vaccine-made-in-australia/100697324">reports</a>. </p>
<p>That’s something to be celebrated, and domestic manufacturing would hopefully mean a shorter and less complex supply chain with less opportunity for difficulties in future. But it does highlight it would have been good to have something worked out earlier. </p>
<p>It would also be prudent for the government to consider what it might take to lure Pfizer to develop mRNA manufacturing capability in Australia. You could argue, from a market point of view, it could be strategic for Moderna to have a manufacturing competitor here in Australia too. </p>
<p>If we are serious about building our biotechnology sector in Australia, then having monopoly of just one player in the country might not be ideal.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/supermarket-shortages-are-different-this-time-how-to-respond-and-avoid-panic-174529">Supermarket shortages are different this time: how to respond and avoid panic</a>
</strong>
</em>
</p>
<hr>
<img src="https://counter.theconversation.com/content/174605/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Archa Fox receives funding from the Australian Research Council. She is a member of the Australia New Zealand RNA Production Consortium that has lobbied for establishment of onshore mRNA vaccine manufacturing in Australia</span></em></p>We’re reliant on overseas supply - and the many moving parts of delivery. Each of those parts require staff on the ground – and many workers in this system are likely being affected by Omicron.Archa Fox, Associate Professor and ARC Future Fellow, The University of Western AustraliaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1741952022-01-09T13:14:44Z2022-01-09T13:14:44ZOmicron: Vaccines remain the best defence against this COVID-19 variant and others<figure><img src="https://images.theconversation.com/files/439616/original/file-20220106-13-ngc07h.jpg?ixlib=rb-1.1.0&rect=125%2C26%2C5622%2C4136&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The best way to stop new variants from arising is to increase the proportion of vaccinated individuals while maintaining infection prevention measures like wearing masks and social distancing.</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><iframe style="width: 100%; height: 175px; border: none; position: relative; z-index: 1;" allowtransparency="" src="https://narrations.ad-auris.com/widget/the-conversation-canada/omicron--vaccines-remain-the-best-defence-against-this-covid-19-variant-and-others" width="100%" height="400"></iframe>
<p>We have made it through another pandemic winter holiday. Fortunately, COVID-19 fatalities have decreased since the year before, however, the numbers still weren’t ideal. Using Dec. 25 as a reference date, <a href="https://ourworldindata.org/explorers/coronavirus-data-explorer?zoomToSelection=true&time=2020-03-01..latest&facet=none&pickerSort=asc&pickerMetric=location&Metric=Confirmed+deaths&Interval=7-day+rolling+average&Relative+to+Population=true&Align+outbreaks=false&country=USA%7ECAN">the death rate from COVID-19</a> in the United States was 4.27 per million in 2021, compared to 7.48 per million in 2020. In Canada, it was 0.42 per million in 2021, compared to 2.95 per million the previous year — a much more significant decrease. </p>
<p>The difference that vaccination is making becomes clear when comparing the <a href="https://ourworldindata.org/explorers/coronavirus-data-explorer?zoomToSelection=true&time=2020-03-01..latest&facet=none&pickerSort=asc&pickerMetric=location&Metric=People+fully+vaccinated&Interval=7-day+rolling+average&Relative+to+Population=true&Align+outbreaks=false&country=USA%7ECAN">corresponding rates of fully vaccinated people: 61.4 per cent in the U.S. compared to 77.1 per cent in Canada</a>. The higher vaccination rate in Canada corresponds to the more sharply reduced death rate.</p>
<p>As a medical doctor and researcher of COVID-19, I am optimistic about the power of increased vaccination rates in combination with infection prevention practices to fight the pandemic. </p>
<p>Waiting for <a href="https://theconversation.com/5-failings-of-the-great-barrington-declarations-dangerous-plan-for-covid-19-natural-herd-immunity-148975">natural herd immunity</a> will not fix this or save lives. In the U.S., the <a href="https://www.nytimes.com/interactive/2021/us/covid-cases.html">55 million people who have tested positive for COVID-19</a> since the pandemic began represent only about 17 per cent of the roughly 330 million population — nowhere near the <a href="https://theconversation.com/covid-19-may-never-go-away-but-practical-herd-immunity-is-within-reach-162406">level needed for herd immunity</a>. The only ethical means of achieving herd immunity is vaccination.</p>
<h2>Omicron</h2>
<p>Unfortunately, the Omicron variant may have <a href="https://pubmed.ncbi.nlm.nih.gov/34873578/">greater potential to infect people than past variants</a>, and may be more able to infect fully vaccinated and boosted individuals, according to research awaiting peer review. This new form of the virus is a product of its natural evolution. The longer a pandemic lasts, the more changes occur with a virus. </p>
<p>The best way to stop new variants from arising is to increase the proportion of vaccinated individuals while maintaining infection prevention measures, like following recommendations for face masks and social distancing. <a href="https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html#:%7E:text=Evidence%20suggests%20the%20US%20COVID,interrupting%20chains%20of%20transmission.">Vaccinated individuals are less likely to pass on the virus if they do become infected</a>.</p>
<p>Most cases and deaths <a href="https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status">continue to affect unvaccinated individuals</a>. Further sickness and death are largely preventable, just as most of the illness and death in recent months were. Vaccine refusal, in the absence of valid medical reasons, and not adhering to infection prevention measures are largely responsible for the continued hardship of the pandemic. </p>
<h2>Vaccines and variants</h2>
<p>Vaccines remain an effective tool towards ending the pandemic, particularly against Omicron. This is despite research awaiting peer review indicating the new variant may have <a href="https://pubmed.ncbi.nlm.nih.gov/34873578/">greater potential to infect people than past variants</a>, and may be more able to infect fully vaccinated and boosted individuals. </p>
<p>More data is needed to establish how much more or less infectious the Omicron variant is compared to others, but <a href="https://asm.org/Articles/2021/December/How-Ominous-is-the-Omicron-Variant-B-1-1-529">Omicron’s ability to infect vaccinated individuals (albeit less so than unvaccinated individuals) is concerning</a>. That means infection prevention activities, like wearing a mask and social distancing regardless of vaccination status, are still essential. <a href="https://doi.org/10.1038/d41586-021-03614-z">Poor adherence to these measures can be enough to increase cases in a community</a>, even with many vaccinated folks. </p>
<figure class="align-center ">
<img alt="Illustration of a row of coronaviruses in a gradient of colours" src="https://images.theconversation.com/files/439629/original/file-20220106-19-173dcvj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/439629/original/file-20220106-19-173dcvj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=217&fit=crop&dpr=1 600w, https://images.theconversation.com/files/439629/original/file-20220106-19-173dcvj.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=217&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/439629/original/file-20220106-19-173dcvj.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=217&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/439629/original/file-20220106-19-173dcvj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=272&fit=crop&dpr=1 754w, https://images.theconversation.com/files/439629/original/file-20220106-19-173dcvj.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=272&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/439629/original/file-20220106-19-173dcvj.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=272&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">The longer a pandemic lasts, the more changes occur with a virus.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>While vaccines are less protective against becoming infected with Omicron than other variants, <a href="https://directorsblog.nih.gov/2021/12/14/the-latest-on-the-omicron-variant-and-vaccine-protection/">they offer significant protection against developing an infection</a> and <a href="http://doi.org/10.1056/NEJMc2119270">severe illness</a>. </p>
<p>For those who have already had COVID-19 but have not been vaccinated, the evidence available so far suggests that they should still get vaccinated <a href="https://www.imperial.ac.uk/mrc-global-infectious-disease-analysis/covid-19/report-49-Omicron/">because past infection did not protect against Omicron</a>. While there are claims that Omicron produces milder illness, one cannot rely on this when infected individuals still face a significant chance of severe disease.</p>
<p>Several months of winter remain, and COVID-19 <a href="https://globalnews.ca/news/8479373/covid-canada-omicron-christmas/">cases are ballooning again</a>. There is reason to believe that the pandemic will get worse before it gets better. </p>
<h2>Pandemic toolkit</h2>
<p>Booster shots are readily available in the U.S. and are increasingly available in Canada. <a href="https://directorsblog.nih.gov/2021/12/14/the-latest-on-the-omicron-variant-and-vaccine-protection/">Boosters have been shown to confer increased protection against the Omicron variant</a>. </p>
<p>It is everyone’s social responsibility to get the booster, with the exception of the very few people who are allergic to vaccine components. Research showed that <a href="http://doi.org/10.1001/jamanetworkopen.2021.22255">being highly allergic to something that is not vaccine-related rarely equates with an expected severe allergic reaction to the vaccine</a>. </p>
<figure class="align-center ">
<img alt="Illustration of a hand holding a syringe pointed at a coronavirus against a background of stopwatches" src="https://images.theconversation.com/files/439630/original/file-20220106-27-1yqmm7w.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/439630/original/file-20220106-27-1yqmm7w.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=209&fit=crop&dpr=1 600w, https://images.theconversation.com/files/439630/original/file-20220106-27-1yqmm7w.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=209&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/439630/original/file-20220106-27-1yqmm7w.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=209&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/439630/original/file-20220106-27-1yqmm7w.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=263&fit=crop&dpr=1 754w, https://images.theconversation.com/files/439630/original/file-20220106-27-1yqmm7w.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=263&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/439630/original/file-20220106-27-1yqmm7w.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=263&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Vaccines remain an effective tool towards ending the pandemic, particularly against Omicron.</span>
<span class="attribution"><span class="source">(Pixabay)</span></span>
</figcaption>
</figure>
<p>I have an allergy to shellfish that has placed me in the hospital when I inadvertently consumed it. Nothing happened to me when receiving any of my three shots of COVID-19 vaccines, and the above research suggests that this would be the case for most people with non-vaccine allergies. </p>
<p>The risks of COVID-19 far outweigh the very small risk of having an allergic reaction to the vaccine. In the unlikely event that you did have an allergic reaction to the vaccine, such reactions are typically mild and readily treated.</p>
<p>The pandemic will get better if we work together. While news of Omicron and implications on vaccine effectiveness are disheartening, more systems are in place to respond to this change and future changes in the pandemic. Pfizer, one of the drug makers of the effective COVID-19 vaccines, <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-provide-update-omicron-variant">has already announced a readiness to produce vaccines adapted to the changing virus</a>. We can expect other manufacturers to follow suit, ensuring that the therapies needed to meet this challenge are available. </p>
<p>This leaves it up to consumers — us — to do our part in ending the pandemic.</p><img src="https://counter.theconversation.com/content/174195/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Julian Daniel Sunday Willett does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Even with a variant like Omicron that may be more transmissible than earlier variants, vaccines remain the most effective tool for protection against COVID-19 and for ending the pandemic.Julian Daniel Sunday Willett, PhD Candidate, Quantitative Life Sciences, McGill UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1733232021-12-09T22:29:53Z2021-12-09T22:29:53ZSafety, side effects, allergies and doses. The COVID-19 Pfizer vaccine for 5-11 year olds explained<figure><img src="https://images.theconversation.com/files/436314/original/file-20211208-137612-19ufg0r.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/mixed-asian-young-girl-showing-her-2013119786">Shutterstock</a></span></figcaption></figure><p>Australian children aged 5-11 will start to receive the Pfizer COVID-19 vaccine <a href="https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/tga-provisionally-approves-pfizer-covid-19-vaccine-for-5-to-11-year-olds">from January 10</a>, after it cleared the final regulatory step and was recommended for use in this age group by the <a href="https://www.health.gov.au/resources/publications/atagi-recommendations-on-pfizer-covid-19-vaccine-use-in-children-aged-5-to-11-years">Australian Technical Advisory Group on Immunisation</a> (ATAGI).</p>
<p>ATAGI recommends children aged 5-11 receive two 10 microgram doses (which is one-third of the over-12s dose), eight weeks apart.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1469064866371497984"}"></div></p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/covid-vaccines-for-5-to-11-year-olds-are-inching-closer-heres-what-we-know-so-far-169732">COVID vaccines for 5 to 11 year olds are inching closer. Here's what we know so far</a>
</strong>
</em>
</p>
<hr>
<h2>What does the trial data say about safety and efficacy?</h2>
<p>The <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2116298">Pfizer vaccine trial</a> included 2,268 children aged 5-11. Of these children, 1,517 were given two doses of 10 microgram vaccine three weeks apart, and 751 who were given a placebo. The results found the vaccine was safe and had good efficacy. </p>
<p>Children given the vaccine had similar antibody levels after the second dose to older adolescents and young adults (aged 16-25). This indicates their immune system was able to recognise the lower amount of vaccine mRNA – the vital ingredient in the Pfizer vaccine – and still produce a good amount of antibody to protect against the virus. </p>
<p>There were no serious reactions in this trial, however the sample size wasn’t large enough to detect rare adverse events. </p>
<figure class="align-center ">
<img alt="Boy smiles and cuddles his mother after being vaccinated." src="https://images.theconversation.com/files/436316/original/file-20211208-23-18ubofu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/436316/original/file-20211208-23-18ubofu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=350&fit=crop&dpr=1 600w, https://images.theconversation.com/files/436316/original/file-20211208-23-18ubofu.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=350&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/436316/original/file-20211208-23-18ubofu.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=350&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/436316/original/file-20211208-23-18ubofu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=440&fit=crop&dpr=1 754w, https://images.theconversation.com/files/436316/original/file-20211208-23-18ubofu.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=440&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/436316/original/file-20211208-23-18ubofu.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=440&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">The most common side effect is a sore arm.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/happy-boy-mom-getting-vaccine-shot-2000430659">Shutterstock</a></span>
</figcaption>
</figure>
<p>The <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2116298">most common side effects</a> occurred in the first two to three days and included:</p>
<ul>
<li>painful arm (around 70% at any time in the first week after vaccination but usually in the first few days) </li>
<li>headache (around 25%) </li>
<li>tiredness (around 35%).</li>
</ul>
<p>The vaccine was around 90% effective at preventing confirmed COVID-19 infection, with three COVID cases in the vaccine group and 16 in the placebo group.</p>
<p>Based on this data, the Therapeutic Goods Administration (TGA) <a href="https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/tga-provisionally-approves-pfizer-covid-19-vaccine-for-5-to-11-year-olds">provisionally approved the vaccine</a> for use in 5-11 year-old Australians on Sunday, following United States’ Food and Drug Administration (FDA) approval at the <a href="https://www.fda.gov/media/153447/download">end of October</a>. </p>
<h2>How safe and effective has it been overseas?</h2>
<p>Australia has around <a href="https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/tga-provisionally-approves-pfizer-covid-19-vaccine-for-5-to-11-year-olds">2.3 million</a> children aged 5-11. So we can look to the real-world experience of the Pfizer vaccine in the US to see what we can expect. </p>
<p>More than <a href="https://data.cdc.gov/Vaccinations/COVID-19-Vaccination-Demographics-in-the-United-St/km4m-vcsb">5 million US children aged 5-11</a> have had one dose and more than 2 million have had a second dose. </p>
<figure class="align-center ">
<img alt="Two children in masks wait by a door." src="https://images.theconversation.com/files/436315/original/file-20211208-68670-18bege4.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/436315/original/file-20211208-68670-18bege4.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/436315/original/file-20211208-68670-18bege4.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/436315/original/file-20211208-68670-18bege4.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/436315/original/file-20211208-68670-18bege4.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/436315/original/file-20211208-68670-18bege4.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/436315/original/file-20211208-68670-18bege4.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">The US has administered more than 2 million second doses to 5-11 year olds.</span>
<span class="attribution"><a class="source" href="https://unsplash.com/photos/RYABMCLP7aM">Kelly Sikkema/Unsplash</a></span>
</figcaption>
</figure>
<p>One potential concern authorities are watching out for is the risk of heart inflammation, called myocarditis. This is a rare side effect after the second dose in young males aged 12-17, with an <a href="https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report-02-12-2021">estimated risk</a> of around ten cases per 100,000. </p>
<p>No cases of myocarditis, or the related condition pericarditis, were reported in the clinical trial of 5-11 year olds.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/the-benefits-of-a-covid-vaccine-far-outweigh-the-small-risk-of-treatable-heart-inflammation-163970">The benefits of a COVID vaccine far outweigh the small risk of treatable heart inflammation</a>
</strong>
</em>
</p>
<hr>
<p>No data is yet available on the real world effectiveness of the vaccine to protect against hospitalisation or infection in children aged 5-11, however this will emerge.</p>
<h2>Why an 8 week interval?</h2>
<p>The US, European Union, Canada and Israel have approved Pfizer for younger children. The US has gone with a three week interval between doses, while <a href="https://www.canada.ca/en/public-health/services/immunization/national-advisory-committee-on-immunization-naci/recommendations-use-covid-19-vaccines/pfizer-biontech-10-mcg-children-5-11-years-age.html">Canada recommends</a> eight weeks. </p>
<p>There are <a href="https://www.health.gov.au/sites/default/files/documents/2021/12/atagi-recommendations-on-pfizer-covid-19-vaccine-use-in-children-aged-5-to-11-years.docx">two reasons</a> for a wider interval. The first is a <a href="https://www.medrxiv.org/content/medrxiv/early/2021/10/26/2021.10.26.21265397.full.pdf">potentially better immune response</a>. Studies in adults <a href="https://www.medrxiv.org/content/10.1101/2021.07.26.21261140v1">have shown</a> a larger gap between doses has resulted in a higher antibody immune response and better vaccine effectiveness, although this has not been shown yet for children under 12. </p>
<p>The second is a possible lower risk of <a href="https://www.medrxiv.org/content/10.1101/2021.12.02.21267156v1">developing myocarditis</a>. In a Canadian study, young adults aged 18-24 had lower rates of myocarditis when the interval between dose one and two was greater than eight weeks compared to those with an interval of less than 30 days between doses. </p>
<p>While similar data for children under 12 is not yet available, a recommendation for a wider interval allows us to continue to monitor real-world international experience of the risk of myocarditis. </p>
<h2>Who should be first in line to get the vaccine?</h2>
<p>Some children with underlying medical conditions are more likely to get sicker with COVID. This <a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2780706">includes</a> those with obesity, diabetes, neurological diseases, heart and lung conditions. These children should be among the first to get the vaccine next January.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/it-might-be-uncomfortable-to-talk-about-but-obesity-puts-children-at-risk-of-severe-covid-171116">It might be uncomfortable to talk about. But obesity puts children at risk of severe COVID</a>
</strong>
</em>
</p>
<hr>
<h2>If my child is about to turn 12, should I wait?</h2>
<p>There is no major difference in the immune systems of an 11 and 12 year old. </p>
<p>The age cut-off was chosen based on the ages of the children in the vaccine trials. These age groupings were most likely designed to match the ages children are when they attend primary and high school. </p>
<p>If your 11 year old is about to turn 12, they should get the dose at 11 and not wait. </p>
<figure class="align-center ">
<img alt="Boy in a mask sits in a classroom." src="https://images.theconversation.com/files/436317/original/file-20211208-159504-1o39w15.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/436317/original/file-20211208-159504-1o39w15.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/436317/original/file-20211208-159504-1o39w15.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/436317/original/file-20211208-159504-1o39w15.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/436317/original/file-20211208-159504-1o39w15.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/436317/original/file-20211208-159504-1o39w15.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/436317/original/file-20211208-159504-1o39w15.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">Your child should get the dose recommended for their age.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/black-schoolboy-writing-notebook-during-class-2018661608">Shutterstock</a></span>
</figcaption>
</figure>
<p>If they had the 10 microgram dose and turn 12 before their second dose is due, ATAGI says they may get a 30 microgram second dose when they are 12.</p>
<h2>How will the vaccine be administered?</h2>
<p>The lower (10 microgram) child’s dose has been packaged in orange-top vials so it doesn’t get confused with the purple- or grey-top (30 microgram) dose vial used for adults. </p>
<p>The vaccine will be given in the child’s upper arm, and you and child will need to wait for at least 15 minutes after vaccination in case of a reaction. </p>
<p>The vaccine will be available through general practices, Aboriginal Health Services, community pharmacies and state and territory clinics. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/is-your-child-frightened-of-needles-heres-how-to-prepare-them-for-their-covid-vaccine-170791">Is your child frightened of needles? Here's how to prepare them for their COVID vaccine</a>
</strong>
</em>
</p>
<hr>
<p>Your child <a href="https://www.health.gov.au/sites/default/files/documents/2021/12/atagi-recommendations-on-pfizer-covid-19-vaccine-use-in-children-aged-5-to-11-years.docx">can get other vaccines at the same time</a>, if they’re due, but there is very limited data on the side effects when both a COVID and non-COVID vaccine are given at the same time. </p>
<p>If your child has had COVID-19 disease in the past they should still get vaccinated but it is important to make sure they have completely recovered before getting a vaccine. You can wait up to six months after natural infection before getting the vaccine. If in doubt talk with your GP.</p>
<h2>Can my child with allergies still get the vaccine?</h2>
<p>Children who have had an allergic reaction to a substance called PEG (<a href="https://mvec.mcri.edu.au/references/covid-19-vaccines-and-allergy/">polyethylene glycol</a>) – which is a commonly used ingredient of other medications, hand sanitisers, cosmetics and bathroom products – should talk to their GP before getting the vaccine.</p>
<p>If your child has an allergic reaction after the first dose, talk to your GP before getting dose two. </p>
<p>Children who are allergic to foods such as nuts, milk or eggs, or those who have asthma or hay fever, can <a href="https://ncirs.org.au/covid-19/covid-19-vaccines-frequently-asked-questions">safely receive</a> the Pfizer vaccine. </p>
<h2>When will kids under 5 be vaccinated?</h2>
<p>Results from clinical trials in children under five years old are <a href="https://www.theatlantic.com/science/archive/2021/09/pfizer-ceo-vaccine-young-children-2-4/620236/">expected soon</a>.</p>
<p>A lower dose of 3 micrograms of the Pfizer vaccine is being trialled in <a href="https://clinicaltrials.gov/ct2/show/NCT04816643?term=Pfizer+children+under+2+years&cond=COVID-19&draw=2&rank=2">children aged six months to two years</a>. </p>
<p>Moderna is also <a href="https://trials.modernatx.com/study/?id=mRNA-1273-P204">trialling lower doses of its vaccine</a> in children under five. </p>
<p>Vaccinating 5-11 year-old Australian children is is an important next step in our ability to protect both ourselves and the community against COVID-19. The safety of the vaccines will be closely monitored as we roll them out in January and aim to give first doses before children go back to school.</p><img src="https://counter.theconversation.com/content/173323/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Nicholas Wood receives funding from the NHMRC for a Career Development Fellowship. He holds a Churchill Fellowship</span></em></p>The Pfizer COVID-19 vaccine will be available for children aged 5-11 from January 10, after it cleared the final regulatory step. Here’s what you need to know.Nicholas Wood, Associate Professor, Discipline of Childhood and Adolescent Health, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1727392021-11-27T17:52:02Z2021-11-27T17:52:02ZOmicron is the new COVID kid on the block: five steps to avoid, ten to take immediately<figure><img src="https://images.theconversation.com/files/434237/original/file-20211127-13-wc9y6t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">What not to do: ban travel. Scenes at South Africa's OR Tambo International airport after the first flight bans were announced.</span> <span class="attribution"><span class="source">Phill Magakoe / AFP via Getty Images</span></span></figcaption></figure><p>South Africa reacted <a href="https://www.news24.com/news24/southafrica/news/omicron-variant-south-africa-being-punished-by-international-community-says-dirco-20211127">with outrage</a> to <a href="https://www.bbc.com/news/world-59442129">travel bans</a>, first <a href="https://www.gov.uk/foreign-travel-advice/south-africa">triggered by the UK</a>, imposed on it in the wake of the <a href="https://www.nicd.ac.za/new-covid-19-variant-detected-in-south-africa/">news</a> that its genomics surveillance team had detected a new variant of the SARS-CoV-2 virus. The <a href="https://www.ngs-sa.org/">Network for Genomics Surveillance in South Africa</a> has been monitoring changes in SARS-CoV-2 since the pandemic first broke out. </p>
<p>The new variant – identified as B.1.1.529 has been <a href="https://www.who.int/news/item/26-11-2021-classification-of-omicron-(b.1.1.529)-sars-cov-2-variant-of-concern">declared a variant of concern</a> by the World Health Organisation and assigned the name Omicron. </p>
<p>The mutations identified in Omicron provide theoretical concerns that the variant could be slightly more transmissible than the Delta variant and have reduced sensitivity to antibody activity induced by past infection or vaccines compared to how well the antibody neutralises ancestry virus. </p>
<p>As vaccines differ in the magnitude of neutralising antibody induced, the extent to which vaccines are compromised in preventing infections due to Omicron will likely differ, as was the case for the Beta variant. </p>
<p>However, as vaccines also induce a T-cell response against a diverse set of epitopes, which appears to be important for prevention of severe COVID, it is likely that they would still provide comparable protection against severe COVID due to Omicron compared with other variants. </p>
<p>The same was observed for the AstraZeneca vaccine. Despite not protecting against the mild-moderate Beta COVID in South Africa, it still <a href="https://www.clinicaltrialsarena.com/news/astrazeneca-vaxzevria-effective-variants/">showed high levels of protection</a> (80% effective) against hospitalisation due to the Beta and Gamma variants in Canada. </p>
<p>In view of the new variant, there are a few steps that governments shouldn’t be taking. And some they should be taking.</p>
<h2>What not to do</h2>
<p>Firstly, don’t indiscriminately impose further restrictions, except on indoor gatherings. It was unsuccessful in reducing infections over the past 3 waves in South Africa, <a href="https://businesstech.co.za/news/trending/538856/new-modelling-shows-what-to-expect-from-fourth-covid-19-wave-in-south-africa/">considering 60%-80%</a> people were infected by the virus based on sero-surveys and modelling data. At best, the economically damaging restrictions only spread out the period of time over which the infections took place by about 2-3 weeks. </p>
<p>This is unsurprising in the South African context, where ability to adhere to the high levels of restrictions are impractical for the majority of the population and adherence is generally poor.</p>
<p>Secondly, don’t have domestic (or international) travel bans. The virus will disseminate irrespective of this – as has been the case in the past. It’s naive to believe that imposing travel bans on a handful of countries will stop the import of a variant. This virus will disperse across the globe unless you are an island nation that shuts off the rest of the world. </p>
<p>The absence of reporting of the variants from countries that have limited sequencing capacity does not infer absence of the variant. Furthermore, unless travel bans are imposed on all other nations that still allow travel with the “red-listed” countries, the variant will directly or indirectly still end up in countries imposing selective travel bans, albeit perhaps delaying it slightly. </p>
<p>In addition, by the time the ban has been imposed, the variant will likely have already been spread. This is already evident from cases of Omicron being reported from <a href="https://ewn.co.za/2021/11/26/new-covid-variant-discovered-in-sa-now-identified-in-belgium">Belgium</a> in a person with no links to contact with someone from Southern Africa, as well <a href="https://www.aljazeera.com/news/2021/11/27/omicron-variant-covid-southern-africa-travel-restrictions">as cases in</a> Israel, UK and Germany.</p>
<p>All travel bans accomplish in countries with selective red-listed countries is delay the inevitable. More could possibly be accomplished by rigorous exit and entry screening programmes to identify potential cases and mandating vaccination.</p>
<p>Third, don’t announce regulations that are not implementable or enforceable in the local context. And don’t pretend that people adhere to them. This includes banning alcohol sales, whilst being unable to effectively police the black market. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/the-hunt-for-coronavirus-variants-how-the-new-one-was-found-and-what-we-know-so-far-172692">The hunt for coronavirus variants: how the new one was found and what we know so far</a>
</strong>
</em>
</p>
<hr>
<p>Fourth, don’t delay and create hurdles to boosting high risk individuals. The government should be targeting adults older than 65 with an additional dose of the Pfizer vaccine after they’ve had two shots. The same thing goes for other risk groups such as people with kidney transplants, or people with cancer and on chemotherapy, people with any other sort of underlying immuno-suppressive condition.</p>
<p>South Africa shouldn’t be ignoring World Health Organisation’s guidance which recommends booster doses of high risk groups. It should de-prioritise, for the time being, vaccinating young children with a single dose.</p>
<p>Fifth, stop selling the herd immunity concept. It’s not going to materialise and paradoxically undermines vaccine confidence. The first generation vaccines are highly effective in protecting against severe COVID-19, but less predictable in protecting against infection and mild COVID due to waning of antibody and ongoing mutations of the virus. Vaccination still reduces transmission modestly, which remains of great value, but is unlikely to lead to “herd-immunity” in our lifetimes. </p>
<p>Instead we should be talking about how to adapt and learn to live with the virus. </p>
<p>There is also a list of things that should be considered in the wake of the Omicron variant, irrespective of whether it displaces the Delta variant (which remains unknown).</p>
<h2>What to do</h2>
<p>Firstly, ensure health care facilities are prepared, not only on paper – but actually resourced with staff, personal protective equipment and oxygen, etc. </p>
<p>There are 2000 interns and community service doctors in South Africa waiting for their 2022 placement confirmation. We cannot once again be found wanting with under-prepared health facilities. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/top-scientist-why-south-africa-shouldnt-be-giving-12-17-year-olds-covid-shots-now-171141">Top scientist: why South Africa shouldn't be giving 12-17 year olds COVID shots -- now</a>
</strong>
</em>
</p>
<hr>
<p>Provide booster doses of J&J or Pfizer to <em>all</em> adults who received a single dose J&J. It’s needed to increase protection against severe COVID. A single dose of the J&J vaccine <a href="https://www.dailymaverick.co.za/article/2021-08-06-jj-vaccine-effective-against-delta-in-south-africas-sisonke-trial/">reduced hospitalisation</a> due to Delta variant in South Africa by 62% in South African healthcare workers, whereas two doses of AZ and mRNA vaccines in general had greater than 80%-90% protection against severe disease from the <a href="https://doi.org/10.1038/s41586-021-04120-y">Delta variant</a>. </p>
<p>Studies confirm a two dose schedule of the Johnson & Johnson vaccine is superior in protecting against hospitalisation than a single dose. And if you want durability of protection, you need to boost, which can be done with another dose of Johnson & Johnson or a dose of mRNA vaccine. </p>
<p>The <a href="https://www.thelancet.com/journals/lanepe/article/PIIS2666-7762(21)00235-0/fulltext">evidence is clear</a> that the type of immune responses from a heterologous approach of AZ or JJ followed by a mRNA vaccines such as Pfizer/Biontech induces superior neutralising and cell mediated immune responses than two doses of the non-replicating vector vaccines. </p>
<p>Thirdly, implement vaccine passports for entry into any indoor space where others gather, including places of worship and public transport. Vaccination might be a choice currently, however, choices come with consequences. Even if vaccines only reduce transmission modestly, over and above the infections they prevent, a breakthrough case in a vaccinated individual poses less risk of transmission to others than infection in an unvaccinated and previously uninfected individual.</p>
<p>Fourth, continue efforts at reaching out to the unvaccinated and under-immunized. This should include the use of pop up facilities where people are likely to gather and other targeted community outreach programs. </p>
<p>Fifth, immediately boost high risk groups older than 65 and others who have immunosuppressive conditions. The primary goal of vaccination therefore needs to be on reducing severe disease and death. This requires targeted strategies on who to prioritise. </p>
<p>Sixth, encourage responsible behaviour to avoid re-imposing alcohol and other restrictions to punish all due to irresponsibility on part of a minority. </p>
<p>Seventh, monitor bed availability at regional level to help decide on regional action to avoid overwhelming of facilities. Higher levels of restrictions need to be tailored for when we expect overwhelming of health facilities. As hospitalisation usually lag behind community infection rates by 2-3 weeks, keeping an eye on case rates and hospitalization rates could predict which facilities in which regions may come under threat. </p>
<p>This would allow for a more focused approach to imposing restrictions to relieve anticipated pressure on health facilities 2-3 weeks before expected. This will not change the total number of hospitalisations. But it will spread it out over a longer period of time and make it more manageable.</p>
<p>Eighth, learn to live with the virus, and take a holistic view on the direct and indirect effects of the pandemic on livelihoods. The detrimental indirect economic, societal, educational, mental health and other health effects of a sledge-hammer approach to dealing with the ongoing pandemic threatens to outstrip the direct effect of COVID in South Africa. </p>
<p>Ninth, follow the science and don’t distort it for political expediency.</p>
<p>Tenth, learn from mistakes of the past, and be bold in the next steps.</p><img src="https://counter.theconversation.com/content/172739/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Shabir A. Madhi institution receives funding from SAMRC, BMGF, Novavax, Pfizer and JJ for research undertaken in by the institution. Also, receives advisory fees from BMGF. </span></em></p>The world needs to learn to live with the virus. And governments must follow the science and don’t distort it for political expediency.Shabir A. Madhi, Dean Faculty of Health Sciences and Professor of Vaccinology at University of the Witwatersrand; and Director of the SAMRC Vaccines and Infectious Diseases Analytics Research Unit, University of the WitwatersrandLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1699192021-11-19T13:17:02Z2021-11-19T13:17:02ZCould oral antiviral pills be a game-changer for COVID-19? An infectious disease physician explains why these options are badly needed<figure><img src="https://images.theconversation.com/files/430413/original/file-20211104-19-tij9pk.jpg?ixlib=rb-1.1.0&rect=25%2C16%2C5582%2C3715&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">If authorized, molnupiravir could be a key oral treatment to help keep COVID-19 patients out of the hospital. </span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/experimental-antiviral-drug-molnupiravir-royalty-free-image/1290262013">Plyushkin/iStock via Getty Images Plus</a></span></figcaption></figure><p>Nearly two years into the pandemic, it has become starkly clear that we need better treatments for COVID-19 for people in the earlier stages of disease. </p>
<p>Two new antiviral drugs could soon be the first effective oral treatments for COVID-19 to help keep people out of the hospital. An advisory committee to the Food and Drug Administration plans to <a href="https://www.fda.gov/news-events/press-announcements/fda-hold-advisory-committee-meeting-discuss-merck-and-ridgebacks-eua-application-covid-19-oral">review the data supporting molnupiravir</a> – a pill made by Merck and partner Ridgeback Therapeutics – on Nov. 30, 2021.</p>
<p>And in early November, Pfizer released <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizers-novel-covid-19-oral-antiviral-treatment-candidate">preliminary results for its antiviral pill</a>, Paxlovid, <a href="https://www.statnews.com/2021/11/05/experimental-pfizer-pill-prevents-covid-hospitalizations-and-deaths/">another potentially promising tool for COVID-19 treatment</a>. On Nov. 16, <a href="https://www.statnews.com/pharmalot/2021/11/16/pfizer-covid19-bourla-pill-paxlovid-fda/?utm_source=STAT+Newsletters&utm_campaign=4d3df69fe9-Daily_Recap&utm_medium=email&utm_term=0_8cab1d7961-4d3df69fe9-153726530">Pfizer formally requested emergency use authorization</a> of the oral pill from the FDA. </p>
<p>If these drugs get authorized in the coming weeks, they could be an important new treatment option for people with COVID-19, especially for those at high risk in the early stages of infection. The ability to treat COVID-19 with a pill rather than an injection or infusion means more people can be treated faster.</p>
<p>As an <a href="https://uvahealth.com/findadoctor/profile/patrick-e-jackson">infectious diseases physician</a> <a href="https://scholar.google.com/citations?user=NAnp8WsAAAAJ&hl=en">and scientist</a> at the University of Virginia, I have helped care for hundreds of people with COVID-19. I’ve also helped conduct clinical trials to find new treatments. Molnupiravir and Paxlovid would fill a need that hasn’t been met by other COVID-19 drugs, which are either difficult to administer or only suitable for patients in the hospital.</p>
<p>Here’s a preview of why these new antiviral drugs are important, how they work and how they could be used.</p>
<h2>Filling a gap in treatment</h2>
<p>Researchers have so far found <a href="https://theconversation.com/new-treatments-for-covid-19-may-stave-off-the-worst-effects-of-the-virus-166540">just a few drugs</a> that are effective for the treatment of COVID-19. Until now, only <a href="https://www.covid19treatmentguidelines.nih.gov/therapies/anti-sars-cov-2-antibody-products/anti-sars-cov-2-monoclonal-antibodies/">antiviral monoclonal antibodies</a> could be used to treat patients who are not hospitalized. However, these antibody drugs – which work by blocking the virus from entering cells – have to be given in a monitored setting like a doctor’s office. </p>
<p>And many patients who could benefit from monoclonal antibodies <a href="https://www.washingtonpost.com/health/covid-monoclonal-abbott/2021/08/19/a39a0b5e-0029-11ec-a664-4f6de3e17ff0_story.html">don’t have access</a> because administration sites aren’t located nearby. They are also not affordable for many people <a href="https://www.who.int/news/item/24-09-2021-on-new-recommendation-for-treatment-of-covid-19-patients-who-calls-for-equitable-access-to-casirivimab-and-imdevimab-for-covid-19">outside the U.S.</a> In the U.S., monoclonal antibodies are free to patients under emergency use authorization but could ultimately become far more expensive if and when they receive full approval by the FDA.</p>
<p>Early data suggests that both <a href="https://www.merck.com/news/merck-and-ridgebacks-investigational-oral-antiviral-molnupiravir-reduced-the-risk-of-hospitalization-or-death-by-approximately-50-percent-compared-to-placebo-for-patients-with-mild-or-moderat/">molnupiravir</a> and <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizers-novel-covid-19-oral-antiviral-treatment-candidate">Paxlovid</a> are effective new drugs that patients can take at home to prevent complications of COVID-19 – which could be particularly beneficial for those at high risk of severe disease. Once authorized, these pills will allow patients to be treated earlier in the course of infection, at the point when antiviral drugs are more effective. By stopping the virus from growing in the body early on, the drugs can prevent the inflammation that causes severe COVID-19.</p>
<figure class="align-center ">
<img alt="A young man in a mask receives a COVID-19 vaccination shot." src="https://images.theconversation.com/files/430445/original/file-20211105-28-10kvfyi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/430445/original/file-20211105-28-10kvfyi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/430445/original/file-20211105-28-10kvfyi.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/430445/original/file-20211105-28-10kvfyi.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/430445/original/file-20211105-28-10kvfyi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/430445/original/file-20211105-28-10kvfyi.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/430445/original/file-20211105-28-10kvfyi.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">Although oral antiviral pills could be a major step forward in treating COVID-19, vaccines still offer the best protection from the virus.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/asian-male-patient-getting-vaccinated-against-royalty-free-image/1284041821?adppopup=true">Prostock-Studio/iStock via Getty Images Plus</a></span>
</figcaption>
</figure>
<h2>How molnupiravir and Paxlovid work</h2>
<p>Molnupiravir works by causing the virus to record <a href="https://doi.org/10.1038/s41594-021-00651-0">inaccurate genetic information</a>. SARS-CoV-2 stores its instructions for making new viruses in a strand of RNA. Inside the cell, the virus makes copies of the RNA and then continues to make duplicates of those copies. When a patient takes molnupiravir, the drug masquerades as one of the key molecules in RNA and gets incorporated into the strands that the virus produces. When an RNA strand containing molnupiravir gets copied in turn, the virus makes errors in the copy. Over multiple rounds of copying, molnupiravir forces more and more mistakes until the virus is no longer able to function – a phenomenon in virology called “<a href="https://doi.org/10.4155/fmc-2018-0457">error catastrophe</a>.”</p>
<p>Paxlovid uses a different mechanism to prevent the virus from replicating. <a href="https://doi.org/10.1016/j.bbadis.2020.165878">SARS-CoV-2 creates proteins</a> that are needed to build new viruses as one long string, called a polyprotein. But the polyproteins have to be chopped into smaller parts by <a href="https://doi.org/10.1016/j.bmcl.2020.127377">a viral enzyme called a protease</a> in order to become active. Paxlovid <a href="https://doi.org/10.1126/science.abl4784">blocks the virus’s protease</a> from doing this job, thereby preventing the virus from completing its life cycle.</p>
<h2>How COVID-19 pills would be used</h2>
<p>There are currently two primary forms of treatment for COVID-19 in the U.S.: antiviral and anti-inflammatory medications. Antiviral drugs stop the virus from growing in the body and are given within the first few days of symptoms to prevent severe disease. Anti-inflammatory drugs moderate the immune response and are used to help sicker patients who need oxygen.</p>
<p><a href="https://www.merck.com/news/merck-and-ridgebacks-investigational-oral-antiviral-molnupiravir-reduced-the-risk-of-hospitalization-or-death-by-approximately-50-percent-compared-to-placebo-for-patients-with-mild-or-moderat/">Molnupiravir</a> and <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizers-novel-covid-19-oral-antiviral-treatment-candidate">Paxlovid</a> were studied in separate clinical trials with similar designs. In both studies, the drugs were tested in outpatients with risk factors for severe COVID-19 who were at an early stage in their illness. Both studies also looked at how likely patients were to either die or be hospitalized. However, neither study has yet been peer-reviewed.</p>
<p>Molnupiravir reduced the risk of death or hospitalization by about 50% in non-hospitalized adult patients with mild to moderate COVID-19 when treated within five days of symptom onset. Paxlovid reduced this risk by about 89% for patients treated within three days of symptoms and 85% for patients treated within five days. Importantly, no patients who took either drug died in the studies. Because the drugs were not studied head to head, it’s difficult to say whether one will be better than the other in the real world. In early November, <a href="https://www.gov.uk/government/news/first-oral-antiviral-for-covid-19-lagevrio-molnupiravir-approved-by-mhra">Britain became the first country to approve molnupiravir</a> for use.</p>
<p>Molnupiravir did not help <a href="https://www.merck.com/news/merck-and-ridgeback-biotherapeutics-provide-update-on-progress-of-clinical-development-program-for-molnupiravir-an-investigational-oral-therapeutic-for-the-treatment-of-mild-to-moderate-covid-19/">hospitalized patients</a> recover faster from COVID-19. It is likely that Paxlovid would also not be useful at the point of hospitalization. Most patients who are in the hospital with COVID-19 are sick because of unregulated inflammation and not because the virus is still replicating in their bodies.</p>
<p>If and when these drugs get authorized in the U.S., they will probably be used for the same higher-risk patients who are eligible for monoclonal antibodies today. Monoclonal antibodies may still be used, though, for pregnant people, people on dialysis and some immune-compromised patients. </p>
<p>The U.S. has already purchased millions of doses of both <a href="https://www.merck.com/news/merck-announces-supply-agreement-with-u-s-government-for-molnupiravir-an-investigational-oral-antiviral-candidate-for-treatment-of-mild-to-moderate-covid-19/">molnupiravir</a> and <a href="https://www.reuters.com/world/us/biden-says-us-has-secured-doses-new-pfizer-covid-pill-2021-11-05/">Paxlovid</a> in anticipation of their authorization. However, the pills will only be useful if people also have access to cheap, fast and accurate COVID-19 tests, which are <a href="https://www.propublica.org/article/heres-why-rapid-covid-tests-are-so-expensive-and-hard-to-find">currently in short supply</a>. If COVID-19 is diagnosed too late, patients will already be outside the window of time when antiviral drugs can be helpful.</p>
<p>[<em>More than 140,000 readers get one of The Conversation’s informative newsletters.</em> <a href="https://memberservices.theconversation.com/newsletters/?source=inline-140K">Join the list today</a>.]</p>
<p>Other antiviral drugs are in development, including an oral form of the <a href="https://doi.org/10.1038/s41422-021-00570-1">first COVID-19 drug, remdesivir</a> and long acting <a href="https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/azd7442-phiii-trial-positive-in-covid-outpatients.html">injectable monoclonal antibodies</a>. </p>
<p>Researchers are also working on repurposing existing drugs to treat COVID. Inhaled steroids <a href="https://doi.org/10.1016/S0140-6736(21)01744-X">like budesonide</a> and an <a href="https://doi.org/10.1016/S2214-109X(21)00448-4">antidepressant called fluvoxamine</a> are particularly promising. </p>
<p>While it’s exciting to see new treatments for COVID-19, prevention is still the best strategy. The COVID-19 vaccines continue to be the most effective tool for helping to end the pandemic.</p>
<p>[<em>Understand new developments in science, health and technology, each week.</em> <a href="https://theconversation.com/us/newsletters/science-editors-picks-71/?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=science-understand">Subscribe to The Conversation’s science newsletter</a>.]</p><img src="https://counter.theconversation.com/content/169919/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Patrick Jackson receives funding from the National Institutes of Health and the Ivy Foundation. He is affiliated with Indivisible Charlottesville. </span></em></p>Merck and Pfizer both have oral antiviral pills under review by the FDA. Such treatments could help turn the tide of the pandemic.Patrick Jackson, Assistant Professor of Infectious Diseases, University of VirginiaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1717582021-11-18T13:59:55Z2021-11-18T13:59:55ZHow the private sector can boost COVID vaccination in Nigeria<figure><img src="https://images.theconversation.com/files/431913/original/file-20211115-15-tq6cio.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The Lagos State government recently approved some private health facilities to administer COVID-19 vaccines in the state</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/medic-administers-a-dose-of-the-moderna-covid-19-news-photo/1234864610?adppopup=true">Olukayode Jaiyeola/NurPhoto via Getty Images</a></span></figcaption></figure><p><em>Nigeria’s Lagos State government recently <a href="https://www.premiumtimesng.com/news/headlines/492149-covid-19-vaccination-to-cost-n6000-in-lagos-as-state-owned-centre-charges-n350000-per-day-for-treatment.html">announced</a> that private health facilities will start administering COVID-19 vaccines within the state. This is part of its effort to accelerate vaccine rollout beyond the 1.2 million doses that had been administered in the state by 27 October. This, <a href="https://www.thecable.ng/covid-19-lagos-vaccination-rate-far-below-who-recommendation-says-sanwo-olu">the state governor admitted</a>, is below the <a href="https://www.who.int/news/item/07-10-2021-who-un-set-out-steps-to-meet-world-covid-vaccination-targets">World Health Organization (WHO) target</a> of 40% of the population of every country by the end of 2021. The private facilities will charge fees to individual citizens for their services. Virologist Oyewale Tomori spoke to The Conversation Africa about private sector involvement in the fight against the pandemic.</em> </p>
<p><strong>How has the government been managing the COVID-19 vaccine roll out so far?</strong></p>
<p>As at 18 November, Nigeria has <a href="https://graphics.reuters.com/world-coronavirus-tracker-and-maps/countries-and-territories/nigeria/">administered</a> at least 9,017,951 doses of COVID vaccines. Assuming every person needs 2 doses, that’s enough to have vaccinated about 2.2% of the country’s population. AstraZeneca/Oxford, Janssen and Moderna are <a href="https://www.afro.who.int/news/nigerians-awaiting-second-dose-astrazeneca-vaccine-heave-sigh-relief-soon">the vaccines</a> Nigeria is administering. The government is doing its best under the circumstances. We still have an insufficient, inadequate, inconsistent and unpredictable supply of vaccines because Nigeria was almost fully dependent on supply through the <a href="https://www.gavi.org/covax-facility">COVAX facility</a>, a worldwide initiative aimed at equitable access to COVID-19 vaccines. It has made limited efforts in procuring supply through other sources. You can only roll out what you have, and we do not have enough vaccines. This Lagos State initiative will still depend on the vaccines procured by the government. </p>
<p><strong>What role has the private sector played in this?</strong></p>
<p>The private sector - principally private faith-based health facilities - has been involved in administering polio, measles and yellow fever vaccines. Given the high level of efficiency associated with the private sector, their involvement in COVID-19 vaccination should enhance government efforts to ensure rapid and efficient rollout of available vaccines. In <a href="https://www.cdc.gov/vaccines/covid-19/retail-pharmacy-program/index.html">the USA</a> and many European countries, private sector pharmacists are actively involved in COVID-19 vaccination. They play major roles in the delivery and administration of vaccines to the public.
One hopes this planned increased involvement in COVID-19 vaccine delivery by the private sector will raise the level of public trust in the current and future vaccination exercises. </p>
<p><strong>What are the other opportunities for private sector involvement?</strong></p>
<p>The <a href="https://www.premiumtimesng.com/news/headlines/492149-covid-19-vaccination-to-cost-n6000-in-lagos-as-state-owned-centre-charges-n350000-per-day-for-treatment.html">goal</a> is to vaccinate four million residents by 25 December in the approved 400 private health facilities. If this experiment succeeds, we can get the private sector more involved in providing other vaccines, especially the routine vaccines like measles and diptheria-tetanus-pertussis. </p>
<p>While there is no law preventing the private sector from administering vaccines, I think there is a government reluctance in fully involving the private sector in mass and routine vaccinations. The reluctance has to do with some unscrupulous elements in the private sector. They are usually interested in profits alone, unlike faith-based organisations. I suspect this is why only one state is allowing the private sector at present. </p>
<p><strong>What are the challenges in involving the private sector?</strong></p>
<p>The private sector will <a href="https://www.premiumtimesng.com/news/headlines/492149-covid-19-vaccination-to-cost-n6000-in-lagos-as-state-owned-centre-charges-n350000-per-day-for-treatment.html">charge some fees</a> administration costs - for the extra services they plan to offer during the vaccination exercises. Though sometimes these services are better than those offered in public facilities. Possibly because of better environment, prompt personal attention and shorter waiting time. It is important to provide clear communication and appropriate information that the charges are for the extra services rendered and not payment for the vaccines.</p>
<p>Secondly, effectively monitoring the performance and service delivery by the private sector might be a challenge. And having insufficient vaccine doses to go round might be another. </p>
<p>Starting with a few private facilities that can be monitored by both the government and the private sector itself will be the right way to go. More facilities can then be included as time goes on and when more vaccines are available. </p>
<p>The vaccines are to be administered by the approved 400 private health facilities, as <a href="https://www.premiumtimesng.com/news/headlines/492149-covid-19-vaccination-to-cost-n6000-in-lagos-as-state-owned-centre-charges-n350000-per-day-for-treatment.html">the governor said</a>. Currently, <a href="https://lagosstate.gov.ng/blog/2017/07/05/lagos-and-equitable-healthcare-services/">there are</a> 26 registered general hospitals, 256 public healthcare centres, 2,886 private hospitals or specialist clinics and laboratories or diagnostic centres in addition to an estimated 160 traditional medicine clinics in the state. So starting with 400 that meet the criteria looks like starting small for easier monitoring and evaluation. </p>
<p><strong>How should the government address these challenges?</strong></p>
<p>Government, in consultation with the private sector, should ensure that the guidelines and standards of operation for both the private and public sectors are effectively implemented and their implementation monitored as the performance of private sector health facilities are evaluated.</p>
<p>The government should also provide adequate vaccine doses and sufficient number of syringes and other requirements for administering the vaccines.</p><img src="https://counter.theconversation.com/content/171758/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Oyewale Tomori does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Properly engaged and monitored, Nigeria’s private sector can do more in COVID vaccination exercise.Oyewale Tomori, Fellow, Nigerian Academy of ScienceLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1715892021-11-12T05:02:04Z2021-11-12T05:02:04ZPfizer’s pill is the latest COVID treatment to show promise. Here are some more<figure><img src="https://images.theconversation.com/files/431597/original/file-20211111-21-1pw54ft.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C998%2C660&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/new-york-usa-november-2021-pfizer-2071222382">Shutterstock</a></span></figcaption></figure><p>Pfizer says its antiviral COVID treatment Paxlovid cuts the chance of ending up in hospital or dying <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizers-novel-covid-19-oral-antiviral-treatment-candidate">by 89%</a>. </p>
<p>What differentiates this from other medicines we have used since the start of the pandemic is it provides the opportunity for patients to be treated at home, with a combination of a capsule and a pill.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1456581881772785673"}"></div></p>
<p>The phase 2/3 trial data on which those hospitalisation rates are based have yet to be independently verified. Nor has the treatment been approved by any country for use outside a clinical trial. </p>
<p>Yet this development adds to our growing portfolio of potential options to directly target SARS-CoV-2, the virus that causes COVID-19, and to treat COVID symptoms.</p>
<h2>What is it?</h2>
<p>Paxlovid is a combination of two different drugs – the HIV drug <a href="https://www.nps.org.au/australian-prescriber/articles/ritonavir">ritonavir</a> (a capsule) and an experimental drug PF-07321332 (a pill).</p>
<p>Ritonavir protects the body from metabolising PF-07321332. It acts by being broken down by the body first (known as a sacrificial chemical) to ensure enough PF-07321332 reaches the virus intact.</p>
<p>PF-07321332 is a so-called <a href="https://www.healthline.com/health/hiv-aids/protease-inhibitors">protease inhibitor</a> (as is ritonavir). It blocks the action of a vital enzyme (protease) and stops SARS-CoV-2 from making copies of itself.</p>
<h2>What did the trial show?</h2>
<p>The trial included 1,219 “high risk” adults with COVID who were not in hospital. Each person had at least one characteristic or underlying medical condition associated with an increased risk of developing severe COVID. One group received the treatment, the other placebo.</p>
<p><a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizers-novel-covid-19-oral-antiviral-treatment-candidate">The trial’s interim results showed</a> a reduction in the risk of hospitalisation or death by 89% in the Paxlovid group compared to placebo. </p>
<p>At day 28, there were no deaths reported in the Paxlovid group, compared with ten deaths in the placebo group. Side-effects were similar in both groups and were generally mild.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/could-a-simple-pill-beat-covid-19-pfizer-is-giving-it-a-go-160988">Could a simple pill beat COVID-19? Pfizer is giving it a go</a>
</strong>
</em>
</p>
<hr>
<p>The company said the results were so promising it was recommended no new patients needed to be enrolled into the study. And the company was recommended to submit the data to the US Food and Drug Administration for emergency use approval.</p>
<p>Before the drug could be used in Australia, the Therapeutic Goods Administration (TGA) would need to assess its efficacy and safety. </p>
<p>Just as importantly, the TGA would need to decide who may prescribe it and under what conditions. This may include whether it would be available from GPs, and what sort of patient risk factors would be considered.</p>
<p><iframe id="tc-infographic-616" class="tc-infographic" height="400px" src="https://cdn.theconversation.com/infographics/616/0f14bd7141c03b8e4326bc62ffcacb1c6fdc697d/site/index.html" width="100%" style="border: none" frameborder="0"></iframe></p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/what-is-sotrovimab-the-covid-drug-the-government-has-bought-before-being-approved-for-use-in-australia-165802">What is sotrovimab, the COVID drug the government has bought before being approved for use in Australia?</a>
</strong>
</em>
</p>
<hr>
<h2>One of several potential antiviral drugs</h2>
<p>Paxlovid is one potential COVID drug for use at home. The idea is these could be prescribed at the first sign of infection to prevent serious illness and death. People would <a href="https://theconversation.com/how-can-i-treat-myself-if-ive-got-or-think-ive-got-coronavirus-134654">manage their own symptoms</a>, monitored while at home, and only be transferred to hospital if their condition deteriorates.</p>
<p>Merck has its own antiviral drug, <a href="https://theconversation.com/take-at-home-covid-drug-molnupiravir-may-be-on-its-way-but-vaccination-is-still-our-first-line-of-defence-169246">molnupiravir</a>, also for home use. It’s been approved for use in the UK, and is being considered for use in Australia.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1456235035862917129"}"></div></p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/take-at-home-covid-drug-molnupiravir-may-be-on-its-way-but-vaccination-is-still-our-first-line-of-defence-169246">Take-at-home COVID drug molnupiravir may be on its way — but vaccination is still our first line of defence</a>
</strong>
</em>
</p>
<hr>
<p>Then there’s AstraZeneca’s emerging <a href="https://www.theguardian.com/australia-news/2021/nov/10/astrazenecas-new-covid-treatment-what-is-it-and-how-does-it-work">COVID drug Evusheld</a>. The TGA has just given this “<a href="https://www.tga.gov.au/media-release/tga-grants-provisional-determination-astrazeneca-pty-ltd-covid-19-preventative-treatment-tixagevimab-and-cilgavimab-evusheld">provisional determination</a>”, meaning the company can now submit data for evaluation.</p>
<p>Evusheld contains two long-acting monoclonal antibody drugs – tixagevimab and cilgavimab. It’s an injection that could be given in hospital or as an outpatient to prevent infections from getting worse.</p>
<p><a href="https://www.astrazeneca.com/media-centre/press-releases/2021/azd7442-prophylaxis-trial-met-primary-endpoint.html">Human trials</a> have shown when Evusheld was used before exposure to COVID, there were significantly fewer symptoms. </p>
<p>Although Evusheld may potentially be used to prevent COVID, it would not be a substitute for vaccination. But it could provide additional protection for people who may have an inadequate response to vaccination or who cannot be immunised. </p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1458548255457828865"}"></div></p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/stopping-blocking-and-dampening-how-aussie-drugs-in-the-pipeline-could-treat-covid-19-162349">Stopping, blocking and dampening – how Aussie drugs in the pipeline could treat COVID-19</a>
</strong>
</em>
</p>
<hr>
<h2>Treating COVID symptoms</h2>
<p>We also have a range of existing and emerging treatments for use in hospital to treat the symptoms of infection – inflammation on the lungs and difficulty breathing.</p>
<hr>
<p><iframe id="tc-infographic-615" class="tc-infographic" height="400px" src="https://cdn.theconversation.com/infographics/615/645fd6301a40a2be823b1ab347f0608d94071f90/site/index.html" width="100%" style="border: none" frameborder="0"></iframe></p>
<hr>
<p>If patients with mild COVID have certain risk factors for disease progression, such as <a href="https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html">diabetes or a heart condition</a>, doctors may consider using hospital administered treatments such as sotrovimab, Ronapreve, or inhaled budesonide to prevent disease progression.</p>
<p>According to Pfizer’s trial results, Paxlovid could be used as an alternative to in-hospital treatment for preventing disease progression in patients with the same risk factors.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/heres-what-happens-when-youre-hospitalised-with-covid-167544">Here's what happens when you’re hospitalised with COVID</a>
</strong>
</em>
</p>
<hr>
<h2>Where next?</h2>
<p>There are several steps before we can routinely expect to take COVID drugs at home to prevent the worst of the symptoms. We need independent verification of these drugs’ <a href="https://www.nature.com/articles/d41586-021-03074-5?utm_source=twt_nat&utm_medium=social&utm_campaign=nature">efficacy and safety</a>, and of course, regulatory approval.</p>
<p>Then there’s the <a href="https://www.forbes.com/sites/williamhaseltine/2021/10/08/anti-covid-drugs-are-coming-but-at-what-cost/?sh=1cbc33e577a1">issue of cost</a>. </p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1457471886066020357"}"></div></p>
<p>Developing new medicines, particularly at the pace required because of COVID, means these new drugs aren’t cheap. One consideration for state and federal governments will be balancing the costs of the medicines against health outcomes.</p>
<p>The <a href="https://www.canstar.com.au/health-insurance/hospital-stay-cost/">daily cost of a patient in hospital</a> is around A$5,000 for an uncomplicated (non-COVID) admission. This is much more than the <a href="https://scholar.harvard.edu/files/melissabarber/files/estimated_cost-based_generic_prices_for_molnupiravir_for_the_treatment_of_covid-19_infection.pdf">reported cost</a> of a full course of molnupiravir to the US government at US$700 (about A$960).</p>
<p>But the costs of Paxlovid, and other new COVID medicines, have not been released and may be very much higher than the hospital costs. Some medicines subsidised by the government for other conditions can cost almost <a href="https://www.pbs.gov.au/medicine/item/11332K-11333L-11337Q-11344C-11345D-11346E-11353M-11354N-11355P">A$19,000 per pack of tablets</a>.</p><img src="https://counter.theconversation.com/content/171589/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Associate Professor Wheate in the past has received funding from the ACT Cancer Council, Tenovus Scotland, Medical Research Scotland, Scottish Crucible, and the Scottish Universities Life Sciences Alliance. He is Fellow of the Royal Australian Chemical Institute and a member of the Australasian Pharmaceutical Science Association. Nial is science director of the medicinal cannabis company Canngea Pty Ltd, a board member of the Australian Medicinal Cannabis Association, and a Standards Australia committee member for sunscreen agents.</span></em></p><p class="fine-print"><em><span>Elise Schubert is a registered pharmacist and a PhD Candidate receiving scholarship from the University of Sydney and Canngea Pty Ltd.</span></em></p>Paxlovid is one potential COVID drug for use at home. The idea is these can potentially be prescribed at the first sign of infection to prevent serious illness and death.Nial Wheate, Associate Professor of the Sydney Pharmacy School, University of SydneyElise Schubert, Pharmacist and PhD Candidate, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1711412021-11-05T15:52:21Z2021-11-05T15:52:21ZTop scientist: why South Africa shouldn’t be giving 12-17 year olds COVID shots – now<figure><img src="https://images.theconversation.com/files/430465/original/file-20211105-29-11sshib.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">People queuing to get vaccinated. Instead of vaccinating 12-17 year olds, government should focus on giving boosters to people who need it.</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p><em>South Africa is one of the leading countries in Africa in terms of COVID vaccine rollout, along with <a href="https://www.afro.who.int/news/fifteen-african-countries-hit-10-covid-19-vaccination-goal">Mauritius, Tunisia and Morocco</a>. It has, however, had it’s fair share of challenges. Shabir Madhi has been a key player in shaping the country’s response. Ina Skosana and Ozayr Patel asked him for an assessment of <a href="https://www.nicd.ac.za/covid-19-unpacking-south-africas-plan-to-vaccinate-adolescents/">plans to vaccinate adolescents</a>, and next steps.</em></p>
<p><audio preload="metadata" controls="controls" data-duration="1520" data-image="" data-title="Pasha 132: Why South Africa should not vaccinate 12 to 17-year-olds yet" data-size="24390470" data-source="The Conversation Africa" data-source-url="" data-license="CC BY-NC-ND" data-license-url="http://creativecommons.org/licenses/by-nc-nd/4.0/">
<source src="https://cdn.theconversation.com/audio/2316/vaccine-lessons-final-version.mp3" type="audio/mpeg">
</audio>
<div class="audio-player-caption">
Pasha 132: Why South Africa should not vaccinate 12 to 17-year-olds yet.
<span class="attribution"><span class="source">The Conversation Africa</span>, <a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a><span class="download"><span>23.3 MB</span> <a target="_blank" href="https://cdn.theconversation.com/audio/2316/vaccine-lessons-final-version.mp3">(download)</a></span></span>
</div></p>
<hr>
<h2>Should South Africa be vaccinating adolescents?</h2>
<p>I don’t believe this is the most efficient use of the vaccines. In a country like South Africa, we’d be much better off offering a third dose of the Pfizer/BioNTech vaccine to the 65% of adults above the age of 65 who have been vaccinated, and intensifying efforts at vaccinating the elderly and high risk groups who have not yet received even a single dose. </p>
<p>We shouldn’t be using these vaccines to give to children between 12 to 17 years a single dose.</p>
<p>Young children rarely get severe disease from COVID-19. Vaccinating children with a single dose of the Pfizer vaccine is unlikely to provide much value to the child in terms of individual protection, unless they have underlying medical conditions pre-disposing them to severe COVID-19. If this is the case they should receive the full two dose schedule. A single dose also doesn’t work too well in reducing the ability of a person to <a href="https://www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/covid-19-vaccine-what-you-need-to-know">transmit the virus</a>. </p>
<p>This is the main reason <a href="https://www.nicd.ac.za/covid-19-unpacking-south-africas-plan-to-vaccinate-adolescents/">being given</a> for vaccinating 12 to 17 year olds. </p>
<p>South Africa might be banking on the fact that a large percentage of the population – estimates are between <a href="https://www.news24.com/fin24/companies/health/80-of-south-africans-may-have-had-covid-discovery-says-20210818">70% to 80%</a> – might have been infected already. In that context, a single dose of vaccine is probably all you require to protect against severe COVID-19. </p>
<p>This hybrid immunity, where you start off with your immune system being primed by natural infection followed by a vaccine, induces quite potent immunity. Consequently, people that have passed infection probably only require a single dose of any vaccine. That’s the only way South Africa can really justify using a single dose of vaccine in the 12 to 17 year old age group. Needless to say, waiting to get infected and risking developing long-COVID, being hospitalised for COVID-19 or dying from COVID-19 is not really a bright idea. </p>
<p>The liberal rollout of COVID-19 vaccines in South Africa to low risk groups, such as young children, appears to be more about chasing after numbers rather than deriving the maximal protection against severe disease and deaths. </p>
<p>I’m not saying that you shouldn’t vaccinate children. There’s a time and place. But that time and place is not right now in South Africa, or globally in the context of the tragic inequity of vaccine access. </p>
<p>Starting to vaccinate children against COVID-19 (and use of booster doses in healthy adults) is more than just a country specific decision. Most countries on the continent have less than 5% of the <a href="https://www.one.org/africa/issues/covid-19-tracker/explore-vaccines/">adult population vaccinated</a>, and in fact, less than 10% of people above the age of 60 <a href="https://ourworldindata.org/covid-vaccinations">are vaccinated</a>. </p>
<p>This is being perpetuated by countries with access to vaccines using them liberally.</p>
<h2>Would you recommend a booster for the general population?</h2>
<p>Absolutely. For certain groups of adults. </p>
<p>We now understand that the first two doses of vaccine provide good protection against severe disease in people above the <a href="https://www.ncoa.org/article/covid-vaccines-what-seniors-need-to-know">age of 65</a> and those with other underlying medical conditions. However, it is also apparent that people older than 65 or with underlying immunosupressive medical conditions require a third dose of the mRNA vaccines, such as by Pfizer/Biontech. This is required to boost their immune response and enhance their protection even against severe COVID-19.</p>
<p>The primary goal of vaccination therefore needs to be on reducing severe disease and death. This requires targeted strategies on who to prioritise.</p>
<p>Evidence <a href="https://www.yalemedicine.org/news/johnson-and-johnson-covid-booster">from the US</a> is that a two dose schedule of the Johnson & Johnson vaccine is superior in protecting against hospitalisation than a single dose. And if you want durability of protection, you need to boost, which can be done with another dose of Johnson & Johnson. </p>
<p>My own preference is to boost with one of the messenger RNA vaccines. In South Africa this is the Pfizer vaccine. The evidence <a href="https://www.npr.org/sections/health-shots/2021/10/13/1045485935/study-of-covid-vaccine-boosters-suggests-moderna-or-pfizer-works-best">is clear</a> that the type of immune responses from this approach is superior to two doses of the J&J vaccine and possibly even two doses of the Pfizer vaccine. </p>
<h2>Is vaccine coverage high enough to justify boosters?</h2>
<p>Absolutely. If we can justify providing vaccines to the 12 to 17 year old age group, it means we’ve got vaccines that we don’t know what to do with.</p>
<p>In my view it would be much better offering these doses to boost adults above the age of 55. In particular, people older than 65 do require an additional dose of the Pfizer vaccine after they’ve had two shots. The same thing goes for other risk groups such as people with kidney transplants, or people with cancer and on chemotherapy, people with any other sort of underlying immunosuppressive condition. </p>
<p>South Africa is, once again, going against the World Health Organisation which <a href="https://www.who.int/emergencies/diseases/novel-coronavirus-2019/media-resources/science-in-5/episode-53---covid-19-booster-shots">is recommendating</a> booster doses of such high risk groups, and instead vaccinating young children. </p>
<h2>Is South Africa in a stable position vis-a-vis another surge?</h2>
<p>The main thing that’s going to determine how well the country manages another resurgence is the percentage of people above the age of 50 who have been vaccinated. We need to get 85% to 90% of this age group vaccinated and 80% of those with underlying medical conditions. </p>
<p>If we don’t reach those marks, when we do have a resurgence – and we will have a resurgence in the next two to three months – it will end up with hospitals coming under pressure once again. </p>
<p>What’s in South Africa’s favour is the high percentage of the population that’s been infected with the virus. Natural infection does seem to confer protection against <a href="https://www.nature.com/articles/d41586-021-02795-x">severe disease</a>. </p>
<p>So this combination of natural immunity – probably 75% to 80% of the population has now have developed some level of <a href="https://www.news24.com/fin24/companies/health/80-of-south-africans-may-have-had-covid-discovery-says-20210818">natural immunity</a> – coupled with vaccine induced immunity and a hybrid of the two probably puts South Africa in a relatively stable position in relation to severe cases likely to be lower with a future resurgence than experienced in the past. This could, however, change if there are new major immune-evasive mutations in the virus. </p>
<h2>What’s been learnt from the vaccine roll-out in South Africa?</h2>
<p>We’ve learned that rolling out a vaccine is as complex as securing supplies. And we’ve missed some targets.</p>
<p>For example, we were meant to have vaccinated the majority of people above the age of 60 by July this year. Currently we’re sitting at around about 62% to 63% of people above <a href="https://sacoronavirus.co.za/latest-vaccine-statistics/">the age of 60</a>. In the 50 to 59 year age group we are looking at <a href="https://sacoronavirus.co.za/latest-vaccine-statistics/">just over 50%</a>. </p>
<p>The reasons are multiple. But part of it speaks to the issue of planning and rollout, not just in South Africa, but in many countries. People don’t appreciate what it entails, starting from community engagement, adequate communication around what the vaccines are about, what the purpose of the vaccine programme is, and then finally being able to implement. </p>
<p>The other challenge was that the initial planning for the rollout was top down. The expectation was that people were going to rush forward to register on the <a href="https://vaccine.enroll.health.gov.za/#/">electronic vaccine data system</a> without really understanding how adaptable it was for South Africa. The system was inaccessible to most people.</p>
<p>There was a quick escalation in coverage once walk ins were set up for targeted age groups. Also, the use of pop up facilities is beginning to play a big part in increasing <a href="https://www.africanews.com/2021/08/22/south-africa-pop-up-vaccination-centres-boost-number-of-jabs//">vaccine coverage rates</a>.</p>
<p>This also speaks to the issue of community sensitisation and engagement of community structures. Unfortunately resources set aside for this purpose were siphoned off by <a href="https://www.dailymaverick.co.za/article/2021-10-19-digital-vibes-scandal-the-story-behind-the-story/">corruption</a>. </p>
<p>Also, South Africa hasn’t had enough champions across the spectrum of society. In other countries support this has been a major contributor to success.</p>
<p>On the plus side, South Africa secured adequate supplies of vaccine. That in itself was quite an achievement, considering the poor planning until Government came under pressure early in January 2021. The challenge now is being able to use the doses wisely before they expire.</p><img src="https://counter.theconversation.com/content/171141/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Shabir A. Madhi receives funding from BMGF, SAMRC and Novavax related to COVID-19 studies. All funding goes to his institution.</span></em></p>The focus of the government seems to be about how many people can get vaccinated rather than ensuring the greatest protection against severe disease and deaths.Shabir A. Madhi, Dean Faculty of Health Sciences and Professor of Vaccinology at University of the Witwatersrand; and Director of the SAMRC Vaccines and Infectious Diseases Analytics Research Unit, University of the WitwatersrandLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1713132021-11-05T11:15:52Z2021-11-05T11:15:52ZPasha 132: COVID South Africa: Top scientist on vaccine rollout lessons, and next steps<figure><img src="https://images.theconversation.com/files/430466/original/file-20211105-1798-1dmtokj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>South Africa is several months into its COVID vaccination roll-out – a complex process with wide repercussions. It has recently extended the roll-out to adolescents between the ages of 12 and 17 years. But is this the best use of the available supply of vaccine doses? </p>
<p>Our guest in this episode of Pasha is Shabir Madhi, dean of the faculty of health sciences and professor of vaccinology at the University of the Witwatersrand. He is also director of the South African Medical Research Council’s vaccines and infectious diseases analytics research unit. Professor Madhi believes that the country would be better off offering a third dose of vaccine to older adults who have already been vaccinated. </p>
<p>The focus of the government seems to be about how many people can get vaccinated. Instead, it should be about ensuring the greatest protection against severe disease, hospitalisation and death. People with comorbidities and people over the age of 50 are more vulnerable, so they should receive a booster instead of adolescents receiving a first dose.</p>
<p>Prof Madhi talks about South Africa’s vaccine coverage and how the country should go forward with vaccination efforts. </p>
<hr>
<p><strong>Photo:</strong><br>
“The Limpopo provincial government launched a COVID-19 vaccine registration drive in Tooseng village for people over 60 years old”
By Mukurukuru Media found on <a href="https://www.shutterstock.com/image-photo/polokwane-limpopo-south-africa-04212021-provincial-1964090200">Shutterstock</a>.</p>
<p><strong>Music:</strong>
“Happy African Village” by John Bartmann, found on <a href="http://freemusicarchive.org/music/John_Bartmann/Public_Domain_Soundtrack_Music_Album_One/happy-african-village">FreeMusicArchive.org</a> licensed under <a href="https://creativecommons.org/publicdomain/zero/1.0/">CC0 1</a>.</p>
<p>“Expressions of the mind (Piano loop)” by ShadyDave, found on <a href="https://freesound.org/people/ShadyDave/sounds/325647/">Freesound</a> licensed under <a href="http://creativecommons.org/licenses/by-nc/3.0/">Attribution Noncommercial License.</a></p><img src="https://counter.theconversation.com/content/171313/count.gif" alt="The Conversation" width="1" height="1" />
South Africa has a vaccine supply, but the challenge is using the doses effectively before they expire.Ozayr Patel, Digital EditorLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1699072021-10-29T23:11:21Z2021-10-29T23:11:21ZThe FDA authorizes Pfizer’s COVID-19 vaccine for children ages 5 to 11 – a pediatrician explains how the drug was tested for safety and efficacy<figure><img src="https://images.theconversation.com/files/428434/original/file-20211026-19-1v5f0xs.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">For many parents, the long-awaited COVID-19 vaccine authorization for younger kids can't come soon enough. </span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/little-boy-getting-vaccinated-at-the-pediatricians-royalty-free-image/1300101068?adppopup=true">Vladimir Vladimirov/E+ via Getty Images</a></span></figcaption></figure><p>Elementary school children in the United States will soon have one more layer of protection to keep them safe from COVID-19. </p>
<p>On Oct. 29, 2021, the Food and Drug Administration authorized emergency use of the Pfizer-BioNTech COVID-19 vaccine for children ages 5 to 11. The move came days after a tense and careful deliberation of its key scientific advisory committee, on Oct. 26, 2021, in which members voted 17-0 to authorize the Pfizer shot, with one abstention.</p>
<p>The next necessary step in the process is for the <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations-process.html">Centers for Disease Control and Prevention</a> to issue its guidance on how to use the vaccine in this age group, based on the FDA’s authorization. The CDC’s Advisory Committee on Immunization Practices is scheduled to meet on Nov. 2, 2021, and the agency’s official recommendation is expected as soon as later that day. Rollout of the Pfizer shots for children ages 5 to 11 will likely begin days after.</p>
<p>Once the CDC issues its recommendation, the <a href="https://www.whitehouse.gov/briefing-room/statements-releases/2021/10/20/fact-sheet-biden-administration-announces-update-on-operational-planning-for-covid-19-vaccinations-for-kids-ages-5-11/">28 million eligible U.S. children in this age group</a> will have the opportunity to receive the Pfizer shot through health departments, medical institutions, doctor’s offices and pharmacies, as well as school and community-based sites.</p>
<p>The FDA authorization comes after months of <a href="https://theconversation.com/kids-arent-just-littler-adults-heres-why-they-need-their-own-clinical-trials-for-a-covid-19-vaccine-162821">pediatric clinical trial</a> investigation involving about 4,500 children ages 5 to 11. Pfizer released new data on Oct. 22, 2021, stating that its vaccine is almost <a href="https://www.fda.gov/media/153409/download">91% effective at preventing COVID-19</a> in that age group, with similar tolerability and antibody responses to that seen in older age groups.</p>
<p>Moderna has also <a href="https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-positive-top-line-data-phase-23-study-covid-19">released preliminary results </a> showing that its low-dose vaccine is safe and produces a strong immune response in children ages 6 to 11 years. It plans to submit data to the FDA for review soon.</p>
<p>As a <a href="https://uvahealth.com/findadoctor/profile/debbie-ann-shirley">pediatrician</a> <a href="https://scholar.google.com/citations?user=M6zP_sMAAAAJ&hl=en">specializing in infectious diseases</a>, I have worked closely on many aspects of the COVID-19 response at the University of Virginia. I have helped care for children with severe COVID-19 and also observed the burden of the pandemic on children and their families. Vaccines, which work by <a href="https://theconversation.com/what-happens-when-the-covid-19-vaccines-enter-the-body-a-road-map-for-kids-and-grown-ups-164624">teaching your immune system to make disease-fighting antibodies</a> without giving you the actual disease, have emerged as the most important tool that we currently have to prevent severe COVID-19.</p>
<p>Here’s how the COVID-19 vaccine was tested for efficacy and safety on children and how access to these shots could alter the impact of COVID-19 for American kids.</p>
<h2>The risks of COVID-19 in school-age children</h2>
<p>The FDA advisory committee openly grappled with the risks and benefits of the vaccine and the weightinesss of the decision for younger children. Ultimately, it concluded that parents should be presented with the option to vaccinate their kids against COVID-19. One committee member – Centers for Disease Control and Prevention vaccine expert Amanda Cohn – noted that COVID-19 was the eighth-highest killer of kids in the 5-11 age group over the past year. She pointed out that children are continuing to be hospitalized and to die or otherwise suffer <a href="https://theconversation.com/how-to-help-kids-with-long-covid-thrive-in-school-169076">adverse long-term effects</a> from a largely vaccine-preventable disease. </p>
<p>As of Oct. 21, 2021, more than <a href="https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-state-level-data-report/">6 million</a> American children have tested positive for COVID-19. Cases in children rapidly increased during <a href="https://theconversation.com/delta-variant-makes-it-even-more-important-to-get-a-covid-19-vaccine-even-if-youve-already-had-the-coronavirus-164203">the delta variant surge</a>, which coincided with the opening of in-person school across much of the country. Children now account for a quarter of <a href="https://downloads.aap.org/AAP/PDF/AAP%20and%20CHA%20-%20Children%20and%20COVID-19%20State%20Data%20Report%2010.14%20FINAL.pdf">new weekly cases</a>. </p>
<p>While severe disease and hospitalization from COVID-19 are far more rare in children than in adults, intensive care admission and the need for invasive ventilation do occur in children. There have been over <a href="https://covid.cdc.gov/covid-data-tracker/?ACSTrackingID=USCDC_2145-DM67940&ACSTrackingLabel=10.15.2021%20-%20COVID-19%20Data%20Tracker%20Weekly%20Review&deliveryName=USCDC_2145-DM67940#demographics">1.9 million</a> COVID-19 cases in children ages 5 to 11, with <a href="https://www.fda.gov/media/153508/download">nearly 100 deaths</a>.</p>
<p><a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7036e2.htm">Rates of COVID-19 hospitalization</a> among children and adolescents rose to the highest rates ever in August and September 2021, with <a href="https://www.fda.gov/media/153508/download">over 8,300</a> children in the 5-11 age group hospitalized since the beginning of the pandemic. Many children hospitalized with COVID-19 have underlying medical conditions, but <a href="https://doi.org/10.1001/jamanetworkopen.2021.5298">one-third</a> of them <a href="https://www.fda.gov/media/153409/download">do not</a>. </p>
<p>Additionally, more than <a href="https://covid.cdc.gov/covid-data-tracker/#mis-national-surveillance">5,200 children</a> have been diagnosed with the rare but serious condition called multisystem inflammatory syndrome in children, or MIS-C, in the weeks after COVID-19 infection. MIS-C can cause inflammation of the heart, brain, skin, gut and other organs, requiring hospitalization and often intensive care. The syndrome <a href="https://www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/misc-and-covid19-rare-inflammatory-syndrome-in-kids-and-teens">most commonly occurs in children</a> <a href="https://covid.cdc.gov/covid-data-tracker/#mis-national-surveillance">6 to 11 years</a> of age. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/428440/original/file-20211026-15-fyhs2w.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Doctor providing breathing support for child in operating room." src="https://images.theconversation.com/files/428440/original/file-20211026-15-fyhs2w.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/428440/original/file-20211026-15-fyhs2w.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=401&fit=crop&dpr=1 600w, https://images.theconversation.com/files/428440/original/file-20211026-15-fyhs2w.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=401&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/428440/original/file-20211026-15-fyhs2w.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=401&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/428440/original/file-20211026-15-fyhs2w.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/428440/original/file-20211026-15-fyhs2w.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/428440/original/file-20211026-15-fyhs2w.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Though serious cases of COVID-19 are more rare in children than adults, hospitalizations of children spiked over the summer during the delta variant surge.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/doctor-and-patient-in-operating-theatre-royalty-free-image/532049626?adppopup=true">Simonkr/E+ via Getty Images</a></span>
</figcaption>
</figure>
<p>The pandemic has also harmed children’s <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7024e1.htm">social, emotional</a> and <a href="https://www.aap.org/en/advocacy/child-and-adolescent-healthy-mental-development/aap-aacap-cha-declaration-of-a-national-emergency-in-child-and-adolescent-mental-health/">mental well-being</a> and <a href="https://www.mckinsey.com/industries/public-and-social-sector/our-insights/covid-19-and-education-the-lingering-effects-of-unfinished-learning">delayed their education progress</a>. Safe and effective vaccines are one of the most promising ways that children can be protected from COVID-19, prevent spread and have as little disruption as possible in their schooling and everyday life.</p>
<h2>COVID-19 vaccine development for children</h2>
<p>Before use in the general public, all vaccines go through rigorous phases of testing starting with pre-clinical studies in the laboratory and in animals. Then they must go through three phases of clinical studies in people, allowing investigators and regulators to evaluate the vaccine’s safety at each stage before moving on to test it in larger numbers of people. </p>
<p>Once a vaccine is shown to be safe and effective in adults, <a href="https://theconversation.com/kids-arent-just-littler-adults-heres-why-they-need-their-own-clinical-trials-for-a-covid-19-vaccine-162821">trials move on to children</a>, who may differ in their reactions and immune response to vaccines. Going down stepwise by age, Pfizer studied children <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use">ages 12 to 15</a> before the younger age groups. The FDA expanded its emergency authorization of the Pfizer COVID-19 vaccine to include that age group in May 2021. In adolescents ages 12 to 18, the vaccine was shown to <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7042e1.htm?s_cid=mm7042e1_w">reduce hospitalizations by 93%</a> from June through September 2021.</p>
<p>Even after vaccines are authorized or approved for use, monitoring for safety continues. This allows very rare side effects not seen in large late-phase trials to be detected and investigated. Safety surveillance with the COVID-19 vaccines following authorization in adults and older adolescents ages 16 and up quickly identified a rare increase in inflammation of the heart known as myocarditis following COVID-19 vaccines, particularly in young males. Most patients <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myocarditis.html">responded well</a> to supportive care and rapidly improved. <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7035e5.htm">Myocarditis</a> can also occur with COVID-19 or as a complication of <a href="https://doi.org/10.1001/jama.2021.2091">multisystem inflammatory syndrome</a>. </p>
<p>The Pfizer trial for those under age 12 began with three different doses; ultimately, researchers determined the optimal dosage for children ages 5 to 11 to be <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-results">one-third</a> of the dose given to adults and adolescents and administered as a two-shot regimen three weeks apart. </p>
<p>No serious side effects related to the vaccine, and no cases of myocarditis were reported. The <a href="https://www.fda.gov/media/153447/download">Pfizer data</a> also showed that the vaccine in that age group seems to provide similar high levels of protective antibody responses to those seen in older age groups. And the antibodies produced demonstrated an ability to neutralize the delta variant.</p>
<h2>Next steps</h2>
<p>Ongoing studies will continue to follow vaccinated children closely for safety and to provide more insight into the durability of immunity. The results of the Pfizer vaccine trial for the younger two age cohorts, those 2 to 5 years and 6 months to 2 years, are expected <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-results">later this year</a>. Testing of the Moderna and Johnson & Johnson vaccines in clinical trials in children is also underway. </p>
<p>Given that the pediatric clinical trial data show the overall benefits outweigh risks in this age group, I look forward to being one step closer to offering the COVID-19 vaccine to newly eligible children and their families if the CDC recommendations make this possible.</p>
<p>[<em>Over 115,000 readers rely on The Conversation’s newsletter to understand the world.</em> <a href="https://theconversation.com/us/newsletters/the-daily-3?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=100Ksignup">Sign up today</a>.]</p><img src="https://counter.theconversation.com/content/169907/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Debbie-Ann Shirley does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Pediatric clinical trials for the COVID-19 Pfizer vaccine for children ages 5 to 11 have shown that the Pfizer shot is safe and effective.Debbie-Ann Shirley, Associate Professor of Pediatrics, University of VirginiaLicensed as Creative Commons – attribution, no derivatives.