tag:theconversation.com,2011:/nz/topics/astrazeneca-106816/articlesAstraZeneca – 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>
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<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">
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<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>
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<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>
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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>
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<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>
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<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">
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<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>
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<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/1932332022-10-30T10:52:33Z2022-10-30T10:52:33ZVaccines could be a game-changer in the fight against malaria in Africa<figure><img src="https://images.theconversation.com/files/491862/original/file-20221026-13-1efpnj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The first malaria vaccine, Mosquirix, was approved by the WHO in 2021.</span> <span class="attribution"><span class="source">Brian Ongoro/AFP via Getty Images</span></span></figcaption></figure><p>The development of an effective vaccine for malaria has proved to be far more challenging than developing a vaccine to protect people from COVID-19. Several different COVID-19 vaccines were <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/overview-COVID-19-vaccines.html">developed and approved</a> for use within a year of the disease’s emergence. </p>
<p>In contrast, it took over 30 years of intensive research and numerous clinical trials by the Walter Reed Army Institute of Research and partners before the <a href="https://www.who.int/news/item/06-10-2021-who-recommends-groundbreaking-malaria-vaccine-for-children-at-risk">first malaria vaccine</a>, Mosquirix, was approved for use by the World Health Organization (WHO) in 2021. </p>
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Read more:
<a href="https://theconversation.com/malaria-vaccine-is-a-major-leap-forward-but-innovation-mustnt-stop-here-169639">Malaria vaccine is a major leap forward: but innovation mustn't stop here</a>
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<p>Creating a vaccine for a vector-borne disease such as malaria is very challenging. The parasite takes on <a href="https://www.dw.com/en/oxford-malaria-vaccine-promising-results-in-trials/a-63065352">different forms in different hosts</a>. And it’s constantly evolving to evade the human immune system and control interventions.</p>
<p>In a major step towards the equitable roll-out of Mosquirix, the WHO awarded the vaccine <a href="https://www.gsk.com/en-gb/media/press-releases/who-grants-prequalification-to-gsk-s-mosquirix-the-first-and-only-approved-malaria-vaccine/">prequalification status</a> in September 2022. The prequalification step follows approval. It ensures that only good quality products are procured and distributed by United Nations agencies and other major donors. </p>
<p>Most recently, researchers from Burkina Faso and Oxford University’s Jenner Institute – the same institution that developed the Oxford/AstraZeneca COVID-19 vaccine – made their own revelation. They <a href="https://www.bbc.com/news/health-62797776">released</a> very encouraging data from a clinical trial assessing the novel R21 malaria vaccine. </p>
<p>Like Mosquirix, the R21 vaccine targets the sporozoite. This is the malaria parasite stage that is transferred to humans when the malaria-infected female Anopheles mosquito is taking a blood meal. When effective, both vaccines ensure that the sporozoites are destroyed before they enter the liver. It effectively prevents malaria infection by halting the parasite life cycle in the human host.</p>
<p>The fight against malaria has been significantly strengthened with the addition of malaria vaccines to the suite of prevention measures. These vaccines have the potential to reduce malaria-related illness and and death in children under the age of five – one of the populations currently <a href="https://www.who.int/news-room/fact-sheets/detail/malaria">most affected by malaria</a>. </p>
<h2>What studies show</h2>
<p>Both vaccines – Mosquirix and R21 – target the same parasite stage and use the same malaria proteins. But Oxford’s R21 vaccine contains a higher number of these malaria proteins. And it uses a different adjuvant – a chemical substance that stimulates the body’s immune response. These two factors are thought to improve the efficacy of the R21 vaccine by causing a stronger immune response. </p>
<p>The preliminary data are drawn from a <a href="https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(22)00442-X/fulltext">two-year study</a> involving 409 children aged five to 17 months. The children received a booster dose 12 months after receiving the first three doses of the vaccine. The data suggest that the R21 vaccine resulted in a <a href="https://www.sabcnews.com/sabcnews/oxford-malaria-vaccine-data-bodes-well-for-effort-to-combat-deadly-disease/">higher level of protection</a> than Mosquirix. </p>
<p>Eight out of every 10 children who received four doses of the R21 vaccine did not develop malaria over the trial period – making this malaria vaccine the <a href="https://www.ox.ac.uk/news/2022-09-08-malaria-booster-vaccine-continues-meet-who-specified-75-efficacy-goal">first to meet the WHO minimum efficacy target</a> of 75% for 12 months in the target population of young African children.</p>
<p>These study results are encouraging. </p>
<p>But researchers have cautioned against a direct comparison between the performance of the R21 and Mosquirix vaccines. Unlike the Mosquirix vaccine, the R21 vaccine was given to children before the start of the malaria season. And it was only <a href="https://www.medicalnewstoday.com/articles/malaria-new-vaccine-candidate-shows-promise-in-clinical-trials#Plans-for-a-phase-3-trial">tested</a> on a small number of children from one region in Burkina Faso. In addition, a number of control and prevention measures were in place. </p>
<p>A larger study is needed to confirm vaccine efficacy in African children across the continent. This study must be done in regions with differing malaria transmission intensities, differing levels of malnutrition and anaemia in the target populations, and varying coverage of control interventions. </p>
<p>Four thousand eight hundred children from four African countries – two of which have malaria transmission all year round – have been enrolled in a <a href="https://www.nature.com/articles/d41586-022-02902-6">phase 3 clinical trial</a>. The aim of this trial is to demonstrate vaccine safety and efficacy in a larger, more diverse group of children. The researchers from the Jenner Institute expect the R21 vaccine to be approved for use next year, as long as no unexpected safety concerns are raised in this larger trial.</p>
<p>Manufacturing and distribution bottlenecks <a href="https://blogs.worldbank.org/health/new-data-illuminates-acute-vaccine-supply-delivery-gaps-developing-countries">prevented</a> the timely and equitable distribution of COVID-19 vaccines. To avoid a repeat, the University of Oxford has signed a manufacturing agreement with the Serum Institute of India, the largest manufacturer of vaccines globally. Under this agreement, the Serum Institute has agreed to supply at least 200 million doses annually. This is significantly more than the 15 million to 18 million doses of Mosquirix that GlaxoSmithKline is contracted to produce every year <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/oxford-malaria-vaccine-data-bodes-well-effort-combat-deadly-disease-2022-09-07/">until 2028</a>.</p>
<p>But, according to <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/why-worlds-first-malaria-shot-wont-reach-millions-children-who-need-it-2022-07-13/">the WHO</a>, this quantity is far lower than the projected demand for vaccines. To increase manufacturing capacity, the Jenner Institute is in talks with African vaccine manufacturers.</p>
<h2>Moving forward</h2>
<p>Getting the vaccines manufactured is only the first step. </p>
<p>Other hurdles include ensuring that countries can procure the vaccines, that there is equitable delivery of the vaccines to the requesting countries, and that there is prompt vaccines distribution to all healthcare facilities within the malaria risk areas. And most importantly, that there is optimal uptake of the vaccines.</p>
<p>Misinformation, <a href="https://www.phillyvoice.com/covid-19-vaccine-hesitancy-parents-children/">vaccine hesitancy</a> and safety concerns have contributed to a lower rate of vaccination against COVID-19, particularly among children. </p>
<p>For a malaria vaccine to have an impact, health promotion is key. Awareness campaigns must address safety concerns, while emphasising expected positive impacts of the vaccine. These campaigns must target both healthcare professionals and affected communities. They must be delivered before and during vaccine roll-out to ensure any new misinformation or concerns are promptly and effectively addressed.</p><img src="https://counter.theconversation.com/content/193233/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jaishree Raman is affiliated with the National Institute for Communicable Diseases, the Wits Research Institute for Malaria and University of Pretoria's Institute for Sustainable Malaria Control and receives funding from the South African Research Trust, the Gates Foundation, the Global Fund, the Clinton Health Access Initiative, the South African Medical Research Council, and the National Institute for Communicable Diseases.</span></em></p>For a malaria vaccine to have an impact, health promotion is key. Awareness campaigns must address safety concerns and emphasise expected positive impacts.Jaishree Raman, Principal Medical Scientist and Head of Laboratory for Antimalarial Resistance Monitoring and Malaria Operational Research, National Institute for Communicable DiseasesLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1848092022-06-27T12:24:39Z2022-06-27T12:24:39ZShould you get a COVID-19 booster shot now or wait until fall? Two immunologists help weigh the options<figure><img src="https://images.theconversation.com/files/470339/original/file-20220622-11-hea4if.jpg?ixlib=rb-1.1.0&rect=58%2C0%2C6562%2C4312&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Clinical studies show that mixing and matching booster vaccines can lead to a more robust immune response.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/doctor-prepares-the-syringe-royalty-free-image/1379312638?adppopup=true">SDI Productions/E+ via Getty Images</a></span></figcaption></figure><p>While COVID-19 vaccines continue to be <a href="https://www.commonwealthfund.org/blog/2022/impact-us-covid-19-vaccination-efforts-march-update">highly effective</a> at preventing hospitalization and death, it has become clear that the protection offered by the current vaccines <a href="https://theconversation.com/how-long-does-protective-immunity-against-covid-19-last-after-infection-or-vaccination-two-immunologists-explain-177309">wanes over time</a>. This necessitates the use of <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html#">booster shots</a> that are safe and effective in enhancing the immune response against the virus and extending protection.</p>
<p>But when to get a first or second booster, and which shot to choose, are open questions. Many people find themselves unsure whether to wait on new, updated formulations of the COVID-19 vaccines or to mix and match combinations of the original vaccine strains. </p>
<p>SARS-CoV-2, the virus that causes COVID-19, uses <a href="https://doi.org/10.1038/s41580-021-00418-x">its knob-shaped spike protein</a> to gain entry into cells and to cause infection. Each of the existing and upcoming vaccines relies on emulating the spike protein to trigger the immune response. However, each vaccine type presents the spike protein to the immune system in different ways. </p>
<p>As <a href="https://scholar.google.com/citations?user=jJVj3sUAAAAJ&hl=en">immunologists</a> studying inflammatory and <a href="https://sc.edu/study/colleges_schools/medicine/about_the_school/faculty-staff/nagarkatti_mitzi.php">infectious diseases</a>, including COVID-19, we are interested in understanding how the COVID-19 vaccine designs differ in the type of immunity they trigger and the protection that results.</p>
<h2>New bivalent vaccines</h2>
<p>Moderna and Pfizer-BioNTech, the two companies whose mRNA vaccines have been the primary options for COVID-19 vaccination across all age groups, both have new vaccine formulations on the way. An advisory committee of the Food and Drug Administration is set to meet on June 28, 2022, to <a href="https://www.statnews.com/2022/06/25/pfizer-says-its-omicron-containing-boosters-outperform-current-vaccine/">evaluate the newest versions</a> and to decide on which are likely to be recommended for use in this fall’s booster shots.</p>
<p>Moderna’s new bivalent vaccine mixes mRNA that encodes for the spike proteins of the original SARS-CoV-2 virus as well as the slightly different spike protein of the <a href="https://www.sciencenews.org/article/covid-coronavirus-omicron-variant-mutation-infectious">more infectious omicron variant</a>. </p>
<p>In early June 2022, Moderna said that in clinical trials, <a href="https://www.npr.org/2022/06/08/1103659340/moderna-vaccine-booster-omicron">its bivalent vaccine outcompetes the original vaccine strain</a>, inducing a stronger immune response and longer protection against the original SARS-CoV-2 and <a href="https://investors.modernatx.com/news/news-details/2022/Moderna-Announces-Omicron-Containing-Bivalent-Booster-Candidate-mRNA-1273.214-Demonstrates-Superior-Antibody-Response-Against-Omicron/default.aspx">its variants, including omicron</a>. </p>
<p>Moderna later announced that its newest formulation also <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-booster-candidate-produces-strong-antibodies-against-omicron-subvariants-2022-06-22/">performs well against the newest omicron subvariants, BA.4 and BA.5</a>, which are quickly becoming the dominant strains in the U.S. Because of the significantly stronger immune response that the new shot induces, Moderna predicts that <a href="https://www.npr.org/2022/06/08/1103659340/moderna-vaccine-booster-omicron">such protection may last a year</a> and plans to <a href="https://www.cbsnews.com/news/covid-vaccine-moderna-omicron-variant-booster-shot-august/">introduce its new vaccine in August</a>. </p>
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<figcaption><span class="caption">The new Moderna booster could be available by fall 2022.</span></figcaption>
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<p>And most recently, <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-omicron-adapted-covid-19">on June 25, Pfizer-BioNTech also announced</a> results for its two new COVID-19 vaccine formulations: a bivalent formulation consisting of mRNA that encodes for the spike proteins of the original SARS-CoV-2 strain and the original BA.1 omicron subvariant, and a “monovalent” version that is only directed at the spike protein of BA.1. </p>
<p>The company’s preliminary studies demonstrated that both the monovalent and the bivalent vaccines triggered antibodies that neutralized the newer omicron BA.4 and BA.5 subvariants, although to a lesser degree than the BA.1 subvariant. However, Pfizer’s monovalent vaccine <a href="https://www.statnews.com/2022/06/25/pfizer-says-its-omicron-containing-boosters-outperform-current-vaccine/">triggered better virus-neutralizing antibodies</a> against the omicron BA.1 subvariant than did the bivalent vaccine.</p>
<p>However, whether the differences in the levels of such antibodies seen with the monovalent versus bivalent vaccines translate into different levels of protection against newer omicron variants remains to be established in clinical trials. </p>
<h2>Progress on the Novavax vaccine</h2>
<p>Another vaccine formulation that is working its way toward authorization is Novavax, a vaccine built using the spike protein of the original SARS-CoV-2 virus. The Novavax vaccine has the advantage of being <a href="https://www.science.org/content/blog-post/novavax-vaccine-finally">similar to traditional vaccines</a>, such as the <a href="https://www.cdc.gov/vaccines/hcp/vis/vis-statements/dtap.html">DTaP vaccines against diphtheria, tetanus and pertussis</a>, or the vaccines against other viral infections such as hepatitis and shingles. The Novavax vaccine has been clinically tested in South Africa, the United Kingdom and the U.S. and found to be <a href="https://doi.org/10.1056/NEJMoa2116185">safe and highly effective</a> with <a href="https://www.who.int/news-room/feature-stories/detail/the-novavax-vaccine-against-covid-19-what-you-need-to-know">90% efficacy</a> against mild, moderate and severe forms of COVID-19. </p>
<p>An advisory committee to the Food and Drug Administration <a href="https://www.science.org/content/article/fda-advisers-greenlight-novavax-covid-19-vaccine">endorsed the Novavax vaccine</a> in early June 2022. Now, the FDA is reviewing changes that Novavax made during its manufacturing process before making its decision to authorize the shot.</p>
<p>In Australia, the Novavax vaccine was recently registered provisionally as a booster for individuals aged 18 years and over. The company is <a href="https://ir.novavax.com/Novavax-Initiates-Phase-3-Trial-of-its-COVID-19-Omicron-Strain-Vaccine-as-a-Booster">performing phase 3 clinical trials</a> to determine if its vaccine can be used safely and effectively as a booster in people who have previously taken mRNA vaccines.</p>
<p>When these new vaccines become available in the coming months, people will have significantly more options for mixing and matching vaccines in order to enhance the duration and quality of their immune protection against COVID-19. </p>
<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/1795272022-03-29T18:55:45Z2022-03-29T18:55:45ZHow does the COVID-19 prevention drug Evusheld work and who should receive it? An infectious disease specialist explains<figure><img src="https://images.theconversation.com/files/454810/original/file-20220328-17-p5v6as.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C1024%2C683&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">While many immunocompromised and high-risk patients may benefit from AstraZeneca's Evusheld, drug distribution and access have been uneven.</span> <span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/VirusOutbreakCovidAntibodyDrug/2716fff2b7694fb69cb8ca8d2953813a">AP Photo/Ted S. Warren</a></span></figcaption></figure><p><em>The U.S. Food and Drug Administration granted <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-new-long-acting-monoclonal-antibodies-pre-exposure">emergency use authorization</a> to AstraZeneca’s COVID-19 antibody drug Evusheld on Dec. 8, 2021. Infectious disease physician Patrick Jackson of the University of Virginia explains how it works, who’s eligible and why some patients are having difficulties accessing it.</em></p>
<h2>1. What is Evusheld, and how does it work?</h2>
<p>Evusheld is the <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-new-long-acting-monoclonal-antibodies-pre-exposure">first FDA-authorized drug</a> to prevent COVID-19 in high-risk people who aren’t adequately protected by vaccination alone. <a href="https://www.fda.gov/media/154701/download">Data from a preliminary study</a> that has not yet been peer reviewed showed Evusheld reduced the risk of symptomatic COVID-19 by 77% in unvaccinated high-risk adults.</p>
<p>When the immune system is exposed to a foreign protein – for example, by infection or vaccination – it produces antibodies in response to the potential threat. Evusheld is a combination of two antibodies, tixagevimab and cilgavimab, that bind to the spike protein of the virus that causes COVID-19 and prevent it from entering and infecting cells. Evusheld is a <a href="https://doi.org/10.1038/s41586-020-2548-6">monoclonal antibody drug</a>, meaning that it is made of mass-produced identical antibodies that originally came from a <a href="https://courses.lumenlearning.com/microbiology/chapter/polyclonal-and-monoclonal-antibody-production/">single type</a> of white blood cell. Evusheld <a href="https://bloodcancer.org.uk/news/antivirals-and-monoclonal-antibodies-whats-the-difference/">functions differently</a> from antiviral drugs like molnupiravir, which work by stopping the virus from replicating within cells.</p>
<p>Tixagevimab and cilgavimab are versions of natural human antibodies that have been modified to <a href="https://doi.org/10.1126/scitranslmed.abl8124">last much longer</a> in the body than they normally would. This allows Evusheld to provide COVID-19 protection for several months following a single dose. It is expected that Evusheld will need to be given <a href="https://www.astrazeneca.com/media-centre/statements/2022/fda-evusheld-dosage-update-us.html">about every six months</a> to keep antibody levels high enough to be effective against the virus. Patients may need to keep getting Evusheld doses as long as there is a significant risk of COVID-19.</p>
<p>Evusheld is not intended to treat COVID-19, but to help prevent vulnerable patients from getting sick in the first place.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/M3zllm8QbCM?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Monoclonal antibodies have a wide range of medical uses, including pregnancy tests and cancer treatment.</span></figcaption>
</figure>
<h2>2. Who should be receiving Evusheld?</h2>
<p>Evusheld can be used by people ages 12 and up who fall into <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-new-long-acting-monoclonal-antibodies-pre-exposure">two specific groups</a> unable to receive the full benefit of COVID-19 vaccination.</p>
<p>The first group is people who are moderately to severely immunocompromised because of a medical condition or treatment. While most in this group get some protection from the COVID-19 vaccines, the immune systems of some <a href="https://doi.org/10.1093/cid/ciac103">may not be able to make enough</a> protective antibodies on their own. This includes people receiving treatment for certain cancers, solid organ or stem cell transplant recipients and people with certain immune system disorders. People who take immunosuppressive medications, such as high-dose steroids and common autoimmune disease treatments, may also be eligible.</p>
<p>Evusheld is also authorized for the small number of people who had a severe reaction to the COVID-19 vaccines and can’t receive the full recommended dose regimen. It is important to note that this does not apply to <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/after.html">common mild reactions</a>, such as pain at the injection site or mild fever. Most people who have rare allergic reactions to the COVID-19 vaccines can still <a href="https://doi.org/10.1001/jamainternmed.2021.8515">safely receive additional doses</a>, and should discuss their options with their doctor.</p>
<h2>3. When are you supposed to take Evusheld?</h2>
<p>Evusheld is used to prevent COVID-19 before a person has been exposed to the virus. Currently it isn’t approved to treat someone who is already sick with COVID-19 or to prevent an infection after recent exposure. </p>
<p>There are <a href="https://www.covid19treatmentguidelines.nih.gov/management/clinical-management/nonhospitalized-adults--therapeutic-management/">several COVID-19 treatments</a> available for high-risk people who do become infected. Unpublished data that have not yet been peer reviewed suggest that Evusheld may have a role in <a href="https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/azd7442-phiii-trial-positive-in-covid-outpatients.html">COVID-19 treatment</a> in addition to prevention, but using the drug in this way has not yet been authorized by the FDA.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/454796/original/file-20220328-23-121o4r1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Health care provider preparing to give a patient a shot." src="https://images.theconversation.com/files/454796/original/file-20220328-23-121o4r1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/454796/original/file-20220328-23-121o4r1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/454796/original/file-20220328-23-121o4r1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/454796/original/file-20220328-23-121o4r1.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/454796/original/file-20220328-23-121o4r1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/454796/original/file-20220328-23-121o4r1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/454796/original/file-20220328-23-121o4r1.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">Immunocompromised patients can bolster their protection against COVID-19 with both vaccination and monoclonal antibody drugs like Evusheld.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/doctor-preparing-to-inject-male-patient-with-royalty-free-image/1297299344">Andrej Filipovic/iStock via Getty Images Plus</a></span>
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<p>Evusheld is given <a href="https://www.fda.gov/media/154703/download">at least two weeks after</a> a patient’s last vaccine dose. This is to ensure the vaccine has had enough time to establish its full protective effects. This recommendation may change as researchers learn more about how vaccines and monoclonal antibodies like Evusheld work together. </p>
<p>Generally, immunocompromised people who can get vaccinated and boosted for COVID-19 should do so in addition to taking Evusheld. While they may not be as strongly protected as others, vaccination is still likely to provide some benefit. </p>
<h2>4. How effective is Evusheld against variants?</h2>
<p>One significant shortcoming of monoclonal antibody drugs like Evusheld is that they are <a href="https://www.covid19treatmentguidelines.nih.gov/therapies/anti-sars-cov-2-antibody-products/anti-sars-cov-2-monoclonal-antibodies/">not all equally effective</a> against different variants of the virus that causes COVID-19.</p>
<p>Evusheld entered clinical trials before the omicron variant <a href="https://covariants.org/per-country?region=World">dominated infections</a> around the world. Lab studies have given <a href="https://covdb.stanford.edu/page/susceptibility-data/">conflicting results</a> on how effective Evusheld might be against the omicron subvariants currently circulating in the U.S. It also isn’t clear how well those lab studies predict real-world protection against COVID-19.</p>
<p>In response to this concern, the FDA <a href="https://www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-revisions-evusheld-dosing">recently doubled</a> the authorized dose of Evusheld. The idea is that if the Evusheld antibodies are less effective against one of the omicron subvariants, more antibodies might still offer protection. Future variants may make Evusheld more or less effective.</p>
<h2>5. Are there any other preventive treatments?</h2>
<p>Other than the vaccines, Evusheld is currently the only drug approved or authorized in the U.S. for the prevention of COVID-19.</p>
<p>Until recently, two other monoclonal antibody drugs, casirivimab-imdevimab and bamlanivimab-etesevimab, were used to prevent disease in people who were recently exposed to COVID-19. Unfortunately, these drugs are <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-certain-monoclonal-antibodies-treat-covid-19-due-omicron">not effective</a> against the omicron variant that is now the source of almost all U.S. COVID-19 cases.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/454809/original/file-20220328-15-1h2yobe.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Closeup of Evusheld vials on a tray" src="https://images.theconversation.com/files/454809/original/file-20220328-15-1h2yobe.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/454809/original/file-20220328-15-1h2yobe.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=399&fit=crop&dpr=1 600w, https://images.theconversation.com/files/454809/original/file-20220328-15-1h2yobe.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=399&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/454809/original/file-20220328-15-1h2yobe.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=399&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/454809/original/file-20220328-15-1h2yobe.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=501&fit=crop&dpr=1 754w, https://images.theconversation.com/files/454809/original/file-20220328-15-1h2yobe.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=501&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/454809/original/file-20220328-15-1h2yobe.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"></a>
<figcaption>
<span class="caption">Evusheld is currently authorized for use as a COVID-19 prophylactic in only certain groups of people.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/vials-of-a-test-production-are-pictured-at-the-assembly-news-photo/1238317963">Jonathan Nackstrand/AFP via Getty Images</a></span>
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</figure>
<p>Researchers are looking into whether another monoclonal antibody, <a href="https://clinicaltrials.gov/ct2/show/NCT05210101">sotrovimab</a>, which is currently being used as a treatment for COVID-19 in <a href="https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-sotrovimab-emergency-use-authorization">certain U.S. regions</a> that have not yet been overtaken by the <a href="https://theconversation.com/what-is-the-new-covid-19-variant-ba-2-and-will-it-cause-another-wave-of-infections-in-the-us-179619">BA.2 omicron subvariant</a>, could also be used to bolster immunity in immunocompromised people.</p>
<p>There is no evidence that drugs like <a href="https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/#toc-6">hydroxychloroquine</a> or <a href="https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/#toc-17">ivermectin</a> are useful for preventing COVID-19.</p>
<h2>6. Why is it so difficult to access Evusheld?</h2>
<p>The U.S. government has <a href="https://www.reuters.com/world/us/astrazeneca-says-us-buy-additional-500000-evusheld-doses-2022-01-12/">purchased hundreds of thousands of doses</a> of Evusheld and is distributing these through state and territorial health departments. But that’s far fewer doses than the <a href="https://www.theatlantic.com/health/archive/2022/02/covid-pandemic-immunocompromised-risk-vaccines/622094/">7 million or more immunocompromised people</a>, or <a href="https://doi.org/10.1001/jama.2016.16477">roughly 2.7% of American adults</a>, who might benefit from this drug. While AstraZeneca has said there are <a href="https://khn.org/news/article/evusheld-covid-prevention-monoclonal-antibody-therapy-availability-hhs/">more doses</a>, it is unclear whether the U.S. plans to purchase more. </p>
<p>While some hospitals have had overwhelming demand, others have <a href="https://www.nytimes.com/2022/03/06/us/politics/evusheld-covid-treatment.html">unused doses</a>. Some hospitals have had to <a href="https://khn.org/news/article/evusheld-covid-prevention-monoclonal-antibody-therapy-availability-hhs/">implement allocation systems</a> to ensure that patients at highest risk are prioritized, and those policies are <a href="https://www.npr.org/sections/health-shots/2022/01/25/1075432400/hospitals-use-a-lottery-to-allocate-scarce-covid-drugs-for-the-immunocompromised">not standardized</a>. The recent FDA decision to <a href="https://www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-revisions-evusheld-dosing">increase the standard Evusheld dose</a> also means that supply won’t be able to stretch as far. </p>
<p>Unfortunately, because Congress has failed to fund ongoing COVID-19 programs, this might further <a href="https://www.whitehouse.gov/briefing-room/statements-releases/2022/03/15/fact-sheet-consequences-of-lack-of-funding-for-efforts-to-combat-covid-19-if-congress-does-not-act/">decrease the supply</a> of Evusheld available to patients.</p>
<h2>7. How do I know if I need Evusheld, and how can I get it?</h2>
<p>If you think you might benefit from Evusheld, talk to your doctor about whether you qualify. The doctor can write you a prescription. </p>
<p>Evusheld is administered as two injections during one session, and patients are observed for one hour to monitor for rare allergic reactions. Because of limited supply and these special monitoring requirements, Evusheld is given only at certain locations. Many state health departments have websites that let you look up nearby medical centers that have Evusheld. The federal government also has a <a href="https://covid-19-therapeutics-locator-dhhs.hub.arcgis.com/">treatment locator</a> for Evusheld and other COVID-19 drugs, though this may not be completely up to date.</p>
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<p class="fine-print"><em><span>Patrick Jackson receives funding from the National Institutes of Health. He is affiliated with Indivisible Charlottesville.</span></em></p>Evusheld is an antibody drug from AstraZeneca intended to help prevent COVID-19 infection for immunocompromised and other vulnerable patients.Patrick Jackson, Assistant Professor of Infectious Diseases, University of VirginiaLicensed 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>
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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>
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<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">
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<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>
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</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>
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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>
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<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>
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<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>
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<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>
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<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/1726092021-11-29T04:25:59Z2021-11-29T04:25:59ZDoes AstraZeneca’s COVID vaccine give longer-lasting protection than mRNA shots?<p>Last week, AstraZeneca’s chief executive officer <a href="https://www.bloomberg.com/opinion/articles/2021-11-24/did-astrazeneca-covid-vaccine-really-keep-britain-safer-than-europe-not-so-fast">said</a> the company’s COVID vaccine may provide longer-lasting protection than mRNA vaccines like Pfizer’s, especially in older people.</p>
<p>CEO Pascal Soriot said this might explain the United Kingdom’s <a href="https://www.ft.com/content/92e77bf1-2266-4534-a043-daa6c8bb413f">more stable hospitalisation rate</a> compared to the escalating COVID situation in continental Europe.</p>
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<p>The UK used the AstraZeneca vaccine a lot more widely than other European countries, many of which <a href="https://www.theguardian.com/world/2021/nov/23/astrazeneca-chief-links-europes-covid-surge-to-rejection-of-firms-vaccine">restricted its use</a> to older age groups or <a href="https://www.bbc.com/news/world-europe-56744474">abandoned using it altogether</a> after reports of very rare blood clots.</p>
<p>The theory behind this is the AstraZeneca vaccine may provide more durable “T cell protection”. T cells are a crucial part of our immune system, and differ from antibodies.</p>
<p>There’s not enough evidence yet to support the CEO’s claim. But we do know a lot more about adenovirus vector vaccines, such as AstraZeneca’s, as they’ve been around for decades, while mRNA vaccines are relatively newer.</p>
<p>Theoretically, it is possible adenovirus vector vaccines do give more durable protection against COVID via T cells.</p>
<p>Let me explain.</p>
<h2>What is AstraZeneca’s vaccine again?</h2>
<p>AstraZeneca’s COVID vaccine is an adenovirus vector vaccine.</p>
<p>This means it uses an adenovirus – a common type of virus that affects humans and many other animals. The adenovirus is genetically modified so it doesn’t replicate.</p>
<p>It’s used as a way to deliver the vaccine’s information into our cells.</p>
<p>In this case, the information packaged in the adenovirus tells our body how to make the coronavirus <a href="https://theconversation.com/revealed-the-protein-spike-that-lets-the-2019-ncov-coronavirus-pierce-and-invade-human-cells-132183">spike protein</a>. This teaches our immune system how to deal with the coronavirus if we’re exposed.</p>
<p>Adenovirus vectors have been used in medicine for a few decades in other vaccines and <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4507798/">also cancer therapy</a>. They’re very good at stimulating both antibody production and T cell responses.</p>
<h2>What are T cells?</h2>
<p><a href="http://www.biology.arizona.edu/immunology/tutorials/antibody/structure.html">Antibodies</a> bind tightly to a specific target, locking onto invading viruses and preventing them from entering our cells.</p>
<p>But the immune system is more than just antibodies.</p>
<p>T cells are also really important for our immune response, and have different roles. One type, known as “killer T cells”, attack and destroy virus-infected cells.</p>
<p>Another type, known as “helper T cells”, interpret the nature of the infection and help the immune system respond appropriately. This includes activating killer T cells to destroy virus-infected cells, and also helping B cells make antibodies. </p>
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<p>Antibodies wane over time, which can lead to more breakthrough infections <a href="https://theconversation.com/why-are-we-seeing-more-covid-cases-in-fully-vaccinated-people-an-expert-explains-166741">in fully vaccinated people</a>.</p>
<p>When viruses are not stopped by antibodies, we rely on killer T cells to eradicate the virus. And T cells almost certainly help prevent severe outcomes if you get COVID.</p>
<p>It’s a lot harder for a virus to escape a T cell-based immune response. So a vaccine that generates strong T cell immunity should help retain effectiveness over time against variants including Delta and Omicron.</p>
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<em>
<strong>
Read more:
<a href="https://theconversation.com/why-are-we-seeing-more-covid-cases-in-fully-vaccinated-people-an-expert-explains-166741">Why are we seeing more COVID cases in fully vaccinated people? An expert explains</a>
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<p>All COVID vaccines stimulate our bodies to produce both antibodies and T cells.</p>
<p>So the key questions are: does AstraZeneca’s vaccine produce a longer-lasting T cell response than the mRNA vaccines? And might this be one reason why the UK, which relied heavily on the AstraZeneca vaccine, has a more stable hospitalisation rate than other parts of Europe?</p>
<p>Unfortunately, there are not enough data yet to answer these conclusively.</p>
<p>There are many reasons why hospitalisation rates can vary between countries, so it’s difficult to know how much of a factor the use of AstraZeneca’s vaccine would be.</p>
<p>But we can lean on what we know about adenovirus vector vaccines to break down this theory.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/from-adenoviruses-to-rna-the-pros-and-cons-of-different-covid-vaccine-technologies-145454">From adenoviruses to RNA: the pros and cons of different COVID vaccine technologies</a>
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<h2>It’s plausible</h2>
<p>Adenovirus vector vaccines are very good at stimulating immune responses, <a href="https://ashpublications.org/blood/article/110/6/1916/24190/Adenoviral-vectors-persist-in-vivo-and-maintain">particularly T cell responses</a>.</p>
<p>Current wisdom tells us the mRNA vaccines <a href="https://www.bloomberg.com/news/articles/2021-11-15/pfizer-shot-generated-the-most-antibodies-in-a-comparative-study">provide a stronger antibody response</a> than the viral vector vaccines like AstraZeneca’s.</p>
<p>But this antibody protection seems to <a href="https://theconversation.com/why-its-normal-for-covid-19-vaccine-immunity-to-wane-and-how-booster-shots-can-help-171786">wane relatively quickly</a> over 4-6 months.</p>
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<p>It’s possible immune memory with the mRNA vaccines isn’t as strong, and the AstraZeneca vaccine may produce a longer-lasting T cell response that supports more durable immune memory.</p>
<p>This could slow the loss of antibodies and generate a better killer T cell response.</p>
<h2>Why might AstraZeneca produce a longer-lasting response?</h2>
<p>One reason might be because the RNA in Pfizer’s and Moderna’s vaccines doesn’t last very long in the body, <a href="https://theconversation.com/no-covid-vaccines-dont-stay-in-your-body-for-years-169247">only a week or so</a>, because RNA is very fragile.</p>
<p>But the DNA delivered by adenovirus vector vaccines will likely hang around in the body for a bit longer.</p>
<p>DNA is more stable than RNA, and might allow for a more prolonged, low-level activation of our immune system that provides longer-lasting protection.</p>
<p>This might explain longer-lasting T cell responses with the AstraZeneca vaccine.</p>
<p>But this is only speculative for now as such direct tests haven’t been done yet.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/no-covid-vaccines-dont-stay-in-your-body-for-years-169247">No, COVID vaccines don't stay in your body for years</a>
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<h2>If true, we can learn from this</h2>
<p>This isn’t about which vaccine is “<a href="https://theconversation.com/which-covid-vaccine-is-best-heres-why-thats-really-hard-to-answer-161185">better</a>”, or picking and choosing which vaccine to get. </p>
<p>Both are excellent vaccines that have saved many, many lives already. We shouldn’t <a href="https://theconversation.com/covid-vaccination-has-turned-into-a-battle-of-the-brands-but-not-everyones-buying-it-162181">play a tribal game</a> where we say we’re only going to get one type of vaccine.</p>
<p>It’s important to learn from both types of vaccine, while we continue to learn about immunity to COVID, so we can incorporate the best characteristics of both into next-generation vaccines that help us better fight COVID and future pandemics.</p>
<p>I’m sure mRNA vaccine producers will learn from this and develop new formulas to give a longer-lasting response. </p>
<p>It’s worth remembering Pfizer and Moderna’s vaccines are the first mRNA vaccines ever approved for use in humans.</p>
<p>There was an immediate need to get antibodies against COVID in our bodies as soon as possible, and they’ve done a fantastic job doing that.</p><img src="https://counter.theconversation.com/content/172609/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Nathan Bartlett does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>There’s not enough evidence yet to support the AstraZeneca CEO’s statement. But it is theoretically plausible.Nathan Bartlett, Associate Professor, School of Biomedical Sciences and Pharmacy, University of NewcastleLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/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>
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<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>
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<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>
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<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>
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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>
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<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>
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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>
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<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>
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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>
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<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>
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<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>
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<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>
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<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>
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<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/1703682021-10-27T02:03:48Z2021-10-27T02:03:48ZAustralians will soon receive COVID booster vaccines. Why do we need them, and how effective are they?<p>Australia’s drug regulator, the Therapeutic Goods Administration (TGA), today <a href="https://www.tga.gov.au/media-release/tga-approves-booster-doses-pfizer-covid-19-vaccine-comirnaty">provisionally approved the Pfizer COVID vaccine to be used as a booster</a> for anyone over the age of 18.</p>
<p>The TGA said people can take the third dose from six months after their second dose.</p>
<p>People can take Pfizer as a third dose regardless of which two shots they got first.</p>
<p>Moderna’s vaccine is yet to be approved as a booster, while the federal government <a href="https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/minister-hunts-press-conference-in-canberra-on-20-october-2021-on-the-vaccination-rollout-vaccine-booster-update-stem-cell-mission-grants-booster-program-and-net-zero-emissions-policy">does not expect AstraZeneca’s vaccine to be used as a booster</a>.</p>
<p>Health Minister Greg Hunt said he expects <a href="https://www.abc.net.au/news/2021-10-27/tga-approves-covid-vaccine-booster-shots-for-over-18-year-olds/100571442">the booster program to start from November 8</a>. However, the federal government is awaiting further advice from the Australian Technical Advisory Group on Immunisation (ATAGI) about who should receive it and when.</p>
<p>Given our approved vaccines were originally marketed as two-dose jabs, why are we now looking at an extra dose?</p>
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<h2>Why another jab?</h2>
<p>Scientists have often said we may <a href="https://theconversation.com/why-do-we-need-booster-shots-and-could-we-mix-and-match-different-covid-vaccines-155951">need another jab</a> in the future to have better long-term protection against COVID. This is because of concerns about the possibility the immunity will decrease over time. </p>
<p>Initially it was hard to predict when this might happen. But it’s clear now the need and timing for an extra vaccine dose depends on what group of people you’re talking about.</p>
<p>For those living with cancer or other diseases affecting the immune system, current COVID vaccines often <a href="https://www.nature.com/articles/s41591-021-01542-z">fail to generate a strong level of immunity</a>. Getting a third dose seems to help, leading the <a href="https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(21)00313-1/fulltext">United States and United Kingdom</a> to recommend additional jabs for people who are immunocompromised. </p>
<p>Earlier in October, boosters for people who are severely immunocompromised became available in <a href="https://www.health.gov.au/resources/publications/atagi-recommendations-on-the-use-of-a-third-primary-dose-of-covid-19-vaccine-in-individuals-who-are-severely-immunocompromised">Australia</a>. These are available <a href="https://www.smh.com.au/politics/federal/tga-approves-pfizer-booster-shots-for-all-adults-20211027-p593hp.html">28 days after the second dose</a>.</p>
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<a href="https://theconversation.com/why-is-a-third-covid-19-vaccine-dose-important-for-people-who-are-immunocompromised-166569">Why is a third COVID-19 vaccine dose important for people who are immunocompromised?</a>
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<p>Among those who do have a strong response to a two-dose vaccine, their level of protection against infection or serious disease is being tracked over time.</p>
<p>Earlier this year, Israel reported increasing rates of infection in fully vaccinated people aged 60 years and older. This led the government to <a href="https://www.reuters.com/world/middle-east/israel-offer-third-shot-pfizer-vaccine-people-over-60-israeli-news-reports-2021-07-29/">provide third doses</a> for this age group.</p>
<p>In the short-term, the strategy appears to have worked, with <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2114255">infections dropping ten-fold</a> at least two weeks after the boost.</p>
<h2>What is ‘waning immunity’?</h2>
<p>We’ve heard a lot about “waning immunity”, but this may actually be referring to more than one topic.</p>
<p>Across a population, we can track how well vaccines are performing at preventing people from getting infected, getting sick, or needing to go to the hospital. </p>
<p>There is evidence of gradual <a href="https://www.nature.com/articles/d41586-021-02532-4">decreasing vaccine effectiveness</a> over time. </p>
<p>However, the ability of vaccination to <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02183-8/fulltext">prevent hospitalisation from COVID remains very high</a> even after six months.</p>
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<p>At an individual level, scientists can also study the waning of immune responses over time.</p>
<p>There are two key parts to this immunity: the antibodies that can bind to the virus and stop infection completely, and the cells that remember the virus for (hopefully) years to come, ready to be reactivated if the virus gets in.</p>
<p>After a few months, the levels of these antibodies have <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2114583">dropped somewhat</a> among those who receive two doses, likely explaining why vaccine effectiveness declines and breakthrough infections in fully vaccinated people occur. </p>
<p>But if our immunity drops, why are people still protected from hospitalisation and severe disease?</p>
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<a href="https://theconversation.com/how-long-do-covid-vaccines-take-to-start-working-161876">How long do COVID vaccines take to start working?</a>
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<p>That’s where our immune memory comes in. If you do get infected after being vaccinated, your white blood cells will quickly jump into action, producing lots of antibodies and getting ready to kill the virus.</p>
<p>Although longer-term immunity from vaccination dramatically reduces the need for hospitalisation, breakthrough infections following the waning of immunity <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7038e3.htm">do result in further spread of the virus</a>, complicating efforts to control the epidemic.</p>
<p>So, after six months, the vaccines may be less likely to stop us from becoming infected at all, but they’re still extremely important for preventing hospitalisation and death.</p>
<p>Therefore, administering boosters will likely reduce infection and transmission, but the effect of boosters to prevent serious disease and death is more modest, at least in those under 60.</p>
<h2>Are boosters effective?</h2>
<p><a href="https://www.nature.com/articles/s41591-021-01527-y">Early reports</a> have shown strong immune responses to the third dose, and similar side effects to the first shots (mostly pain and fatigue).</p>
<p>Vaccinating people who previously received AstraZeneca with mRNA vaccines can produce <a href="https://www.nature.com/articles/s41591-021-01463-x">particularly strong antibody responses</a>.</p>
<p>This is important in Australia, as most vulnerable older people received the comparatively less potent AstraZeneca vaccine, and using a potent mRNA booster vaccine is wise.</p>
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<h2>3-dose vaccine, or booster dose?</h2>
<p>Most discussion of additional doses uses the terms “third dose” and “booster dose” interchangeably. But there’s a key distinction.</p>
<p>Many vaccines for other diseases are given as <a href="https://www.health.gov.au/health-topics/immunisation/immunisation-throughout-life/national-immunisation-program-schedule">three-dose vaccines</a>, including the Hepatitis B and Human Papillomavirus (HPV) vaccines. In these cases, you’re considered fully vaccinated after having three doses, and in some cases, are expected to have life-long immunity.</p>
<p>This is different from situations in which people might need intermittent booster vaccines to maintain their immunity, such as the annual flu vaccine. </p>
<p>For COVID, a third dose vaccine isn’t likely to provide life-long immunity against any infection, and further doses may be needed.</p>
<p>The third dose of Pfizer will be the same formulation that’s currently being given across Australia. In the US, Moderna is planning to administer <a href="https://apnews.com/article/coronavirus-pandemic-vaccine-moderna-booster-shot-fda-2de19cdff021ad11b95c6b67fd5d8617">a half-dose</a> as the third shot. </p>
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<a href="https://theconversation.com/can-i-get-astrazeneca-now-and-pfizer-later-why-mixing-and-matching-covid-vaccines-could-help-solve-many-rollout-problems-161404">Can I get AstraZeneca now and Pfizer later? Why mixing and matching COVID vaccines could help solve many rollout problems</a>
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<h2>When should boosters be given?</h2>
<p>The best timing of third doses for widespread use isn’t yet clear, and there are two conflicting considerations.</p>
<p>On the one hand, earlier administration will provide more immediate protection from breakthrough infections and virus spread.</p>
<p>However, a longer gap between vaccine doses <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00432-3/fulltext">generally results in higher and more durable immunity</a>.</p>
<p>The best timing of booster vaccines requires careful follow-up in trials.</p>
<h2>Are boosters ethical?</h2>
<p>There’s a question about whether wealthy countries should be embarking on third-dose rollouts given global vaccine supply is limited.</p>
<p>Many developing countries have vaccinated very small proportions of their populations. They remain vulnerable to widespread outbreaks and the overwhelming of already fragile health-care systems.</p>
<p>Also, large numbers of infections across the world can drive additional variants and economic and political instability.</p>
<p>There’s a moral and political imperative for wealthy countries to <a href="https://www.who.int/initiatives/act-accelerator/covax">donate vaccines</a> to initiatives such as the World Health Organization’s COVAX program.</p>
<p>In this context, the decision to <a href="https://www.abc.net.au/news/2021-10-14/opposition-aid-groups-urge-government-extend-csl-astra-zeneca/100539494">shut down local manufacturing of the AstraZeneca vaccine</a> in Australia from early next year is disappointing. Australia had been exporting many of these doses to its Pacific neighbours.</p>
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Read more:
<a href="https://theconversation.com/are-covid-19-boosters-ethical-with-half-the-world-waiting-for-a-first-shot-a-bioethicist-weighs-in-167606">Are COVID-19 boosters ethical, with half the world waiting for a first shot? A bioethicist weighs in</a>
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<img src="https://counter.theconversation.com/content/170368/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jennifer Juno receives funding from the National Health and Medical Research Council and the Medical Research Future Fund.</span></em></p><p class="fine-print"><em><span>Stephen Kent receives funding from the Australian National Health and Medical Research Council and the Medical Research Future Fund.</span></em></p>Protection from infection wanes over time. So boosters will offer extra protection and hopefully reduce the spread of the virus even further.Jennifer Juno, Senior research fellow, The Peter Doherty Institute for Infection and ImmunityStephen Kent, Professor and Laboratory Head, The University of MelbourneLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1697832021-10-20T13:09:18Z2021-10-20T13:09:18ZCOVID: new antibody treatment could offer up to 18 months’ protection against severe disease<figure><img src="https://images.theconversation.com/files/427521/original/file-20211020-27-1d7few6.jpg?ixlib=rb-1.1.0&rect=732%2C129%2C5734%2C3589&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Antibodies (light blue) binding to the spike proteins (dark purple) on the outside of the coronavirus.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-illustration/neutralize-sarscov2-by-binding-protein-blocking-1941307924">Design_Cells/Shutterstock</a></span></figcaption></figure><p>A new treatment could soon help protect people from developing severe COVID. AstraZeneca has just released <a href="https://www.astrazeneca.com/media-centre/press-releases/2021/azd7442-phiii-trial-positive-in-covid-outpatients.html">results</a> from a phase 3 clinical trial – the <a href="https://www.healthline.com/health/clinical-trial-phases">final stage</a> of testing before a drug is authorised – that suggest its new COVID treatment, AZD7442, is effective at reducing severe disease or death in non-hospitalised COVID patients.</p>
<p>The treatment contains antibodies, which are usually produced naturally in response to a COVID infection or vaccination. They work by recognising specific parts of SARS-CoV-2 – the virus that causes COVID – and either attack these directly or bind to them to stop the virus from working and flag it for destruction by other parts of the immune system. </p>
<p>After they’ve done their job of clearing the virus, the antibodies remain in the body for a period of time, making up part of our immunological memory. If what they target is encountered again, they can leap into action.</p>
<p>The new treatment, AZD7442, uses special antibodies called monoclonal antibodies. These are antibodies produced in a lab that imitate the body’s natural defences – in this case mimicking the immune system’s response to COVID. </p>
<p>Artificially developing antibodies to fight disease isn’t a new technique. This technology is already used to treat many diseases, including <a href="https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/drugs/rituximab">leukaemia</a>, <a href="https://www.herceptin.com/hcp/treating-HER2-cancer.html">breast cancer</a> and <a href="https://www.frontiersin.org/articles/10.3389/fmed.2020.00303/full">lupus</a>. In fact, this isn’t even the first time the technique has been used for COVID. The <a href="https://www.gov.uk/government/news/first-monoclonal-antibody-treatment-for-covid-19-approved-for-use-in-the-uk">first</a> COVID monoclonal antibody treatment was approved in the UK in August 2021.</p>
<h2>How does AstraZeneca’s treatment work?</h2>
<p>AZD7442 is a cocktail of two monoclonal antibodies – tixagevimab and cilgavimab – that are designed to reduce the severity of a SARS-CoV-2 infection and so prevent people from getting severely ill. </p>
<p>Both of these antibodies <a href="https://pubmed.ncbi.nlm.nih.gov/33532768/">bind to different parts</a> of virus’s spike proteins, which <a href="https://theconversation.com/new-coronavirus-variant-what-is-the-spike-protein-and-why-are-mutations-on-it-important-152463">cover its outer surface</a> and are what the virus uses to infect cells. It’s thought that attaching to these proteins is what gives the medicine its effect, as this stops the virus from being able to get inside cells and reproduce.</p>
<p>The two monoclonal antibodies in the cocktail are based on antibodies taken from patients who survived COVID. Scientists at AstraZeneca took blood samples from patients and isolated immune cells called <a href="https://www.immunology.org/public-information/bitesized-immunology/cells/b-cells">B cells</a>, which are the antibody factories of the human body. They then grew more of these B cells in the lab, and used them to make large quantities of the two antibodies, which they had identified as specifically targeting the coronavirus’s spike protein.</p>
<p>But the key difference between this and other antibody-based treatments is that in AZD7442, the antibodies have been modified so they stay in the body for longer. </p>
<p>Studies using similarly modified antibodies against another respiratory virus – <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa1913556">respiratory syncytial virus</a> – have shown that this approach gives long-term protection, with the modified antibodies having triple the durability of conventional antibodies. It’s hoped that a single dose of AZD7442 could offer <a href="https://pubmed.ncbi.nlm.nih.gov/29373476/">12 to 18 months</a> protection from severe COVID, though we’ll have to wait to see exactly how long protection lasts.</p>
<h2>How well does it work?</h2>
<p>AstraZeneca’s <a href="https://www.astrazeneca.com/media-centre/press-releases/2021/azd7442-phiii-trial-positive-in-covid-outpatients.html">phase 3 trial</a> investigated the effectiveness of the treatment when given to patients who were infected with SARS-CoV-2.</p>
<p>The study looked at 822 participants who were over the age of 18. Only around 13% were 65 years and over, but 90% had health conditions that put them at high risk of severe COVID, such as cancer, diabetes, obesity, chronic lung disease or asthma, cardiovascular disease or a weakened immune system. </p>
<p>The trial results show that of the 407 people who received AZD7442, 18 developed severe COVID or died, compared with 37 of the 415 people who received a placebo. This suggests that those in the AZD7442 group were 50% less likely to develop severe COVID than those taking a placebo.</p>
<p>The trial also looked specifically at patients who received treatment quickly – that is, within five days of their symptoms starting. In this group, AZD7442 reduced the risk of severe disease or death by 67%, suggesting that early treatment with AZD7442 provides greater protection.</p>
<p>It’s important to note, however, that these results have been released by AstraZeneca but don’t yet appear to have been formally reviewed by other scientists. So any findings need to be treated with caution.</p>
<h2>How useful will it be?</h2>
<p>These results suggest that AZD7442 could be a valuable tool for patients in need of instant immunity against COVID, such as those who have not responded to vaccines because of a weakened immune system or those in other high-risk groups. </p>
<p>However, more detail of the characteristics of the patients who did and did not benefit from the medicine is required to fully understand who will benefit most from receiving this drug. </p>
<p>And when considering how useful AZD7442 could be, it’s important to consider when in the course of the disease the treatment will be given. For many, severe disease with COVID isn’t caused by the virus replicating, but by the <a href="https://www.frontiersin.org/articles/10.3389/fimmu.2020.02037/full">immune system going awry</a>. </p>
<p>This means that to prevent severe disease, drugs such as AZD7442 need to be given early in infection, before the overzealous immune response kicks in. Give them too late, and treatments like this that target the virus directly are unlikely to offer much benefit (unlike those that can control inflammation and immune overreaction, such as <a href="https://www.who.int/news-room/q-a-detail/coronavirus-disease-covid-19-dexamethasone">dexamethasone</a> or <a href="https://www.who.int/news/item/06-07-2021-who-recommends-life-saving-interleukin-6-receptor-blockers-for-covid-19-and-urges-producers-to-join-efforts-to-rapidly-increase-access">tocilizumab</a>). </p>
<p>But one thing that could help the treatment be deployed early during infection is the fact that it only needs to be injected into a muscle, rather than be given intravenously. This means it can be given at a clinic, without patients needing to come into hospital. </p>
<p>However, monoclonal antibody treatments are <a href="https://www.evidence.nhs.uk/document?id=1968626&returnUrl=search%3Fpa%3D14%26q%3Ddrug%2Bprices&q=drug+prices">notoriously expensive</a>, and the cost of AZD7442 has not yet been released. This could be the biggest barrier to the drug having a big impact worldwide – assuming, of course, that its phase 3 results pass the scrutiny of regulators and the drug is approved.</p><img src="https://counter.theconversation.com/content/169783/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Rebecca Aicheler 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>AstraZeneca’s durable monoclonal antibody treatment has shown promise in phase 3 clinical trials.Rebecca Aicheler, Senior Lecturer in Immunology, Cardiff Metropolitan UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1693682021-10-14T07:34:22Z2021-10-14T07:34:22ZWhy Sydney’s COVID numbers didn’t get as bad as the modelling suggested<p>Last Monday, Sydney emerged from a lockdown of more than 100 days after reaching the milestone of having 70% of the over-16 population fully vaccinated.</p>
<p>Modelling predicted New South Wales would “open up” <a href="https://ozsage.org/media_releases/modelling-of-nsw-roadmap-to-freedom-icu-capacity-for-the-delta-epidemic-2021/">with around 1,900 daily cases when this target was reached</a>.</p>
<p>However, the state recorded just <a href="https://twitter.com/NSWHealth/status/1447321300519645186">496 new local cases on that day</a>. And the current seven-day average for NSW is <a href="https://covidlive.com.au/nsw">488 cases</a>, with numbers trending downwards.</p>
<p>What’s more, other modelling suggested COVID-19 <a href="https://www.burnet.edu.au/news/1506_initial_modelling_projections_for_second_epidemic_wave_in_sydney_nsw">hospitalisations would peak between 2,200 and 4,000</a> in greater Sydney in late September.</p>
<p>On September 21, peak COVID hospital occupancy for all of NSW was <a href="https://covidlive.com.au/report/daily-hospitalised/nsw">1,268 patients</a>. There are currently 711 COVID patients hospitalised in NSW, as of October 14. </p>
<p>We propose there are two main factors which might account for these discrepancies.</p>
<h2>Vaccine effectiveness underestimated</h2>
<p>Firstly, predictions of vaccine impact have typically used estimates of effectiveness against the Delta variant based on the UK Scientific Advisory Group for Emergencies (SAGE) roadmap, <a href="https://www.gov.uk/government/publications/spi-m-o-summary-of-further-modelling-of-easing-restrictions-roadmap-step-4-9-june-2021">published in June</a>. This suggested an effectiveness against hospitalisation of 87% for Pfizer and 86% for AstraZeneca. </p>
<p>However, more recent data across numerous countries has shown effectiveness against severe infection and hospitalisation is somewhat greater. A different UK study suggested 95% protection against hospitalisation for both <a href="https://www.gov.uk/government/publications/veep-vaccine-effectiveness-table-7-september-2021">Pfizer and AstraZeneca</a>. And a study from the Netherlands found 96% and 94% protection against hospitalisation for <a href="https://www.medrxiv.org/content/10.1101/2021.09.15.21263613v1.full.pdf">Pfizer and AstraZeneca, respectively</a>. </p>
<p>This difference may account for the disparity between the actual NSW hospitalisation numbers and those predicted based on the current vaccine rollout. </p>
<h2>Real-time protection</h2>
<p>The second reason for the current NSW situation could be a concept we’ve termed “protection in real-time”.</p>
<p>The rapid pace of vaccine uptake during NSW’s Delta wave ensured there was a large proportion of <em>recent</em> vaccines within the population.</p>
<p>This may offset the impact of waning vaccine immunity.</p>
<p>Optimal immunity after vaccination occurs at about two weeks after getting the second dose. But a partial protective effect of vaccination with Pfizer was apparent in clinical trials <a href="https://www.nejm.org/doi/full/10.1056/nejmoa2034577">as early as 12 days after the first dose</a>.</p>
<p>In addition, protection against severe infection may only require a lower level of <a href="https://www.nature.com/articles/s41591-021-01377-8">immune response after vaccination</a>.</p>
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Read more:
<a href="https://theconversation.com/how-long-does-immunity-last-after-covid-vaccination-do-we-need-booster-shots-2-immunology-experts-explain-164073">How long does immunity last after COVID vaccination? Do we need booster shots? 2 immunology experts explain</a>
</strong>
</em>
</p>
<hr>
<h2>How has this played out overseas?</h2>
<p>The protection in real-time concept can be used to explain the impact of vaccination in other countries, which may provide a “real world” perspective of the future of the pandemic in Australia.</p>
<p>Denmark reached 25% vaccination of the total population before the arrival of the Delta variant. During the Delta wave there were reduced hospitalisations and deaths compared to previous waves and a dissociation between case numbers and deaths.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/426377/original/file-20211014-23-1djwszk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/426377/original/file-20211014-23-1djwszk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=425&fit=crop&dpr=1 600w, https://images.theconversation.com/files/426377/original/file-20211014-23-1djwszk.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=425&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/426377/original/file-20211014-23-1djwszk.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=425&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/426377/original/file-20211014-23-1djwszk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=534&fit=crop&dpr=1 754w, https://images.theconversation.com/files/426377/original/file-20211014-23-1djwszk.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=534&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/426377/original/file-20211014-23-1djwszk.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=534&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">You can see the black line (cases) starts to separate from the green line (hospitalisations) and the red line (deaths) as the vaccine rollout progresses.</span>
<span class="attribution"><span class="source">Data from ourworldindata.org/covid-vaccinations and covidlive.com.au</span>, <span class="license">Author provided</span></span>
</figcaption>
</figure>
<p>NSW’s achievement of reaching the 70% threshold last week actually equates to around 56% of the total population of NSW. At the peak of its Delta wave in July, Denmark reached 50% vaccination coverage of the entire population.</p>
<p>The restrictions in place at this time in Denmark were requiring proof of vaccination, past infection or a recent negative COVID test to enter certain indoor settings, such as restaurants and cinemas. </p>
<p>With a population size similar to greater Sydney, the coming months in Denmark may serve as an important comparison as to how the pandemic may unfold in Australia.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1444045856135475200"}"></div></p>
<p>Similarly in Singapore, vaccination rates are high, at around 80% of the total population, and the pace of the vaccine rollout is very similar to Denmark. </p>
<p>Singapore has seen a recent spike in cases since the relaxation of restrictions, with case numbers at their highest. However, <a href="https://www.moh.gov.sg/news-highlights/details/update-on-local-covid-19-situation-(26-sep-2021)">98% of these cases are mild or asymptomatic</a>. This suggests vaccines are having a major impact on lessening the severity of COVID, but a less pronounced ability to completely interrupt disease transmission.</p>
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<p>Another example of the impact of real-time protection is the situation in Israel. Israel is often used as as the benchmark of vaccine effectiveness. Its vaccine program involved a rapid rollout of mRNA vaccines, predominately Pfizer’s. Initial studies in the country found the vaccine <a href="https://www.nejm.org/doi/full/10.1056/nejmoa2101765">had high effectiveness against symptomatic COVID-19 and hospitalisation</a>. </p>
<p>However, the arrival of Delta in Israel resulted in a large increase in COVID-19 cases with accompanying spikes in hospitalisations and deaths.</p>
<p>While this may provide some insight into the impact of Delta in Australia, there are key differences.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/426385/original/file-20211014-23-9of4ed.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/426385/original/file-20211014-23-9of4ed.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=436&fit=crop&dpr=1 600w, https://images.theconversation.com/files/426385/original/file-20211014-23-9of4ed.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=436&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/426385/original/file-20211014-23-9of4ed.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=436&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/426385/original/file-20211014-23-9of4ed.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=548&fit=crop&dpr=1 754w, https://images.theconversation.com/files/426385/original/file-20211014-23-9of4ed.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=548&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/426385/original/file-20211014-23-9of4ed.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=548&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Israel experienced a large increase in COVID cases, hospitalisations and deaths after the arrival of the Delta variant.</span>
<span class="attribution"><span class="source">Data from ourworldindata.org/covid-vaccinations and covidlive.com.au</span>, <span class="license">Author provided</span></span>
</figcaption>
</figure>
<h2>Why did hospitalisations rise in Israel? And what are the lessons for Australia?</h2>
<p>Israel saw a large proportion of the eligible population vaccinated quickly. Around 50% of the total population was fully vaccinated by mid-March. But after this, there was a marked slow-down in uptake.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/426375/original/file-20211014-25-b0pbog.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/426375/original/file-20211014-25-b0pbog.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=425&fit=crop&dpr=1 600w, https://images.theconversation.com/files/426375/original/file-20211014-25-b0pbog.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=425&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/426375/original/file-20211014-25-b0pbog.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=425&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/426375/original/file-20211014-25-b0pbog.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=534&fit=crop&dpr=1 754w, https://images.theconversation.com/files/426375/original/file-20211014-25-b0pbog.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=534&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/426375/original/file-20211014-25-b0pbog.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=534&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">The NSW and Australian populations have been vaccinated much more recently than Israel’s.</span>
<span class="attribution"><span class="source">Data from ourworldindata.org/covid-vaccinations and covidlive.com.au</span>, <span class="license">Author provided</span></span>
</figcaption>
</figure>
<p>Thus, a combination of waning immunity and a large unvaccinated population may have exposed Israel to Delta.</p>
<p>While the Pfizer vaccine demonstrates excellent effectiveness against severe COVID-19, recent evidence from Israel suggests some waning of protection against severe disease over time, which prompted the introduction of the country’s <a href="https://pubmed.ncbi.nlm.nih.gov/34525275/">booster program in July</a>. A third dose was initially offered to over-60s, before being extended to everyone aged 12 and over.</p>
<p>In Australia, the widespread rollout of booster shots in the near future would be premature. The priority now is to get everyone eligible fully vaccinated, and consider boosters for targeted groups. </p>
<p>The federal government announced last week <a href="https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/booster-shot-for-severely-immunocompromised-australians">booster shots would be available to Australians who are “severely immunocompromised”</a> from this week.</p>
<p>Governments should also consider a “mix and match” approach of booster shots. This strategy is being pursued in the UK, based on evidence that <a href="https://www.medrxiv.org/content/10.1101/2021.10.10.21264827v1.full.pdf">combining different vaccines may lead to stronger immunity</a>.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1399157003730128901"}"></div></p><img src="https://counter.theconversation.com/content/169368/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jamie Triccas receives funding from the National Health and Medical Research Council (NHMRC) and the Medical Research Future Fund (MRFF).</span></em></p><p class="fine-print"><em><span>Megan Steain receives funding from the Medical Research Future Fund (MRFF).</span></em></p>Modelling suggested Sydney would open up when NSW had around 1,900 new daily cases. Last Monday, it eased restrictions with just 496 new cases.Jamie Triccas, Professor of Medical Microbiology, School of Medical Sciences, Faculty of Medicine and Health, University of SydneyMegan Steain, Lecturer, School of Medical Sciences, Faculty of Medicine and Health, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1683712021-10-04T19:07:53Z2021-10-04T19:07:53ZWho can’t have a COVID vaccine and how do I get a medical exemption?<p>As Australia works towards getting 80% of over-16s fully vaccinated against COVID and higher, there’s more pressure to mandate vaccination across a range of sectors.</p>
<p>Some sectors in certain states and territories already have a COVID vaccine mandate in place, such as health and aged-care staff. Victoria last week mandated COVID vaccination for <a href="https://www.theage.com.au/politics/victoria/your-questions-answered-mandatory-vaccines-for-authorised-workers-in-victoria-20211001-p58wid.html">all authorised workers in the state</a>, which has been a <a href="https://www.theage.com.au/national/victoria/mandatory-jab-for-authorised-workers-a-difficult-but-necessary-decision-20211003-p58wrr.html">tough but necessary decision</a>. Governments and businesses are also considering mandates for many other groups.</p>
<p>Vaccine passports are also on the way, meaning you’ll need to show proof of being fully vaccinated to do things like travel internationally, and to visit venues in hospitality, entertainment, retail and others in certain states and territories. </p>
<p>But there are some people who can’t get a COVID vaccine for medical reasons, though these are very rare. So what are these conditions, and if you have one of them, how can you prove it?</p>
<h2>Permanent exemptions</h2>
<p>It’s recommended all Australians over 12 receive two doses of a COVID vaccine. We have robust data now on these vaccines, so we know they’re safe and effective. Serious adverse events are very rare.</p>
<p>There are few situations where someone can’t have a COVID vaccine for medical reasons. The criteria to receive a <a href="https://www.servicesaustralia.gov.au/im011">permanent medical exemption</a> are very narrow and rarely required.</p>
<p>The only criteria are:</p>
<ul>
<li><p>anaphylaxis following a previous dose of a COVID vaccine</p></li>
<li><p>or previous anaphylaxis to any component of a COVID vaccine.</p></li>
</ul>
<p>For live vaccines, such the measles, mumps, and rubella (MMR) and varicella vaccines, people who are significantly immunocompromised can get a permanent medical exemption. But this isn’t relevant for COVID vaccines because they’re not live vaccines.</p>
<p>There are <a href="https://immunisationhandbook.health.gov.au/">some conditions</a> people commonly believe may require a vaccine exemption, but the following are <strong>not</strong> reasons to be exempt from COVID vaccination: </p>
<ul>
<li><p>egg allergy, even severe </p></li>
<li><p>a chronic underlying medical condition – these individuals are often at higher risk of more serious disease from COVID, such as people who are immunocompromised who can still receive the COVID vaccines because they’re not live vaccines</p></li>
<li><p>family history of any adverse events following immunisation.</p></li>
</ul>
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<h2>Temporary exemptions</h2>
<p>There are some situations when a COVID vaccine may need to be temporarily deferred. For example, if someone has an acute illness with a fever of 38.5°C or over. However, this would usually be for a short period only and wouldn’t require them to obtain a written temporary medical exemption. </p>
<p>But there are also some “acute major medical illnesses” where people may be able to get a temporary <a href="https://www.servicesaustralia.gov.au/im011">immunisation medical exemption form</a>. This needs to assessed and given by a medical provider, and only temporarily exempts you from a COVID vaccine.</p>
<p>Last week ATAGI, the Australian Technical Advisory Group on Immunisation, which provides medical advice to the federal government on the use of vaccines including COVID vaccines, released expanded guidance on which of these conditions <a href="https://www.health.gov.au/sites/default/files/documents/2021/09/atagi-expanded-guidance-on-temporary-medical-exemptions-for-covid-19-vaccines.pdf">may warrant a temporary medical exemption</a>.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/soon-youll-need-to-be-vaccinated-to-enjoy-shops-cafes-and-events-but-what-about-the-staff-there-168266">Soon you'll need to be vaccinated to enjoy shops, cafes and events — but what about the staff there?</a>
</strong>
</em>
</p>
<hr>
<p>These exemptions include people with acute major medical conditions such as major surgery or hospital admission for a serious illness.</p>
<p>Temporary exemptions are only recommended to be provided for up to six months. Ideally, they’re reviewed within six months to see whether the person has recovered and can now be safely vaccinated. They’re also only given if another COVID vaccine isn’t suitable or available.</p>
<p>Temporary exemptions may also be specific to a certain vaccine, such as:</p>
<ul>
<li><p>if a person has a history of heart inflammation (myocarditis or pericarditis) attributed to a previous dose, or has had another illness causing heart inflammation in the past six months, or acute decompensated heart failure. This is only for mRNA vaccines, including those by Pfizer and Moderna</p></li>
<li><p>if a person has a history of specific very rare bleeding and clotting conditions including: capillary leak syndrome, cerebral venous sinus thrombosis, heparin-induced thrombocytopenia, idiopathic splanchnic thrombosis, or antiphospholipid syndrome (with thrombosis and/or miscarriage). This is only for the AstraZeneca vaccine.</p></li>
</ul>
<p>If possible and safe, individuals who can’t get one of the above vaccines for one of these reasons should receive an alternative COVID vaccine.</p>
<p>Temporary exemptions may also be for people who:</p>
<ul>
<li><p>have had COVID, until they’ve completely recovered. ATAGI recommends vaccination can be deferred for up to six months, because past infection <a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/advice-for-providers/clinical-considerations">reduces the chance of reinfection for at least this amount of time</a>. However, they don’t need to delay vaccination if they’ve recovered from COVID and their job requires them to be vaccinated, or they’re at higher risk of COVID due to exposure or personal risk. Having chronic symptoms following COVID, known as “long COVID”, isn’t a medical reason not to receive a COVID vaccine. If people who’ve recently had COVID are unsure about whether to get vaccinated, they should talk to their medical provider about the best time to proceed with vaccination</p></li>
<li><p>have had a serious adverse event from a previous COVID vaccine dose that can’t be attributed to another cause. An adverse event is considered serious if the person is hospitalised or it causes persistent or significant disability. These events need to be reported to the <a href="https://www.health.gov.au/health-topics/immunisation/health-professionals/reporting-and-managing-adverse-vaccination-events">adverse event surveillance system</a> in the person’s state or territory and/or to Australia’s medical regulator, the Therapeutic Goods Administration (TGA). They’re carefully assessed on a case-by-case basis by an experienced specialist to work out how likely a recurrence of the serious adverse event is if another dose of COVID vaccine is given</p></li>
<li><p>are assessed to be a risk to themselves or others during the vaccination process. For example, this could be due to a severe neurodevelopmental condition such as autism spectrum disorder. Specialist services may be available that can help facilitate safe vaccination for these individuals, such as with the assistance of distraction or awake sedation. </p></li>
</ul>
<p>Pregnancy isn’t a valid reason for exemption, in the absence of any of the criteria listed above.</p>
<h2>How would I get an exemption, if I’m eligible?</h2>
<p>COVID vaccine medical exemptions can be obtained from general practitioners, paediatricians, clinical immunologists, infectious disease, general or public health physicians, gynaecologists or obstetricians.</p>
<p>If someone thinks they qualify for an exemption based on the above, it’s often best to visit a GP first to discuss. </p>
<p>The federal government will introduce a certificate system <a href="https://www.smh.com.au/national/digital-covid-19-vaccine-exemptions-available-next-month-but-almost-no-one-eligible-20210924-p58ugc.html">for people to prove they have a medical exemption</a> later this month. These would be available through the Services Australia app.</p>
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<p>With mandates looming, GPs and other providers will feel pressure to dispense exemptions to people not wanting to be vaccinated. Employers will be seeking clarity about who can receive one. This can often cause distress and conflict if the request for an exemption is denied, for both the provider and patient.</p>
<p>Also, if mandates aren’t applied equally and fairly, there’s a risk of compounding disadvantage.</p>
<p>These mandates are made at a jurisdictional level, so there may also be differences regarding which groups are affected depending on the state or territory.</p>
<p>The stakes are high for those who remain unvaccinated, so it’s vital employers, individuals and medical providers are aware of the <a href="https://www.health.gov.au/sites/default/files/documents/2021/09/atagi-expanded-guidance-on-temporary-medical-exemptions-for-covid-19-vaccines.pdf">new ATAGI clinical guidance</a> regarding the medical exemption criteria and that jurisdictions provide additional clarity about the process.</p><img src="https://counter.theconversation.com/content/168371/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Margie Danchin receives funding from the NHMRC, WHO, DFAT and the Commonwealth and State Departments of Health. She is Chair, Collaboration on Social Science and Immunisation (COSSI).</span></em></p>There are very few situations where someone can’t have a COVID vaccine for medical reasons.Margie 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/1669612021-09-07T00:50:02Z2021-09-07T00:50:02ZWhen will I need my COVID vaccine booster shot? And can I switch to a different brand?<p>Australia’s vaccine rollout is really starting to gain pace, especially in <a href="https://www.nsw.gov.au/covid-19/find-the-facts-about-covid-19#vaccination-totals-to-date">New South Wales</a> and <a href="https://twitter.com/CaseyBriggs/status/1434770049978363907">Victoria</a>. </p>
<p>We need to get two doses of vaccine into as many adults as possible — firstly because that helps reduce severity of illness and infection, but also because reaching vaccination targets is likely to bring some new freedoms.</p>
<p>The COVID-19 vaccines (Pfizer, Moderna and Astra Zeneca) continue to be highly effective in reducing risk of severe disease, hospitalisation and death, even against the Delta variant. </p>
<p>But as soon as we finish one vaccine rollout we may need to begin the next rollout of booster doses.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/why-is-a-third-covid-19-vaccine-dose-important-for-people-who-are-immunocompromised-166569">Why is a third COVID-19 vaccine dose important for people who are immunocompromised?</a>
</strong>
</em>
</p>
<hr>
<h2>When will I need my booster shot?</h2>
<p>First, we need to differentiate between a booster dose and a third dose as part of the initial round of vaccinations. They are two very different things.</p>
<p>Some people who are <a href="https://www.medscape.com/viewarticle/957963?src=WNL_dne_210902_mscpedit&uac=82473HY&impID=3609450&faf=1">immunosupressed</a> might need a <a href="https://www.gov.uk/government/publications/third-primary-covid-19-vaccine-dose-for-people-who-are-immunosuppressed-jcvi-advice/joint-committee-on-vaccination-and-immunisation-jcvi-advice-on-third-primary-dose-vaccination">third dose</a> as part of their primary COVID-19 vaccination schedule. In other words, their third dose comes not long after their second dose and is given to improve their initial protection. </p>
<p>A booster shot is given much later after the initial two dose round of shots. A good example is the way we give tetanus and whooping cough booster vaccines. </p>
<p>There’s a great explainer on who might need a third dose as part of their primary vaccination schedule over <a href="https://theconversation.com/why-is-a-third-covid-19-vaccine-dose-important-for-people-who-are-immunocompromised-166569">here</a>. </p>
<p>For the rest of us, we don’t know for sure when you will need a booster shot. You’ll read lots of different figures on this — six months, eight months, more — and that’s because the research is ongoing. We don’t yet have a definite answer to the best timing for a booster dose. </p>
<p>Pfizer recently <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-submission-initial-data-us-fda">announced</a> its research had shown a booster dose resulted an increase in antibodies against the initial virus as well as against the highly infectious Delta variant. These results are awaiting publication and the safety of the booster dose needs to be known. The European regulator (known as the European Medicines Agency) has also started to evaluate an application for the use of a <a href="https://www.ema.europa.eu/en/news/ema-evaluating-data-booster-dose-covid-19-vaccine-comirnaty">booster dose of the Pfizer vaccine</a>.</p>
<p>We know that there is a <a href="https://theconversation.com/how-long-does-immunity-last-after-covid-vaccination-do-we-need-booster-shots-2-immunology-experts-explain-164073">decline in antibodies</a> after the primary course and some evidence of <a href="https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-08-30/09-COVID-Oliver-508.pdf">waning protection against infection</a>. </p>
<p>In a recent letter to <a href="https://www.nejm.org/doi/full/10.1056/NEJMc2112981?query=featured_home">The New England Journal of Medicine</a>, published online earlier this month, doctors and public health experts at University of California San Diego said their data suggested vaccine effectiveness against any symptomatic disease may wane over time since vaccination:</p>
<blockquote>
<p>Vaccine effectiveness exceeded 90% from March through June but fell to 65.5% […] in July.</p>
</blockquote>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/how-long-does-immunity-last-after-covid-vaccination-do-we-need-booster-shots-2-immunology-experts-explain-164073">How long does immunity last after COVID vaccination? Do we need booster shots? 2 immunology experts explain</a>
</strong>
</em>
</p>
<hr>
<p>Over time, data will emerge on immune responses and safety after a booster dose. </p>
<p>It may be that booster doses are particularly needed for certain groups in our community — for example, older people or frontline workers. There is also discussion of whether severely immunosuppressed people should get a booster dose from around six months after their third primary dose. </p>
<p>The US is planning to make <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html">COVID booster shots</a> widely available to Americans <a href="https://www.reuters.com/world/us/us-begin-offering-covid-19-vaccine-booster-shots-september-2021-08-18/">from September</a> onwards, starting <a href="https://www.cnbc.com/2021/08/18/covid-booster-shots-us-to-begin-wide-distribution-of-third-vaccine-doses-next-month.html">eight months</a> after people’s second dose of the Pfizer or Moderna vaccines. </p>
<p>The US booster plan is dependent on the Food and Drug Administration <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html">determining that a third dose</a> of the two-dose vaccines is safe and effective, and following advice from the Centers for Disease Control.</p>
<p>Israel’s booster rollout has begun, with people there becoming eligible for a booster <a href="https://www.cnbcno.com/2021/08/30/israel-doubles-down-on-covid-booster-shots-as-breakthrough-cases-rise.html">five months</a> after their second dose.</p>
<p>The European Centre for Disease Prevention and Control recently <a href="https://www.ecdc.europa.eu/en/publications-data/covid-19-public-health-considerations-additional-vaccine-doses">said</a> that there is </p>
<blockquote>
<p>no urgent need for the administration of booster doses of vaccines to fully vaccinated individuals in the general population.</p>
</blockquote>
<h2>Can we mix and match, by getting a different brand of vaccine for the booster?</h2>
<p>We don’t yet know for sure. </p>
<p>There may be benefits to getting a different vaccine to the one you first got as a booster. We also know that new vaccines designed specifically to target novel variants are in development and it may be better to receive a booster of a variant-specific vaccine.</p>
<p>It will be worth keeping a close eye on a key trial by the UK-based <a href="https://www.covboost.org.uk/about">COV-BOOST</a> group, which is aiming to find out which vaccines against COVID-19 are most effective as a booster vaccination, depending on which vaccine was used to provide the initial primary vaccine course.</p>
<p>This study will give us good information on whether it will be better to get a booster shot that is the same brand as your primary dose, or whether to switch to another. </p>
<p>For example, should a person who initially got Pfizer for their first two doses get an AstraZeneca shot for their booster? Or vice versa? Or should they get a booster of a new variant vaccine?</p>
<p>A <a href="https://clinicaltrials.gov/ct2/show/NCT04889209%20term=moderna+variant&cond=Covid19&draw=2&rank=3">trial</a> is underway in the US looking at the safety and immune responses of using a different booster vaccine to the first two doses, but also includes a Beta (B.1.351) variant vaccine.</p>
<p>It’s possible <a href="https://theconversation.com/why-do-we-need-booster-shots-and-could-we-mix-and-match-different-covid-vaccines-155951">mixing and matching</a> different vaccines might <a href="https://www.science.org/news/2021/06/mixing-covid-19-vaccines-appears-boost-immune-responses">broaden your protection</a> — but the research is ongoing, and it’s too early to say.</p>
<p>Hopefully, supply chain issues for the Pfizer vaccine will improve in the coming months. </p>
<p>The prime minister recently <a href="https://www.pm.gov.au/media/four-million-pfizer-doses-arrive-super-charge-vaccine-roll-out">announced</a> Australia has secured an extra <a href="https://www.abc.net.au/news/2021-09-03/covid-19-vaccine-swap-pfizer-four-million-doses-from-uk/100431828">four million doses</a> as part of a deal with the UK, on top of <a href="https://www.pm.gov.au/media/four-million-pfizer-doses-arrive-super-charge-vaccine-roll-out">extra doses</a> coming as part of deals with Singapore and Poland. </p>
<p>This will help with the rollout of initial doses.</p>
<h2>For now, the priority is getting the two doses into arms</h2>
<p>Monitoring of the effectiveness of the COVID vaccines will continue, particularly against the delta variant and any new variants that emerge. </p>
<p>Trials are also underway of the safety and immune responses to a variety of different booster vaccines, including the next generation variant vaccines.</p>
<p>The World Health Organization <a href="https://www.who.int/news/item/10-08-2021-interim-statement-on-covid-19-vaccine-booster-doses">said</a> in August:</p>
<blockquote>
<p>In the context of ongoing global vaccine supply constraints, administration of booster doses will exacerbate inequities by driving up demand and consuming scarce supply while priority populations in some countries, or subnational settings, have not yet received a primary vaccination series. </p>
<p>The focus for the time being remains on increasing global vaccination coverage with the primary series.</p>
</blockquote>
<p>For now, Australia must focus on getting our primary adult coverage as high as possible in order to protect against severe disease, hospitalisation, and death.</p>
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Read more:
<a href="https://theconversation.com/why-well-get-covid-booster-vaccines-quickly-and-how-we-know-theyre-safe-156120">Why we'll get COVID booster vaccines quickly and how we know they're safe</a>
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<img src="https://counter.theconversation.com/content/166961/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>You’ll read lots of different figures on this — six months, eight months, more — and that’s because the research is ongoing. We don’t yet have a concrete answer.Nicholas Wood, Associate Professor, Discipline of Childhood and Adolescent Health, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1669752021-09-06T15:14:22Z2021-09-06T15:14:22ZMessenger RNA: how it works in nature and in making vaccines<figure><img src="https://images.theconversation.com/files/419555/original/file-20210906-21-yivy2j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">mRNA technologies for vaccine production is gaining more prominence </span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/general-view-at-aspen-pharmacare-sterile-manufacturing-news-photo/1232178759?adppopup=true">Lulama Zenzile/Die Burger/Gallo Images via Getty Images</a></span></figcaption></figure><p>Vaccines <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5402432/">have long been</a> an integral part of public health programmes around the world, reducing the spread and severity of infectious diseases. The success of <a href="https://www.nicd.ac.za/wp-content/uploads/2017/08/NICD_Vaccine_Booklet_D132_FINAL.pdf">immunisation strategies</a> to protect children from diseases like polio, hepatitis B, and measles, and adults from influenza and pneumococcal disease, can be seen <a href="https://www.nature.com/articles/s41586-019-1656-7">globally</a>. </p>
<p>The COVID-19 pandemic created an urgent need for an effective vaccine. This is where messenger RNA (mRNA) vaccines, which are <a href="https://www.nature.com/articles/s41563-020-0746-0">classified</a> as a next-generation technology, gained prominence. Decades of research and clinical development into synthetic mRNA platforms for cancer treatments and vaccines for infectious diseases like influenza, malaria, and rabies, finally paid off as both <a href="https://www.who.int/news-room/feature-stories/detail/the-moderna-covid-19-mrna-1273-vaccine-what-you-need-to-know?gclid=CjwKCAjw092IBhAwEiwAxR1lRlM_GHRHjP6lh-AiQPV-RcVuE7gTd1KvD1Rbd2-cRaGHzeIjXf0LjhoCtSQQAvD_BwE">Moderna</a> and <a href="https://www.who.int/news-room/feature-stories/detail/who-can-take-the-pfizer-biontech-covid-19--vaccine">Pfizer/BioNTech’s</a> COVID-19 mRNA vaccines received emergency use authorisation. As a result, mRNA technologies have been catapulted into the public spotlight. </p>
<h2>Developing synthetic mRNA into vaccines</h2>
<p>Ribonucleic acid (RNA) is a natural molecule found in all our cells. There are many types of RNA, each with distinct functions. As the name implies, <a href="https://www.yourgenome.org/video/from-dna-to-protein">mRNA acts as an important messenger in human cells</a>. These molecules carry unique codes that tell our cells which proteins to make and when to make them. The code is copied from a strand of DNA in the nucleus of the cell, in a process called transcription. The mRNA is then transported into the cytoplasm (the solution contained in the cell) where the message is ‘read’ and translated by the cell’s protein production machinery. The result is an important protein, such as an enzyme, antibody, hormone, or structural component of the cell. </p>
<p>Nearly 40 years ago scientists <a href="https://www.nature.com/articles/nrd4278">found</a> that they could mimic transcription and produce synthetic mRNA without a cell. The process, known as in-vitro transcription, can generate many mRNA molecules from a strand of DNA in a test tube. This requires an enzyme (called RNA polymerase) and nucleotides (the molecules that are the building blocks of DNA and RNA). When mixed together, the polymerase reads the strand of DNA and converts the code into a strand of mRNA, by linking different nucleotides together in the correct order. </p>
<p>When in vitro transcribed mRNA is introduced into a cell, it is ‘read’ by the cell’s protein production machinery in a similar manner to how natural mRNA functions. In principle, the process can be used to generate synthetic mRNA that codes for any protein of interest. In the case of vaccines, the mRNA codes for a piece of a viral protein known as an antigen. Once translated, the antigen triggers an immune response to help confer protection against the virus. mRNA is short-lived and does not change the cell’s DNA. So it is safe for the development of vaccines and therapies. </p>
<p>A major advantage of in vitro transcription is that it does not require cells to produce the mRNA. It has certain manufacturing advantages over other vaccine technologies – rapid turnaround times and reduced biological safety risks, for example. It took only <a href="https://www.modernatx.com/modernas-work-potential-vaccine-against-covid-19">25 days</a> to manufacture a clinical batch of Moderna’s lipid nanoparticle mRNA vaccine candidate, which in March 2020 became the first COVID-19 vaccine to enter human clinical trials. </p>
<p>Importantly, as in vitro transcription is cell-free, the manufacturing pipeline for synthetic mRNAs is flexible and new vaccines or therapies can be streamlined into existing facilities. By replacing the DNA code, facilities can easily switch from producing one kind of mRNA vaccine to another. This not only future-proofs existing mRNA production facilities but could prove vital for rapid vaccine responses to new pandemics and emerging disease outbreaks.</p>
<h2>How do mRNA vaccines work?</h2>
<p>The mRNA vaccines we are familiar with today have benefited from many years of research, design and optimisation. Understanding how synthetic RNA is recognised in cells has proven essential in developing effective vaccines. Typically, the mRNA codes for a known viral antigen. In the case of COVID-19 mRNA vaccines, sequences coding for the SARS-CoV-2 spike protein or the receptor-binding domain have been used. These antigen-encoding mRNA molecules are incorporated into very small particles made primarily of lipids (fats). The lipid particle has two main functions: it protects the mRNA from degradation and helps deliver it into the cell. Once in the cytoplasm, the mRNA is translated into the antigen which triggers an immune response. </p>
<p>This process is essentially a training exercise for your immune system, and it normally takes a few weeks for your adaptive immunity to mature and synchronise. mRNA vaccines have been <a href="https://pubmed.ncbi.nlm.nih.gov/33477534/">shown</a> to stimulate both arms of the adaptive immune response, which are important for establishing protection. Humoral (B cell) immunity produces antibodies while cellular (T cell) immunity helps to detect infected cells. The current mRNA COVID-19 vaccine schedule uses a two dose (prime-boost) approach, which aims to strengthen your adaptive immune response towards the SARS-CoV-2 virus. </p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/covid-19-vaccines-produce-t-cell-immunity-that-lasts-and-works-against-virus-variants-166757">COVID-19 vaccines produce T-cell immunity that lasts and works against virus variants</a>
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<p>Another type of mRNA vaccine, referred to as <a href="https://www.nature.com/articles/s41434-020-00204-y">self-amplifying RNA</a>, may only require a single low dose to achieve the same level of protection. In a cell, these self-amplifying RNA vaccines can copy the mRNA code. This means that more antigen can be produced from less RNA. Several <a href="https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines">COVID-19 RNA vaccines</a> currently in clinical trials are exploring self-amplifying RNA technologies. </p>
<h2>mRNA vaccines beyond COVID-19</h2>
<p>It is an exciting time for mRNA technologies. Thanks to the collaborative efforts of governments, funding agencies, academia, biotech and pharmaceutical companies, large-scale manufacturing of mRNA drug products is becoming a reality. The success of <a href="https://www.nejm.org/doi/full/10.1056/nejmoa2035389">Moderna</a> and <a href="https://www.nejm.org/doi/full/10.1056/nejmoa2034577">Pfizer/BioNTech’s</a> COVID-19 vaccines has helped re-energise ongoing mRNA research. </p>
<p>Both mRNA and self-amplifying RNA have shown potential as vaccines for multiple infectious diseases including influenza, respiratory syncytial virus, rabies, Ebola, malaria and HIV-1. Coupled with therapeutic applications, most notably as <a href="https://www.pennmedicine.org/news/news-blog/2021/june/how-mrna-vaccines-help-fight-cancer-tumors-too">immunotherapy</a> for the treatment of cancers, mRNA technologies will continue to improve and expand, forming an integral part of future drug development.</p><img src="https://counter.theconversation.com/content/166975/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>At the time of writing Kristie Bloom 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 the following funding associated with her academic appointment: The National Research Foundation (NRF), The Poliomyelitis Research Foundation (PRF), and The South African Medical Research Council (SAMRC).</span></em></p>Thanks to the collaborative efforts of governments, funding agencies, academia, biotech and pharmaceutical companies, large-scale manufacturing of mRNA drug products is becoming a reality.Kristie Bloom, Group Leader: Next-generation Vaccines, Antiviral Gene Therapy Research Unit, University of the WitwatersrandLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1667342021-09-02T03:06:13Z2021-09-02T03:06:13ZFrom vaccination to ventilation: 5 ways to keep kids safe from COVID when schools reopen<figure><img src="https://images.theconversation.com/files/418797/original/file-20210901-21-1cwhyp9.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/girl-face-mask-back-school-after-1751409815">Shutterstock</a></span></figcaption></figure><p>Last week the New South Wales government announced schools are <a href="https://www.smh.com.au/national/nsw/return-to-schools-in-nsw-begins-on-october-25-all-students-back-by-november-8-20210827-p58mfy.html">scheduled to re-open in October</a>. While face-to-face learning undoubtedly has benefits for both children and parents, the announcement left unanswered a series of important questions about how this can be done safely. </p>
<p>By the time NSW lifts restrictions (estimated to be around October), only 60-70% of the population in NSW — and possibly less in Australia — who are 16 years and over may be fully vaccinated. </p>
<p>The Australian Technical Advisory Group on Immunisation (ATAGI) has <a href="https://www.health.gov.au/news/atagi-recommendations-on-the-use-of-covid-19-vaccines-in-all-young-adolescents-in-australia">recommended</a> vaccination for children 12 and over, but most of these children will not be fully vaccinated by October, and children under 12 will remain unvaccinated for now. </p>
<p>In NSW, with well over 1,000 cases a day and rising, there will still be substantial community transmission when schools open. It is unclear when schools in Victoria (<a href="https://www.abc.net.au/news/2021-09-01/victorias-new-covid-lockdown-and-restrictions-approach/100425020">where cases are also on the rise</a>) will open, but there may still be some transmission in the state when they do.</p>
<p>So, what do we need to do to make sure kids are as safe as possible at school? </p>
<hr>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/418829/original/file-20210901-19-1btzwu6.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/418829/original/file-20210901-19-1btzwu6.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=351&fit=crop&dpr=1 600w, https://images.theconversation.com/files/418829/original/file-20210901-19-1btzwu6.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=351&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/418829/original/file-20210901-19-1btzwu6.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=351&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/418829/original/file-20210901-19-1btzwu6.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=442&fit=crop&dpr=1 754w, https://images.theconversation.com/files/418829/original/file-20210901-19-1btzwu6.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=442&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/418829/original/file-20210901-19-1btzwu6.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=442&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="attribution"><span class="source">The Conversation</span>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
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<h2>1. Vaccinate the adults around them</h2>
<p>In California, a <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7035e2.htm?s_cid=mm7035e2_e">primary school outbreak occurred</a> when an unvaccinated teacher, who came to work despite symptoms, read to students with their mask off. Most kids who became infected were well over 2 metres from the teacher, which confirms the <a href="http://science.sciencemag.org/content/373/6558/eabd9149.full">1-2m distancing rule</a> is not effective for an airborne virus. </p>
<p>Every child and teacher in a classroom or childcare centre with an infected person is at risk. Shared air is the <a href="https://theconversation.com/the-pressure-is-on-for-australia-to-accept-the-coronavirus-really-can-spread-in-the-air-we-breathe-160641">major way SARS-CoV-2</a> — the virus that causes COVID-19 — spreads.</p>
<p>Children often get the virus <a href="https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/transmission_k_12_schools.html">from the adults around them</a>, so vaccinating adults in a child’s household, and teachers, can help protect them. </p>
<p>Vaccination is now mandatory for teachers in NSW, but around <a href="https://www.smh.com.au/national/nsw/two-thirds-of-teachers-have-at-least-one-vaccination-as-parents-divided-over-school-return-20210825-p58lv2.html">67% have had one dose</a>. This probably <a href="https://www.abc.net.au/news/2021-08-27/covid-vaccine-rates-state-by-state/100410718">corresponds</a> to less than 40% of the NSW population being fully vaccinated.</p>
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<a href="https://images.theconversation.com/files/418830/original/file-20210901-26-qczw52.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Teacher reading books to kids sitting on the floor." src="https://images.theconversation.com/files/418830/original/file-20210901-26-qczw52.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/418830/original/file-20210901-26-qczw52.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/418830/original/file-20210901-26-qczw52.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/418830/original/file-20210901-26-qczw52.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/418830/original/file-20210901-26-qczw52.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/418830/original/file-20210901-26-qczw52.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/418830/original/file-20210901-26-qczw52.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Anyone in the same room with an infected person, especially if that person isn’t wearing a mask, is at risk of catching the virus.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/students-class-volunteering-teacher-77123365">Shutterstock</a></span>
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<p>One dose of vaccination gives about 31% protection and two doses gives 67% (AstraZeneca) to 88% (Pfizer) <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2108891#.YRRDlqm9sXU.twitter">protection</a> against the Delta variant. Most kids will still be unvaccinated if schools in the two largest states re-open for the last term of the year. This means it’s even more important to ensure the adults are vaccinated.</p>
<h2>2. Mandate masks for teachers and students</h2>
<p>We can mandate masks in schools for teachers and students, and highly recommend mask use for younger children in childcare. </p>
<p>The American Academy of Pediatrics <a href="https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/clinical-guidance/cloth-face-coverings/">recommends</a> masks for children two years and up; children over this age can wear masks <a href="https://www.healthychildren.org/English/health-issues/conditions/COVID-19/Pages/Cloth-Face-Coverings-for-Children-During-COVID-19.aspx">without much trouble</a>.</p>
<p>As mask use in schools has been more common overseas, there are now numerous <a href="https://www.urmc.rochester.edu/strong-center-developmental-disabilities/resources/masks-toolkit.aspx">toolkits</a> (including translated versions) and recommendations to support children to wear a mask. For example, your child is more likely wear a mask if it has their favourite colour, sports team, character or special interest on it. </p>
<p>Importantly, a DIY cloth mask can be made to fit your child’s face and be high quality if <a href="https://www.acs.org/content/acs/en/pressroom/presspacs/2021/acs-presspac-june-23-2021/sneeze-cam-reveals-best-fabric-combos-for-cloth-masks-video.html">key design principles</a> are followed. It is important to ensure children have choices and understand the reason why they are wearing a mask (<a href="https://www.urmc.rochester.edu/strong-center-developmental-disabilities/resources/masks-toolkit.aspx">for instance</a>: “When we wear a mask, the virus can’t jump from person to person.”</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/cant-get-your-kid-to-wear-a-mask-here-are-5-things-you-can-try-166648">Can't get your kid to wear a mask? Here are 5 things you can try</a>
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<h2>3. Ventilated classrooms</h2>
<p>Classrooms can be ventilated by opening windows (ideally two windows at opposite ends of the room). If there is only one window, a fan can help move the dirty air out. If opening windows is not possible there is fortunately a cheap fix available — <a href="https://www.tandfonline.com/doi/full/10.1080/02786826.2021.1877257">portable air purifiers</a>, which dramatically reduce the viral load in classrooms. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/poorly-ventilated-schools-are-a-super-spreader-event-waiting-to-happen-it-may-be-as-simple-as-opening-windows-165958">Poorly ventilated schools are a super-spreader event waiting to happen. It may be as simple as opening windows</a>
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<p>There are DIY methods for <a href="https://www.youtube.com/watch?v=KzKcWTmvFdY&t=442s">making air purifiers</a>, too. </p>
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<h2>4. Reduce numbers of people indoors</h2>
<p>Reducing the number of people packed together in a classroom can reduce the risk of COVID. For example, during high epidemic periods, if the decision is made to open schools, a group of kids can come in every second day and learn online on alternate days. </p>
<p><a href="https://www.tandfonline.com/doi/full/10.1080/07448481.2020.1866579">We have shown</a> this approach, when combined with masks, reduces the risk of transmission on university campus.</p>
<p>Use of outdoor spaces for lessons is also a smart move as the weather gets warmer. While Delta <a href="https://www.abc.net.au/news/2021-08-06/nsw-covid-delta-outdoor-transmission-risk/100353394">can transmit outdoors</a>, the risk is likely much lower.</p>
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<h2>5. Test school kids</h2>
<p>Finally, rapid point-of-care testing in schools will <a href="https://www.sciencenews.org/article/coronavirus-covid-school-testing-kids-safe">help reduce transmission</a>, and self-testing kits (when approved in Australia) can help. </p>
<p>Saliva tests are <a href="https://www.health.nsw.gov.au/Infectious/covid-19/update/Pages/saliva-testing.aspx">also a practical way</a> to test children. These tests are now available in official health settings, so governments could make them available to schools.</p>
<h2>What about childcare centres?</h2>
<p>We also need to consider childcare centres. Contrary to popular narrative, <a href="https://jamanetwork.com/journals/jamapediatrics/fullarticle/2783022?guestAccessKey=52a9e0cf-bc64-4ec0-a945-49fd1373950f&utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_content=tfl&utm_term=081621">a new study shows</a> kids up to three years old transmit more than older kids. So, vaccinating childcare workers and parents of young kids is also essential. </p>
<p>All the measures above, except masks for 0-2 year olds, can easily be used in childcare settings.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/418999/original/file-20210902-19-1w06r8j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Girls getting swabbed in the mouth." src="https://images.theconversation.com/files/418999/original/file-20210902-19-1w06r8j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/418999/original/file-20210902-19-1w06r8j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=351&fit=crop&dpr=1 600w, https://images.theconversation.com/files/418999/original/file-20210902-19-1w06r8j.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=351&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/418999/original/file-20210902-19-1w06r8j.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=351&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/418999/original/file-20210902-19-1w06r8j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=441&fit=crop&dpr=1 754w, https://images.theconversation.com/files/418999/original/file-20210902-19-1w06r8j.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=441&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/418999/original/file-20210902-19-1w06r8j.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=441&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Rapid testing in schools could help reduce transmission.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/doctor-performs-medical-swab-girl-who-1766535644">Shutterstock</a></span>
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</figure>
<p>Record numbers of <a href="https://www.cnbc.com/2021/08/25/pediatric-covid-hospitalizations-surge-to-highest-on-record-in-us-as-doctors-brace-for-more.html">children are being hospitalised</a> with COVID-19 in the USA. It <a href="https://www.theguardian.com/world/2021/aug/27/delta-covid-variant-doubles-risk-hospitalisation-new-study-finds">remains unclear</a> whether the high numbers of sick children are due mostly to Delta’s increased transmissibility, or whether it <a href="https://www.medpagetoday.com/special-reports/exclusives/93979">also causes more severe disease</a> in children, as it does in adults. Although the risk of severe disease remains much lower in children than adults. </p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/under-12s-are-increasingly-catching-covid-19-how-sick-are-they-getting-and-when-will-we-be-able-to-vaccinate-them-165948">Under-12s are increasingly catching COVID-19. How sick are they getting and when will we be able to vaccinate them?</a>
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</em>
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<p>One thing we do know is that as vaccination rates increase in adults, unvaccinated groups, the largest of which is children, will be proportionally more at risk. The 70-80% targets for vaccination of eligible adults for relaxing restrictions corresponds to 56-64% of the whole population, which leaves plenty of room for Delta to spread like wildfire in unvaccinated adults and kids. So there is good reason to protect kids if we open schools.</p>
<p>In addition, the productivity losses from lockdowns are an important component of the <a href="https://newsroom.kpmg.com.au/australias-gdp-likely-drop-10b-following-extended-covid-19-restrictions/">estimated</a> A$220 million daily economic cost in NSW alone. Sick kids make it harder for their parents to work productively, if at all. And they make it more likely parents themselves become sick and are unable to work.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/vital-signs-introducing-ozsage-a-source-of-practical-expert-advice-for-how-to-reopen-australia-from-covid-safely-166943">Vital Signs. Introducing OzSAGE, a source of practical expert advice for how to reopen Australia from COVID safely</a>
</strong>
</em>
</p>
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<img src="https://counter.theconversation.com/content/166734/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>C Raina MacIntyre receives funding from NHMRC and MRFF. She is currently involved in face mask research.</span></em></p><p class="fine-print"><em><span>Holly Seale is an investigator on research studies funded by NHMRC and has previously received funding for investigator driven research from NSW Ministry of Health, as well as from Sanofi Pasteur and Seqirus. She is the Deputy Chair of the Collaboration on Social Science and Immunisation.</span></em></p><p class="fine-print"><em><span>Richard Holden is President-elect of the Academy of the Social Sciences in Australia.</span></em></p><p class="fine-print"><em><span>Greg Kelly 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>Most kids will be unvaccinated if schools in the two largest states re-open in term 4. There may still be community transmission, but there are measures we can take to shield kids from the virus.C Raina MacIntyre, Professor of Global Biosecurity, NHMRC Principal Research Fellow, Head, Biosecurity Program, Kirby Institute, UNSW SydneyGreg Kelly, Senior lecturer, The University of QueenslandHolly Seale, Associate professor, UNSW SydneyRichard Holden, Professor of Economics, UNSW SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1625722021-08-23T12:03:26Z2021-08-23T12:03:26ZHow a vial of Pfizer COVID-19 vaccine travels from a lab in Missouri to an arm in Bangladesh<figure><img src="https://images.theconversation.com/files/416375/original/file-20210816-22-klxfz7.jpg?ixlib=rb-1.1.0&rect=154%2C187%2C7194%2C4605&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">A Bangladeshi man gets his jab.</span> <span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/VirusOutbreakBangladesh/6546941f2ebf4f7d8a26625ed5d5a5ab/photo?Query=Bangladesh%20AND%20vaccine&mediaType=photo&sortBy=arrivaldatetime:desc&dateRange=Anytime&totalCount=33&currentItemNo=4">AP Photo/Mahmud Hossain Opu</a></span></figcaption></figure><p>Inoculating the planet from COVID-19 presents an unprecedented logistical challenge like none we’ve seen before. Mobilizing for a world war may be the closest comparison – but in this case, the enemy is invisible and everywhere.</p>
<p>Some of the vaccines require <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">super-cold storage</a> at virtually all points along the journey until they reach someone’s upper arm. And the vaccines are <a href="https://www.dw.com/en/the-covid-19-vaccines-where-do-they-come-from-where-will-they-go/a-56134178">primarily being produced</a> in wealthier countries, though the need – especially now – <a href="https://www.nytimes.com/2021/08/02/world/europe/covax-covid-vaccine-problems-africa.html?action=click&module=Spotlight&pgtype=Homepage">is greatest in the poorest</a>.</p>
<p>While <a href="https://www.nytimes.com/interactive/2021/world/covid-vaccinations-tracker.html">many rich countries</a> such as Israel, Canada and those of the U.K. have managed to inoculate most of their citizens, the <a href="https://fortune.com/2021/06/30/covid-vaccines-global-vaccination-rates-by-country/">vast majority of people</a> overall have yet to receive a single dose.</p>
<p><a href="https://scholar.google.com/citations?user=ncDgo0QAAAAJ&hl=en&oi=ao">I have been studying global supply chains</a> for over two decades, including those for drugs and other health-related products. To illustrate the process and how complicated and challenging it is, I’ll take you on the journey of a single dose of Pfizer – which received <a href="https://www.npr.org/sections/coronavirus-live-updates/2021/08/23/1030251410/pfizer-covid-vaccine-fda-approval">full Food and Drug Administration approval</a> on Aug. 23, 2021 – all the way from a factory in Missouri to an arm in Bangladesh. </p>
<h2>From Missouri to Massachusetts to Michigan</h2>
<p>Even though it’s commonly known as the Pfizer vaccine, it was actually developed <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-co-develop-potential-covid-19-vaccine">under a partnership with BioNTech</a>, which is based in Germany. </p>
<p><a href="https://www.pfizer.com/news/hot-topics/mrna_technology_at_the_forefront_during_global_pandemic">It is one</a> of <a href="https://extranet.who.int/pqweb/sites/default/files/documents/Status_COVID_VAX_15July2021.pdf">two vaccines that use new mRNA technology</a>, which <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">provides genetic instructions that encode a viral protein</a>. Once the vaccinated person’s cells start making the coronavirus protein, it prompts their immune system to design powerful antibodies that can neutralize the virus if they ever encounter it.</p>
<p>A vaccine dose’s <a href="https://www.nytimes.com/interactive/2021/health/pfizer-coronavirus-vaccine.html">60-day journey to distribution starts with raw ingredients</a> in a Pfizer factory in Chesterfield, Missouri, a suburb of St. Louis. This factory produces the key raw material called plasmids, which are basically strands of DNA that contain the genetic instructions for building coronavirus proteins. </p>
<p>Bottles of the DNA material are frozen, bagged, sealed and packed into a container and shipped to Andover, Massachusetts. There, the DNA is processed into mRNA, which is the active ingredient in the vaccine – also referred to as the “drug substance.” </p>
<p>The mRNA is packaged in plastic bags – each containing enough material to produce 10 million doses – frozen and shipped to Kalamazoo, Michigan, where the vaccine reaches the last stage of the process: formulation and filling.</p>
<p>First, the drug substance is combined with lipid nanoparticles – basically fat – to protect the mRNA and help it enter the human cells. Next, the combination is squirted into glass vials, six doses per vial, packaged and frozen for distribution. </p>
<p>Here I have presented a simplified three-step process. Making a vaccine, however, is more much complex, requiring more than 200 different materials supplied by factories spread across the world. </p>
<figure class="align-center ">
<img alt="A man wearing protective gear and a yellow shirt dumps dry ice into a box containing Pfizer vaccines" src="https://images.theconversation.com/files/416804/original/file-20210818-27-1e9hhe2.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/416804/original/file-20210818-27-1e9hhe2.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/416804/original/file-20210818-27-1e9hhe2.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/416804/original/file-20210818-27-1e9hhe2.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/416804/original/file-20210818-27-1e9hhe2.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/416804/original/file-20210818-27-1e9hhe2.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/416804/original/file-20210818-27-1e9hhe2.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">Pfizer’s custom boxes use dry ice to keep vaccine vials at ultra-cold temperatures.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/VirusOutbreakWastedVaccineDoses/dc6f3fc52c3f41be963574cb4f71aa59/photo?Query=Pfizer%20AND%20boxes&mediaType=photo&sortBy=arrivaldatetime:desc&dateRange=Anytime&totalCount=203&currentItemNo=38">AP Photo/Morry Gash, Pool</a></span>
</figcaption>
</figure>
<h2>Keeping vials super-cold</h2>
<p>While awaiting distribution, the Pfizer vaccine vials must be <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-covid-19-vaccine-stability-data">stored at temperatures</a> from minus 112 F to minus 76 F (minus 80 C to minus 60 C) in ultra-cold freezers.</p>
<p>To put this in perspective, the average annual temperature at the South Pole <a href="https://www.climatestotravel.com/climate/antarctica">is about minus 58 F (minus 50 C)</a>. Ice creams and frozen steaks are kept, during storage and transport, <a href="https://cwi-logistics.com/news/how-cold-does-a-warehouse-have-to-be-to-keep-ice-cream//">below minus 20 F (minus 29 C)</a>.</p>
<p>Pfizer designed its own custom cooler box to make it easier to transport its vaccines across the U.S. and around the world. <a href="https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/pfizer-bioNTech-faqs.html">Vials are placed into trays</a>, with 195 vials per tray. Each box can fit five trays. Each box of 5,850 doses has a GPS tracker and contains a monitor that keeps a log of the temperature. </p>
<p>Pfizer’s custom boxes don’t require any other specialized equipment to transport the vaccines, and the ultra-cold temperature in the cooler boxes is maintained during transport using dry ice that needs to be replaced every five days.</p>
<p>A problem with the dry ice is that it’s carbon dioxide in solid form. The dry ice gradually turns from solid to gas, which can be dangerous without proper ventilation.</p>
<p>Once it has a shipment ready for delivery to a given destination, Pfizer <a href="https://www.biopharmadive.com/news/coronavirus-vaccine-freight-forwarder-distribution/589880/">contacts one of the global freight carriers</a> it’s partnered with, such as UPS or DHL, which picks up a designated number of boxes and ships them directly to the country in need within one or two days. </p>
<figure class="align-center ">
<img alt="Two men stand next to a cold storage warehouse that contains boxes of Pfizer vaccine." src="https://images.theconversation.com/files/416808/original/file-20210818-15-1m9pi0r.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/416808/original/file-20210818-15-1m9pi0r.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/416808/original/file-20210818-15-1m9pi0r.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/416808/original/file-20210818-15-1m9pi0r.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/416808/original/file-20210818-15-1m9pi0r.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/416808/original/file-20210818-15-1m9pi0r.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/416808/original/file-20210818-15-1m9pi0r.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">Countries must have ultra-cold storage infrastructure, such as this warehouse in Turkey, to accept doses of Pfizer’s vaccine.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/VirusOutbreakTurkey/5d1afecb5c184ffd9b23d67785538aec/photo?Query=cold%20storage%20vaccine&mediaType=photo&sortBy=arrivaldatetime:desc&dateRange=Anytime&totalCount=100&currentItemNo=9">Turkish Health Ministry via AP</a></span>
</figcaption>
</figure>
<h2>A vial’s last mile</h2>
<p>For a country to receive Pfizer vaccines, it needs to have the capacity to store ultra-cold medical items.</p>
<p>While this isn’t a problem for wealthier nations, poorer countries are less likely to have the necessary infrastructure in place. </p>
<p>Upon arrival in a country, the shipment goes into a deep freezer, typically at the airport or a central storage facility, until it is ready to be used. The vaccine has to be kept in ultra-cold storage until within about a month before it’s injected into someone’s shoulder. </p>
<p>In poorer countries that do have the right infrastructure, such as Bangladesh, distribution still needs to be restricted to a few select hospitals in large urban areas where there are ultra-cold storage facilities. For example, Bangladesh will use Pfizer vaccines at <a href="https://www.dhakatribune.com/bangladesh/2021/06/30/7-dhaka-vaccine-centres-to-administer-pfizer-jabs-from-thursday">seven hospitals in its capital city, Dhaka</a>.</p>
<p>The frosty journey of the Pfizer vaccine itself is just one part of getting people their jabs. Ancillary supplies needed for vaccination include special syringes delivering a 0.3-milliliter (mL) dose, needles, sterile alcohol pads and personal protective equipment for the health care worker delivering the shot.</p>
<p>Preparing the injection of the Pfizer vaccine requires a complex dance. First the nurse thaws the vaccine in a refrigerator to a range of 36 F to 46 F (2 C to 8 C), where it can be held for up to 31 days. Just before vaccination, the nurse brings the vial to room temperature of 36 F to 77 F (2 C to 25 C), at which it can survive no more than six hours. </p>
<p>Because the Pfizer vaccine is shipped as a concentrate, the <a href="https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/downloads/diluent-poster.pdf">nurse needs to dilute it with 1.8 milliliters of saline</a>, resulting in a mixture sufficient for six doses. </p>
<p>There’s a further complication in that many low- and medium-income countries use syringes that ensure a fixed maximum dose and are automatically disabled after single use. This takes away the guesswork and prevents mistakes. UNICEF is responsible for delivering these extra supplies to poorer countries that are getting their vaccines through COVAX, the <a href="https://www.gavi.org/covax-facility">global initiative set up to distribute</a> COVID-19 vaccines to low- and middle-income countries. </p>
<figure class="align-center ">
<img alt="Several syringes containing diluted 0.3 mL doses of Pfizer vaccine sit in a box" src="https://images.theconversation.com/files/416807/original/file-20210818-15-ho04l0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/416807/original/file-20210818-15-ho04l0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/416807/original/file-20210818-15-ho04l0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/416807/original/file-20210818-15-ho04l0.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/416807/original/file-20210818-15-ho04l0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/416807/original/file-20210818-15-ho04l0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/416807/original/file-20210818-15-ho04l0.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 last step of the process before inoculation involves diluting the vaccine with saline to create 0.3-milliliter doses.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/VirusOutbreakCalifornia/6dff429a78cf466b87943fc6e3abe910/photo?Query=pfizer%20AND%20syringes&mediaType=photo&sortBy=arrivaldatetime:asc&dateRange=Anytime&totalCount=226&currentItemNo=67">AP Photo/Jae C. Hong</a></span>
</figcaption>
</figure>
<h2>A monumental achievement</h2>
<p>Other vaccines have much less demanding cold supply chain requirements, don’t require dilution and use syringes with standard dose sizes, allowing more countries to use them, including in rural areas. </p>
<p>Most of the COVID-19 vaccines <a href="https://extranet.who.int/pqweb/sites/default/files/documents/Status_COVID_VAX_15July2021.pdf">approved for use by the World Health Organization</a>, such as those made by AstraZeneca and Johnson & Johnson, require only standard cold storage of 35.6 F to 46.4 F (2 C to 8 C). </p>
<p>I focused on Pfizer in part because it makes up the lion’s share of <a href="https://www.whitehouse.gov/briefing-room/statements-releases/2021/06/10/fact-sheet-president-biden-announces-historic-vaccine-donation-half-a-billion-pfizer-vaccines-to-the-worlds-lowest-income-nations">doses donated by the U.S.</a> to COVAX.</p>
<p>As of Aug. 22, 2021, a <a href="https://ourworldindata.org/covid-vaccinations">total of 4.97 billion COVID-19 vaccine doses</a> had been administered, a feat unimaginable in the fall of 2020. But global coverage has been highly uneven. While a little over half of the population in high-income countries have been vaccinated, only 1.4% of low-income populations have received theirs. Many of these countries are in Africa.</p>
<p>The <a href="https://extranet.who.int/pqweb/sites/default/files/documents/Status_COVID_VAX_15July2021.pdf">development of several vaccines, 10 of which are WHO-approved</a>, <a href="https://covid19.nih.gov/news-and-stories/vaccine-development">many within a year</a>, was a monumental achievement of science and global collaboration – especially since it <a href="https://www.weforum.org/agenda/2020/06/vaccine-development-barriers-coronavirus">previously took on average a decade</a>. </p>
<p>But creating supply chains to deliver all those lifesaving vaccines to people all over the world will be an equally remarkable accomplishment. </p>
<p>[<em>Like what you’ve read? Want more?</em> <a href="https://theconversation.com/us/newsletters/the-daily-3?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=likethis">Sign up for The Conversation’s daily newsletter</a>.]</p><img src="https://counter.theconversation.com/content/162572/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ravi Anupindi 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>Each dose of Pfizer has a long and complex path involving mixing, storage at temperatures colder than the South Pole and specific protocols that must be followed before it becomes a jab.Ravi Anupindi, Professor of Technology and Operations, University of MichiganLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1654002021-08-19T07:48:44Z2021-08-19T07:48:44ZIf you’re over 60, there’s no sense in ‘waiting for Pfizer’. Here’s why you should get AstraZeneca today<figure><img src="https://images.theconversation.com/files/416705/original/file-20210818-27-isks1f.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C8179%2C5464&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>At least <a href="https://www.abc.net.au/news/2021-08-18/nsw-records-633-new-covid-19-cases/100385884">60 people have now died</a> in the current New South Wales COVID outbreak. </p>
<p>We’ve been keeping track of how old these people were, and have observed 85% of the COVID deaths up to August 18 (51 out of 60) were among people aged over 60. </p>
<p>We’ve also been taking note of reports on their vaccination status. It appears 96% of those over 60 who have died (49 of 51) were not vaccinated, or had only received one dose.</p>
<p>These deaths are tragic and, in all likelihood, were preventable. So if you’re over 60 and are yet to be vaccinated, now is not the time to hesitate.</p>
<h2>Older age increases your risk from COVID-19</h2>
<p>Age is a major risk factor for serious illness and death from COVID-19. </p>
<p>A person aged 65-74 is at six times greater risk of hospitalisation and 95 times greater risk of dying <a href="https://www.cdc.gov/coronavirus/2019-ncov/covid-data/investigations-discovery/hospitalization-death-by-age.html">compared to an adult under 30</a>. </p>
<p>People over 85 are 15 times more likely to be hospitalised and 600 times more likely to die than 18 to 29-year-olds.</p>
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<p>This is why Australia’s vaccination program has prioritised older adults. </p>
<p>So why do people in this age group remain unvaccinated?</p>
<h2>Most older Australians are vaccinated</h2>
<p>It’s important to acknowledge that of the <a href="https://www.abs.gov.au/statistics/people/population/national-state-and-territory-population/latest-release">5,632,555 Australians</a> aged 60+, <a href="https://www.health.gov.au/sites/default/files/documents/2021/08/covid-19-vaccination-doses-by-age-and-sex.png">more than 4.4 million</a> (79%) have had a first dose of a COVID-19 vaccine.</p>
<p>This ranges from 71% for 60 to 64-year-olds, to 86% for 75 to 79-year-olds.</p>
<p>So despite the criticism of Australia’s vaccination program, more than three-quarters of Australians aged 60+ have at least partial protection from COVID-19.</p>
<p>Still, that leaves 1.2 million Australians aged 60+ yet to receive a first dose of any COVID vaccine, despite having been eligible for vaccination for several months.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/a-history-of-blood-clots-is-not-usually-any-reason-to-avoid-the-astrazeneca-vaccine-161889">A history of blood clots is not usually any reason to avoid the AstraZeneca vaccine</a>
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<h2>What are they waiting for?</h2>
<p>For a variety of reasons, no vaccine ever achieves 100% take-up. But most Australians over 60 want to be vaccinated. Surveys have shown over 65s are the <a href="https://melbourneinstitute.unimelb.edu.au/publications/research-insights/ttpn/vaccination-report">least hesitant</a> age group. As of August 7, only 6.75% of adults over 65 were unwilling to be vaccinated.</p>
<p>Some people have experienced difficulty accessing the vaccine. In particular, we need to improve access in areas which are <a href="https://www.smh.com.au/national/most-vulnerable-least-protected-city-s-west-lags-in-jabs-race-20210803-p58fih.html">more vulnerable to COVID outbreaks</a>.</p>
<p>But according to data from the <a href="https://www.abs.gov.au/statistics/people/people-and-communities/household-impacts-covid-19-survey/latest-release#covid-19-vaccination">Australian Bureau of Statistics</a> published last month, <a href="https://www.theguardian.com/australia-news/2021/jul/14/one-in-four-unvaccinated-australians-over-70-waiting-for-different-vaccine-poll-finds">around 25%</a> of unvaccinated people over 70 are waiting for a different vaccine option. </p>
<p>We can read this to mean they’re waiting for what they perceive to be a “better” vaccine — an mRNA vaccine from Pfizer or Moderna.</p>
<p>Sadly, with the NSW outbreak escalating, and the increasing frequency and likelihood of COVID outbreaks across Australia, some of these folks may die waiting.</p>
<h2>AstraZeneca is a highly effective vaccine</h2>
<p>The vaccine for which all people aged 60+ in Australia are currently eligible is <a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/learn-about-covid-19-vaccines/about-the-astrazeneca-covid-19-vaccine">AstraZeneca</a>.</p>
<p>While adequate supply of the Pfizer vaccine has been an ongoing issue and shipments of the Moderna vaccine are yet to commence, AstraZeneca is being produced in Australia and is widely available.</p>
<p>But not everyone is keen on it.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/australians-under-60-will-no-longer-receive-the-astrazeneca-vaccine-so-whats-changed-162930">Australians under 60 will no longer receive the AstraZeneca vaccine. So what's changed?</a>
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<p>Some of the lack of enthusiasm surrounding the AstraZeneca vaccine relates to the perception it is less effective than Pfizer. </p>
<p>The most important outcome, however, is prevention of serious illness from COVID-19, and both vaccines perform similarly well on this metric after two doses. Recent modelling from <a href="https://www.doherty.edu.au/uploads/content_doc/DohertyModelling_NationalPlan_including_adendmum.pdf">the Doherty Institute</a> assumed an 86% reduction in hospitalisation with the Delta variant after two doses of AstraZeneca, compared to 87% after two doses of Pfizer. </p>
<p>For <a href="https://www.doherty.edu.au/uploads/content_doc/DohertyModelling_NationalPlan_including_adendmum.pdf">deaths from Delta</a>, the difference is also very small. The AstraZeneca vaccine is believed to achieve a 90% reduction after two doses, compared to 92% with Pfizer. </p>
<p>Although milder COVID-19 infections occur more commonly in people who have been fully-vaccinated with AstraZeneca, “breakthrough” infections <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2108891">also occur with Pfizer</a>.</p>
<p>So, the benefits of AstraZeneca are clear and the differences between AstraZeneca and Pfizer in terms of effectiveness against the most worrisome outcomes of COVID-19 are very small. </p>
<h2>But what about the risks?</h2>
<p>Both vaccines have common side effects including pain at the injection site, fatigue and headache. While these side effects are more common with AstraZeneca, they <a href="https://www1.racgp.org.au/newsgp/clinical/astrazeneca-and-pfizer-what-are-the-side-effects-f">don’t last long</a> with either vaccine.</p>
<p>So that brings us to blood clots. In March, just weeks into the launch of Australia’s vaccination program, reports emerged of a rare clotting syndrome following use of the AstraZeneca vaccine. </p>
<p>Named thrombosis with thrombocytopenia syndrome (<a href="https://www.healthdirect.gov.au/thrombosis-with-thrombocytopenia-syndrome-tts">TTS</a>) to describe the unusual combination of serious blood clots with a low platelet count, the discovery of this significant complication saw changes to COVID-19 vaccination guidelines in many countries, including Australia.</p>
<p>Deaths from TTS have received extensive coverage in the media, and concern about this condition is undoubtedly a key reason for reluctance towards AstraZeneca.</p>
<p>But importantly, the risk of TTS is small, and becomes lower as you get older (the opposite of the risk from COVID-19). The Australian Technical Advisory Group on Immunisation <a href="https://www.health.gov.au/news/australian-technical-advisory-group-on-immunisation-atagi-weekly-covid-19-meeting-on-11-august-2021-update">has estimated</a> below age 60, the incidence of TTS is 2.7 per 100,000 doses. Over age 60 the incidence is thought to be 1.8 in every 100,000 doses.</p>
<p>Of <a href="https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report-19-08-2021">112 cases</a> of confirmed or probable TTS that have occurred in Australia to date, a total of six people have died. One was over 60 (a 72-year-old woman).</p>
<p>Based on these statistics, if the 1.2 million Australians over 60 not yet vaccinated all received AstraZeneca, we would expect about 22 to develop TTS and one or two of them to die.</p>
<p>While these are serious albeit rare complications, remember that in NSW, in an outbreak with <a href="https://www.nsw.gov.au/covid-19/find-the-facts-about-covid-19">close to 10,000</a> cases of COVID-19 diagnosed to date, more than 50 people over 60 have already died and more will unfortunately follow.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/over-18-and-considering-astrazeneca-this-may-help-you-decide-165085">Over 18 and considering AstraZeneca? This may help you decide</a>
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<h2>Balancing the risks and the benefits</h2>
<p>Balancing risks and benefits is key to informed decision-making before taking any medication; none are risk-free. </p>
<p>For those 1.2 million Australians over 60 yet to be vaccinated, the benefits of taking the vaccine available now — AstraZeneca — are high, and for most people will outweigh the small risks. </p>
<p>The threat of COVID-19 is no longer theoretical, especially for those living in Sydney and other major metropolitan cities.</p>
<p>And this year’s jabs <a href="https://www.theguardian.com/world/2021/jul/30/israel-to-offer-pfizer-covid-booster-shots-to-people-over-60">will not be the last</a> over 60s receive. While it’s very likely mRNA boosters (Pfizer and Moderna) will be offered in 2022, you’ll need to be alive to get one.</p><img src="https://counter.theconversation.com/content/165400/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>With the reality of the COVID situation in Australia, particularly in New South Wales, some older adults could literally die waiting.Nancy Baxter, Professor and Head of Melbourne School of Population & Global Health, The University of MelbourneBenjamin Veness, Adjunct Professorial Fellow, CQUniversity AustraliaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1650852021-07-28T19:57:55Z2021-07-28T19:57:55ZOver 18 and considering AstraZeneca? This may help you decide<figure><img src="https://images.theconversation.com/files/413452/original/file-20210728-27-6a8o7q.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/young-african-american-woman-getting-flu-1906058728">Shutterstock</a></span></figcaption></figure><p>If you are 18 or older, and in an area where there is a COVID-19 outbreak, the best vaccine for you is the <a href="https://www.health.gov.au/news/atagi-statement-response-to-nsw-covid-19-outbreak-24th-july-2021">one you can get right now</a>. That possibly means you should get the AstraZeneca vaccine, as Pfizer is still in short supply. </p>
<p>This updated advice was given by ATAGI (the Australian Technical Advisory Group on Immunisation), the government’s expert vaccine advisory body, on July 24. Why would it change to recommending either AstraZeneca or Pfizer, after months of preferring Pfizer for younger people? </p>
<p><a href="https://www.health.gov.au/news/health-alerts/novel-coronavirus-2019-ncov-health-alert/coronavirus-covid-19-case-numbers-and-statistics">More young people</a> are being hospitalised, in ICU and dying during this current outbreak in Australia, where the Delta strain is dominating. </p>
<p>Whether this is a function of the Delta strain being more dangerous to young people, or because older people are (as a group) more likely to be protected by already being vaccinated, remains a <a href="https://www.theguardian.com/world/2021/jul/07/delta-mutations-mean-young-people-less-protected-against-covid-experts-warn">subject of debate</a>. </p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/why-is-delta-such-a-worry-its-more-infectious-probably-causes-more-severe-disease-and-challenges-our-vaccines-163579">Why is Delta such a worry? It's more infectious, probably causes more severe disease, and challenges our vaccines</a>
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<p>There is little argument, however, that the Delta strain is <a href="https://virological.org/t/viral-infection-and-transmission-in-a-large-well-traced-outbreak-caused-by-the-delta-sars-cov-2-variant/724">more infectious</a>, which is why we want to vaccinate our population <a href="https://www.bmj.com/content/373/bmj.n1513">as quickly as possible</a>.</p>
<p>So if you are 18 or older and have not been vaccinated yet, you may be asking whether getting an AstraZeneca vaccine right now is the right thing for you to do. To answer this we need to consider the benefits and risks of the AstraZeneca vaccination.</p>
<h2>What do vaccines achieve?</h2>
<p>When thinking about what any COVID-19 vaccine should achieve, there is an order of priority. </p>
<p>First, it should stop people who catch COVID-19 from <a href="https://www.abc.net.au/news/2021-06-25/nearly-all-us-covid-deaths-in-us-among-unvaccinated/100243160">dying</a>. </p>
<p>Second, it should reduce risk of severe disease (symptoms bad enough to need ICU treatment). </p>
<p>Third, hospitalisations should go down. </p>
<figure class="align-center ">
<img alt="Woman in a mask at a supermarket looks at her smartphone." src="https://images.theconversation.com/files/413457/original/file-20210728-23-2wbhuq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/413457/original/file-20210728-23-2wbhuq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/413457/original/file-20210728-23-2wbhuq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/413457/original/file-20210728-23-2wbhuq.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/413457/original/file-20210728-23-2wbhuq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/413457/original/file-20210728-23-2wbhuq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/413457/original/file-20210728-23-2wbhuq.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">Vaccines need to protect people from death and severe disease.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/young-woman-wearing-protective-mask-on-1685691634">Shutterstock</a></span>
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<p>If a vaccine is doing more than these three things, it is a bonus. </p>
<p>We are very lucky the AstraZeneca and Pfizer vaccines not only achieve all three, they also decrease numbers of people suffering illness of any sort (including mild symptoms), and possibly even <a href="https://www.gavi.org/vaccineswork/mounting-evidence-suggests-covid-vaccines-do-reduce-transmission-how-does-work?gclid=Cj0KCQjw3f6HBhDHARIsAD_i3D9thQ1RAv9-Ud1A8KrfjX81ODSTiH0G3JnyidpDAQBsTcGZFhDyf0QaAjgTEALw_wcB">reduce transmission</a> (making people who have caught COVID-19 less infective). </p>
<h2>Do vaccines work against the Delta variant?</h2>
<p>Since Delta became the dominant strain of COVID-19 <a href="https://www.ecdc.europa.eu/en/publications-data/threat-assessment-emergence-sars-cov-2-b1617-variants">worldwide</a>, researchers have been working hard to see how well current vaccines perform against it. </p>
<p>So far, the news is good. Let’s look at the evidence.</p>
<p>In the <a href="https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1005517/Technical_Briefing_19.pdf">United Kingdom</a> where the Delta strain is the cause of <a href="https://www.bbc.com/news/health-57525891">the majority of infections at the moment</a>, there were 229,218 COVID infections between February and July. Of these, 12.5% were in fully vaccinated people. These are known as “breakthrough infections” (because they “broke through” the protection of the vaccine). </p>
<p>Of those breakthrough infections, 3.8%, required a visit to ED. Just 2.9% required hospital admission, and less than 1% died.</p>
<p>This means even though the vaccines didn’t fully protect people against disease, they did achieve their primary purpose: to save lives and keep people out of hospital. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/most-covid-deaths-in-england-now-are-in-the-vaccinated-heres-why-that-shouldnt-alarm-you-163671">Most COVID deaths in England now are in the vaccinated – here's why that shouldn't alarm you</a>
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<p>Another study in the UK that narrowed down to look at just hospitalisation with Delta strain concludes AstraZeneca is <a href="https://media.tghn.org/articles/Effectiveness_of_COVID-19_vaccines_against_hospital_admission_with_the_Delta_B._G6gnnqJ.pdf">92% effective</a> against hospitalisation, after two doses. </p>
<p>Other studies have shown a <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01358-1/fulltext">60%</a> to <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2108891">67%</a> reduction in symptomatic disease.</p>
<p>Although AstraZeneca works to reduce infectivity of the Delta strain, vaccinated people can <a href="https://khub.net/documents/135939561/390853656/Impact+of+vaccination+on+household+transmission+of+SARS-COV-2+in+England.pdf/35bf4bb1-6ade-d3eb-a39e-9c9b25a8122a?t=1619601878136">still transmit it to others</a>. </p>
<p>That’s why it’s so important for vaccinated people to still observe all the other evidence-based ways of reducing spread including wearing masks, social distancing, and lockdown restrictions – at least until we have <a href="https://www.abc.net.au/news/health/2021-06-11/australians-need-to-be-vaccinated-to-stop-covid-restrictions/100195208">enough people in the community vaccinated</a>.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/when-will-we-reach-herd-immunity-here-are-3-reasons-thats-a-hard-question-to-answer-164560">When will we reach herd immunity? Here are 3 reasons that's a hard question to answer</a>
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<h2>But what are the down sides?</h2>
<p>Of course there are <a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/learn-about-covid-19-vaccines/about-the-astrazeneca-covid-19-vaccine#risks-of-vaccination">potential risks</a> from the AstraZeneca vaccine: injection site pain, tiredness, headache, muscle pain, fever and chills are the most commonly reported side effects. </p>
<p>Most of these are mild and temporary, going away within one to two days. </p>
<figure class="align-center ">
<img alt="Man in a home office takes his glasses off and rubs his eyes." src="https://images.theconversation.com/files/413460/original/file-20210728-13-w6beuq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/413460/original/file-20210728-13-w6beuq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/413460/original/file-20210728-13-w6beuq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/413460/original/file-20210728-13-w6beuq.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/413460/original/file-20210728-13-w6beuq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/413460/original/file-20210728-13-w6beuq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/413460/original/file-20210728-13-w6beuq.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">Most symptoms are mild and resolve quickly.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/business-overwork-deadline-people-concept-tired-612496850">Shutterstock</a></span>
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<p>There are also rare but severe side effects: <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html">anaphylaxis</a> (two to five per million people), and thrombosis with thrombocytopenia (TTS) – known colloquially as “clots”. The only risk factor that has been shown to predict how likely you are to get TTS after an AstraZeneca vaccine is <a href="https://www.health.gov.au/sites/default/files/documents/2021/06/covid-19-vaccination-weighing-up-the-potential-benefits-against-risk-of-harm-from-covid-19-vaccine-astrazeneca_1.pdf">age</a>. </p>
<p>TTS clots are very different from other blood clots you may hear about. In the same way that having a basal cell cancer removed from your skin does not make you more at risk of getting a brain tumour, having a blood clot in your medical history (or family history) does not make you more at risk of TTS. </p>
<p>In addition, we <a href="https://www.healthdirect.gov.au/thrombosis-with-thrombocytopenia-syndrome-tts">have effective treatments</a> for TTS now, so the death rate is low. </p>
<p>To keep it in perspective, your <a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/learn-about-covid-19-vaccines/about-the-astrazeneca-covid-19-vaccine">risk of getting a blood clot</a> from TTS is still far less than your risk of dying in a car accident <a href="https://www.bitre.gov.au/statistics/safety">in the next year</a>, and most people still don’t think twice about getting into a car. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/how-rare-are-blood-clots-after-the-astrazeneca-vaccine-what-should-you-look-out-for-and-how-are-they-treated-161280">How rare are blood clots after the AstraZeneca vaccine? What should you look out for? And how are they treated?</a>
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<p>Obviously, if there is no COVID-19 in the community then the risk from the vaccine will outweigh the risk from the disease – even a tiny risk is bigger than zero. </p>
<p>The reason ATAGI changed its advice to recommend the AstraZeneca vaccine to younger age groups in areas of outbreak is because as soon as COVID-19 starts to spread in the community, the risk of serious disease and death skyrockets. Which makes the vaccine suddenly become a very sensible option in <a href="https://www.health.gov.au/news/health-alerts/novel-coronavirus-2019-ncov-health-alert/coronavirus-covid-19-case-numbers-and-statistics">Sydney</a> and other high-risk areas.</p>
<h2>How can you get it?</h2>
<p>If and when you decide to have the AstraZeneca vaccine and you live in NSW, you can simply book in with any place that is giving it in your area. This may be a GP or state vaccination clinic. </p>
<p>You are <a href="https://www.smh.com.au/national/nsw/all-hands-on-deck-pharmacies-mass-clinics-to-offer-under-40s-astrazeneca-shot-20210727-p58df8.html">not required to see a GP first</a>, but of course you should only book once you’ve had your questions answered and are ready to go ahead with it. </p>
<p>Apart from contacting local providers directly, you can register for vaccination via the eligibility checker <a href="https://covid-vaccine.healthdirect.gov.au/eligibility?lang=en">here</a> (you fill in your details after completing the checker).</p>
<p>Pharmacies will <a href="https://www.health.nsw.gov.au/immunisation/Documents/pharmacist-new-standard.pdf">not be administering AstraZeneca vaccines</a> to people under 40 at this stage. </p>
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<img alt="Young man on a train looks at his phone." src="https://images.theconversation.com/files/413461/original/file-20210728-13-3myapd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/413461/original/file-20210728-13-3myapd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/413461/original/file-20210728-13-3myapd.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/413461/original/file-20210728-13-3myapd.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/413461/original/file-20210728-13-3myapd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/413461/original/file-20210728-13-3myapd.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/413461/original/file-20210728-13-3myapd.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">You can register for a vaccination online.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/passengers-protective-masks-standing-subway-car-1708869862">Shutterstock</a></span>
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<p>Finally, I have had in my practice many young people express frustration at being unable to get a vaccine before now, because they see it as a vital step forward for our community and the world. </p>
<p>Their lives have often been hugely disrupted by COVID-19 and they believe the risk of any vaccine is better than continuing with the status quo. </p>
<p>As one patient told me: “I’m young, I live a risky life. Getting this vaccine is the safest thing I have done all week.”</p><img src="https://counter.theconversation.com/content/165085/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Natasha Yates is affiliated with RACGP. </span></em></p>What do you need to weigh up when working out whether to get the AstraZeneca vaccine? Here’s what the evidence says.Natasha Yates, Assistant Professor, General Practice, Bond UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1643922021-07-27T19:55:40Z2021-07-27T19:55:40ZGrowing evidence suggests Russia’s Sputnik V COVID vaccine is safe and very effective. But questions about the data remain<figure><img src="https://images.theconversation.com/files/413053/original/file-20210726-23-1kdpcqx.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C4994%2C3271&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Antonio Calanni/AP/AAP</span></span></figcaption></figure><p>Russia was the first country to register a COVID vaccine, with its health ministry giving emergency approval to the Sputnik V vaccine in August 2020. </p>
<p>This decision was met with <a href="https://theconversation.com/russias-coronavirus-vaccine-hasnt-been-fully-tested-doling-it-out-risks-side-effects-and-false-protection-144347">scepticism</a> from the <a href="https://www.statnews.com/2021/05/26/data-needed-know-if-sputnik-v-vaccine-too-good-to-be-true/">international scientific community</a> because it came a month before results of phase 1 and 2 trials were published.</p>
<p>Growing data from clinical trials and real world rollouts suggests the vaccine is safe and very effective. But there are several outstanding questions around the vaccine, such as whether it’s associated with the very rare blood clotting condition seen with AstraZeneca’s vaccine, and how well it performs against variants of the coronavirus.</p>
<p>So what kind of vaccine is Sputnik V, how does it work, and what data are we missing?</p>
<h2>How does Sputnik V work?</h2>
<p>Sputnik V was designed by <a href="https://sputnikvaccine.com/about-us/">The Gamaleya National Research Center for Epidemiology and Microbiology</a>. It has its very own <a href="https://twitter.com/sputnikvaccine">Twitter account</a> advertising its status as the “world’s first registered COVID-19 vaccine” and approval in 69 countries including Russia, South Korea, Argentina and the UAE.</p>
<p>Like the Oxford-AstraZeneca vaccine, the basis for the vaccine is a harmless form of adenovirus, one of several viruses that can cause the common cold.</p>
<p>The adenovirus acts as a packaging system for DNA to deliver instructions to our cells. This DNA instructs cells to make the spike protein from SARS-CoV-2. The immune system is then trained to generate an immune response to the spike protein, which provides protection against the real SARS-CoV-2 virus.</p>
<p>Unlike the other adenovirus-based vaccines, Sputnik V uses two different adenoviruses for the first and second dose. This is done as people can develop an immune response against the adenovirus vector used in the first shot of the vaccine, which could possibly reduce the overall effectiveness. </p>
<p>The two doses are separated by three weeks, rather than the <a href="https://www.medicalnewstoday.com/articles/astrazeneca-vaccine-3-month-dosage-interval-might-be-preferable">8-12 weeks</a> usually recommended for the Oxford-AstraZeneca vaccine.</p>
<p>Sputnik V doesn’t require the ultra-cold temperatures like the mRNA-based vaccines, which makes it an attractive candidate for many countries desperate for vaccines. Gamaleya has been open to sharing its manufacturing platform, <a href="https://www.theatlantic.com/ideas/archive/2021/05/biden-has-power-vaccinate-world/618802/">unlike some other vaccines</a>. </p>
<h2>How well does Sputnik V work against COVID-19?</h2>
<p>Data from the phase <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31866-3/fulltext">1 and 2 clinical trial</a> was published in September in the highly reputed medical journal The Lancet. The data showed no major adverse reactions, and side effects that were common to the other COVID-19 vaccines. These were primarily fever, headaches and pain at the injection site. </p>
<p>Most impressively were the results of the <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00234-8/fulltext">larger phase 3 trial</a> published in The Lancet in February this year, which reported 91.6% efficacy against symptomatic infection. This places Sputnik on par with the mRNA vaccines by Pfizer and Moderna, for which the original efficacies were <a href="https://www.nejm.org/doi/full/10.1056/nejmoa2034577">95%</a> and <a href="https://www.nejm.org/doi/full/10.1056/nejmoa2035389">94.1%</a> respectively. </p>
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<p>The results from the phase 3 trial also suggested a single dose was protective, with an efficacy of 79.4%. This led to the approval of “Sputnik Light” in some countries, a single dose regimen that overcomes some of the issues <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/big-promises-few-doses-why-russias-struggling-make-sputnik-v-doses-2021-05-14/">manufacturing</a> the second dose of Sputnik V. The two different adenoviruses used in the first and second dose of Sputnik V need to be produced using separate cell cultures. Only having to produce a single type of adenovirus streamlines the production.</p>
<p>Outside of these trials, a press release from Gamaleya says real world analysis of the vaccine given to nearly 3.8 million Russians reported an efficacy of <a href="https://www.prnewswire.co.uk/news-releases/rdif-sputnik-v-demonstrates-97-6-efficacy-according-to-analysis-of-data-from-3-8-million-vaccinated-persons-in-russia-making-it-the-most-efficient-covid-19-vaccine-in-the-world-874566207.html">97.6%</a> against infection. This led Gamaleya to claim Sputnik V is “the world’s most effective vaccine”.</p>
<p>Despite the encouraging efficacy results, there are still some concerns. Both the phase 1 and 2 safety trials, and the <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00234-8/fulltext">phase 3 efficacy trials</a>, have been <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00899-0/fulltext#back-bib1">criticised for not sharing</a> their raw data or the full details of their study design, as well as inconsistencies in the published data.</p>
<p>Sputnik V isn’t yet approved by the European Medicines Agency (EMA) or the World Health Organization, meaning it cannot be used by COVAX, the COVID vaccine global access initiative. <a href="https://www.reuters.com/world/the-great-reboot/exclusive-european-efforts-assess-russias-sputnik-v-vaccine-stymied-by-data-gaps-2021-07-13/">Gamaleya has yet to provide the EMA</a> with all the necessary manufacturing and clinical data necessary to gain this approval.</p>
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<h2>What are the unanswered questions about Sputnik V?</h2>
<p>There are a number of outstanding issues with the vaccine.</p>
<p>Of particular importance is the question of whether it’s associated with the <a href="https://theconversation.com/what-is-thrombocytopenia-the-rare-blood-condition-possibly-linked-to-the-astrazeneca-vaccine-158522">very rare blood clotting condition</a> that’s been linked to the AstraZeneca and Johnson and Johnson vaccines, which also use adenovirus vectors.</p>
<p>Gamaleya claims there have been no reports of this occurring in individuals given Sputnik V. Analysis following the administration of <a href="https://www.businesstoday.in/latest/economy-politics/story/sputnik-v-among-the-safest-covid-19-vaccines-buenos-aires-health-ministry-299632-2021-06-25">2.8 million doses of Sputnik V</a> in Argentina supports this. The results, announced via a press release by the Argentine health ministry, reported no deaths associated with vaccination and showed mostly mild adverse events.</p>
<p>And there was no indication of an association between Sputnik V and this condition in the clinical trials.</p>
<p>However, there hasn’t been enough published real world data to be completely confident researchers would be able to pick up on the condition if it did emerge.</p>
<p>It’s also unclear how well Sputnik performs against the rapidly spreading variants of concern, such as Delta. Some of these variants are partially able to escape from the immune response generated by COVID vaccines.</p>
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Read more:
<a href="https://theconversation.com/why-is-delta-such-a-worry-its-more-infectious-probably-causes-more-severe-disease-and-challenges-our-vaccines-163579">Why is Delta such a worry? It's more infectious, probably causes more severe disease, and challenges our vaccines</a>
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<p><a href="https://www.mdpi.com/2076-393X/9/7/779">Research</a> published in July examined antibodies in the blood of people vaccinated with Sputnik V to see how it performed against the Alpha, Beta, Gamma and Delta variants. It found there was a reduction in the ability of their antibodies to block infection. It’s unclear how this reduction would impact the vaccine’s effectiveness against hospitalisation and death, as we’re still waiting to see published real world data on this. </p>
<p>We need further studies which directly compare blood samples from people vaccinated with the different vaccines before Sputnik’s <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/russias-sputnik-v-vaccine-less-effective-against-delta-variant-tass-2021-06-29/">claims of being highly effective against variants</a> can be confirmed. We’ll also need to see real world analysis of its effectiveness against variants, <a href="https://www.ft.com/content/5a24d39a-a702-40d2-876d-b12a524dc9a5">such as that performed with Pfizer and AstraZeneca</a>.</p><img src="https://counter.theconversation.com/content/164392/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Megan Steain receives funding from the Medical Research Future Fund (MRFF).</span></em></p><p class="fine-print"><em><span>Jamie Triccas receives funding from Medical Research Future Fund (MRFF) and The National Health and Medical Research Council (NHMRC)</span></em></p>What kind of vaccine is Sputnik V, how does it work, and what data are we missing?Megan Steain, Lecturer, School of Medical Sciences, Faculty of Medicine and Health, University of SydneyJamie Triccas, Professor of Medical Microbiology, School of Medical Sciences, Faculty of Medicine and Health, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1650012021-07-26T19:55:48Z2021-07-26T19:55:48ZHow Australia’s fickleness on COVID vaccines is perpetuating global vaccine inequity<p>Despite assurances from Prime Minister Scott Morrison that Australia was at “<a href="https://theconversation.com/scott-morrison-to-announce-two-new-covid-vaccine-deals-149458">the front of the queue</a>” for COVID-19 vaccines, Australia’s rate of vaccination ranks <a href="https://www.yourlifechoices.com.au/health/covid19/were-bottom-of-the-oecd-class-in-vaccination-rates/">last in the OECD</a>. </p>
<p>Nevertheless, Australia is still ahead of <a href="https://www.nytimes.com/interactive/2021/world/covid-vaccinations-tracker.html">scores of other nations</a> when it comes to vaccination rates, with many countries in the developing world unlikely to be able to vaccinate significant numbers of their people <a href="https://www.nature.com/articles/d41586-021-01762-w">before 2023</a>. </p>
<p>Global vaccine inequity is a “<a href="https://www.bbc.com/news/world-55709428">catastrophic moral failure</a>”, according to the director-general of the World Health Organization, Tedros Adhanom Ghebreyesus. </p>
<p>But we are too focused on our own situation in Australia to realise the damage our fickle approach to vaccines is doing to global vaccine equity. We are also forgetting our human rights obligations to help speed up access to vaccines for all. </p>
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<span class="caption">South Africa is averaging over 10,000 new cases per day, yet has only fully vaccinated about 4% of its population.</span>
<span class="attribution"><span class="source">Alet Pretorius/AP</span></span>
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<h2>Vaccine access and international human rights law</h2>
<p>Australia has international human rights obligations to protect the <a href="https://www.ohchr.org/en/professionalinterest/pages/cescr.aspx">health</a> and <a href="https://www.ohchr.org/en/professionalinterest/pages/ccpr.aspx">life</a> of its own people. This means taking reasonable steps to prevent COVID-19 infections and mitigate the impact of the virus on Australians, including by acquiring and administering vaccines. </p>
<p>However, Australia also has <a href="https://www.etoconsortium.org/en/main-navigation/library/maastricht-principles/">obligations</a> to the people of other nations to facilitate access to vaccines for all. </p>
<p>These duties are not only about global humanism — there is also a strong global health argument to ensure everyone around the world is vaccinated. As GAVI, one of the organisations leading the global COVAX vaccine initiative, has reminded us, “<a href="https://www.gavi.org/vaccineswork/why-no-one-safe-until-everyone-safe-during-pandemic">no one is safe until everyone is safe</a>”. </p>
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<p>While large populations remain unvaccinated, variants of concern such as Delta will continue to evolve and may compromise global vaccine protection. Furthermore, global economic and social activity cannot return to anything like normal without extensive COVID-19 vaccination in all nations.</p>
<p>Global vaccine equity makes public health and economic sense for all countries, both rich and poor. Thus, Australia has an obligation — both to those in poorer countries <em>and to its own people</em> — to do what it reasonably can to increase vaccine access all over the world.</p>
<h2>Vaccine procurement and hoarding</h2>
<p>One of the main reasons for vaccine inequity is the shortage of vaccines. Access is a zero-sum game where one nation’s vaccine supply reduces the availability of doses for others.</p>
<p><a href="https://www.who.int/initiatives/act-accelerator/covax">The COVAX initiative</a> was established last year to enable global access to COVID-19 vaccines. COVAX’s role is to procure and allocate vaccines <a href="https://www.who.int/publications/m/item/allocation-mechanism-for-covax-facility-vaccines-explainer">with an aim of vaccinating</a> 20% of the people in participating countries by the end of 2021 — a <a href="https://www.abc.net.au/news/2021-06-22/most-poorer-countries-do-not-have-enough-covax-shots/100233082">target it is unlikely</a> to reach due to lack of supply. Once the 20% threshold is reached, COVAX intends to distribute its vaccines according to need.</p>
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Read more:
<a href="https://theconversation.com/the-best-hope-for-fairly-distributing-covid-19-vaccines-globally-is-at-risk-of-failing-heres-how-to-save-it-158779">The best hope for fairly distributing COVID-19 vaccines globally is at risk of failing. Here's how to save it</a>
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<p>Despite COVAX, many nations have pursued their own procurement policies directly with vaccine manufacturers. In April, the <a href="https://digitallibrary.un.org/record/3921880?ln=en">UN Committee on Economic, Social and Cultural Rights</a> suggested such “vaccine nationalism” breached countries’ human rights obligations by undermining equitable access to vaccines.</p>
<p>However, the terms of the COVAX facility do not ban such bilateral deals. It is difficult, therefore, to maintain that it must dictate worldwide procurement.</p>
<p>But the hoarding of scarce vaccines does constitute a breach of countries’ obligations to protect global human rights. Indeed, the rights of a country’s own people are harmed by hoarding, as this perpetuates vaccine scarcity and delays the end of the global pandemic for everyone. </p>
<p>In this respect, it is wrong for rich countries to negotiate deals for vaccine booster shots before poorer countries have achieved significant vaccination rates. Tedros, the WHO chief, has <a href="https://www.abc.net.au/news/2021-07-13/who-tedros-covid-19-boosters-vaccine-inequality/100287792">rightly condemned</a> this.</p>
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<h2>Why AstraZeneca hesitancy has an impact beyond our borders</h2>
<p>Australia has <a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/covid-19-vaccine-government-response/australias-vaccine-agreements#:%7E:text=The%20Government%20has%20made%20two,population%20to%20receive%202%20doses.">procured</a> enough AstraZeneca doses to vaccinate the entire country. In addition, we have advance-purchased enough Pfizer and Moderna doses to cover the entire population again, and enough Novavax to do so yet again. </p>
<p>The <a href="https://www.smh.com.au/national/nsw/premier-s-plea-consider-astrazeneca-if-you-are-under-40-20210722-p58c3f.html">only vaccine currently available in large amounts</a> in Australia is AstraZeneca because the local biotech company CSL <a href="https://www.smh.com.au/business/companies/csl-open-to-new-manufacturing-options-after-astrazeneca-production-20210504-p57om8.html">manufactures it</a>, and the government failed to prioritise its other deals last year.</p>
<p>The shifting official advice on AstraZeneca, however, has fuelled hesitancy in Australia, and has had an unintended impact on global vaccine supply, further disadvantaging those in poorer countries.</p>
<p>The AstraZeneca vaccine is safe and highly <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/astrazeneca-covid-19-vaccine-effective-against-variants-found-india-2021-06-22/">effective</a>, bearing in mind that almost all medicines entail <a href="https://www.medicalnewstoday.com/articles/161255">risks</a>. However, under advice from the Australian Technical Advisory Group on Immunisation (<a href="https://www.health.gov.au/committees-and-groups/australian-technical-advisory-group-on-immunisation-atagi">ATAGI</a>), it is <a href="https://www.health.gov.au/news/atagi-statement-on-revised-recommendations-on-the-use-of-covid-19-vaccine-astrazeneca-17-june-2021">not the preferred vaccine for people under 60</a>. Most Australians, including many over 60, are now waiting for Pfizer. </p>
<p>That is not surprising given the ATAGI advice, and the messaging from the <a href="https://www.abc.net.au/news/2021-04-08/scott-morrison-announces-pfizer-preferred-for-younger-people/100057184">federal government</a> and <a href="https://www.abc.net.au/news/2021-06-30/qld-cho-rejects-morrisons-astrazeneca-comments-covid-vaccine/100256022">some state governments</a>, together with negative inputs from many <a href="https://www.theage.com.au/national/unqualified-and-dishonest-the-experts-who-undermined-confidence-in-astrazeneca-will-cost-australians-lives-20210722-p58c1f.html">medical professionals</a> and the <a href="https://www.smh.com.au/national/norman-swan-admits-i-probably-did-cause-some-vaccine-hesitancy-20210505-p57p82.html">media</a>. </p>
<p>This has induced an <a href="https://www.smh.com.au/national/worried-about-astrazeneca-me-too-the-way-we-think-about-risk-might-be-the-problem-20210720-p58beh.html">exaggerated perception of the risk of blood clots</a> caused by the vaccine. The reputation of the AstraZeneca vaccine has been wrongly and perhaps irreparably tarnished here.</p>
<p>The ATAGI advice has been influenced by Australia’s low COVID infection rate. And it has now <a href="https://www.health.gov.au/news/atagi-statement-response-to-nsw-covid-19-outbreak-24th-july-2021">changed its advice for all adults in NSW</a>, given the state’s large outbreak at the moment.</p>
<p>ATAGI has faithfully fulfilled its mandate of assessing risks on an individual basis, but that mandate is <a href="https://twitter.com/Pollytics/status/1417761636287324166?s=20">not entirely suitable</a> for a pandemic affecting all of society. The advice does not seem to account for the societal benefits for all — health, social and economic — of a more rapid vaccination rollout with an overwhelmingly safe and effective vaccine. </p>
<p>Unsurprisingly, ATAGI took no account of the impact of Australia’s AstraZeneca hesitancy on global vaccine access. Yet, Australia is now rapidly commandeering <a href="https://www.abc.net.au/news/2021-07-09/australia-to-get-pfizer-covid19-vaccine-supply-august/100279944">more Pfizer doses</a> as a result, which is pushing other nations further down the vaccine queue. And this is while we eschew our plentiful AstraZeneca supplies.</p>
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<h2>Addressing the zero-sum game</h2>
<p>Beyond issues regarding the sharing of vaccines, a bigger imperative is to address the root of the problem: <a href="https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3876848">vaccine scarcity</a>. All nations, including Australia, must do what they can to increase the production of vaccines so the supply can more swiftly meet the demand.</p>
<p>Hence, those countries with vaccine manufacturing capacity must utilise it more effectively. For example, Australia must ensure CSL continues to manufacture as much AstraZeneca as it can, at least until it switches production to another vaccine (possibly <a href="https://www.smh.com.au/business/companies/we-do-not-have-capacity-to-make-the-novavax-vaccine-says-csl-20210114-p56u1a.html">Novavax</a>). </p>
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Read more:
<a href="https://theconversation.com/over-700-health-experts-are-calling-for-urgent-action-to-expand-global-production-of-covid-vaccines-159701">Over 700 health experts are calling for urgent action to expand global production of COVID vaccines</a>
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<p>We are concerned over reports <a href="https://www.theguardian.com/australia-news/2021/jul/16/australian-production-of-astrazeneca-vaccine-in-early-july-just-one-tenth-what-government-promised">CSL has slowed its AstraZeneca manufactureing</a>, though hopefully this is only temporary. </p>
<p>It is a major public policy failure that AstraZeneca has been perceived as “not good enough” for Australians. If we won’t take it, we must donate it to save lives elsewhere, especially while we queue-jump for more Pfizer doses.</p>
<p>Australia has human rights obligations to greatly enhance its support for global vaccine equity. Failure to do so not only harms global health, but also the reputation and safety of our country.</p><img src="https://counter.theconversation.com/content/165001/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>If Australians won’t take the AstraZeneca vaccine, we must donate it to save lives elsewhere, especially while we queue-jump for more Pfizer doses.Sarah Joseph, Professor of Human Rights Law, Griffith UniversityGregory Dore, Infectious Diseases Physician, St Vincent's Hospital, Sydney; Scientia Professor, Kirby Institute, UNSW SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1646332021-07-26T07:16:13Z2021-07-26T07:16:13ZYes, there’s confusion about ATAGI’s AstraZeneca advice. But it’s in an extremely difficult position<figure><img src="https://images.theconversation.com/files/413068/original/file-20210726-27-185djwq.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://photos.aap.com.au">Daniel Pockett/AAP</a></span></figcaption></figure><p>One can totally understand the frustration around where the AstraZeneca vaccine fits in our vaccine rollout in Australia.</p>
<p>At a time when we’re grappling with so much uncertainty, we need unambiguous information from the federal government about who should have this vaccine.</p>
<p>Instead, it feels very much like we’re swirling in a murky sea of information that is confusing and, at times, seems to be contradictory.</p>
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Read more:
<a href="https://theconversation.com/morrison-government-orders-pfizer-boosters-while-hoping-new-atagi-advice-will-warm-people-to-astrazeneca-165069">Morrison government orders Pfizer 'boosters', while hoping new ATAGI advice will warm people to AstraZeneca</a>
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<p>The confusion is compounded by the changing advice from ATAGI. ATAGI, the Australian Technical Advisory Group on Immunisation, is the group of vaccine experts which advises the government.</p>
<p>There is no doubt that for many people, some of its language has been difficult to make sense of, including the use of vague terms like “preferred”. As in, the Pfizer vaccine is the “<a href="https://www.health.gov.au/news/atagi-statement-on-revised-recommendations-on-the-use-of-covid-19-vaccine-astrazeneca-17-june-2021">preferred vaccine</a>” for those under 60 years of age.</p>
<p>How exactly this should be interpreted by someone trying to make the important decision about whether to get the vaccine is unclear, and raises more questions than it answers. </p>
<p>The public commentary from a number of political leaders, <a href="https://www.theguardian.com/australia-news/2021/jul/14/scott-morrison-blames-atagi-doctors-for-australias-slow-covid-vaccine-rollout">including the prime minister</a>, that ATAGI has been too conservative and too risk averse hasn’t helped either, with the implication ATAGI cannot be fully trusted to provide sensible advice.</p>
<p>The reality is, ATAGI is in an extremely difficult position and is grappling with competing concerns, considerable uncertainty, and a constantly changing landscape.</p>
<h2>What is ATAGI’s role?</h2>
<p>ATAGI can only give general advice to the government for the whole population.</p>
<p>Its task is to think about the whole population as if it were merged into a single person, or in the case of AstraZeneca, a series of people of different age ranges. It then has to formulate advice based on population-based averages of the benefits and risks of getting the AstraZeneca vaccine, which has a number of limitations.</p>
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<p>It’s important to understand context plays a key role in formulating this advice to the government. The risk of the blood clotting and bleeding condition, called thrombosis with <a href="https://theconversation.com/what-is-thrombocytopenia-the-rare-blood-condition-possibly-linked-to-the-astrazeneca-vaccine-158522">thrombocytopenia</a>, from the AstraZeneca vaccine is <a href="https://www.health.gov.au/news/atagi-statement-on-revised-recommendations-on-the-use-of-covid-19-vaccine-astrazeneca-17-june-2021">slightly higher</a> for younger people.</p>
<p>This is only part of what’s driven the advice for Pfizer to be the preferred vaccine for those under 60.</p>
<p>In fact, the risk of dying from this condition is incredibly rare whatever your age. </p>
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Read more:
<a href="https://theconversation.com/concerned-about-the-latest-astrazeneca-news-these-3-graphics-help-you-make-sense-of-the-risk-162175">Concerned about the latest AstraZeneca news? These 3 graphics help you make sense of the risk</a>
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<p>What has been the bigger driver of the advice is the fact you’re less likely to develop severe disease from COVID if you’re younger, which means the corresponding benefits of vaccination are much lower if you take a narrow view of the benefits of the vaccine being solely the prevention of severe disease.</p>
<h2>How did ATAGI draw its conclusions on AstraZeneca?</h2>
<p>ATAGI initially said Pfizer was the preferred vaccine for under-50s <a href="https://www.health.gov.au/news/atagi-statement-on-astrazeneca-vaccine-in-response-to-new-vaccine-safety-concerns">in April</a>, and then changed this to under-60s <a href="https://www.health.gov.au/news/atagi-statement-on-revised-recommendations-on-the-use-of-covid-19-vaccine-astrazeneca-17-june-2021">in June</a>.</p>
<p>There are several assumptions in ATAGI’s advice which need to be understood. </p>
<p>Firstly, it calculated the risks and benefits of AstraZeneca across three scenarios — low, medium and high exposure risk. ATAGI has presented its advice assuming a low amount COVID circulating in the community, which has been the case until Sydney’s latest outbreak.</p>
<p>A low amount of COVID in the community means there’s a low chance of severe COVID, which is even smaller for younger people. This means there’s less of a benefit of being vaccinated for younger people, which is what has driven the advice for the Pfizer vaccine to be preferred for younger people. </p>
<p>However, the problem with this low prevalence assumption is we’re vaccinating to protect us not just right now, but also against the <em>future risk</em> of COVID, and future lockdowns, like the situation we’re seeing in Sydney now.</p>
<p>Once you’re in this situation, even if ATAGI changes its recommendations in response to more COVID circulating, <a href="https://theconversation.com/morrison-government-orders-pfizer-boosters-while-hoping-new-atagi-advice-will-warm-people-to-astrazeneca-165069">which it did on Saturday</a>, in some sense the horse has already bolted.</p>
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<p>Another assumption implicit in ATAGI’s advice that it <a href="https://www.health.gov.au/news/atagi-statement-on-revised-recommendations-on-the-use-of-covid-19-vaccine-astrazeneca-17-june-2021">prefers</a> under-60s get Pfizer, is that Pfizer is available and you have the option to get it now.</p>
<p>However, given the limited supply of Pfizer vaccine, the decision to hold off on the AstraZeneca vaccine is not one to get Pfizer, it is one to hold off on getting vaccinated at all. This leaves you exposed and vulnerable to COVID. This is an important distinction to make, which of course will change as we get more Pfizer vaccine.</p>
<p>Another major limitation in the ATAGI advice is the panel, in dealing with population-level data, takes a very narrow view of the benefits of vaccination: the prevention of severe disease.</p>
<p>It doesn’t take into account other benefits that may be relevant to many people. It doesn’t take into account the prevention of long COVID; the benefits of being vaccinated allowing travel and other freedoms; and, most glaringly, the importance many people place on getting vaccinated to protect their loved ones and the community.</p>
<p>These may weigh heavily on individuals but aren’t taken into account when you look at the risk-benefit calculation from a narrow perspective.</p>
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<h2>So what’s the bottom line on AstraZeneca?</h2>
<p>We must remember the AstraZeneca vaccine is a fantastic vaccine.</p>
<p>It’s safe and effective, and two doses offer almost complete protection against severe disease and death from COVID, <a href="https://www.gov.uk/government/news/vaccines-highly-effective-against-hospitalisation-from-delta-variant">including</a> <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/two-doses-pfizer-astrazeneca-shots-effective-against-delta-variant-study-finds-2021-07-21/">the Delta variant</a>.</p>
<p>It does carry a small risk of the blood clotting and bleeding condition, but this risk is incredibly small. COVID is much more of a threat to your health than the vaccine, as we are seeing <a href="https://twitter.com/smh/status/1419250626320474114">in NSW right now</a>.</p>
<p>If you’re under 60 years of age, the decision to have the AstraZeneca vaccine is one only you can make. But if you do make it, you should understand the benefits go beyond just preventing severe disease.</p><img src="https://counter.theconversation.com/content/164633/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Hassan Vally 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>ATAGI is grappling with competing concerns, considerable uncertainty, and a constantly changing landscape.Hassan Vally, Associate Professor, La Trobe UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1650692021-07-25T09:57:34Z2021-07-25T09:57:34ZMorrison government orders Pfizer ‘boosters’, while hoping new ATAGI advice will warm people to AstraZeneca<p>While still struggling with a current shortage of Pfizer, the Morrison government announced it has secured 85 million doses of that vaccine for future “booster” shots.</p>
<p>This will be made up of 60 million doses in 2022, and 25 million doses in 2023. Delivery will start in the first quarter of next year.</p>
<p>Scott Morrison said on Sunday this was “prudent future proofing”, although there is still not definitive advice on when boosters will be needed.</p>
<p>Meanwhile the Australian Technical Advisory Group on Immunisation (ATAGI) has liberalised its advice on AstraZeneca.</p>
<p>It said in a statement on Saturday all people aged 18 and over in greater Sydney, including those under 60, “should strongly consider getting vaccinated with any available vaccine including COVID-19 Vaccine AstraZeneca”.</p>
<p>This was on the basis of the increasing risk of COVID and “ongoing constraints” of Pfizer, the advice said.</p>
<p>Last week Scott Morrison said the government was constantly appealing to ATAGI to review its advice on AZ according to the balance of risk. Many people have shied away from AZ, supplies of which are plentiful, after ATAGI’s caution about it for younger people because of rare blood clots.</p>
<p>Asked about some general practioners being reluctant to give AZ to people under 40, Morrison said he certainly hoped GPs “would be very mindful of the ATAGI advice”.</p>
<p>ATAGI is presently considering whether children between 12 and 15 years old should be vaccinated against COVID, with the government expecting advice in mid-August.</p>
<p>As the crisis continues in Sydney, on Sunday NSW reported 141 new locally acquired cases and two deaths, including a woman in her 30s. This followed Saturday’s report of 163 new cases in the previous 24 hours.</p>
<p>Victoria on Sunday reported 11 new local cases, and is on track to end its lockdown soon, as is South Australia.</p>
<p>Morrison again stressed the lockdown was the primary weapon in fighting the Sydney outbreak.</p>
<p>“There’s not an easy way to bring these cases down. And it’s the lockdown that does that work. The vaccines can provide some assistance, but they are not going to end this lockdown. What’s going to end this lockdown is it being effective.”</p>
<p>But NSW Premier Gladys Berejiklian, who tried unsuccessfully to get the vaccination program refocused on south west Sydney, the centre of the outbreak, has a different emphasis. “Please know that what will get us through this outbreak is a combination of our restrictions, but also of more people being vaccinated”.</p>
<p>Morrison has refused to alter the focus, saying this would “interrupt the rhythm of the national vaccine program”.</p>
<p>The federal government has found 50,000 extra Pfizer doses for NSW. Asked where these came from, Morrison said: “There are small variations in supply and delivery, which from time to time may ensure that there’s tens of thousands of doses that might be free at any given time.”</p>
<p>Morrison condemned Saturday’s Sydney anti-lockdown demonstration attended by thousands of people, which saw violence, dozens of people charged, and more being pursued where they can be identified.</p>
<p>He said it was not just selfish. “It was also self-defeating. It achieves no purpose. It will not end the lockdown sooner, it will only risk the lockdowns running further,” he said.</p>
<p>Asked about Queensland Nationals MP George Christensen, who attended a rally in Mackay, Morrison said: “As for other parts of the country that aren’t in lockdown, well, there is such a thing as free speech, and I’m not about to be imposing those sorts of restrictions on people’s free speech”.</p>
<p>Christensen said on Facebook, “Civil disobedience eventually becomes the only response to laws that restrict freedom. This is what we’ve seen in Melbourne today.”</p>
<p>Pressed on this, Morrison said: “The comments I made before related to an event that took place in Queensland where there are no lockdowns”.</p>
<p>The Prime Minister told the Liberal National Party state council in a virtual address on Sunday: “After a difficult start, the vaccine program is now making up lost ground, and quickly”.</p><img src="https://counter.theconversation.com/content/165069/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Michelle Grattan 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>The prime minister has condemned the anti-lockdown rallies while defending free speech.Michelle Grattan, Professorial Fellow, University of CanberraLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1629752021-07-14T12:57:07Z2021-07-14T12:57:07ZBig Pharma’s COVID-19 reputation boost may not last — here’s why<figure><img src="https://images.theconversation.com/files/411053/original/file-20210713-23-q0rjjq.JPG?ixlib=rb-1.1.0&rect=0%2C56%2C4165%2C2687&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The first Pfizer-BioNTech COVID-19 vaccine dose in Canada sits ready for use at The Michener Institute in Toronto in mid-December 2020, less than a year from when the World Health Organization declared COVID-19 a pandemic.</span> <span class="attribution"><span class="source">THE CANADIAN PRESS/Frank Gunn </span></span></figcaption></figure><p>The race for developing effective COVID-19 vaccines has <a href="https://fortune.com/longform/covid-vaccine-big-pharma-drugmakers-coronavirus-pharmaceutical-industry/">put the pharmaceutical industry in the spotlight</a>. </p>
<p>Over the past few months, the world has witnessed rapid clinical trials and approvals of several highly effective vaccines like Pfizer, Moderna and AstraZeneca. This unprecedented achievement has been made possible by <a href="https://doi.org/10.1038/s41587-021-00912-9">close intra-industry, state industry and international collaborations</a>. </p>
<p>Big Pharma’s proactive approach to vaccine development has also brought an unexpected consequence: its reputation has been notably enhanced since early 2020. A survey conducted in February 2021 found that <a href="https://www.fiercepharma.com/marketing/pharma-reputation-hits-high-americans-two-thirds-now-give-positive-rating-harris-poll">almost two-thirds of Americans now give the pharmaceutical industry high marks</a>.</p>
<p><a href="https://www.ft.com/content/7ad9d74e-f4e7-4b30-9391-0b934662b6ac">But reputation risks loom</a> even as pharma companies are being celebrated as pandemic heroes. </p>
<p>The controversy over the AstraZeneca vaccine’s potential serious side-effects is a prime example. The English company has experienced a public backlash <a href="https://www.theguardian.com/business/2021/mar/26/how-the-astrazeneca-vaccine-became-a-political-football-and-a-pr-disaster">due to a lack of a crisis response plan and conflicting messages delivered by different stakeholders</a>. </p>
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<img alt="AstraZeneca sign on the side of a building." src="https://images.theconversation.com/files/411054/original/file-20210713-15-37yx3u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/411054/original/file-20210713-15-37yx3u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=329&fit=crop&dpr=1 600w, https://images.theconversation.com/files/411054/original/file-20210713-15-37yx3u.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=329&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/411054/original/file-20210713-15-37yx3u.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=329&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/411054/original/file-20210713-15-37yx3u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=414&fit=crop&dpr=1 754w, https://images.theconversation.com/files/411054/original/file-20210713-15-37yx3u.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=414&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/411054/original/file-20210713-15-37yx3u.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=414&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">The global headquarters of AstraZeneca in London.</span>
<span class="attribution"><span class="source">(AP Photo/Kirsty Wigglesworth)</span></span>
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<p>Will the reputation boost enable the pharmaceutical industry to fundamentally rebuild its negative public image? As someone who researches public relations, I believe that only by prioritizing socially responsible practices can Big Pharma achieve true reputation redemption. </p>
<h2>Big Pharma’s damaged reputation</h2>
<p>Prior to the COVID-19 pandemic, the pharmaceutical industry had been battling reputational damage for years. Notably, <a href="https://news.gallup.com/poll/266060/big-pharma-sinks-bottom-industry-rankings.aspx">it sank to the bottom of Gallup’s August 2019 United States industry favourability poll</a>, with a total positive score of only 27 per cent. According to Gallup’s analysis, high drug costs, massive advertising and lobbying spending and the opioid crisis have all tarnished the industry’s public image. </p>
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Read more:
<a href="https://theconversation.com/oxycontin-how-purdue-pharma-helped-spark-the-opioid-epidemic-57331">Oxycontin: how Purdue Pharma helped spark the opioid epidemic</a>
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<p>This is consistent with public relations research conducted in Europe. In <a href="https://doi.org/10.1177/2046147X18774588">a qualitative analysis published by <em>Public Relations Inquiry</em></a>, a team of Ghent University researchers analyzed how Belgian pharma companies responded to the pervasive “Bad Pharma” public image. </p>
<p>Their analysis revealed that Bad Pharma perceptions reflected larger societal issues, including widening income and health gaps. The public expects the pharmaceutical industry to save and improve lives by developing innovative, affordable and effective medicines. Accordingly, the industry loses trust when the public believes its actions and motives are at odds with those expectations. Such a decline in public trust can’t be easily fixed by corporate responsibility reports or public relations campaigns.</p>
<p>The pharmaceutical industry’s reputational challenges also correlate to how the media covers it. A <a href="https://doi.org/10.1007/s43441-019-00048-8">2020 analysis of Big Pharma-related coverage</a> found that the majority of stories were neutral and involved reporting on topics like finances, stocks, profits, mergers, acquisitions and restructuring. Coverage is more negative when it delves, less often, into more sentimental topics. </p>
<p>In other words, the media mostly reports on Big Pharma from a business perspective instead of from a social and public health perspective. This lack of media attention to the industry’s social responsibilities contributes to growing public distrust of it in recent years.</p>
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<img alt="A man holds a sign that reads Drug Users Deserve Health Care with Heart." src="https://images.theconversation.com/files/411056/original/file-20210713-25-5pdfbs.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/411056/original/file-20210713-25-5pdfbs.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=397&fit=crop&dpr=1 600w, https://images.theconversation.com/files/411056/original/file-20210713-25-5pdfbs.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=397&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/411056/original/file-20210713-25-5pdfbs.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=397&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/411056/original/file-20210713-25-5pdfbs.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=498&fit=crop&dpr=1 754w, https://images.theconversation.com/files/411056/original/file-20210713-25-5pdfbs.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=498&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/411056/original/file-20210713-25-5pdfbs.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=498&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">A man holds a sign in Vancouver in 2017 during a march on the first National Day of Action to draw attention to the opioid overdose epidemic.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Darryl Dyck</span></span>
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<h2>Risks underlie vaccine-led reputation boost</h2>
<p>Considering the above factors, it’s unsurprising that the pharmaceutical industry’s all-hands-on-deck efforts on COVID-19 vaccines, in combination with extensive media coverage, has resulted in <a href="https://www.vox.com/policy-and-politics/2021/4/2/22362078/covid-19-vaccines-pfizer-pharma-companies-popularity">a substantial improvement in public sentiment</a>. According to <a href="https://www.filesforprogress.org/datasets/2021/3/dfp-pharma-infrastructure-funding.pdf">a survey conducted by think tank Data for Progress in March 2021</a>, 56 per cent of respondents had a favourable view of pharmaceutical companies, double the rating of Gallup’s 2019 poll. </p>
<p>Nonetheless, a closer look at the data reveals two caveats. </p>
<p>First, drug costs remain the top concern for the public. The Data for Progress survey suggests that 72 per cent of American voters support policy measures that would lower the cost of prescription drugs. The pharma industry, meantime, insists that the discounted prices it’s currently offering for COVID-19 vaccines will not last very long. </p>
<h2>Vaccine prices to rise?</h2>
<p>In February, Pfizer CFO Frank D'Amelio said in <a href="https://www.biopharmadive.com/news/coronavirus-vaccines-pricing-questions-moderna-pfizer/594762/">a call with Wall Street analysts</a> that after the pandemic, Pfizer is “going to get more on price” and hinted there would be a substantial price increase for its COVID-19 vaccine. </p>
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<a href="https://images.theconversation.com/files/411057/original/file-20210713-17-5dcfkv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Two men sit in front of a Pfizer sign." src="https://images.theconversation.com/files/411057/original/file-20210713-17-5dcfkv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/411057/original/file-20210713-17-5dcfkv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=410&fit=crop&dpr=1 600w, https://images.theconversation.com/files/411057/original/file-20210713-17-5dcfkv.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=410&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/411057/original/file-20210713-17-5dcfkv.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=410&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/411057/original/file-20210713-17-5dcfkv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=516&fit=crop&dpr=1 754w, https://images.theconversation.com/files/411057/original/file-20210713-17-5dcfkv.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=516&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/411057/original/file-20210713-17-5dcfkv.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=516&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Pfizer Canada executives hold a news conference in Montréal in 2012.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Graham Hughes</span></span>
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<p>The company currently charges US$19.50 per dose for its vaccine, but the typical price is $150 to $175 per dose for other vaccines it sells. If implemented, this aggressive pricing policy would undoubtedly result in public criticism, especially from developing countries that have already been neglected during the first round of global vaccine allocation.</p>
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Read more:
<a href="https://theconversation.com/global-herd-immunity-remains-out-of-reach-because-of-inequitable-vaccine-distribution-99-of-people-in-poor-countries-are-unvaccinated-162040">Global herd immunity remains out of reach because of inequitable vaccine distribution – 99% of people in poor countries are unvaccinated</a>
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<p>Second, the remarkable speed of research and innovation achieved during COVID-19 vaccine development is mainly due to intensive government funding support and concerted collaborations across multiple sectors. It’s uncertain whether these special measures herald the arrival of a new model in which governments have better regulation over Big Pharma issues like patent control, advertising, clinical data transparency and spending on lobbying.</p>
<p>If the pharmaceutical industry wants to achieve the ultimate image makeover, it must capitalize on the current goodwill by prioritizing socially responsible practices. That begins with fairer drug pricing and a genuine commitment to resolving public health disparities.</p><img src="https://counter.theconversation.com/content/162975/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Sibo Chen receives funding from Ryerson University and the Social Sciences and Humanities Research Council of Canada. </span></em></p>If Big Pharma wants to achieve the ultimate image makeover, it must capitalize on the current public good will about its COVID-19 vaccines by prioritizing socially responsible practices.Sibo Chen, Assistant Professor, School of Professional Communication, Toronto Metropolitan UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1640672021-07-12T06:02:33Z2021-07-12T06:02:33ZFirst Nations people urgently need to get vaccinated, but are not being consulted on the rollout strategy<figure><img src="https://images.theconversation.com/files/410385/original/file-20210708-21-1ce9ez0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">A senior Aboriginal man is being vaccinated against COVID-19.</span> <span class="attribution"><a class="source" href="http://https://www.photos.aap.com.au/">PR Handout Image/AAP</a></span></figcaption></figure><p>This year, just <a href="https://www1.health.gov.au/internet/main/publishing.nsf/Content/1D03BCB527F40C8BCA258503000302EB/$File/covid_19_australia_epidemiology_report_44_reporting_period_ending_20_june_2021.pdf">five cases of COVID-19</a> have been recorded among Aboriginal and Torres Strait Islander people in Australia. This good result is due to both significant government support measures and <a href="https://www.mja.com.au/journal/2020/first-nations-people-leading-way-covid-19-pandemic-planning-response-and-management">prompt and effective action</a> by Aboriginal and Torres Strait Islander leaders and organisations. </p>
<p>As the highly contagious Delta variant spreads in Australia, the task of ensuring all Australians are vaccinated becomes even more urgent. But since the vaccine rollout began in late February, <a href="https://www.theguardian.com/australia-news/datablog/ng-interactive/2021/jul/07/covid-19-vaccine-rollout-australia-vaccination-rate-progress-how-many-people-vaccinated-percent-tracker-by-state-victoria-vic-nsw-queensland-qld-daily-live-data-stats-updates-total-number-world-ranking-distribution-schedule-tracking-chart-percentage-new-cases-today">only about 9% of Australians have been fully vaccinated</a>.</p>
<p>The Delta variant is a particular concern for higher-risk populations, including Aboriginal and Torres Strait Islanders. Vaccinations of First Nations people must be carried out more quickly. </p>
<p>And in light of the elite Sydney private school <a href="https://www.theguardian.com/australia-news/2021/jul/06/sydney-private-school-st-josephs-college-students-given-pfizer-vaccine-despite-under-40s-being-ineligible">erroneously giving all Year 12 students</a> vaccines that were intended only for First Nations students, there’s also a need for stricter guidelines and better oversight.</p>
<p>When questioned about the mistake this week, NSW Health Minister Brad Hazzard demanded that <a href="https://www.smh.com.au/national/nsw/move-on-health-minister-evades-questions-over-private-school-vaccine-program-20210707-p587oo.html">critics “move on”</a>. But authorities should not dismiss public concern that vaccines are not being distributed to those who need them most.</p>
<p>To ensure this, the vaccination rollout for First Nations people needs to involve Aboriginal community-controlled health organisations in the planning and implementation. We have already seen that when community-controlled organisations take control, vaccine delivery is successful and communities feel safer.</p>
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<strong>
Read more:
<a href="https://theconversation.com/comprehensive-indigenous-health-care-in-prisons-requires-federal-funding-of-community-controlled-services-158131">Comprehensive Indigenous health care in prisons requires federal funding of community-controlled services</a>
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<h2>How many First Nations people have been vaccinated</h2>
<p>Vaccine supply is a concern across the country, but the issue is most urgent at the moment in New South Wales, where <a href="https://www.aboriginalaffairs.nsw.gov.au/media/website_pages/new-knowledge/facts-and-figures/KEY-DATA-ABORIGINAL-PEOPLE-SEP-2020.pdf">a third of all Aboriginal and Torres Strait Islander people live</a>, and where case numbers are growing.</p>
<p>Australia is now predominantly reliant on the <a href="https://www.abc.net.au/news/2021-07-09/australia-to-get-pfizer-covid19-vaccine-supply-august/100279944">300,000 to 350,000 Pfizer vaccines coming into the country each week</a>. Thankfully, this number is <a href="https://www.abc.net.au/news/2021-07-09/australia-pfizer-doses-announcement-scott-morrison-vaccines/100280104">due to increase substantially</a> in coming months.</p>
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<p>In March, a vaccine implementation plan for Aboriginal and Torres Strait Islander peoples <a href="https://www.health.gov.au/resources/publications/covid-19-vaccination-program-aboriginal-and-torres-strait-islander-peoples-implementation-plan">was published by the federal health department</a>. The publication iterated the urgent need for Aboriginal and Torres Strait Islander people to be a high priority in the rollout.</p>
<p>First Nations people over the age of 55 have been able to get vaccinated <a href="https://theconversation.com/the-second-phase-of-australias-covid-vaccine-rollout-is-underway-despite-a-rocky-start-heres-what-you-need-to-know-157426">since March</a>. It’s also been a little over a month since Aboriginal and Torres Strait Islander people aged between 16 to 49 years have been eligible for COVID-19 vaccines. </p>
<p>However, there is currently limited publicly available data on just how many vaccines have actually been distributed to Aboriginal and Torres Strait Islander people so far. </p>
<p>Western Australia had <a href="https://www.abc.net.au/news/2021-07-04/indigenous-covid-vaccine-pastor/100263770">completely vaccinated just over 2%</a> of its Aboriginal and Torres Strait Islander population as of June 21.</p>
<p>In Queensland, about <a href="https://www.qld.gov.au/health/conditions/health-alerts/coronavirus-covid-19/current-status/statistics">5,277 total vaccines have been distributed</a> in the Torres Strait and Cape York, where just under two-thirds of the population is Aboriginal and/or Torres Strait Islander. </p>
<p>In the Northern Territory, <a href="https://www.abc.net.au/news/2021-07-07/nt-chief-health-officer-dr-hugh-heggie-covid-vaccine-rollout/100270964">17% of the total population</a> was fully vaccinated as of July 7. In remote areas, <a href="https://www.abc.net.au/news/2021-07-01/remote-vaccine-uptake-northern-territory-utju-covid19/100258084">26% of residents</a> had received their first dose at the start of the month.</p>
<p>This is good news for Aboriginal and Torres Strait Islander people in the territory, who make up just under a third of the total population. </p>
<h2>Community-controlled organisations addressing vaccine hesitancy</h2>
<p>While <a href="https://www.abc.net.au/news/2021-07-04/indigenous-covid-vaccine-pastor/100263770">the media has reported on vaccine hesitancy</a> in Aboriginal and Torres Strait Islander communities, there is anecdotal evidence that hesitancy is actually decreasing and that remote community clinics are vaccinating many First Nations people.</p>
<p>This includes the Mala’la clinic at Maningrida in Arnhem Land where media reports say <a href="https://www.abc.net.au/news/2021-07-07/maningrida-coronavirus-vaccine-rollout-nt-pfizer-community/100270352">1300 people were vaccinated across four days</a> in July. The clinic became <a href="https://www.abc.net.au/news/2021-03-06/nt-maningrida-health-clinic-handed-to-aboriginal-control/13216290">community-run</a> in March of this year after 45 years of government oversight.</p>
<p>This success highlights the importance of having Aboriginal and Torres Strait Islander organisations involved in the rollout. This involves recognising that <a href="https://www.theguardian.com/commentisfree/2021/jul/06/healing-among-indigenous-people-is-more-crucial-now-than-ever-heres-a-way-forward">self-determination</a>, as well as health information being delivered in <a href="https://www1.racgp.org.au/newsgp/clinical/will-the-new-covid-vaccine-ads-help-curb-hesitancy">first languages</a>, results in improved uptake of services and better health outcomes. </p>
<p>For example, in Pitjantjatjara, community worker Frank Dixon <a href="https://www.abc.net.au/news/2021-07-01/remote-vaccine-uptake-northern-territory-utju-covid19/100258084">provided the men of his community with information about the vaccine and accompanied them to their vaccinations</a>. Mala'la Health Service’s chairman, Charlie Gunabarra, has also delivered information about the vaccine to his community and was the first among them to get vaccinated.</p>
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Read more:
<a href="https://theconversation.com/is-it-more-infectious-is-it-spreading-in-schools-this-is-what-we-know-about-the-delta-variant-and-kids-163724">Is it more infectious? Is it spreading in schools? This is what we know about the Delta variant and kids</a>
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<p>Despite this, there is evidence First Nations people are not being sufficiently included in planning and implementation of the rollout. </p>
<p>For example, a meeting of the national COVID vaccine taskforce last week excluded the National Aboriginal Community Controlled Health Organisation. The Aboriginal and Torres Strait Islander Advisory Group on COVID-19 was also <a href="https://www.theguardian.com/australia-news/2021/jul/06/australia-urged-to-prioritise-vaccine-rollout-in-indigenous-communities-as-leaders-meet-to-war-game-strategy">excluded from the discussion</a>. </p>
<p>Pat Turner, the head of the National Aboriginal Community Controlled Health Organisation, said the lack of First Nations inclusion was “<a href="https://www.sbs.com.au/nitv/article/2021/07/06/aboriginal-peak-health-body-left-out-national-vaccine-task-force-meeting">deeply concerning</a>”.</p>
<p>The vaccine rollout must be managed so First Nations people and other vulnerable groups are prioritised. This means securing better vaccine supplies and putting Aboriginal and Torres Strait Islander people at the heart of decision-making.</p>
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<p><em>Correction: this article originally stated 50 people were vaccinated across three day and has now been changed to 1,300 over four days</em></p><img src="https://counter.theconversation.com/content/164067/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Kalinda Griffiths receives funding from the National Health and Medical Research Council, the Australian Research Council and the Ramaciotti Foundations. She is also 'Thinker in Residence' for the Australian Health Promotion Association of Australia. </span></em></p>As the delta strain spreads in Australia, there is increasing urgency to ensure Aboriginal and Torres Strait Islander people are vaccinated.Kalinda Griffiths, Scientia lecturer, UNSW SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1641642021-07-09T05:49:03Z2021-07-09T05:49:03ZShould I have my AstraZeneca booster shot at 8 weeks rather than 12? Here’s the evidence so you can decide<figure><img src="https://images.theconversation.com/files/410496/original/file-20210709-19-eimpsf.jpg?ixlib=rb-1.1.0&rect=1%2C0%2C997%2C519&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/close-top-view-on-white-calendar-1861762180">from www.shutterstock.com</a></span></figcaption></figure><p>Prime Minister Scott Morrison appeared to have made a “captain’s call” yesterday by <a href="https://www.abc.net.au/news/2021-07-08/scott-morrison-covid-vaccine-nsw-outbreak/100277466">encouraging people</a> in New South Wales outbreak areas to have their AstraZeneca booster closer to eight weeks after their initial shot rather than wait for the generally recommended 12 weeks.</p>
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<p>We would be encouraging the eight to 12-week second dose be done at the earlier part of that period […]. That is consistent with medical advice […] and given the risks to people from the outbreak in that area we believe it is important they get that second dose of AstraZeneca as soon as possible.</p>
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<p>The official health advice from ATAGI, the Australian Technical Advisory Group on Immunisation, remains most people have their booster shot <a href="https://www.health.gov.au/sites/default/files/documents/2021/06/covid-19-vaccination-atagi-clinical-guidance-on-covid-19-vaccine-in-australia-in-2021_1.pdf">at 12 weeks</a> for optimal COVID protection, but under certain circumstances that can go down to four weeks. Those circumstances include imminent travel or if there’s a risk of COVID-19 exposure.</p>
<p>ATAGI’s concern, and that of <a href="https://www.smh.com.au/national/vaccine-experts-warn-against-reducing-time-between-astrazeneca-doses-20210707-p587n6.html">some other vaccine experts</a>, is if you have your booster shot earlier than 12 weeks, your body won’t develop enough immunity to reliably protect you from serious disease.</p>
<p>Confused? Here is what we know so far.</p>
<h2>What’s the official advice?</h2>
<p>The evidence underpinning the <a href="https://www.health.gov.au/sites/default/files/documents/2021/06/covid-19-vaccination-atagi-clinical-guidance-on-covid-19-vaccine-in-australia-in-2021_1.pdf">recommended 12 week gap</a> between the first and second AstraZeneca shots comes from a study published in <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00432-3/fulltext">the Lancet</a>. </p>
<p>The study found leaving less than six weeks between the initial shot and the booster gave 55.1% efficacy (protection from symptomatic disease). Leaving 6-8 weeks between shots increased efficacy to 59.9%, and waiting 9-11 weeks, efficacy was 63.7%. However, if the gap was 12 weeks or longer efficacy jumped to 81.3%.</p>
<p>So to get the best protection from the AstraZeneca vaccine, you need at least 12 weeks between your first and second shot.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/408593/original/file-20210628-27-1lcjcwa.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/408593/original/file-20210628-27-1lcjcwa.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=509&fit=crop&dpr=1 600w, https://images.theconversation.com/files/408593/original/file-20210628-27-1lcjcwa.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=509&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/408593/original/file-20210628-27-1lcjcwa.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=509&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/408593/original/file-20210628-27-1lcjcwa.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=640&fit=crop&dpr=1 754w, https://images.theconversation.com/files/408593/original/file-20210628-27-1lcjcwa.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=640&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/408593/original/file-20210628-27-1lcjcwa.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=640&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="attribution"><a class="source" href="https://www.sciencedirect.com/science/article/pii/B978032335761600002X">The Conversation (adapted from Vaccine Immunology, Plotkin's Vaccines [Seventh Edition] 2018)</a>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
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<p>Now we find ourselves with an active outbreak of the highly transmissible Delta variant of SARS-CoV-2 in Sydney. So we need to ask ourselves whether aiming for the highest level of protection is best, or whether we need to aim for a reasonable level of immunity as quickly as possible.</p>
<p>The Lancet paper didn’t include data on the Delta variant as it wasn’t widely circulating at the time, but this is fast becoming the <a href="https://www.euronews.com/2021/06/23/delta-variant-to-account-for-90-of-new-covid-19-cases-in-europe-by-late-august-warns-eu-ag">dominant variant globally</a>.</p>
<p>Yet we do know <a href="https://theconversation.com/should-i-get-my-second-astrazeneca-dose-yes-it-almost-doubles-your-protection-against-delta-163259">two doses</a> of the AstraZeneca vaccine protects against serious COVID-19 after infection with the Delta variant, whereas <a href="https://www.nature.com/articles/s41586-021-03777-9">one dose doesn’t</a>.</p>
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<em>
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Read more:
<a href="https://theconversation.com/should-i-get-my-second-astrazeneca-dose-yes-it-almost-doubles-your-protection-against-delta-163259">Should I get my second AstraZeneca dose? Yes, it almost doubles your protection against Delta</a>
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<h2>What’s the evidence for 8 weeks to protect against Delta?</h2>
<p>Morrison’s call for some people to have their AstraZeneca booster shot from around eight weeks hasn’t come completely out of the blue. It’s an approach <a href="https://www.health-ni.gov.uk/news/introduction-shorter-interval-between-vaccine-doses">the UK has been using</a> to get ahead of the infectious Delta variant, the same variant circulating in NSW.</p>
<p>We know leaving less time between AstraZeneca shots generally reduces vaccine efficacy. But what about that in the context of the Delta variant? This is where things get a bit tricky if we actually want to put a figure on precisely how much vaccine efficacy reduces.</p>
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<p>A study published in <a href="https://www.nature.com/articles/s41586-021-03777-9">Nature</a> reported a single dose of AstraZeneca vaccine induced essentially no Delta virus-neutralising antibodies. </p>
<p>However, two doses induced a neutralising antibody response in 95% of people, albeit at a significantly lower level than with the Alpha variant (which originated in the UK).</p>
<p>Still, neutralising antibodies against Delta were there in the vast majority of people after two shots, antibodies that could mean the difference between a mild illness and hospitalisation with severe disease. </p>
<p>There are some limitations with this study. First, it did not directly assess vaccine efficacy (you need to conduct a clinical trial for that). Second, it used a range of intervals between first and second shots, so we cannot definitively say the precise protection from the Delta strain at eight weeks versus 12 weeks. </p>
<p>However, assessing the capacity of vaccinated peoples’ antibodies to neutralise viruses in the lab is a good indicator of the quality of vaccine-induced protection — and this study really highlighted the need for a booster shot for protection against the Delta variant. </p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/the-symptoms-of-the-delta-variant-appear-to-differ-from-traditional-covid-symptoms-heres-what-to-look-out-for-163487">The symptoms of the Delta variant appear to differ from traditional COVID symptoms. Here's what to look out for</a>
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<p>So with infection numbers in Sydney looking more ominous by the day, coupled with the knowledge one vaccine dose is all but useless against the Delta virus, it is clear getting two doses into the arms of as many people as possible as quickly as possible, is the strategy. </p>
<p>Two doses, even at eight weeks apart, while not providing the highest possible level of protection, will still protect many from severe disease. </p>
<h2>What else do I need to think about?</h2>
<p>A drop in immunity is not the only thing to consider when weighing up the pros and cons of having your AstraZeneca booster shot early.</p>
<p>We’ve just heard more Pfizer shots are on their way <a href="https://www.abc.net.au/news/2021-07-09/australia-to-get-pfizer-covid19-vaccine-supply-august/100279944">sooner than expected</a>. If a Pfizer booster shot is made available to people who have already had two shots of AstraZeneca (and this is a big if), this could be a game changer.</p>
<p>In this case — and remember this mix-and-match approach has not been officially sanctioned — it might not matter too much if an early second dose of the AstraZeneca vaccine gives you sub-optimal immunity. The Pfizer booster would lift your immunity instead. </p>
<p>However, it remains to be seen whether such a major policy shift would happen in time to protect people currently in lockdown in NSW.</p>
<h2>Take-home message</h2>
<p>The Delta variant is <a href="https://theconversation.com/why-is-delta-such-a-worry-its-more-infectious-probably-causes-more-severe-disease-and-challenges-our-vaccines-163579">highly transmissible</a>. So weeks do matter, and with Australia still heavily reliant on the AstraZeneca vaccine, for now it does makes sense to reduce the time between the first and second jab. </p>
<p>This is clearly preferable to remaining unprotected for an extra month, particularly if you are at higher risk of infection and/or severe disease.</p><img src="https://counter.theconversation.com/content/164164/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Nathan Bartlett does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Weeks do matter when it comes to the Delta strain. With Australia still heavily reliant on the AstraZeneca vaccine, for now it makes sense to reduce the time between the first and second jab.Nathan Bartlett, Associate Professor, School of Biomedical Sciences and Pharmacy, University of NewcastleLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1637842021-07-02T13:28:25Z2021-07-02T13:28:25ZSouth Africa’s vaccine quagmire, and what needs to be done now<figure><img src="https://images.theconversation.com/files/409367/original/file-20210701-27-18xg1qr.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">Photo by Sharon Seretlo/Gallo Images via Getty Images</span></span></figcaption></figure><p>South Africa’s approach to its COVID-19 vaccine programme has been characterised by a large number of missteps. In aggregate it has left the country behind many others on the continent, and essentially left millions unvaccinated as a savage third wave descends on the country.</p>
<p>This has happened despite an established vaccine procurement and distribution network, access to the first large batch of vaccines on the continent, and a large number of pandemic and vaccine experts.</p>
<p>As the country battles a <a href="https://theconversation.com/south-africas-latest-covid-19-lockdown-puts-spotlight-back-on-vaccination-failures-163521">severe third wave crisis</a>, at great cost to health, economy and society, the rollout of a vaccine programme remains the only sustainable means to protect the population against COVID-19 severe disease and death and return to some level of acceptable economic activity.</p>
<p>Strategically, therefore, policy needs to be hyper-focused on the delivery of a responsive vaccine programme to protect especially high risk groups against severe disease and death.</p>
<p>In this article, we outline the history of the vaccine strategy and its pitfalls. We also suggest a way forward.</p>
<h2>Some context</h2>
<p>As the pandemic first unfolded South Africa had, from a vaccine perspective, a number of things going for it. It has a large childhood vaccine programme although with weaknesses in <a href="https://www.who.int/immunization/monitoring_surveillance/data/zaf.pdf">overall coverage</a>. It also has a private sector able to distribute adult vaccines, and experience of rolling out large programmes, such as antiretrovirals.</p>
<p>While reeling from a devastating first wave and associated lockdown in this period, the country was well poised to rapidly implement a mass vaccine programme.</p>
<p>In September 2020, for instance, a vaccine subgroup (the MAC Vac) of the <a href="https://sacoronavirus.co.za/2021/06/24/ministerial-advisory-committee-on-covid-19-vaccines-vmac/">Ministerial Advisory Committee on COVID-19 (MAC)</a> was set up. It was made up of a small group of virologists, regulators and other public entities. It recommended supporting <a href="https://www.who.int/initiatives/act-accelerator/covax">COVAX</a>, a pooled procurement and distribution initiative aimed at securing large volumes of vaccines for countries that might struggle with bilateral agreements.</p>
<p>But during early December 2020 it became worryingly clear that government had <a href="https://www.timeslive.co.za/news/south-africa/2020-12-31-sa-was-right-to-choose-covax-rather-than-one-supplier-says-health-ddg/">no vaccine strategy</a> at any level of maturity apart from the fragile COVAX arrangement.</p>
<p>To quote the deputy director general of the Department of Health, <a href="https://www.timeslive.co.za/news/south-africa/2020-12-31-sa-was-right-to-choose-covax-rather-than-one-supplier-says-health-ddg/">Dr Anban Pillay</a>:</p>
<blockquote>
<p>We have not delayed the procurement at all. We took a decision at the time we will go to (sic) COVAX facility because COVAX was purchasing vaccine (sic) from multiple vaccine producers, rather than taking the risk and going with one vaccine supplier.</p>
</blockquote>
<p>Despite also asserting that individual companies had in fact been approached, there was no evidence of this, including within the publicly released MAC Vac advisories.</p>
<p>In late June 2021 the first 1.4 million doses of Pfizer vaccine were <a href="http://www.thepresidency.gov.za/speeches/statement-president-cyril-ramaphosa-progress-national-effort-contain-covid-19-pandemic%2C-union-buildings%2C-tshwane-6">finally delivered</a> to South Africa through the COVAX facility. It still remains unclear what will be delivered of the roughly 10.6 million doses still owed to South Africa during 2021. </p>
<p>As no signs of a coherent strategy by the government were surfacing, a group of academics drafted a <a href="http://www.samj.org.za/index.php/samj/article/view/13163/9676">10-point vaccine strategy</a> in early December 2020 to prompt a strategic response from government.</p>
<p>But no strategy emerged during that month.</p>
<h2>January – February 2021</h2>
<p>In frustration a group of South Africa’s health academics and activists published an article <a href="https://www.dailymaverick.co.za/article/2021-01-02-vaccines-for-south-africa-now/">in early January 2021</a> condemning the absence of a vaccine strategy. They raised the concern that South Africa would enter the winter wave of SARS-CoV-2 infections without a significant part of the population vaccinated against infection or severe illness.</p>
<p>The article provoked a response. The health minister called <a href="https://sacoronavirus.co.za/2021/01/03/minister-zweli-mkhize-public-briefing-statement-south-africas-covid-19-vaccine-strategy-3-january-2021/">a news conference</a>, announcing that a strategy would be forthcoming and that confidential bilateral negotiations were in fact under way.</p>
<p>He failed to disclose any details.</p>
<p>A day later, on 4 January 2021, the Department of Health for the first time began belated bilateral negotiations of any seriousness with the Serum Institute of India for whatever doses they could make available of the AstraZeneca vaccine.</p>
<p>Within a week a commitment of some 1.5 million doses was made for delivery during February and March, with the potential option to purchase another 1.5 million. </p>
<p>This revealed what was possible if government began to act with purpose.</p>
<p>Also, within a relatively short period, an application for registration was submitted to the South African Health Products Regulatory Authority and emergency approval provided.</p>
<p>However, there was no rollout strategy, with no vaccine sites or registration system to manage the process. The <a href="https://mg.co.za/news/2021-02-01-first-astrazeneca-vaccines-arrive-in-south-africa/">first AstraZeneca vaccine batch then arrived</a> on 1 February 2021 with much fanfare and was immediately transferred to the Free State for quality assurance.</p>
<p>As there was no other commitment to purchase, until this period no other <a href="https://www.businesslive.co.za/bd/national/health/2021-01-06-big-pharma-yet-to-apply-to-sa-for-vaccine-registration/">vaccines were being evaluated by the regulatory authority</a> apart from a rolling application by Johnson & Johnson. And as government had indicated it would be the sole purchaser and distributor of COVID-19 vaccines, no other party had applied for registration.</p>
<p>Despite the rolling application, the Aspen facility in Gqeberha was set to fill and finish 300 million doses of Johnson & Johnson vaccine in 2021. But there were no plans to use these in South Africa as the government appeared to show little interest up to that point. </p>
<p>A <a href="https://www.businessinsider.co.za/jj-single-dose-coronavirus-vaccine-data-to-come-within-days-2021-1">26 January 2021 statement by Aspen’s chief financial officer</a> appeared to confirm this. It stated that:</p>
<blockquote>
<p>Aspen confirmed it had the capacity to make up to 300 million doses of the vaccine, in a Port Elizabeth plant, and that all those doses would be earmarked for export.</p>
</blockquote>
<p>Confusion then ensued when the health minister announced that due to the AstraZeneca vaccine not demonstrating efficacy against mild to moderate COVID-19 against what is now referred to as the Beta variant in the small South African AstraZeneca trial, the rollout of the vaccine <a href="https://www.npr.org/sections/goatsandsoda/2021/02/08/965390228/why-south-africa-is-putting-the-astrozeneca-vaccine-on-hold">was put on ice</a>. The decision was criticised by <a href="https://www.dailymaverick.co.za/article/2021-03-17-local-experts-at-odds-on-whether-the-astrazeneca-vaccine-should-be-used-in-south-africa/">local scientists</a>, and not supported by the <a href="https://www.politicsweb.co.za/opinion/a-bitter-spat-over-govts-vaccine-plans-2">World Health Organisation</a>.</p>
<h2>March 2021</h2>
<p>Due to the intervention of researchers involved in the Johnson & Johnson vaccine trial in South Africa <a href="https://www.dailymaverick.co.za/article/2021-05-17-behind-the-scenes-how-the-first-500000-vaccine-doses-administered-in-sa-were-secured/">a workaround was quickly negotiated</a> for 500,000 trial doses to be made available. These would be prioritised for health workers with implementation in March 2021. </p>
<p>However, this was an expanded observational trial <a href="https://bhekisisa.org/article/2021-05-27-the-sisonke-trial-rewrote-history-eight-lessons-for-the-nationwide-vaccine-roll-out/">(Sisonke trial)</a>, not a rollout. It could only rely on trial sites for expansion, severely restricting the scaling up of the programme. </p>
<p>Nevertheless, the Sisonke workaround was a local initiative that spared the lives of many frontline health workers.</p>
<h2>April 2021</h2>
<p>The minister of health then controversially chose to discard the initial one million AstraZeneca doses rather than use them. It is our understanding that this was based on the MAC VaC advice. </p>
<p>He also took a decision to forgo the additional doses that would have been made available from the Serum Institute of India in terms of both bilateral agreements and the first round of COVAX. This was despite the <a href="https://apps.who.int/iris/bitstream/handle/10665/339477/WHO-2019-nCoV-vaccines-SAGE-recommendation-AZD1222-2021.1-eng.pdf?sequence=5&isAllowed=y">World Health Organisation position</a> that while not effective against infection by the Beta variant, it would be effective against the original wild-type variant still prevalent in South Africa and would probably offer protection against severe illness due to the Beta variant, which was subsequently <a href="https://www.biorxiv.org/content/10.1101/2021.03.11.435000v2.full">corroborated</a> in animal model studies. The protection against Beta-variant severe COVID-19 in the animal model study was evident despite the low levels of neutralising antibody induced by the AstraZeneca vaccines against the Beta variant, indicating such protection is likely mediated by CD4+ and CD8+ cellular immune responses that are largely unaffected even due to mutations in the Beta variant. </p>
<p>A number of experts <a href="http://www.samj.org.za/index.php/samj/article/view/13238/97">were critical</a> of this decision. They argued that South Africa should urgently use all available vaccines.</p>
<p>The minister also indicated that South Africa would not make use of <a href="https://ir.novavax.com/2021-06-30-Novavax-Publishes-Results-of-United-Kingdom-Phase-3-Clinical-Trial-in-New-England-Journal-of-Medicine,-Demonstrating-High-Levels-of-Efficacy-of-COVID-19-Vaccine">NOVAVAX</a> either, <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2103055">despite it being the only vaccine</a> shown to protect against mild to moderate COVID-19 from the Beta variant and considered in the same league as the mRNA vaccines for efficacy against severe COVID-19. No evidence was offered for the decision.</p>
<p>The AstraZeneca decision effectively knocked South Africa out of the running for the first round of COVAX doses, which were made up of AstraZeneca (237 million doses) and <a href="https://www.gavi.org/sites/default/files/covid/covax/COVAX-First-round-allocation-of-AZ-and-SII.pdf">some Pfizer (1.2 million doses)</a>.</p>
<p>The decision not to pursue the NOVAVAX vaccine potentially explains why they did not seek authorisation through the South African Health Products Regulatory Authority. </p>
<p>While the South African government did begin to take bilateral contracts seriously, our understanding is that substantial negotiations with Johnson & Johnson and Pfizer only began from February 2021.</p>
<p>This guaranteed that South Africa would face a winter wave of the epidemic with most of the 17 million or so high risk population unvaccinated. </p>
<p>The bilateral negotiations bore fruit with both Johnson & Johnson and Pfizer making significant commitments. But delivery was to be spread out intermittently through the remainder of the year – largely missing the predicted winter wave.</p>
<h2>May – July 2021</h2>
<p>South Africa officially started its rollout in May 2021 with Pfizer. But it did so with limited sites.</p>
<p>Expansion to scale is now restricted by the availability of doses rather than the ability to expand the number of sites.</p>
<p>The achievement of scale during June was then scuppered by the <a href="https://www.nytimes.com/2021/06/11/us/politics/johnson-covid-vaccine-emergent.html">Federal Drug Administration’s (FDA) determination</a> that the very 2.2 million initial Johnson & Johnson doses earmarked for South Africa by Aspen were contaminated and needed to be destroyed.</p>
<p>Despite the very long lead time to this decision, no apparent contingency arrangements were negotiated in the meantime. This resulted in a scramble to compensate for the failure of Johnson & Johnson to deliver on time.</p>
<p>Although replacement doses were subsequently made available, South Africa’s already belated vaccination drive was substantially diminished.</p>
<p>By the end of June 2021 South Africa had administered only 3 million doses, 480,000 of which were from Johnson & Johnson through the Sisonke trial and the remaining 2.2 million from Pfizer. </p>
<p>The end of June target for vaccinations was however 5 million outside of the Sisonke trial. Going into July 2021 South Africa should therefore have stock of around 4.3 million doses available if the 6.5 million doses promised by the end of June <a href="https://www.reuters.com/world/africa/south-africa-targets-5-million-elderly-people-phase-2-covid-19-vaccine-rollout-2021-05-16/">have arrived</a>. </p>
<p>However, this stock is largely due to the slow pace of vaccinations. We should have had only around 1.7 million doses available at the end of June if everything had gone according to plan.</p>
<p>The bungling continues. Vaccines have moved up to around 100,000 doses administered per day. But, inexplicably, virtually no vaccinations occur over weekends at the majority of sites. And government has not made arrangements for non medical scheme members to make use of private sector vaccination sites.</p>
<h2>What has been learned?</h2>
<p>Without a proactive strategy government will perpetually respond to events. Any reasonable strategy must account for contingencies. </p>
<p>What could go wrong? What is not yet known for certain but may be true?</p>
<p>This requires combining evidence with hedging decisions for unknowns where no evidence is yet available. </p>
<p>In this pandemic, as in many other aspects of government policy, decisions have to be made even when perfect information is unavailable.</p>
<p>With this in mind four strategic errors were made.</p>
<p>First, vaccine nationalism was plainly the greatest risk to securing doses in late 2020. Without timely and assertive bilateral contracting beyond COVAX it was guaranteed that South Africa would be at the back of the international queue when it began to realise its mistake.</p>
<p>Second, low vaccine efficacy, especially when confronted with variants, is a contingent risk you have to mitigate through careful vaccine candidate selection (for procurement) together with diversification – booking multiple candidates. This includes the advance contracting of booster doses updated for variants of concern. </p>
<p>Third, the ground-game – or rollout process – requires advance preparation to rapidly achieve scale. However, scaling up requires that you start early and learn from mistakes. South Africa has started. Finally. But it is nowhere near the levels required before the winter wave of infections.</p>
<p>Fourth, a substantial winter third wave was predictable and every effort was required to vaccinate the high risk population, particularly for those over the age of 60 and with co-morbidities, by May 2021 with at least one dose of a vaccine that could prevent severe illness. South Africa unfortunately gave this option away despite a contingent probability that AstraZeneca vaccinations would protect against severe COVID-19.</p>
<h2>A look at the strategy for 2022?</h2>
<p>South Africa has clearly suffered the consequences of poor strategic decisions to this point. It doesn’t need to continue along these lines. </p>
<p>But strategy going forward needs to account for three key factors.</p>
<p>First, from the end of July 2021 <a href="https://www.politico.eu/article/france-coronavirus-vaccine-glut/">many of the advanced</a> countries <a href="https://www.nytimes.com/2021/03/26/us/biden-coronavirus-vaccine.html">will have surplus doses</a> and are likely to shift their focus to updated vaccines that address variants of concern. It is therefore probable that the COVID-19 vaccine world will be characterised by a simultaneous glut of original vaccines and constrained supplies of updated booster shots.</p>
<p>Second, global herd immunity, even though an aspirational goal, is unlikely to materialise with the current generation of COVID-19 vaccines and the ongoing evolution of the virus. Instead the objective should be centred on protecting against severe illness and death despite ongoing transmission. One possible contingency is that a single complete mass vaccination programme permanently reduces COVID-19 to a mild illness – with ongoing infections acting as a booster to immune responses. The alternative, less likely contingency is that new variants emerge that evade even natural infection and vaccine induced immunity against severe illness. Both contingencies need to be prepared for.</p>
<p>Third, the pace of vaccinations remains constrained by access to doses rather than the capability of the public and private health systems to administer vaccines. Addressing these supply constraints is therefore a priority.</p>
<p>Taking account of these factors, the following four considerations should form part of the strategy for 2021 and into 2022:</p>
<p>First, bilateral negotiations need to be assertively pursued despite the doses already booked. These should focus on the more effective vaccines that are likely to move into surplus during the latter part of 2021 and into 2022. Therefore negotiations need to be ongoing with proactive procurement for both 2021 and the whole of 2022.</p>
<p>Second, South Africa should be advance purchasing the updated vaccines which could have higher effectiveness against the variants of concern. These should include agreements well into 2022.</p>
<p>Third, rather than advance purchasing too few doses, or just enough, consideration should be given to purchasing more than is required. This would cater for the contingent risk of ongoing transmission resulting in severe illness in the vaccinated population.</p>
<p>It would be a mistake for South Africa to again take its foot off the pedal when the opportunities for bilateral contracting are increasing. But the window for astute early action is closing.</p>
<p>Fourth, and more generally, greater transparency in strategy, implementation, and the strategic rationale for decisions is required, given the importance these decisions hold for the well-being of the country.</p><img src="https://counter.theconversation.com/content/163784/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Imraan Valodia receives funding from a number of national and international research funding agencies.</span></em></p><p class="fine-print"><em><span>Shabir Madhi's institution (Wits Health Consortium, a subsidiary of The University of the Witwatersrand) is receiving funding from the South African Medical Research Council and The Bill & Melinda Gates Foundation to conduct the COVID-19 vaccine study in South Africa. Neither of the funders are involved in the actual conduct of the study.</span></em></p><p class="fine-print"><em><span>Willem Daniel Francois Venter has received speaker fees and honoraria from Gilead Sciences, AbbVie, Cipla, Johnson and Johnson, Pfizer, ViiV Healthcare, Mylan and the Southern African HIV Clinicians Society; and conference sponsorship from Johnson and Johnson, BD, Gilead, Merck, Cipla and Mylan. He receives funding from USAID and Unitaid and study drug donations from ViiV and Gilead and is part of ART optimisation collaborations.</span></em></p><p class="fine-print"><em><span>Alex van den Heever and Martin Veller do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>South Africa has clearly suffered the consequences of poor strategic decisions to this point. It doesn’t need to continue along these lines.Alex van den Heever, Chair of Social Security Systems Administration and Management Studies, Adjunct Professor in the School of Governance, University of the WitwatersrandImraan Valodia, Dean of the Faculty of Commerce, Law and Management, and Head of the Southern Centre for Inequality Studies, University of the WitwatersrandMartin Veller, Former Dean of the Faculty of Health Sciences, University of the WitwatersrandShabir 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 WitwatersrandWillem Daniel Francois Venter, Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, University of the WitwatersrandLicensed as Creative Commons – attribution, no derivatives.