tag:theconversation.com,2011:/us/topics/vaccine-side-effects-97852/articlesVaccine side effects – The Conversation2022-09-22T12:40:17Ztag:theconversation.com,2011:article/1908262022-09-22T12:40:17Z2022-09-22T12:40:17ZWhen should you get the new COVID-19 booster and the flu shot? Now is the right time for both<figure><img src="https://images.theconversation.com/files/485731/original/file-20220920-16871-cf9dvv.jpg?ixlib=rb-1.1.0&rect=140%2C60%2C6569%2C4386&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">It is safe to get the newly formulated COVID-19 booster shot and the flu shot at the same time.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/close-up-photo-female-nurse-giving-vaccine-to-woman-royalty-free-image/1361778753?adppopup=true">SDI Productions/ E+ via Getty Images</a></span></figcaption></figure><p>At this point in the COVID-19 pandemic, nearly everyone has experienced the panic and uncertainty that come with having mild COVID-like symptoms – such as a cough and sore throat – only to test negative day after day. With cold and flu season just around the corner, that state of frustrating uncertainty is likely to strike most of us again. </p>
<p>Both COVID-19 and the flu are contagious respiratory illnesses that have <a href="https://www.cdc.gov/flu/symptoms/flu-vs-covid19.htm">similar symptoms</a>, making it difficult to distinguish between the two viral infections without a lab test. Testing is the only way to know which virus is causing your symptoms. In fact, labs are working to create one test that can detect <a href="https://doi.org/10.1001/jama.2022.11031">both COVID-19 and the flu</a>. </p>
<p>As a <a href="https://hhs.purdue.edu/directory/elizabeth-libby-richards/">nursing professor</a> with <a href="https://scholar.google.com/citations?user=Pdh4gSgAAAAJ&hl=en&oi=ao">experience in public health promotion</a>, I am often asked about the differences between the flu and COVID-19. This year I am fielding many questions about the timing of getting the new COVID-19 booster and the flu shot and whether they can be given together.</p>
<h2>Parsing the symptoms</h2>
<p>Symptoms of both COVID-19 and the flu can range from mild – or no noticeable symptoms at all – to severe. While flu infection does not typically affect one’s ability to taste or smell, <a href="https://my.clevelandclinic.org/health/symptoms/16708-loss-of-taste-and-smell">loss of taste or smell</a> has been a common symptom associated with COVID-19 infection. Both infections can cause fevers, chills, body aches and fatigue. More severe symptoms of either infection include difficulty breathing and subsequent infections like pneumonia. </p>
<p>During the 2021-2022 flu season, <a href="https://www.washingtonpost.com/health/2022/01/05/flurona-coronavirus-flu-symptoms/">the term “flurona”</a> made its way into the COVID-19 vernacular. Flurona refers to a simultaneous infection with both the flu and COVID-19. While only a few cases of co-infections <a href="https://doi.org/10.3389/fmed.2021.681469">have been reported</a>, it would not be surprising to see more of them this coming flu season. Vaccination for both the flu and COVID-19 is your best protection against both.</p>
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<figcaption><span class="caption">What flurona is – and isn’t.</span></figcaption>
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<h2>Timing the shots</h2>
<p>With the <a href="https://theconversation.com/will-omicron-specific-booster-shots-be-more-effective-at-combating-covid-19-5-questions-answered-189610">newly formulated COVID-19 booster shot</a> now available and flu season just around the corner, a natural question is whether there is an optimal timing for the two shots.</p>
<p>The answer to that question is to get both as soon as possible. It is important to consider that it takes approximately two weeks after vaccination for the body to develop antibodies from both the <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/how-they-work.html">COVID-19 vaccines</a> and the <a href="https://www.cdc.gov/flu/prevent/keyfacts.htm">flu vaccine</a>. </p>
<p>As long as you have completed your primary COVID-19 vaccine series and it has been at least eight weeks since your last COVID-19 booster, now is the time to <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html?">get the updated COVID-19 vaccine</a> that targets both the original strain of SARS-CoV-2 – the virus that causes COVID-19 – and the most recent omicron subvariants. The original COVID-19 vaccines and booster series have dramatically reduced the <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7023e2.htm">number of COVID-19 infection and death rates</a>, as well as <a href="https://www.cdc.gov/mmwr/volumes/71/wr/mm7112e1.htm">cases of severe COVID-19</a> that lead to hospitalization. </p>
<p>While everyone 6 months of age and older are recommended to receive both the COVID-19 and flu vaccines, certain populations have a higher risk for severe infection, such as <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.html">pregnant women</a>, and should be extra vigilant about getting vaccinated. </p>
<p>Further, among those vaccinated against COVID-19, symptoms during an infection <a href="https://www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/breakthrough-infections-coronavirus-after-vaccination#">tend to be milder</a>. However, due in part to the quickly evolving nature of the virus, it’s become clear that immune protection from COVID-19 vaccination or infection does not last forever. While studies show that the primary COVID-19 series maintains efficacy against severe disease and death six months after vaccination, protection against infection decreases by between <a href="https://doi.org/10.1016/S0140-6736(22)00152-0">20% to 30% by six months</a> after vaccination. </p>
<p>This decline in immune protection is exactly <a href="https://www.yalemedicine.org/news/covid-19-booster">why booster shots are so critical</a>. Without a large uptake of <a href="https://theconversation.com/low-vaccine-booster-rates-are-now-a-key-factor-in-covid-19-deaths-and-racial-disparities-in-booster-rates-persist-187272">booster shots in the population</a>, COVID-19 infection rates could surge again.</p>
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<figcaption><span class="caption">The updated COVID-19 booster shots are now available.</span></figcaption>
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<p>Timing is also important with the flu vaccine. Flu cases typically begin to rise in October and peak between December and February, <a href="https://www.cdc.gov/flu/about/season/flu-season.htm">but can last through May</a>. Ideally, people should get vaccinated before flu begins to spread, making <a href="https://www.cdc.gov/flu/season/faq-flu-season-2022-2023.htm">September or early October</a> the ideal flu vaccination time. </p>
<h2>A difficult flu season ahead</h2>
<p>Due to lockdowns, reduced travel, school closures and mask mandates in the first and second years of the pandemic, both the <a href="https://www.cdc.gov/flu/about/burden/past-seasons.html">2020-2021 and 2021-2022 flu seasons</a> were estimated to have fewer hospitalizations and deaths from the flu compared to many of the pre-pandemic years. </p>
<p>In the fall of 2021, experts became concerned about the potential for a <a href="https://theconversation.com/flu-season-paired-with-covid-19-presents-the-threat-of-a-twindemic-making-the-need-for-vaccination-all-the-more-urgent-169011">COVID-19 and flu “twindemic,”</a> especially as COVID-19 restrictions were lifting and masks were coming off. Fortunately, the worst didn’t bear out – flu numbers in the 2021-2022 season did not return to pre-pandemic levels. However, the possibility of a “twindemic” is not out of the picture for the coming flu season.</p>
<p>Flu seasons are <a href="https://www.cdc.gov/flu/about/burden/faq.htm">inherently difficult to predict</a>. With most people traveling again, schools open, mask mandates lifted and workers headed back to the office, people are undoubtedly going to be exposed to germs that they have been more protected from for the last two and a half years. </p>
<p>To further compound this, flu vaccine rates <a href="https://www.cdc.gov/flu/fluvaxview/dashboard/vaccination-dashboard.html#">have been lower during the pandemic</a>, suggesting that Americans may be out of the habit of getting their annual flu shot. </p>
<h2>Pairing the shots</h2>
<p>Many are also wondering whether they can or should get both the updated COVID-19 booster and the flu shot at the same time. The good news is, <a href="https://www.cdc.gov/flu/season/faq-flu-season-2022-2023.htm">yes, it is safe</a> for both adults and children 12 years of age and up who are eligible for the updated COVID-19 booster to get these vaccines simultaneously. </p>
<p>A recent study found that common vaccine side effects such as pain at the injection site <a href="https://doi.org/10.1001/jamanetworkopen.2022.22241">occurred at slightly higher rates</a> when someone received the flu vaccine and a COVID-19 vaccine at the same time, as opposed to receiving only a COVID-19 booster. However, those reactions, including fatigue and headache, were mild and resolved within a day or two.</p>
<p>You don’t need to make two separate vaccine visits as long as you are due for your next COVID-19 shot. However, I don’t recommend waiting to get your flu shot if you are not yet due for a COVID-19 booster. The Centers for Disease Control and Prevention suggests everyone receive their flu vaccine by <a href="https://www.cdc.gov/flu/season/faq-flu-season-2022-2023.htm">the end of October</a>. But if you miss that deadline, it is absolutely better to get vaccinated later in the season than not at all.</p>
<h2>Community matters too</h2>
<p>Getting the flu and COVID-19 vaccines isn’t just about your own health, it’s about family and community health too. Communities with higher vaccination rates have <a href="https://theconversation.com/what-is-herd-immunity-a-public-health-expert-and-a-medical-laboratory-scientist-explain-170520">fewer opportunities to spread the virus</a>. </p>
<p>Keep in mind <a href="https://www.cdc.gov/flu/prevent/whoshouldvax.htm">that many people cannot be vaccinated</a> because they have weakened immune systems or are undergoing treatments. They depend on those around them for protection. While one person may experience mild symptoms if they contract the flu or COVID-19, they could spread the virus to others who could become severely ill. Because it’s impossible to predict how people will react if they get sick, getting the flu and COVID-19 vaccines is the best prevention strategy.</p><img src="https://counter.theconversation.com/content/190826/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Libby Richards has received funding from the National Institutes of Health. She is is affiliated with the American Public Health Association. </span></em></p>When COVID-19 and the flu co-infect, it’s ‘flurona.’ But such cases are rare, and there are effective ways to protect yourself from both viruses.Libby Richards, Associate Professor of Nursing, Purdue UniversityLicensed 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>
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<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>
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<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>
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<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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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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<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/1745802022-01-17T17:34:19Z2022-01-17T17:34:19ZMyocarditis: COVID-19 is a much bigger risk to the heart than vaccination<figure><img src="https://images.theconversation.com/files/440923/original/file-20220114-19-c1e1zo.jpg?ixlib=rb-1.1.0&rect=91%2C51%2C6244%2C4469&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Myocarditis is an inflammation of the heart muscle most commonly caused by a virus.</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><iframe style="width: 100%; height: 175px; border: none; position: relative; z-index: 1;" allowtransparency="" src="https://narrations.ad-auris.com/widget/the-conversation-canada/myocarditis--covid-19-is-a-much-bigger-risk-to-the-heart-than-vaccination" width="100%" height="400"></iframe>
<p>The <a href="https://doi.org/10.1161/CIRCRESAHA.121.317997">heart has played a central role</a> in COVID-19 since the beginning. Cardiovascular conditions are among the highest risk factors for hospitalization. A significant number of patients hospitalized with SARS-CoV-2 infections have signs of heart damage, and many recover from infection with lasting cardiovascular injury.</p>
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<img alt="" src="https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=600&fit=crop&dpr=1 600w, https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=600&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=600&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=754&fit=crop&dpr=1 754w, https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=754&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=754&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption"></span>
<span class="attribution"><a class="source" href="https://theconversation.com/ca/topics/vaccine-confidence-in-canada-107061">Click here for more articles in our series about vaccine confidence.</a></span>
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<p>It’s not surprising that debates over COVID-19 vaccines frequently centre around issues involving cardiovascular health. The high-profile <a href="https://theathletic.com/news/christian-eriksen-hospital-collapse-euro-2020/Jtev3AXbH8H4/">collapse of Danish soccer player Christian Eriksen in June</a> initiated a myth about the link between <a href="https://www.science20.com/w_glen_pyle/a_false_start_for_sudden_cardiac_death_in_athletes_and_covid19_vaccines-255817">sudden cardiac death and vaccination among athletes</a> that persists several months later. </p>
<p>Perhaps the <a href="https://montrealgazette.com/opinion/columnists/christopher-labos-how-worried-should-we-be-about-myocarditis">most common point of conflict concerning COVID-19 vaccines</a> is the risk of myocarditis following immunization, particularly among young people.</p>
<p>What do the numbers tell us about COVID-19, vaccines and myocarditis?</p>
<h2>What is myocarditis?</h2>
<p>Myocarditis is an inflammation of the heart muscle most commonly caused by a virus like <a href="https://doi.org/10.1038/s41569-020-00435-x">influenza, coxsackie, hepatitis or herpes</a>. Other causes include bacteria, fungi, toxins, chemotherapy and autoimmune conditions.</p>
<p>Some viruses infect heart muscle and cause direct injury to the heart, while others cause heart damage indirectly through the immune system. Activation of the immune system in response to an infection triggers the release of chemicals in the body called <a href="https://www.livescience.com/what-are-cytokines.html">cytokines</a>, which help clear infections. In some cases, the levels of cytokines rise to unusually high levels to produce a “cytokine storm” that causes damage to heart muscle.</p>
<h2>Myocarditis by the numbers</h2>
<figure class="align-center ">
<img alt="A soccer player on the field in a red uniform" src="https://images.theconversation.com/files/440920/original/file-20220114-28-6aopnv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/440920/original/file-20220114-28-6aopnv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/440920/original/file-20220114-28-6aopnv.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/440920/original/file-20220114-28-6aopnv.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/440920/original/file-20220114-28-6aopnv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/440920/original/file-20220114-28-6aopnv.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/440920/original/file-20220114-28-6aopnv.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">Soccer player Alphonso Davies, 21, of Canada’s national men’s team, was sidelined by heart inflammation after having COVID-19.</span>
<span class="attribution"><span class="source">(AP Photo/Efrem Lukatsky)</span></span>
</figcaption>
</figure>
<p>Before COVID-19 the incidence of myocarditis was between <a href="https://doi.org/10.1016/j.jacc.2016.09.937">one and 10 cases per 100,000 people per year</a>. Rates are highest in males between 18 and 30 years old. Interestingly, most cases of myocarditis in the <a href="https://www.myocarditisfoundation.org/about-myocarditis/">highest risk group are in otherwise healthy and active people</a>. </p>
<p>According to the <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7035e5.htm">U.S. Centers for Disease Control and Prevention</a>, the risk of myocarditis after infection with COVID-19 is much higher, at 146 cases per 100,000. The risk is higher for males, older adults (ages 50+) and children under 16 years old. Soccer player Alphonso Davies, 21, of Canada’s national men’s team, was sidelined by heart inflammation after having COVID-19.</p>
<h2>Post-vaccination myocarditis</h2>
<p>Myocarditis following COVID-19 vaccination is rare and the risk is much smaller than the risks of cardiac injury linked to COVID-19 itself. </p>
<p>Based on <a href="http://doi.org/10.1056/NEJMoa2110737">a study out of Israel</a>, the risk of post-vaccine myocarditis is 2.13 cases per 100,000 vaccinated, which is within the range usually seen in the general population. This study is consistent with others in the United States and Israel which put the <a href="https://doi.org/10.1038/s41569-021-00662-w">overall incidence of post-vaccine myocarditis between 0.3 and five cases per 100,000 people</a>.</p>
<figure class="align-center ">
<img alt="A young person wearing a face mask getting a vaccination" src="https://images.theconversation.com/files/440922/original/file-20220114-22-icdnc7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/440922/original/file-20220114-22-icdnc7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/440922/original/file-20220114-22-icdnc7.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/440922/original/file-20220114-22-icdnc7.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/440922/original/file-20220114-22-icdnc7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/440922/original/file-20220114-22-icdnc7.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/440922/original/file-20220114-22-icdnc7.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">In the rare cases of myocarditis following COVID-19 vaccination, the vast majority are mild and resolve quickly.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<h2>The kids are alright</h2>
<p>The highest incidence of myocarditis after vaccination with mRNA vaccines has occurred within three to four days after the second vaccination in <a href="http://doi.org/10.1056/NEJMoa2109730">males who are under age 30</a>. In <a href="https://doi.org/10.1161/CIRCULATIONAHA.121.056583">pediatric data</a>, the median age is 15.8 years, with most patients being male (90.6 per cent) and white (66.2 per cent) or Hispanic (20.9 per cent). Reliable data on booster shots in this age group is not yet available.</p>
<p>Most studies show a clear benefit of COVID-19 mRNA vaccination with respect to myocarditis. Only <a href="https://doi.org/10.1038/s41591-021-01630-0">one study by Martina Patone, from the University of Oxford, and colleagues</a> found more ambiguous results for those under 40 years of age based on myocarditis rates alone. However, if considering the other ill effects of infection with SARS-CoV-2 — both cardiac and not — there was still a strong benefit in immunizing younger people with COVID-19 vaccines other than Moderna, <a href="https://doi.org/10.1136/bmj-2021-068665">which research suggests has a higher risk for myocarditis than Pfizer’s vaccine</a>.</p>
<h2>Repairing the damage</h2>
<p>The <a href="https://doi.org/10.1161/CIRCRESAHA.118.313578">treatment for myocarditis</a> varies depending on its severity. Adults with mild forms of myocarditis typically need only rest and non-steroidal anti-inflammatory drugs (NSAIDS) like ibuprofen. More severe cases require medications or even mechanical circulatory supports like left ventricular assist devices to support heart function. In some cases when treatment is no longer effective, a heart transplant is required.</p>
<p>In a <a href="https://doi.org/10.1161/CIRCULATIONAHA.121.056583">multicentre series of patients under 21 years old</a>, those with mild symptoms received only NSAIDs or no anti-inflammatory therapy at all. Patients with more severe symptoms can receive stronger therapies including intravenous immunoglobulin, glucocorticoids or colchicine in addition to NSAIDs.</p>
<h2>How serious is it?</h2>
<figure class="align-right ">
<img alt="Illustration of a heart" src="https://images.theconversation.com/files/440924/original/file-20220114-28-2c4vs6.png?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/440924/original/file-20220114-28-2c4vs6.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=720&fit=crop&dpr=1 600w, https://images.theconversation.com/files/440924/original/file-20220114-28-2c4vs6.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=720&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/440924/original/file-20220114-28-2c4vs6.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=720&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/440924/original/file-20220114-28-2c4vs6.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=905&fit=crop&dpr=1 754w, https://images.theconversation.com/files/440924/original/file-20220114-28-2c4vs6.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=905&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/440924/original/file-20220114-28-2c4vs6.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=905&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Adults who develop myocarditis from COVID-19 have poorer outcomes than non-myocarditis COVID-19 cases, including a higher risk of death.</span>
<span class="attribution"><span class="source">(Pixabay)</span></span>
</figcaption>
</figure>
<p>Over 80 per cent of <a href="https://doi.org/10.1161/JAHA.119.015351">myocarditis cases</a> not related to COVID-19 or COVID-19 vaccination resolve spontaneously, while five per cent of patients die or require a heart transplant within one year of diagnosis. </p>
<p>Adults who develop <a href="https://doi.org/10.1111/eci.13679">myocarditis from COVID-19 have poorer outcomes</a> than non-myocarditis COVID-19 cases, including a higher risk of death. It should be noted that myocarditis associated with SARS-CoV-2 infection is just one of several heart conditions linked to COVID-19 with outcomes that are worse than non-COVID-19 cases.</p>
<p>In cases of myocarditis following COVID-19 vaccination, the vast majority of cases are mild and resolve quickly. In adults, <a href="http://doi.org/10.1056/NEJMoa2109730">95 per cent of cases were deemed to be mild</a>. Similarly, in children, <a href="https://doi.org/10.1161/CIRCULATIONAHA.121.056583">98.6 per cent are mild</a>, and there has not been any reported need for mechanical heart support (extracorporeal membrane oxygenation, when blood is pumped outside the body to a heart-lung machine) or deaths. All children who had heart weakness had complete normalization of their heart function on followup.</p>
<h2>Take-home message</h2>
<p>The dynamic changes in the global pandemic, combined with rapid developments in research, make it challenging for the public to take in all the information about the risks and benefits of COVID-19 vaccines. In cases like this it is useful to turn to the guidance of medical organizations whose mandates are to protect the health and welfare of society. </p>
<p>Considering all of the available research, organizations including the <a href="https://www.heart.org/en/coronavirus/coronavirus-questions/questions-about-covid-19-vaccination">American Heart Association</a>, <a href="https://ccs.ca/app/uploads/2021/05/CCS_Vaccine_Info_May2021_v2.pdf">Canadian Cardiovascular Society</a>, <a href="https://www.heartandstroke.ca/how-you-can-help/advocate/covid19-vaccines-what-we-are-doing">Heart and Stroke Foundation of Canada</a>, <a href="https://cps.ca/en/documents/position/covid-19-vaccine-for-children">Canadian Paediatric Society</a> and the <a href="https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-vaccination-trends/">American Academy of Pediatrics</a> encourage all who are eligible to be vaccinated against COVID-19.</p>
<p>That’s a message we should all take to heart.</p>
<p><em>This is an updated version of a story originally published on Jan. 17, 2022. It clarifies that a study found patients with myocarditis from COVID-19 had poorer outcomes compared to COVID-19 patients who did not develop myocarditis.</em></p>
<p><em>Do you have a question about COVID-19 vaccines? Email us at <a href="mailto:ca-vaccination@theconversation.com">ca-vaccination@theconversation.com</a> and vaccine experts will answer questions in upcoming articles.</em></p><img src="https://counter.theconversation.com/content/174580/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Glen Pyle receives funding from the Canadian Institutes of Health Research, the Heart and Stroke Foundation of Canada, and the Natural Sciences and Engineering Research Council of Canada. He is the co-lead for COVID-19 Resources Canada "Science Explained", a member of Science Up First, and is part of the advisory council for Royal City Science.</span></em></p><p class="fine-print"><em><span>Jennifer H. Huang 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>Myocarditis following COVID-19 vaccination is rare, and the risk is much smaller than the risks of cardiac injury linked to COVID-19 itself.Glen Pyle, Professor, Laboratory of Molecular Cardiology, University of GuelphJennifer H. Huang, Associate Professor of Pediatric Cardiology, Oregon Health & Science UniversityLicensed 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>
<hr>
<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">
<figcaption>
<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>
</figcaption>
</figure>
<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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<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>
</strong>
</em>
</p>
<hr>
<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">
<figcaption>
<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>
</figcaption>
</figure>
<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>
</strong>
</em>
</p>
<hr>
<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>
<figure class="align-center ">
<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">
<figcaption>
<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>
</figcaption>
</figure>
<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/1644552021-07-19T12:11:41Z2021-07-19T12:11:41ZNew COVID-19 vaccine warnings don’t mean it’s unsafe – they mean the system to report side effects is working<figure><img src="https://images.theconversation.com/files/411706/original/file-20210716-21-lunh2y.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C5000%2C3366&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Put into context, the benefits of vaccination still far outweigh the risks of rare adverse events.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/illustration/vaccine-vial-over-squared-board-with-its-royalty-free-illustration/1263990592">PenWin/iStock via Getty Images Plus</a></span></figcaption></figure><p>While the COVID-19 vaccines currently available in the U.S. have been <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html">proved to be safe and effective</a>, recent reports of rare <a href="https://www.cancer.gov/publications/dictionaries/cancer-terms/def/adverse-event">adverse events</a>, or side effects, have raised concerns. On July 12, 2021, the Food and Drug Administration approved an update to the Johnson & Johnson COVID-19 vaccine <a href="https://www.fda.gov/media/150723/download">fact sheet</a> to include an increased risk of the rare nerve condition <a href="https://www.cdc.gov/campylobacter/guillain-barre.html">Guillain-Barré syndrome</a>. This follows previous reports linking the J&J vaccine with a <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/JJUpdate.html">rare blood clot</a>. </p>
<p>While reports like these can be scary, they’re a sign that the vaccine safety reporting system is working. They also highlight how the relative risks of rare side effects like these need to be put into context.</p>
<p>As a pharmacist who has been managing operations for the University of Virginia Health System’s COVID-19 vaccine program for the past seven months, I’ve seen how uncertainty and fear over potential side effects can drive vaccine hesitancy. Understanding how information about adverse events is collected and what it means for vaccine safety may help people make informed decisions about their health.</p>
<h2>Tracking safety before, during and after approval</h2>
<p>The FDA enforces rigorous testing and approval processes that manufacturers must follow before a new vaccine can be made available to the public. Regardless of whether a vaccine is approved through the <a href="https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/vaccine-development-101">typical FDA approval process</a> or an <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization">Emergency Use Authorization (EUA)</a>, the steps required to test a new drug for safety and effectiveness are the same. An EUA can get a vaccine to the public more quickly by <a href="https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained">streamlining the regulatory process</a>, but no shortcuts are taken. Every step is taken to ensure the vaccine is both safe and effective.</p>
<p>Vaccine clinical trials occur in <a href="https://www.fda.gov/patients/drug-development-process/step-3-clinical-research">four sequential phases</a>. In the first three phases, study investigators are the ones who identify, quantify and document safety issues. Phase 1 typically introduces the vaccine to fewer than 100 people over several months under controlled conditions. Typically, the majority of potential adverse events are identified in this stage. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/411711/original/file-20210716-19-ggc6p6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="People getting vaccinated at various vaccine stations in a clinic." src="https://images.theconversation.com/files/411711/original/file-20210716-19-ggc6p6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/411711/original/file-20210716-19-ggc6p6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=347&fit=crop&dpr=1 600w, https://images.theconversation.com/files/411711/original/file-20210716-19-ggc6p6.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=347&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/411711/original/file-20210716-19-ggc6p6.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=347&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/411711/original/file-20210716-19-ggc6p6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=436&fit=crop&dpr=1 754w, https://images.theconversation.com/files/411711/original/file-20210716-19-ggc6p6.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=436&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/411711/original/file-20210716-19-ggc6p6.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=436&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Everyday people can contribute to vaccine safety monitoring even after it is approved by the FDA.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/people-get-vaccinated-at-a-vaccination-clinic-at-save-max-news-photo/1233919589">Xinhua News Agency via Getty Images</a></span>
</figcaption>
</figure>
<p>After the FDA reviews phase 1 data and deems the vaccine safe enough to be studied further, the vaccine moves on to phases 2 and 3, where it will be given to larger numbers of people over longer periods of time. Here, investigators determine optimal dosage and screen for rare side effects. </p>
<p>If phase 2 and 3 data meets FDA approval standards, the vaccine will then move on to phase 4 and become available to the public. The vaccine is observed over much larger populations and extended periods of time, and manufacturers are required to regularly check and report potential safety concerns to the FDA.</p>
<p>What’s different about this final phase is that the public can also contribute to safety reporting. The <a href="https://vaers.hhs.gov/about.html">Vaccine Adverse Event Reporting System (VAERS)</a> is a national safety monitoring system run by the FDA and Centers for Disease Control and Prevention. While certain types of adverse events, such as injuries during vaccine administration and serious complications, are <a href="https://vaers.hhs.gov/docs/VAERS_Table_of_Reportable_Events_Following_Vaccination.pdf">mandatory for health care providers to report</a>, anyone can submit a report. Recent adverse events associated with the COVID-19 vaccine, including <a href="https://theconversation.com/rare-neurological-disorder-guillain-barre-syndrome-linked-to-covid-19-141511">Guillain-Barré</a> and thrombosis for Johnson & Johnson and <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-june-25-2021">myocarditis</a> for Pfizer, were identified through VAERS.</p>
<h2>Serious adverse event risk from vaccines is small</h2>
<p>A rare adverse event may take months or years to identify for a simple reason: It’s rare. For some drugs that are less commonly used, new safety data takes longer to discover because a relatively small number of patients use the drug. For example, though the shingles vaccine Shingrix was approved 2017, it wasn’t until <a href="https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-requires-warning-about-guillain-barre-syndrome-gbs-be-included-prescribing-information-shingrix">March 2021</a> after over 3.7 million patients had gotten the shot that the FDA announced a potential increased risk of Guillain-Barré. And it still hasn’t been confirmed that the Shringrix vaccine causes the nerve condition.</p>
<p>For cases like the COVID-19 vaccine, however, millions of people will receive the drug shortly after it’s released to the public, and new issues or patterns often emerge more quickly. </p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/zBkVCpbNnkU?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Adverse events that occur closely following vaccination may not be caused by or even related to the vaccine.</span></figcaption>
</figure>
<p>This can lead to two problems.</p>
<p>First, <a href="https://doi.org/10.1038/d41586-021-00880-9">not every reported adverse event is directly related to the vaccine</a>. For example, many of the tens of millions of people who have received the Pfizer vaccine have likely experienced a sunburn. People might report that they experienced a sunburn to VAERS, but the vaccine has no effect on your skin’s ability to protect against the sun. <a href="https://vaers.hhs.gov/about.html">VAERS is very clear</a> that it “is not designed to determine if a vaccine caused a health problem, but is especially useful for detecting unusual or unexpected patterns of adverse event reporting.” Correlation does not imply causation.</p>
<p>Second, a plausibly identified adverse event does not necessarily make the vaccine unsafe. According to CDC, there have been <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-july-13-2021">100 preliminary reports</a> of Guillain–Barré out of 12.5 million J&J doses, or 0.0008% of people who received the vaccine. Administering one vaccine to a huge sample of people can make it easier to identify a possible connection between the shot and a side effect. But that doesn’t mean the risk of getting that side effect is very likely, or that it outweighs the benefit of getting vaccinated.</p>
<p>These risks, while real and potentially life-threatening, must be viewed in context with the much larger risk of negative outcomes from the diseases vaccines protect people from. For example, <a href="https://doi.org/10.2165/00002018-200022060-00003">1%-7% of patients</a> who take cholesterol drugs called statins are likely to experience potentially harmful muscle injury. However, these drugs are still taken by millions of people because they are highly effective at <a href="https://doi.org/10.1002/14651858.CD004816.pub4">preventing heart disease and stroke</a>. And in the case of Guillain–Barré, about <a href="https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Guillain-Barr%C3%A9-Syndrome-Fact-Sheet">one in 100,000</a> people, or 0.001%, develop this condition yearly in the U.S. from any cause. By comparison, the U.S. has had more than <a href="https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days">33 million cases of COVID-19, and over 600,000 deaths</a> caused by this disease.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/411712/original/file-20210716-15-kgvj71.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Close-up of three Johnson & Johnson vaccine vials." src="https://images.theconversation.com/files/411712/original/file-20210716-15-kgvj71.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/411712/original/file-20210716-15-kgvj71.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=395&fit=crop&dpr=1 600w, https://images.theconversation.com/files/411712/original/file-20210716-15-kgvj71.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=395&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/411712/original/file-20210716-15-kgvj71.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=395&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/411712/original/file-20210716-15-kgvj71.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=497&fit=crop&dpr=1 754w, https://images.theconversation.com/files/411712/original/file-20210716-15-kgvj71.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=497&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/411712/original/file-20210716-15-kgvj71.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=497&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">While the Johnson & Johnson vaccine has been linked to a possible increased risk of certain rare adverse events, the vaccine is still safe to use.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/this-picture-taken-on-april-24-shows-vials-of-the-single-news-photo/1232493543">Ramon Van Flymen/AFP via Getty Images</a></span>
</figcaption>
</figure>
<h2>COVID-19 is a bigger risk than vaccine side effects</h2>
<p>In such extraordinary times as during a pandemic, it’s understandable that people may be hesitant to take on any more risk than they have to. But there are safety nets in place to monitor the COVID-19 vaccines, and they are still working as they should.</p>
<p>The COVID-19 vaccines are proven to be overwhelmingly safe for most people. <a href="https://clinicaltrials.gov/ct2/show/record/NCT04505722">More than 40,000</a> patients participated in J&J’s clinical trials before the company applied for emergency use authorization, mirroring <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine">Pfizer’s</a> and <a href="https://www.modernatx.com/covid19vaccine-eua/providers/clinical-trial-data">Moderna’s</a> study sample sizes. Some <a href="https://doi.org/10.1056/NEJMoa2101544">0.4% of participants</a> in the J&J trial experienced serious adverse events unrelated to COVID-19 infection. In contrast, the trial demonstrated that people who get the vaccine are <a href="https://doi.org/10.1056/NEJMoa2101544">85% less likely to get severe COVID-19</a> than those who remain unvaccinated.</p>
<p>The extremely rare side effects associated with the COVID-19 vaccines were discovered because safety reporting tools were used appropriately. Being aware of the risks of a treatment, however rare, can help people make health decisions that work best for them. However, these risks must be viewed in context. And in the case of the COVID-19 vaccines, they must be weighed against the consequences of remaining unvaccinated and letting the pandemic rage on.</p>
<p><em>Article updated to correct a typo in the percentage of Guillain-Barré cases identified among recipients of Johnson & Johnson COVID-19 vaccine.</em></p>
<p>[<em><a href="https://theconversation.com/us/newsletters/science-editors-picks-71/?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=science-corona-important">The Conversation’s most important coronavirus headlines, weekly in a science newsletter</a></em>]</p><img src="https://counter.theconversation.com/content/164455/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Justin Vesser does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Ongoing tracking is meant to spot very rare risks – like the connection between the Johnson & Johnson shot and Guillain-Barré syndrome. And it relies on public reporting.Justin Vesser, Manager of Ambulatory Pharmacy Services, University of VirginiaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1634222021-07-14T06:50:19Z2021-07-14T06:50:19ZAstraZeneca advice has just changed (again). Here’s what you need to know if you’re in lockdown<p>Sydney’s COVID outbreak has just prompted official advice on the AstraZeneca vaccine <a href="https://www.abc.net.au/news/2021-07-13/astrazeneca-covid-19-atagi-advice-sydney-outbreak-second-dose/100286392">to change</a> to encourage more people to get fully vaccinated sooner.</p>
<p>Now, the Australian Technical Advisory Group on Immunisation (ATAGI) <a href="https://www.health.gov.au/news/atagi-statement-on-use-of-covid-19-vaccines-in-an-outbreak-setting">recommends</a> people in outbreak areas have their booster shot at 4-8 weeks after their initial dose rather than wait for 12 weeks. ATAGI now also advises people in outbreak areas under 60 to “re-assess the benefits to them and their contacts” from getting an AstraZeneca vaccine now if the Pfizer vaccine is not available.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1415088334599249923"}"></div></p>
<p>Advice for people outside outbreak areas remains unchanged.</p>
<p>Here’s how to make sense of the latest advice if you’re in an outbreak area.</p>
<h2>The situation has changed</h2>
<p>Getting vaccinated, like taking any medication, is a case of balancing the risks against the benefits. And clearly, when there’s a COVID outbreak such as Sydney’s, the potential benefit of vaccination just increased.</p>
<p>We know two doses of AstraZeneca vaccine (or the Pfizer vaccine) are really good <a href="https://www.gov.uk/government/news/vaccines-highly-effective-against-hospitalisation-from-delta-variant">at preventing you</a> <a href="https://www.bmj.com/content/373/bmj.n1088">from serious disease and hospitalisation</a>. There’s growing evidence COVID vaccines also <a href="https://theconversation.com/mounting-evidence-suggests-covid-vaccines-do-reduce-transmission-how-does-this-work-160437">reduce your chance</a> of infecting others. And we know <a href="https://theconversation.com/should-i-get-my-second-astrazeneca-dose-yes-it-almost-doubles-your-protection-against-delta-163259">two doses are needed</a> to improve your protection from <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01358-1/fulltext">the Delta variant</a>, which is currently circulating in NSW.</p>
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<em>
<strong>
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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<p>Now let’s turn to the AstraZeneca vaccine. In parts of Australia with low rates of (or no) community transmission, the advice remains to wait 12 weeks after your initial dose for your booster shot. This is the <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00432-3/fulltext">time needed</a> for your body to mount the best immune response.</p>
<p>However, as case numbers in Sydney have climbed, we’ve had calls from Prime Minister <a href="https://www.abc.net.au/news/2021-07-08/scott-morrison-covid-vaccine-nsw-outbreak/100277466">Scott Morrison</a>, NSW Chief Health Officer <a href="https://www.theguardian.com/australia-news/2021/jul/11/nsw-urges-people-to-bring-forward-second-astrazeneca-dose-to-six-weeks-from-first">Kerry Chant</a> and Australia’s Chief Medical Officer <a href="https://www.theage.com.au/national/nsw/sydneysiders-encouraged-to-bring-forward-second-astrazeneca-dose-20210711-p588ot.html">Paul Kelly</a> for people in outbreak areas to bring forward their AstraZeneca booster shots. Now ATAGI joins them.</p>
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<h2>Will I be protected if I go early?</h2>
<p>Leaving less than 12 weeks between your first and second doses of AstraZeneca is a trade-off. There is slightly lower vaccine effectiveness against serious disease compared to if you’d waited for the full 12 weeks, but you will have some protection. In an outbreak, some reasonable protection now may be better than remaining unprotected while hanging out for greater immunity later.</p>
<p>The difficulty is pinning down exactly how much the vaccine’s efficacy drops by going early. The only figures we have that chart the different lengths of time between AstraZeneca shots and the corresponding levels of vaccine efficacy come from earlier variants of the virus (before Delta). We don’t actually have the figures as they relate to the Delta variant, circulating in NSW right now. </p>
<p>With that caveat in mind, here’s the <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00432-3/fulltext">best data</a> we have about how different gaps between first and second dose of AstraZeneca affect its efficacy. It’s the <a href="https://www.health.gov.au/news/atagi-statement-on-use-of-covid-19-vaccines-in-an-outbreak-setting">same data ATAGI has cited</a> to explain its latest advice.</p>
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<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/411183/original/file-20210714-25-13xx8xw.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/411183/original/file-20210714-25-13xx8xw.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=508&fit=crop&dpr=1 600w, https://images.theconversation.com/files/411183/original/file-20210714-25-13xx8xw.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=508&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/411183/original/file-20210714-25-13xx8xw.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=508&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/411183/original/file-20210714-25-13xx8xw.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=639&fit=crop&dpr=1 754w, https://images.theconversation.com/files/411183/original/file-20210714-25-13xx8xw.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=639&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/411183/original/file-20210714-25-13xx8xw.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=639&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.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00432-3/fulltext">The Lancet</a>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
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<p>If you’ve decided to go early with your booster shot, don’t worry if you can’t book an earlier appointment than 12 weeks. Your first shot has already started you on the protective road.</p>
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Read more:
<a href="https://theconversation.com/should-i-have-my-astrazeneca-booster-shot-at-8-weeks-rather-than-12-heres-the-evidence-so-you-can-decide-164164">Should I have my AstraZeneca booster shot at 8 weeks rather than 12? Here's the evidence so you can decide</a>
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<h2>What if I’m under 60?</h2>
<p>Earlier advice was for Pfizer to be the preferred vaccine for people under 60. This was due to an increased risk of the <a href="https://www.health.gov.au/resources/publications/patient-information-sheet-on-astrazeneca-covid-19-vaccine-and-thrombosis-with-thrombocytopenia-syndrome-tts">rare blood clot syndrome</a> known as TTS (thrombosis with thrombocytopenia syndrome) associated with the AstraZenenca vaccine in this age group. This advice is still current for most parts of Australia.</p>
<p>But in outbreak areas, ATAGI <a href="https://www.health.gov.au/news/atagi-statement-on-use-of-covid-19-vaccines-in-an-outbreak-setting">now advises</a> people under 60 to consider having the AstraZeneca shot now, if the Pfizer vaccine is not available. Again, in an outbreak, starting on your road to becoming fully vaccinated may be better than hanging on for a Pfizer shot, which may not arrive for a few months.</p>
<p>Yes, people under 60 are <a href="https://www.health.gov.au/resources/publications/patient-information-sheet-on-astrazeneca-covid-19-vaccine-and-thrombosis-with-thrombocytopenia-syndrome-tts">at increased risk</a> of those rare clots compared to older age groups. But the risks are still small, and you should balance that with the potential benefits of vaccination during an outbreak.</p>
<p><a href="https://www.health.gov.au/news/atagi-update-following-weekly-covid-19-meeting-7-july-2021">Risk estimates of TTS</a> are updated regularly as new cases are reported. The latest figures show if you’re under 60, your risk of TTS is 2.6 per 100,000 doses. If you’re aged 60 or over, the risk is 1.6 per 100,000 doses.</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>Your GP or vaccine provider will also discuss what to look out for should you experience these rare blood clots. If you have <a href="https://www.health.gov.au/resources/publications/patient-information-sheet-on-astrazeneca-covid-19-vaccine-and-thrombosis-with-thrombocytopenia-syndrome-tts">symptoms including</a>: a new severe and persistent headache (appearing a few days after the vaccine or one that does not improve after simple painkillers, and which may be accompanied by nausea and vomiting), abdominal pain, pin-prick bruising or bleeding, chest pain, leg swelling or trouble breathing in the few days to few weeks after the AstraZeneca vaccine, you will need to seek medical advice.</p>
<p>This could be due to the rare clotting syndrome and the earlier it is recognised the earlier it can be treated.</p>
<p>Common side-effects from the AstraZeneca vaccine <a href="http://www.ausvaxsafety.org.au">include</a> headache, muscle aches, fatigue, fever and pain or redness at the injection site. These usually start in the first 24-48 hours after vaccination and may last a few days. You can manage these with over-the-counter medicines for fever and pain, such as paracetamol. </p>
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<em>
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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>One last thing to think about</h2>
<p>If you are having trouble booking in at your local GP clinic, you can attend one of the NSW mass vaccination hubs, which may be out of your local government area.</p>
<p>Although you are permitted to leave the home for medical care (including vaccination), please only do so if you have <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">no COVID symptoms, however mild</a>.</p>
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<img alt="" src="https://images.theconversation.com/files/409219/original/file-20210701-21135-1tqngqe.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/409219/original/file-20210701-21135-1tqngqe.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=371&fit=crop&dpr=1 600w, https://images.theconversation.com/files/409219/original/file-20210701-21135-1tqngqe.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=371&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/409219/original/file-20210701-21135-1tqngqe.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=371&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/409219/original/file-20210701-21135-1tqngqe.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=466&fit=crop&dpr=1 754w, https://images.theconversation.com/files/409219/original/file-20210701-21135-1tqngqe.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=466&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/409219/original/file-20210701-21135-1tqngqe.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=466&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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<p>The last thing we want to see is people spreading COVID while trying to get vaccinated, with the potentially devastating impact on health-care workers, clinics and the wider community.</p>
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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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<img src="https://counter.theconversation.com/content/163422/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Nicholas Wood receives funding for a Career Development Fellowship from the NHMRC. He is a Churchill Fellow</span></em></p>If you’re in Sydney, the advice is for people to bring forward the timing of their second AstraZeneca shot, and for the under 60s to consider having it if they can’t get hold of Pfizer.Nicholas Wood, Associate Professor, Discipline of Childhood and Adolescent Health, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1637172021-07-01T07:00:41Z2021-07-01T07:00:41ZWhat’s the new COVID vaccine indemnity scheme? Two legal experts explain<figure><img src="https://images.theconversation.com/files/409221/original/file-20210701-20999-1ognx9u.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C4985%2C3315&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Hau Dinh/AP/AAP</span></span></figcaption></figure><p>On Monday night, Prime Minister Scott Morrison announced a new vaccine indemnity scheme.</p>
<p>An indemnity scheme would mean health practitioners who are found liable to pay compensation for any serious adverse events suffered by people receiving COVID vaccines, will have the compensation paid for them by the Commonwealth of Australia.</p>
<p><a href="https://www.abc.net.au/news/2021-07-01/health-experts-politicians-atagi-on-astrazeneca-covid-vaccine/100257946">Morrison also said</a> if people under 60 wish to access to the AstraZeneca vaccine, they can “go and speak to their doctor”.</p>
<p>The media reporting that followed suggests there’s some confusion as to what all this means, for people and health practitioners.</p>
<p>So how does an indemnity scheme work, and does it provide any benefits to people in the very rare event they get a serious adverse reaction to a COVID vaccine?</p>
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<h2>Wait, what was announced?</h2>
<p>Currently, Pfizer is the preferred vaccine for under-60s in Australia.</p>
<p>But the <a href="https://www.pm.gov.au/media/national-cabinet-statement-5">national cabinet media release said</a> “GPs can continue to administer AstraZeneca to Australians under 60 years of age with informed consent”.</p>
<p>The expert panel of immunisation experts which advises the federal government has always said people under 60 can get AstraZeneca if <a href="https://theconversation.com/under-40s-can-ask-their-gp-for-an-astrazeneca-shot-whats-changed-what-are-the-risks-are-there-benefits-163571">the benefits are likely to outweigh the risks</a>, and if they make an informed decision to consent.</p>
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Read more:
<a href="https://theconversation.com/under-40s-can-ask-their-gp-for-an-astrazeneca-shot-whats-changed-what-are-the-risks-are-there-benefits-163571">Under-40s can ask their GP for an AstraZeneca shot. What's changed? What are the risks? Are there benefits?</a>
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<p>The prime minister <a href="https://www.pm.gov.au/media/national-cabinet-statement-5">also said</a> the new COVID-19 vaccine indemnity scheme “will provide confidence to medical practitioners to administer both AstraZeneca and Pfizer vaccines to Australians”.</p>
<p>The proposed indemnity scheme is designed to support health practitioners, and reduce real or perceived barriers to them administering the AstraZeneca vaccine to under-60s.</p>
<p>However most, if not all, relevant health practitioners already have indemnity insurance in place, either through private medical indemnity insurers or through their employers.</p>
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<p>The proposed new vaccine indemnity scheme therefore appears to shift exposure to claims for compensation from the existing insurers to the Commonwealth of Australia. It’s unlikely to prohibit health practitioners being sued, for example, for negligent advice in relation to the risks and benefits of a particular vaccine.</p>
<p>It’s also worth noting this doesn’t just apply to GPs, but other health practitioners too, such as nurses.</p>
<h2>What does the new vaccine indemnity <em>not</em> do?</h2>
<p>The new vaccine indemnity doesn’t provide automatic access to the AstraZeneca vaccine for anyone who simply asks for it.</p>
<p>A health practitioner will use their professional judgement as to whether the AstraZeneca vaccine is suitable for a particular patient.</p>
<p>Some patients may have pre-existing conditions which make them unsuitable, and in those circumstances a health practitioner may well refuse to provide that vaccine.</p>
<p>It’s also worth noting individual health-care practitioners aren’t protected from facing complaints or disciplinary action if they engage in any unsatisfactory professional conduct. Perhaps seriously inappropriate advice or treatment could give rise to disciplinary action.</p>
<h2>Are there new benefits for you?</h2>
<p>Australia doesn’t have a no-fault vaccine injury compensation scheme or bespoke COVID-19 vaccine compensation scheme. Countries such as the <a href="https://www.nejm.org/doi/full/10.1056/NEJMp2034438?query=TOC&ssotoken=">United States</a> and <a href="https://urldefense.com/v3/__https:/ssrn.com/abstract=3654197__;!!NVzLfOphnbDXSw!X0qc2wPTG1R8iaFCWaJdSajYK_oY1JVYBzMGrTH41rNw-naNqBoHaBWljLtDxU-_xrmD$">United Kingdom</a> do have such schemes, even if they are perhaps imperfect.</p>
<p>In these countries and some others, in the very rare instance you have a really bad reaction to a COVID vaccine and, for example suffer a prolonged or permanent disability, you can access compensation.</p>
<p>Some media reports interpreted Australia’s new vaccine indemnity announcement as including such a “no-fault” injury compensation scheme to compensate Australian patients who suffer adverse reactions to COVID-19 vaccines.</p>
<p>Adding to the confusion was that on Tuesday federal Chief Medical Officer Paul Kelly <a href="https://www.phaa.net.au/documents/item/5234">mentioned</a> such a scheme was coming.</p>
<p>Details of the proposed indemnity scheme <a href="https://www.theaustralian.com.au/nation/politics/criticism-grows-over-nofault-covid-compensation-pledge/news-story/17ea3e46153cee87b4c1c3ff2b99078e">have not been released</a>. But the prime minister’s announcement made no direct reference to no-fault compensation.</p>
<p>Without a special vaccine compensation scheme, patients may only get compensation if a health practitioner fails to exercise reasonable care or acts in breach of Australian Consumer Law. Sometimes actions against vaccine manufacturers are also possible.</p>
<p>One exception might be an injury flowing from a vaccination related to someone’s employment. </p>
<p>In other words, compensation almost always requires fault on the part of the health practitioner or the vaccine manufacturer.</p>
<h2>Could I get compensation without a vaccine injury compensation scheme in place?</h2>
<p>There are existing pathways for people to obtain financial assistance when there’s been no fault on the part of the health practitioner advising or administering a vaccine.</p>
<p>Subject to meeting eligibility requirements, people may obtain sickness benefits from Centrelink, or in cases of persisting disability, a disability support person.</p>
<p>Financial supports under the National Disability Insurance Scheme are also available, but only for people under 65 who suffer significant permanent disabilities.</p>
<p>In the very rare event a vaccine causes someone to die, accessing assistance for their dependants is somewhat more complex.</p>
<h2>What should happen next?</h2>
<p>The new vaccine indemnity may encourage health practitioners to provide the AstraZeneca vaccine more broadly, by reducing financial risks to them and their insurers.</p>
<p>Most people seeking vaccination will be purely motivated by the health benefits. But some people might like the idea of being compensated in the very rare instance something goes badly wrong. One group of researchers from the UK <a href="https://www.biicl.org/documents/10510_briefing_note_for_cv-19_vaccine_acceptability_-_11_nov_20_-_final.pdf">argue</a> that a better financial safety net for patients would encourage more people to seek vaccination, more quickly. Whether this will happen in Australia is a question the national cabinet could consider. </p>
<p>We will know more when the details of the new vaccine indemnity scheme are released. It seems unlikely at this stage but perhaps we’ll be pleasantly surprised by the inclusion of a benefit scheme for anyone who suffers a serious adverse event from a COVID vaccine.</p><img src="https://counter.theconversation.com/content/163717/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Bill Madden is also a lawyer in private practice based in Sydney.</span></em></p><p class="fine-print"><em><span>Tina Cockburn 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>At the moment, the scheme only applies to health practitioners, not patients.Bill Madden, Adjunct Professor, Australian Centre for Health Law Research, School of Law, Queensland University of TechnologyTina Cockburn, Associate Professor, Australian Centre for Health Law Research, Queensland University of TechnologyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1629302021-06-17T09:36:43Z2021-06-17T09:36:43ZAustralians under 60 will no longer receive the AstraZeneca vaccine. So what’s changed?<p>Australians aged under 60 will no longer receive first doses of the AstraZeneca vaccine due to the rare risk of a serious blood clotting disorder among people aged 50 to 59.</p>
<p>The government has accepted the advice of 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">Australian Technical Advisory Group on Immunisation</a> (ATAGI), which recommends those aged under 60 now receive the Pfizer vaccine. It previously recommended Pfizer to those aged under 50. </p>
<p>The change is based on the advisory group’s assessment of the risks of the clotting disorder, called thrombosis and thrombocytopenia syndrome or TTS, versus benefits of the AstraZeneca vaccine in protecting against COVID-19. </p>
<p>While the risk of TTS is still very low overall, it is more common in younger age groups. And younger people are less likely to die or become seriously ill from COVID-19. </p>
<h2>What is the clotting disorder and how common is it?</h2>
<p>Thrombosis with thrombocytopenia syndrome (<a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/learn-about-covid-19-vaccines/about-the-astrazeneca-covid-19-vaccine#thrombosis-with-thrombocytopenia-syndrome-tts">TTS</a>) is a rare clotting problem that can occur after vaccination with the AstraZeneca vaccine. </p>
<p>We don’t fully understand why TTS occurs, but we know it’s caused by an overactive immune response. This is a very different mechanism to clots people might get after travelling or being immobile for lengthy periods.</p>
<p>The condition involves blood clots as well as a depletion in blood clotting cells known as platelets. The clots associated with TTS can appear in parts of the body where we don’t normally see blood clots, like the brain or the abdomen.</p>
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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>In Australia we have <a href="https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report-17-06-2021">now seen 60 cases of TTS</a>, with 37 confirmed and 23 probable. </p>
<p>Of the 12 recent cases, seven occurred in people aged between 50 and 59. </p>
<p>Sadly, two people have died. </p>
<p>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">risk of TTS</a> reduces with age. For people aged under 50, there are 3.1 cases of TTS per 100,000 doses. This reduces to 1.9 cases for those aged 80 and above:</p>
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<a href="https://images.theconversation.com/files/406949/original/file-20210617-13-mnr6mj.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/406949/original/file-20210617-13-mnr6mj.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/406949/original/file-20210617-13-mnr6mj.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=331&fit=crop&dpr=1 600w, https://images.theconversation.com/files/406949/original/file-20210617-13-mnr6mj.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=331&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/406949/original/file-20210617-13-mnr6mj.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=331&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/406949/original/file-20210617-13-mnr6mj.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=415&fit=crop&dpr=1 754w, https://images.theconversation.com/files/406949/original/file-20210617-13-mnr6mj.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=415&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/406949/original/file-20210617-13-mnr6mj.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=415&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<p>As awareness of TTS grows, clinicians’ ability to detect and diagnose the condition has also improved. This means the risk of becoming severely ill and dying from this condition has fallen dramatically. </p>
<h2>How does this compare to the chance of dying from COVID-19?</h2>
<p>Globally, <a href="https://www.worldometers.info/coronavirus/">177 million cases</a> of COVID-19 have been reported, with around 3.83 million deaths, or just over 2%. </p>
<p>The risk of dying from COVID-19 increases with age. The rates depend on the country you live in and your sex. <a href="https://www.worldometers.info/coronavirus/coronavirus-age-sex-demographics/">In China</a>, for instance, the death rate was reportedly:</p>
<ul>
<li>for under-50s, less than 1%</li>
<li>50 to 59 years, 1.3%</li>
<li>60 to 69 years, 3.6%</li>
<li>70 to 79 years, 8%</li>
<li>80 and above, 14.8%. </li>
</ul>
<p>In terms of data from Australia, in 2020, <a href="https://www.health.gov.au/news/atagi-statement-on-revised-recommendations-on-the-use-of-covid-19-vaccine-astrazeneca-17-june-2021">for every 600 people</a> with COVID-19 aged in their 50s, one person died and 18 required admission to a hospital intensive care unit (ICU). </p>
<p>For every 600 people aged in their 70s with COVID-19, 24 died and 42 were admitted to ICU. </p>
<p>So the benefits of vaccination to prevent severe COVID-19 are greater among older age groups. </p>
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<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 if you’ve already had one dose?</h2>
<p>If you’re aged 50 to 59 and have already had one dose, and didn’t have a significant reaction, the advice is for you to return for your second dose. </p>
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<p>Relatively few Australians have received a second dose of the AstraZeneca vaccine. But <a href="https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report-17-06-2021#section-518">data from the United Kingdom</a> shows TTS appears much less commonly after second doses – 1.5 cases per million doses. </p>
<p>If you have concerns about the risk of TTS, talk to your doctor or vaccine provider.</p>
<p>In the future, as more evidence emerges and is assessed by Australia’s regulators, we may use other vaccines for follow-up doses. But this is not currently the recommendation.</p>
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<em>
<strong>
Read more:
<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>How does the advisory group decide?</h2>
<p>ATAGI is a group of experts that closely monitors vaccines both in Australia and internationally for side effects, as well as how well they are working. </p>
<p>It also considers the amount of disease circulating that the vaccine is designed to protect from. </p>
<p>These factors are considered at the time of initial approval, and then monitored continuously. When some of these factors change, the way we use vaccines also needs to change. </p>
<p>Today’s change demonstrates the strength and robustness of the ongoing surveillance of adverse events of vaccines and our regulators’ commitment to ensure the safety of the community receiving these vaccines.</p>
<p>We’re fortunate to have excellent control of COVID-19 in Australia and low rates of severe disease. We’re also fortunate to have an alternate vaccine in the form of Pfizer, albeit still in relatively short supply. </p>
<p>Out of an abundance of caution and considering all of these and other factors, it makes sense to increase the age cut-off for the use of this vaccine in our country at present. </p>
<p>This may be subject to further changes in the future, in either direction, as the situation around us continues to evolve. </p>
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<em>
<strong>
Read more:
<a href="https://theconversation.com/how-do-we-actually-investigate-rare-covid-19-vaccine-side-effects-160000">How do we actually investigate rare COVID-19 vaccine side-effects?</a>
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<img src="https://counter.theconversation.com/content/162930/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Paul Griffin is part of AstraZeneca's Advisory Board</span></em></p>Experts are continually monitoring how well COVID vaccines are working, their side effects, and the amount of disease in the community. These factors can change, and advice will adapt accordingly.Paul Griffin, Associate Professor, Infectious Diseases and Microbiology, The University of QueenslandLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1616672021-06-08T09:23:55Z2021-06-08T09:23:55ZWhat are the side effects of the Pfizer vaccine? An expert explains<p>As of Tuesday this week, all Australian adults aged 40-49 <a href="https://www.health.gov.au/news/covid-19-vaccines-to-be-available-to-everyone-aged-40-years-and-over">are eligible</a> to receive a COVID-19 vaccine. </p>
<p>Some states and territories had already opened up their rollout to under 50s, including <a href="https://www.abc.net.au/news/2021-05-27/vic.-health-minister-says-people-aged-40-49-can-get-vaccine/13361858">Victoria</a>, which invited 40-49-year-olds to come forward from late May in light of the current outbreak. In the <a href="https://www.sbs.com.au/news/anyone-over-the-age-of-16-can-now-get-the-covid-19-vaccine-in-the-northern-territory">Northern Territory</a>, everyone aged over 16 is now eligible, while in <a href="https://thewest.com.au/news/coronavirus/wa-rolls-out-covid-vaccines-for-over-30s-c-3048192">Western Australia</a> adults over 30 will be eligible from Thursday.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1402103271095930889"}"></div></p>
<p>Most Australians under 50 will receive the Pfizer vaccine, which is <a href="https://www.health.gov.au/news/atagi-statement-on-astrazeneca-vaccine-in-response-to-new-vaccine-safety-concerns">the preferred COVID vaccine</a> for people in this age group. This is based on advice from Australia’s Technical Advisory Group on Immunisation around the risk of rare blood clotting disorders following the AstraZeneca vaccine. </p>
<p>To this point, we’ve been quite fixated on the side effects and small risks associated with the AstraZeneca vaccine. But with many Australians now lining up for the Pfizer shot, let’s take a look at what we know about side effects and rare adverse events after this vaccine.</p>
<h2>We’re monitoring the safety of the Pfizer vaccine in real time</h2>
<p>In Australia <a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/learn-about-covid-19-vaccines/about-the-pfizerbiontech-covid-19-vaccine">the Pfizer vaccine</a> is registered for use in people over 16. Two doses are needed, with a gap of at least three weeks between doses.</p>
<p>This vaccine has now been administered to many millions of people <a href="https://covid.cdc.gov/covid-data-tracker/#vaccinations">around the world</a>. We know a lot about its safety from both clinical trials and safety surveillance programs in the community.</p>
<p><a href="http://www.ausvaxsafety.org.au">AusVaxSafety</a> has been collecting and regularly updating vaccine safety data from Australians who have received a COVID vaccine, either Pfizer or AstraZeneca.</p>
<p>As of May 30, <a href="https://www.ausvaxsafety.org.au/safety-data/covid-19-vaccines">more than 245,000 people</a> had responded to text message or email questionnaires on side effects after their first dose of the Pfizer vaccine, and over 140,000 people had responded after dose two.</p>
<p>Close to two-thirds of people reported no reactions after the first dose, and 40% reported no reactions after the second. </p>
<p>The most common side effects include headache, muscle aches and fatigue, and these are more common after dose two compared to dose one. </p>
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<p>These sorts of side effects are very similar to those reported <a href="https://www.nejm.org/doi/full/10.1056/nejmoa2034577">in clinical trials</a> and what’s been set out in the Pfizer vaccine’s <a href="https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2021-PI-01092-1&d=202106081016933">product information</a>. They occur because our immune system <a href="https://www.who.int/news-room/feature-stories/detail/side-effects-of-covid-19-vaccines">is responding</a> to the vaccine.</p>
<p>Side effects will usually present in the first 24-48 hours after vaccination. We know from AusVaxSafety surveillance and <a href="https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00224-3/fulltext">safety data from overseas</a> they usually last less than two to three days, and nearly everyone who experiences side effects is back to normal one week after vaccination.</p>
<p>You can manage symptoms such as pain or fever with medicines like paracetamol or ibuprofen. But if your symptoms persist or get worse, you should see your GP. </p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/were-gathering-data-on-covid-vaccine-side-effects-in-real-time-heres-what-you-can-expect-158945">We're gathering data on COVID vaccine side effects in real time. Here's what you can expect</a>
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<h2>What about allergic reactions?</h2>
<p>There have been <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7002e1.htm#">reports of anaphylaxis</a> after the Pfizer vaccine. Anaphylaxis is an acute allergic reaction where people experience a rash, lip and tongue swelling, trouble breathing and sometimes shock (low blood pressure and fast heart rate).</p>
<p>Overall it’s estimated anaphylaxis occurs in approximately <a href="https://jamanetwork.com/journals/jama/fullarticle/2776557">five people per million</a> doses of the Pfizer vaccine administered. Anaphylaxis nearly always happens in the first 15 minutes to half hour <a href="https://pubmed.ncbi.nlm.nih.gov/29413255/">after vaccination</a>, which is why people are asked to wait in the clinic after receiving a COVID-19 vaccine. </p>
<p>Anaphylaxis is easily treated (reversed) with an injection of adrenaline by nursing and medical staff at the vaccination centres, and people affected generally make a complete recovery.</p>
<p>If you happen to have had an acute allergic reaction after vaccination, it’s important you tell your doctor before getting a second dose of the same vaccine. You may be referred for a specialist allergy consultation.</p>
<h2>Myocarditis and pericarditis</h2>
<p>Recently there have been reports from overseas, including the <a href="https://www.theguardian.com/world/2021/may/23/cdc-studying-reports-of-heart-inflammation-in-young-covid-vaccine-recipients">United States</a> and <a href="https://www.reuters.com/world/middle-east/israel-sees-probable-link-between-pfizer-vaccine-small-number-myocarditis-cases-2021-06-01/">Israel</a>, of myocarditis (heart inflammation) and pericarditis (inflammation of the lining of the heart) following vaccination with the Pfizer vaccine.</p>
<p>The <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myocarditis.html">US Centres for Disease Control</a> notes these cases have been mostly in younger males (aged 16 years and older), usually appear within several days of vaccination, and are more common after the second dose. </p>
<p>However, no causal link has been formally established. It’s important to note <a href="https://www.nhlbi.nih.gov/health-topics/heart-inflammation">heart inflammation</a> can be caused by many factors. These include infections, particularly from viruses or bacteria; or damage to the heart’s tissue or muscle as a result of autoimmune diseases, medicines, environmental factors, or other triggers, including, rarely, vaccines.</p>
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<em>
<strong>
Read more:
<a href="https://theconversation.com/how-do-we-know-the-covid-vaccine-wont-have-long-term-side-effects-155714">How do we know the COVID vaccine won't have long-term side-effects?</a>
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<p>The COVID-19 subcommittee of the WHO Global Advisory Committee on Vaccine Safety is also reviewing this issue. They have noted that in most of the <a href="https://www.who.int/news/item/26-05-2021-gacvs-myocarditis-reported-with-covid-19-mrna-vaccines">reported cases</a>, the people have recovered.</p>
<p>Australia’s <a href="https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report-03-06-2021">Therapeutic Goods Administration</a>, meanwhile, is continuing to monitor myocarditis and pericarditis as “adverse events of special interest”.</p>
<p>Rigorous studies where we compare the number of myocarditis cases in vaccinated and unvaccinated populations <a href="https://www.who.int/news/item/26-05-2021-gacvs-myocarditis-reported-with-covid-19-mrna-vaccines">are underway</a> in countries such as Israel, the United Kingdom and the United States to assess whether there is any link between myocarditis and the Pfizer vaccine.</p>
<p>But at this stage, there’s no significant cause for concern.</p>
<h2>The benefits outweigh any risks</h2>
<p>Real-world <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00947-8/fulltext">studies</a> are showing the Pfizer vaccine has clear benefits in reducing deaths and hospitalisations due to COVID-19. </p>
<p>As we’re seeing right now in Victoria, community outbreaks continue to pose a significant risk. Our path out of this pandemic relies on a high uptake of vaccines, and use of the highly effective Pfizer vaccine is key.</p><img src="https://counter.theconversation.com/content/161667/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>Australia is now rolling out the Pfizer vaccine to people aged under 50, with the 40-49 age group newly eligible. Here’s what you can expect.Nicholas Wood, Associate Professor, Discipline of Childhood and Adolescent Health, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1609232021-05-14T07:52:55Z2021-05-14T07:52:55ZCould the AstraZeneca vaccine cause Guillain-Barré syndrome? We don’t know yet — but there’s minimal cause for concern<p>The Therapeutic Goods Administration (TGA) <a href="https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report-13-05-2021">yesterday revealed</a> there have been six reports of <a href="https://www.healthline.com/health/guillain-barre-syndrome">Guillain-Barré syndrome</a> in Australia following the AstraZeneca COVID vaccine.</p>
<p>This is an autoimmune disorder, which causes muscle weakness, numbness and tingling. It can be life threatening if it involves the respiratory muscles.</p>
<p>But at this stage, there isn’t cause for serious concern. The six reports are out of <a href="https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report-13-05-2021">1.8 million doses</a> of the AstraZeneca vaccine administered in Australia so far. This means the syndrome has affected about one in 300,000, which is less than the rate at which it occurs in the population normally; in adults, we see about 2–3 cases per 100,000 people every year. </p>
<p>Neither the TGA nor any other country have confirmed there’s a link between the AstraZeneca vaccine and Guillain-Barré syndrome. So these cases may have occurred by chance. At the same time, it is possible there’s a connection.</p>
<h2>What is Guillain-Barré syndrome?</h2>
<p>Guillain-Barré syndrome occurs when the immune system attacks healthy nerve cells. In <a href="https://www.mayoclinic.org/diseases-conditions/guillain-barre-syndrome/symptoms-causes">about two-thirds of cases</a>, it follows a viral or bacterial infection.</p>
<p>The most common infection linked to the syndrome is the bacteria <em><a href="https://www.cdc.gov/campylobacter/guillain-barre.html#:%7E:text=About%20two%2Dthirds%20of%20people,common%20risk%20factors%20for%20GBS.">Campylobacter jejuni</a></em>, which infects the gastrointestinal tract and commonly causes diarrhoea.</p>
<p>We’ve also seen it occur after infection with viruses such as <a href="https://theconversation.com/explainer-what-is-guillain-barre-syndrome-and-is-it-caused-by-the-zika-virus-53884">Zika virus</a> and the human immunodeficiency virus (<a href="https://www.healthline.com/health/guillain-barre-syndrome#causes">HIV</a>). It has been linked to <a href="https://theconversation.com/rare-neurological-disorder-guillain-barre-syndrome-linked-to-covid-19-141511">COVID-19 too</a>, but we don’t have much data on this yet.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/400713/original/file-20210514-19-ni9z8n.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/400713/original/file-20210514-19-ni9z8n.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=338&fit=crop&dpr=1 600w, https://images.theconversation.com/files/400713/original/file-20210514-19-ni9z8n.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=338&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/400713/original/file-20210514-19-ni9z8n.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=338&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/400713/original/file-20210514-19-ni9z8n.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=424&fit=crop&dpr=1 754w, https://images.theconversation.com/files/400713/original/file-20210514-19-ni9z8n.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=424&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/400713/original/file-20210514-19-ni9z8n.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">In people with Guillain-Barré syndrome, the immune system attacks healthy nerve cells.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-illustration/demyelination-neuron-damage-myelin-sheath-seen-1972301618">Shutterstock</a></span>
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<p>The reason for the link between Guillain-Barré syndrome and infections is complex, but essentially scientists believe it’s caused by something called “<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3266166/">molecular mimicry</a>”. </p>
<p>This occurs when the structures on the surface of pathogens resemble (or mimic) structures on your cells. For Guillain-Barré syndrome, this relates to sugar structures (glycans) on the myelin sheath (the insulating covering on neurons that enables them to transmit nerve impulses). </p>
<p>For people with Guillain-Barré syndrome, these sugar structures on their nerve cells appear similar to sugar-containing molecules on the surface of some bacteria or viruses. As a result, antibodies generated to target the infection also attack nerve cells (autoantibodies), destroying the myelin sheath nerves need to conduct signals. This stops muscles from working properly.</p>
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<strong>
Read more:
<a href="https://theconversation.com/explainer-what-is-guillain-barre-syndrome-and-is-it-caused-by-the-zika-virus-53884">Explainer: what is Guillain-Barré syndrome and is it caused by the Zika virus?</a>
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<p>The syndrome can affect different muscles, meaning the weakness can be felt in different places. For example, it might affect speech, breathing or bladder control. </p>
<p>It can be treated with antibodies from healthy donors (immunoglobulin therapy) which inhibits the autoantibodies causing damage. Another option is to filter the autoantibodies out of the blood (plasma exchange). In time, most people will recover with treatment; the condition is very rarely fatal. </p>
<p>The syndrome is more common in people <a href="https://www.webmd.com/brain/what-is-guillain-barre">50 and older</a>, which is a concern as this is the age group receiving the AstraZeneca vaccine in Australia. But it’s still vanishingly rare, and this risk — if indeed there is a link — doesn’t come close to outweighing the benefit of the vaccine for this age group. </p>
<h2>So, how could Guillain-Barré syndrome be linked with the AstraZeneca vaccine?</h2>
<p>Along with the TGA, the <a href="https://www.reuters.com/article/brief-ema-says-assessing-reports-of-guil/brief-ema-says-assessing-reports-of-guillain-barre-syndrome-with-astrazenecas-covid-19-vaccine-idUSFWN2MU167">European Medicines Agency</a> is reportedly assessing reports of Guillain-Barré syndrome in a small number of people who <a href="https://casereports.bmj.com/content/14/4/e242956">have received</a> the AstraZeneca vaccine. </p>
<p>There is a possible explanation — though it’s important to stress that in the absence of empirical evidence, this is currently only speculation. The adenovirus — that’s the viral vector used in the AstraZeneca vaccine — like many viruses, contains proteins linked to sugar structures (glycoproteins). </p>
<p>So one potential mechanism is that some of the antibodies generated against the vector following vaccination recognise these glycoproteins and cross-react with sugar structures on nerve cells. This is similar to the process I described above in terms of how Guillain-Barré syndrome could be linked to infection.</p>
<p>Notably, the blood clots linked to the AstraZeneca vaccine are also thought to be <a href="https://www.sciencemag.org/news/2021/05/what-s-future-vaccines-linked-rare-clotting-disorders-science-breaks-down-latest">an autoimmune driven illness</a>. This has opened up the possibility autoimmune reactions can be triggered by the AstraZeneca vaccine. </p>
<p>Still, the numbers of either event are very low and currently the data is lacking to definitively show that these adverse events are being caused by autoimmunity induced by the adenovirus vector. We need more research.</p>
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Read more:
<a href="https://theconversation.com/how-do-we-actually-investigate-rare-covid-19-vaccine-side-effects-160000">How do we actually investigate rare COVID-19 vaccine side-effects?</a>
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<p>In very rare cases, we’ve seen Guillain-Barré syndrome in the days and weeks after <a href="https://www.cdc.gov/vaccinesafety/concerns/guillain-barre-syndrome.html">flu vaccination</a>.</p>
<p>As the flu vaccine is different from year to year, this only happens sometimes. But when scientists have observed an increased risk, it’s been only 1–2 additional cases per million flu vaccines. You’d be at greater risk of contracting Guillain-Barré syndrome after getting the flu than after getting the flu shot. </p>
<p>The same is very likely to be true of COVID.</p>
<h2>What now?</h2>
<p>The TGA has called Guillain-Barré syndrome an “<a href="https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report-13-05-2021">adverse event of special interest</a>”. This means it’s still not clear if there’s a causal relationship. From here, the TGA will continue to monitor the situation and collate the data as it comes in, until it can get a clearer picture.</p>
<p>But there’s no need to panic, or to feel discouraged from receiving the AstraZeneca vaccine; this remains an important part of Australia’s vaccination strategy. </p>
<p>For those over 50, you’re still <a href="https://www.sciencemag.org/news/2021/05/what-s-future-vaccines-linked-rare-clotting-disorders-science-breaks-down-latest">at much greater risk</a> of any adverse outcomes — Guillain-Barré syndrome, blood clots or otherwise — if you contract COVID-19, than from the vaccine.</p>
<p>The risk of COVID remains significant and for those eligible, the AstraZeneca vaccine remains a sensible option to protect yourself and the wider community.</p>
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<em>
<strong>
Read more:
<a href="https://theconversation.com/rare-neurological-disorder-guillain-barre-syndrome-linked-to-covid-19-141511">Rare neurological disorder, Guillain-Barre Syndrome, linked to COVID-19</a>
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<img src="https://counter.theconversation.com/content/160923/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>The TGA has reported a handful of cases of the autoimmune disorder Guillain-Barré syndrome following the AstraZeneca vaccine.Nathan Bartlett, Associate Professor, School of Biomedical Sciences and Pharmacy, University of NewcastleLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1600002021-05-06T04:52:19Z2021-05-06T04:52:19ZHow do we actually investigate rare COVID-19 vaccine side-effects?<figure><img src="https://images.theconversation.com/files/399109/original/file-20210506-14-wffzox.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C1000%2C666&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/smiling-young-woman-tshirt-showing-plaster-1954104319">from www.shutterstock.com</a></span></figcaption></figure><p>Investigations <a href="https://www.abc.net.au/news/2021-04-29/nsw-two-men-die-after-receiving-covid-19-vaccination/100103076">are under way</a> to determine whether the deaths of two people in New South Wales who developed blood clots are linked to the AstraZeneca vaccine.</p>
<p>We’ve also heard today that <a href="https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report-06-05-2021">11 Australians</a> have so far developed blood clots (thrombosis with thrombocytopenia syndrome) linked with the vaccine.</p>
<p>But what are these investigations? And who decides whether events like these are actually linked to COVID-19 vaccines, or something else?</p>
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<em>
<strong>
Read more:
<a href="https://theconversation.com/im-over-50-and-can-now-get-my-covid-vaccine-is-the-astrazeneca-vaccine-safe-does-it-work-what-else-do-i-need-to-know-159814">I'm over 50 and can now get my COVID vaccine. Is the AstraZeneca vaccine safe? Does it work? What else do I need to know?</a>
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<h2>What triggers the process?</h2>
<p>There is a lot of interest in the safety of COVID-19 vaccines. So the public and health-care workers are “highly tuned in” to reporting suspected side-effects. </p>
<p>Anyone can <a href="https://www.tga.gov.au/covid-19-vaccine-safety-monitoring-and-reporting">report these</a> to Australia’s drug regulator, the Therapeutic Goods Administration (TGA). Alternatively, people who have been vaccinated can do so when prompted with a survey via the <a href="https://www.ausvaxsafety.org.au/">AusVaxSafety</a> system.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1369167449086554116"}"></div></p>
<p>This is a good thing as it means we are likely to pick up any serious or unusual events. Every report is valuable and contributes to our safety monitoring. However, just because an event happened after a vaccine does not mean the vaccine <em>caused</em> it.</p>
<p>A serious event could be caused by an underlying medical condition, a medication the person was taking at the time, or some other factor unrelated to the vaccine. </p>
<p>For example, before COVID-19 and vaccines against it, dozens of people across Australia developed blood clots, in their <a href="https://www.racgp.org.au/download/documents/AFP/2010/July/201007ho.pdf">legs, lungs</a>, <a href="https://www.ahajournals.org/doi/pdf/10.1161/strokeaha.116.013617">brain</a> and other parts of the body, every day, often without warning or clear cause. </p>
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<em>
<strong>
Read more:
<a href="https://theconversation.com/covid-vaccines-have-been-developed-in-record-time-but-how-will-we-know-theyre-safe-153888">COVID vaccines have been developed in record time. But how will we know they're safe?</a>
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<h2>What happens next?</h2>
<p>When a person has a suspected vaccine side-effect it is usually <a href="https://www.tga.gov.au/reporting-adverse-events">reported</a> to the state or territory health department; some reports go directly to the TGA. </p>
<p>Most reactions reported after vaccination are mild to moderate. <a href="https://www.ausvaxsafety.org.au/safety-data/covid-19-vaccines">AusVaxSafety surveys</a> in more than 365,000 people in Australia confirm what we saw in vaccine trials. Up to two-thirds of people experience symptoms such as fever, muscle aches, joint pains and headache within the first one or two days after vaccination, which go away without treatment. This is the immune system responding to the vaccine.</p>
<h2>What if it’s serious?</h2>
<p>If the person dies or had a serious event needing hospitalisation within the days to weeks after vaccination — like the clotting cases you will have heard about, or there was an unusual unexpected event — there are further investigations. </p>
<p>Health department and TGA staff gather as much information as possible about the person, including their medical history, risk factors, any medications they are on, details and timing of the vaccine, hospitalisation records, any laboratory test results and whether they have recovered or have any ongoing issues. This will involve liaising with the person’s GP, specialists and the hospital.</p>
<p>Many states and territories then convene an <a href="https://www.health.nsw.gov.au/Infectious/covid-19/vaccine/Pages/clinicians.aspx">expert panel</a> of doctors to discuss a serious case. These panels often include the treating doctor, discuss the case in detail and may advise extra tests that may help them understand the event. </p>
<p>A full clinical dossier is then provided to the TGA, which then further reviews the case and decides whether a group of independent expert advisors, known as a “vaccine safety investigation group” or VSIG, is needed to review the case in detail and assess if the vaccine caused it.</p>
<p>The VSIG <a href="https://www.tga.gov.au/alert/astrazeneca-chadox1-s-covid-19-vaccine-2">often includes</a> independent medical experts in vaccine safety, infectious diseases, haematology, public health and vaccine confidence, other medical specialists, and a consumer representative.</p>
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<a href="https://images.theconversation.com/files/398804/original/file-20210505-19-1pn14lh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Socially distanced meeting, with videocall" src="https://images.theconversation.com/files/398804/original/file-20210505-19-1pn14lh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/398804/original/file-20210505-19-1pn14lh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/398804/original/file-20210505-19-1pn14lh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/398804/original/file-20210505-19-1pn14lh.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/398804/original/file-20210505-19-1pn14lh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/398804/original/file-20210505-19-1pn14lh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/398804/original/file-20210505-19-1pn14lh.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">An independent panel of advisers meet to review the case in detail and to report to the TGA.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/online-video-conference-social-distancing-webinar-1818069497">from www.shutterstock.com</a></span>
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<p>The group reviews the clinical details of the event. It then uses an <a href="https://www.who.int/vaccine_safety/publications/CausalityAssessmentAEFI_EN.pdf?ua=1">internationally accepted method</a> to rate the level of certainty of a link between the serious event and the vaccine.</p>
<p>First, the group determines if there is enough clinical information to come to a decision, and if not, will request further information from the state/territory health department and may need to reconvene when that information is available.</p>
<p>The group then determines if the case is classified as:</p>
<ul>
<li><p>caused by the immunisation process (such as errors in vaccine technique) or the vaccine itself (the official terminology is “consistent causal association to immunisation”)</p></li>
<li><p>uncertain if the vaccine or immunisation process caused the event (“indeterminate”)</p></li>
<li><p>a coincidence (“inconsistent causal association to immunisation”). This could when because an underlying condition or something other than vaccine was the cause.</p></li>
</ul>
<p>The TGA then <a href="https://www.tga.gov.au/alert/astrazeneca-chadox1-s-covid-19-vaccine-3">publishes</a> the results of this independent assessment on its website. This is accompanied by a summary of the case(s) and extra clinical advice for doctors. The TGA also feeds the results back to the state/territory health department and treating doctor.</p>
<p>This information will also be included in <a href="https://www.tga.gov.au/communicating-covid-19-safety-information">weekly updates</a> published on the TGA website and is reviewed by other key advisory groups, including the <a href="https://www.health.gov.au/committees-and-groups/australian-technical-advisory-group-on-immunisation-atagi">Australian Technical Advisory Group on Immunisation</a> and the government, who monitor the progress of immunisation programs, including for COVID-19. </p>
<h2>Here’s the context</h2>
<p>While such serious vaccine-related events <a href="https://www.abc.net.au/news/2021-04-29/nsw-two-men-die-after-receiving-covid-19-vaccination/100103076">grab the headlines</a>, it’s important to remember they are <a href="https://theconversation.com/what-is-thrombocytopenia-the-rare-blood-condition-possibly-linked-to-the-astrazeneca-vaccine-158522">rare</a>. Most side-effects are mild-to-moderate and short-lived. On the other hand, the <a href="https://www.health.gov.au/resources/publications/covid-19-vaccination-weighing-up-the-potential-benefits-against-risk-of-harm-from-covid-19-vaccine-astrazeneca">benefits of COVID-19 vaccination</a> in ending the pandemic are enormous. </p>
<p>When concerning events occur after vaccination, it’s important to know Australia has strong systems to properly investigate them, look at any possible link and communicate the results to the public.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/a-balancing-act-between-benefits-and-risks-making-sense-of-the-latest-vaccine-news-158634">A balancing act between benefits and risks: making sense of the latest vaccine news</a>
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<img src="https://counter.theconversation.com/content/160000/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><p class="fine-print"><em><span>Kristine Macartney is the Director of the National Centre for Immunisation Research and Surveillance (NCIRS). NCIRS receives funding from the Australian and state governments, the WHO, the Gavi Vaccine Alliance and the NHMRC. She is a member of numerous vaccine advisory groups, including ATAGI, ACV, and an independent expert on the WHO Global Advisory Committee on Vaccine Safety.</span></em></p>A serious event such as a blood clot could be caused by an underlying medical condition, a medication the person was taking at the time, or some other factor unrelated to the vaccine.Nicholas Wood, Associate Professor, Discipline of Childhood and Adolescent Health, University of SydneyKristine Macartney, Professor, Discipline of Paediatrics and Child Health, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1595232021-05-03T18:31:21Z2021-05-03T18:31:21ZWhat are the blood clots associated with the Johnson & Johnson COVID-19 vaccine? 4 questions answered<figure><img src="https://images.theconversation.com/files/396940/original/file-20210425-13-18kjzlj.jpg?ixlib=rb-1.1.0&rect=44%2C94%2C4149%2C2577&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The pause on the Johnson & Johnson vaccine was lifted on April 23, 2021. </span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/johnson-johnson-covid-19-vial-and-box-seen-at-a-vaccination-news-photo/1232239576?adppopup=true"> SOPA Images/Light Rocket via Getty Images</a></span></figcaption></figure><p><em>Two vaccines – the Johnson & Johnson vaccine in the U.S. and the AstraZeneca vaccine in Europe – have been linked to an increased chance of a rare type of blood clot. Researchers are investigating what causes these clots and are starting to propose some answers. <a href="https://scholars.okstate.edu/en/persons/mousumi-som">Dr. Mousumi Som</a>, a professor of medicine at Oklahoma State University, explains what these rare clots are and how they are forming after people get vaccinated.</em></p>
<h2>1. What are the blood clots?</h2>
<p>A small number of people in the U.S. have <a href="https://theconversation.com/johnson-and-johnson-vaccine-suspension-a-doctor-explains-what-this-means-for-you-158923">developed dangerous blood clots</a> after receiving the Johnson & Johnson vaccine. The clots have mostly been occurring in people’s brains and, paradoxically, are <a href="https://www.ama-assn.org/delivering-care/public-health/what-doctors-wish-patients-knew-about-johnson-johnson-vaccine">associated with low platelet counts</a>. </p>
<p>Normally, platelets help a person stop bleeding when they get injured. If you get a cut or have an injury, the body responds by sending platelets which act as a temporary patch. The patch attracts other platelets and they stick together <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5767294/">to stop blood loss</a>. Since platelets normally help the clotting process, this combination of low platelets and extreme clotting makes these clots medically unusual.</p>
<p>These specific types of clots – called cerebral venous sinus thrombosis – although rare, affect around <a href="https://doi.org/10.1161/STROKEAHA.116.013617">two to five people per million per year</a> and are <a href="https://n.neurology.org/content/96/15_Supplement/5143">potentially life-threatening without treatment</a>. Vaccines aren’t normally a trigger for this kind of clot.</p>
<h2>2. Who is having these clots?</h2>
<p>As of April 24, 2021, out of the 8 million people vaccinated with the Johnson & Johnson vaccine in the U.S., about <a href="https://www.businessinsider.com/cdc-johnson-johnson-blood-clot-case-count-rises-to-15-2021-4?op=1">16 people have developed these blood clots</a>. The clots occurred from six to 13 days after immunization, and the majority were in <a href="https://www.scientificamerican.com/article/blood-clots-and-the-johnson-johnson-vaccine-what-we-know-so-far/">women between the ages of 18 and 48</a>. </p>
<p>On April 26, 2021, news reports indicated that at least <a href="https://apnews.com/article/health-coronavirus-california-7f23281ab23fadaaaba7e79e210f73d1">one man had developed a clot</a>. The man is in his 30s and was hospitalized from a clot in his leg about two weeks after receiving the Johnson & Johnson vaccine. </p>
<p>Health officials in Europe have also reported that the AstraZeneca vaccine – a COVID-19 vaccine authorized and approved in Europe but not in the U.S. – has caused about <a href="https://doi.org/10.1056/NEJMe2106315">200 cases of low-platelet clotting</a>. Importantly, both the Johnson & Johnson vaccine and the AstraZeneca vaccine use a type of harmless virus called an <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/viralvector.html">adenovirus to deliver instructions to the human body</a> on how to build an immune response to COVID-19. This is called a viral vector vaccine. </p>
<p>The fact that the both vaccines use a viral vector and both are associated with blood clots has <a href="https://emergency.cdc.gov/han/2021/han00442.asp">led many health experts to think</a> that the clotting issues of the two vaccines <a href="https://theconversation.com/is-it-the-adenovirus-vaccine-technology-used-by-astrazeneca-and-johnson-and-johnson-causing-blood-clots-theres-no-evidence-yet-158944">may share the same mechanism</a>. </p>
<h2>3. Why are women getting more clots than men?</h2>
<p>At this point, doctors still don’t know what makes <a href="https://www.hematology.org/covid-19/vaccine-induced-immune-thrombotic-thrombocytopenia">women more susceptible than men</a>, nor what puts a person at risk for these clots. These clots can occur, though rarely, in people who don’t get a vaccine. Scientists know that women are three times more likely to develop this type of clot without receiving the vaccine. Many researchers think this is because of <a href="https://doi.org/10.1161/STROKEAHA.108.543884">birth control or other hormonal replacements</a> that women take.</p>
<h2>4. Why might the vaccines be causing blood clots?</h2>
<p>Researchers believe that this specific <a href="https://doi.org/10.1056/NEJMoa2104840">low-platelet clotting</a> is similar to a reaction some individuals get when they <a href="https://doi.org/10.1007/s12028-009-9320-y">receive a blood thinner called heparin</a>, called heparin-induced thrombocytopenia. </p>
<p>Doctors sometimes use heparin to thin a person’s blood in the case of a heart attack or a blood clot when blood flow needs to be reestablished. But some people experience the opposite reaction, and their blood ends up clotting more instead. This happens because the body triggers an unwanted immune response after receiving heparin. </p>
<p>In these patients, heparin attaches to a product released from platelets called platelet factor 4. When this happens, the immune system considers the combined platelet factor 4 and heparin a problem, so it creates antibodies in response. These antibodies attach to the heparin and platelet factor 4 complex, and the body – which now thinks it needs to repair an injury – causes more clotting while using up even more platelets. This <a href="https://doi.org/10.1161/CIRCULATIONAHA.106.632653">results in the low platelet count seen in these patients.</a></p>
<p>When doctors have looked at the blood of patients who developed clots after receiving the Johnson & Johnson or AstraZeneca vaccine, it looked very similar to the blood of people who have the low-platelet clotting reaction to heparin. This has led scientists and doctors to believe that the <a href="https://www.ema.europa.eu/en/news/astrazenecas-covid-19-vaccine-ema-finds-possible-link-very-rare-cases-unusual-blood-clots-low-blood">same process might be leading to these clots</a> caused by the two vaccines.</p><img src="https://counter.theconversation.com/content/159523/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Mousumi Som works fr the Oklahoma State University Center for Health Sciences. She has received funding from Eli Lilly and NIAID for drug related research on COVID treatments. She is affiliated with the National Board of Osteopathic Medical Examiners and the Osteopathic Founders Foundation. . </span></em></p>The CDC first paused, then unpaused, the administration of the Johnson & Johnson COVID-19 vaccine due to concerns about blood clots. But what are those clots, and how do they form?Mousumi Som, Professor of Internal Medicine, Oklahoma State UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1598142021-05-02T20:23:07Z2021-05-02T20:23:07ZI’m over 50 and can now get my COVID vaccine. Is the AstraZeneca vaccine safe? Does it work? What else do I need to know?<figure><img src="https://images.theconversation.com/files/397961/original/file-20210429-14-14x177v.jpg?ixlib=rb-1.1.0&rect=0%2C4%2C1000%2C661&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/confident-senior-woman-arms-crossed-park-1621992598">from www.shutterstock.com</a></span></figcaption></figure><p>From today, Australians aged 50 or older <a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/getting-vaccinated-for-covid-19/when-will-i-get-a-covid-19-vaccine">are eligible</a> to receive their COVID-19 vaccine from special respiratory clinics or <a href="https://theconversation.com/australian-vaccine-rollout-needs-all-hands-on-deck-after-the-latest-astrazeneca-news-mass-vaccination-hubs-included-158519">mass vaccination hubs</a> in some states. Appointments with selected GPs are available from May 17.</p>
<p>However, a <a href="https://www.theguardian.com/australia-news/2021/apr/27/essential-poll-fewer-than-50-of-over-50s-willing-to-get-pfizer-or-astrazeneca-vaccines">recent poll</a> shows many people over 50 <a href="https://www.theage.com.au/national/huge-hit-doctors-vaccine-researchers-see-surge-in-vaccine-hesitancy-20210428-p57n0q.html">are hesitant</a> to get vaccinated, particularly with the AstraZeneca vaccine <a href="https://www.abc.net.au/news/2021-04-09/covid-vaccine-astrazeneca-blood-clots-over-50-safe/100057540">earmarked for them</a>. That’s mostly due to reports of very rare, but serious, <a href="https://theconversation.com/what-is-thrombocytopenia-the-rare-blood-condition-possibly-linked-to-the-astrazeneca-vaccine-158522">blood clots</a> that can develop after vaccination.</p>
<p>So it’s <a href="https://theconversation.com/a-balancing-act-between-benefits-and-risks-making-sense-of-the-latest-vaccine-news-158634">understandable</a> why people want to know about any safety issues and how they relate to age. It’s also natural to want to know how well the vaccine works to protect people over 50.</p>
<p>Here’s what we know about this safe and effective vaccine from clinical trials and around <a href="https://www.nytimes.com/interactive/2021/world/covid-vaccinations-tracker.html">136 countries using it</a> so far.</p>
<h2>Does the AstraZeneca vaccine protect people over 50?</h2>
<p>Clinical trials, which have <a href="https://www.health.gov.au/sites/default/files/documents/2021/03/covid-19-vaccination-atagi-clinical-guidance-on-covid-19-vaccine-in-australia-in-2021_0.pdf">included more than 57,000 people to date</a>, found the AstraZeneca vaccine to be <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32466-1/fulltext">safe and effective</a>. </p>
<p>When researchers pooled the results from four large trials — including about 8,600 vaccinated people and a similar number of unvaccinated persons — there were <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00432-3/fulltext">81% fewer COVID-19 cases in vaccinated people</a> than in unvaccinated ones. No one who got the vaccine was hospitalised due to COVID-19.</p>
<p>While the studies haven’t been designed specifically to look at efficacy in distinct age groups yet, there is good evidence the AstraZeneca vaccine <a href="https://www.who.int/publications/i/item/WHO-2019-nCoV-vaccines-SAGE_recommendation-AZD1222-background-2021.1">protects both the elderly and younger adults</a> from COVID-19. In clinical trials, adults aged 18-55 and those older than 55 had <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32466-1/fulltext">similar immune responses</a>.</p>
<p><strong>How about serious disease and death?</strong></p>
<p>When it comes to protecting people from serious disease, there’s good news again. We have data from <a href="https://www.medrxiv.org/content/10.1101/2021.03.01.21252652v1.full-text">England</a> and <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00677-2/fulltext">Scotland</a> that one dose of it reduces COVID-19 hospitalisations by 80-88% in the elderly, similar to that of <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00677-2/fulltext">the Pfizer vaccine (88-91%)</a>. </p>
<p>Based on our understanding of how vaccines work — generally, vaccines are more effective in younger adults — it’s safe to assume the vaccine is at least 80% effective in preventing severe COVID-19 in people over 50.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/397984/original/file-20210430-17-ewdv7l.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Emergency sign" src="https://images.theconversation.com/files/397984/original/file-20210430-17-ewdv7l.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/397984/original/file-20210430-17-ewdv7l.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=446&fit=crop&dpr=1 600w, https://images.theconversation.com/files/397984/original/file-20210430-17-ewdv7l.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=446&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/397984/original/file-20210430-17-ewdv7l.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=446&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/397984/original/file-20210430-17-ewdv7l.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=560&fit=crop&dpr=1 754w, https://images.theconversation.com/files/397984/original/file-20210430-17-ewdv7l.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=560&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/397984/original/file-20210430-17-ewdv7l.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=560&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">We want to avoid people ending up in hospital with serious COVID-19. With the AstraZeneca vaccine, hospitalisations are down around 80%.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-illustration/emergency-sign-334306280">from www.shutterstock.com</a></span>
</figcaption>
</figure>
<p><strong>What about the new variants?</strong></p>
<p><a href="https://theconversation.com/new-covid-variants-have-changed-the-game-and-vaccines-will-not-be-enough-we-need-global-maximum-suppression-157870">New variants of SARS-CoV-2</a>, the virus that causes COVID-19, affect the efficacy of the AstraZeneca vaccine, but <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00628-0/fulltext">only slightly</a> for the B.1.1.7 strain (the UK variant). It’s about 70% effective against this strain, compared with about 82% for the original strain.</p>
<p>However, there have been some concerns about protection against the <a href="https://www.nejm.org/doi/10.1056/NEJMoa2102214">B.1.351 strain</a> (the South African variant). This is because the AstraZeneca vaccine provides less protection against mild COVID-19 disease in people infected with it. </p>
<p><strong>Does the AstraZeneca vaccine limit spread of COVID-19?</strong></p>
<p>We still need more long-term data to say for certain whether the vaccine prevents transmission of COVID-19.</p>
<p>However, <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">preliminary UK research</a> provides some welcome news. Researchers looked at more than 365,000 households and nearly one million contacts of COVID-19 cases. They found the vaccine reduced transmission from people vaccinated with one dose by 40-50%. This is great news in terms of slowing the spread of the disease.</p>
<h2>How safe is the AstraZeneca vaccine in people over 50?</h2>
<p>Both clinical trials and real-world data <a href="https://www.who.int/publications/i/item/WHO-2019-nCoV-vaccines-SAGE-recommendation-AZD1222-GRADE-ETR-2021.1">confirm</a> the AstraZeneca vaccine has a good safety profile similar to other vaccines commonly used in Australia. </p>
<p>Side-effects are common and are mostly mild to moderate, with few recipients needing medical attention. The <a href="https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report-28-04-2021">most common</a> are reactions at the injection site, fatigue, headache and muscle pain. <a href="https://www.health.gov.au/sites/default/files/documents/2021/03/covid-19-vaccination-atagi-clinical-guidance-on-covid-19-vaccine-in-australia-in-2021_0.pdf">These occur</a> in half to three-quarters of people under 55 after their first dose, and are less common in older people. The side-effects generally start within 24 hours and last around one or two days, and indicate your immune system is working. </p>
<p>In Australia, data from the <a href="https://www.ausvaxsafety.org.au/">AusVaxSafety vaccine surveillance system</a> shows <a href="https://www.ausvaxsafety.org.au/safety-data/covid-19-vaccines">about 22% of people</a> vaccinated with the AstraZeneca vaccine missed a day or more of work or studies as they were unwell. Fewer than 2% needed to see a doctor.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/covid-vaccines-have-been-developed-in-record-time-but-how-will-we-know-theyre-safe-153888">COVID vaccines have been developed in record time. But how will we know they're safe?</a>
</strong>
</em>
</p>
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<h2>What about the blood clots I’ve been hearing about?</h2>
<p>Serious reactions to the vaccine have been very rare, one of which includes thrombosis with thrombocytopenia syndrome, which is on everyone’s mind right now.</p>
<p>This is a <a href="https://brightoncollaboration.us/thrombosis-with-thrombocytopenia-syndrome-interim-case-definition/">very rare condition</a> in which blood clots (thrombosis) and low levels of platelets (thrombocytopenia) occur <a href="https://www.thanz.org.au/documents/item/577">4-28 days after receiving the vaccine</a>. This can lead to <a href="https://www.health.gov.au/sites/default/files/documents/2021/04/patient-information-sheet-on-astrazeneca-covid-19-vaccine-and-thrombosis-with-thrombocytopenia-syndrome-tts.pdf">disability</a> <a href="https://www.gov.uk/government/news/mhra-issues-new-advice-concluding-a-possible-link-between-covid-19-vaccine-astrazeneca-and-extremely-rare-unlikely-to-occur-blood-clots">and 20-25% of people with these clots die</a>.</p>
<p>About <a href="https://www.health.gov.au/news/atagi-reinforce-recommendations-on-use-of-covid-19-vaccines-following-review-of-vaccine-safety-data-and-benefits">six in every million</a> people vaccinated with the AstraZeneca vaccine develop the condition. And it tends to be <a href="https://www.tga.gov.au/alert/astrazeneca-chadox1-s-covid-19-vaccine-3">more common</a> in people under 50. Other than younger age, there are no other risk factors for these clots we know of yet.</p>
<p>In Australia, there have been <a href="https://www.tga.gov.au/alert/astrazeneca-chadox1-s-covid-19-vaccine-3">six cases of this type of blood clotting</a>: one person in their 30s, four in their 40s, and one in their 80s. Of these, a person in their 40s has <a href="https://www.tga.gov.au/alert/astrazeneca-chadox1-s-covid-19-vaccine-2">died from it</a>.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/what-is-thrombocytopenia-the-rare-blood-condition-possibly-linked-to-the-astrazeneca-vaccine-158522">What is thrombocytopenia, the rare blood condition possibly linked to the AstraZeneca vaccine?</a>
</strong>
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</p>
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<h2>As Australia is largely COVID-free, is it worth me getting the AstraZeneca vaccine?</h2>
<p>The risk-benefit analysis for Australians right now differs depending on the amount of COVID-19 in the community, your age and the availability of alternative vaccines. </p>
<p>Based on a small amount of data so far, the <a href="https://www.health.gov.au/sites/default/files/documents/2021/04/covid-19-vaccination-weighing-up-the-potential-benefits-against-risk-of-harm-from-covid-19-vaccine-astrazeneca_0.pdf">risk of these blood clots</a> after the AstraZeneca vaccine, for people aged 50-59 is about 0.4 per 100,000 and for those aged 60-69, 0.2 per 100,000.</p>
<p>But the risk of getting severe COVID-19 or the risk of admission into intensive care from COVID-19 is much higher for the over 50s — <a href="https://osf.io/a9jdq/">nearly ten-fold</a> higher than the risk of clots after the vaccine.</p>
<p>It’s about 6.5 per 100,000 people aged 50-59 and 7.0 per 100,000 for people aged 60-69, based on data from <a href="https://www.health.gov.au/sites/default/files/documents/2021/04/covid-19-vaccination-weighing-up-the-potential-benefits-against-risk-of-harm-from-covid-19-vaccine-astrazeneca_0.pdf">Victoria’s second wave in July 2020</a>. There are different risk-benefit calculations for different scenarios.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/397987/original/file-20210430-15-1m45bsa.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/397987/original/file-20210430-15-1m45bsa.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=279&fit=crop&dpr=1 600w, https://images.theconversation.com/files/397987/original/file-20210430-15-1m45bsa.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=279&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/397987/original/file-20210430-15-1m45bsa.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=279&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/397987/original/file-20210430-15-1m45bsa.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=351&fit=crop&dpr=1 754w, https://images.theconversation.com/files/397987/original/file-20210430-15-1m45bsa.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=351&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/397987/original/file-20210430-15-1m45bsa.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=351&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">In a scenario similar to the second wave of COVID-19 in Victoria, the risk of ICU admission due to COVID-19 is much higher than the risk of blood clots from the AstraZeneca vaccine.</span>
<span class="attribution"><span class="source">from the Australian Government Department of Health</span></span>
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</figure>
<p>Australia has almost no disease in the community. However, this could change very quickly if there were new outbreaks. We also have no alternative to the AstraZeneca vaccine for most people over 50 (more Pfizer vaccine is not available until the <a href="https://www.abc.net.au/news/2021-04-09/national-cabinet-astrazeneca-covid-vaccine-clots-rollout/100058440">last quarter of 2021</a>). So <a href="https://theconversation.com/a-balancing-act-between-benefits-and-risks-making-sense-of-the-latest-vaccine-news-158634">balancing the risks and benefits of the vaccine</a>, is extremely challenging. People may not perceive their risk of COVID-19 as high enough to warrant vaccination and are preferring to wait, perhaps six months or more until other vaccines are available.</p>
<p>However, the potential benefits of the vaccine go far beyond what we’ve already mentioned. Vaccination will contribute to the prevention of long COVID-19 (symptoms that linger for months) as well as increased ability to move around freely in society, including being able to attend large events. Vaccination will help us avoid lockdowns or school closures, allow us to travel overseas and return to normal life. </p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/a-balancing-act-between-benefits-and-risks-making-sense-of-the-latest-vaccine-news-158634">A balancing act between benefits and risks: making sense of the latest vaccine news</a>
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<h2>How do I get vaccinated?</h2>
<p>You can use the <a href="https://covid-vaccine.healthdirect.gov.au/eligibility?lang=en">government’s vaccine eligibility tracker</a> to check whether you can receive your COVID-19 vaccine from today, and to make an appointment.</p>
<p>This will give you details of the state- and territory-run vaccination clinics near you that are open from today (<a href="https://www.smh.com.au/national/nsw/the-clinics-where-over-50s-can-get-their-covid-19-vaccine-next-week-20210428-p57n5s.html">not all</a> are taking appointments for the over 50s yet). From May 17, you can receive your vaccine at some GP clinics.</p>
<p>Two doses of the AstraZeneca vaccine are needed for best protection, preferably <a href="https://www.health.gov.au/sites/default/files/documents/2021/04/covid-19-vaccination-after-your-astrazeneca-vaccine-covid-19-vaccination-after-your-astrazeneca-vaccine.pdf">12 weeks apart</a>.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/396995/original/file-20210426-15-1wlylft.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/396995/original/file-20210426-15-1wlylft.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=1235&fit=crop&dpr=1 600w, https://images.theconversation.com/files/396995/original/file-20210426-15-1wlylft.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=1235&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/396995/original/file-20210426-15-1wlylft.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=1235&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/396995/original/file-20210426-15-1wlylft.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1553&fit=crop&dpr=1 754w, https://images.theconversation.com/files/396995/original/file-20210426-15-1wlylft.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1553&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/396995/original/file-20210426-15-1wlylft.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1553&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">Department of Health/The Conversation</span>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
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</figure><img src="https://counter.theconversation.com/content/159814/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Meru Sheel receives funding from the Westpac Scholars Trust.</span></em></p><p class="fine-print"><em><span>Cyra Patel is an employee at the National Centre for Immunisation Research and Surveillance (NCIRS). NCIRS receives service contract funding from the Australian Government Departments of Health, NSW and other state government Departments of Health. </span></em></p><p class="fine-print"><em><span>Margie Danchin receives funding from NHMRC, Commonwealth and State Departments of Health, DFAT and WHO</span></em></p>The AstraZeneca COVID vaccine is now available to Australians over 50. Here’s what you need to know before you roll up your sleeve.Meru Sheel, Epidemiologist | Senior Research Fellow, Australian National UniversityCyra Patel, PhD candidate, Australian National UniversityMargie 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/1595292021-04-23T05:46:13Z2021-04-23T05:46:13ZCOVID vaccine may lead to a harmless lump in your armpit, so women advised to delay mammograms for 6 weeks<figure><img src="https://images.theconversation.com/files/396434/original/file-20210422-23-11wdpg4.jpg?ixlib=rb-1.1.0&rect=7%2C1%2C991%2C589&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/senior-woman-having-mammography-scan-hospital-1334759717">from www.shutterstock.com</a></span></figcaption></figure><p>Australian women are being asked to think about the timing of breast cancer screening as they prepare to receive their COVID vaccine.</p>
<p>This is in light of <a href="https://www.sciencedirect.com/science/article/pii/S0899707121000206">US evidence</a> that a normal consequence of COVID vaccination, temporary swelling of the lymph nodes in the armpit, <a href="https://www.ajronline.org/doi/10.2214/AJR.21.25688">may interfere</a> with how doctors interpret mammograms.</p>
<p>So women <a href="https://www.ranzcr.com/documents-download/professional-documents/position-papers/5272-position-statement-on-covid-vaccines-and-breast-screening">have been advised</a> to either have a mammogram first, or delay it until six weeks after vaccination, to avoid any confusion.</p>
<p>This advice is particularly relevant now we are <a href="https://www.abc.net.au/news/2021-04-22/national-cabinet-over-50-vaccination-mass-hub-astrazeneca/100087334">preparing to vaccinate the over-50s</a>, the key target age for routine breast cancer screening under Australia’s <a href="https://www.health.gov.au/initiatives-and-programs/breastscreen-australia-program">BreastScreen program</a>.</p>
<h2>What’s all this about lumps?</h2>
<p>When people have vaccines in their upper arm, it’s normal for the lymph nodes in the armpit on that side of the body to be activated and swell. It’s your body preparing a protective immune response.</p>
<p>After their COVID shot, some people develop more severe swelling in the armpit than others. While <a href="https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html">estimates vary</a>, only <a href="https://www.ajronline.org/doi/10.2214/AJR.21.25688">about one in ten people</a> vaccinated can feel a lump there, and it’s not always painful. </p>
<p>It’s important to stress these lumps are not breast cancer, and are not harmful. They also disappear within one or two weeks of vaccination.</p>
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<strong>
Read more:
<a href="https://theconversation.com/explainer-how-does-the-immune-system-work-27163">Explainer: how does the immune system work?</a>
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<p>However, a swollen lymph node can affect imaging such as breast cancer screening by mammography or ultrasound. This is because it <em>looks like</em> breast cancer that has spread (metastasised) from the breast to the lymph node. This can have important consequences.</p>
<p>An enlarged lymph node may cause a woman to have further testing to confirm or rule out breast cancer. This can lead to further imaging, invasive procedures such as biopsies, and patient anxiety.</p>
<p>So it’s important to note this potential impact of COVID vaccination on mammography, ahead of Australia ramping up its vaccine rollout, especially in the over-50s.</p>
<h2>So what’s behind the new advice?</h2>
<p>Reports of COVID vaccine-related swollen lymph nodes <a href="https://www.sciencedirect.com/science/article/pii/S0899707121000206">emerged from the United States</a>, where <a href="https://ourworldindata.org/covid-vaccinations">almost 90 million people</a> have been vaccinated with the Pfizer or Moderna vaccines.</p>
<p>This led to <a href="https://www.ajronline.org/doi/10.2214/AJR.21.25688">swollen lymph nodes showing up</a> on breast imaging, including mammography and ultrasound.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1368203896456441857"}"></div></p>
<p>According to the Royal Australian and New Zealand College of Radiologists, this type of swelling has not been reported <a href="https://www.ranzcr.com/documents-download/professional-documents/position-papers/5272-position-statement-on-covid-vaccines-and-breast-screening">with the AstraZeneca vaccine</a>. This is the vaccine earmarked for the over-50s in Australia from May.</p>
<p>However, as activating the immune system is how all vaccines work, we’ve seen similar swelling after vaccines <a href="https://www.sciencedirect.com/science/article/pii/S0899707121000206">other than COVID</a>. So it’s likely we’ll also see it with other COVID vaccines. However, we have yet to see published data from the United Kingdom and other countries that have more experience administering the AstraZeneca vaccine to confirm this.</p>
<p>Nevertheless, the college <a href="https://www.ranzcr.com/documents-download/professional-documents/position-papers/5272-position-statement-on-covid-vaccines-and-breast-screening">has recommended</a> women have their mammogram before their COVID vaccine, or six weeks after vaccination, without specifying any particular COVID vaccine.</p>
<p>Others have proposed a more pragmatic approach of monitoring any suspected case of a swollen lymph node in the armpit on the side of the injection, and <a href="https://www.ajronline.org/doi/10.2214/AJR.21.25688">only investigating further</a> if the swelling doesn’t go down after six weeks.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/women-should-be-told-about-their-breast-density-when-they-have-a-mammogram-66125">Women should be told about their breast density when they have a mammogram</a>
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<h2>Why is this so important?</h2>
<p>It’s essential for both COVID vaccination and mammography screening of women without symptoms to continue.</p>
<p>While it is important screening identifies women with breast cancer, it is also important not to over-investigate otherwise healthy women. So it makes sense to delay the screening of otherwise healthy non-symptomatic women for a short time, and to not over-investigate women who do not have cancer.</p>
<p>It’s also important for women with breast cancer symptoms to seek medical advice immediately, and for the appropriate diagnostic imaging to take place.</p>
<p>However, in light of the recent advice, women should mention their COVID vaccination status to their health-care team — GP, radiographer and specialist doctor — so they can take this into account when interpreting imaging. That’s whether or not their mammograms are part of the breast cancer screening program.</p>
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<em>
<strong>
Read more:
<a href="https://theconversation.com/what-causes-breast-cancer-in-women-what-we-know-dont-know-and-suspect-86314">What causes breast cancer in women? What we know, don't know and suspect</a>
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<img src="https://counter.theconversation.com/content/159529/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Rik Thompson is affiliated with the Clinical Oncology Society of Australia, which has recently developed a Fact and Issues Sheet on Mammographic/Breast Denisty. He has received research support from the Princes Alexandra Research Foundation for studies on Mammographic density. </span></em></p><p class="fine-print"><em><span>Thomas Lloyd is a Senior Staff Specialist, Department of Diagnostic Radiology, Princess Alexandra Hospital, Metro South Health and a Visiting Radiologist Breastscreen Queensland.</span></em></p>As Australian women over 50 prepare to have their COVID shot, they need to factor in timing of their mammogram. Here’s why.Rik Thompson, Professor of Breast Cancer Research, Institute of Health and Biomedical Innovation and School of Biomedical Sciences,, Queensland University of TechnologyThomas Lloyd, Adjunct Professor, Radiology, Faculty of Health, Queensland University of TechnologyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1587282021-04-19T12:26:18Z2021-04-19T12:26:18ZNo, vaccine side effects don’t tell you how well your immune system will protect you from COVID-19<figure><img src="https://images.theconversation.com/files/395509/original/file-20210416-15-4ygaa1.jpg?ixlib=rb-1.1.0&rect=856%2C297%2C6838%2C4899&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">It's not a bad sign if you feel fine after your COVID-19 shot.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/woman-proud-to-have-received-vaccine-royalty-free-image/1298099790">Luis Alvarez/DigitalVision via Getty Images</a></span></figcaption></figure><p><em>If someone gets a headache or feels a bit under the weather after receiving a COVID-19 vaccine, it’s become common to hear them say something like “Oh, it just means my immune system is really working hard.” On the flip side, when people don’t notice any side effects, they sometimes worry the shot isn’t doing its job or their immune system isn’t reacting at all.</em></p>
<p><em>Is there any link between <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/pdfs/321466-A_FS_What_Expect_COVID-19_Vax_Final_12.13.20.pdf">what you can notice after a vaccine</a> and what’s happening on the cellular level inside your body? <a href="https://www.umassmed.edu/news/news-archives/2020/12/robert-finberg-named-distinguished-professor-of-medicine/">Robert Finberg</a> is a physician who specializes in infectious diseases and immunology at the Medical School at the University of Massachusetts. He explains how this perception doesn’t match the reality of how vaccines work.</em></p>
<h2>What does your body do when you get a vaccine?</h2>
<p>Your immune system responds to the foreign molecules that make up any vaccine via two different systems.</p>
<p>The initial response is due to what’s called the <a href="https://www.ncbi.nlm.nih.gov/books/NBK26846/">innate immune response</a>. This system is activated as soon as your cells notice you’ve been exposed to any foreign material, from a splinter to a virus. Its goal is to eliminate the invader. White blood cells called neutrophils and macrophages travel to the intruder and work to destroy it.</p>
<p>This first line of defense is relatively short-lived, lasting hours or days.</p>
<p>The second line of defense takes days to weeks to get up and running. This is the long-lasting <a href="https://doi.org/10.1111/j.1600-065X.2008.00731.x">adaptive immune response</a>. <a href="https://doi.org/10.1101/2021.03.03.21252872">It relies on your immune system’s T and B cells</a> that learn to recognize particular invaders, such as a protein from the coronavirus. If the invader is encountered again, months or even years in the future, it’s these immune cells that will recognize the old enemy and start generating the antibodies that will take it down.</p>
<p>In the case of the SARS-CoV-2 vaccines, it takes approximately two weeks to develop the adaptive response that brings long-lasting protection against the virus.</p>
<p><a href="https://doi.org/10.1016/j.anai.2020.01.025">When you get the vaccine shot</a>, what you’re noticing in the first day or two is part of the innate immune response: your body’s inflammatory reaction, aimed at quickly clearing the foreign molecules that breached your body’s perimeter. </p>
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<p>It varies from person to person, but how dramatic the initial response is does not necessarily relate to the long-term response. In the case of the two mRNA COVID-19 vaccines, <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/Moderna.html">well over 90% of people immunized</a> <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/Pfizer-BioNTech.html">developed the protective adaptive immune response</a> while fewer than 50% <a href="http://dx.doi.org/10.15585/mmwr.mm7008e3">developed any side effects</a>, and most were mild. </p>
<p>You may never know how strongly your body’s adaptive immune response is gearing up.</p>
<p>The bottom line is you can’t gauge how well the vaccine is working within your body based on what you can detect from the outside. Different people do mount stronger or weaker immune responses to a vaccine, but post-shot side effects won’t tell you which you are. It’s the second, adaptive immune response that <a href="https://doi.org/10.1038/s41577-020-00479-7">helps your body gain vaccine immunity</a>, not the inflammatory response that triggers those early aches and pains.</p>
<h2>What are side effects, anyway?</h2>
<p>Side effects are normal responses to the injection of a foreign substance. They include things like fever, muscle pain and discomfort at the injection site, and are mediated by the innate immune response.</p>
<p>Neutrophils or macrophages in your body notice the vaccine molecules and produce cytokines – molecular signals that cause fever, chills, fatigue and muscle pain. Doctors expect this cytokine reaction to happen any time a foreign substance is injected into the body.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/395511/original/file-20210416-17-pbukly.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="man removes hat for temperature check at COVID-19 vaccination site" src="https://images.theconversation.com/files/395511/original/file-20210416-17-pbukly.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/395511/original/file-20210416-17-pbukly.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=501&fit=crop&dpr=1 600w, https://images.theconversation.com/files/395511/original/file-20210416-17-pbukly.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=501&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/395511/original/file-20210416-17-pbukly.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=501&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/395511/original/file-20210416-17-pbukly.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=630&fit=crop&dpr=1 754w, https://images.theconversation.com/files/395511/original/file-20210416-17-pbukly.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=630&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/395511/original/file-20210416-17-pbukly.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=630&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">You might not notice any symptoms at all after your COVID-19 vaccine.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/man-removes-his-hat-for-a-temperature-check-as-he-arrives-news-photo/1231819773">SOPA Images/LightRocket via Getty Images</a></span>
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<p>In studies where neither recipients nor researchers knew which individuals were getting the mRNA vaccine or a placebo, approximately <a href="https://doi.org/10.1056/NEJMoa2034577">half of people aged 16 to 55 who received a SARS-CoV-2 vaccine</a> developed a headache after the second dose. This reaction may relate to the vaccine – but a quarter of people who received just a placebo also developed a headache. So in the case of very common symptoms, it can be quite difficult to attribute them to the vaccine with any certainty.</p>
<p>Researchers anticipate some reports of side effects. <a href="https://www.pharmacytimes.com/view/adverse-event-not-the-same-as-side-effect">Adverse events</a>, on the other hand, are things that physicians do not expect to happen as a result of the vaccine. They would include organ failure or serious damage to any part of the body.</p>
<p>The blood clots that triggered the U.S. to <a href="https://theconversation.com/johnson-and-johnson-vaccine-suspension-a-doctor-explains-what-this-means-for-you-158923">pause distribution of the Johnson & Johnson vaccine</a> are a very rare event, apparently happening with one-in-a-million frequency. Whether they are definitely caused by the vaccine is still under investigation – but if scientists conclude they are, blood clots would be an extremely rare side effect. </p>
<h2>What component in the shot causes side effects?</h2>
<p>The only “active ingredient” <a href="https://doi.org/10.1056/NEJMoa2034577">in the Pfizer</a> and <a href="https://doi.org/10.1056/nejmoa2035389">Moderna vaccines</a> is the <a href="https://theconversation.com/what-is-mrna-the-messenger-molecule-thats-been-in-every-living-cell-for-billions-of-years-is-the-key-ingredient-in-some-covid-19-vaccines-158511">mRNA instructions that tell the recipient’s cells</a> to build a viral protein. But the shots have other components that help the mRNA travel inside your body.</p>
<p>To get the vaccine’s mRNA into the vaccinated person’s cells where it can do its job, it must evade enzymes in the body that would naturally destroy it. Researchers protected the mRNA in the vaccine by wrapping it in a bubble of lipids that help it avoid destruction. Other ingredients in the shots – like polyethylene glycol, which is part of this lipid envelope – could cause allergic responses.</p>
<h2>If I feel sick after my shot, does that signal strong immunity?</h2>
<p>Scientists haven’t identified any relationship between the initial inflammatory reaction and the long-term response that leads to protection. There’s no scientific proof that someone with more obvious side effects from the vaccine is then better protected from COVID-19. And there’s no reason that having an exaggerated innate response would make your adaptive response any better. </p>
<p><a href="https://doi.org/10.1056/NEJMoa2035389">Both the authorized</a> <a href="https://doi.org/10.1056/NEJMoa2034577">mRNA vaccines</a> provided protective immunity to over 90% of recipients, but fewer than 50% reported any reaction to the vaccine and far fewer had severe reactions.</p>
<p>[<em>Insight, in your inbox each day.</em> <a href="https://theconversation.com/us/newsletters/the-daily-3?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=insight">You can get it with The Conversation’s email newsletter</a>.]</p><img src="https://counter.theconversation.com/content/158728/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Robert Finberg receives funding from Pfizer for COVID-19 vaccine studies. He serves on the governor's vaccine advisory board for the state of Massachusetts. </span></em></p>It’s normal for different people to mount stronger or weaker immune responses to a vaccine, but post-shot side effects won’t tell you which you are.Robert Finberg, Professor of Medicine, UMass Chan Medical SchoolLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1574052021-03-25T00:43:02Z2021-03-25T00:43:02ZThere’s no need to pause vaccine rollouts when there’s a safety scare. Give the public the facts and let them decide<figure><img src="https://images.theconversation.com/files/391340/original/file-20210324-21-v5pniy.jpg?ixlib=rb-1.1.0&rect=0%2C1%2C1000%2C664&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/nurse-holds-syringe-glass-jar-labeled-1927585205">from www.shutterstock.com</a></span></figcaption></figure><p>When someone gets sick after receiving a vaccine, this might be a complication or coincidence. As the recent rollout out of the AstraZeneca vaccine in Europe shows, it can be very <a href="https://theconversation.com/data-suggest-no-increased-risk-of-blood-clots-from-the-astrazeneca-vaccine-australia-shouldnt-pause-its-rollout-157137">difficult to know</a> how to respond. </p>
<p>For instance, reports of blood clots associated with the AstraZeneca vaccine led to several European countries <a href="https://theconversation.com/blood-clot-fears-how-misapplication-of-the-precautionary-principle-may-undermine-public-trust-in-vaccines-157168">suspending their vaccination programs</a> recently, only <a href="https://www.theage.com.au/world/europe/eu-s-drug-regulator-backs-astrazeneca-vaccine-after-safety-investigation-20210319-p57c43.html">to resume them</a> once these clots were judged to be a coincidence. However, authorities <a href="https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazeneca-benefits-still-outweigh-risks-despite-possible-link-rare-blood-clots">couldn’t rule out</a> increased rates of a rare brain blood clot associated with low levels of blood platelets. </p>
<p>There are also problems with the Pfizer and Moderna vaccines. By early February 2021, among the over 20 million people vaccinated in the United States, there have been 20 reported cases of <a href="https://onlinelibrary.wiley.com/doi/10.1002/ajh.26132?af=R">immune thrombocytopenia</a>, a blood disorder featuring a reduced number of platelets in the blood. Experts suspect this is probably a rare vaccine side-effect but <a href="https://www.nytimes.com/2021/02/08/health/immune-thrombocytopenia-covid-vaccine-blood.html">argue vaccination should continue</a>.</p>
<p>So what happens with the next safety scare, for these or other vaccines? We argue it’s best to give people the facts so they have the autonomy to make their own decisions. When governments pause vaccine rollouts while investigating apparent safety issues, this is paternalism, and can do more harm than good.</p>
<h2>The ‘precautionary principle’ can backfire</h2>
<p>Like any medicine, vaccines have risks associated with their benefits. And no one wants to recommend or use a vaccine with serious side-effects.</p>
<p>So when faced with recent unconfirmed serious side-effects following vaccination, European countries were tempted by the “<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1446778/">precautionary principle</a>”, or “better safe than sorry”. They opted to pause and gather more evidence.</p>
<p>Some might argue a precautionary approach could help protect the public’s confidence in vaccination in the long term. However, suspending or withdrawing a vaccine <a href="https://www.thetimes.co.uk/article/confidence-plunges-amid-pause-on-astrazeneca-vaccine-pmwz5w6qv">could also undermine confidence</a>. Once a vaccine program is stopped due to safety concerns, it may not recover. This happened with the HPV (human papillomavirus) vaccine <a href="https://www.thelancet.com/journals/lanpub/article/PIIS2468-2667(20)30010-4/fulltext">in Japan</a>.</p>
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<strong>
Read more:
<a href="https://theconversation.com/people-with-severe-allergies-warned-off-pfizer-covid-vaccine-for-now-but-that-may-change-as-more-details-emerge-151837">People with severe allergies warned off Pfizer COVID vaccine for now. But that may change as more details emerge</a>
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<p>The precautionary approach can also be lethal. In a pandemic, suspending or withdrawing an effective vaccine leads to preventable deaths. The number of preventable deaths depends on three factors.</p>
<p><strong>1. Delay</strong></p>
<p>The first is how many people will be delayed in receiving a vaccine. Fortunately, the AstraZeneca vaccine is not the only approved vaccine in Europe, so its suspension or withdrawal would not wholly prevent vaccination; however, some people’s vaccinations could be delayed. </p>
<p><strong>2. Deaths</strong></p>
<p>The second factor is the <a href="https://www.abc.net.au/news/2021-03-18/astrazeneca-vaccine-ban-costs-lives-as-europe-faces-another-wave/13255292">risk of people dying</a> if vaccines are delayed. For example, in England (a country that did not suspend the AstraZeneca vaccine), <a href="https://www.england.nhs.uk/2021/03/56-59/">people aged 56-59</a> are currently being invited to book appointments for vaccination. <a href="https://www.nature.com/articles/s41586-020-2918-0">A study in 2020</a> <a href="https://static-content.springer.com/esm/art%3A10.1038%2Fs41586-020-2918-0/MediaObjects/41586_2020_2918_MOESM1_ESM.pdf">suggests</a> roughly 0.3% of unvaccinated 55-59 year-olds infected with coronavirus die. But in countries that have not yet vaccinated older people, the risks of a suspension will be higher. The same study suggests the risk of dying for (unvaccinated) 70-74 year-olds infected with the coronavirus is roughly 1.7%. For those infected over 80, the risk is 8.3%.</p>
<p><strong>3. How widespread is the virus?</strong></p>
<p>A third factor is how common infections are at the time of suspension. When rates of infection are higher, we expect more deaths. </p>
<p>According to the <a href="https://covid19-surveillance-report.ecdc.europa.eu/">European Centre for Disease Prevention and Control</a>, as low as 8 or as many as 1,518 out of 100,000 people are infected with the virus. The rate varies between countries. Australia could afford to be precautionary because testing figures currently suggest a low incidence of COVID-19 (<a href="https://www.health.gov.au/news/health-alerts/novel-coronavirus-2019-ncov-health-alert/coronavirus-covid-19-current-situation-and-case-numbers#at-a-glance">only 0.2%</a> of COVID-19 tests conducted in the past week have returned positive results). Indeed, <a href="https://theconversation.com/australias-covid-vaccine-rollout-is-well-behind-schedule-but-dont-panic-157048">its slow vaccine rollout</a> is consistent with a precautionary approach, as evidence is gathered from other countries.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/391341/original/file-20210324-23-7eh83.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Vaccine news about vaccine pause on smartphone screen" src="https://images.theconversation.com/files/391341/original/file-20210324-23-7eh83.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/391341/original/file-20210324-23-7eh83.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/391341/original/file-20210324-23-7eh83.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/391341/original/file-20210324-23-7eh83.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/391341/original/file-20210324-23-7eh83.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/391341/original/file-20210324-23-7eh83.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/391341/original/file-20210324-23-7eh83.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">European countries suspended their vaccine rollout, then resumed. But this isn’t the only way to handle safety scares.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/moscow-russia-16-march-2021-cnn-1936882855">from www.shutterstock.com</a></span>
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Read more:
<a href="https://theconversation.com/data-suggest-no-increased-risk-of-blood-clots-from-the-astrazeneca-vaccine-australia-shouldnt-pause-its-rollout-157137">Data suggest no increased risk of blood clots from the AstraZeneca vaccine. Australia shouldn't pause its rollout</a>
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<h2>Paternalism or autonomy?</h2>
<p>Safety regulation involves value judgements around evidence and weighing risks and benefits. It also involves judgements about who we allow to make decisions about that balance.</p>
<p><a href="https://plato.stanford.edu/entries/paternalism/">Paternalism</a> is the practice of making judgements for other people about what is best for them. And the strongest form of paternalism (“<a href="https://plato.stanford.edu/entries/paternalism/#HardVsSoftPate">hard paternalism</a>”) fails to respect the autonomy of competent adults, and breaches their right to make decisions about their own lives. </p>
<p>Suspension or withdrawal of vaccines is hard paternalism. Preventing someone from accessing an effective life-saving vaccine to protect them from low risks of rare side-effects is a severe restriction of their autonomy.</p>
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Read more:
<a href="https://theconversation.com/blood-clot-fears-how-misapplication-of-the-precautionary-principle-may-undermine-public-trust-in-vaccines-157168">Blood clot fears: how misapplication of the precautionary principle may undermine public trust in vaccines</a>
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<p>There are limits to autonomy. Where an intervention will clearly do more harm than good, it is the government’s responsibility to prevent it. And when there are limited public resources, it is necessary to distribute benefits and burdens fairly.</p>
<p>But what matters ethically is not only vaccine confidence and public health, but whether people can make their own autonomous decisions about the risks they want to take: the risks of COVID-19 or the risks of vaccination.</p>
<h2>So how would this work?</h2>
<p>Autonomous decision-making here requires:</p>
<ul>
<li><p>disclosure of even small risks if the outcomes are significant</p></li>
<li><p>admission of limits to confidence (for instance, how much we know about the risks and what we don’t know)</p></li>
<li><p>disclosing this information in ways appropriate and comprehensible to all sections of the community</p></li>
<li><p>helping people to think for themselves about the inevitable uncertainties of life.</p></li>
</ul>
<p>Safeguarding autonomy here also requires putting safeguards in place to protect those who do not have the capacity to provide valid consent.</p>
<p>When looking at the background rates of blood clots, anaphylaxis or any other rare adverse events, it seems pretty clear vaccines are <a href="https://theconversation.com/covid-vaccines-have-been-developed-in-record-time-but-how-will-we-know-theyre-safe-153888">safe and the associated risks are small</a>. </p>
<p>We must investigate all vaccine safety signals thoroughly. But the process also needs to maintain the public’s confidence in vaccines through effective and transparent communication of risk. Communicating risk in terms people understand is challenging but it is essential to ensure informed decision-making. </p>
<p>For most people, the benefits of being vaccinated will outweigh the risks. But we should treat people as adults and allow them to make up their own minds. </p>
<p>Governments should not be nannies, nor nervous ninnies. Suspending vaccination fails to respect people’s right to make their own choices. It also threatens to cause much more harm overall.</p><img src="https://counter.theconversation.com/content/157405/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Julian Savulescu receives funding from the Uehiro Foundation on Ethics and Education, NHMRC, Wellcome Trust, Australian Research Council, UK Research and Innovation (Arts and Humanities Research Council) as part of the Ethics Accelerator Award AH/V013947/1, WHO. He is a Partner Investigator on an Australian Research Council Linkage award (LP190100841, Oct 2020-2023) which involves industry partnership from Illumina. He does not personally receive any funds from Illumina.</span></em></p><p class="fine-print"><em><span>Dominic Wilkinson receives funding from the Wellcome trust and the UKRI/AHRC Pandemic Ethics Accelerator project.</span></em></p><p class="fine-print"><em><span>Jonathan Pugh works for the University of Oxford. This work was supported by the UKRI/ AHRC funded UK Ethics Accelerator project, grant number AH/V013947/1.’ He has previously been funded by the Wellcome Trust.</span></em></p><p class="fine-print"><em><span>Margie Danchin receives funding from the NHMRC, Commonwealth and State governments, University of Melbourne and WHO and currently receives a clinician scientist fellowship from the Murdoch Chidlrens Research Institute.</span></em></p>Pausing COVID-19 vaccine rollouts can backfire. There are better ways to manage safety issues while they’re being investigated.Julian Savulescu, Visiting Professor in Biomedical Ethics, Murdoch Children's Research Institute; Distinguished Visiting Professor in Law, University of Melbourne; Uehiro Chair in Practical Ethics, University of OxfordDominic Wilkinson, Consultant Neonatologist and Professor of Ethics, University of OxfordJonathan Pugh, Research Fellow in Applied Moral Philosophy, University of OxfordMargie Danchin, Associate Professor, University of Melbourne, Murdoch Children's Research InstituteLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1557142021-02-23T19:11:30Z2021-02-23T19:11:30ZHow do we know the COVID vaccine won’t have long-term side-effects?<figure><img src="https://images.theconversation.com/files/385476/original/file-20210222-13-7imnr3.jpg?ixlib=rb-1.1.0&rect=0%2C8%2C5991%2C3979&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>As Australia’s COVID-19 vaccine rollout begins this week, many people still have questions about the <a href="https://www.abc.net.au/news/health/2021-01-27/covid-vaccine-safety-questions/13089036">safety of COVID-19 vaccines</a>, both in the short and long term.</p>
<p>As vaccine experts, we hear these concerns all the time, and it’s normal to have questions about a vaccine.</p>
<p>The good news is that scientists have already been testing COVID-19 vaccines for months. For starters, serious side-effects are very, very rare. And, together with what we know about previous vaccines, if side-effects are going to occur, they usually happen within a few months after getting a vaccine. This is why international medical regulators, including Australia’s Therapeutic Goods Administration (TGA), require the first few months of safety data before approving new vaccines. This, plus information coming from vaccine recipients in the northern hemisphere, gives us confidence that COVID-19 vaccines are safe.</p>
<p>In fact, most side-effects occur within the first one or two days. And most of these are minor, such as pain at the injection site, fatigue or fever — which are signs your immune system is building a response against the thing you’ve been vaccinated against.</p>
<h2>What do we know about long-term side effects?</h2>
<p>Since December, <a href="https://ourworldindata.org/covid-vaccinations">more than 200 million people</a> have received at least one dose of a COVID-19 vaccine worldwide — more than the total number of people who have been infected with the virus (<a href="https://www.worldometers.info/coronavirus/">112 million</a>).</p>
<p>Given the sheer number of vaccines administered to date, common, uncommon and rare side-effects would have been detected by now. What’s more, we’ve been testing these vaccines in clinical trials since mid-2020, and both the Pfizer and AstraZeneca vaccines have shown excellent safety results.</p>
<p>This gives us confidence the vaccines that’ll be used around Australia are safe.</p>
<p>We’ve also seen some people raise concerns online about mRNA vaccines, such as the Pfizer-BioNTech vaccine, being a <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html">“new” technology</a>. mRNA (or “messenger” RNA) is found in all living cells. <a href="https://www.gavi.org/vaccineswork/will-mrna-vaccine-alter-my-dna">mRNA is a message</a> that tells cells how to make proteins that trigger the immune response inside the body. That immune response is what protects against infection if an individual is exposed to the virus. mRNA is not the same as DNA (your genes), and it cannot combine with our DNA to change our genetic code. <a href="https://www.forbes.com/sites/victoriaforster/2021/01/11/covid-19-vaccines-cant-alter-your-dna-heres-why/?sh=cfed61224911">mRNA vaccines do not affect or interact with DNA</a> in any way. So we can be assured there’ll be no long-term DNA-altering effects from these vaccines.</p>
<p>What’s more, checking the safety of the vaccines doesn’t just stop after they’ve been registered for use. Once a vaccine has been introduced, <a href="https://www.immune.org.nz/vaccines/vaccine-safety/safety-monitoring">ongoing monitoring</a> of its safety is a crucial part of the vaccine development process. </p>
<p>Australia has a <a href="https://theconversation.com/covid-vaccines-have-been-developed-in-record-time-but-how-will-we-know-theyre-safe-153888">robust system for this ongoing monitoring</a>. The system was established to detect any unexpected side-effects from vaccines (if they occur) and ensure they’re investigated promptly. This type of monitoring is standard practise in Australia for vaccines. The data about COVID-19 vaccination collected in these surveillance systems will be published weekly on the <a href="https://www.tga.gov.au/communicating-covid-19-safety-information">TGA website</a>. This should reassure Australians that if there’s a new serious side-effect, we will know about it, communicate it, and act on it quickly.</p>
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Read more:
<a href="https://theconversation.com/covid-vaccines-have-been-developed-in-record-time-but-how-will-we-know-theyre-safe-153888">COVID vaccines have been developed in record time. But how will we know they're safe?</a>
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<p><a href="https://www.cdc.gov/vaccinesafety/concerns/concerns-history.html">Withdrawal of vaccines</a> after introduction to the general population is a very rare event.
In the United States, a rotavirus vaccine called <a href="https://www.cdc.gov/mmwr/preview/mmwrhtml/mm4843a5.htm">Rotashield</a> led to a small increase in the number of small intestinal blockages. This prompted its withdrawal in the late 1990s. In Australia, an <a href="https://www.tga.gov.au/alert/seasonal-flu-vaccine-investigation-febrile-reactions-young-children-following-2010-seasonal-trivalent-influenza-vaccination">increased risk of febrile seizures</a> in young children following a specific influenza vaccine was identified in 2010. It was subsequently withdrawn from use in that age group, and we now vaccinate with a different, <a href="https://www.ausvaxsafety.org.au/safety-data/influenza-vaccine">safer flu vaccine</a>. This vaccine is <a href="https://immunisationhandbook.health.gov.au/vaccine-preventable-diseases/influenza-flu">no longer available in Australia</a>, and has been subsequently reformulated. </p>
<p>Both of these side-effects were observed within weeks of vaccination.</p>
<p>We now have improved monitoring systems in Australia to detect such serious side-effects <a href="https://bmjopen.bmj.com/content/10/2/e031851">even sooner</a>, in the general population after clinical trials, than we did a decade ago.</p>
<h2>But what about short-term side-effects?</h2>
<p><strong>Pfizer-BioNTech COVID-19 vaccine</strong></p>
<p>The expected side-effects of the Pfizer vaccine have been reported from <a href="https://www.nejm.org/doi/pdf/10.1056/NEJMoa2034577?articleTools=true">trials</a> involving roughly 43,000 participants aged 16 years and older from the US, Argentina, Brazil and South Africa. Half of the participants received the Pfizer vaccine and half received a placebo. And as part of COVID-19 vaccine rollouts around the world, <a href="https://ourworldindata.org/covid-vaccinations">millions of people</a> have already been given this vaccine since December, meaning we have safety data now from both clinical trials and two months of “real world” vaccination. </p>
<p>For those receiving this vaccine in the large clinical trials which <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine">started in July 2020</a>, <a href="https://www.fda.gov/media/144246/download">about 80%</a> have reported pain at the injection site. Other common side-effects included fatigue, headache, muscle pain, chills, joint pain and fever.</p>
<p>These were most often reported one or two days after the day of vaccination, and typically only lasted about one day. While some vaccine recipients may need a day off work due to some of these side-effects, this does not indicate the vaccine is unsafe. </p>
<p>In trials, no difference was seen in the rate of severe side-effects between the Pfizer vaccine and placebo. Early in the US program, <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7002e1.htm">21 cases of anaphylaxis</a> were reported. It’s <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7002e1.htm">estimated</a> anaphylaxis occurs at a rate of 11 in every one million recipients (0.0011%) of the Pfizer COVID-19 vaccine. Most occurred within 15 minutes, and all patients recovered. This is why it’s a good idea though to remain at the vaccine clinic for up to <a href="https://immunisationhandbook.health.gov.au/vaccination-procedures/after-vaccination">15 minutes</a> after vaccination so that treatment and care can be provided if necessary. </p>
<p>A <a href="https://www.tga.gov.au/media-release/investigation-reveals-no-specific-risk-covid-19-vaccinations-elderly-patients">further concern was raised in January</a>, after the death of 30 very frail elderly patients in Norway after receiving the Pfizer-BioNTech COVID-19 vaccine. But <a href="https://www.ema.europa.eu/en/documents/covid-19-vaccine-safety-update/covid-19-vaccine-safety-update-comirnaty-january-2021_en.pdf">investigation by the European regulator</a> concluded these weren’t related to the vaccine, but rather to underlying conditions present before vaccination. </p>
<p><strong>Oxford-AstraZeneca COVID-19 vaccine</strong></p>
<p>This vaccine has been tested in ongoing trials with around 55,000 participants from the <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32661-1/fulltext">United Kingdom, Brazil, South Africa</a> and <a href="https://clinicaltrials.gov/ct2/show/NCT04516746">the US</a>. About half received the Oxford-AstraZeneca vaccine and half a placebo. <a href="https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting#annex-1-vaccine-analysis-print">Millions of doses</a> have been already been administered among the general population, particularly in the UK.</p>
<p>Data from four <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32661-1/fulltext">clinical trials</a> which commenced in April 2020 in the UK, Brazil and South Africa, show the most common side-effects were pain at the injection site, fatigue, headache and muscle pain. Similar to the Pfizer vaccine, there was no difference in the rate of reported severe side-effects for the vaccine compared with the placebo.</p>
<p>Just 0.7% of <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32661-1/fulltext">participants</a> (79 people) from the four clinical trials who received the Oxford-AstraZeneca vaccine reported a serious side-effect after receiving at least one dose, compared with 0.8% (89 people) of those in the placebo group. <a href="https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting#annex-1-vaccine-analysis-print">No additional safety concerns</a> have been identified since the vaccination program began in the UK.</p>
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Read more:
<a href="https://theconversation.com/should-i-get-a-covid-vaccine-while-im-pregnant-or-breastfeeding-is-it-safe-for-me-and-my-baby-153309">Should I get a COVID vaccine while I'm pregnant or breastfeeding? Is it safe for me and my baby?</a>
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<h2>If recommended a COVID-19 vaccine, take it</h2>
<p>With countries continuing to monitor those who have received vaccines, we should be reassured there are no major safety concerns detected for serious side-effects so far. With millions of people vaccinated already, our confidence about the safety of COVID-19 vaccines is very high.</p>
<p>In Australia, and internationally, we have robust systems in place to continually monitor vaccine safety, ensuring Australians can be safely afforded the protection that COVID-19 vaccines are designed to provide.</p><img src="https://counter.theconversation.com/content/155714/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 affiliated with the Australasian Society of Infectious Diseases, and is a member of government advisory committees including Australian Technical Advisory Group on Immunisation and COVID-19 Vaccines and Treatment for Australia - Science and Industry Technical Advisory Group.</span></em></p><p class="fine-print"><em><span>Margie Danchin receives funding from the National Health and Medical Research Council, WHO and Commonwealth and State government. She is a member of the Australian Technical Advisory Group on Immunisation COVID-19 Vaccine working group on vaccine safety, confidence and evaluation and chair of the Collaboration on Social Science and Immunisation (COSSI). </span></em></p><p class="fine-print"><em><span>Nicholas Wood receives funding from the NHMRC for a Career Development Fellowship</span></em></p><p class="fine-print"><em><span>Lucy Deng and Samantha Carlson 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>Years of vaccine research tells us that, if side effects are going to occur, they normally occur within the first months after getting a vaccine.Samantha Carlson, Post Doctoral Research Officer, Telethon Kids InstituteChristopher 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 SydneyMargie Danchin, Associate Professor, University of Melbourne, Murdoch Children's Research InstituteNicholas Wood, Associate Professor, Discipline of Childhood and Adolescent Health, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1538882021-02-12T06:25:24Z2021-02-12T06:25:24ZCOVID vaccines have been developed in record time. But how will we know they’re safe?<figure><img src="https://images.theconversation.com/files/383703/original/file-20210211-13-2npu01.jpg?ixlib=rb-1.1.0&rect=1%2C4%2C997%2C595&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/male-medical-mask-looking-bandage-after-1804544254">from www.shutterstock.com</a></span></figcaption></figure><p>With the rollout of COVID-19 vaccines about to begin in Australia, people <a href="https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30926-9/fulltext">may be wondering</a> if they’re safe (and effective) in the long term. What might be the health consequences a year after vaccination, or further into the future? </p>
<p>While it’s true COVID-19 vaccines have been developed in <a href="https://theconversation.com/covid-19-vaccines-were-developed-in-record-time-but-are-these-game-changers-safe-150249">record time</a>, the importance of tracking vaccine safety is not new. We <a href="https://www.health.gov.au/resources/publications/vaccine-safety-in-australia-ausvaxsafety-summary-report-2019">routinely monitor</a> the safety of all vaccinations, years after they’ve been used in millions of people.</p>
<p>And in <a href="https://www.tga.gov.au/resource/covid-19-vaccine-safety-monitoring-plan">guidance</a> from the Therapeutic Goods Administration (TGA) this week, we have a clearer picture of how we’ll know about any unexpected, rare or long-term side-effects of the COVID-19 vaccines. In fact, we’ll use and build on many existing systems to look out for these.</p>
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Read more:
<a href="https://theconversation.com/less-than-a-year-to-develop-a-covid-vaccine-heres-why-you-shouldnt-be-alarmed-150414">Less than a year to develop a COVID vaccine – here's why you shouldn't be alarmed</a>
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<h2>Vaccine trials only tell us so much</h2>
<p>Late-stage vaccine trials in tens of thousands of people only last for a defined period of time, typically 12 months. Vaccine manufacturers present data on vaccine safety (and efficacy) for that time-frame to regulatory bodies. Safety data is <a href="https://theconversation.com/how-will-covid-19-vaccines-be-approved-for-use-in-australia-153640">rigorously assessed</a> before a vaccine is approved for use. </p>
<p>But when approved vaccines are then given to the general public, we can monitor for any new events that may occur unexpectedly in both the short and longer term. Tracking potential side-effects in the real world in all people who have a vaccine, and outside the tightly controlled conditions of a trial, means we can ensure the vaccine is safe when given to millions — or billions — of people.</p>
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Read more:
<a href="https://theconversation.com/how-will-covid-19-vaccines-be-approved-for-use-in-australia-153640">How will COVID-19 vaccines be approved for use in Australia?</a>
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<p>So how might this work for COVID-19 vaccines? The Pfizer/BioNTech vaccine phase 3 trial reported safety data until <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2034577">about 14 weeks</a> after the second dose. The Oxford/AstraZeneca trial <a href="https://www.sciencedirect.com/science/article/pii/S0140673620326611?via%3Dihub#sec1">reported safety data</a> after about three months after the first dose, and two months after the second dose.</p>
<p>However, participants in both these large trials will continue to be followed up for both efficacy and safety until the end of the study from around 12 months after the first dose of vaccine. </p>
<p>COVID vaccine safety is also being monitored in several other ways, by individual countries, including Australia. Countries also share their vaccine safety monitoring data via a <a href="https://www.who-umc.org/vigibase/vigibase/">global database</a>.</p>
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Read more:
<a href="https://theconversation.com/people-with-severe-allergies-warned-off-pfizer-covid-vaccine-for-now-but-that-may-change-as-more-details-emerge-151837">People with severe allergies warned off Pfizer COVID vaccine for now. But that may change as more details emerge</a>
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<h2>Here’s how we’ll monitor COVID vaccine safety in Australia</h2>
<p>The TGA has overall responsibility for monitoring the safety of medicines and vaccines in Australia. Just this week, the TGA <a href="https://www.tga.gov.au/resource/covid-19-vaccine-safety-monitoring-plan">released its plans</a> for monitoring the safety of COVID-19 vaccines.</p>
<p>This includes the timely collection and management of reports of COVID-19 vaccine adverse events, an ability to urgently detect any safety concerns and to communicate safety issues to the public.</p>
<p><strong>‘Passive’ surveillance</strong></p>
<p>A cornerstone of the system Australia has had in place for decades to capture any possible vaccine reactions is “passive” surveillance. In practice, this means anyone can report a reaction to the TGA, the public included.</p>
<p>If your GP or nurse thinks you may have had a reaction they should report this to their state or territory health department, which then informs the TGA. This is mandatory in some jurisdictions but not in others.</p>
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<a href="https://images.theconversation.com/files/383705/original/file-20210211-15-iky2xy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Woman holding smartphone about to make a call" src="https://images.theconversation.com/files/383705/original/file-20210211-15-iky2xy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/383705/original/file-20210211-15-iky2xy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=401&fit=crop&dpr=1 600w, https://images.theconversation.com/files/383705/original/file-20210211-15-iky2xy.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=401&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/383705/original/file-20210211-15-iky2xy.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=401&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/383705/original/file-20210211-15-iky2xy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=504&fit=crop&dpr=1 754w, https://images.theconversation.com/files/383705/original/file-20210211-15-iky2xy.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=504&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/383705/original/file-20210211-15-iky2xy.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=504&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">Consumers are being encouraged to report any suspected side-effects after their COVID vaccine.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/womens-hands-use-smartphone-online-shopping-1699070266">www.shutterstock.com</a></span>
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<p>The TGA is encouraging health professionals and consumers to report suspected side-effects to COVID-19 vaccines and there is a <a href="https://www.tga.gov.au/reporting-suspected-side-effects-associated-covid-19-vaccine">guide on its website</a> on how to do this. </p>
<p>The TGA has a <a href="https://www.tga.gov.au/database-adverse-event-notifications-daen">database</a> that records any reported possible reactions. If there are any suspected safety issues, these are immediately investigated and necessary action is taken. For example, if necessary an immunisation program can be stopped or special precautions implemented. TGA can also issue safety <a href="https://www.tga.gov.au/alerts">alerts</a>.</p>
<p><strong>‘Active’ surveillance</strong></p>
<p>Since 2014, Australia has also been actively looking for any safety concerns via the <a href="http://www.ausvaxsafety.org.au">AusVaxSafety</a> surveillance system, led by the <a href="http://www.ncirs.org.au">National Centre for Immunisation Research and Surveillance</a>, which we are affiliated with.</p>
<p>We send texts or emails to people asking them to fill out a survey on their health after being vaccinated. This system enables us to detect any suspected safety issues in near real time. Last year, AusVaxSafety <a href="https://www.ausvaxsafety.org.au/safety-data/influenza-vaccine">surveyed</a> nearly 290,000 people after they had the 2020 influenza vaccine and found more than 94% felt completely well. Others had mild and expected short-term side effects. </p>
<p>This system <a href="https://www.ausvaxsafety.org.au/active-and-enhanced-vaccine-safety-surveillance-covid-19-vaccines-australia">will be used</a> to pick up any safety concerns when the COVID-19 vaccines roll out in the next few weeks. If you are vaccinated at selected sites, including GP practices and COVID-19 vaccine hubs, you will be told about this automated system. You don’t have to register or enrol but will be sent an SMS on day 3 and day 8 after each vaccine dose (you can decide whether to fill out the survey). Your anonymised results will be reported to your state or territory health department and the TGA.</p>
<p>This system will probably be in place to monitor safety of the COVID-19 vaccines for a few years. And as new vaccine brands come on board, we will continue to monitor those too.</p>
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<strong>
Read more:
<a href="https://theconversation.com/what-will-australias-covid-vaccination-program-look-like-4-key-questions-answered-150748">What will Australia's COVID vaccination program look like? 4 key questions answered</a>
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<h2>We can also learn from other countries</h2>
<p>The United States has recently developed an equivalent system, <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html">V-safe</a>. Safety data from this system from about two million people who have had a COVID-19 vaccine <a href="https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-01/06-COVID-Shimabukuro.pdf">indicates</a> the vaccines are safe. The short-term side-effects are very similar to those reported in the vaccine trials. The most common reactions include injection site pain, headache, tiredness and muscle aches, usually in the first two days and then resolving within a week after vaccination.</p>
<p>And worldwide, more than <a href="https://ourworldindata.org/covid-vaccinations">150 million COVID-19 vaccine doses</a> have already been given, with no unexpected safety concerns.</p>
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Read more:
<a href="https://theconversation.com/who-pays-compensation-if-a-covid-19-vaccine-has-rare-side-effects-heres-the-little-we-know-about-australias-new-deal-147846">Who pays compensation if a COVID-19 vaccine has rare side-effects? Here's the little we know about Australia's new deal</a>
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<h2>In a nutshell</h2>
<p>The potential benefits to us all from a mass vaccination program against COVID-19 far outweigh the potential side-effects, based on data from millions of people who have already been vaccinated around the world. Yet, we know all medicines, vaccines included, have the potential for side-effects.</p>
<p>However, by using, and building on, our already established safety surveillance system, we will be “on top” of rapidly identifying any possible safety concerns. That’s immediately after vaccination and into the longer term.</p><img src="https://counter.theconversation.com/content/153888/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Nicholas Wood receives funding from NHMRC for a Career Development Fellowship. He is an investigator on the AusVaxSafety surveillance system and Associate Director Clinical Research at NCIRS</span></em></p><p class="fine-print"><em><span>Kristine Macartney is the Director of NCIRS which leads the AusVaxSafety program. NCIRS receives funding from the Australian Government Departments of Health and Foreign Affairs and Trade (DFAT), state governments, the WHO, Gavi, the NHMRC and other non-pharmaceutical sources.</span></em></p>We already track potential vaccine side-effects in Australia. So we’ll be using, and building on, years of experience in monitoring any long-term effects of COVID-19 vaccines.Nicholas Wood, Associate Professor, Discipline of Childhood and Adolescent Health, University of SydneyKristine Macartney, Professor, Discipline of Paediatrics and Child Health, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1521582020-12-18T19:15:14Z2020-12-18T19:15:14ZIf I have allergies, should I get the coronavirus vaccine? An expert answers this and other questions<figure><img src="https://images.theconversation.com/files/375789/original/file-20201217-15-qqrmbk.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C5391%2C3597&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Sandra Lindsay, left, a nurse at Long Island Jewish Medical Center, is inoculated with the COVID-19 vaccine by Dr. Michelle Chester. </span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/sandra-lindsay-left-a-nurse-at-long-island-jewish-medical-news-photo/1230125095?adppopup=true">Mark Lennihan/Pool via Getty Images</a></span></figcaption></figure><p><em>Editor’s Note: With a coronavirus vaccination effort now underway, you might have questions about what this means for you and your family. If you do, <a href="mailto:lynne.anderson@theconversation.com">send them to The Conversation,</a> and we will find a physician or researcher to answer them. Here, Dr. Mona Hanna-Attisha, a public health pediatrician whose research exposed the Flint, Michigan, water crisis, answers questions about the vaccine and allergies, and when kids might be able to get the vaccine.</em></p>
<h2>If I have allergies, should I still get the vaccine?</h2>
<p>If you have a history of allergies to food, pets, insects or other things, the Centers for Disease Control and Prevention recommends <a href="https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/clinical-considerations.html#contraindications-precautions">that you proceed with vaccination, with an observation period</a>. If you have a history of severe allergic reaction, or what is called <a href="https://www.mayoclinic.org/diseases-conditions/anaphylaxis/symptoms-causes/syc-20351468">anaphylaxis</a>, to another vaccine or injectable therapy, your doctor can do a risk assessment, defer your vaccination, or proceed and then observe you after vaccination. The only reason to avoid vaccination is a severe allergic reaction to any component of the COVID-19 vaccine. The CDC has <a href="https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/clinical-considerations.html#contraindications-precautions">specific recommendations for post-vaccine observation</a>.</p>
<h2>As the vaccine goes out to a broader population, how will adverse events be tracked?</h2>
<p>The CDC and Food and Drug Administration encourage the public to report possible adverse events to the <a href="https://vaers.hhs.gov">Vaccine Adverse Event Reporting System</a>, or VAERS. This national system collects these data to look for adverse events that are unexpected, appear to happen more often than expected or have unusual patterns of occurrence. Anyone who has experienced an adverse event should report it to the system.</p>
<p>Reporting an adverse event is a crucial step to ensuring safety and to help the CDC monitor the vaccines. <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety.html">Safety is a top priority</a>, and scientists and public health officials need to know about adverse reactions.</p>
<p>An adverse event is different in most cases from a typical vaccine side effect. Vaccines may cause a <a href="https://theconversation.com/vaccines-against-sars-cov-2-will-have-side-effects-thats-a-good-thing-151090">side effect</a>, such as soreness at the injection site or redness. <a href="https://vaers.hhs.gov/index">Adverse events</a> are more serious and can sometimes be life-threatening. If you are unsure whether you have experienced a side effect or adverse event, you can still report the event. </p>
<p>Participants are given a <a href="https://www.fda.gov/media/144414/download">fact sheet</a> when they are vaccinated. Health care providers who vaccinate people will be required to report to VAERS certain adverse events following vaccination. In addition, under the terms of the emergency use authorization, health care providers also must follow any revised safety reporting requirements that may arise.</p>
<p>The CDC is also implementing a new smartphone-based tool called <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html">v-safe</a> to check in on people’s health after they receive a COVID-19 vaccine. When you receive your vaccine, you should also receive an information sheet telling you how to enroll in v-safe. If you enroll, you will receive regular text messages directing you to surveys where you can report any problems or adverse reactions you have after receiving a COVID-19 vaccine.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/375805/original/file-20201217-17-q5777b.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Triage guidelines from CDC for administering the Pfizer-BioNTech COVID-19 vaccine." src="https://images.theconversation.com/files/375805/original/file-20201217-17-q5777b.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/375805/original/file-20201217-17-q5777b.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=419&fit=crop&dpr=1 600w, https://images.theconversation.com/files/375805/original/file-20201217-17-q5777b.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=419&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/375805/original/file-20201217-17-q5777b.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=419&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/375805/original/file-20201217-17-q5777b.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=527&fit=crop&dpr=1 754w, https://images.theconversation.com/files/375805/original/file-20201217-17-q5777b.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=527&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/375805/original/file-20201217-17-q5777b.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=527&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Clinical guidelines from the Centers for Disease Control and Prevention for determining which patients should receive the Pfizer-BioNTech COVID-19 vaccination.</span>
<span class="attribution"><a class="source" href="https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/clinical-considerations.html">CDC</a></span>
</figcaption>
</figure>
<h2>When might kids younger than 16 be vaccinated?</h2>
<p>It is likely to be <a href="https://theconversation.com/when-can-children-get-the-covid-19-vaccine-5-questions-parents-are-asking-150721">several months</a>. The currently authorized Pfizer and soon-to-be-authorized <a href="https://www.nytimes.com/2020/12/17/health/covid-vaccine-fda-moderna.html?action=click&module=Top%20Stories&pgtype=Homepage">Moderna vaccine</a> are not applicable for children. More research and clinical trials need to be done to include younger children in COVID-19 vaccine trials. </p>
<p>According to the <a href="https://services.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/covid-19-vaccine-frequently-asked-questions">American Academy of Pediatrics</a>, Pfizer has enrolled children down to age 12 and submitted a request for emergency use authorization for vaccination down to age 16. <a href="https://www.nytimes.com/2020/12/17/health/covid-vaccine-fda-moderna.html?action=click&module=Top%20Stories&pgtype=Homepage">Moderna</a>, whose vaccine is expected to receive emergency use authorization from the FDA any day, is about to start a similar study. </p>
<p>In the United Kingdom, AstraZeneca has approval to enroll children ages 5 to 12 in clinical trials, but the pharmaceutical company has not yet enrolled any children in trials in the U.S.</p><img src="https://counter.theconversation.com/content/152158/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Mona Hanna-Attisha does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>A serious allergic reaction was reported in a health care worker in Alaska after she received the COVID-19 vaccine. Does this mean that people with allergies need to be concerned? An expert answers.Mona Hanna-Attisha, Professor of Medicine, Michigan State UniversityLicensed as Creative Commons – attribution, no derivatives.