Other rare conditions related to COVID-19 vaccines include anaphylaxis, Guillain-Barré syndrome and immune thrombocytopenia. What happened to the AstraZeneca vaccine? Now rare in rich countries, it’s still saving lives around the world While most people with myocarditis related to vaccine have mild symptoms and recover over days or weeks, a small number have more serious disease or prolonged symptoms. Myocarditis (inflammation of the heart muscle) has been seen more frequently, particularly in teenage boys and young men after mRNA vaccines (around two to ten cases for every 100,000 second Pfizer COVID-19 vaccine doses). This was rapidly reported and its detection shaped the COVID-19 vaccine rollout. It occurs in around one in 50,000 doses of the AstraZeneca COVID-19 vaccine, with 173 cases reported in Australia. Thrombosis with thrombocytopenia syndrome is a serious but rare clotting disorder. Some rare but serious events caused by COVID-19 vaccines were detected within months of the vaccine rollout. These studies look at whether the risk of a condition is increased in people shortly after vaccination, compared to other times or in unvaccinated people. Detailed epidemiological studies have also included many millions of people. Safety monitoring has occurred across the whole populations in more than 190 countries. As vaccines are given to the wider population, many countries (including Australia) monitor for rare and serious side effects.
More than 13 billion COVID-19 vaccine doses have been given globally. Initial clinical trials can only detect relatively common side effects. These trials are large – around 20,000-30,000 people are closely monitored for many months – but can only detect relatively common side effects. Clinical trials, including for COVID-19 vaccines, compare a group who receive the vaccine with another receiving a placebo (or another vaccine).
Covid vaccine side effect trial#
Safety assessments start early in product development then proceed to clinical trial assessments. Strong vaccine safety systems are designed to identify and investigate potential new health issues related to a vaccine. Just because someone had COVID before they had a heart attack doesn’t mean it was the cause The key question is whether a vaccine caused or worsened the risk of a condition. Heart attacks, strokes, new autoimmune diseases, and death can all occur shortly after a vaccine. It’s important to consider these other factors, because not everything that happens after a vaccine is due to the vaccine. But other factors are crucial when determining whether one thing caused another. The condition occurring in a window of time after vaccination is an obvious criterion. Good vaccine safety systems address these questions. People naturally want to know the cause of a problem. This is particularly the case when the problem has an uncertain cause, is not well understood or is only recently described. In any new large vaccine rollout, some people will experience a serious medical problem in the period after the new vaccine is given, and wonder “was it from the vaccine?”.
University of Sydney provides funding as a member of The Conversation AU.
Monash University and University of Western Australia provide funding as founding partners of The Conversation AU. She has previously received a sitting fee from the Therapeutic Goods Administration for participation in an expert advisory group.
Julie Leask receives funding from the World Health Organization, UNICEF, NHMRC and the National Centre for Immunisation Research and Surveillance. He is a member of the COVID-19 SITAG and past member of the Australian Technical Advisory Group on Immunisation. He is the Chair of the Advisory Committee for Vaccines (advising the Therapeutic Goods Administration) and is a member of the Australian Technical Advisory Group on Immunisation.Ĭhristopher Blyth receives funding from the NHMRC and MRFF. She is a member of the WHO Global Advisory Committee on Vaccines (GACVS), the Australian Technical Advisory Group on Immunisation (ATAGI) and the Advisory Committee on Vaccines (ACV) and other advisory groups.Īllen Cheng receives funding from the Australian Health and Medical Research Council. NCIRS receives funding from the Australian and state and territory government departments of health and DFAT, the WHO, Gavi the Vaccine Alliance, the NHMRC and MRFF. Kristine Macartney receives salary in her role as the Director of the National Centre for Immunisation Research and Surveillance (NCIRS). Professor, Susan Wakil School of Nursing and Midwifery, University of Sydney Paediatrician, Infectious Diseases Physician and Clinical Microbiologist, Telethon Kids Institute, The University of Western Australia Professor in Infectious Diseases Epidemiology, Monash University Professor, Discipline of Paediatrics and Child Health, University of Sydney
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