![]() The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes. Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI -3.2 to 29.6) risk ratio 1.16 (95 % CI 0.97 to 1.39). The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI -23.2 to 37.4) risk ratio 1.06 (95 % CI 0.84 to 1.33). The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9) risk ratio 1.36 (95 % CI 1.02 to 1.83). Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9) risk ratio 1.43 (95 % CI 1.07 to 1.92). Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI -0.4 to 20.6 and -3.6 to 33.8), respectively. Secondary analysis of serious adverse events reported in the placebo-controlled, phase III randomized clinical trials of Pfizer and Moderna mRNA COVID-19 vaccines in adults ( NCT04368728 and NCT04470427), focusing analysis on Brighton Collaboration adverse events of special interest. We adapted the Brighton Collaboration list to evaluate serious adverse events of special interest observed in mRNA COVID-19 vaccine trials. The MHRA says reports of myocarditis and pericarditis are “very rare, and the events reported are typically mild with individuals usually recovering within a short time with standard treatment and rest.In 2020, prior to COVID-19 vaccine rollout, the Brighton Collaboration created a priority list, endorsed by the World Health Organization, of potential adverse events relevant to COVID-19 vaccines. In August 2021, the UK government released information about the possible link between Covid-19 vaccinations and cases of myocarditis and pericarditis. In June 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) updated information about both Moderna and Pfizer vaccines to include warnings about myocarditis, following research into the issue in Israel and America. This article is based on a Swedish study published by the journal JAMA Cardiology, which found that “both first and second doses of mRNA vaccines were associated with increased risk of myocarditis and pericarditis”-both inflammatory conditions affecting the heart. The second screenshot shared in the Facebook post is of an article also published by the Express about a large study into the “risk of ‘heart problems’” associated with the Pfizer and Moderna Covid-19 vaccines. I’m in Pattern of higher myocarditis and pericarditis reports following Pfizer and Moderna vaccines You can help us take action – and get our regular free email The FDA defines an adverse event as: “Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment ”. The document actually lists a mixture of reported adverse events following vaccination-not confirmed side effects caused by the vaccine. The suggestion that the adverse events listed in these documents amounted to “side effects” was also misleading. However, much of the data in this document didn’t actually come from Pfizer’s clinical trials, and some adverse event data from the trials has been publicly available on the FDA website at least since December 2020. The Scottish Daily Express also published a similarly-worded clarification after deleting a version of the same article.Īs stated by the Daily Express and Scottish Daily Express, the articles incorrectly claimed that the publication of a new document about adverse events was the first time the public had been allowed to see the clinical trial data Pfizer submitted to the US Food and Drug Administration (FDA). This may suggest that all these adverse events were side effects which is not the case.Īlso the headline refers to an article which was deleted, and a standalone correction published, after Full Fact wrote a fact check about it in March. The first headline reads: “Pfizer vaccine side effects - new documents uncover 158,000 adverse events”. A post shared hundreds of times on Facebook claims that the “truth” is “starting to unravel” about the Covid-19 vaccines, citing two headlines published by the Express.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |