Friday, November 22, 2024

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COVID-19

Claims about vaccine adverse events based on article since-deleted over inaccuracies

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.

The first headline reads: “Pfizer vaccine side effects – new documents uncover 158,000 adverse events”.

This may suggest that all these adverse events were side effects which is not the case.

Also 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 Scottish Daily Express also published a similarly-worded clarification after deleting a version of the same article. 

As 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). 

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 suggestion that the adverse events listed in these documents amounted to “side effects” was also misleading. The document actually lists a mixture of reported adverse events following vaccination—not confirmed side effects caused by the vaccine. 

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 ”.

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Pattern of higher myocarditis and pericarditis reports following Pfizer and Moderna vaccines 

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. 

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. 

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. In August 2021, the UK government released information about the possible link between Covid-19 vaccinations and cases of myocarditis and pericarditis.

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.”

Image courtesy of Mat Napo

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This article has been archived for your research. The original version from Full Fact can be found here.