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Claims about Pfizer-BioNTech vaccine for Covid-19 not made by US Food and Drug Administration

A screenshot of a tweet doing the rounds on Facebook in South Africa claims the US Food and Drug Administration (FDA) has made a shocking admission about one of the Covid-19 vaccines.  

It reads: “FDA in their virtual meeting yesterday: ‘we were falsely mislead by (Pfizer) about the safety of the vaccine’ … Heart attacks are 71x higher than other vaccines … the vaccines are killing two people for every one life saved. Listen from 4hr 20 mark.”

The original tweet was posted on 19 September 2021 by Francis Boulle, a British entrepreneur with large social media followings on Twitter and Instagram. This tweet about the FDA got over 4,000 retweets and over 5,000 likes.

The tweet includes a link to an eight-hour-long YouTube video posted by the FDA. It is a live-stream of a 17 September meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) .

But did the FDA claim they were falsely misled by pharmaceutical company Pfizer and is it true that the Covid-19 vaccine developed by Pfizer and BioNTech causes 71 times more heart attacks and is “killing two people for every one life saved”? We investigated.

VaccineHeart_False

Not claim made by FDA

The main topic under discussion at the 17 September meeting of VRBPAC was, according to the agenda, “to discuss Pfizer-BioNTech’s supplemental Biologics License Application for administration of a third dose, or ‘booster’ dose, of the COVID-19 vaccine, Comirnaty, in individuals 16 years of age and older”. 

At the all-day meeting various experts spoke, from the FDA, academic institutions, the Israeli ministry of health and others. Pfizer gave a “sponsor presentation” and an FDA medical officer reviewed the “effectiveness and safety” of the booster. 

There was also an hour-long “open public session” in the middle of the day. Here short presentations were given by members of the public – not officials from the FDA – “on issues pending before the committee”.  

At the “4hr 20 mark” mentioned in the tweetfour hours and 20 minutes into the video – a man called Steve Kirsch was presenting to the FDA committee. He introduced himself as “the executive director of the Covid-19 Early Treatment Fund” and his presentation was titled “Pfizer vaccine kills more people than it saves”.  

Kirsch said that “heart attacks happen 71 times more often following these [Pfizer] vaccines compared to any other vaccine”.

This was not a statement by the FDA or any VRBPAC personnel. 

A spokesperson from the FDA told news organisation Reuters that "the statements made by Mr Kirsch during the open public hearing portion of the meeting were not based in science and go against FDA’s public health mission”. 

Kirsch widely debunked

The Covid-19 Early Treatment Fund or CETF, was established in March 2020 to fund research into the treatment of the new coronavirus with existing drugs. But it has become openly dismissive of the use and efficacy of the Covid-19 vaccines used in the United States.

Kirsch is an entrepreneur with a background in computer science and electrical engineering, but since the start of the Covid-19 pandemic he has been found to have spread misinformation about the vaccines. 

The Massachusetts Institute of Technology – coincidentally the institution at which Kirsch studied – have gone so far as to call him a misinformation superspreader

Little evidence for supposed risks of Covid-19 vaccine

The US Centers for Disease Control and Prevention (CDC) lists some of the side effects of the Pfizer vaccine as tiredness, headache, muscle pain, chills and fever. 

The CDC did report that myocarditis, an inflammation of the heart muscle, and pericarditis, an inflammation of the outer lining of the heart, are possible but rare side effects of the Covid-19 vaccine. 

But we could find no evidence of a higher rate of heart attack with the Pfizer vaccine. Instead one study found that there was a greater risk of heart issues following Covid-19 infection than as a result of receiving a vaccine for the virus. 

There is no reliable evidence for Hirsch’s statement and it was made by him, a known and repeatedly debunked critic of the Covid-19 vaccines, not the US Food and Drug Administration.

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