FACT CHECK: Did The FDA Accuse Pfizer Of Misrepresenting The Safety Of Its COVID-19 Vaccine?

Trevor Schakohl | Fact Check Reporter

An image shared on Instagram claims the Food and Drug Administration (FDA) said Pfizer misled it regarding the safety of its COVID-19 vaccine.

 

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A post shared by @freedom_collector

Verdict: False

The FDA did not issue public statements to that effect. A similar comment was made during a September 2021 open public hearing session by a tech entrepreneur who is not affiliated with the agency.

Fact Check:

The Instagram post’s image shows part of a Sept. 18, 2021 tweet by “mining entrepreneur” Francis Boulle. He quotes the FDA as stating in a virtual meeting the day before: “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.”

The FDA’s Vaccines and Related Biological Products Advisory Committee hosted an 8-hour remote meeting in September discussing Pfizer and BioNTech’s application to administer COVID-19 vaccine “booster” doses to individuals over 16 years old. (RELATED: Does This Video Show French Farmers Protesting Vaccine Policies?)

During the meeting, COVID-19 Early Treatment Fund (CETF) founder Steve Kirsch cited Vaccine Adverse Event Reporting System (VAERS) data to argue against approval of booster shots. Kirsch displayed data that allegedly showed “heart attacks happen 71 times more often following these vaccines compared to any other.” Kirsch claimed the VAERS data showed at least two people died from them for every life they saved.

However, Kirsch is not part of the FDA. He is not listed as a staffer on the agency’s website or on his bio page on the CETF website. The meeting’s transcript identifies it as an open session, meaning that members of the general public could attend.

“Steve Kirsch is not, and has never been, employed by the FDA and is not a member of FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC),” said Allison Hunt, an FDA spokesperson, in an email to Check Your Fact. She also noted that the FDA “strongly disagrees with the analysis Mr. Kirsch put forth during the VRBPAC meeting, as we believe the data from VAERS that he referenced were not properly interpreted.”

The FDA’s press releases and social media posts do not make a statement claiming the Pfizer-BioNTech vaccine kills two people for every person it saves or that Pfizer misled the agency about its safety. The FDA allowed those 12 and older eligible to receive a booster dose of the vaccine Jan. 3.

The Centers for Disease Control and Prevention states COVID-19 vaccines are safe and effective and “reports of death after vaccination are rare.” Reports of adverse events to VAERS following vaccination, which include deaths, are not indicative of an actual fault in the vaccine itself and can be submitted by anyone.

Update: This post has been updated with the comments from Allison Hunt. 

Trevor Schakohl

Fact Check Reporter
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