FDA didn’t say Pfizer misled them about vaccine safety. The statement came from a public commenter

The U.S. Food & Drug Administration’s vaccine advisory committee routinely holds virtual meetings to give guidance and make recommendations on the COVID-19 vaccines. The meetings are streamed live, and members of the public can participate during an open comment period.

But sometimes those comments can be a source of misinformation that spreads on social media.

That’s what happened in this Instagram post, which appears to feature a screenshot of the Sept. 17, 2021, meeting’s livestream and incorrectly attributes a criticism of the vaccines to the FDA. Text along the top reads:

"FDA in their virtual meeting yesterday: ‘We were falsely misled 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 the 4 hr 20 mark."

The post was flagged as part of Facebook’s efforts to combat false news and misinformation on its News Feed. (Read more about our partnership with Facebook.) 

The FDA did not say this, and the agency strongly disputed the substance of the statement. 

The statements were made during the meeting’s public comment session by Steve Kirsch, a tech entrepreneur who founded the COVID-19 Early Treatment Fund, which aims to fund research on existing drugs to treat COVID-19. 

Kirsch began promoting unproven COVID-19 drugs and campaigning against the vaccines as the pandemic progressed, Technology Review reported, and many of his professional associates have distanced themselves from him, with all 12 board members of the Early Treatment Fund resigning in May. The organization’s website is full of misinformation about the vaccines. 

"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," FDA spokesperson Abby Capobianco told PolitiFact in an email. 

Capobianco said that Kirsch asked to speak at the public hearing portion of the meeting, which is open to anyone who signs up. The FDA does not screen remarks from speakers in advance.

She added that the statements made by Kirsch were "not based in science" and "go against FDA’s public health mission."

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About four hours into the meeting, Kirsch claimed that the COVID-19 vaccine "kills more people than it saves," among other false statements. 

Kirsch said he based his comments on data from the federal government’s Vaccine Adverse Event Reporting System, or VAERS.

The FDA and the Centers for Disease Control and Prevention, which jointly run VAERS, specifically warn that its reports cannot be relied on alone to make conclusions about whether a vaccine causes a particular side effect. Rather, it’s intended to help researchers detect patterns that may warrant further study.

Unlike other official government data sources that are screened by statisticians and analysts before being made available to the public, VAERS is an open-access system. It’s designed so that anyone — parents, patients and health care professionals — can freely report any health effects that might occur after a vaccination, whether or not those effects are believed to be caused by the vaccine. 

The reports aren’t verified before they’re entered and have included car accidents and incidents of self injury among reported adverse events following vaccination. Still, anyone with a computer can search the data, download it, and interpret the numbers as they wish — making VAERS fertile ground for vaccine misinformation.

So Kirsch’s use of VAERS reports to draw conclusions about the vaccines was problematic.

"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,’ Capobianco said. "This is due to the limitations of VAERS itself, as well as the limitations regarding certain private patient information that is not available to individuals outside of FDA and CDC."

The approved COVID-19 vaccines have met rigorous standards for safety, effectiveness and manufacturing quality, and reports of deaths are rare. More than 543 million doses have been administered in the U.S. from Dec. 14, 2020, through Feb. 3, 2022, according to the FDA. During this time, VAERS received 12,122 reports of death (0.0022%) among people who received a COVID-19 vaccine. That includes people who died of any cause.

The FDA requires healthcare providers to report any death after vaccination to VAERS, even if it’s unclear whether the vaccine was the cause, Capobianco said. Reports of adverse events to VAERS following vaccination, including deaths, don’t necessarily mean that a vaccine caused a health problem, she said, and a review of available clinical information, including death certificates, autopsy, and medical records, hasn’t established a causal link to COVID-19 vaccines.

An Instagram post claims that the FDA said in a vaccine advisory meeting that Pfizer "falsely misled" the agency about the safety of the COVID-19 vaccines and that the shots are killing more people than they save.

This is inaccurate. No one affiliated with the FDA said this, and the agency strongly disputed the substance of the statements. 

The comments were made by Steve Kirsch, a tech entrepreneur who has promoted unproven COVID-19 drugs and misinformation about the vaccines in the past. He based his claims on VAERS, which contains unverified reports and cannot be used alone to draw conclusions about vaccine safety.

We rate the claim that the FDA made the statement Pants on Fire!