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Posts misrepresent FDA committee presentation on vaccine side effects

December 14, 2020 GMT

CLAIM: Presentation slide shows the U.S. Food and Drug Administration’s list of possible adverse outcomes of the COVID-19 vaccine include stroke and death. 

AP’S ASSESSMENT: Missing context. No serious adverse effects have been reported by Pfizer in clinical trials, nor has the FDA found such evidence in its review of the data. The FDA said the slide being shared online lists possible severe reactions to the vaccine that the agency is watching for as a safety precaution despite no severe reactions being reported so far

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THE FACTS: As the U.S. began distributing the vaccine developed by Pfizer and BioNTech to health care workers and nursing home residents, social media users shared misleading posts claiming that the FDA was intentionally burying the vaccine’s possible “life-threatening” side effects. 

One Twitter post claimed the FDA “knows that the rushed-to-market COVID-19 vaccines may cause a wide range of life-threatening side effects, including death, yet they continue to be promoted as safe and effective.”

The posts misrepresent a slide from an Oct. 22 presentation during a meeting of an FDA advisory committee. The slide is titled, “FDA Safety Surveillance of COVID-19 Vaccines: DRAFT Working list of possible adverse event outcomes.” It lists more than 20 possible side effects, including stroke and death, and is marked “Subject to change.” 

None of the symptoms listed in the slide have been found to be associated with the Pfizer vaccine to date. 

The FDA said that the slide actually shows “possible, not known, adverse event outcomes that the FDA will be monitoring for as the vaccine is deployed.” According to the FDA, the agency  will be monitoring the outcomes based on safety data and experience with similar vaccines. Existing vaccine monitoring platforms will be used to keep track of COVID-19 vaccine reactions. 

The FDA has said it has found no serious side effects among the more than 37,000 volunteers who participated in the Pfizer vaccine trial who were monitored for two months after their last shot. 

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Experts have said the main side effects for the vaccines include sore arm and flu-like reactions that last for a day or two. British officials issued a warning that people with serious allergies should not get the Pfizer vaccine after two health care workers who have a history of allergies experienced a serious reaction to the vaccine. Both have since recovered. 

“The U.S. government has a well-established post-authorization/post-approval vaccine safety monitoring infrastructure that will be scaled up to meet the needs of a large-scale COVID-19 vaccination program,” an FDA official told the AP in an email.

The FDA approved an emergency use authorization, known as an EUA, of Pfizer’s vaccine on Friday. The FDA told the AP that it would only issue an EUA if the vaccine had clear and compelling efficacy in a “large well-designed phase 3 clinical trial.”

“If an EUA is issued, the process will not be rushed, and no shortcuts will be taken around having the relevant phase 3 efficacy results,” the FDA official said.

Posts making misleading claims about the slides were shared thousands of times across social media platforms. One website, Green Med Info, which says it focuses on the science of natural healing, shared the FDA slide in an article headlined, “COVID-19 Vaccine Bombshell: FDA Documents Reveal DEATH + 21 Serious Conditions As Possible Adverse Outcomes.”

The Green Med Info article contends that the FDA is aware of the possibly lethal side effects of the vaccine. Again, though, the FDA has found no evidence of serious side effects.

The founder of Green Med Info, Sayer Ji, told the AP in an email that while he hopes the vaccine is safe and effective, he found the FDA’s draft list of possible outcomes concerning. 

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This is part of The Associated Press’ ongoing effort to fact-check misinformation that is shared widely online, including work with Facebook to identify and reduce the circulation of false stories on the platform.

Here’s more information on Facebook’s fact-checking program: https://www.facebook.com/help/1952307158131536