Instagram Post Misrepresents FDA Document About Monitoring Vaccine Safety

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A Food and Drug Administration presentation on monitoring the safety of COVID-19 vaccines listed possible adverse events the agency might track. But an Instagram post misrepresents the document, falsely claiming it shows the vaccines are known to cause harmful side effects — including death.


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A popular Instagram post cites a government document to falsely claim that federal officials know that the COVID-19 vaccines cause death and other dangerous side effects — “yet will not publicly warn” citizens.

The image — shared on Instagram accounts such as “awaken_the_mind,” “the_truth_hunters” and “the_truth_hunters_2” — claims: “FDA DOCUMENTS: mRNA VACCINE CAUSES DEATH + 21 SIDE EFFECTS.” It goes on to allege that an “internal FDA document revealed a shocking revilation” about the purported side effects — such as Guillain-Barré syndrome, stroke, autoimmune disease and “pregnancy & birth outcomes.”

But the post is wrong. The Food and Drug Administration presentation cited, which is actually publicly available, doesn’t say that. And as we’ve previously reported, there is no evidence that vaccines have caused any deaths. As of March 15, the CDC reported that it has found “no evidence that vaccination contributed to patient deaths.”

The “mRNA” refers to one of the ways that COVID-19 vaccines are designed. The first two vaccines approved in the U.S. — one from Pfizer/BioNTech and the other from Moderna — both use modified messenger RNA, or mRNA, to provide instructions for cells to make spike proteins. That triggers an immune response against the spike protein of the SARS-CoV-2 virus, which causes COVID-19. (For more, see our SciCheck stories,A Guide to Pfizer/BioNTech’s COVID-19 Vaccine and “A Guide to Moderna’s COVID-19 Vaccine.”)

The third vaccine approved in the U.S., a one-dose vaccine from Johnson & Johnson, is designed differently and does not use mRNA.

The link cited at the bottom of the Instagram post goes to a presentation by Steve Anderson, who directs the Office of Biostatistics & Epidemiology at the FDA’s Center for Biologics Evaluation and Research, or CBER. That presentation was given at an Oct. 30 meeting by the Advisory Committee on Immunization Practices, a committee that provides vaccine-related guidance for the Centers for Disease Control and Prevention.

Anderson’s report outlined a variety of ways that CBER would monitor vaccine safety upon rollout. The government uses several monitoring systems to that end.

One slide in Anderson’s presentation showed a “[w]orking list of possible adverse event outcomes” that the FDA planned to monitor — the list now cited in the Instagram post. It wasn’t addressing mRNA vaccines in particular, as the Instagram post claims.

And the presentation didn’t say the vaccines actually are known to cause those health issues, let alone kill people. The same misrepresentation was made by a dubious website in December and debunked by our fact-checking colleagues at PolitiFact and the Associated Press.

An FDA spokesperson told us that “the document cited is a slide deck on how FDA would plan to conduct safety surveillance on a potential COVID-19 vaccine once authorized” and noted the same deck was also presented at an earlier FDA advisory committee meeting in October.

“No specific COVID-19 vaccine was discussed at that meeting, but rather that meeting was held to discuss — in general — the criteria FDA may take into account when making a decision about emergency use authorization for a COVID-19 vaccine,” the spokesperson said. “The list of adverse events on slide 16 is a list of possible outcomes that the FDA could potentially monitor for when conducting safety surveillance once a vaccine was authorized.”

Daniel Salmon, director of the Institute for Vaccine Safety at Johns Hopkins University, told us in a phone interview that it’s “unfortunate” that the list — part of a precautionary safety process — is being misconstrued to wrongly suggest that the vaccines are dangerous.

There’s a difference between a report of an adverse event following immunization and an adverse event caused by the vaccine, he said. Officials develop a list of adverse events following immunization to monitor in order to proactively ensure the vaccine rollout is safe. The list is compiled by experts using a variety of factors; for example, officials may want to track outcomes associated with the disease from which the vaccines are designed to protect.

By tracking specific adverse events that are reported through its various surveillance systems, the government can conduct rapid analyses to determine whether any observed events following vaccination are more common than expected, Salmon said. In other words, experts can assess whether any health outcomes that are observed are consistent with what would be expected in a given population.

“The message here should be: government’s being careful, being cautious, being prudent,” he said.

According to the CDC, the ongoing monitoring of the COVID-19 vaccines is “the most intensive safety monitoring in U.S. history.” And in the months since the distortion first spread, tens of millions of doses of the COVID-19 vaccines have been safely administered in the country.

With more than 109 million doses administered in the U.S. as of March 15, the CDC says, it received 1,913 reports through the Vaccine Adverse Event Reporting System of deaths that took place after someone received a vaccine. As we’ve explained before, reports of deaths through VAERS do not necessarily mean that a vaccine caused an adverse event, since anyone can submit reports — regardless of whether an immunization is thought to have contributed to the event.

CDC and FDA physicians review the facts surrounding each death reported through VAERS. And the CDC reported on March 15: “A review of available clinical information including death certificates, autopsy, and medical records revealed no evidence that vaccination contributed to patient deaths.”

Many people who get the vaccines experience mild side effects — such as pain at the injection site, a headache, chills or fever — the CDC notes. A “small number of people have had a severe allergic reaction (called ‘anaphylaxis’) after vaccination, but this is extremely rare. If this occurs, vaccination providers have medicines available to effectively and immediately treat the reaction.”

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Sources

Anderson, Steven. “CBER Plans for Monitoring COVID-19 Vaccine Safety and Effectiveness.” Food and Drug Administration. 30 Oct 2020.

COVID-19 Vaccine Reporting Systems.” Centers for Disease Control and Prevention. 27 Feb 2021.

COVID-19 Vaccine Safety Surveillance.” Food and Drug Administration. 9 Feb 2021.

Dupuy, Beatrice. “Posts misrepresent FDA committee presentation on vaccine side effects.” Associated Press. 14 Dec 2020.

Funke, Daniel. “Alternative health website spreads false claim about COVID-19 vaccine side effects.” PolitiFact. 9 Dec 2020.

McDonald, Jessica. “Instagram Post Makes Invalid Comparison Between COVID-19 and Flu Vaccines.” FactCheck.org. 19 Feb 2021.

McDonald, Jessica. “A Guide to Pfizer/BioNTech’s COVID-19 Vaccine. FactCheck.org. Updated 3 Mar 2021.

McDonald, Jessica. “A Guide to Moderna’s COVID-19 Vaccine.” FactCheck.org. Updated 3 Mar 2021.

Robertson, Lori. “A Guide to Johnson & Johnson’s COVID-19 Vaccine.” FactCheck.org. 27 Feb 2021.

Safety of COVID-19 Vaccines.” Centers for Disease Control and Prevention. Updated 16 Mar 2021.

Selected Adverse Events Reported after COVID-19 Vaccination.” Centers for Disease Control and Prevention. Updated 16 Mar 2021.

Salmon, Daniel. Director of the Institute for Vaccine Safety, Johns Hopkins University. Phone interview with FactCheck.org. 17 Mar 2021.

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