Correction Sept. 27, 2021: Paragraph nine amended to clarify that not all suspected adverse events may be recorded by the VAERS system, which gathers unverified user-submitted reports.
An article shared more than 7,500 times online has claimed “FDA experts” revealed in a recorded meeting that COVID-19 vaccines kill more people than they save. The U.S. Food and Drug Administration (FDA) told Reuters these claims were false – and that the individual who made them was not a member of the agency.
According to the article, which was published on a website known for spreading misinformation (here and here), an agency expert said COVID-19 vaccines “kill twice as many as they save” during the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Sept. 17.
Social media users (here, here, here, here, here, here) have since shared the article (here) along with audio clips of the man making this assertion.
In the clips, the man is heard identifying himself as Steve Kirsch, the executive director of the COVID-19 Early Treatment Fund, which promotes antiviral medicines (full recording of the meeting: here [Kirsch timestamp, 4:20:20]).
He makes a number of claims, including that COVID-19 vaccines are unsafe and that they kill more people than they save, before estimating the number of deaths to be around 150,000 (Kirsch’s slideshow: here).
Firstly, Kirsch is not and has never been an FDA employee or member of the VRBPAC, the FDA told Reuters in an email. The U.S. entrepreneur had submitted a request to speak at the open public hearing section of the meeting, which is open to anyone, as detailed in the agency’s announcement (here).
The spokesperson added: “FDA does not screen remarks from speakers during the open public hearing portion of the meeting in advance.
“Furthermore, 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’s presentation appears to cite research from a paper he co-authored (here). The analysis relies heavily on data from the U.S. Vaccine Adverse Event Reporting System (VAERS), which documents suspected reactions to COVID-19 shots to detect possible safety issues. It is managed by the FDA and the Centers for Disease Control and Prevention (CDC).
Of more than 380 million doses of COVID-19 vaccines administered in the U.S. up to Sept. 13, VAERS received 7,653 reports of death (0.0020%) among people who were vaccinated. Healthcare providers are required to report any death after vaccination to VAERS even if there is no indication it was caused by the vaccine and reported incidents are not evidence of a causal link, according to CDC guidance. It says reports of death after COVID-19 vaccination are rare (here).
In Kirsch’s paper and committee meeting presentation, Kirsch calculates a so-called “underreporting factor” of adverse reactions by comparing the number of VAERS reports of anaphylaxis (severe allergic reaction) after vaccination with estimates of people vaccinated in the United States. He subsequently applies this number to reported deaths, claiming that more than 150,000 people have died in the United States as a result of COVID-19 vaccines.
Reuters presented these calculations to the FDA, who said: “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.”
They added: “Although under reporting is a limitation in VAERS with regard to COVID-19 vaccine safety monitoring, there currently is not evidence to suggest it would underestimate the amount of COVID-19 vaccine-related deaths to such a large degree.”
As well as VAERS, there are multiple systems the FDA and CDC use to monitor vaccine safety. Given the COVID-19 vaccine is operated under “Emergency Use Authorization” in the United States, vaccine administrators and manufacturers are mandated to report all adverse reactions. This would likely result in increased recording of suspected deaths associated with the COVID-19 vaccine, the FDA spokesperson said.
An analysis of safety surveillance data from Vaccine Safety Datalink that monitored more than 10 million people, including 6.2 million vaccinated, found no vaccine-outcome association met the requirement to signal serious adverse effects, including death (here). Vaccine Safety Datalink is a vaccine-monitoring effort by the CDC and nine healthcare organisations.
The FDA said: “A review of available clinical information, including death certificates, autopsy, and medical records, has not established a causal link to COVID-19 vaccines.”
There is, however, a plausible causal relationship, as the CDC documents (here), between Johnson & Johnson’s Janssen COVID-19 vaccine and blood clots with low platelets — a rare and serious adverse event that has caused three deaths, according to the CDC (here).
A CDC spokesperson told Reuters in an email: “To date, CDC has not detected any unusual or unexpected patterns for deaths following immunization that would indicate that COVID vaccines are causing or contributing to deaths, outside of the 3 confirmed deaths following the Janssen vaccine.”
False. COVID-19 vaccines are safe and not causing more deaths than they prevent. The claim is based on misinterpreted data.
This article was produced by the Reuters Fact Check team. Read more about our fact-checking work here.
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