The FDA did not say Covid-19 vaccines are causing more heart attacks

A claim that the US Food and Drug Administration (FDA) said heart attacks are 71 times higher following the Covid-19 vaccine than following other vaccines, and that the vaccines are killing two people for every one they save is not true.

This claim appears in a tweet by British entrepreneur and former Made in Chelsea star Francis Boulle, posted in September 2021 and recently shared on Facebook by members of the public. The tweet, which links to a recording of a virtual meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) and states: “FDA in their virtual meeting yesterday: ‘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’”.

This quote did not come from an FDA or VRBPAC official. The virtual meeting, which took place on 17 September 2021, included an open public hearing session, where members of the public could make their own short presentations.

The above claims were made by a member of the public named Steve Kirsch, an entrepreneur who established the Covid-19 Early Treatment Fund (CETF) to invest in research on the potential of already-approved drugs to treat Covid-19.

According to the MIT Technology Review, over the course of 2021 Mr Kirsch regularly promoted conspiracy theories and inaccurate claims about the Covid-19 vaccines and other treatments for the virus.

During his presentation given as part of the open public hearing session, Mr Kirsch claimed that “VAERS shows heart attacks happen 71 times more often following these vaccines compared to any other vaccines”, and that “even if the vaccines had 100% protection, it still mean we kill two people to save one life.” This is not true.

Data does not show Covid-19 vaccines are linked to more heart attacks

Mr Kirsch said that his claim that heart attacks happen 71 times more often following Covid-19 vaccines compared to any other vaccines was based on data from the Centers for Disease Control and Prevention (CDC)’s Vaccine Adverse Events Reporting System (VAERS).

VAERS is an open reporting system that allows anyone to log an adverse event—that is, an unexpected medical event after vaccination—on its database. It is not a reliable source of data for measuring the true prevalence of side effects.

As of 27 May 2022 the VAERS database includes 4,547 reports of heart attacks following the Covid-19 vaccine, and 600 reports following all other vaccines, though some of these may have happened outside the United States. There have therefore been around 7.5 times as many reports of heart attacks happening after the Covid-19 vaccine than after other vaccines.

However, this does not mean that the Covid-19 vaccine is responsible for more heart attacks than other vaccines. We’ve explained before that VAERS reports do not necessarily indicate that a health problem which occurred after vaccination was directly caused by the vaccine, and the larger number of VAERS reports for the Covid-19 vaccine does not mean that the vaccine is causing more health problems than other vaccines.

No evidence has been found to suggest that Covid-19 vaccines directly cause heart attacks. As we’ve previously written, a small number of cases of myocarditis and pericarditis (heart inflammation) have been linked to the Moderna and Pfizer mRNA vaccines. 

The Medicines and Healthcare products Regulatory Agency (MHRA) has said: “These reports are very rare, and the events reported are typically mild with individuals usually recovering within a short time with standard treatment and rest.”

We have checked multiple false claims linking heart attacks to Covid vaccines. The British Heart Foundation says there is no evidence of an increased risk of death from cardiac arrest following vaccination. 

No evidence that Covid-19 vaccines kill more people than they save

A major study of VAERS data published by the CDC in March 2022 found no link between receiving two Covid-19 vaccinations and the number of deaths reported after vaccination in the US.

The study found that in the first six months of the vaccine rollout, 4,496 people who had been vaccinated later died  but it uncovered “no unusual patterns in cause of death among the death reports received.”

As the study mentions, the CDC has noted a “plausible causal relationship” between the Johnson & Johnson vaccine and a rare serious adverse event of blood clots in large blood vessels, which occurs at a rate of around 3.83 cases per one million doses of the vaccine, and has resulted in approximately nine deaths.

In the UK, the MHRA has said there is evidence of a likely link between the AstraZeneca vaccine and a very rare type of blood clot occurring with low levels of platelets. As of 18 May, it had received reports of 81 deaths.

It is difficult to be certain about how many people the Covid-19 vaccines have saved. In November, a study from the World Health Organisation Regional Office for Europe and  European Centre for Disease Prevention and Control estimated that 470,000 lives had been saved in people aged 60 and over across 33 countries in Europe since the start of the vaccine roll out. In England alone, it estimated that 157,000 deaths had been averted.

US healthcare foundation The Commonwealth Fund has estimated that the vaccines averted over one million Covid-19 deaths in America up to November 2021.

Image courtesy of Brano