An article widely shared on social media claims more than 150,000 people have died from COVID-19 vaccines. The U.S. Food and Drug Administration (FDA) told Reuters this claim is inaccurate and based on misinterpreted data.
The article, published on Sept. 22 on a website known for spreading misinformation (here and here), claims scientists concluded through an “in-depth analysis” that “at least 150,000 Americans have been killed”.
Social media users have also shared the blog and repeated its claims here,
The website credits the findings to Jessica Rose, who was a postdoctoral researcher in biology at the Israel Institute of Technology from 2016-20, according to her resume posted online (here). She is now a self-described independent researcher.
The blog article cites a paper titled: “Estimating the number of COVID vaccine deaths in America” (here), which Rose co-authored alongside Mathew Crawford, a statistician (here). Both appear to be members of a group questioning COVID-19 vaccines (here).
The document itself states that it used a “simple analysis” of data from the U.S. Vaccine Adverse Event Reporting System (VAERS) – not an in-depth study as the article in question suggests.
VAERS, managed by the FDA and the Centers for Disease Control and Prevention (CDC), documents suspected reactions to COVID-19 vaccines to detect possible safety issues.
Of more than 390 million doses of COVID-19 shots administered in the U.S. up to Sept. 27, VAERS received 8,164 reports of death (0.0021%) 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).
Rose and Crawford’s paper calculates a so-called “underreporting rate” of adverse reactions by comparing data submitted to VAERS on anaphylaxis (severe allergic reaction) after vaccination with estimates of people vaccinated in the United States. They then subtract the average number of background deaths for previous years from the deaths after vaccination reported to VAERS before multiplying the resulting number by their estimated underreporting rate. They say these calculations produce an estimated total of more than 150,000 people who have died in the United States as a result of COVID-19 vaccines.
An FDA spokesperson told Reuters in an email that it “strongly disagrees” with the analysis put forth in the report.
They added that the claim 150,000 people have died in the United States as a result of COVID-19 vaccines is not accurate and is based on data from VAERS that was not properly interpreted.
The spokesperson said: “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.”
The FDA and CDC have multiple systems in place in addition to VAERS to monitor vaccine safety. “A review of available clinical information, including death certificates, autopsy, and medical records, has not established a causal link to COVID-19 vaccines,” the FDA told Reuters.
There is, however, a plausible causal relationship between Johnson & Johnson’s Janssen COVID-19 vaccine, as the CDC documents (here), and blood clots with low platelets — a rare and serious adverse event that has caused three deaths (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.”
Reuters presented the FDA and CDC’s comments to Rose and Crawford, who claimed the FDA had failed to explain how VAERS data should be interpreted.
Crawford wrote in an email to Reuters: “The FDA is trying to pull the wool over people’s eyes in an obtuse way.”
He added: “While VAERS lacks precision, it is historically more accurate than precise. This allows for a reasonable degree of statistical analysis of proportionality.”
Rose told Reuters she agreed with Crawford’s comments. In their report, Rose and Crawford claim to back up their analysis by citing a CDC study on underreporting levels from previous years (here).
The FDA told Reuters it was aware of the reference but that Rose and Crawford’s paper failed to address “spontaneous adverse event reporting in the context of emergency use authorization (EUA).”
It noted that VAERS reporting levels of adverse events were at their highest after the 2009 H1N1 inactivated pandemic influenza vaccine. The CDC’s study showed 76% of cases of anaphylaxis were captured.
“This suggests that the degree of under reporting in VAERS may be mitigated in the setting of a pandemic where there is a heavy emphasis on vaccine safety,” the spokesperson said.
They added that there is also likely to be increased capturing of death reports associated with the COVID-19 vaccine programme, given it has operated on an unprecedented scale under “Emergency Use Authorization” in the United States, which mandates vaccine administrators and manufacturers to report all adverse reactions.
In an email to Reuters, Crawford suggested “most medical professionals” are not aware of the existence of VAERS and the FDA’s emergency use requirements. However, he did not provide evidence to support the claims.
Reuters previously addressed a similar document containing the claim that COVID-19 vaccines have killed more than 150,000 people, along with other miscalculations using VAERS data, here.
False. COVID-19 vaccines are safe and there is no evidence to suggest they have caused more than 150,000 deaths. 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.