Pfizer-BioNTech did not disclose the deaths of two participants in its COVID-19 vaccine clinical trials before the FDA granted emergency use authorization (EUA) in December 2020. Documents released nearly three years later revealed the deaths of a 63-year-old Kansas woman and a 58-year-old Georgia woman, both classified as “sudden cardiac death.” Researchers have criticized Pfizer for failing to report these incidents within the required 24-hour timeframe, with one case taking 37 days to be filed.
Dr. Jeyanthi Kunadhasan, an Australian anesthesiologist and researcher with the watchdog group Daily Clout, called for an investigation by Kansas Attorney General Kris Kobach. She raised concerns that withholding this information may have impacted the perception of the vaccine’s safety profile.
“If the additional two deaths had been disclosed at the time of the EUA, it would have shown that the BNT162b2 mRNA COVID vaccine intervention provided no reduction in deaths.”
— Dr. Jeyanthi Kunadhasan, Anesthesiologist, Daily Clout
These revelations are part of a broader controversy surrounding transparency. In 2022, a federal court ordered the FDA to release 1.2 million pages of clinical trial documents after rejecting a 75-year delay request. This included the trial data that Pfizer had an opportunity to disclose to the FDA’s Vaccines and Related Biological Products Advisory Committee but did not.
Kansas Attorney General Kobach has also filed a lawsuit against Pfizer, accusing the company of misleading the public about the vaccine’s safety and effectiveness. The suit alleges the company failed to disclose risks like myocarditis, pericarditis, failed pregnancies, and deaths while promoting the vaccine as “safe and effective.”
Pfizer classified the deaths as unrelated to the vaccine and omitted them from a December 2020 New England Journal of Medicine paper that lauded the vaccine’s safety and efficacy. Critics say this omission reflects a troubling pattern of selective reporting.
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