A researcher who analyzed FDA documents related to the emergency use authorization of Pfizer’s COVID-19 vaccine is demanding the autopsy report on a Kansas woman who died of cardiac arrest 41 days after receiving her second dose of the vaccine. Pfizer took 37 days, instead of the required 24 hours, to report the death.
Pfizer-BioNTech did not disclose the deaths of two vaccinated participants in its COVID-19 vaccine clinical trials, according to a team of Daily Clout researchers who analyzed documents related to the Pfizer clinical trials.
The deaths occurred before the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) for the vaccine in December 2020. However, it wasn’t until September 2023, nearly three years later, that the FDA publicly released documents revealing the deaths of a 63-year-old Kansas woman and a 58-year-old Georgia woman who participated in the trials.
The revelations prompted Dr. Jeyanthi Kunadhasan — an Australian anesthesiologist and perioperative physician and one of the researchers analyzing the Pfizer documents on behalf of Daily Clout — to write to Kansas Attorney General Kris Kobach, requesting his office investigate the death of the 63-year-old Kansas woman.
“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,” Kunadhasan wrote in her letter.
In June, Kobach sued Pfizer, alleging the company misled the public by marketing its COVID-19 vaccine as “safe and effective” while concealing known risks — including myocarditis and pericarditis, failed pregnancies and deaths — and critical data on limited effectiveness.
In 2022, a federal court ordered the FDA to release the approximately 1.2 million pages of documents pertaining to the clinical trials for the Pfizer-BioNTech COVID-19 vaccine, after rejecting the FDA’s request for 75 years to release the records.
The documents Kunadhasan analyzed revealed that Pfizer had the opportunity to disclose the deaths before the Dec. 10, 2020, meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) — but did not do so.
Pfizer also did not disclose the deaths — both classified in the documents as “sudden cardiac death” unrelated to the victims’ vaccination — in a December 2020 New England Journal of Medicine paper touting the “safety and efficacy” of the Pfizer-BioNTech vaccine.
Kunadhasan told The Defender:
“The death highlighted in Kansas is significant as it occurred well within the reporting period considered for the EUA, and as my letter shows was not disclosed. There was every opportunity to disclose this death at the VRBPAC meeting.
“This death even had an autopsy, which I show was probably available before the VRBPAC meeting, and again was not disclosed.”
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