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FDA is on the Hot Seat for Misreported Deaths Linked to Pfizer Vaccine Prior to Authorization

The Food and Drug Administration, in an extraordinary revelation, misreported the number of deaths linked to the Pfizer-BioNTech vaccine group and the control group prior to the vaccine’s initial Emergency Use Authorization in 2021.

Pfizer buried the reporting of deaths in the placebo group due to heart inflammation compared to those in the ‘vaccinated’ group. Alex Berenson, who has been indefinitely suspended from Twitter, made this information available in a public Substack post.

“In their initial safety report to the FDA, which contained data through November 2020, the researchers had said four placebo recipients and two vaccine recipients died, one after the first dose and one after the second,” Berenson reports. “The July update reversed that trend. Between November 2020 and March 2021, 13 vaccine recipients died, compared to only 10 placebo subjects.”

“Further, nine vaccine recipients had died from cardiovascular events such as heart attacks or strokes, compared to six placebo recipients who died of those causes,” the report continued. “The imbalance was small but notable, considering that regulators worldwide had found that the Pfizer and Moderna mRNA vaccines were linked to heart inflammation in young men.”

The former NY Times journalist and best-selling author also pointed to a November 8 update that showed how the FDA and Pfizer misled the public.

“On November 8, the agency released its ‘Summary Basis for Regulatory Action,’ a 30-page note explaining why on August 23 it granted full approval to Pfizer’s vaccine, replacing the emergency authorization from December 2020,” he goes on.

And buried on page 23 of the report is this stunning sentence: “From Dose 1 through the March 13, 2021 data cutoff date, there were a total of 38 deaths, 21 in the COMIRNATY [vaccine] group and 17 in the placebo group.”

“Pfizer said publicly in July it had found 15 deaths among vaccine recipients by mid-March,” Berenson noted. “But it told the FDA there were 21 – at the same data cutoff end date, March 13.”

“21. Not 15,” he added. “The placebo figure in the trial was also wrong. Pfizer had 17 deaths among placebo recipients, not 14. Nine extra deaths overall, six among vaccine recipients.”

The journalist then proffered some explanations that vary from incompetence to outright deception.

“Could the discrepancy result from some odd data lag? Maybe, but the FDA briefing book also contains the number of Covid cases that Pfizer found in vaccine recipients in the trial,” he said. “Those figures are EXACTLY the same as those Pfizer posted publicly in July.”

“Yet the death counts were different,” he said. “Pfizer somehow miscounted – or publicly misreported, or both – the number of deaths in one of the most important clinical trials in the history of medicine.”

The news comes as the Food and Drug Administration revealed in a court case that it intends to release the full data to the public regarding its Covid-19 vaccine authorizations to the American public — over the course of 55 years. The FDA has told the courts it needs time to redact the data.


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OPINION: This article contains commentary which reflects the author's opinion.