FDA is on the hot seat for misreported deaths related to Pfizer vaccine before approval
The Food and Drug Administration, in an unusual disclosure, erroneously reported deaths related to the Pfizer-BioNTech vaccine group and the control group prior to initial Emergency Use Authorization. year 2021.
Pfizer buried reports of deaths in the placebo group from heart inflammation compared with those in the ‘vaccinated’ group. Alex Berenson, who has been suspended indefinitely on Twitter, provided this information in a Public Substack posts.
In their initial safety report to the FDA, which contained data through November 2020, the researchers reported that four people who received a placebo and two who received the vaccine died, one after the dose, Berenson reports. first and one after the second dose. “The July update reversed that trend. Between November 2020 and March 2021, 13 people who received the vaccine died, compared with just 10 people who received a placebo.”
“Furthermore, nine vaccine recipients died from cardiovascular events such as heart attack or stroke, compared with six placebo recipients who died from those causes,” the report continued. “The imbalance is small but remarkable, considering that regulators worldwide have found that the Pfizer and Moderna mRNA vaccines are associated with heart inflammation in young men.”
The former NY Times journalist and best-selling author also points to a November 8 update showing how the FDA and Pfizer misled the public.
“On November 8, the agency published the ‘Summary Basis for Regulatory Action’, a 30-page note explaining why on August 23 it granted entirely for Pfizer’s vaccine, replacing the emergency authorization from December 2020,” he continued.
And buried on page 23 of the report is this wonderful sentence: “From Dose 1 to the data cutoff date of March 13, 2021, there were a total of 38 deaths, 21 over the TIME period. [vaccine] group and 17 in the placebo group. ”
“Pfizer said publicly in July that it had found 15 deaths among people who received the vaccine in mid-March,” Berenson noted. “But it told the FDA there were 21 – on the same day that the data cut ends, March 13.”
“21. Not 15,” he added. “The placebo number in the trial was also wrong. Pfizer had 17 deaths in placebo recipients, not 14. In total there were 9 deaths, 6 in vaccine recipients.”
The journalist then offers several explanations ranging from incompetence to outright deception.
“Could the difference be due to some delayed data? Possibly, but the FDA summary book also contains the number of Covid cases that Pfizer found in vaccine recipients in the trial,” he said. “Those numbers are exactly the same as those that Pfizer publicly posted in July.”
“However, the death toll varies,” he said. “Pfizer somehow miscalculated — or publicly misreported, or both — the death toll 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 hearing that it planned release Full data to the public regarding the licensing of a Covid-19 vaccine to the US public – in the process
https://smartzune.com/fda-is-on-the-hot-seat-for-misreported-deaths-linked-to-pfizer-vaccine-prior-to-authorization/ FDA is on the hot seat for misreported deaths related to Pfizer vaccine before approval