Pfizer Accused of Concealing COVID Vaccine Trial Deaths for Authorization
A recent study has unveiled concerning revelations about Pfizer’s conduct during Covid vaccine trials. The research suggests that Pfizer-BioNTech deliberately withheld crucial information about a significant number of deaths that occurred during the trials. This withholding appears to have been a strategic move to expedite the authorization for public use from federal regulators.
The investigation, led by Corinne Michels, Ph.D., a distinguished professor of biology, delved into the original data from the Pfizer-BioNTech COVID-19 mRNA vaccine (BNT162b2) clinical trial. It analyzed 38 deaths that transpired between July 27, 2020, and March 13, 2021, involving 44,060 participants.
The trial phase included both those who received the vaccine and those who were administered a placebo. Notably, at week 20, after the FDA issued the Emergency Use Authorization for the vaccine, placebo recipients were allowed to switch to the vaccinated group. This ‘unblinding’ process typically occurs when the benefits of the drug are substantial and withholding treatment would be unethical.
Surprisingly, the data showed no significant difference in deaths between the vaccinated and placebo groups during the initial 20-week period. However, after week 20, when most former placebo recipients had received the vaccine, deaths in the vaccine group continued.
The most alarming finding was a 3.7-fold increase in cardiac deaths among those who received the vaccine. Astonishingly, 80% of these relevant deaths were not included in Pfizer’s regulatory documentation, potentially obscuring critical safety signals.
The study also highlighted inconsistencies between Pfizer-BioNTech’s interim report and subsequent publications. It uncovered four additional deaths in the vaccine group and one more in the placebo group, which were omitted from the FDA submission despite a study design requirement.
Furthermore, the study raised concerns about the low reported death count, which was only 18% of the expected number based on population mortality rates. This discrepancy was attributed to a large number of ‘discontinued subjects,’ including those ‘lost to follow-up.’ Despite efforts, Pfizer-BioNTech could not account for 395 subjects who dropped out, a matter of significant concern.
The oversight of trial sites was also brought into question, as some centers experienced a high number of dropouts while others had almost none. The study recommended that sites with excessive dropouts should have been evaluated for performance.
The timing of death reports was another area of concern. It was noted that Pfizer-BioNTech did not promptly enter death reports before the EUA submission deadline. Delays of over 20 and 30 days were commonplace, with one case taking a staggering 72 days to be recorded.
In summary, this analysis sheds light on potentially unethical practices during the Pfizer-BioNTech vaccine trials. Delays in reporting deaths, discrepancies in data, and a significant number of dropouts raise serious questions about the transparency and integrity of the trial process. These findings underscore the importance of rigorous oversight and transparency in pharmaceutical research and development.
