A recent analysis published in the International Journal of Vaccine Theory, Practice, and Research has raised concerns about Pfizer-BioNTech's handling of data from their COVID-19 vaccine clinical trials.
It suggests that the vaccine makers delayed reporting fatalities among participants in the BNT162b2 clinical trial until after the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for the product.
Furthermore, the analysis points out that there was a failure to account for a significant number of subjects who dropped out of the trial. These actions collectively resulted in regulators and the public being unaware of a 3.7-fold increase in cardiac deaths among those who received the vaccine.
This analysis, described as a “forensic analysis,” was led by Corinne Michels, Ph.D., a retired distinguished professor of biology at Queens College, New York. It marked the first independent examination of original data from the Pfizer-BioNTech COVID-19 mRNA vaccine clinical trial.
The trial phase involved 44,060 subjects, with half receiving the BNT162b2 vaccine and the other half receiving a placebo. Notably, after the FDA issued EUA, subjects in the placebo group were allowed to switch to the vaccinated group, which is a departure from typical trial protocols.
The decision to unblind a vaccine trial is usually based on safety and effectiveness in reaching specific endpoints. Surprisingly, after 33 weeks, there was no significant difference in deaths between the vaccinated and placebo groups during the initial 20-week period.
However, after week 20, deaths continued to occur among those in the vaccine group. The analysis revealed inconsistencies between the data presented in Pfizer-BioNTech's 6-month interim report and subsequent publications by trial site administrators.
Most notably, there was evidence of a 3.7-fold increase in deaths due to cardiac events in the BNT162b2 vaccinated individuals compared to those who received the placebo. This indicates that 79% of relevant deaths were not included in Pfizer's regulatory documentation.
The study also highlighted issues with the timing of death reports. The reported number of deaths, 38, was surprisingly low considering the pandemic context. This led the authors to estimate that 222 subjects should have died based on population mortality expectations.
The study raised concerns about a large number of “discontinued subjects,” particularly those “lost to follow-up.” Pfizer-BioNTech's efforts to locate these individuals were unsuccessful, and they could not account for 395 subjects who had dropped out.
Additionally, the authors noted disparities in the number of dropped-out subjects across trial centers. Some centers reported none or very few, while others reported significant numbers. The authors argued that trial sites with excessive dropouts should have been evaluated for performance.
Finally, the data suggested that Pfizer-BioNTech did not promptly report deaths before the EUA submission deadline, especially for the BNT162b2 group. Delays of 20+ and 30+ days were common, and deaths were recorded on the reporting day, not the actual date of death.
Overall, this analysis raises critical questions about Pfizer-BioNTech's handling of clinical trial data and the transparency of their reporting process, particularly in relation to fatalities associated with the BNT162b2 vaccine.
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