Pfizer Failed to Disclose Participant Trial Data before receiving EUA Obstructing Accurate Risk Assessment

Originally posted on Quora November 10, 2022

In what is unfolding into the least transparent and most fraudulent medical marketing campaign in human history, one that continues to collapse day by day, Pfizer, who controls 70% of US and EU markets for CVs, not only failed to test for prevention of transmission, and conflated relative and absolute risks in their advertising of effectiveness, but failed to disclose participant level trial data sets that would have made accurate assessments of risks to benefits, based on triage, feasible. This was brought to the attention of Albert Bourla (J) (CEO of Pfizer) and Stéphane Bancel (J) (CEO of Moderna), without any fanfare from MSM, by BMJ researchers who conducted a recent study analyzing the absolute risks of serious adverse events from MRNA CVs compared to the placebo group in phase 3. An analysis of the phase 3 trial data showed that, while rare, there was a statistically significant greater incidence of serious adverse events in both the Pfizer and Moderna treatment groups than in both placebo groups. In fact, the researchers found a much greater disparity in serious adverse events than what had been reported by the FDA, noting that the FDA included thousands of participants who had only received one dose of Pfizer, with very few follow-ups, and a median follow up time of 1 month after the shot, while they limited their analysis to only participants who had received both Pfizer shots and a median follow-up time of 2 months. This resulted in finding a 36% higher risk of a serious adverse events in the Pfizer treatment group compared to the placebo group.

The FDA reported 126 of 21,621 (0.6 %) of vaccinated participants experienced at least one SAE at data cutoff compared to 111 of 21,631 (0.5 %) of placebo participants. In contrast, our analysis found 127 SAEs among 18,801 vaccine recipients versus 93 SAEs among 18,785 placebo recipients. While summary results for the population we analyzed was provided in a table, FDA did not report an analysis of them. The substantially larger denominators in FDA’s analysis (5,666 more participants) reflect the fact that their analysis included all individuals receiving at least one dose (minus 196 HIV-positive participants), irrespective of the duration of post-injection follow-up time. In contrast, our analysis was based on the study population with median follow-up ≥ 2 months after dose 2 (minus 120 HIV-positive participants), of which 98.1 % had received both doses. [2], [17] The FDA’s analysis of SAEs thus included thousands of additional participants with very little follow-up, of which the large majority had only received 1 dose.

While this appears to be a small difference on the surface it significantly alters the rational calculus for the 40% or so who never developed symptoms. In July of 2021, the FDA reported four serious adverse events of interest (meaning they could be life altering) three of which were coagulation disorders. Unfortunately, since Pfizer failed to disclose participant level data it is not possible to assess an accurate harm to benefit ratio without knowing the demographical information of the participants who experienced serious adverse events (e.g. age, sex, health etc.), the type of serious adverse event or even the number of participants who experienced serious adverse events or multiple events. All that could be determined is that the excess risk of serious adverse events of interest exceeded the reduction in virus induced hospitalizations. An even greater limitation is found in the fact the Pfizer trial data did not record serious adverse events past one month after the second dose making it likely that serious adverse events were undercounted. Most importantly it’s impossible for anyone to give their informed consent, the cornerstone of bioethics, to take these experimental shots the data of which was concealed from public scrutiny.