by Barbara Gehrett, MD; Chris Flowers, MD; and Loree Britt, Daily Clout:
We evaluated Pfizer’s 38-page “5.3.6 Cumulative Analysis of Post-Authorization Adverse Events Reports of PF-07302048 (BNT162b2) received through 28-Feb-2021,” commonly known as “5.3.6,” starting in September of 2022. Patterns emerged across the System Organ Classes (SOCs). These patterns included Pfizer’s apparent concealment of various cases of adverse events, as well as unexplained causes of death.
Because we saw these patterns, we shifted our attention from Pfizer’s descriptions of adverse events and reviewed each SOC on its own. Thus, we found many data discrepancies. We saw that Pfizer manipulated data by setting various different “thresholds” for counting adverse events in each SOC. In addition, Pfizer frequently assigned adverse events to SOCs that were inappropriate, which obscured adverse event signals. We dedicated a year to this intensive analysis of this report, which contains 42,086 patients (“cases”) and 158,893 adverse events. Pfizer clearly did not expect this thoroughgoing analysis, which exposes data manipulation.