Forensic Analysis of Deaths in Pfizer-BioNTech COVID-19 Vaccine Trials

Many Deaths Occurred after Data Analysis Cutoff–Concealing Cardiovascular Death Signal from FDA VRBPAC

A new analysis from Michels et al has found that many deaths in the Pfizer-BioNTech COVID-19 Vaccine Trials program occurred after the data cutoff used to create the briefing booklet reviewed by the FDA CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) on December 10, 2020. This effectively concealed mortality data from the approval decision by the EUA mechanism.

Michels report suggest Pfizer was aware and busily working on the case report forms of these deaths coming in from the clinical trial sites: “In many of these 38 cases, the documentation provided in the CRF did not adequately support the cause of death diagnosis or did not allow one to rule out the possibility of a cardiovascular event with an autopsy. Frequent communications between Pfizer/BioNTech physicians and trial site medical staff are obvious in the CRFs, which were often quite lengthy some well over 400 to 900 pages.”

I have served in a variety of roles at similar FDA meetings in the past. We always ask the company for more data that has come in since the time of the cutoff.

“Pfizer knew about some of these additional deaths at the time of the critical VRBPAC meeting according to Michels: “Pfizer/BioNTech should have voluntarily made known any new information that could contribute to the FDA’s decision. It was factually misleading for them not to do so. On the other hand, everyone at the VRBPAC meeting should have realized that the data from November 14th was outdated. Surprisingly, no members of VRBPAC requested an update on adverse events that occurred between the EUA data cutoff date (November 14) and the date of this meeting (December 10, 2020).”

The major findings from the Michels analysis are given below. The bottom line is that the cardiovascular disaster that occurred in the vaccinated population that took place once the public program was started could have been anticipated if we had public reporting and analysis of these deaths from the trials.

“We found that 14 of the 38 deaths, well over one-third of the deaths (36.7%), were the result of cardiovascular events, a 3.7-fold increase in deaths due to cardiovascular events in the treatment arm of the clinical trial. Moreover, the increased number of deaths due to cardiovascular events more than accounts for the difference between the number of deaths in the BNT162b2 arm (21 deaths) compared to the number in the Placebo arm (17 deaths).”

Originally published on the author’s Substack