Pfizer-BioNTech withheld reporting on vaccine-associated deaths for its COVID-19 mRNA vaccine clinical trial participants until after the U.S. Food and Drug Administration (FDA) approved an emergency use authorization for the treatment.
According to new forensic analysis in the International Journal of Vaccine Theory, Practice, and Research, Pfizer failed to disclose evidence of more than a 3.7-fold increase in the number of cardiac deaths among vaccine recipients compared to those who received a placebo.
“This means that 79 percent of relevant deaths were not recorded in time to be included in Pfizer’s regulatory paperwork,” Angelo DePalma, Ph.D. wrote for Children’s Health Defense (CHD) regarding the study. “By not including relevant subject deaths in the case report, Pfizer obscured cardiac adverse event signals, allowing the EUA to proceed unchallenged.”
A comparison of the number of deaths per week during the 33 weeks of the study found no significant difference between the number of deaths in vaccinated versus placebo groups for the first 20 weeks, the placebo-controlled portion of the trial.
“After week 20, as subjects in the placebo were vaccinated, deaths among this still unvaccinated cohort of this group slowed and eventually plateaued,” researchers found. Deaths in the “vaccinated subjects continued at the same rate,” leading the scientists to inconsistencies between the data Pfizer reported and the actual number of deaths reported after vaccination.
According to CHD, Pfizer’s clinical trial abandoned standard practices when at week 20 it allowed “unblinding,” where the placebo group was allowed to switch to the vaccinated group. Typically, they note, this only occurs when the benefit of the drug is so great that not treating subjects becomes unethical.
“Normally the decision to unblind a vaccine trial would be based on the product’s safety and effectiveness in reaching certain endpoints or objectives,” CHD explained. “But, perhaps unexpectedly, after 33 weeks the data revealed no significant difference between deaths in the vaccinated and placebo groups for the initial 20-week placebo-controlled portion of the trial.”
CHD added, “Had Pfizer-BioNTech met their legal and ethical obligation to report all serious adverse events their data would have shown equal deaths in placebo and vaccine groups — which would have shown no clear benefit for the vaccine.”
On Oct. 31, Pfizer reported a net loss of $2.38 billion due to “write-offs of Covid products.”
