FDA Ignores ICAN’s Inquiries Regarding Inconsistent Death Data in Pfizer’s Trial

 

On November 16, 2021, ICAN, through its attorneys, sent a letter to the FDA, regarding several inconsistencies in reports of death in the clinical trials for Pfizer’s COVID-19 vaccine, COMIRNATY.

Specifically, ICAN demanded to know why the FDA’s Summary Basis for Regulatory Action for COMIRNATYlisted 38 deaths total (21 deaths in the COMIRNATY group and 17 in the placebo group) from Dose 1 through March 13, 2021, but the death data in the Statistical Review-COMIRNATY, which reported on data from the same time period, did not add up to 21 in the vaccine group or 17 in the placebo group. Further, ICAN  inquired as to why both sets of these death count statistics differed from was stated in the Clinical Review Memo, which reflected 15 deaths in the vaccine group, 14 deaths in the placebo group, and 6 deaths “during unblinded follow-up following vaccination.”

ICAN also demanded to know whether the FDA was aware that, according to data in Statistical Review-COMIRNATY, in the first month after the second dose, there were 3 deaths in the vaccine group and 5 in the placebo group but, by six months or unblinding, there were 15 deaths in vaccine group and 14 in the placebo group. Even more concerning, by March 13, 2021, there were 21 deaths in the vaccine group and 17 in the placebo group. The FDA needs to explain whether the reason that these numbers continued to diverge – with more deaths in the vaccinated – was that the observation period in the trial was extended or if there is another reason for this divergence.

Finally, ICAN noted that even though the number of COVID-19-related deaths in the placebo group was higher than in the vaccine group (6 versus 1), significantly, cardiac-related deaths were nearly double in the vaccine group compared to the placebo group (9 versus 5). Americans deserve to know why, on one hand, the reduction in COVID-19-related deaths was considered causally related to the vaccine (of course), while, on the other hand, the accompanying increase in cardiac deaths in the vaccinated was not considered causally related to the vaccine.

If the government wants to claim that COVID-19 vaccines save lives, the public deserves to know that the data underlying the government’s claim is consistent and accurate. Unfortunately, that is not presently the case for the COMIRNATY vaccine. To that end, ICAN’s letter sought confirmation that causality regarding death was being assessed by biostatisticians, whose job it is to assess, in an unbiased manner, outcome differences between two groups for their statistical significance, effect, size, etc., and to draw appropriate causality conclusion.

Being that the approval of COMIRNATY by the FDA was the triggering event for the imposition of a vast number of COVID-19 vaccine mandates, it is hard to imagine a more crucial scenario in which the data being relied upon is accurate. Sadly, FDA does not appear to take its obligation to the American people seriously since it has failed to address these critical open questions. ICAN will continue to pursue the answers to these crucial questions about the safety data of COMIRNATY and will keep you updated along the way.

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