The Texas court ruling that the US Food and Drug Administration (FDA) must release the documents which led to authorization of the Pfizer/BioNTech vaccine, continue to provide more revelations about the flawed nature of the trial results.
The results that led to initial approvals claimed there had been four deaths in the placebo group and only two in the vaccination group. By the time of the publication of the six-month follow-up data, the ratio was 15 in the vaccination group and 14 in the placebo group. However, this was not the full story and more evidence has emerged.
Data submitted to the FDA on 18th May 2021 gives a fuller picture of deaths up to the point of unblinding, including approximately 6 months of follow up.
The data included all deaths up to March 13, 2021 but there were two deaths of patients who had taken two doses of placebo and then a dose of vaccine. These deaths have been excluded from this analysis.
One such subject was a 65-year-old man from Texas who had received two placebo injections and then got the Moderna vaccine while still in the trial. He developed COVID during the critical post-vaccination period, was hospitalized within a week of receiving the vaccine, and died 11 days post-injection. His death was categorized as an unvaccinated COVID death in the trial findings.
The gold standard for drug therapies is all-cause mortality. Why was this death categorized as unvaccinated?
There is a discrepancy between the text in the document and the table. Although the text says, ‘From Dose 1 to the data cutoff (March 13, 2021) there were a total of 38 deaths among participants >16 years of age (19 BNT162b2 recipients, 2 Placebo/BNT162b2 recipients and 17 placebo recipients)’, the table shows 22 deaths in the vaccine group (including the two placebo-then-vaccine recipients) and 16 in the placebo group.
Deaths highlighted in yellow are sudden, unexplained deaths.
There was a significant difference in the vaccinated group of sudden deaths after 60 days. Five people in that group had a sudden death while there was only one in the placebo group. This is a red flag that regulators should have been very concerned about.
From a statistical point of view, the extra deaths equal a risk of 1 out of 5,500 people in the vaccinated group. Again, the gold standard in drug trials is all-cause mortality. These data show an unacceptable level of risk associated with injecting the mRNA therapies. This was known at the six-month review point. Why were these warning signals ignored? Why was the study unblinded at that point? Was Pfizer afraid that if the trial continued that more such evidence would emerge?
It is time to hold people accountable!