On Nov. 8, the Food and Drug Administration published a report updating the clinical trial results of Pfizer’s mRNA-based COVID-19 vaccine. The trial included around 44,000 people over the age of 16, equally divided into two groups. One group received the vaccine and the other a placebo.
Page 23 of the report showed that over the course of the trial, there were a total of 38 deaths among participants: 21 in the vaccinated group and 17 in the placebo group. Because the number of deaths in the vaccinated group was not significantly less than the placebo group (but is, in fact, more than the placebo group), the vaccine failed to prove itself by the standard of all-cause mortality.
All-cause mortality is the number of death due to any cause in both the control and treated groups of a clinical trial. This is not the most reliable clinical endpoint for the evaluation of a medical treatment that is supposed to reduce mortality because it is objective and properly accounts for unanticipated effects, which may offset the anticipated benefits of a treatment.
The National Academy of Sciences published a volume that explained the evaluative advantage of all-cause mortality with many lessons from the annals of medical history. A contributor to the volume, renowned anesthetist John P. Bunker, said: “When dealing with mortality as an endpoint of treatment, all-cause mortality is ignored at the peril of the investigators and the public.”
The burden of proving statistical significance is on the vaccine, not the placebo. The primary hypothesis of the clinical trial was that the vaccine would save lives, and for the hypothesis to be upheld, the death rate in the vaccinated group had to be significantly less than that of the placebo group – which did not happen in this case.
There is currently no scientific basis for retaining the hypothesis that the administration of the Pfizer COVID-19 vaccine could save lives....<<<Read More>>>...