On July 28, Pfizer and its partner BioNTech posted a six-month data update from their key Covid vaccine clinical trial, the one that led regulators worldwide to okay the shot.
At a time when questions about vaccine effectiveness were rising, the report received worldwide attention. Pfizer said the vaccine’s efficacy remained relatively strong, at 84 percent after six months.
It also reported 15 of the roughly 22,000 people who received the vaccine in the trial had died, compared to 14 of the 22,000 people who received placebo (a saline shot that didn’t contain the vaccine).
These were not just Covid deaths. In fact, they were mostly not from Covid. Only three of the people in the trial died of Covid-related illnesses – one who received the vaccine, and two who who received the saline shot. The other deaths were from other illnesses and diseases, mostly cardiovascular.
Researchers call this datapoint “all-cause mortality.” Pfizer barely mentioned it, stuffing the details of the deaths in an appendix to the report.
But all-cause mortality is arguably the MOST important measure for any drug or vaccine – especially one meant to be given prophylactically to large numbers of healthy people, as vaccines are.
(SOURCE: Appendix to “Six Month Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine,” available at https://www.medrxiv.org/content/10.1101/2021.07.28.21261159v1.supplementary-material)
Although the researchers released their update in July, the data was already more than four months old. They had stopped collecting information about deaths as of March 13, the “data cut-off.”
But even at the time, their figures were somewhat troubling.
In their initial safety report to the FDA, which contained data through November 2020, the researchers had said four placebo recipients and two vaccine recipients died, one after the first dose and one after the second. The July update reversed that trend. Between November 2020 and March 2021, 13 vaccine recipients died, compared to only 10 placebo subjects.
Further, nine vaccine recipients had died from cardiovascular events such as heart attacks or strokes, compared to six placebo recipients who died of those causes. The imbalance was small but notable, considering that regulators worldwide had found that the Pfizer and Moderna mRNA vaccines were linked to heart inflammation in young men.
(I reported accurately on this study on Twitter on July 29, and the next day Twitter suspended me for a week for doing so, the fourth of my five defamatory “strikes” for Covid “misinformation.”)
At best, the results suggested that the Pfizer/BioNTech vaccine – now pushed on nearly a billion people worldwide at a cost of tens of billions of dollars and ruinous and worsening civil liberties restrictions – did nothing to reduce overall deaths.
Worse, Pfizer and BioNTech had vaccinated almost all the placebo recipients in the trial shortly after the Food and Drug Administration okayed the vaccine for emergency use on Dec. 11, 2020.
As a result, they had destroyed our best chance to compare the long-term health of a large number of vaccine recipients with a scientifically balanced group of people who had not received the drug. The July 28 report appeared to be the last clean safety data update we would ever have.
