Summary
Pfizer told the world 15 people out of 22,000 people who received the vaccine in its trial had died as of mid-March. Turns out the real number then was 21, compared to only 17 deaths in people who hadn’t been vaccinated. Though the absolute numbers are small, overall deaths were 24% higher among vaccine recipients. All but three of the deaths were from other illnesses and diseases, mostly cardiovascular. Pfizer and Moderna mRNA vaccines were linked to heart inflammation in young men. Researchers stopped collecting data after six months. Pfizer and BioNTech gave their vaccines to almost all the placebo recipients in the trial beginning in December 2020, which destroyed the study for long-term analysis.
Details
Pfizer told the world 15 people who received the vaccine in its trial had died as of mid-March. Turns out the real number then was 21, compared to only 17 deaths in people who hadn’t been vaccinated.
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,”
https://www.medrxiv.org/content/10.1101/2021.07.28.21261159v1.supplementary-material)
SOURCE: Summary Basis for Regulatory Action,” a 30-page note explaining why on August 23 it granted full approval to Pfizer’s vaccine, replacing the emergency authorization from December 2020.
https://www.fda.gov/media/151733/download, page 23
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