FDA insists deaths unrelated to vaccine trial
Six people died during trials testing Pfizer’s new Covid vaccine, the US Food and Drug Administration announced Tuesday.
At the same time, the FDA insisted the deaths posed no threat to the safety or effectiveness of the vaccine.
The statements were featured in a 53-page report from the FDA Tuesday which detailed the trial by Pfizer and BioNTech back in November.
According to the report, only two people who died during the trial had received the vaccine, while four others had received a placebo, leading researchers to claim there was no connection between the deaths and the vaccines.
The report notes:
Both vaccine recipients were >55 years of age; one experienced a cardiac arrest 62 days after vaccination #2 and died 3 days later, and the other died from arteriosclerosis 3 days after vaccination #1.
The placebo recipients died from myocardial infarction (n=1), hemorrhagic
stroke (n=1) or unknown causes (n=2); three of the four deaths occurred in the older group (>55 years of age).
“All deaths represent events that occur in the general population of the age groups where they occurred, at a similar rate,” the report said.