EUA for BioNTech Manufacturing GmbH (in partnership with Pfizer, Inc.)
“In the U.S., there are no licensed vaccines or anti-viral drugs for the prevention of COVID-19…
7. Safety and Pharmacovigilance…
Among participants 16 through 55 years of age who had received at least 1 dose of COMIRNATY (N=12,995) or placebo (N=13,026), serious adverse events from Dose 1 up to the participant unblinding date in ongoing follow-up were reported by 103 (0.8%) COMIRNATY recipients and 117 (0.9%) placebo recipients. In a similar analysis in participants 56 years of age and older (COMIRNATY=8,931, placebo=8,895), serious adverse events were reported by 165 (1.8%) COMIRNATY recipients and 151 (1.7%) placebo recipients who received at least 1 dose of COMIRNATY or placebo, respectively...
From Dose 1 through the March 13, 2021 data cutoff date, there were a total of 38 deaths, 21 in the COMIRNATY group and 17 in the placebo group. None of the deaths were considered related to vaccination.”
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