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FDA report finds all-cause mortality higher among vaccinated – Israel Nation News

FDA report shows Pfizer’s clinical trials found 24% higher all-cause mortality rate among the vaccinated compared to placebo group.

The clinical trials of Pfizer’s coronavirus vaccine found that the all-cause mortality rate of the vaccinated group was higher than that of the control group, months after the trials were launched, according to a recently released FDA report.

According to the report, which was released by the US Food and Drug Administration to provide background information on its August 2021 decision to grant full approval for the Pfizer-BioNTech coronavirus vaccine after offering limited emergency authorization of use in last December, six months after the vaccine’s clinical trial began, the total number of deaths reported in the vaccinated group was nearly one-quarter higher than the number of deaths in the placebo group.

http://archive.today/2021.11.19-040650/https://www.israelnationalnews.com/News/News.aspx/317091

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November 8, 2021 Summary Basis for Regulatory Action – Comirnaty – FDA

Introduction

BioNTech Manufacturing GmbH (in partnership with Pfizer Inc.) submitted a Biologics License Application (BLA) STN BL 125742 for licensure of COVID-19 Vaccine, mRNA. The proprietary name of the vaccine is COMIRNATY. COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The vaccine is administered intramuscularly (IM) as a series of two 30 μg doses (0.3 mL each) 3 weeks apart.

For commentary, see FDA report finds all-cause mortality higher among vaccinated – Israel Nation News.

http://archive.today/2021.10.11-032110/https://www.fda.gov/media/151733/download