How did the FDA arrive at the decision to approve Comirnaty (COVID-19 Vaccine mRNA)? What is different now when compared to the December 2020 authorization of Pfizer-BioNTech COVID-19 Vaccine?
FDA conducted a thorough evaluation of the data and information submitted in the Biologics License Application (BLA) for Comirnaty before making a determination that the vaccine is safe and effective in preventing COVID-19 in individuals 16 years of age and older.
The EUA for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial in approximately 18,000 individuals who received the vaccine and approximately 18,000 who received a placebo. The vaccine was 95% effective in preventing COVID-19 disease among these clinical trial participants with eight COVID-19 cases in the vaccine group and 162 in the placebo group. The duration of safety follow-up for the vaccinated and placebo participants was a median of two months after receiving the second dose.
Comments
Post a Comment