FDA scientists endorse ‘highly effective’ Pfizer/BioNTech Covid-19 vaccine ahead of key panel
Scientists at the Food and Drug Administration endorsed the efficacy and safety of the Covid-19 vaccine from Pfizer and BioNTech in detailed documents released Tuesday, setting the stage for an emergency authorization as early as this week.
The documents are a prelude to a Thursday meeting of outside experts, which is likely the final step before the FDA grants an emergency use authorization, or EUA. The FDA reviewers state that the two-dose vaccine was “highly effective” in preventing symptomatic Covid-19, and that the data “suggest a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA.” The data also suggest that the two-dose vaccine may begin preventing some Covid-19 cases after the first dose.
