Pfizer, BioNTech: Vaccine More Than 91% Effective After 6 Months In Study

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Pfizer Inc. (PFE) and BioNTech SE (BNTX) announced updated topline results from analysis of 927 confirmed symptomatic cases of COVID-19 observed in their pivotal Phase 3 study through March 13, 2021, showing the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, was 91.3% effective against COVID-19, measured seven days through up to six months after the second dose.

The vaccine was 100% effective against severe disease as defined by the U.S. Centers for Disease Control and Prevention, and 95.3% effective against severe COVID-19 as defined by the U.S. Food and Drug Administration. Safety data from the Phase 3 study has also been collected from more than 12,000 vaccinated participants who have a follow-up time of at least six months after the second dose, demonstrating a favorable safety and tolerability profile. These data confirm the favorable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the U.S. FDA, said Albert Bourla, Chairman and CEO, Pfizer.  "The high vaccine efficacy observed through up to six months following a second dose and against the variant prevalent in South Africa provides further confidence in our vaccine's overall effectiveness."

The updated analysis of Phase 3 clinical trial was conducted in accordance with guidance from the FDA for all companies investigating COVID-19 vaccines to review safety and efficacy at key milestones. Results from this analysis of 46,307 trial participants build upon and confirm previously released data and demonstrate strong protection against COVID-19 through six months post-second dose. From the 927 confirmed symptomatic cases of COVID-19 in the trial, 850 cases of COVID-19 were in the placebo group and 77 cases were in the BNT162b2 group, corresponding to a vaccine efficacy of 91.3%.