Pfizer, BioNTech confirm high efficacy of COVID-19 vaccine up to 6 months

By The Science Advisory Board staff writers

April 2, 2021 -- Pfizer-BioNTech's BNT162b2 COVID-19 vaccine is 91.3% effective against the virus six days through up to six months after the second dose, according to results from a phase III study where 927 participants exhibited signs of COVID-19. Participants were followed through March 13, 2021.

In the study, 927 patients contracted COVID-19, 850 were in the placebo group, and 77 were in the vaccine group, equating to a 91.3% efficacy rate. However, BNT162b2 is 100% effective against severe disease as defined by the U.S. Centers for Disease Control and Prevention (CDC). Using the U.S. Food and Drug Administration's (FDA) definition of severe COVID-19, the vaccine is 95.3% effective.

In terms of variants, in South Africa where the B.1.351 variant is prevalent, 800 participants were enrolled in the study and nine cases of COVID-19 were observed, all in the placebo group. This indicates the vaccine is 100% effective against the variant.

Regarding safety data, the vaccine demonstrates a favorable safety and tolerability profile as demonstrated in data collected from more than 12,000 vaccinated participants with a follow-up time of at least six months after the second dose.

The data paves the way for Pfizer and BioNTech to submit a biologics license application to the FDA, the firms said.

Pfizer-BioNTech's COVID-19 vaccine shows 100% effectiveness in adolescents
Pfizer-BioNTech's BNT162b2 COVID-19 vaccine demonstrated 100% efficacy and robust antibody responses in people between the ages of 12 and 15, according...
Pfizer starts evaluation of SARS-CoV-2 oral antiviral
Pfizer is advancing its clinical research of PF-07321332, a new investigational oral antiviral therapy against SARS-CoV-2, to evaluate the safety and...
Pfizer-BioNTech study supports 97% effectiveness of COVID-19 vaccine
Real-world evidence released by the Israel Ministry of Health demonstrates dramatically lower incidence rates of COVID-19 disease in individuals fully...
Pfizer, BioNTech study 3rd booster of vaccine to protect against variants
Pfizer and BioNTech have started to evaluate the safety and immunogenicity of a third dose of their COVID-19 vaccine BNT162b2 as a booster on immunity...
Pfizer, BioNTech vaccine neutralizes SARS-CoV-2 variants in vitro
Pfizer and BioNTech has released results from in vitro neutralization studies of blood sera from individuals vaccinated with its COVID-19 vaccine, providing...

Copyright © 2021

Science Advisory Board on LinkedIn
Science Advisory Board on Facebook
Science Advisory Board on Twitter