December 10, 2020 | Fernando P. Polack, M.D., Stephen J. Thomas, M.D., Nicholas Kitchin, M.D., Judith Absalon, M.D., Alejandra Gurtman, M.D., Stephen Lockhart, D.M., John L. Perez, M.D., Gonzalo Pérez Marc, M.D., Edson D. Moreira, M.D., Cristiano Zerbinii, M.D., Ruth Bailey, B.Sc., Kena A. Swanson, Ph.D., Satrajit Roychoudhury, Ph.D., Kenneth Koury, Ph.D., Ping Li, Ph.D., Warren V. Kalina, Ph.D., David Cooper, Ph.D., Robert W. Frenck, Jr., M.D., Laura L. Hammitt, M.D., Özlem Türeci, M.D., Haylene Nell, M.D., Axel Schaefer, M.D., Serhat Ünal, M.D., Dina B. Tresnan, D.V.M., Ph.D., Susan Mather, M.D., Philip R. Dormitzer, M.D., Ph.D., Uğur Şahin, M.D., Kathrin U. Jansen, Ph.D., and William C. Gruber, M.D., for the C4591001 Clinical Trial Group
The BNT162b2 mRNA Covid-19 vaccine, developed by BioNTech and Pfizer, was found to be safe and highly effective in preventing Covid-19. In a multinational, placebo-controlled trial, 43,548 participants aged 16 years or older were randomly assigned to receive either two doses of BNT162b2 (30 μg per dose, 21 days apart) or a placebo. The primary endpoints were efficacy against laboratory-confirmed Covid-19 and safety. The results showed that BNT162b2 was 95% effective in preventing Covid-19, with a 95% credible interval of 90.3 to 97.6. Similar efficacy was observed across various subgroups, including age, sex, race, ethnicity, body-mass index, and the presence of coexisting conditions. The safety profile was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache, with a low incidence of serious adverse events. The study concluded that a two-dose regimen of BNT162b2 provided 95% protection against Covid-19 and had a safety profile similar to other viral vaccines.The BNT162b2 mRNA Covid-19 vaccine, developed by BioNTech and Pfizer, was found to be safe and highly effective in preventing Covid-19. In a multinational, placebo-controlled trial, 43,548 participants aged 16 years or older were randomly assigned to receive either two doses of BNT162b2 (30 μg per dose, 21 days apart) or a placebo. The primary endpoints were efficacy against laboratory-confirmed Covid-19 and safety. The results showed that BNT162b2 was 95% effective in preventing Covid-19, with a 95% credible interval of 90.3 to 97.6. Similar efficacy was observed across various subgroups, including age, sex, race, ethnicity, body-mass index, and the presence of coexisting conditions. The safety profile was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache, with a low incidence of serious adverse events. The study concluded that a two-dose regimen of BNT162b2 provided 95% protection against Covid-19 and had a safety profile similar to other viral vaccines.