Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months

September 15, 2021 | S.J. Thomas, E.D. Moreira, Jr., N. Kitchin, J. Absalon, A. Gurtman, S. Lockhart, J.L. Perez, G. Perez Marc, F.P. Polack, C. Zerbinii, R. Bailey, K.A. Swanson, X. Xu, S. Roychoudhury, K. Koury, S. Bouguermouh, W.V. Kalina, D. Cooper, R.W. Frenck, Jr., L.L. Hammitt, Ö. Türeci, H. Nell, A. Schaefer, S. Ünal, Q. Yang, P. Liberator, D.B. Tresnan, S. Mather, P.R. Dormitzer, U. Şahin, W.C. Gruber, and K.U. Jansen, for the C4591001 Clinical Trial Group*
The study evaluates the safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine through 6 months after vaccination. The vaccine, which is highly efficacious against Covid-19, was found to be safe and have an acceptable adverse-event profile. Vaccine efficacy against Covid-19 was 91.3% (95% CI, 89.0 to 93.2) among participants without evidence of previous SARS-CoV-2 infection, with a gradual decline in efficacy over time. Efficacy against severe disease was 96.7% (95% CI, 80.3 to 99.9). In South Africa, where the B.1.351 variant was prevalent, the vaccine efficacy was 100% (95% CI, 53.5 to 100). The vaccine showed consistent efficacy across diverse populations, including age, sex, race, and risk factors for Covid-19. Safety data confirmed the favorable safety profile observed at a median of 2 months after immunization. The study concludes that BNT162b2 remains highly effective in preventing Covid-19 up to 6 months after the second dose, despite the emergence of SARS-CoV-2 variants.The study evaluates the safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine through 6 months after vaccination. The vaccine, which is highly efficacious against Covid-19, was found to be safe and have an acceptable adverse-event profile. Vaccine efficacy against Covid-19 was 91.3% (95% CI, 89.0 to 93.2) among participants without evidence of previous SARS-CoV-2 infection, with a gradual decline in efficacy over time. Efficacy against severe disease was 96.7% (95% CI, 80.3 to 99.9). In South Africa, where the B.1.351 variant was prevalent, the vaccine efficacy was 100% (95% CI, 53.5 to 100). The vaccine showed consistent efficacy across diverse populations, including age, sex, race, and risk factors for Covid-19. Safety data confirmed the favorable safety profile observed at a median of 2 months after immunization. The study concludes that BNT162b2 remains highly effective in preventing Covid-19 up to 6 months after the second dose, despite the emergence of SARS-CoV-2 variants.
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