Mary Wilson
Well-known member
medRxiv preprint
doi: https://doi.org/10.1101/2021.07.28.21261159; this version posted July 28, 2021.
Stephen J. Thomas, M.D.1 , Edson D. Moreira Jr., M.D.2, Nicholas Kitchin, M.D.3a, Judith Absalon, M.D.3b, Alejandra Gurtman, M.D.3b, Stephen Lockhart, D.M.3a, John L. Perez, M.D.3c, Gonzalo Pérez Marc, M.D.4, Fernando P. Polack, M.D.5, Cristiano Zerbini, M.D.6, Ruth Bailey, B.Sc.3a, Kena A. Swanson, Ph.D.3b, Xia Xu, Ph.D.3c, Satrajit Roychoudhury, Ph.D.7, Kenneth Koury, Ph.D.3b, Salim Bouguermouh, M.D., Ph.D.3b, Warren V. Kalina, Ph.D.3b, David Cooper, Ph.D.3b, Robert W. Frenck, Jr., M.D.8, Laura L. Hammitt, M.D.9, Ӧzlem Türeci, M.D.10, Haylene Nell, M.D.11, Axel Schaefer, M.D.12, Serhat Ünal, M.D.13, Qi Yang, Ph.D.3b, Paul Liberator, Ph.D.3b, Dina B. Tresnan, D.V.M., Ph.D.14a, Susan Mather, M.D.14b, Philip R. Dormitzer, M.D., Ph.D.3b, Uğur Şahin, M.D.10; William C. Gruber, M.D.3b, Kathrin U. Jansen, Ph.D.3b and the C4591001 Clinical Trial Group
ABSTRACT
Background: BNT162b2 is a lipid nanoparticle-formulated, nucleoside-modified RNA vaccine encoding a prefusion-stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. BNT162b2 is highly efficacious against COVID-19 and is currently authorized for emergency use or conditional approval worldwide. At the time of authorization, data beyond 2 months post- vaccination were unavailable.
Methods: In an ongoing, placebo-controlled, observer-blinded, multinational, pivotal efficacy study, 44,165 ≥16-year-old participants and 2,264 12-15-year-old participants were randomized to receive 2 doses, 21 days apart, of 30 μg BNT162b2 or placebo. Study endpoints reported here are vaccine efficacy (VE) against laboratory-confirmed COVID-19 and safety data, both up to 6 months post-vaccination.
Results: BNT162b2 continued to be safe and well tolerated. Few participants had adverse events leading to study withdrawal. VE against COVID-19 was 91% (95% CI 89.0‒93.2) through up to 6 months of follow-up, among evaluable participants and irrespective of previous SARS-CoV-2 infection. VE of 86%‒100% was seen across countries and in populations with diverse characteristics of age, sex, race/ethnicity, and COVID-19 risk factors in participants without evidence of previous SARS-CoV-2 infection. VE against severe disease was 97% (95% CI 80.3‒99.9). In South Africa, where the SARS-CoV-2 variant of concern, B.1.351 (beta), was predominant, 100% (95% CI 53.5, 100.0) VE was observed.
Conclusion: With up to 6 months of follow-up and despite a gradually declining trend in vaccine efficacy, BNT162b2 had a favorable safety profile and was highly efficacious in preventing COVID-19. (ClinicalTrials.gov number, NCT04368728)
https://www.medrxiv.org/content/10.1101/2021.07.28.21261159v1.full.pdf
doi: https://doi.org/10.1101/2021.07.28.21261159; this version posted July 28, 2021.
Stephen J. Thomas, M.D.1 , Edson D. Moreira Jr., M.D.2, Nicholas Kitchin, M.D.3a, Judith Absalon, M.D.3b, Alejandra Gurtman, M.D.3b, Stephen Lockhart, D.M.3a, John L. Perez, M.D.3c, Gonzalo Pérez Marc, M.D.4, Fernando P. Polack, M.D.5, Cristiano Zerbini, M.D.6, Ruth Bailey, B.Sc.3a, Kena A. Swanson, Ph.D.3b, Xia Xu, Ph.D.3c, Satrajit Roychoudhury, Ph.D.7, Kenneth Koury, Ph.D.3b, Salim Bouguermouh, M.D., Ph.D.3b, Warren V. Kalina, Ph.D.3b, David Cooper, Ph.D.3b, Robert W. Frenck, Jr., M.D.8, Laura L. Hammitt, M.D.9, Ӧzlem Türeci, M.D.10, Haylene Nell, M.D.11, Axel Schaefer, M.D.12, Serhat Ünal, M.D.13, Qi Yang, Ph.D.3b, Paul Liberator, Ph.D.3b, Dina B. Tresnan, D.V.M., Ph.D.14a, Susan Mather, M.D.14b, Philip R. Dormitzer, M.D., Ph.D.3b, Uğur Şahin, M.D.10; William C. Gruber, M.D.3b, Kathrin U. Jansen, Ph.D.3b and the C4591001 Clinical Trial Group
ABSTRACT
Background: BNT162b2 is a lipid nanoparticle-formulated, nucleoside-modified RNA vaccine encoding a prefusion-stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. BNT162b2 is highly efficacious against COVID-19 and is currently authorized for emergency use or conditional approval worldwide. At the time of authorization, data beyond 2 months post- vaccination were unavailable.
Methods: In an ongoing, placebo-controlled, observer-blinded, multinational, pivotal efficacy study, 44,165 ≥16-year-old participants and 2,264 12-15-year-old participants were randomized to receive 2 doses, 21 days apart, of 30 μg BNT162b2 or placebo. Study endpoints reported here are vaccine efficacy (VE) against laboratory-confirmed COVID-19 and safety data, both up to 6 months post-vaccination.
Results: BNT162b2 continued to be safe and well tolerated. Few participants had adverse events leading to study withdrawal. VE against COVID-19 was 91% (95% CI 89.0‒93.2) through up to 6 months of follow-up, among evaluable participants and irrespective of previous SARS-CoV-2 infection. VE of 86%‒100% was seen across countries and in populations with diverse characteristics of age, sex, race/ethnicity, and COVID-19 risk factors in participants without evidence of previous SARS-CoV-2 infection. VE against severe disease was 97% (95% CI 80.3‒99.9). In South Africa, where the SARS-CoV-2 variant of concern, B.1.351 (beta), was predominant, 100% (95% CI 53.5, 100.0) VE was observed.
Conclusion: With up to 6 months of follow-up and despite a gradually declining trend in vaccine efficacy, BNT162b2 had a favorable safety profile and was highly efficacious in preventing COVID-19. (ClinicalTrials.gov number, NCT04368728)
https://www.medrxiv.org/content/10.1101/2021.07.28.21261159v1.full.pdf