Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months.
Stephen J. Thomas,Edson D. Moreira,Nicholas Kitchin,Judith Absalon,Alejandra Gurtman,Stephen Lockhart,John L. Perez,Gonzalo Pérez Marc,Fernando P. Polack,Cristiano Zerbini,Ruth Bailey,Kena A. Swanson,Xia Xu,Satrajit Roychoudhury,Kenneth Koury,Salim Bouguermouh,Warren Kalina,David K. C. Cooper,Robert W. Frenck,Laura L. Hammitt,Özlem Türeci,Haylene Nell,Axel Schaefer,Serhat Ünal,Qi Yang,Paul A. Liberator,Dina B. Tresnan,Susan Mather,Philip R. Dormitzer,Ugur Sahin,William C. Gruber,Kathrin U. Jansen +31 more
TLDR
In this paper, BNT162b2 is a lipid nanoparticle-formulated, nucleoside-modified RNA vaccine encoding a prefusion-stabilized, membrane-anchored full-length spike protein.Abstract:
Background BNT162b2 is a lipid nanoparticle-formulated, nucleoside-modified RNA vaccine encoding a prefusion-stabilized, membrane-anchored severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) full-length spike protein. BNT162b2 is highly efficacious against coronavirus disease 2019 (Covid-19) and is currently approved, conditionally approved, or authorized for emergency use worldwide. At the time of initial authorization, data beyond 2 months after vaccination were unavailable. Methods In an ongoing, placebo-controlled, observer-blinded, multinational, pivotal efficacy trial, we randomly assigned 44,165 participants 16 years of age or older and 2264 participants 12 to 15 years of age to receive two 30-μg doses, at 21 days apart, of BNT162b2 or placebo. The trial end points were vaccine efficacy against laboratory-confirmed Covid-19 and safety, which were both evaluated through 6 months after vaccination. Results BNT162b2 continued to be safe and have an acceptable adverse-event profile. Few participants had adverse events leading to withdrawal from the trial. Vaccine efficacy against Covid-19 was 91.3% (95% confidence interval [CI], 89.0 to 93.2) through 6 months of follow-up among the participants without evidence of previous SARS-CoV-2 infection who could be evaluated. There was a gradual decline in vaccine efficacy. Vaccine efficacy of 86 to 100% was seen across countries and in populations with diverse ages, sexes, race or ethnic groups, and risk factors for Covid-19 among participants without evidence of previous infection with SARS-CoV-2. Vaccine efficacy against severe disease was 96.7% (95% CI, 80.3 to 99.9). In South Africa, where the SARS-CoV-2 variant of concern B.1.351 (or beta) was predominant, a vaccine efficacy of 100% (95% CI, 53.5 to 100) was observed. Conclusions Through 6 months of follow-up and despite a gradual decline in vaccine efficacy, BNT162b2 had a favorable safety profile and was highly efficacious in preventing Covid-19. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.).read more
Citations
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Effectiveness of mRNA BNT162b2 COVID-19 vaccine up to 6 months in a large integrated health system in the USA: a retrospective cohort study.
Sara Y. Tartof,Jeff Slezak,Heidi Fischer,Vennis Hong,Bradley Ackerson,Omesh N. Ranasinghe,Timothy B. Frankland,Oluwaseye A. Ogun,Joann M. Zamparo,Sharon Gray,Srinivas Rao Valluri,Kaije Pan,Frederick J. Angulo,Luis Jodar,John M McLaughlin +14 more
TL;DR: In this paper, the overall and variant-specific effectiveness of BNT162b2 (tozinameran, Pfizer BioNTech) against SARS-CoV-2 infections and COVID-19-related hospital admissions by time since vaccination among members of a large US health-care system was evaluated.
Journal ArticleDOI
Comparing COVID-19 vaccines for their characteristics, efficacy and effectiveness against SARS-CoV-2 and variants of concern: A narrative review.
TL;DR: In this article, the authors provide an up-to-date comparative analysis of the characteristics, adverse events, efficacy, effectiveness and impact of the variants of concern for nineteen COVID-19 vaccines.
Journal ArticleDOI
Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age.
Emmanuel B. Walter,Kawsar R. Talaat,Charu Sabharwal,Alejandra Gurtman,Stephen Lockhart,Grant Paulsen,Elizabeth D. Barnett,Flor M. Munoz,Yvonne Maldonado,Barbara A. Pahud,Joseph B. Domachowske,Eric A. F. Simões,Uzma N. Sarwar,Nicholas Kitchin,Luke Cunliffe,Pablo Rojo,Ernest Kuchar,Mika Rämet,Iona Munjal,John L. Perez,Robert W. Frenck,Eleni Lagkadinou,Kena A. Swanson,Hua Ma,Xia Xu,Kenneth Koury,Susan Mather,Todd Belanger,David K. C. Cooper,Özlem Türeci,Philip R. Dormitzer,Ugur Sahin,Kathrin U. Jansen,William C. Gruber +33 more
TL;DR: A phase 1, dose-finding study and an ongoing phase 2-3 randomized trial are being conducted to investigate the safety, immunogenicity, and efficacy of two doses of the BNT162b2 vaccine administered 21 days apart in children 6 months to 11 years of age.
Neutralising antibody titres as predictors of protection against SARS-CoV-2 variants and the impact of boosting: a meta-analysis.
Deborah Cromer,Megan Steain,Arnold Reynaldi,Timothy E. Schlub,Timothy E. Schlub,Adam K. Wheatley,Jennifer A Juno,Stephen J. Kent,Stephen J. Kent,James A. Triccas,David S. Khoury,Miles P. Davenport +11 more
TL;DR: In this paper, the authors explored whether in-vitro neutralization titres remain predictive of vaccine protection from infection with SARS-CoV-2 variants and used the model to predict the impact of booster vaccination on protection against SARS CoV2 variants.
Journal ArticleDOI
BNT162b2 and mRNA-1273 COVID-19 vaccine effectiveness against the SARS-CoV-2 Delta variant in Qatar.
Patrick Tang,Mohammad Rubayet Hasan,Hiam Chemaitelly,Hiam Chemaitelly,Hadi M. Yassine,Hadi M. Yassine,Fatiha M. Benslimane,Fatiha M. Benslimane,Hebah A. Al Khatib,Hebah A. Al Khatib,Sawsan AlMukdad,Sawsan AlMukdad,Peter Coyle,Peter Coyle,Peter Coyle,Houssein H. Ayoub,Zaina Al Kanaani,Einas Al Kuwari,Andrew Jeremijenko,Anvar Hassan Kaleeckal,Ali Nizar Latif,Riyazuddin Mohammad Shaik,Hanan F. Abdul Rahim,Gheyath K. Nasrallah,Gheyath K. Nasrallah,Mohamed Ghaith Al Kuwari,Hamad Eid Al Romaihi,Adeel A. Butt,Adeel A. Butt,Mohamed H. Al-Thani,Abdullatif Al Khal,Roberto Bertollini,Laith J. Abu-Raddad +32 more
TL;DR: In this article, the authors conducted a matched test-negative case-control study to assess the real-world effectiveness of COVID-19 messenger RNA vaccines against infection with Delta in Qatar's population.
References
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Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine.
Fernando P. Polack,Stephen J. Thomas,Nicholas Kitchin,Judith Absalon,Alejandra Gurtman,Stephen Lockhart,John L. Perez,Gonzalo Pérez Marc,Edson D. Moreira,Cristiano Zerbini,Ruth Bailey,Kena A. Swanson,Satrajit Roychoudhury,Kenneth Koury,Ping Li,Warren Kalina,David A. Cooper,Robert W. Frenck,Laura L. Hammitt,Özlem Türeci,Haylene Nell,Axel Schaefer,Serhat Ünal,Dina B. Tresnan,Susan Mather,Philip R. Dormitzer,Ugur Sahin,Kathrin U. Jansen,William C. Gruber +28 more
TL;DR: A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older and safety over a median of 2 months was similar to that of other viral vaccines.
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Cryo-EM structure of the 2019-nCoV spike in the prefusion conformation.
Daniel Wrapp,Nianshuang Wang,Kizzmekia S. Corbett,Jory A. Goldsmith,Ching-Lin Hsieh,Olubukola M. Abiona,Barney S. Graham,Jason S. McLellan +7 more
TL;DR: The authors show that this protein binds at least 10 times more tightly than the corresponding spike protein of severe acute respiratory syndrome (SARS)–CoV to their common host cell receptor, and test several published SARS-CoV RBD-specific monoclonal antibodies found that they do not have appreciable binding to 2019-nCoV S, suggesting that antibody cross-reactivity may be limited between the two RBDs.
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Edward E. Walsh,Robert W. Frenck,Ann R. Falsey,Ann R. Falsey,Nicholas Kitchin,Judith Absalon,Alejandra Gurtman,Stephen Lockhart,Kathleen M. Neuzil,Mark J. Mulligan,Ruth Bailey,Kena A. Swanson,Ping Li,Kenneth Koury,Warren Kalina,David A. Cooper,Camila R. Fontes-Garfias,Pei Yong Shi,Özlem Türeci,Tompkins Kristin Rachael,Kirsten E. Lyke,Vanessa Raabe,Philip R. Dormitzer,Kathrin U. Jansen,Ugur Sahin,William C. Gruber +25 more
TL;DR: The safety and immunogenicity data from this U.S. phase 1 trial of two vaccine candidates in younger and older adults support the selection of BNT162b2 for advancement to a pivotal phase 2–3 safety and efficacy evaluation.
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BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting.
Noa Dagan,Noam Barda,Noam Barda,Noam Barda,Eldad Kepten,Oren Miron,Oren Miron,Shay Perchik,Mark A. Katz,Mark A. Katz,Mark A. Katz,Miguel A. Hernán,Marc Lipsitch,Ben Y. Reis,Ran D. Balicer,Ran D. Balicer +15 more
TL;DR: This study in a nationwide mass vaccination setting suggests that the BNT162b2 mRNA vaccine is effective for a wide range of Covid-19–related outcomes, a finding consistent with that of the randomized trial.
Journal ArticleDOI
Impact and effectiveness of mRNA BNT162b2 vaccine against SARS-CoV-2 infections and COVID-19 cases, hospitalisations, and deaths following a nationwide vaccination campaign in Israel: an observational study using national surveillance data.
Eric J. Haas,Eric J. Haas,Frederick J. Angulo,John M McLaughlin,Emilia Anis,Emilia Anis,Shepherd Roee Singer,Shepherd Roee Singer,Farid Khan,Nati Brooks,Meir Smaja,Gabriel Mircus,Kaijie Pan,Jo Southern,David L. Swerdlow,Luis Jodar,Yeheskel Levy,Sharon Alroy-Preis +17 more
TL;DR: In this article, the real-world effectiveness of two doses of BNT162b2 against a range of SARS-CoV-2 outcomes and to evaluate the nationwide public-health impact following the widespread introduction of the vaccine was estimated.
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