Six Month Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine
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 A. 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 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 as mentioned in this paper.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)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.
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mRNA vaccines induce durable immune memory to SARS-CoV-2 and variants of concern.
Rishi R. Goel,Mark M Painter,Sokratis A. Apostolidis,Divij Mathew,Wenzhao Meng,Aaron M. Rosenfeld,Kendall A. Lundgreen,Arnold Reynaldi,David S. Khoury,Ajinkya Pattekar,Sigrid Gouma,Leticia Kuri-Cervantes,Philip Hicks,Sarah Dysinger,Amanda Hicks,Harsh Sharma,Sarah Herring,Scott Korte,Amy E. Baxter,Derek A. Oldridge,Josephine R. Giles,Madison E. Weirick,Christopher M McAllister,Moses Awofolaju,Nicole Tanenbaum,Elizabeth M Drapeau,Jeanette Dougherty,Sherea Long,Kurt D'Andrea,Jacob T. Hamilton,Maura McLaughlin,Justine C. Williams,Sharon Adamski,Oliva Kuthuru,Ian Frank,Michael R. Betts,Laura A. Vella,Alba Grifoni,Daniela Weiskopf,Alessandro Sette,Alessandro Sette,Scott E. Hensley,Miles P. Davenport,Paul Bates,Eline T. Luning Prak,Allison R. Greenplate,E. John Wherry,S. Adamski,Z. Alam,M. M. Addison,K. T. Byrne,A. Chandra,H. C. Descamps,Nicholas Han,Y. Kaminskiy,S. C. Kammerman,Justin Kim,A. R. Greenplate,J. T. Hamilton,N. Markosyan,J. Han Noll,D. K. Omran,A. Pattekar,E. Perkey,E. M. Prager,D. Pueschl,A. Rennels,J. B. Shah,J. S. Shilan,N. Wilhausen,A. N. Vanderbeck +70 more
TL;DR: The durability of immune memory after SARS-CoV-2 mRNA vaccination was investigated in this article, where the majority of these cells cross-binding the Alpha, Beta, and Delta variants.
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Waning of BNT162b2 vaccine protection against SARS-CoV-2 infection in Qatar
Hiam Chemaitelly,Hiam Chemaitelly,Patrick Tang,Mohammad Rubayet Hasan,Sawsan AlMukdad,Sawsan AlMukdad,Hadi M. Yassine,Hadi M. Yassine,Fatiha M. Benslimane,Fatiha M. Benslimane,Hebah A. Al Khatib,Hebah A. Al Khatib,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 investigated the persistence of BNT162b2 (Pfizer-BioNTech) vaccine effectiveness against infection and disease in Qatar, where the Beta and Delta variants have dominated incidence and PCR testing is done at a mass scale.
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Duration of effectiveness of vaccines against SARS-CoV-2 infection and COVID-19 disease: results of a systematic review and meta-regression
Daniel R. Feikin,Melissa M. Higdon,Laith J. Abu-Raddad,Nick Andrews,Rafael Araos,Yair Goldberg,Michelle J. Groome,Amit Huppert,Katherine L. O’Brien,Pete Smith,Annelies Wilder-Smith,Scott L. Zeger,Maria Deloria Knoll,Minal Patel +13 more
TL;DR: COVID-19 vaccine efficacy or effectiveness against severe disease remained high, although it did decrease somewhat by 6 months after full vaccination, and the decrease is likely caused by, at least in part, waning immunity.
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Delta spike P681R mutation enhances SARS-CoV-2 fitness over Alpha variant
Yang Liu,Jianying Liu,Bryan A. Johnson,Hongjie Xia,Zhiqiang Ku,Craig Schindewolf,Steven G. Widen,Zhiqiang An,Scott C. Weaver,Vineet D. Menachery,Xuping Xie,Pei Yong Shi +11 more
TL;DR: In this paper, the Delta spike mutation P681R plays a key role in the Alpha-to-Delta variant replacement and the Delta SARS-CoV-2 Delta variant has rapidly replaced the Alpha variant around the world.
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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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