Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine
Autor(a) principal: | |
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Data de Publicação: | 2020 |
Outros Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da FIOCRUZ (ARCA) |
Texto Completo: | https://www.arca.fiocruz.br/handle/icict/46039 |
Resumo: | BioNTech |
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Polack, Fernando PedroThomas, Stephen J.Kitchin, NicholasAbsalon, JudithGurtman, AlejandraLockhart, StephenL. Perez, JohnPérez Marc, GonzaloMoreira Junior, Edson DuarteZerbini, Cristiano Augusto de FreitasBailey, RuthSwanson, Kena A.Roychoudhury, SatrajitKoury, KennethPing, LiKalina, Warren V.Cooper, DavidFrenck Jr., Robert W.Hammitt, Laura L.Türeci, ÖzlemNell, HayleneSchaefer, AxelÜnal, SerhatTresnan, Dina B.Mather, SusanDormitzer, Philip R.Şahin, UğurJansen, Kathrin U.Gruber, William C.2021-02-11T13:05:55Z2021-02-11T13:05:55Z2020POLACK, Fernando Pedro et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. New England Journal of Medicine, v. 383, n. 27, p. 2603-2615, 10 Dec. 2020.0028-4793https://www.arca.fiocruz.br/handle/icict/4603910.1056/NEJMoa20345771533-4406BioNTechPfizerClinicalTrials.gov number, NCT04368728Fundación para la Investigación en Infectología Infantil. Buenos Aires, Argentina.State University of New York. Upstate Medical University. Syracuse, NY, United States.Pfizer. Vaccine Clinical Research and Development Group. Hurley, United Kingdom.Pfizer. Vaccine Clinical Research and Development Group. Pearl River, NY, United States.Pfizer. Vaccine Clinical Research and Development Group. Pearl River, NY, United States.Pfizer. Vaccine Clinical Research and Development Group. Hurley, United Kingdom.Pfizer. Vaccine Clinical Research and Development Group. Collegeville, PA, United States.iTrials-Hospital Militar Central. Buenos Aires, Argentina.Obras Sociais Irmã Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil.Centro Paulista de Investigação Clínica. São Paulo, SP, Brasil.Pfizer. Vaccine Clinical Research and Development Group. Hurley, United Kingdom.Pfizer. Vaccine Clinical Research and Development Group. Pearl River, NY, United States.Pfizer. Global Product Development. Peapack, NJ, United States.Pfizer. Vaccine Clinical Research and Development Group. Pearl River, NY, United States.Pfizer. Vaccine Clinical Research and Development Group. Collegeville, PA, United States.Pfizer. Vaccine Clinical Research and Development Group. Pearl River, NY, United States.Pfizer. Vaccine Clinical Research and Development Group. Pearl River, NY, United States.Cincinnati Children's Hospital Medical Center. Cincinnati, OH, United States.Johns Hopkins Bloomberg School of Public Health. Baltimore, MD, United States.BioNTech. Mainz, Deutschland.Tiervlei Trial Centre. Karl Bremer Hospital. Cape Town, South Africa.Medizentrum-Essen-Borbeck. Essen, Deutschland.Hacettepe Üniversitesi. Ankara, Türkiye.Pfizer. Safety Surveillance and Risk Management. Worldwide Safety. Groton, CT, United States.Pfizer. Safety Surveillance and Risk Management. Worldwide Safety. Collegeville, PA, United States.Pfizer. Vaccine Clinical Research and Development Group. Pearl River, NY, United States.BioNTech. Mainz, Deutschland.Pfizer. Vaccine Clinical Research and Development Group. Pearl River, NY, United States.Pfizer. Vaccine Clinical Research and Development Group. Pearl River, NY, United States.BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. METHODS: In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 fulllength spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. RESULTS: A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. CONCLUSIONS: A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines.engMassachusetts Medical SocietyCOVID-19Vacinas viraisSegurançaEficáciaSARS-CoV-2BetacoronavirusInfecçõesPandemiaCOVID-19Viral vaccineSafetyEfficacySARS-CoV-2BetacoronavirusInfectionPandemicSafety and efficacy of the BNT162b2 mRNA Covid-19 vaccineinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-83097https://www.arca.fiocruz.br/bitstream/icict/46039/1/license.txt36b51ef91c52b5338d9d29ba0cc807bcMD51ORIGINALPolack, Fernando P Safety....pdfPolack, Fernando P Safety....pdfapplication/pdf774219https://www.arca.fiocruz.br/bitstream/icict/46039/2/Polack%2c%20Fernando%20P%20Safety....pdf3bf357f6ff6a3b9e41987bb209d748c9MD52TEXTPolack, Fernando P Safety....pdf.txtPolack, Fernando P Safety....pdf.txtExtracted 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dc.title.pt_BR.fl_str_mv |
Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine |
title |
Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine |
spellingShingle |
Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine Polack, Fernando Pedro COVID-19 Vacinas virais Segurança Eficácia SARS-CoV-2 Betacoronavirus Infecções Pandemia COVID-19 Viral vaccine Safety Efficacy SARS-CoV-2 Betacoronavirus Infection Pandemic |
title_short |
Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine |
title_full |
Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine |
title_fullStr |
Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine |
title_full_unstemmed |
Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine |
title_sort |
Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine |
author |
Polack, Fernando Pedro |
author_facet |
Polack, Fernando Pedro Thomas, Stephen J. Kitchin, Nicholas Absalon, Judith Gurtman, Alejandra Lockhart, Stephen L. Perez, John Pérez Marc, Gonzalo Moreira Junior, Edson Duarte Zerbini, Cristiano Augusto de Freitas Bailey, Ruth Swanson, Kena A. Roychoudhury, Satrajit Koury, Kenneth Ping, Li Kalina, Warren V. Cooper, David Frenck Jr., Robert W. Hammitt, Laura L. Türeci, Özlem Nell, Haylene Schaefer, Axel Ünal, Serhat Tresnan, Dina B. Mather, Susan Dormitzer, Philip R. Şahin, Uğur Jansen, Kathrin U. Gruber, William C. |
author_role |
author |
author2 |
Thomas, Stephen J. Kitchin, Nicholas Absalon, Judith Gurtman, Alejandra Lockhart, Stephen L. Perez, John Pérez Marc, Gonzalo Moreira Junior, Edson Duarte Zerbini, Cristiano Augusto de Freitas Bailey, Ruth Swanson, Kena A. Roychoudhury, Satrajit Koury, Kenneth Ping, Li Kalina, Warren V. Cooper, David Frenck Jr., Robert W. Hammitt, Laura L. Türeci, Özlem Nell, Haylene Schaefer, Axel Ünal, Serhat Tresnan, Dina B. Mather, Susan Dormitzer, Philip R. Şahin, Uğur Jansen, Kathrin U. Gruber, William C. |
author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author author author author author |
dc.contributor.author.fl_str_mv |
Polack, Fernando Pedro Thomas, Stephen J. Kitchin, Nicholas Absalon, Judith Gurtman, Alejandra Lockhart, Stephen L. Perez, John Pérez Marc, Gonzalo Moreira Junior, Edson Duarte Zerbini, Cristiano Augusto de Freitas Bailey, Ruth Swanson, Kena A. Roychoudhury, Satrajit Koury, Kenneth Ping, Li Kalina, Warren V. Cooper, David Frenck Jr., Robert W. Hammitt, Laura L. Türeci, Özlem Nell, Haylene Schaefer, Axel Ünal, Serhat Tresnan, Dina B. Mather, Susan Dormitzer, Philip R. Şahin, Uğur Jansen, Kathrin U. Gruber, William C. |
dc.subject.other.pt_BR.fl_str_mv |
COVID-19 Vacinas virais Segurança Eficácia SARS-CoV-2 Betacoronavirus Infecções Pandemia |
topic |
COVID-19 Vacinas virais Segurança Eficácia SARS-CoV-2 Betacoronavirus Infecções Pandemia COVID-19 Viral vaccine Safety Efficacy SARS-CoV-2 Betacoronavirus Infection Pandemic |
dc.subject.en.en.fl_str_mv |
COVID-19 Viral vaccine Safety Efficacy SARS-CoV-2 Betacoronavirus Infection Pandemic |
description |
BioNTech |
publishDate |
2020 |
dc.date.issued.fl_str_mv |
2020 |
dc.date.accessioned.fl_str_mv |
2021-02-11T13:05:55Z |
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2021-02-11T13:05:55Z |
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dc.identifier.citation.fl_str_mv |
POLACK, Fernando Pedro et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. New England Journal of Medicine, v. 383, n. 27, p. 2603-2615, 10 Dec. 2020. |
dc.identifier.uri.fl_str_mv |
https://www.arca.fiocruz.br/handle/icict/46039 |
dc.identifier.issn.pt_BR.fl_str_mv |
0028-4793 |
dc.identifier.doi.none.fl_str_mv |
10.1056/NEJMoa2034577 |
dc.identifier.eissn.pt_BR.fl_str_mv |
1533-4406 |
identifier_str_mv |
POLACK, Fernando Pedro et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. New England Journal of Medicine, v. 383, n. 27, p. 2603-2615, 10 Dec. 2020. 0028-4793 10.1056/NEJMoa2034577 1533-4406 |
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eng |
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Massachusetts Medical Society |
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Massachusetts Medical Society |
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