Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
Autor(a) principal: | |
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Data de Publicação: | 2021 |
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/49660 |
Resumo: | Moreira Junior, Edson Duarte. Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil. Fundacion INFANT (F.P.P.) and iTrials-Hospital Militar Central (G.P.M.), Buenos Aires; State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.) — both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., P.L.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) — both in Brazil; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children’s Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (ÖT., U.Ş.), and Medizentrum Essen Borbeck, Essen (A.S.) — both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.). |
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Polack, Fernando P.Thomas, Stephen J.Kitchin, NicholasPerez, John L,Marc, Gonzalo PérezMoreira Junior, Edson DuarteZerbini, CristianoBailey, RuthSwanson, Kena A.Roychoudhury, SatrajitKoury, KennethLi, PingKalina, Warren V.Cooper, DavidFrenck Junior, Robert W.Hammitt, Laura L.Türeci, ÖzlemNell, HayleneSchaefer, AxelÜnal, SerhatTresnan, Dina B.Mather, SusanDormitzer, Philip R.Şahin, UğurJansen, Kathrin U.Gruber, William C.Clinical Trial Group2021-11-04T14:14:58Z2021-11-04T14:14:58Z2021POLACK, Fernando P. et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. New England Journal of Medicine, 2021.0028-4793https://www.arca.fiocruz.br/handle/icict/4966010.1056/NEJMoa2034577Moreira Junior, Edson Duarte. Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil. Fundacion INFANT (F.P.P.) and iTrials-Hospital Militar Central (G.P.M.), Buenos Aires; State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.) — both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., P.L.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) — both in Brazil; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children’s Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (ÖT., U.Ş.), and Medizentrum Essen Borbeck, Essen (A.S.) — both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).BioNTech and Pfizer."Múltipla - ver em Notas"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. (Funded by BioNTech and Pfizer.engMassachusetts Medical SocietyCOVID-19SARS-CoV-2Síndrome respiratória aguda graveVacinasEficáciaCOVID-19SARS-CoV-2Severe Acute Respiratory SyndromeVaccinesEfficacySafety 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/49660/1/license.txt36b51ef91c52b5338d9d29ba0cc807bcMD51ORIGINALPolack, Fernando P. Safety....pdfPolack, Fernando P. 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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 P. COVID-19 SARS-CoV-2 Síndrome respiratória aguda grave Vacinas Eficácia COVID-19 SARS-CoV-2 Severe Acute Respiratory Syndrome Vaccines Efficacy |
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 P. |
author_facet |
Polack, Fernando P. Thomas, Stephen J. Kitchin, Nicholas Perez, John L, Marc, Gonzalo Pérez Moreira Junior, Edson Duarte Zerbini, Cristiano Bailey, Ruth Swanson, Kena A. Roychoudhury, Satrajit Koury, Kenneth Li, Ping Kalina, Warren V. Cooper, David Frenck Junior, 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. Clinical Trial Group |
author_role |
author |
author2 |
Thomas, Stephen J. Kitchin, Nicholas Perez, John L, Marc, Gonzalo Pérez Moreira Junior, Edson Duarte Zerbini, Cristiano Bailey, Ruth Swanson, Kena A. Roychoudhury, Satrajit Koury, Kenneth Li, Ping Kalina, Warren V. Cooper, David Frenck Junior, 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. Clinical Trial Group |
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 |
dc.contributor.author.fl_str_mv |
Polack, Fernando P. Thomas, Stephen J. Kitchin, Nicholas Perez, John L, Marc, Gonzalo Pérez Moreira Junior, Edson Duarte Zerbini, Cristiano Bailey, Ruth Swanson, Kena A. Roychoudhury, Satrajit Koury, Kenneth Li, Ping Kalina, Warren V. Cooper, David Frenck Junior, 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. Clinical Trial Group |
dc.subject.other.pt_BR.fl_str_mv |
COVID-19 SARS-CoV-2 Síndrome respiratória aguda grave Vacinas Eficácia |
topic |
COVID-19 SARS-CoV-2 Síndrome respiratória aguda grave Vacinas Eficácia COVID-19 SARS-CoV-2 Severe Acute Respiratory Syndrome Vaccines Efficacy |
dc.subject.en.pt_BR.fl_str_mv |
COVID-19 SARS-CoV-2 Severe Acute Respiratory Syndrome Vaccines Efficacy |
description |
Moreira Junior, Edson Duarte. Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil. Fundacion INFANT (F.P.P.) and iTrials-Hospital Militar Central (G.P.M.), Buenos Aires; State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.) — both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., P.L.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) — both in Brazil; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children’s Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (ÖT., U.Ş.), and Medizentrum Essen Borbeck, Essen (A.S.) — both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.). |
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2021 |
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2021-11-04T14:14:58Z |
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2021-11-04T14:14:58Z |
dc.date.issued.fl_str_mv |
2021 |
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dc.identifier.citation.fl_str_mv |
POLACK, Fernando P. et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. New England Journal of Medicine, 2021. |
dc.identifier.uri.fl_str_mv |
https://www.arca.fiocruz.br/handle/icict/49660 |
dc.identifier.issn.pt_BR.fl_str_mv |
0028-4793 |
dc.identifier.eissn.none.fl_str_mv |
10.1056/NEJMoa2034577 |
identifier_str_mv |
POLACK, Fernando P. et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. New England Journal of Medicine, 2021. 0028-4793 10.1056/NEJMoa2034577 |
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https://www.arca.fiocruz.br/handle/icict/49660 |
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eng |
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Massachusetts Medical Society |
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Massachusetts Medical Society |
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