Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

Bibliographic Details
Main Author: Polack, Fernando P.
Publication Date: 2021
Other Authors: 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
Format: Article
Language: eng
Source: Repositório Institucional da FIOCRUZ (ARCA)
Download full: https://arca.fiocruz.br/handle/icict/49660
Summary: 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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spelling 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://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 SyndromeVaccinesEfficacy03 Saúde e Bem-EstarSafety 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://arca.fiocruz.br/bitstreams/f2814a12-4136-47e3-911d-4168501cecca/download36b51ef91c52b5338d9d29ba0cc807bcMD51falseAnonymousREADORIGINALPolack, Fernando P. Safety....pdfPolack, Fernando P. 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dc.title.none.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
03 Saúde e Bem-Estar
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.none.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
03 Saúde e Bem-Estar
dc.subject.en.none.fl_str_mv COVID-19
SARS-CoV-2
Severe Acute Respiratory Syndrome
Vaccines
Efficacy
dc.subject.ods.none.fl_str_mv 03 Saúde e Bem-Estar
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.).
publishDate 2021
dc.date.accessioned.fl_str_mv 2021-11-04T14:14:58Z
dc.date.available.fl_str_mv 2021-11-04T14:14:58Z
dc.date.issued.fl_str_mv 2021
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
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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://arca.fiocruz.br/handle/icict/49660
dc.identifier.issn.none.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
url https://arca.fiocruz.br/handle/icict/49660
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Massachusetts Medical Society
publisher.none.fl_str_mv Massachusetts Medical Society
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
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collection Repositório Institucional da FIOCRUZ (ARCA)
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repository.name.fl_str_mv Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv repositorio.arca@fiocruz.br
_version_ 1839716337417453568