id CRUZ_6b156b6d11d01da4c065d9d7cd6d5298
oai_identifier_str oai:www.arca.fiocruz.br:icict/46039
network_acronym_str CRUZ
network_name_str Repositório Institucional da FIOCRUZ (ARCA)
repository_id_str 2135
spelling 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 texttext/plain50206https://www.arca.fiocruz.br/bitstream/icict/46039/3/Polack%2c%20Fernando%20P%20Safety....pdf.txtce33364210be56fcf06d3a02018d2498MD53icict/460392023-03-15 14:34:29.978oai:www.arca.fiocruz.br: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Repositório InstitucionalPUBhttps://www.arca.fiocruz.br/oai/requestrepositorio.arca@fiocruz.bropendoar:21352023-03-15T17:34:29Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)false
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
dc.date.available.fl_str_mv 2021-02-11T13:05:55Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
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
url https://www.arca.fiocruz.br/handle/icict/46039
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)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Repositório Institucional da FIOCRUZ (ARCA)
collection Repositório Institucional da FIOCRUZ (ARCA)
bitstream.url.fl_str_mv https://www.arca.fiocruz.br/bitstream/icict/46039/1/license.txt
https://www.arca.fiocruz.br/bitstream/icict/46039/2/Polack%2c%20Fernando%20P%20Safety....pdf
https://www.arca.fiocruz.br/bitstream/icict/46039/3/Polack%2c%20Fernando%20P%20Safety....pdf.txt
bitstream.checksum.fl_str_mv 36b51ef91c52b5338d9d29ba0cc807bc
3bf357f6ff6a3b9e41987bb209d748c9
ce33364210be56fcf06d3a02018d2498
bitstream.checksumAlgorithm.fl_str_mv MD5
MD5
MD5
repository.name.fl_str_mv Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv repositorio.arca@fiocruz.br
_version_ 1813009001490677760