| Author | Polack, Fernando Pedro | pt_BR |
| Author | Thomas, Stephen J. | pt_BR |
| Author | Kitchin, Nicholas | pt_BR |
| Author | Absalon, Judith | pt_BR |
| Author | Gurtman, Alejandra | pt_BR |
| Author | Lockhart, Stephen | pt_BR |
| Author | L. Perez, John | pt_BR |
| Author | Pérez Marc, Gonzalo | pt_BR |
| Author | Moreira Junior, Edson Duarte | pt_BR |
| Author | Zerbini, Cristiano Augusto de Freitas | pt_BR |
| Author | Bailey, Ruth | pt_BR |
| Author | Swanson, Kena A. | pt_BR |
| Author | Roychoudhury, Satrajit | pt_BR |
| Author | Koury, Kenneth | pt_BR |
| Author | Ping, Li | pt_BR |
| Author | Kalina, Warren V. | pt_BR |
| Author | Cooper, David | pt_BR |
| Author | Frenck Jr., Robert W. | pt_BR |
| Author | Hammitt, Laura L. | pt_BR |
| Author | Türeci, Özlem | pt_BR |
| Author | Nell, Haylene | pt_BR |
| Author | Schaefer, Axel | pt_BR |
| Author | Ünal, Serhat | pt_BR |
| Author | Tresnan, Dina B. | pt_BR |
| Author | Mather, Susan | pt_BR |
| Author | Dormitzer, Philip R. | pt_BR |
| Author | Şahin, Uğur | pt_BR |
| Author | Jansen, Kathrin U. | pt_BR |
| Author | Gruber, William C. | pt_BR |
| Access date | 2021-02-11T13:05:55Z | |
| Available date | 2021-02-11T13:05:55Z | |
| Document date | 2020 | |
| Citation | 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. | pt_BR |
| ISSN | 0028-4793 | pt_BR |
| URI | https://www.arca.fiocruz.br/handle/icict/46039 | |
| Sponsorship | BioNTech | pt_BR |
| Sponsorship | Pfizer | pt_BR |
| Sponsorship | ClinicalTrials.gov number, NCT04368728 | pt_BR |
| Language | eng | en |
| Publisher | Massachusetts Medical Society | pt_BR |
| Rights | open access | pt_BR |
| Subject in Portuguese | COVID-19 | pt_BR |
| Subject in Portuguese | Vacinas virais | pt_BR |
| Subject in Portuguese | Segurança | pt_BR |
| Subject in Portuguese | Eficácia | pt_BR |
| Subject in Portuguese | SARS-CoV-2 | pt_BR |
| Subject in Portuguese | Betacoronavirus | pt_BR |
| Subject in Portuguese | Infecções | pt_BR |
| Subject in Portuguese | Pandemia | pt_BR |
| Title | Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine | pt_BR |
| Type | Article | pt_BR |
| DOI | 10.1056/NEJMoa2034577 | |
| Abstract | 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. | en |
| Affilliation | Fundación para la Investigación en Infectología Infantil. Buenos Aires, Argentina. | pt_BR |
| Affilliation | State University of New York. Upstate Medical University. Syracuse, NY, United States. | pt_BR |
| Affilliation | Pfizer. Vaccine Clinical Research and Development Group. Hurley, United Kingdom. | pt_BR |
| Affilliation | Pfizer. Vaccine Clinical Research and Development Group. Pearl River, NY, United States. | pt_BR |
| Affilliation | Pfizer. Vaccine Clinical Research and Development Group. Pearl River, NY, United States. | pt_BR |
| Affilliation | Pfizer. Vaccine Clinical Research and Development Group. Hurley, United Kingdom. | pt_BR |
| Affilliation | Pfizer. Vaccine Clinical Research and Development Group. Collegeville, PA, United States. | pt_BR |
| Affilliation | iTrials-Hospital Militar Central. Buenos Aires, Argentina. | pt_BR |
| Affilliation | Obras Sociais Irmã Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil. | pt_BR |
| Affilliation | Centro Paulista de Investigação Clínica. São Paulo, SP, Brasil. | pt_BR |
| Affilliation | Pfizer. Vaccine Clinical Research and Development Group. Hurley, United Kingdom. | pt_BR |
| Affilliation | Pfizer. Vaccine Clinical Research and Development Group. Pearl River, NY, United States. | pt_BR |
| Affilliation | Pfizer. Global Product Development. Peapack, NJ, United States. | pt_BR |
| Affilliation | Pfizer. Vaccine Clinical Research and Development Group. Pearl River, NY, United States. | pt_BR |
| Affilliation | Pfizer. Vaccine Clinical Research and Development Group. Collegeville, PA, United States. | pt_BR |
| Affilliation | Pfizer. Vaccine Clinical Research and Development Group. Pearl River, NY, United States. | pt_BR |
| Affilliation | Pfizer. Vaccine Clinical Research and Development Group. Pearl River, NY, United States. | pt_BR |
| Affilliation | Cincinnati Children's Hospital Medical Center. Cincinnati, OH, United States. | pt_BR |
| Affilliation | Johns Hopkins Bloomberg School of Public Health. Baltimore, MD, United States. | pt_BR |
| Affilliation | BioNTech. Mainz, Deutschland. | pt_BR |
| Affilliation | Tiervlei Trial Centre. Karl Bremer Hospital. Cape Town, South Africa. | pt_BR |
| Affilliation | Medizentrum-Essen-Borbeck. Essen, Deutschland. | pt_BR |
| Affilliation | Hacettepe Üniversitesi. Ankara, Türkiye. | pt_BR |
| Affilliation | Pfizer. Safety Surveillance and Risk Management. Worldwide Safety. Groton, CT, United States. | pt_BR |
| Affilliation | Pfizer. Safety Surveillance and Risk Management. Worldwide Safety. Collegeville, PA, United States. | pt_BR |
| Affilliation | Pfizer. Vaccine Clinical Research and Development Group. Pearl River, NY, United States. | pt_BR |
| Affilliation | BioNTech. Mainz, Deutschland. | pt_BR |
| Affilliation | Pfizer. Vaccine Clinical Research and Development Group. Pearl River, NY, United States. | pt_BR |
| Affilliation | Pfizer. Vaccine Clinical Research and Development Group. Pearl River, NY, United States. | pt_BR |
| Subject | COVID-19 | en |
| Subject | Viral vaccine | en |
| Subject | Safety | en |
| Subject | Efficacy | en |
| Subject | SARS-CoV-2 | en |
| Subject | Betacoronavirus | en |
| Subject | Infection | en |
| Subject | Pandemic | en |
| e-ISSN | 1533-4406 | pt_BR |
| xmlui.metadata.dc.subject.ods | 03 Saúde e Bem-Estar | |
