Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine

dc.creatorPolack, Fernando Pedro
dc.creatorThomas, Stephen J.
dc.creatorKitchin, Nicholas
dc.creatorAbsalon, Judith
dc.creatorGurtman, Alejandra
dc.creatorLockhart, Stephen
dc.creatorL. Perez, John
dc.creatorPérez Marc, Gonzalo
dc.creatorMoreira Junior, Edson Duarte
dc.creatorZerbini, Cristiano Augusto de Freitas
dc.creatorBailey, Ruth
dc.creatorSwanson, Kena A.
dc.creatorRoychoudhury, Satrajit
dc.creatorKoury, Kenneth
dc.creatorPing, Li
dc.creatorKalina, Warren V.
dc.creatorCooper, David
dc.creatorFrenck Jr., Robert W.
dc.creatorHammitt, Laura L.
dc.creatorTüreci, Özlem
dc.creatorNell, Haylene
dc.creatorSchaefer, Axel
dc.creatorÜnal, Serhat
dc.creatorTresnan, Dina B.
dc.creatorMather, Susan
dc.creatorDormitzer, Philip R.
dc.creatorŞahin, Uğur
dc.creatorJansen, Kathrin U.
dc.creatorGruber, William C.
dc.date2021-02-11T13:05:55Z
dc.date2021-02-11T13:05:55Z
dc.date2020
dc.date.accessioned2023-09-26T20:55:09Z
dc.date.available2023-09-26T20:55:09Z
dc.identifierPOLACK, 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.identifier0028-4793
dc.identifierhttps://www.arca.fiocruz.br/handle/icict/46039
dc.identifier10.1056/NEJMoa2034577
dc.identifier1533-4406
dc.identifier.urihttps://repositorioslatinoamericanos.uchile.cl/handle/2250/8866153
dc.descriptionBioNTech
dc.descriptionPfizer
dc.descriptionClinicalTrials.gov number, NCT04368728
dc.descriptionBACKGROUND: 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.
dc.formatapplication/pdf
dc.languageeng
dc.publisherMassachusetts Medical Society
dc.rightsopen access
dc.subjectCOVID-19
dc.subjectVacinas virais
dc.subjectSegurança
dc.subjectEficácia
dc.subjectSARS-CoV-2
dc.subjectBetacoronavirus
dc.subjectInfecções
dc.subjectPandemia
dc.subjectCOVID-19
dc.subjectViral vaccine
dc.subjectSafety
dc.subjectEfficacy
dc.subjectSARS-CoV-2
dc.subjectBetacoronavirus
dc.subjectInfection
dc.subjectPandemic
dc.titleSafety and efficacy of the BNT162b2 mRNA Covid-19 vaccine
dc.typeArticle


Este ítem pertenece a la siguiente institución