Safety and efficacy of a third dose of BNT162b2 Covid-19 vaccine
| Autor(a) principal: | |
|---|---|
| Data de Publicação: | 2022 |
| 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/55131 |
Resumo: | Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Associação Obras Sociais Irmã Dulce. Salvador, BA, Brasil. |
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Moreira Jr, Edson DKitchin, NicholasXu, XiaDychter, Samuel SLockhart, StephenGurtman, AlejandraPerez, John LZerbini, CristianoDever, Michael EJennings, Timothy WBrandon, Donald MCannon, Kevin DKoren, Michael JDenham, Douglas SBerhe, MezgebeFitz‑Patrick, DavidHammitt, Laura LKlein, Nicola PNell, HayleneKeep, GeorginaWang, XingbinKoury, KennethSwanson, Kena ACooper, DavidLu, ClaireTüreci, ÖzlemLagkadinou, EleniTresnan, Dina BDormitzer, Philip RŞahin, UğurGruber, William CJansen, Kathrin U2022-10-13T18:00:00Z2022-10-13T18:00:00Z2022MOREIRA JR, Edson D. et al. safety and efficacy of a third dose of BNT162b2 Covid-19 vaccine. New England Journal of Medicine, v. 386, n. 20, p. 1-12, 2022.1533-4406https://www.arca.fiocruz.br/handle/icict/5513110.1056/NEJMoa2200674.engMassachusetts Medical SocietyBNT162 VaccineCOVID-19SafetyBNT162b2VacinaCOVID-19SegurançaEficáciaBNT162b2VaccineCOVID-19SafetyEfficacyVacina BNT162COVID-19EficáciaSegurançaSafety and efficacy of a third dose of BNT162b2 Covid-19 vaccineinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleFundação Oswaldo Cruz. Instituto Gonçalo Moniz. Associação Obras Sociais Irmã Dulce. Salvador, BA, Brasil.Vaccine Research and Development. Pfizer. Hurley, United Kingdom.Vaccine Research and Development. Pfizer. Collegeville, PA.Vaccine Research and Development. Pfizer. San Diego, California.Vaccine Research and Development. Pfizer. Hurley, United Kingdom.Vaccine Research and Development. Pfizer. Pearl River, NY.Vaccine Research and Development. Pfizer. Collegeville, PA.Centro Paulista de Investigação Clínica. São Paulo, SP, Brasil.Clinical Neuroscience Solutions. Orlando.Clinical Research Professionals. Chesterfield, MO.California Research Foundation. San Diego, California.Accellacare. Wilmington, NC.Jacksonville Center for Clinical Research. Jacksonville, Florida.Clinical Trials of Texas. San Antonio, Texas.North Texas Infectious Diseases Consultants. Dallas, Texas.East-West Medical Research Institute. Honolulu, Hawaii.Johns Hopkins Bloomberg School of Public Health. Baltimore.Kaiser Permanente Vaccine Study Center. Oakland.Tiervlei Trial Centre, Karl Bremer Hospital. Cape Town, South Africa.Vaccine Research and Development. Pfizer. Hurley, United Kingdom.Vaccine Research and Development. Pfizer. Collegeville, PA.Vaccine Research and Development. Pfizer. Pearl River, NY.Vaccine Research and Development. Pfizer. Pearl River, NY.Vaccine Research and Development. Pfizer. Pearl River, NY.Vaccine Research and Development. Pfizer. Pearl River, NY.BioNTech. Mainz, Germany.BioNTech. Mainz, Germany.Worldwide Safety. Safety Surveillance and Risk Management. Pfizer. Groton, CT.Vaccine Research and Development. Pfizer. Pearl River, NY.BioNTech. Mainz, Germany.Vaccine Research and Development. Pfizer. Pearl River, NY.Vaccine Research and Development. Pfizer. Pearl River, NY.Background: Active immunization with the BNT162b2 vaccine (Pfizer-BioNTech) has been a critical mitigation tool against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection during the coronavirus disease 2019 (Covid-19) pandemic. In light of reports of waning protection occurring 6 months after the primary two-dose vaccine series, data are needed on the safety and efficacy of offering a third (booster) dose in persons 16 years of age or older. Methods: In this ongoing, placebo-controlled, randomized, phase 3 trial, we assigned participants who had received two 30-μg doses of the BNT162b2 vaccine at least 6 months earlier to be injected with a third dose of the BNT162b2 vaccine or with placebo. We assessed vaccine safety and efficacy against Covid-19 starting 7 days after the third dose. Results: A total of 5081 participants received a third BNT162b2 dose and 5044 received placebo. The median interval between dose 2 and dose 3 was 10.8 months in the vaccine group and 10.7 months in the placebo group; the median follow-up was 2.5 months. Local and systemic reactogenicity events from the third dose were generally of low grade. No new safety signals were identified, and no cases of myocarditis or pericarditis were reported. Among the participants without evidence of previous SARS-CoV-2 infection who could be evaluated, Covid-19 with onset at least 7 days after dose 3 was observed in 6 participants in the vaccine group and in 123 participants in the placebo group, which corresponded to a relative vaccine efficacy of 95.3% (95% confidence interval, 89.5 to 98.3). Conclusions: A third dose of the BNT162b2 vaccine administered a median of 10.8 months after the second dose provided 95.3% efficacy against Covid-19 as compared with two doses of the BNT162b2 vaccine during a median follow-up of 2.5 months.info:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/55131/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALMoreira, Edson - Safety and Efficacy of a Third Dose of BNT162b2 Covid-19 Vaccine..pdfMoreira, Edson - Safety and Efficacy of a Third Dose of BNT162b2 Covid-19 Vaccine..pdfapplication/pdf692352https://www.arca.fiocruz.br/bitstream/icict/55131/2/Moreira%2c%20Edson%20-%20Safety%20and%20Efficacy%20of%20a%20Third%20Dose%20of%20BNT162b2%20Covid-19%20Vaccine..pdfc43d80a0249de297f6d9b4af6f77f5f8MD52icict/551312023-03-15 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| dc.title.en_US.fl_str_mv |
Safety and efficacy of a third dose of BNT162b2 Covid-19 vaccine |
| title |
Safety and efficacy of a third dose of BNT162b2 Covid-19 vaccine |
| spellingShingle |
Safety and efficacy of a third dose of BNT162b2 Covid-19 vaccine Moreira Jr, Edson D BNT162 Vaccine COVID-19 Safety BNT162b2 Vacina COVID-19 Segurança Eficácia BNT162b2 Vaccine COVID-19 Safety Efficacy Vacina BNT162 COVID-19 Eficácia Segurança |
| title_short |
Safety and efficacy of a third dose of BNT162b2 Covid-19 vaccine |
| title_full |
Safety and efficacy of a third dose of BNT162b2 Covid-19 vaccine |
| title_fullStr |
Safety and efficacy of a third dose of BNT162b2 Covid-19 vaccine |
| title_full_unstemmed |
Safety and efficacy of a third dose of BNT162b2 Covid-19 vaccine |
| title_sort |
Safety and efficacy of a third dose of BNT162b2 Covid-19 vaccine |
| author |
Moreira Jr, Edson D |
| author_facet |
Moreira Jr, Edson D Kitchin, Nicholas Xu, Xia Dychter, Samuel S Lockhart, Stephen Gurtman, Alejandra Perez, John L Zerbini, Cristiano Dever, Michael E Jennings, Timothy W Brandon, Donald M Cannon, Kevin D Koren, Michael J Denham, Douglas S Berhe, Mezgebe Fitz‑Patrick, David Hammitt, Laura L Klein, Nicola P Nell, Haylene Keep, Georgina Wang, Xingbin Koury, Kenneth Swanson, Kena A Cooper, David Lu, Claire Türeci, Özlem Lagkadinou, Eleni Tresnan, Dina B Dormitzer, Philip R Şahin, Uğur Gruber, William C Jansen, Kathrin U |
| author_role |
author |
| author2 |
Kitchin, Nicholas Xu, Xia Dychter, Samuel S Lockhart, Stephen Gurtman, Alejandra Perez, John L Zerbini, Cristiano Dever, Michael E Jennings, Timothy W Brandon, Donald M Cannon, Kevin D Koren, Michael J Denham, Douglas S Berhe, Mezgebe Fitz‑Patrick, David Hammitt, Laura L Klein, Nicola P Nell, Haylene Keep, Georgina Wang, Xingbin Koury, Kenneth Swanson, Kena A Cooper, David Lu, Claire Türeci, Özlem Lagkadinou, Eleni Tresnan, Dina B Dormitzer, Philip R Şahin, Uğur Gruber, William C Jansen, Kathrin U |
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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 author author author |
| dc.contributor.author.fl_str_mv |
Moreira Jr, Edson D Kitchin, Nicholas Xu, Xia Dychter, Samuel S Lockhart, Stephen Gurtman, Alejandra Perez, John L Zerbini, Cristiano Dever, Michael E Jennings, Timothy W Brandon, Donald M Cannon, Kevin D Koren, Michael J Denham, Douglas S Berhe, Mezgebe Fitz‑Patrick, David Hammitt, Laura L Klein, Nicola P Nell, Haylene Keep, Georgina Wang, Xingbin Koury, Kenneth Swanson, Kena A Cooper, David Lu, Claire Türeci, Özlem Lagkadinou, Eleni Tresnan, Dina B Dormitzer, Philip R Şahin, Uğur Gruber, William C Jansen, Kathrin U |
| dc.subject.mesh.en_US.fl_str_mv |
BNT162 Vaccine COVID-19 Safety |
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BNT162 Vaccine COVID-19 Safety BNT162b2 Vacina COVID-19 Segurança Eficácia BNT162b2 Vaccine COVID-19 Safety Efficacy Vacina BNT162 COVID-19 Eficácia Segurança |
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BNT162b2 Vacina COVID-19 Segurança Eficácia |
| dc.subject.en.en_US.fl_str_mv |
BNT162b2 Vaccine COVID-19 Safety Efficacy |
| dc.subject.decs.en_US.fl_str_mv |
Vacina BNT162 COVID-19 Eficácia Segurança |
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Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Associação Obras Sociais Irmã Dulce. Salvador, BA, Brasil. |
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2022 |
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2022-10-13T18:00:00Z |
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2022-10-13T18:00:00Z |
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2022 |
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MOREIRA JR, Edson D. et al. safety and efficacy of a third dose of BNT162b2 Covid-19 vaccine. New England Journal of Medicine, v. 386, n. 20, p. 1-12, 2022. |
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1533-4406 |
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10.1056/NEJMoa2200674. |
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MOREIRA JR, Edson D. et al. safety and efficacy of a third dose of BNT162b2 Covid-19 vaccine. New England Journal of Medicine, v. 386, n. 20, p. 1-12, 2022. 1533-4406 10.1056/NEJMoa2200674. |
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Massachusetts Medical Society |
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