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Six Month Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine
Stephen J Thomas; Edson D Moreira Jr.; Nicholas Kitchin; Judith Absalon; Alejandra Gurtman; Stephen Lockhart; John L Perez; Gonzalo Pérez Marc; Fernando P Polack; Cristiano Zerbini; Ruth Bailey; Kena A Swanson; Xia Xu; Satrajit Roychoudhury; Kenneth Koury; Salim Bouguermouh; Warren V Kalina; David Cooper; Robert W Frenck Jr.; Laura L Hammitt; Özlem Türeci; Haylene Nell; Axel Schaefer; Serhat Ünal; Qi Yang; Paul Liberator; Dina B Tresnan; Susan Mather; Philip R Dormitzer; Uğur Şahin; William C Gruber; Kathrin U Jansen; - C4591001 Clinical Trial Group.
Afiliação
  • Stephen J Thomas; State University of New York, Upstate Medical University, Syracuse , NY
  • Edson D Moreira Jr.; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia, Brazil
  • Nicholas Kitchin; Vaccine Research and Development, Pfizer Inc, Hurley, UK
  • Judith Absalon; Vaccine Research and Development, Pfizer Inc, Pearl River, NY
  • Alejandra Gurtman; Vaccine Research and Development, Pfizer Inc, Pearl River, NY
  • Stephen Lockhart; Vaccine Research and Development, Pfizer Inc, Hurley, UK
  • John L Perez; Vaccine Research and Development, Pfizer Inc, Collegeville, PA
  • Gonzalo Pérez Marc; iTrials-Hospital Militar Central, Buenos Aires, Argentina
  • Fernando P Polack; Fundacion INFANT, Buenos Aires, Argentina
  • Cristiano Zerbini; Centro Paulista de Investigação Clinica, São Paulo, Brazil
  • Ruth Bailey; Vaccine Research and Development, Pfizer Inc, Hurley, UK
  • Kena A Swanson; Vaccine Research and Development, Pfizer Inc, Pearl River, NY
  • Xia Xu; Vaccine Research and Development, Pfizer Inc, Collegeville, PA
  • Satrajit Roychoudhury; Global Product Development, Pfizer Inc, Peapack, NJ
  • Kenneth Koury; Vaccine Research and Development, Pfizer Inc, Pearl River, NY
  • Salim Bouguermouh; Vaccine Research and Development, Pfizer Inc, Pearl River, NY
  • Warren V Kalina; Vaccine Research and Development, Pfizer Inc, Pearl River, NY
  • David Cooper; Vaccine Research and Development, Pfizer Inc, Pearl River, NY
  • Robert W Frenck Jr.; Cincinnati Children's Hospital, Cincinnati, OH
  • Laura L Hammitt; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD
  • Özlem Türeci; BioNTech, Mainz, Germany
  • Haylene Nell; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa
  • Axel Schaefer; Medizentrum Essen Borbeck, Essen, Germany
  • Serhat Ünal; Hacettepe University, Ankara, Turkey
  • Qi Yang; Vaccine Research and Development, Pfizer Inc, Pearl River, NY
  • Paul Liberator; Vaccine Research and Development, Pfizer Inc, Pearl River, NY
  • Dina B Tresnan; Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Inc, Groton, CT
  • Susan Mather; Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Inc, Collegeville, PA
  • Philip R Dormitzer; Vaccine Research and Development, Pfizer Inc, Pearl River, NY
  • Uğur Şahin; BioNTech, Mainz, Germany
  • William C Gruber; Vaccine Research and Development, Pfizer Inc, Pearl River, NY
  • Kathrin U Jansen; Vaccine Research and Development, Pfizer Inc, Pearl River, NY
  • - C4591001 Clinical Trial Group;
Preprint em En | PREPRINT-MEDRXIV | ID: ppmedrxiv-21261159
ABSTRACT
BackgroundBNT162b2 is a lipid nanoparticle-formulated, nucleoside-modified RNA vaccine encoding a prefusion-stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. BNT162b2 is highly efficacious against COVID-19 and is currently authorized for emergency use or conditional approval worldwide. At the time of authorization, data beyond 2 months post-vaccination were unavailable. MethodsIn an ongoing, placebo-controlled, observer-blinded, multinational, pivotal efficacy study, 44,165 [≥]16-year-old participants and 2,264 12-15-year-old participants were randomized to receive 2 doses, 21 days apart, of 30 {micro}g BNT162b2 or placebo. Study endpoints reported here are vaccine efficacy (VE) against laboratory-confirmed COVID-19 and safety data, both up to 6 months post-vaccination. ResultsBNT162b2 continued to be safe and well tolerated. Few participants had adverse events leading to study withdrawal. VE against COVID-19 was 91% (95% CI 89.0-93.2) through up to 6 months of follow-up, among evaluable participants and irrespective of previous SARS-CoV-2 infection. VE of 86%-100% was seen across countries and in populations with diverse characteristics of age, sex, race/ethnicity, and COVID-19 risk factors in participants without evidence of previous SARS-CoV-2 infection. VE against severe disease was 97% (95% CI 80.3-99.9). In South Africa, where the SARS-CoV-2 variant of concern, B.1.351 (beta), was predominant, 100% (95% CI 53.5, 100.0) VE was observed. ConclusionWith up to 6 months of follow-up and despite a gradually declining trend in vaccine efficacy, BNT162b2 had a favorable safety profile and was highly efficacious in preventing COVID-19. (ClinicalTrials.gov number, NCT04368728)
Licença
cc_by_nc_nd
Texto completo: 1 Coleções: 09-preprints Base de dados: PREPRINT-MEDRXIV Tipo de estudo: Cohort_studies / Experimental_studies / Prognostic_studies / Rct Idioma: En Ano de publicação: 2021 Tipo de documento: Preprint
Texto completo: 1 Coleções: 09-preprints Base de dados: PREPRINT-MEDRXIV Tipo de estudo: Cohort_studies / Experimental_studies / Prognostic_studies / Rct Idioma: En Ano de publicação: 2021 Tipo de documento: Preprint