Tags

Type your tag names separated by a space and hit enter

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months.
N Engl J Med. 2021 11 04; 385(19):1761-1773.NEJM

Abstract

BACKGROUND

BNT162b2 is a lipid nanoparticle-formulated, nucleoside-modified RNA vaccine encoding a prefusion-stabilized, membrane-anchored severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) full-length spike protein. BNT162b2 is highly efficacious against coronavirus disease 2019 (Covid-19) and is currently approved, conditionally approved, or authorized for emergency use worldwide. At the time of initial authorization, data beyond 2 months after vaccination were unavailable.

METHODS

In an ongoing, placebo-controlled, observer-blinded, multinational, pivotal efficacy trial, we randomly assigned 44,165 participants 16 years of age or older and 2264 participants 12 to 15 years of age to receive two 30-μg doses, at 21 days apart, of BNT162b2 or placebo. The trial end points were vaccine efficacy against laboratory-confirmed Covid-19 and safety, which were both evaluated through 6 months after vaccination.

RESULTS

BNT162b2 continued to be safe and have an acceptable adverse-event profile. Few participants had adverse events leading to withdrawal from the trial. Vaccine efficacy against Covid-19 was 91.3% (95% confidence interval [CI], 89.0 to 93.2) through 6 months of follow-up among the participants without evidence of previous SARS-CoV-2 infection who could be evaluated. There was a gradual decline in vaccine efficacy. Vaccine efficacy of 86 to 100% was seen across countries and in populations with diverse ages, sexes, race or ethnic groups, and risk factors for Covid-19 among participants without evidence of previous infection with SARS-CoV-2. Vaccine efficacy against severe disease was 96.7% (95% CI, 80.3 to 99.9). In South Africa, where the SARS-CoV-2 variant of concern B.1.351 (or beta) was predominant, a vaccine efficacy of 100% (95% CI, 53.5 to 100) was observed.

CONCLUSIONS

Through 6 months of follow-up and despite a gradual decline in vaccine efficacy, BNT162b2 had a favorable safety profile and was highly efficacious in preventing Covid-19. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.).

Authors+Show Affiliations

From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).From the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (Ö.T., U.Ş.) and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance, and Risk Management, Pfizer, Groton, CT (D.B.T., S.M.).No affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

34525277

Citation

Thomas, Stephen J., et al. "Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine Through 6 Months." The New England Journal of Medicine, vol. 385, no. 19, 2021, pp. 1761-1773.
Thomas SJ, Moreira ED, Kitchin N, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months. N Engl J Med. 2021;385(19):1761-1773.
Thomas, S. J., Moreira, E. D., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Perez, J. L., Pérez Marc, G., Polack, F. P., Zerbini, C., Bailey, R., Swanson, K. A., Xu, X., Roychoudhury, S., Koury, K., Bouguermouh, S., Kalina, W. V., Cooper, D., Frenck, R. W., ... Jansen, K. U. (2021). Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months. The New England Journal of Medicine, 385(19), 1761-1773. https://doi.org/10.1056/NEJMoa2110345
Thomas SJ, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine Through 6 Months. N Engl J Med. 2021 11 4;385(19):1761-1773. PubMed PMID: 34525277.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months. AU - Thomas,Stephen J, AU - Moreira,Edson D,Jr AU - Kitchin,Nicholas, AU - Absalon,Judith, AU - Gurtman,Alejandra, AU - Lockhart,Stephen, AU - Perez,John L, AU - Pérez Marc,Gonzalo, AU - Polack,Fernando P, AU - Zerbini,Cristiano, AU - Bailey,Ruth, AU - Swanson,Kena A, AU - Xu,Xia, AU - Roychoudhury,Satrajit, AU - Koury,Kenneth, AU - Bouguermouh,Salim, AU - Kalina,Warren V, AU - Cooper,David, AU - Frenck,Robert W,Jr AU - Hammitt,Laura L, AU - Türeci,Özlem, AU - Nell,Haylene, AU - Schaefer,Axel, AU - Ünal,Serhat, AU - Yang,Qi, AU - Liberator,Paul, AU - Tresnan,Dina B, AU - Mather,Susan, AU - Dormitzer,Philip R, AU - Şahin,Uğur, AU - Gruber,William C, AU - Jansen,Kathrin U, AU - ,, Y1 - 2021/09/15/ PY - 2021/9/16/pubmed PY - 2021/11/17/medline PY - 2021/9/15/entrez SP - 1761 EP - 1773 JF - The New England journal of medicine JO - N Engl J Med VL - 385 IS - 19 N2 - BACKGROUND: BNT162b2 is a lipid nanoparticle-formulated, nucleoside-modified RNA vaccine encoding a prefusion-stabilized, membrane-anchored severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) full-length spike protein. BNT162b2 is highly efficacious against coronavirus disease 2019 (Covid-19) and is currently approved, conditionally approved, or authorized for emergency use worldwide. At the time of initial authorization, data beyond 2 months after vaccination were unavailable. METHODS: In an ongoing, placebo-controlled, observer-blinded, multinational, pivotal efficacy trial, we randomly assigned 44,165 participants 16 years of age or older and 2264 participants 12 to 15 years of age to receive two 30-μg doses, at 21 days apart, of BNT162b2 or placebo. The trial end points were vaccine efficacy against laboratory-confirmed Covid-19 and safety, which were both evaluated through 6 months after vaccination. RESULTS: BNT162b2 continued to be safe and have an acceptable adverse-event profile. Few participants had adverse events leading to withdrawal from the trial. Vaccine efficacy against Covid-19 was 91.3% (95% confidence interval [CI], 89.0 to 93.2) through 6 months of follow-up among the participants without evidence of previous SARS-CoV-2 infection who could be evaluated. There was a gradual decline in vaccine efficacy. Vaccine efficacy of 86 to 100% was seen across countries and in populations with diverse ages, sexes, race or ethnic groups, and risk factors for Covid-19 among participants without evidence of previous infection with SARS-CoV-2. Vaccine efficacy against severe disease was 96.7% (95% CI, 80.3 to 99.9). In South Africa, where the SARS-CoV-2 variant of concern B.1.351 (or beta) was predominant, a vaccine efficacy of 100% (95% CI, 53.5 to 100) was observed. CONCLUSIONS: Through 6 months of follow-up and despite a gradual decline in vaccine efficacy, BNT162b2 had a favorable safety profile and was highly efficacious in preventing Covid-19. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.). SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/34525277/full_citation L2 - https://www.nejm.org/doi/10.1056/NEJMoa2110345?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -