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Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age.
N Engl J Med. 2021 Nov 09 [Online ahead of print]NEJM

Abstract

BACKGROUND

Safe, effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in children younger than 12 years of age.

METHODS

A phase 1, dose-finding study and an ongoing phase 2-3 randomized trial are being conducted to investigate the safety, immunogenicity, and efficacy of two doses of the BNT162b2 vaccine administered 21 days apart in children 6 months to 11 years of age. We present results for 5-to-11-year-old children. In the phase 2-3 trial, participants were randomly assigned in a 2:1 ratio to receive two doses of either the BNT162b2 vaccine at the dose level identified during the open-label phase 1 study or placebo. Immune responses 1 month after the second dose of BNT162b2 were immunologically bridged to those in 16-to-25-year-olds from the pivotal trial of two 30-μg doses of BNT162b2. Vaccine efficacy against Covid-19 at 7 days or more after the second dose was assessed.

RESULTS

During the phase 1 study, a total of 48 children 5 to 11 years of age received 10 μg, 20 μg, or 30 μg of the BNT162b2 vaccine (16 children at each dose level). On the basis of reactogenicity and immunogenicity, a dose level of 10 μg was selected for further study. In the phase 2-3 trial, a total of 2268 children were randomly assigned to receive the BNT162b2 vaccine (1517 children) or placebo (751 children). At data cutoff, the median follow-up was 2.3 months. In the 5-to-11-year-olds, as in other age groups, the BNT162b2 vaccine had a favorable safety profile. No vaccine-related serious adverse events were noted. One month after the second dose, the geometric mean ratio of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing titers in 5-to-11-year-olds to those in 16-to-25-year-olds was 1.04 (95% confidence interval [CI], 0.93 to 1.18), a ratio meeting the prespecified immunogenicity success criterion (lower bound of two-sided 95% CI, >0.67; geometric mean ratio point estimate, ≥0.8). Covid-19 with onset 7 days or more after the second dose was reported in three recipients of the BNT162b2 vaccine and in 16 placebo recipients (vaccine efficacy, 90.7%; 95% CI, 67.7 to 98.3).

CONCLUSIONS

A Covid-19 vaccination regimen consisting of two 10-μg doses of BNT162b2 administered 21 days apart was found to be safe, immunogenic, and efficacious in children 5 to 11 years of age. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04816643.).

Authors+Show Affiliations

From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (S.L., N.K., L.C.); the Department of Pediatrics, University of Cincinnati College of Medicine and the Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati (G.C.P., R.W.F.); Boston Medical Center, Boston University School of Medicine, Boston (E.D.B.); Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.); Stanford University School of Medicine, Palo Alto, CA (Y.M.); Children's Mercy Hospital, Kansas City, MO (B.A.P.); the University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (E.A.F.S.); Hospital Universitario 12 de Octubre, Madrid (P.R.); Medical University of Warsaw, Warsaw, Poland (E.K.); Tampere University Vaccine Research Center, Tampere, and PEDEGO Research Unit, University of Oulu, Oulu - both in Finland (M.R.); Vaccine Research and Development (J.L.P., H.M., X.X.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; and BioNTech, Mainz, Germany (E.L., Ö.T., U.Ş.).No affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

34752019

Citation

Walter, Emmanuel B., et al. "Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age." The New England Journal of Medicine, 2021.
Walter EB, Talaat KR, Sabharwal C, et al. Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age. N Engl J Med. 2021.
Walter, E. B., Talaat, K. R., Sabharwal, C., Gurtman, A., Lockhart, S., Paulsen, G. C., Barnett, E. D., Muñoz, F. M., Maldonado, Y., Pahud, B. A., Domachowske, J. B., Simões, E. A. F., Sarwar, U. N., Kitchin, N., Cunliffe, L., Rojo, P., Kuchar, E., Rämet, M., Munjal, I., ... Gruber, W. C. (2021). Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age. The New England Journal of Medicine. https://doi.org/10.1056/NEJMoa2116298
Walter EB, et al. Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age. N Engl J Med. 2021 Nov 9; PubMed PMID: 34752019.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age. AU - Walter,Emmanuel B, AU - Talaat,Kawsar R, AU - Sabharwal,Charu, AU - Gurtman,Alejandra, AU - Lockhart,Stephen, AU - Paulsen,Grant C, AU - Barnett,Elizabeth D, AU - Muñoz,Flor M, AU - Maldonado,Yvonne, AU - Pahud,Barbara A, AU - Domachowske,Joseph B, AU - Simões,Eric A F, AU - Sarwar,Uzma N, AU - Kitchin,Nicholas, AU - Cunliffe,Luke, AU - Rojo,Pablo, AU - Kuchar,Ernest, AU - Rämet,Mika, AU - Munjal,Iona, AU - Perez,John L, AU - Frenck,Robert W,Jr AU - Lagkadinou,Eleni, AU - Swanson,Kena A, AU - Ma,Hua, AU - Xu,Xia, AU - Koury,Kenneth, AU - Mather,Susan, AU - Belanger,Todd J, AU - Cooper,David, AU - Türeci,Özlem, AU - Dormitzer,Philip R, AU - Şahin,Uğur, AU - Jansen,Kathrin U, AU - Gruber,William C, AU - ,, Y1 - 2021/11/09/ PY - 2021/11/9/entrez PY - 2021/11/10/pubmed PY - 2021/11/10/medline JF - The New England journal of medicine JO - N Engl J Med N2 - BACKGROUND: Safe, effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in children younger than 12 years of age. METHODS: A phase 1, dose-finding study and an ongoing phase 2-3 randomized trial are being conducted to investigate the safety, immunogenicity, and efficacy of two doses of the BNT162b2 vaccine administered 21 days apart in children 6 months to 11 years of age. We present results for 5-to-11-year-old children. In the phase 2-3 trial, participants were randomly assigned in a 2:1 ratio to receive two doses of either the BNT162b2 vaccine at the dose level identified during the open-label phase 1 study or placebo. Immune responses 1 month after the second dose of BNT162b2 were immunologically bridged to those in 16-to-25-year-olds from the pivotal trial of two 30-μg doses of BNT162b2. Vaccine efficacy against Covid-19 at 7 days or more after the second dose was assessed. RESULTS: During the phase 1 study, a total of 48 children 5 to 11 years of age received 10 μg, 20 μg, or 30 μg of the BNT162b2 vaccine (16 children at each dose level). On the basis of reactogenicity and immunogenicity, a dose level of 10 μg was selected for further study. In the phase 2-3 trial, a total of 2268 children were randomly assigned to receive the BNT162b2 vaccine (1517 children) or placebo (751 children). At data cutoff, the median follow-up was 2.3 months. In the 5-to-11-year-olds, as in other age groups, the BNT162b2 vaccine had a favorable safety profile. No vaccine-related serious adverse events were noted. One month after the second dose, the geometric mean ratio of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing titers in 5-to-11-year-olds to those in 16-to-25-year-olds was 1.04 (95% confidence interval [CI], 0.93 to 1.18), a ratio meeting the prespecified immunogenicity success criterion (lower bound of two-sided 95% CI, >0.67; geometric mean ratio point estimate, ≥0.8). Covid-19 with onset 7 days or more after the second dose was reported in three recipients of the BNT162b2 vaccine and in 16 placebo recipients (vaccine efficacy, 90.7%; 95% CI, 67.7 to 98.3). CONCLUSIONS: A Covid-19 vaccination regimen consisting of two 10-μg doses of BNT162b2 administered 21 days apart was found to be safe, immunogenic, and efficacious in children 5 to 11 years of age. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04816643.). SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/34752019/full_citation L2 - https://www.nejm.org/doi/10.1056/NEJMoa2116298?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -
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