Trial reportThe New England journal of medicine2023
Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age.
Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph
Trial report in The New England journal of medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04816643 (A PHASE 1, OPEN-LABEL DOSE-FINDING STUDY TO EVALUATE SAFETY, TOLERABILITY, AND IMMUNOGENICITY AND PHASE 2/3 PLACEBO-CONTROLLED, OBSERVER-BLINDED SAFETY, TOLERABILITY, AND IMMUNOGENICITY STUDY OF A SARS-COV-2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY CHILDREN), which is not on this map. Cited by 55 papers, 1 of them a synthesis that pooled it.
0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 1 pooled it
19.0field-weighted citation impact, top 1% of its field
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A phase 1, open-label dose-finding study to evaluate safety, tolerability, and immunogenicity and phase 2/3 placebo-controlled, observer-blinded safety, tolerability, and immunogenicity study of a sars-cov-2 rna vaccine candidate against covid-19 in healthy children
Who cites it
55 citing papers in PubMed, 1 synthesis or guideline pooled it, 98 citations in OpenAlex.
- Comparing the Efficacy and Adverse Events of Available COVID-19 Vaccines Through Randomized Controlled Trials: Updated Systematic Review and Network Meta-analysis.Journal of research in health sciences · 2023Pooled it
- Identification of RTS,S/AS01 vaccine-induced humoral biomarkers predictive of protection against controlled human malaria infection.JCI insight · 2024Trial
- Bivalent Omicron BA.4/BA.5 BNT162b2 Vaccine in 6-Month- to <12-Year-Olds.Journal of the Pediatric Infectious Diseases Society · 2024Trial
- Efficacy, immunogenicity and safety of CoronaVac® in children and adolescents aged 6 months to 17 years: a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial.Nature communications · 2024Trial
- Safety and efficacy of the intranasal spray SARS-CoV-2 vaccine dNS1-RBD: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.The Lancet. Respiratory medicine · 2023Trial
- Risk Factors of COVID-19 Severity and Related Death in Children in the Post-Pandemic Era.Microorganisms · 2026Article
- Immunization with mRNA-LNP Elicits De Novo IgG Responses in the Presence of Maternal Antibody.Vaccines · 2026Article
- Preserved SARS-CoV-2 T-cell responses despite impaired humoral immunity in children with profound B-cell lymphopenia.NPJ vaccines · 2026Article
- Vaccine Responses in Early Age.Vaccines · 2026Review
- Article
- A TriNetX global collaborative network retrospective cohort study on the impact of COVID-19 vaccination on juvenile idiopathic arthritis.Scientific reports · 2026Article
- COVID-19 burden in the paediatric population in Latin America during vaccine rollout: a real-world study using national surveillance data.BMC infectious diseases · 2026Observational
- Article
- Establishing long-lasting vaccine immunity: insights from mRNA and adjuvanted protein platforms.NPJ vaccines · 2025Review
- Article
- In-hospital course of children with COVID-19 infection - Results of the German nationwide inpatient sample.Public health in practice (Oxford, England) · 2025Article
- Polymeric particle-based antigen delivery system: From immunological engineering to clinical translation.International journal of pharmaceutics: X · 2025Review
- Immune correlates analysis of antibody responses against SARS-CoV-2 variants in the ENSEMBLE vaccine efficacy trial.iScience · 2025Article
- COVID-19 Vaccine Mistrust, Racial Discrimination, and Conspiracy Beliefs Among Parents in Canada: Implications for Public Health.Journal of medical virology · 2025Article
- Article
Corrections and comments
- Commented on by
Authors and funding
39 authors at 1 institution in 1 country.
Flor M MuñozFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Lawrence D SherFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Charu SabharwalFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Alejandra GurtmanFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Xia XuFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Nicholas KitchinFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Stephen LockhartFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Robert RiesenbergFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Joanna M SexterFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Hanna CzajkaFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Grant C PaulsenFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Yvonne MaldonadoFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Emmanuel B WalterFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Kawsar R TalaatFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Janet A EnglundFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Uzma N SarwarFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Caitlin HansenFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Martha IwamotoFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Chris WebberFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Luke CunliffeFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Benita UkkonenFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Silvina N MartínezFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Barbara A PahudFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Iona MunjalFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Joseph B DomachowskeFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Kena A SwansonFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).ORCID 0000-0002-3389-8414
Hua MaFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Kenneth KouryFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Susan MatherFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Claire LuFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Jing ZouFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Xuping XieFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Pei-Yong ShiFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
David CooperFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Özlem TüreciFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Uğur ŞahinFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
Kathrin U JansenFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
William C GruberFrom Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in California; Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., U.N.S., C.H., M.I., B.A.P., I.M., K.A.S., K.K., C.L., D.C., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) - both in New York; Vaccine Research and Development (X. Xu, H.M.), and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., C.W., L.C.); Atlanta Center for Medical Research, Atlanta (R.R.); Spring Valley Pediatrics, Washington, DC (J.M.S.); Katedra Pediatrii, Instytut Nauk Medycznych, Kolegium Nauk Medycznych, Uniwersytet Rzeszowski, Rzeszow, Poland (H.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.); Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Seattle Children's Hospital, Seattle (J.A.E.); Tampere University, Espoo Vaccine Research Clinic, Espoo, Finland (B.U.); Hospital Universitario HM Puerta del Sur, Madrid (S.N.M.); and BioNTech, Mainz, Germany (Ö.T., U.Ş.).
C4591007 Clinical Trial Group
Johns Hopkins University · US
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSafe and effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in young children.
methodsWe conducted a phase 1 dose-finding study and are conducting an ongoing phase 2-3 safety, immunogenicity, and efficacy trial of the BNT162b2 vaccine in healthy children 6 months to 11 years of age. We present results for children 6 months to less than 2 years of age and those 2 to 4 years of age through the data-cutoff dates (April 29, 2022, for safety and immunogenicity and June 17, 2022, for efficacy). In the phase 2-3 trial, participants were randomly assigned (in a 2:1 ratio) to receive two 3-μg doses of BNT162b2 or placebo. On the basis of preliminary immunogenicity results, a third 3-μg dose (≥8 weeks after dose 2) was administered starting in January 2022, which coincided with the emergence of the B.1.1.529 (omicron) variant. Immune responses at 1 month after doses 2 and 3 in children 6 months to less than 2 years of age and those 2 to 4 years of age were immunologically bridged to responses after dose 2 in persons 16 to 25 years of age who received 30 μg of BNT162b2 in the pivotal trial.
resultsDuring the phase 1 dose-finding study, two doses of BNT162b2 were administered 21 days apart to 16 children 6 months to less than 2 years of age (3-μg dose) and 48 children 2 to 4 years of age (3-μg or 10-μg dose). The 3-μg dose level was selected for the phase 2-3 trial; 1178 children 6 months to less than 2 years of age and 1835 children 2 to 4 years of age received BNT162b2, and 598 and 915, respectively, received placebo. Immunobridging success criteria for the geometric mean ratio and seroresponse at 1 month after dose 3 were met in both age groups. BNT162b2 reactogenicity events were mostly mild to moderate, with no grade 4 events. Low, similar incidences of fever were reported after receipt of BNT162b2 (7% among children 6 months to <2 years of age and 5% among those 2 to 4 years of age) and placebo (6 to 7% among children 6 months to <2 years of age and 4 to 5% among those 2 to 4 years of age). The observed overall vaccine efficacy against symptomatic Covid-19 in children 6 months to 4 years of age was 73.2% (95% confidence interval, 43.8 to 87.6) from 7 days after dose 3 (on the basis of 34 cases).
conclusionsA three-dose primary series of 3-μg BNT162b2 was safe, immunogenic, and efficacious in children 6 months to 4 years of age. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04816643.).
Indexed as
BNT162 VaccineCOVID-19AdolescentAntibodies, ViralChildChild, PreschoolCOVID-19 VaccinesHumansImmunogenicity, VaccineImmunoglobulin GInfantTreatment OutcomeVaccine EfficacyVaccinesYoung AdultAntibodies, ViralBNT162 VaccineCOVID-19 VaccinesImmunoglobulin GVaccines
Identifiers
What OpenQuestion holds
Textmetadata
Read underepoch 390
Registered trials
NCT04816643ClinicalTrials.gov
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.