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Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents.
N Engl J Med. 2021 07 15; 385(3):239-250.NEJM

Abstract

BACKGROUND

Until very recently, vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had not been authorized for emergency use in persons younger than 16 years of age. Safe, effective vaccines are needed to protect this population, facilitate in-person learning and socialization, and contribute to herd immunity.

METHODS

In this ongoing multinational, placebo-controlled, observer-blinded trial, we randomly assigned participants in a 1:1 ratio to receive two injections, 21 days apart, of 30 μg of BNT162b2 or placebo. Noninferiority of the immune response to BNT162b2 in 12-to-15-year-old participants as compared with that in 16-to-25-year-old participants was an immunogenicity objective. Safety (reactogenicity and adverse events) and efficacy against confirmed coronavirus disease 2019 (Covid-19; onset, ≥7 days after dose 2) in the 12-to-15-year-old cohort were assessed.

RESULTS

Overall, 2260 adolescents 12 to 15 years of age received injections; 1131 received BNT162b2, and 1129 received placebo. As has been found in other age groups, BNT162b2 had a favorable safety and side-effect profile, with mainly transient mild-to-moderate reactogenicity (predominantly injection-site pain [in 79 to 86% of participants], fatigue [in 60 to 66%], and headache [in 55 to 65%]); there were no vaccine-related serious adverse events and few overall severe adverse events. The geometric mean ratio of SARS-CoV-2 50% neutralizing titers after dose 2 in 12-to-15-year-old participants relative to 16-to-25-year-old participants was 1.76 (95% confidence interval [CI], 1.47 to 2.10), which met the noninferiority criterion of a lower boundary of the two-sided 95% confidence interval greater than 0.67 and indicated a greater response in the 12-to-15-year-old cohort. Among participants without evidence of previous SARS-CoV-2 infection, no Covid-19 cases with an onset of 7 or more days after dose 2 were noted among BNT162b2 recipients, and 16 cases occurred among placebo recipients. The observed vaccine efficacy was 100% (95% CI, 75.3 to 100).

CONCLUSIONS

The BNT162b2 vaccine in 12-to-15-year-old recipients had a favorable safety profile, produced a greater immune response than in young adults, and was highly effective against Covid-19. (Funded by BioNTech and Pfizer; C4591001 ClinicalTrials.gov number, NCT04368728.).

Authors+Show Affiliations

From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development, Pfizer, Pearl River (A.G., J.A., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (S.J.T.) - both in New York; Vaccine Research and Development (J.L.P., H.M., X.X.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Duke Human Vaccine Institute, Durham, NC (E.B.W.); Senders Pediatrics, South Euclid, OH (S.S.); Clinical Research Professionals, Chesterfield, MO (T.J.); BioNTech, Mainz, Germany (Ö.T., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development, Pfizer, Pearl River (A.G., J.A., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (S.J.T.) - both in New York; Vaccine Research and Development (J.L.P., H.M., X.X.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Duke Human Vaccine Institute, Durham, NC (E.B.W.); Senders Pediatrics, South Euclid, OH (S.S.); Clinical Research Professionals, Chesterfield, MO (T.J.); BioNTech, Mainz, Germany (Ö.T., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development, Pfizer, Pearl River (A.G., J.A., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (S.J.T.) - both in New York; Vaccine Research and Development (J.L.P., H.M., X.X.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Duke Human Vaccine Institute, Durham, NC (E.B.W.); Senders Pediatrics, South Euclid, OH (S.S.); Clinical Research Professionals, Chesterfield, MO (T.J.); BioNTech, Mainz, Germany (Ö.T., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development, Pfizer, Pearl River (A.G., J.A., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (S.J.T.) - both in New York; Vaccine Research and Development (J.L.P., H.M., X.X.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Duke Human Vaccine Institute, Durham, NC (E.B.W.); Senders Pediatrics, South Euclid, OH (S.S.); Clinical Research Professionals, Chesterfield, MO (T.J.); BioNTech, Mainz, Germany (Ö.T., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development, Pfizer, Pearl River (A.G., J.A., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (S.J.T.) - both in New York; Vaccine Research and Development (J.L.P., H.M., X.X.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Duke Human Vaccine Institute, Durham, NC (E.B.W.); Senders Pediatrics, South Euclid, OH (S.S.); Clinical Research Professionals, Chesterfield, MO (T.J.); BioNTech, Mainz, Germany (Ö.T., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development, Pfizer, Pearl River (A.G., J.A., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (S.J.T.) - both in New York; Vaccine Research and Development (J.L.P., H.M., X.X.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Duke Human Vaccine Institute, Durham, NC (E.B.W.); Senders Pediatrics, South Euclid, OH (S.S.); Clinical Research Professionals, Chesterfield, MO (T.J.); BioNTech, Mainz, Germany (Ö.T., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development, Pfizer, Pearl River (A.G., J.A., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (S.J.T.) - both in New York; Vaccine Research and Development (J.L.P., H.M., X.X.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Duke Human Vaccine Institute, Durham, NC (E.B.W.); Senders Pediatrics, South Euclid, OH (S.S.); Clinical Research Professionals, Chesterfield, MO (T.J.); BioNTech, Mainz, Germany (Ö.T., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development, Pfizer, Pearl River (A.G., J.A., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (S.J.T.) - both in New York; Vaccine Research and Development (J.L.P., H.M., X.X.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Duke Human Vaccine Institute, Durham, NC (E.B.W.); Senders Pediatrics, South Euclid, OH (S.S.); Clinical Research Professionals, Chesterfield, MO (T.J.); BioNTech, Mainz, Germany (Ö.T., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development, Pfizer, Pearl River (A.G., J.A., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (S.J.T.) - both in New York; Vaccine Research and Development (J.L.P., H.M., X.X.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Duke Human Vaccine Institute, Durham, NC (E.B.W.); Senders Pediatrics, South Euclid, OH (S.S.); Clinical Research Professionals, Chesterfield, MO (T.J.); BioNTech, Mainz, Germany (Ö.T., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development, Pfizer, Pearl River (A.G., J.A., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (S.J.T.) - both in New York; Vaccine Research and Development (J.L.P., H.M., X.X.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Duke Human Vaccine Institute, Durham, NC (E.B.W.); Senders Pediatrics, South Euclid, OH (S.S.); Clinical Research Professionals, Chesterfield, MO (T.J.); BioNTech, Mainz, Germany (Ö.T., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development, Pfizer, Pearl River (A.G., J.A., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (S.J.T.) - both in New York; Vaccine Research and Development (J.L.P., H.M., X.X.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Duke Human Vaccine Institute, Durham, NC (E.B.W.); Senders Pediatrics, South Euclid, OH (S.S.); Clinical Research Professionals, Chesterfield, MO (T.J.); BioNTech, Mainz, Germany (Ö.T., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development, Pfizer, Pearl River (A.G., J.A., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (S.J.T.) - both in New York; Vaccine Research and Development (J.L.P., H.M., X.X.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Duke Human Vaccine Institute, Durham, NC (E.B.W.); Senders Pediatrics, South Euclid, OH (S.S.); Clinical Research Professionals, Chesterfield, MO (T.J.); BioNTech, Mainz, Germany (Ö.T., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development, Pfizer, Pearl River (A.G., J.A., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (S.J.T.) - both in New York; Vaccine Research and Development (J.L.P., H.M., X.X.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Duke Human Vaccine Institute, Durham, NC (E.B.W.); Senders Pediatrics, South Euclid, OH (S.S.); Clinical Research Professionals, Chesterfield, MO (T.J.); BioNTech, Mainz, Germany (Ö.T., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development, Pfizer, Pearl River (A.G., J.A., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (S.J.T.) - both in New York; Vaccine Research and Development (J.L.P., H.M., X.X.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Duke Human Vaccine Institute, Durham, NC (E.B.W.); Senders Pediatrics, South Euclid, OH (S.S.); Clinical Research Professionals, Chesterfield, MO (T.J.); BioNTech, Mainz, Germany (Ö.T., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development, Pfizer, Pearl River (A.G., J.A., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (S.J.T.) - both in New York; Vaccine Research and Development (J.L.P., H.M., X.X.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Duke Human Vaccine Institute, Durham, NC (E.B.W.); Senders Pediatrics, South Euclid, OH (S.S.); Clinical Research Professionals, Chesterfield, MO (T.J.); BioNTech, Mainz, Germany (Ö.T., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development, Pfizer, Pearl River (A.G., J.A., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (S.J.T.) - both in New York; Vaccine Research and Development (J.L.P., H.M., X.X.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Duke Human Vaccine Institute, Durham, NC (E.B.W.); Senders Pediatrics, South Euclid, OH (S.S.); Clinical Research Professionals, Chesterfield, MO (T.J.); BioNTech, Mainz, Germany (Ö.T., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development, Pfizer, Pearl River (A.G., J.A., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (S.J.T.) - both in New York; Vaccine Research and Development (J.L.P., H.M., X.X.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Duke Human Vaccine Institute, Durham, NC (E.B.W.); Senders Pediatrics, South Euclid, OH (S.S.); Clinical Research Professionals, Chesterfield, MO (T.J.); BioNTech, Mainz, Germany (Ö.T., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development, Pfizer, Pearl River (A.G., J.A., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (S.J.T.) - both in New York; Vaccine Research and Development (J.L.P., H.M., X.X.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Duke Human Vaccine Institute, Durham, NC (E.B.W.); Senders Pediatrics, South Euclid, OH (S.S.); Clinical Research Professionals, Chesterfield, MO (T.J.); BioNTech, Mainz, Germany (Ö.T., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development, Pfizer, Pearl River (A.G., J.A., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (S.J.T.) - both in New York; Vaccine Research and Development (J.L.P., H.M., X.X.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Duke Human Vaccine Institute, Durham, NC (E.B.W.); Senders Pediatrics, South Euclid, OH (S.S.); Clinical Research Professionals, Chesterfield, MO (T.J.); BioNTech, Mainz, Germany (Ö.T., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development, Pfizer, Pearl River (A.G., J.A., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (S.J.T.) - both in New York; Vaccine Research and Development (J.L.P., H.M., X.X.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Duke Human Vaccine Institute, Durham, NC (E.B.W.); Senders Pediatrics, South Euclid, OH (S.S.); Clinical Research Professionals, Chesterfield, MO (T.J.); BioNTech, Mainz, Germany (Ö.T., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development, Pfizer, Pearl River (A.G., J.A., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (S.J.T.) - both in New York; Vaccine Research and Development (J.L.P., H.M., X.X.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Duke Human Vaccine Institute, Durham, NC (E.B.W.); Senders Pediatrics, South Euclid, OH (S.S.); Clinical Research Professionals, Chesterfield, MO (T.J.); BioNTech, Mainz, Germany (Ö.T., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development, Pfizer, Pearl River (A.G., J.A., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (S.J.T.) - both in New York; Vaccine Research and Development (J.L.P., H.M., X.X.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Duke Human Vaccine Institute, Durham, NC (E.B.W.); Senders Pediatrics, South Euclid, OH (S.S.); Clinical Research Professionals, Chesterfield, MO (T.J.); BioNTech, Mainz, Germany (Ö.T., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development, Pfizer, Pearl River (A.G., J.A., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (S.J.T.) - both in New York; Vaccine Research and Development (J.L.P., H.M., X.X.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Duke Human Vaccine Institute, Durham, NC (E.B.W.); Senders Pediatrics, South Euclid, OH (S.S.); Clinical Research Professionals, Chesterfield, MO (T.J.); BioNTech, Mainz, Germany (Ö.T., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development, Pfizer, Pearl River (A.G., J.A., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (S.J.T.) - both in New York; Vaccine Research and Development (J.L.P., H.M., X.X.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Duke Human Vaccine Institute, Durham, NC (E.B.W.); Senders Pediatrics, South Euclid, OH (S.S.); Clinical Research Professionals, Chesterfield, MO (T.J.); BioNTech, Mainz, Germany (Ö.T., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development, Pfizer, Pearl River (A.G., J.A., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (S.J.T.) - both in New York; Vaccine Research and Development (J.L.P., H.M., X.X.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Duke Human Vaccine Institute, Durham, NC (E.B.W.); Senders Pediatrics, South Euclid, OH (S.S.); Clinical Research Professionals, Chesterfield, MO (T.J.); BioNTech, Mainz, Germany (Ö.T., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development, Pfizer, Pearl River (A.G., J.A., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (S.J.T.) - both in New York; Vaccine Research and Development (J.L.P., H.M., X.X.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Duke Human Vaccine Institute, Durham, NC (E.B.W.); Senders Pediatrics, South Euclid, OH (S.S.); Clinical Research Professionals, Chesterfield, MO (T.J.); BioNTech, Mainz, Germany (Ö.T., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).No affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

34043894

Citation

Frenck, Robert W., et al. "Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents." The New England Journal of Medicine, vol. 385, no. 3, 2021, pp. 239-250.
Frenck RW, Klein NP, Kitchin N, et al. Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents. N Engl J Med. 2021;385(3):239-250.
Frenck, R. W., Klein, N. P., Kitchin, N., Gurtman, A., Absalon, J., Lockhart, S., Perez, J. L., Walter, E. B., Senders, S., Bailey, R., Swanson, K. A., Ma, H., Xu, X., Koury, K., Kalina, W. V., Cooper, D., Jennings, T., Brandon, D. M., Thomas, S. J., ... Gruber, W. C. (2021). Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents. The New England Journal of Medicine, 385(3), 239-250. https://doi.org/10.1056/NEJMoa2107456
Frenck RW, et al. Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents. N Engl J Med. 2021 07 15;385(3):239-250. PubMed PMID: 34043894.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents. AU - Frenck,Robert W,Jr AU - Klein,Nicola P, AU - Kitchin,Nicholas, AU - Gurtman,Alejandra, AU - Absalon,Judith, AU - Lockhart,Stephen, AU - Perez,John L, AU - Walter,Emmanuel B, AU - Senders,Shelly, AU - Bailey,Ruth, AU - Swanson,Kena A, AU - Ma,Hua, AU - Xu,Xia, AU - Koury,Kenneth, AU - Kalina,Warren V, AU - Cooper,David, AU - Jennings,Timothy, AU - Brandon,Donald M, AU - Thomas,Stephen J, AU - Türeci,Özlem, AU - Tresnan,Dina B, AU - Mather,Susan, AU - Dormitzer,Philip R, AU - Şahin,Uğur, AU - Jansen,Kathrin U, AU - Gruber,William C, AU - ,, Y1 - 2021/05/27/ PY - 2021/5/28/pubmed PY - 2021/7/20/medline PY - 2021/5/27/entrez SP - 239 EP - 250 JF - The New England journal of medicine JO - N Engl J Med VL - 385 IS - 3 N2 - BACKGROUND: Until very recently, vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had not been authorized for emergency use in persons younger than 16 years of age. Safe, effective vaccines are needed to protect this population, facilitate in-person learning and socialization, and contribute to herd immunity. METHODS: In this ongoing multinational, placebo-controlled, observer-blinded trial, we randomly assigned participants in a 1:1 ratio to receive two injections, 21 days apart, of 30 μg of BNT162b2 or placebo. Noninferiority of the immune response to BNT162b2 in 12-to-15-year-old participants as compared with that in 16-to-25-year-old participants was an immunogenicity objective. Safety (reactogenicity and adverse events) and efficacy against confirmed coronavirus disease 2019 (Covid-19; onset, ≥7 days after dose 2) in the 12-to-15-year-old cohort were assessed. RESULTS: Overall, 2260 adolescents 12 to 15 years of age received injections; 1131 received BNT162b2, and 1129 received placebo. As has been found in other age groups, BNT162b2 had a favorable safety and side-effect profile, with mainly transient mild-to-moderate reactogenicity (predominantly injection-site pain [in 79 to 86% of participants], fatigue [in 60 to 66%], and headache [in 55 to 65%]); there were no vaccine-related serious adverse events and few overall severe adverse events. The geometric mean ratio of SARS-CoV-2 50% neutralizing titers after dose 2 in 12-to-15-year-old participants relative to 16-to-25-year-old participants was 1.76 (95% confidence interval [CI], 1.47 to 2.10), which met the noninferiority criterion of a lower boundary of the two-sided 95% confidence interval greater than 0.67 and indicated a greater response in the 12-to-15-year-old cohort. Among participants without evidence of previous SARS-CoV-2 infection, no Covid-19 cases with an onset of 7 or more days after dose 2 were noted among BNT162b2 recipients, and 16 cases occurred among placebo recipients. The observed vaccine efficacy was 100% (95% CI, 75.3 to 100). CONCLUSIONS: The BNT162b2 vaccine in 12-to-15-year-old recipients had a favorable safety profile, produced a greater immune response than in young adults, and was highly effective against Covid-19. (Funded by BioNTech and Pfizer; C4591001 ClinicalTrials.gov number, NCT04368728.). SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/34043894/full_citation L2 - https://www.nejm.org/doi/10.1056/NEJMoa2107456?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -