Your browser doesn't support javascript.
Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age.
Walter, Emmanuel B; Talaat, Kawsar R; Sabharwal, Charu; Gurtman, Alejandra; Lockhart, Stephen; Paulsen, Grant C; Barnett, Elizabeth D; Muñoz, Flor M; Maldonado, Yvonne; Pahud, Barbara A; Domachowske, Joseph B; Simões, Eric A F; Sarwar, Uzma N; Kitchin, Nicholas; Cunliffe, Luke; Rojo, Pablo; Kuchar, Ernest; Rämet, Mika; Munjal, Iona; Perez, John L; Frenck, Robert W; Lagkadinou, Eleni; Swanson, Kena A; Ma, Hua; Xu, Xia; Koury, Kenneth; Mather, Susan; Belanger, Todd J; Cooper, David; Türeci, Özlem; Dormitzer, Philip R; Sahin, Ugur; Jansen, Kathrin U; Gruber, William C.
  • Walter EB; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Talaat KR; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Sabharwal C; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Gurtman A; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Lockhart S; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Paulsen GC; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Barnett ED; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Muñoz FM; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Maldonado Y; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Pahud BA; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Domachowske JB; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Simões EAF; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Sarwar UN; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Kitchin N; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Cunliffe L; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Rojo P; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Kuchar E; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Rämet M; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Munjal I; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Perez JL; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Frenck RW; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Lagkadinou E; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Swanson KA; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Ma H; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Xu X; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Koury K; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Mather S; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Belanger TJ; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Cooper D; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Türeci Ö; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Dormitzer PR; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Sahin U; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Jansen KU; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
  • Gruber WC; From Duke Human Vaccine Institute, Durham, NC (E.B.W.); Johns Hopkins University, Baltimore (K.R.T.); Vaccine Research and Development, Pfizer, Pearl River (C.S., A.G., B.A.P., U.N.S., I.M., K.A.S., K.K., T.J.B., D.C., P.R.D., K.U.J., W.C.G.), and SUNY Upstate Medical University, Syracuse (J.B.D.) -
N Engl J Med ; 386(1): 35-46, 2022 01 06.
Article in English | MEDLINE | ID: covidwho-1506999
ABSTRACT

BACKGROUND:

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

METHODS:

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

RESULTS:

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

CONCLUSIONS:

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

Full text: Available Collection: International databases Database: MEDLINE Type of study: Cohort study / Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Language: English Journal: N Engl J Med Year: 2022 Document Type: Article

Similar

MEDLINE
LILACS
LIS
Fulltext
Print
XML
PubMed Links
Search on Google

Full text: Available Collection: International databases Database: MEDLINE Type of study: Cohort study / Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Language: English Journal: N Engl J Med Year: 2022 Document Type: Article