Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age

C4591007 Clinical Trial Group, Emmanuel B Walter, Kawsar R Talaat, Charu Sabharwal, Alejandra Gurtman, Stephen Lockhart, Grant C Paulsen, Elizabeth D Barnett, Flor M Muñoz, Yvonne Maldonado, Barbara A Pahud, Joseph B Domachowske, Eric A F Simões, Uzma N Sarwar, Nicholas Kitchin, Luke Cunliffe, Pablo Rojo, Ernest Kuchar, Mika Rämet, Iona MunjalJohn L Perez, Robert W Frenck, Eleni Lagkadinou, Kena A Swanson, Hua Ma, Xia Xu, Kenneth Koury, Susan Mather, Todd J Belanger, David Cooper, Özlem Türeci, Philip R Dormitzer, Uğur Şahin, Kathrin U Jansen, William C Gruber

Tutkimustuotos: ArtikkeliScientificvertaisarvioitu

Abstrakti

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

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

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

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

AlkuperäiskieliEnglanti
Sivut35-46
Sivumäärä12
JulkaisuNEW ENGLAND JOURNAL OF MEDICINE
Vuosikerta386
Numero1
Varhainen verkossa julkaisun päivämäärä9 marrask. 2021
DOI - pysyväislinkit
TilaJulkaistu - 6 tammik. 2022
OKM-julkaisutyyppiA1 Alkuperäisartikkeli tieteellisessä aikakauslehdessä

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