University of Oulu

Walter, E. B., Talaat, K. R., Sabharwal, C., Gurtman, A., Lockhart, S., Paulsen, G. C., Barnett, E. D., Muñoz, F. M., Maldonado, Y., Pahud, B. A., Domachowske, J. B., Simões, E. A. F., Sarwar, U. N., Kitchin, N., Cunliffe, L., Rojo, P., Kuchar, E., Rämet, M., Munjal, I., … Gruber, W. C. (2022). Evaluation of the bnt162b2 covid-19 vaccine in children 5 to 11 years of age. New England Journal of Medicine, 386(1), 35–46.

Evaluation of the BNT162b2 Covid-19 vaccine in children 5 to 11 years of age

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Author: Walter, E. B.1; Talaat, K. R.2; Sabharwal, C.3;
Organizations: 1Duke Human Vaccine Inst, Durham, NC USA.
2Johns Hopkins Univ, Baltimore, MD USA.
3Pfizer, Vaccine Res & Dev, 401 N Middletown Rd, Pearl River, NY 10965 USA.
4Pfizer, Vaccine Res & Dev, Hurley, England.
5Univ Cincinnati, Coll Med, Dept Pediat, Cincinnati, OH USA.
6Cincinnati Childrens Hosp Med Ctr, Div Pediat Infect Dis, Cincinnati, OH 45229 USA.
7Boston Univ, Sch Med, Boston Med Ctr, Boston, MA 02118 USA.
8Texas Childrens Hosp, Baylor Coll Med, Houston, TX 77030 USA.
9Stanford Univ, Sch Med, Palo Alto, CA 94304 USA.
10Childrens Mercy Hosp, Kansas City, MO 64108 USA.
11SUNY Upstate Med Univ, Syracuse, NY 13210 USA.
12Univ Colorado, Sch Med, Aurora, CO USA.
13Childrens Hosp Colorado, Aurora, CO USA.
14BioNTech, Mainz, Germany.
15Hosp Univ 12 Octubre, Madrid, Spain.
16Med Univ Warsaw, Warsaw, Poland.
17Tampere Univ, Vaccine Res Ctr, Tampere, Finland.
18Univ Oulu, PEDEGO Res Unit, Oulu, Finland.
19Pfizer, Vaccine Res & Dev, Collegeville, PA USA.
20Pfizer, Worldwide Safety Safety Surveillance & Risk Manag, Collegeville, PA USA.
Format: article
Version: published version
Access: open
Online Access: PDF Full Text (PDF, 0.7 MB)
Persistent link:
Language: English
Published: Massachusetts Medical Society, 2022
Publish Date: 2022-07-06


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.

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Series: New England journal of medicine
ISSN: 0028-4793
ISSN-E: 1533-4406
ISSN-L: 0028-4793
Volume: 386
Issue: 1
Pages: 35 - 46
DOI: 10.1056/NEJMoa2116298
Type of Publication: A1 Journal article – refereed
Field of Science: 3121 General medicine, internal medicine and other clinical medicine
3142 Public health care science, environmental and occupational health
3123 Gynaecology and paediatrics
Funding: Funded by BioNTech and Pfizer; number, NCT04816643.
Copyright information: © 2021 Massachusetts Medical Society.