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Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents.

Publication ,  Journal Article
Frenck, RW; Klein, NP; Kitchin, N; Gurtman, A; Absalon, J; Lockhart, S; Perez, JL; Walter, EB; Senders, S; Bailey, R; Swanson, KA; Ma, H ...
Published in: N Engl J Med
July 15, 2021

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.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

July 15, 2021

Volume

385

Issue

3

Start / End Page

239 / 250

Location

United States

Related Subject Headings

  • Young Adult
  • Treatment Outcome
  • Pain
  • Male
  • Injections, Intramuscular
  • Immunoglobulin G
  • Immunogenicity, Vaccine
  • Humans
  • General & Internal Medicine
  • Female
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Frenck, R. W., Klein, N. P., Kitchin, N., Gurtman, A., Absalon, J., Lockhart, S., … C4591001 Clinical Trial Group, . (2021). Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents. N Engl J Med, 385(3), 239–250. https://doi.org/10.1056/NEJMoa2107456
Frenck, Robert W., Nicola P. Klein, Nicholas Kitchin, Alejandra Gurtman, Judith Absalon, Stephen Lockhart, John L. Perez, et al. “Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents.N Engl J Med 385, no. 3 (July 15, 2021): 239–50. https://doi.org/10.1056/NEJMoa2107456.
Frenck RW, Klein NP, Kitchin N, Gurtman A, Absalon J, Lockhart S, et al. Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents. N Engl J Med. 2021 Jul 15;385(3):239–50.
Frenck, Robert W., et al. “Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents.N Engl J Med, vol. 385, no. 3, July 2021, pp. 239–50. Pubmed, doi:10.1056/NEJMoa2107456.
Frenck RW, Klein NP, Kitchin N, Gurtman A, Absalon J, Lockhart S, Perez JL, Walter EB, Senders S, Bailey R, Swanson KA, Ma H, Xu X, Koury K, Kalina WV, Cooper D, Jennings T, Brandon DM, Thomas SJ, Türeci Ö, Tresnan DB, Mather S, Dormitzer PR, Şahin U, Jansen KU, Gruber WC, C4591001 Clinical Trial Group. Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents. N Engl J Med. 2021 Jul 15;385(3):239–250.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

July 15, 2021

Volume

385

Issue

3

Start / End Page

239 / 250

Location

United States

Related Subject Headings

  • Young Adult
  • Treatment Outcome
  • Pain
  • Male
  • Injections, Intramuscular
  • Immunoglobulin G
  • Immunogenicity, Vaccine
  • Humans
  • General & Internal Medicine
  • Female