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

May 27, 2021

Robert W. Frenck, Nicola P. Klein, Nicholas Kitchin, Alejandra Gurtman, Judith Absalon, Stephen Lockhart, John L. Perez, Emmanuel B. Walter, Shelly Senders, Ruth Bailey, Kena A. Swanson, Hua Ma, Kenneth Koury, Warren V. Kalina, David Cooper, Timothy Jennings, Donald M. Brandon, Stephen J. Thomas, Özlem Türeci, Dina B. Tresnan, Susan Mather, Philip R. Dormitzer, Uğur Şahin, Kathrin U. Jansen, and William C. Gruber.

The New England Journal of Medicine

In this ongoing multinational trial, placebo-controlled and observer-blinded, funded by BioNTech and Pfizer, 2,260 adolescents aged 12-15 years were randomly assigned 1:1 to receive two injections, 21 days apart, of 30 μg of BNT162b2 (1131 participants) or placebo (1129 participants). The sought results were non-inferiority of the immune response, safety (reactogenicity and adverse events), and efficacy (against Covid-19 after 7 days of dose 2) in the 12-15 year-old cohort. BNT162b2 was found to have a favorable safety profile; mild to moderate reactogenicity (predominantly injection site pain [79-86%], fatigue [60-66%], and headache [55-65%]); no vaccine-related serious adverse events and few serious adverse events overall. The ratio of the geometric mean of the 50% neutralizing titers of SARS-CoV-2 after dose 2 in participants aged 12 to 15 years relative to participants aged 16 to 25 years was 1.76 (CI = 95%, 1.47 to 2.10), meeting the non-inferiority criterion (greater than 0.67) indicating a greater response. The observed vaccine efficacy was 100% (95% CI, 75.3 to 100). It was concluded that the BNT162b2 vaccine in recipients aged 12 to 15 years had a favorable safety profile, produced a greater immune response than in young adults, and was highly effective against Covid-19.

Frenck R, Klein N, Kitchin N, Gurtman A, et al, for the C4591001 Clinical Trial Group. Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents. NEJM. Doi: 10.1056/NEJMoa2107456

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