Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents
Robert W Frenck Jr, 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, Xia Xu, 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, William C Gruber, C4591001 Clinical Trial Group, Samir Arora, Donald Brandon, David Butuk, Fadi Chalhoub, Shane Christensen, Gretchen Crook, Matthew Davis, Douglas Denham, Michael Dever, Brandon Essink, Daniel Finn, Robert Frenck, David Fried, Julia Garcia-Diaz, Charles Harper, Aaron Hartman, Timothy Jennings, Nicola Klein, Onyema Ogbuagu, Suchet Patel, James Peterson, William Randall, Hector Rodriguez, Richard Rupp, Shelly Senders, Stephen Thomas, John Vanchiere, Emmanuel Walter, Robert W Frenck Jr, 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, Xia Xu, 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, William C Gruber, C4591001 Clinical Trial Group, Samir Arora, Donald Brandon, David Butuk, Fadi Chalhoub, Shane Christensen, Gretchen Crook, Matthew Davis, Douglas Denham, Michael Dever, Brandon Essink, Daniel Finn, Robert Frenck, David Fried, Julia Garcia-Diaz, Charles Harper, Aaron Hartman, Timothy Jennings, Nicola Klein, Onyema Ogbuagu, Suchet Patel, James Peterson, William Randall, Hector Rodriguez, Richard Rupp, Shelly Senders, Stephen Thomas, John Vanchiere, Emmanuel Walter
Abstract
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.).
Copyright © 2021 Massachusetts Medical Society.
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Source: PubMed