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Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents.
Frenck, Robert W; Klein, Nicola P; Kitchin, Nicholas; Gurtman, Alejandra; Absalon, Judith; Lockhart, Stephen; Perez, John L; Walter, Emmanuel B; Senders, Shelly; Bailey, Ruth; Swanson, Kena A; Ma, Hua; Xu, Xia; Koury, Kenneth; Kalina, Warren V; Cooper, David; Jennings, Timothy; Brandon, Donald M; Thomas, Stephen J; Türeci, Özlem; Tresnan, Dina B; Mather, Susan; Dormitzer, Philip R; Sahin, Ugur; Jansen, Kathrin U; Gruber, William C.
  • Frenck RW; From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research a
  • Klein NP; From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research a
  • Kitchin N; From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research a
  • Gurtman A; From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research a
  • Absalon J; From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research a
  • Lockhart S; From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research a
  • Perez JL; From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research a
  • Walter EB; From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research a
  • Senders S; From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research a
  • Bailey R; From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research a
  • Swanson KA; From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research a
  • Ma H; From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research a
  • Xu X; From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research a
  • Koury K; From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research a
  • Kalina WV; From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research a
  • Cooper D; From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research a
  • Jennings T; From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research a
  • Brandon DM; From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research a
  • Thomas SJ; From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research a
  • Türeci Ö; From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research a
  • Tresnan DB; From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research a
  • Mather S; From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research a
  • Dormitzer PR; From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research a
  • Sahin U; From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research a
  • Jansen KU; From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research a
  • Gruber WC; From Cincinnati Children's Hospital, Cincinnati (R.W.F.); Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.), and the California Research Foundation, San Diego (D.M.B.) - both in California; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research a
N Engl J Med ; 385(3): 239-250, 2021 07 15.
Article in English | MEDLINE | ID: covidwho-1246454
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 11 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.).
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Antibodies, Neutralizing / Immunogenicity, Vaccine / COVID-19 Vaccines / COVID-19 / Antibodies, Viral Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adolescent / Adult / Child / Female / Humans / Male / Young adult Language: English Journal: N Engl J Med Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Antibodies, Neutralizing / Immunogenicity, Vaccine / COVID-19 Vaccines / COVID-19 / Antibodies, Viral Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adolescent / Adult / Child / Female / Humans / Male / Young adult Language: English Journal: N Engl J Med Year: 2021 Document Type: Article