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BNT162b2 Vaccine Effectiveness against Omicron in Children 5 to 11 Years of Age.
Cohen-Stavi, Chandra J; Magen, Ori; Barda, Noam; Yaron, Shlomit; Peretz, Alon; Netzer, Doron; Giaquinto, Carlo; Judd, Ali; Leibovici, Leonard; Hernán, Miguel A; Lipsitch, Marc; Reis, Ben Y; Balicer, Ran D; Dagan, Noa.
  • Cohen-Stavi CJ; From the Clalit Research Institute, Innovation Division (C.J.C.-S., O.M., R.D.B., N.D.), and the Community Medicine Division (S.Y., A.P., D.N.), Clalit Health Services, and the Faculty of Medicine, Tel-Aviv University (L.L.), Tel Aviv, the Research Authority, Rabin Medical Center, Petah-Tiqva (L.L.)
  • Magen O; From the Clalit Research Institute, Innovation Division (C.J.C.-S., O.M., R.D.B., N.D.), and the Community Medicine Division (S.Y., A.P., D.N.), Clalit Health Services, and the Faculty of Medicine, Tel-Aviv University (L.L.), Tel Aviv, the Research Authority, Rabin Medical Center, Petah-Tiqva (L.L.)
  • Barda N; From the Clalit Research Institute, Innovation Division (C.J.C.-S., O.M., R.D.B., N.D.), and the Community Medicine Division (S.Y., A.P., D.N.), Clalit Health Services, and the Faculty of Medicine, Tel-Aviv University (L.L.), Tel Aviv, the Research Authority, Rabin Medical Center, Petah-Tiqva (L.L.)
  • Yaron S; From the Clalit Research Institute, Innovation Division (C.J.C.-S., O.M., R.D.B., N.D.), and the Community Medicine Division (S.Y., A.P., D.N.), Clalit Health Services, and the Faculty of Medicine, Tel-Aviv University (L.L.), Tel Aviv, the Research Authority, Rabin Medical Center, Petah-Tiqva (L.L.)
  • Peretz A; From the Clalit Research Institute, Innovation Division (C.J.C.-S., O.M., R.D.B., N.D.), and the Community Medicine Division (S.Y., A.P., D.N.), Clalit Health Services, and the Faculty of Medicine, Tel-Aviv University (L.L.), Tel Aviv, the Research Authority, Rabin Medical Center, Petah-Tiqva (L.L.)
  • Netzer D; From the Clalit Research Institute, Innovation Division (C.J.C.-S., O.M., R.D.B., N.D.), and the Community Medicine Division (S.Y., A.P., D.N.), Clalit Health Services, and the Faculty of Medicine, Tel-Aviv University (L.L.), Tel Aviv, the Research Authority, Rabin Medical Center, Petah-Tiqva (L.L.)
  • Giaquinto C; From the Clalit Research Institute, Innovation Division (C.J.C.-S., O.M., R.D.B., N.D.), and the Community Medicine Division (S.Y., A.P., D.N.), Clalit Health Services, and the Faculty of Medicine, Tel-Aviv University (L.L.), Tel Aviv, the Research Authority, Rabin Medical Center, Petah-Tiqva (L.L.)
  • Judd A; From the Clalit Research Institute, Innovation Division (C.J.C.-S., O.M., R.D.B., N.D.), and the Community Medicine Division (S.Y., A.P., D.N.), Clalit Health Services, and the Faculty of Medicine, Tel-Aviv University (L.L.), Tel Aviv, the Research Authority, Rabin Medical Center, Petah-Tiqva (L.L.)
  • Leibovici L; From the Clalit Research Institute, Innovation Division (C.J.C.-S., O.M., R.D.B., N.D.), and the Community Medicine Division (S.Y., A.P., D.N.), Clalit Health Services, and the Faculty of Medicine, Tel-Aviv University (L.L.), Tel Aviv, the Research Authority, Rabin Medical Center, Petah-Tiqva (L.L.)
  • Hernán MA; From the Clalit Research Institute, Innovation Division (C.J.C.-S., O.M., R.D.B., N.D.), and the Community Medicine Division (S.Y., A.P., D.N.), Clalit Health Services, and the Faculty of Medicine, Tel-Aviv University (L.L.), Tel Aviv, the Research Authority, Rabin Medical Center, Petah-Tiqva (L.L.)
  • Lipsitch M; From the Clalit Research Institute, Innovation Division (C.J.C.-S., O.M., R.D.B., N.D.), and the Community Medicine Division (S.Y., A.P., D.N.), Clalit Health Services, and the Faculty of Medicine, Tel-Aviv University (L.L.), Tel Aviv, the Research Authority, Rabin Medical Center, Petah-Tiqva (L.L.)
  • Reis BY; From the Clalit Research Institute, Innovation Division (C.J.C.-S., O.M., R.D.B., N.D.), and the Community Medicine Division (S.Y., A.P., D.N.), Clalit Health Services, and the Faculty of Medicine, Tel-Aviv University (L.L.), Tel Aviv, the Research Authority, Rabin Medical Center, Petah-Tiqva (L.L.)
  • Balicer RD; From the Clalit Research Institute, Innovation Division (C.J.C.-S., O.M., R.D.B., N.D.), and the Community Medicine Division (S.Y., A.P., D.N.), Clalit Health Services, and the Faculty of Medicine, Tel-Aviv University (L.L.), Tel Aviv, the Research Authority, Rabin Medical Center, Petah-Tiqva (L.L.)
  • Dagan N; From the Clalit Research Institute, Innovation Division (C.J.C.-S., O.M., R.D.B., N.D.), and the Community Medicine Division (S.Y., A.P., D.N.), Clalit Health Services, and the Faculty of Medicine, Tel-Aviv University (L.L.), Tel Aviv, the Research Authority, Rabin Medical Center, Petah-Tiqva (L.L.)
N Engl J Med ; 387(3): 227-236, 2022 07 21.
Article in English | MEDLINE | ID: covidwho-1908352
ABSTRACT

BACKGROUND:

Limited evidence is available on the real-world effectiveness of the BNT162b2 vaccine against coronavirus disease 2019 (Covid-19) and specifically against infection with the omicron variant among children 5 to 11 years of age.

METHODS:

Using data from the largest health care organization in Israel, we identified a cohort of children 5 to 11 years of age who were vaccinated on or after November 23, 2021, and matched them with unvaccinated controls to estimate the vaccine effectiveness of BNT162b2 among newly vaccinated children during the omicron wave. Vaccine effectiveness against documented severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and symptomatic Covid-19 was estimated after the first and second vaccine doses. The cumulative incidence of each outcome in the two study groups through January 7, 2022, was estimated with the use of the Kaplan-Meier estimator, and vaccine effectiveness was calculated as 1 minus the risk ratio. Vaccine effectiveness was also estimated in age subgroups.

RESULTS:

Among 136,127 eligible children who had been vaccinated during the study period, 94,728 were matched with unvaccinated controls. The estimated vaccine effectiveness against documented infection was 17% (95% confidence interval [CI], 7 to 25) at 14 to 27 days after the first dose and 51% (95% CI, 39 to 61) at 7 to 21 days after the second dose. The absolute risk difference between the study groups at days 7 to 21 after the second dose was 1905 events per 100,000 persons (95% CI, 1294 to 2440) for documented infection and 599 events per 100,000 persons (95% CI, 296 to 897) for symptomatic Covid-19. The estimated vaccine effectiveness against symptomatic Covid-19 was 18% (95% CI, -2 to 34) at 14 to 27 days after the first dose and 48% (95% CI, 29 to 63) at 7 to 21 days after the second dose. We observed a trend toward higher vaccine effectiveness in the youngest age group (5 or 6 years of age) than in the oldest age group (10 or 11 years of age).

CONCLUSIONS:

Our findings suggest that as omicron was becoming the dominant variant, two doses of the BNT162b2 messenger RNA vaccine provided moderate protection against documented SARS-CoV-2 infection and symptomatic Covid-19 in children 5 to 11 years of age. (Funded by the European Union through the VERDI project and others.).
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 / Vaccine Efficacy / BNT162 Vaccine Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Limits: Child / Child, preschool / Humans Country/Region as subject: Asia Language: English Journal: N Engl J Med Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 / Vaccine Efficacy / BNT162 Vaccine Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Limits: Child / Child, preschool / Humans Country/Region as subject: Asia Language: English Journal: N Engl J Med Year: 2022 Document Type: Article