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Real-World Effectiveness of BNT162b2 Against Infection and Severe Diseases in Children and Adolescents.
Wu, Qiong; Tong, Jiayi; Zhang, Bingyu; Zhang, Dazheng; Chen, Jiajie; Lei, Yuqing; Lu, Yiwen; Wang, Yudong; Li, Lu; Shen, Yishan; Xu, Jie; Bailey, L Charles; Bian, Jiang; Christakis, Dimitri A; Fitzgerald, Megan L; Hirabayashi, Kathryn; Jhaveri, Ravi; Khaitan, Alka; Lyu, Tianchen; Rao, Suchitra; Razzaghi, Hanieh; Schwenk, Hayden T; Wang, Fei; Gage Witvliet, Margot I; Tchetgen Tchetgen, Eric J; Morris, Jeffrey S; Forrest, Christopher B; Chen, Yong.
Afiliación
  • Wu Q; The Center for Health Analytics and Synthesis of Evidence (CHASE), Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania (Q.W., J.T., D.Z., J.C., Y.Lei, Y.W.).
  • Tong J; The Center for Health Analytics and Synthesis of Evidence (CHASE), Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania (Q.W., J.T., D.Z., J.C., Y.Lei, Y.W.).
  • Zhang B; The Center for Health Analytics and Synthesis of Evidence (CHASE), The Graduate Group in Applied Mathematics and Computational Science, School of Arts and Sciences, University of Pennsylvania, Philadelphia, Pennsylvania (B.Z., Y.Lu, L.L., Y.S.).
  • Zhang D; The Center for Health Analytics and Synthesis of Evidence (CHASE), Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania (Q.W., J.T., D.Z., J.C., Y.Lei, Y.W.).
  • Chen J; The Center for Health Analytics and Synthesis of Evidence (CHASE), Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania (Q.W., J.T., D.Z., J.C., Y.Lei, Y.W.).
  • Lei Y; The Center for Health Analytics and Synthesis of Evidence (CHASE), Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania (Q.W., J.T., D.Z., J.C., Y.Lei, Y.W.).
  • Lu Y; The Center for Health Analytics and Synthesis of Evidence (CHASE), The Graduate Group in Applied Mathematics and Computational Science, School of Arts and Sciences, University of Pennsylvania, Philadelphia, Pennsylvania (B.Z., Y.Lu, L.L., Y.S.).
  • Wang Y; The Center for Health Analytics and Synthesis of Evidence (CHASE), Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania (Q.W., J.T., D.Z., J.C., Y.Lei, Y.W.).
  • Li L; The Center for Health Analytics and Synthesis of Evidence (CHASE), The Graduate Group in Applied Mathematics and Computational Science, School of Arts and Sciences, University of Pennsylvania, Philadelphia, Pennsylvania (B.Z., Y.Lu, L.L., Y.S.).
  • Shen Y; The Center for Health Analytics and Synthesis of Evidence (CHASE), The Graduate Group in Applied Mathematics and Computational Science, School of Arts and Sciences, University of Pennsylvania, Philadelphia, Pennsylvania (B.Z., Y.Lu, L.L., Y.S.).
  • Xu J; Department of Health Outcomes Biomedical Informatics, University of Florida, Gainesville, Florida (J.X., J.B., T.L.).
  • Bailey LC; Applied Clinical Research Center, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania (L.C.B., K.H., H.R., C.B.F.).
  • Bian J; Department of Health Outcomes Biomedical Informatics, University of Florida, Gainesville, Florida (J.X., J.B., T.L.).
  • Christakis DA; Center for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, Washington (D.A.C.).
  • Fitzgerald ML; Department of Medicine, Grossman School of Medicine, New York University, New York, New York (M.L.F.).
  • Hirabayashi K; Applied Clinical Research Center, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania (L.C.B., K.H., H.R., C.B.F.).
  • Jhaveri R; Division of Pediatric Infectious Diseases, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois (R.J.).
  • Khaitan A; Department of Pediatrics, Ryan White Center for Pediatric Infectious Diseases and Global Health, Indiana University School of Medicine, Indianapolis, Indiana (A.K.).
  • Lyu T; Department of Health Outcomes Biomedical Informatics, University of Florida, Gainesville, Florida (J.X., J.B., T.L.).
  • Rao S; Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado (S.R.).
  • Razzaghi H; Applied Clinical Research Center, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania (L.C.B., K.H., H.R., C.B.F.).
  • Schwenk HT; Department of Pediatrics, Stanford School of Medicine, Stanford, California (H.T.S.).
  • Wang F; Department of Population Health Sciences, Weill Cornell Medicine, New York, New York (F.W.).
  • Gage Witvliet MI; Department of Sociology, Social Work and Criminal Justice, Lamar University, Beaumont, Texas (M.I.G.W.).
  • Tchetgen Tchetgen EJ; Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania (E.J.T.T., J.S.M.).
  • Morris JS; Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania (E.J.T.T., J.S.M.).
  • Forrest CB; Applied Clinical Research Center, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania (L.C.B., K.H., H.R., C.B.F.).
  • Chen Y; The Center for Health Analytics and Synthesis of Evidence (CHASE), Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania Perelman School of Medicine, and The Graduate Group in Applied Mathematics and Computational Science, School of Arts and Sciences, University of P
Ann Intern Med ; 177(2): 165-176, 2024 02.
Article en En | MEDLINE | ID: mdl-38190711
ABSTRACT

BACKGROUND:

The efficacy of the BNT162b2 vaccine in pediatrics was assessed by randomized trials before the Omicron variant's emergence. The long-term durability of vaccine protection in this population during the Omicron period remains limited.

OBJECTIVE:

To assess the effectiveness of BNT162b2 in preventing infection and severe diseases with various strains of the SARS-CoV-2 virus in previously uninfected children and adolescents.

DESIGN:

Comparative effectiveness research accounting for underreported vaccination in 3 study cohorts adolescents (12 to 20 years) during the Delta phase and children (5 to 11 years) and adolescents (12 to 20 years) during the Omicron phase.

SETTING:

A national collaboration of pediatric health systems (PEDSnet).

PARTICIPANTS:

77 392 adolescents (45 007 vaccinated) during the Delta phase and 111 539 children (50 398 vaccinated) and 56 080 adolescents (21 180 vaccinated) during the Omicron phase. INTERVENTION First dose of the BNT162b2 vaccine versus no receipt of COVID-19 vaccine. MEASUREMENTS Outcomes of interest include documented infection, COVID-19 illness severity, admission to an intensive care unit (ICU), and cardiac complications. The effectiveness was reported as (1-relative risk)*100, with confounders balanced via propensity score stratification.

RESULTS:

During the Delta period, the estimated effectiveness of the BNT162b2 vaccine was 98.4% (95% CI, 98.1% to 98.7%) against documented infection among adolescents, with no statistically significant waning after receipt of the first dose. An analysis of cardiac complications did not suggest a statistically significant difference between vaccinated and unvaccinated groups. During the Omicron period, the effectiveness against documented infection among children was estimated to be 74.3% (CI, 72.2% to 76.2%). Higher levels of effectiveness were seen against moderate or severe COVID-19 (75.5% [CI, 69.0% to 81.0%]) and ICU admission with COVID-19 (84.9% [CI, 64.8% to 93.5%]). Among adolescents, the effectiveness against documented Omicron infection was 85.5% (CI, 83.8% to 87.1%), with 84.8% (CI, 77.3% to 89.9%) against moderate or severe COVID-19, and 91.5% (CI, 69.5% to 97.6%) against ICU admission with COVID-19. The effectiveness of the BNT162b2 vaccine against the Omicron variant declined 4 months after the first dose and then stabilized. The analysis showed a lower risk for cardiac complications in the vaccinated group during the Omicron variant period.

LIMITATION:

Observational study design and potentially undocumented infection.

CONCLUSION:

This study suggests that BNT162b2 was effective for various COVID-19-related outcomes in children and adolescents during the Delta and Omicron periods, and there is some evidence of waning effectiveness over time. PRIMARY FUNDING SOURCE National Institutes of Health.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: COVID-19 / Vacuna BNT162 Tipo de estudio: Clinical_trials / Etiology_studies / Observational_studies Límite: Adolescent / Child / Humans País/Región como asunto: America do norte Idioma: En Revista: Ann Intern Med Año: 2024 Tipo del documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: COVID-19 / Vacuna BNT162 Tipo de estudio: Clinical_trials / Etiology_studies / Observational_studies Límite: Adolescent / Child / Humans País/Región como asunto: America do norte Idioma: En Revista: Ann Intern Med Año: 2024 Tipo del documento: Article