Evidence map›Paper›PMID 38190711›Full record

Observational studyAnnals of internal medicine2024

Real-World Effectiveness of BNT162b2 Against Infection and Severe Diseases in Children and Adolescents.

Qiong Wu, Jiayi Tong, Bingyu Zhang, Dazheng Zhang, Jiajie Chen, Yuqing Lei, Yiwen Lu, Yudong Wang, Lu Li, Yishan Shen and 18 more

Open access · greenAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Annals of internal medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
12.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

28 authors at 11 institutions in 1 country.

Qiong WuThe 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.).ORCID 0000-0001-5747-1899
Jiayi TongThe 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.).ORCID 0000-0002-1213-6699
Bingyu ZhangThe 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.).ORCID 0000-0001-7176-249X
Dazheng ZhangThe 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.).ORCID 0000-0002-1431-0785
Jiajie ChenThe 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.).ORCID 0009-0008-7402-6883
Yuqing LeiThe 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.).ORCID 0009-0003-8867-202X
Yiwen LuThe 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.).ORCID 0000-0002-8610-2416
Yudong WangThe 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.).ORCID 0000-0002-7546-8957
Lu LiThe 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.).ORCID 0000-0002-2891-6067
Yishan ShenThe 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.).ORCID 0000-0003-2611-8456
Jie XuDepartment of Health Outcomes Biomedical Informatics, University of Florida, Gainesville, Florida (J.X., J.B., T.L.).
L Charles BaileyApplied Clinical Research Center, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania (L.C.B., K.H., H.R., C.B.F.).ORCID 0000-0002-8967-0662
Jiang BianDepartment of Health Outcomes Biomedical Informatics, University of Florida, Gainesville, Florida (J.X., J.B., T.L.).ORCID 0000-0002-2238-5429
Dimitri A ChristakisCenter for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, Washington (D.A.C.).
Megan L FitzgeraldDepartment of Medicine, Grossman School of Medicine, New York University, New York, New York (M.L.F.).
Kathryn HirabayashiApplied Clinical Research Center, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania (L.C.B., K.H., H.R., C.B.F.).ORCID 0000-0003-0647-5579
Ravi JhaveriDivision of Pediatric Infectious Diseases, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois (R.J.).ORCID 0000-0001-9921-0419
Alka KhaitanDepartment of Pediatrics, Ryan White Center for Pediatric Infectious Diseases and Global Health, Indiana University School of Medicine, Indianapolis, Indiana (A.K.).
Tianchen LyuDepartment of Health Outcomes Biomedical Informatics, University of Florida, Gainesville, Florida (J.X., J.B., T.L.).
Suchitra RaoDepartment of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado (S.R.).ORCID 0000-0002-0334-6301
Hanieh RazzaghiApplied Clinical Research Center, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania (L.C.B., K.H., H.R., C.B.F.).ORCID 0000-0001-5001-1590
Hayden T SchwenkDepartment of Pediatrics, Stanford School of Medicine, Stanford, California (H.T.S.).ORCID 0000-0002-8164-8655
Fei WangDepartment of Population Health Sciences, Weill Cornell Medicine, New York, New York (F.W.).ORCID 0000-0001-9459-9461
Margot I Gage WitvlietDepartment of Sociology, Social Work and Criminal Justice, Lamar University, Beaumont, Texas (M.I.G.W.).
Eric J Tchetgen TchetgenDepartment of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania (E.J.T.T., J.S.M.).
Jeffrey S MorrisDepartment of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania (E.J.T.T., J.S.M.).ORCID 0000-0002-8520-6088
Christopher B ForrestApplied Clinical Research Center, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania (L.C.B., K.H., H.R., C.B.F.).ORCID 0000-0003-1252-068X
Yong ChenThe 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 Pennsylvania, Leonard Davis Institute of Health Economics, Penn Medicine Center for Evidence-based Practice (CEP), and Penn Institute for Biomedical Informatics (IBI), Philadelphia, Pennsylvania (Y.C.).ORCID 0000-0003-0835-0788
University of Pennsylvania · USChildren's Hospital of Philadelphia · USUniversity of Florida Health · USChildren's Hospital Colorado · USCornell University · USIndiana University School of MedicineLamar University · USLurie Children's Hospital · USNew York University · USSeattle Children's Hospital · USStanford Medicine · US

Funding

OTA-21-015A Post-Acute Sequelae of SARS-CoV-2 Infection Initiative: NYU Langone Health Clinical Science Core, Data Resource Core, and PASC Biorepository CoreOT2HL161847 · NHLBI · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI GROSS, RACHEL SHARON, HORWITZ, LEORA · 2021 to 2025
$651.0M
PANDA-MSD: Predictive Analytics via Networked Distributed Algorithms for Multi-System DiseasesU01TR003709 · NCATS · UNIVERSITY OF PENNSYLVANIA · PI BIAN, JIANG, CHEN, YONG · 2022 to 2025
$4.7M
TRiPOD: Toward Reusable Phenotypes in Observational Data for AD/ADRD - managing definitions and correcting biasR01AG073435 · NIA · UNIVERSITY OF PENNSYLVANIA · PI CHEN, YONG, XU, HUA · 2021 to 2025
$3.9M
Dynamic learning for post-vaccine event prediction using temporal information in VAERSR01AI130460 · NIAID · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI CHEN, YONG, TAO, CUI · 2017 to 2021
$3.4M
AI-ADRD: Accelerating interventions of AD/ADRD via Machine learning methodsRF1AG077820 · NIA · UNIVERSITY OF PENNSYLVANIA · PI BIAN, JIANG, CHEN, YONG · 2023 to 2023
$2.3M
PheBC: bias correction methods for EHR derived phenotypeR01LM013519 · NLM · UNIVERSITY OF PENNSYLVANIA · PI CHEN, YONG, XU, HUA · 2021 to 2024
$1.6M
Advancing Drug Repositioning for Alzheimer’s Disease using Real-world DataR56AG069880 · NIA · UNIVERSITY OF FLORIDA · PI BIAN, JIANG, CHEN, YONG · 2021 to 2022
$1.6M
CICADA: clinical informatics and computational approaches for drug-repositioning of AD/ADRDR56AG074604 · NIA · UNIVERSITY OF PENNSYLVANIA · PI CHEN, YONG, TAO, CUI · 2021 to 2022
$1.5M
A General Framework to Account for Outcome Reporting Bias in Systematic ReviewsR01LM012607 · NLM · UNIVERSITY OF PENNSYLVANIA · PI CHEN, YONG · 2017 to 2020
$1.4M
NCATS NIH HHS U01 TR003709NHLBI NIH HHS OT2 HL161847NIAID NIH HHS R01 AI130460NIA NIH HHS R01 AG073435NIA NIH HHS R56 AG069880NIA NIH HHS R56 AG074604NIA NIH HHS RF1 AG077820NLM NIH HHS R01 LM012607NLM NIH HHS R01 LM013519
6 · The paper itself

Abstract

backgroundThe 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.

objectiveTo 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.

designComparative 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.

settingA national collaboration of pediatric health systems (PEDSnet).

participants77 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.

interventionFirst 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.

resultsDuring 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.

conclusionThis 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.

Indexed as

BNT162 VaccineCOVID-19AdolescentChildComparative Effectiveness ResearchCOVID-19 VaccinesHospitalizationHumansUnited StatesBNT162 VaccineCOVID-19 Vaccines

Identifiers

PMID38190711
PMCPMC11956830
OpenAlexW4390658840

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.