Safety of Ancestral Monovalent BNT162b2, mRNA-1273, and NVX-CoV2373 COVID-19 Vaccines in US Children Aged 6 Months to 17 Years.
In: JAMA network open, Jg. 7 (2024-04-01), Heft 4, S. e248192
Online
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Zugriff:
Importance: Active monitoring of health outcomes after COVID-19 vaccination provides early detection of rare outcomes that may not be identified in prelicensure trials.
Objective: To conduct near-real-time monitoring of health outcomes after COVID-19 vaccination in the US pediatric population.
Design, Setting, and Participants: This cohort study evaluated 21 prespecified health outcomes after exposure before early 2023 to BNT162b2, mRNA-1273, or NVX-CoV2373 ancestral monovalent COVID-19 vaccines in children aged 6 months to 17 years by applying a near-real-time monitoring framework using health care data from 3 commercial claims databases in the US (Optum [through April 2023], Carelon Research [through March 2023], and CVS Health [through February 2023]). Increased rates of each outcome after vaccination were compared with annual historical rates from January 1 to December 31, 2019, and January 1 to December 31, 2020, as well as between April 1 and December 31, 2020.
Exposure: Receipt of an ancestral monovalent BNT162b2, mRNA-1273, or NVX-CoV2373 COVID-19 vaccine dose identified through administrative claims data linked with Immunization Information Systems data.
Main Outcomes and Measures: Twenty-one prespecified health outcomes, of which 15 underwent sequential testing and 6 were only monitored descriptively due to lack of historical rates.
Results: Among 4 102 016 vaccinated enrollees aged 6 months to 17 years, 2 058 142 (50.2%) were male and 3 901 370 (95.1%) lived in an urban area. Thirteen of 15 sequentially tested outcomes did not meet the threshold for a statistical signal. Statistical signals were detected for myocarditis or pericarditis after BNT162b2 vaccination in children aged 12 to 17 years and seizure after vaccination with BNT162b2 and mRNA-1273 in children aged 2 to 4 or 5 years. However, in post hoc sensitivity analyses, a statistical signal for seizure was observed only after mRNA-1273 when 2019 background rates were selected; no statistical signal was observed when 2022 rates were selected.
Conclusions and Relevance: In this cohort study of pediatric enrollees across 3 commercial health insurance databases, statistical signals detected for myocarditis or pericarditis after BNT162b2 (ages 12-17 years) were consistent with previous reports, and seizures after BNT162b2 (ages 2-4 years) and mRNA-1273 vaccinations (ages 2-5 years) should be further investigated in a robust epidemiologic study with confounding adjustment. The US Food and Drug Administration concludes that the known and potential benefits of COVID-19 vaccination outweigh the known and potential risks of COVID-19 infection.
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Safety of Ancestral Monovalent BNT162b2, mRNA-1273, and NVX-CoV2373 COVID-19 Vaccines in US Children Aged 6 Months to 17 Years.
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Autor/in / Beteiligte Person: | Hu, M ; Shoaibi, A ; Feng, Y ; Lloyd, PC ; Wong, HL ; Smith, ER ; Amend, KL ; Kline, A ; Beachler, DC ; Gruber, JF ; Mitra, M ; Seeger, JD ; Harris, C ; Secora, A ; Obidi, J ; Wang, J ; Song, J ; McMahill-Walraven, CN ; Reich, C ; McEvoy, R ; Do, R ; Chillarige, Y ; Clifford, R ; Cooper, DD ; Forshee, RA ; Anderson, SA |
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Zeitschrift: | JAMA network open, Jg. 7 (2024-04-01), Heft 4, S. e248192 |
Veröffentlichung: | Chicago, IL : American Medical Association, [2018]-, 2024 |
Medientyp: | academicJournal |
ISSN: | 2574-3805 (electronic) |
DOI: | 10.1001/jamanetworkopen.2024.8192 |
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