Safety Monitoring of Bivalent COVID ‐19 mRNA Vaccines Among Recipients 6 Months and Older in the United States
Rattachement africain : us. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
PURPOSE: Active monitoring of health outcomes after COVID-19 vaccination provides early detection of rare outcomes post-licensure. We evaluated health outcomes following bivalent COVID-19 Pfizer-BioNTech (BNT162b2) and Moderna (mRNA-1273.222) vaccination in the United States. METHODS: Multiple health outcomes were monitored monthly from August 2022 to July 2023 in four administrative claims databases (CVS Health, Carelon Research, Optum, and Medicare). The study included individuals 6 months and older who received a bivalent COVID-19 BNT162b2 or mRNA-1273.222 vaccination during the study period and met a minimum continuous enrollment requirement in a medical insurance plan prior to COVID-19 vaccination. Descriptive analyses monitored counts of vaccinations, outcomes, and concomitant COVID-19 and influenza vaccination. Maximized Sequential Probability Ratio Testing (MaxSPRT) tested for elevations in the observed incidence rate of outcomes post-vaccination compared to annual historical rates estimated from 2019 or 2020, adjusted for claims delay in the observed rate. Where case counts permitted, historical rates were standardized by age and/or sex for all persons, and race and/or nursing home residency status for Medicare persons only. RESULTS: Overall, 13.9 million individuals 6 months and older received a bivalent COVID-19 vaccine. A statistical signal occurred for two outcomes in one database (significance level of 1%): anaphylaxis following both bivalent COVID-19 vaccines in persons 18-64 years and myocarditis/pericarditis following bivalent BNT162b2 vaccines in individuals 18-35 years. Among 642 142 vaccinated children 6 months-17 years, no signals were identified. CONCLUSIONS: Results were consistent with published COVID-19 vaccine safety studies and support the safety profile of bivalent COVID-19 mRNA vaccines.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé, mais le titre doit être comparé manuellement.
- Titre Crossref
- Safety Monitoring of Bivalent <scp>COVID</scp> ‐19 <scp>mRNA</scp> Vaccines Among Recipients 6 Months and Older in the United States
- Date Crossref
- 01/05/2025
- Éditeur
- Wiley
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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United States Food and Drug Administration pays non établi dans la noticeOrganisme public
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Acumen (United States) pays non établi dans la noticeEntreprise
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New England College of Optometry pays non établi dans la noticeUniversité ou école supérieure
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Optum (United States) pays non établi dans la noticeEntreprise
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CVS Health (United States) pays non établi dans la noticeEntreprise
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IQVIA (United States) pays non établi dans la noticeEntreprise
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US Food and Drug Administration Silver Spring Maryland USA pays non établi dans la noticeInstitution
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Acumen LLC Burlingame California USA pays non établi dans la noticeInstitution
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Optum Epidemiology Boston Massachusetts USA pays non établi dans la noticeInstitution
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Carelon Research Wilmington Delaware USA pays non établi dans la noticeInstitution
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CVS Health Blue Bell Pennsylvania USA pays non établi dans la noticeInstitution
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IQVIA Falls Church Virginia USA pays non établi dans la noticeInstitution
United States Food and Drug Administration, Acumen (United States) et New England College of Optometry, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.