Safety Monitoring of Bivalent COVID-19 mRNA Vaccines Among Recipients 6 Months and Older in the United States.

IF 2.4 4区医学 Q3 PHARMACOLOGY & PHARMACY

Pharmacoepidemiology and Drug Safety Pub Date : 2025-05-01 DOI:10.1002/pds.70151

Patricia C Lloyd, Elizabeth R Smith, Joann F Gruber, Michelle Ondari, Hui Lee Wong, Mao Hu, Tainya C Clarke, Rowan McEvoy, Kandace L Amend, Daniel C Beachler, Cheryl N McMahill-Walraven, John D Seeger, Alex Secora, Djeneba Audrey Djibo, Jennifer Song, Nandini Selvam, Jonathan P DeShazo, Robin Clifford, Eugenio Abente, Yoganand Chillarige, Richard A Forshee, Steven A Anderson, Azadeh Shoaibi

{"title":"Safety Monitoring of Bivalent COVID-19 mRNA Vaccines Among Recipients 6 Months and Older in the United States.","authors":"Patricia C Lloyd, Elizabeth R Smith, Joann F Gruber, Michelle Ondari, Hui Lee Wong, Mao Hu, Tainya C Clarke, Rowan McEvoy, Kandace L Amend, Daniel C Beachler, Cheryl N McMahill-Walraven, John D Seeger, Alex Secora, Djeneba Audrey Djibo, Jennifer Song, Nandini Selvam, Jonathan P DeShazo, Robin Clifford, Eugenio Abente, Yoganand Chillarige, Richard A Forshee, Steven A Anderson, Azadeh Shoaibi","doi":"10.1002/pds.70151","DOIUrl":null,"url":null,"abstract":"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.","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 5","pages":"e70151"},"PeriodicalIF":2.4000,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmacoepidemiology and Drug Safety","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/pds.70151","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}

引用次数: 0

Abstract

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.

查看原文本刊更多论文

美国6个月及以上接种者双价COVID-19 mRNA疫苗的安全性监测

目的：积极监测COVID-19疫苗接种后的健康结果，可早期发现许可后的罕见结果。我们评估了美国辉瑞- biontech （BNT162b2）和Moderna （mRNA-1273.222）二价COVID-19疫苗接种后的健康结果。方法：从2022年8月至2023年7月，在四个行政索赔数据库（CVS health、Carelon Research、Optum和Medicare）中每月监测多项健康结果。该研究纳入了6个月及以上的个体，他们在研究期间接种了二价COVID-19 BNT162b2或mRNA-1273.222疫苗，并在接种COVID-19疫苗前符合医疗保险计划的最低连续登记要求。描述性分析监测疫苗接种计数、结果以及伴随的COVID-19和流感疫苗接种。最大化序列概率比检验（MaxSPRT）检测了与2019年或2020年估计的年历史比率相比，接种疫苗后观察到的结果发病率的升高，并根据观察到的比率的索赔延迟进行了调整。在病例数允许的情况下，历史比率按所有人的年龄和/或性别进行标准化，仅按医疗保险人员的种族和/或养老院居住状况进行标准化。结果：总体而言，有1390万6个月及以上的人接种了二价COVID-19疫苗。在一个数据库中出现了两个结果的统计信号（显著性水平为1%）：18-64岁人群接种两种二价COVID-19疫苗后出现过敏反应，18-35岁人群接种二价BNT162b2疫苗后出现心肌炎/心包炎。在642 142名6个月至17岁接种疫苗的儿童中，未发现任何信号。结论：结果与已发表的COVID-19疫苗安全性研究一致，支持二价COVID-19 mRNA疫苗的安全性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Pharmacoepidemiology and Drug Safety 医学-药学

CiteScore

4.80

自引率

7.70%

发文量

173

审稿时长

3 months

期刊介绍： The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report. Particular areas of interest include: design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology; comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world; methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology; assessments of harm versus benefit in drug therapy; patterns of drug utilization; relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines; evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.