Layton J Bradley, Lloyd Patricia C, Peetluk Lauren S, Jiao Yixin, Djibo Djeneba Audrey, Gruber Joann F, Deng Jie, Bui Christine, Lo An-Chi, Ogilvie Rachel P, Parambi Ron, Miller Michael, Song Jennifer, Weatherby Lisa B, Cho Sylvia, Wong Hui Lee, Clarke Tainya C, Hervol Jessica Rose, Illei Dóra, Bell Elizabeth J, Yang Grace Wenya, Seeger John D, Wernecke Michael, Richey Morgan M, Forshee Richard A, Anderson Steven A, Chillarige Yoganand, McMahill-Walraven Cheryl N, Amend Kandace L, Anthony Mary S, Shoaibi Azadeh
RTI Health Solutions, Research Triangle Park, North Carolina, United States of America.
Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, United States of America.
PLoS One. 2025 May 6;20(5):e0320434. doi: 10.1371/journal.pone.0320434. eCollection 2025.
With data from 2 US claims databases (Optum, CVS Health) supplemented with Immunization Information System COVID-19 vaccine records, we evaluated overall and time-specific vaccine effectiveness (VE) of an initial primary series for 3 monovalent COVID-19 vaccines-BNT162b2, mRNA-1273, and JNJ-7836735-in adults (18-64 years). Vaccinated individuals were matched to unvaccinated comparators, and we estimated VE against any medically diagnosed COVID-19 and hospital/emergency department (ED)-diagnosed COVID-19. Additionally, we estimated VE by era of predominant variants, in subgroups, and compared across vaccine brands. The cohorts consisted of 341,097 (Optum) and 1,151,775 (CVS Health) matched pairs for BNT162b2; 201,604 (Optum) and 651,545 (CVS Health) for mRNA-1273; and 49,285 (Optum) and 149,813 (CVS Health) for JNJ-7836735. The study period began 11 December 2020 (date of first COVID-19 vaccine availability in the US) and ended 15 January 2022 in Optum and 31 March 2022 in CVS Health. Summary VE estimates from meta-analysis against hospital/ED-diagnosed COVID-19 were: BNT162b2, 77% (95% CI, 76%-78%); mRNA-1273, 84% (95% CI, 83%-85%), JNJ-7836735 66% (95% CI, 63%-68%). VE estimates were higher for hospital/ED-diagnosed COVID-19 than for medically diagnosed COVID-19, and VE estimates were highest in adults receiving mRNA-1273 for both outcomes. VE was sustained for approximately 7 months for medically diagnosed and up to 9 months for hospital/ED-diagnosed COVID-19. VE differed by brand and variant era. Ongoing real-world surveillance of COVID-19 vaccines using robust data sources and methodology is needed as new variants and recommendations for updated vaccines have evolved.
利用来自2个美国索赔数据库（Optum、CVS Health）的数据，并辅以免疫信息系统的新冠病毒疫苗记录，我们评估了3种单价新冠病毒疫苗（BNT162b2、mRNA-1273和JNJ-7836735）在成人（18至64岁）中初始主要系列疫苗的总体和特定时间的疫苗效力（VE）。将接种疫苗的个体与未接种疫苗的对照者进行匹配，我们估计了针对任何医学诊断的新冠病毒感染以及医院/急诊科（ED）诊断的新冠病毒感染的疫苗效力。此外，我们按主要变异株流行时期、亚组估计了疫苗效力，并对不同疫苗品牌进行了比较。队列包括针对BNT162b2的341,097对（Optum）和1,151,775对（CVS Health）；针对mRNA-1273的201,604对（Optum）和651,545对（CVS Health）；以及针对JNJ-7836735的49,285对（Optum）和149,813对（CVS Health）。研究期始于2020年12月11日（美国首次提供新冠病毒疫苗的日期），在Optum于2022年1月15日结束，在CVS Health于2022年3月31日结束。针对医院/急诊科诊断的新冠病毒感染的荟萃分析汇总疫苗效力估计值为：BNT162b2为77%（95%CI，76%-78%）；mRNA-1273为84%（95%CI，83%-85%），JNJ-7836735为66%（95%CI，63%-68%）。针对医院/急诊科诊断的新冠病毒感染的疫苗效力估计值高于针对医学诊断的新冠病毒感染的估计值，并且对于这两种结果，在接受mRNA-1273的成年人中疫苗效力估计值最高。针对医学诊断的新冠病毒感染，疫苗效力持续约7个月，针对医院/急诊科诊断的新冠病毒感染则持续长达9个月。疫苗效力因品牌和变异株流行时期而异。随着新的变异株出现以及更新疫苗的建议不断演变，需要利用可靠的数据源和方法对新冠病毒疫苗进行持续的真实世界监测。
