Bajema Kristina L, Yan Lei, Li Yuli, Argraves Stephanie, Rajeevan Nallakkandi, Fox Alexandra, Vergun Robert, Berry Kristin, Bui David, Huang Yuan, Lin Hung-Mo, Hynes Denise M, Lucero-Obusan Cynthia, Schirmer Patricia, Cunningham Francesca, Huang Grant D, Aslan Mihaela, Ioannou George N
Veterans Affairs Portland Health Care System, Portland, OR, USA; Division of Infectious Diseases, Department of Medicine, Oregon Health & Science University, Portland, OR, USA.
Veterans Affairs Cooperative Studies Program Clinical Epidemiology Research Center, Veterans Affairs Connecticut Health Care System, West Haven, CT, USA; Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.
Lancet Infect Dis. 2025 Jun;25(6):625-633. doi: 10.1016/S1473-3099(24)00796-5. Epub 2025 Jan 20.
New respiratory syncytial virus (RSV) vaccines have been approved in the USA for the prevention of RSV-associated lower respiratory tract disease in adults aged 60 years and older. Information on the real-world effectiveness of these vaccines is needed.
We used electronic health records in the Veterans Health Administration to emulate a target trial comparing a single dose of a recombinant stabilised prefusion F protein RSV vaccine versus no vaccination among veterans aged 60 years and older. We matched eligible vaccine recipients with up to four unvaccinated individuals in four monthly nested sequential trials from Sept 1 to Dec 31, 2023. Outcomes were ascertained up to March 31, 2024. The primary outcome was any positive RSV test from day 14 following the matched index date. Secondary outcomes included hospitalisation and emergency department or urgent care encounter occurring within 1 day before or after a positive RSV test. We estimated vaccine effectiveness as 100 × (1 - risk ratio).
We included 146 852 vaccinated individuals matched to 582 936 unique control individuals, weighted equally to represent 146 852 individuals. Across the two groups, 276 039 (94·0%) of 293 704 veterans were male, 17 665 (6·0%) were female, and median age was 75·9 years (IQR 71·7-79·7). Over a median follow-up of 124 days (IQR 102-150), the incidence rate of documented RSV infection was 1·7 (95% CI 1·4-2·1) events per 1000 person-years (88 total events) in the vaccinated group and 7·3 (6·6-8·1) per 1000 person-years in the unvaccinated group (372 total events), and vaccine effectiveness was estimated as 78·1% (72·6-83·5). Among the secondary outcomes, vaccine effectiveness was estimated at 78·7% (72·2-84·8) against RSV-associated emergency department or urgent care encounters, and 80·3% (65·8-90·1) against RSV-associated hospitalisation.
RSV vaccination was effective in preventing RSV-related illness, including associated health-care use, in adults aged 60 years and older during the 2023-24 respiratory illness season, supporting current recommendations for vaccination in this population.
US Department of Veterans Affairs Cooperative Studies Program, US Department of Health and Human Services Biomedical Advanced Research and Development Authority, and US Food and Drug Administration.
新型呼吸道合胞病毒（RSV）疫苗已在美国获批，用于预防60岁及以上成年人的RSV相关下呼吸道疾病。需要了解这些疫苗在现实世界中的有效性信息。
我们利用退伍军人健康管理局的电子健康记录，模拟一项目标试验，比较单剂量重组稳定前融合F蛋白RSV疫苗与60岁及以上退伍军人不接种疫苗的情况。在2023年9月1日至12月31日的四个月度嵌套序贯试验中，我们将符合条件的疫苗接种者与多达四名未接种者进行匹配。随访至2024年3月31日。主要结局是匹配索引日期后第14天的任何RSV阳性检测结果。次要结局包括在RSV阳性检测结果之前或之后1天内发生的住院、急诊科就诊或紧急护理。我们将疫苗有效性估计为100×（1-风险比）。
我们纳入了146852名接种疫苗的个体，与582936名独特的对照个体进行匹配，同等加权以代表146852名个体。在两组中293704名退伍军人中，276039名（94.0%）为男性，17665名（6.0%）为女性，中位年龄为75.9岁（四分位间距71.7-79.7）。在中位随访124天（四分位间距102-150）期间，接种疫苗组记录的RSV感染发病率为每1000人年1.7（95%CI 1.4-2.1）例事件（共88例事件），未接种疫苗组为每1000人年7.3（6.6-8.1）例事件（共372例事件），疫苗有效性估计为78.1%（72.6-83.5）。在次要结局中，针对RSV相关的急诊科就诊或紧急护理，疫苗有效性估计为78.7%（72.2-84.8），针对RSV相关住院，疫苗有效性估计为80.3%（65.8-90.1）。
在2023-24呼吸道疾病季节，RSV疫苗接种对于预防60岁及以上成年人的RSV相关疾病（包括相关医疗保健使用）有效，支持当前针对该人群的疫苗接种建议。
美国退伍军人事务部合作研究项目、美国卫生与公众服务部生物医学高级研究与发展局以及美国食品药品监督管理局。
