Fry Sarah E, Terebuh Pauline, Kaelber David C, Xu Rong, Davis Pamela B
Center for Artificial Intelligence in Drug Discovery, Case Western Reserve University School of Medicine, Cleveland, Ohio.
Department of Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland, Ohio.
JAMA Netw Open. 2025 May 1;8(5):e258322. doi: 10.1001/jamanetworkopen.2025.8322.
Respiratory syncytial virus (RSV) is associated with hospitalization and death among older adults. Characterizing the safety and effectiveness of recently introduced vaccines against RSV is critical.
To assess the safety and effectiveness of vaccines against RSV and the major adverse events among patients aged 60 years or older during the 2023-2024 RSV season.
DESIGN, SETTING, AND PARTICIPANTS: In this study using a data platform containing electronic health records for more than 270 million patients across the US, a test-negative case-control design was used to estimate vaccine effectiveness (VE), and a self-controlled case series of vaccine recipients was included to estimate vaccine-associated adverse events. Records from participants aged 60 years or older with acute respiratory infection (ARI) and testing for RSV between October 1, 2023, and April 30, 2024, were included in the VE study. For vaccine safety analysis, all participants aged 60 years or older who received the RSV vaccine from July 1, 2023, to June 30, 2024 were included. Data were analyzed from August 2024 to March 2025.
Cases were those patients who tested positive for RSV, and controls were those who tested negative for RSV. Patients were classified as vaccinated if the vaccine was received at least 14 days before testing. VE against RSV-associated ARI diagnosis, emergency department or urgent care visits, or hospitalizations was estimated using (1 - odds ratio) × 100%. Excess risks of immune thrombocytopenic purpura and Guillain-Barré syndrome diagnosis for 6 weeks after vaccine administration were calculated.
Of 787 822 patients tested for RSV, 53 963 were positive (733 859 were controls); 1318 cases (2.4%) and 66 928 controls (9.1%) were vaccinated. Overall, VE was 75.1% (95% CI, 73.6%-76.4%) against ARI and was similar for age groups of 60 to 74 years and 75 years or older and against urgent care visits or hospitalizations. Immunocompromised patients had a VE from 67.0% (95% CI, 62.6%-70.9%) for patients aged 60 to 74 years to 73.1% (95% CI, 69.9%-76.0%) for those aged 75 years or older, and the lowest VE (ie, from 29.4% [95% CI, 3.5%-48.4%] for patients aged 60-74 years to 44.4% [95% CI, 1.0%-68.8%] for those aged ≥75 years) was for a subgroup of patients who received stem cell transplants. Among 4 746 518 vaccine recipients, no excess risk of immune thrombocytopenic purpura diagnosis was detected. An excess of 5.2 cases (RSVPreF3+AS01) or 18.2 cases (RSVPreF) of Guillain-Barré syndrome were diagnosed per 1 000 000 doses of RSV vaccine administered.
VE for the RSV protein subunit vaccine in this case-control study was similar to the VE in clinical trials. The VE for immunocompromised patients was mildly (overall) to moderately (for stem cell transplant recipients) diminished. Risk of immune thrombocytopenic purpura after vaccination was not elevated, but the risk of Guilain-Barré syndrome was statistically significantly elevated in patients who received the RSVPreF vaccine but not in those who received RSVPreF+AS01 vaccine, although the risk was small. These observations should inform clinicians' choices and patient instructions.
呼吸道合胞病毒（RSV）与老年人的住院和死亡有关。确定近期推出的RSV疫苗的安全性和有效性至关重要。
评估2023 - 2024年RSV季节期间，6岁及以上患者接种RSV疫苗的安全性、有效性及主要不良事件。
设计、背景和参与者：在本研究中，使用了一个包含美国超过2.7亿患者电子健康记录的数据平台，采用检测阴性病例对照设计来估计疫苗有效性（VE），并纳入疫苗接种者的自我对照病例系列以估计疫苗相关不良事件。VE研究纳入了2023年10月1日至2024年 April 30日期间，60岁及以上患有急性呼吸道感染（ARI）并接受RSV检测的参与者记录。对于疫苗安全性分析，纳入了2023年7月1日至2024年6月30日期间所有60岁及以上接种RSV疫苗的参与者。数据于2024年8月至2025年3月进行分析。
病例为RSV检测呈阳性的患者，对照为RSV检测呈阴性的患者。如果在检测前至少14天接种了疫苗，则患者被分类为接种过疫苗。使用（1 - 比值比）× 100%来估计针对RSV相关ARI诊断、急诊科或紧急护理就诊或住院的VE。计算接种疫苗后6周内免疫性血小板减少性紫癜和吉兰 - 巴雷综合征诊断的超额风险。
在787822名接受RSV检测的患者中，53963名呈阳性（733859名对照）；1318例病例（2.4%）和66928名对照（9.1%）接种了疫苗。总体而言，针对ARI的VE为75.1%（95% CI，73.6% - 76.4%），60至74岁年龄组和75岁及以上年龄组针对紧急护理就诊或住院的VE相似。免疫功能低下的患者，60至74岁患者的VE为67.0%（95% CI，62.6% - 70.9%），75岁及以上患者为73.1%（95% CI，69.9% - 76.0%），而接受干细胞移植的患者亚组的VE最低（即60 - 74岁患者为29.4% [95% CI，3.5% - 48.4%]，≥75岁患者为44.4% [95% CI，1.0% - 68.8%]）。在4746518名疫苗接种者中，未检测到免疫性血小板减少性紫癜诊断的超额风险。每接种1000000剂RSV疫苗，分别诊断出5.2例（RSVPreF3 + AS01）或18.2例（RSVPreF）吉兰 - 巴雷综合征。
本病例对照研究中RSV蛋白亚单位疫苗的VE与临床试验中的VE相似。免疫功能低下患者的VE总体轻度（整体）至中度（对于干细胞移植受者）降低。接种疫苗后免疫性血小板减少性紫癜的风险未升高，但接受RSVPreF疫苗的患者吉兰 - 巴雷综合征的风险在统计学上显著升高，而接受RSVPreF + AS01疫苗的患者则未升高，尽管风险较小。这些观察结果应为临床医生的选择和患者指导提供参考。
