JAMA Netw Open

RSV vaccine effective and safe in older adults

May 14, 2025

Study details: This large, retrospective cohort study assessed the safety and effectiveness of two FDA-approved RSV vaccines—RSVPreF3 (Abrysvo) and RSVPreF3+AS01 (Arexvy)—in adults ≥60 years during the 2023-2024 RSV season. Utilizing a test-negative case-control design, the study included 787,822 patients tested for RSV, with 53,963 positive cases. Vaccine effectiveness (VE) was estimated, and adverse events were analyzed using a self-controlled case series of 4,746,518 vaccine recipients.

Results: The overall VE against RSV-associated acute respiratory infection (ARI) was 75.1% (95% confidence interval [CI], 73.6%-76.4%). VE was consistent across age groups and against urgent care visits or hospitalizations. Immunocompromised patients had a VE ranging from 67.0% to 73.1%, with the lowest VE observed in stem cell transplant recipients. No excess risk of immune thrombocytopenic purpura was detected, but there was a small increased risk of Guillain-Barré syndrome with the RSVPreF vaccine.

Clinical impact: RSV protein subunit vaccine is effective in preventing RSV-associated ARI in older adults, with a favorable safety profile. The findings support the use of RSV vaccines in this population, particularly for those at higher risk of severe disease, such as immunocompromised individuals.

Source:

Fry SE, et al. (2025, May 1). JAMA Netw Open. Effectiveness and Safety of Respiratory Syncytial Virus Vaccine for US Adults Aged 60 Years or Older. https://pubmed.ncbi.nlm.nih.gov/40343698/