Early Safety Findings Among Persons Aged ≥60 Years Who Received a Respiratory Syncytial Virus Vaccine — United States, May 3, 2023–April 14, 2024

Abstract

In May 2023, the Food and Drug Administration (FDA) licensed Arexvy and Abrysvo vaccines for prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in adults aged ≥60 years. In prelicensure trials, Guillain-Barré syndrome (GBS) was identified as a potential safety concern. During August 4, 2023-March 30, 2024, at least 10.6 million adults aged ≥60 years received a recommended RSV vaccine. During May 3, 2023-April 14, 2024, CDC reviewed data reported after RSV vaccination to V-safe, an active U.S. surveillance system that invites enrolled participants to complete web-based surveys, and reports to the Vaccine Adverse Event Reporting System (VAERS), a passive, voluntary surveillance system that accepts adverse event reports from the public, providers , and manufacturers. Findings from V-safe and VAERS were generally consistent with those from trials. Reporting rates of GBS after RSV vaccination in VAERS (5.0 and 1.5 reports per million doses of Abrysvo and Arexvy vaccine administered, respectively) were higher than estimated expected background rates in a vaccinated population. CDC and FDA are conducting population-based surveillance to assess risks for GBS and other adverse events. Findings from these studies will help guide development of Advisory Committee on Immunization Practices recommendations.