The prescribing information for two respiratory syncytial virus, (RSV) vaccines will now include a warning for the increased risk of Guillian-Barre Syndrome within 42 days of vaccination based on data from post-marketing research, according to a safety communication from the US Food and Drug Administration (FDA). The analysis of all GBS cases based on claims data suggest an increased risk of GBS during the 42 days following vaccination, with an estimated nine excess cases per million doses of Abrysvo, and an estimated seven excess cases per million doses of Arexvy, the other RSV vaccine, administered to individuals 65 years or older, according to the FDA. Based on these findings, it is still felt that the benefits of the two vaccines currently outweigh the risks. Speak to your HCP (Health Care Provider) regarding a risk assessment.
Medscape Infectious Disease Article, Feb. 3, 2025