Skip to main content

FDA Adds Warning Label to RSV Vaccines Abrysvo and Arexvy

Medically reviewed by Carmen Pope, BPharm. Last updated on Jan 14, 2025.

By Lori Solomon HealthDay Reporter

MONDAY, Jan. 13, 2025 -- The U.S. Food and Drug Administration now requires and has approved safety labeling changes to the prescribing information for the Abrysvo (Pfizer) and Arexvy (GlaxoSmithKline) respiratory syncytial virus (RSV) vaccines to include warnings and precautions about the risk for Guillain-Barré syndrome (GBS).

For each vaccine, postmarketing observational studies suggest an increased risk of GBS during the 42 days following vaccination.

Arexvy has been approved for the prevention of lower respiratory tract disease caused by RSV in all individuals 60 years of age and older and for those aged 50 to 59 years at increased risk. Abrysvo has been approved for the prevention of lower respiratory tract disease caused by RSV in all individuals 60 years of age and older, as well as individuals aged 18 to 59 years at increased risk. Abrysvo is also approved for pregnant individuals at 32 through 36 weeks of gestational age for the prevention of lower respiratory tract disease caused by RSV in infants from birth through 6 months of age.

More Information

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

© 2025 HealthDay. All rights reserved.

Read this next

No Link Found Between COVID-19 Vaccination During Pregnancy and Spontaneous Abortion

THURSDAY, May 15, 2025 -- There is no association between COVID-19 vaccination in pregnancy and spontaneous abortion, according to a study published online May 2...

RSV Vaccines, Nirsevimab Tied to Reduced RSV-Linked Hospitalization

TUESDAY, May 13, 2025 -- Maternal respiratory syncytial virus (RSV) vaccination and nirsevimab were associated with a reduction in RSV-associated hospitalization rates among...

Combined Flu, SARS-CoV-2 Vaccine as Effective as Individual Vaccines for Older Adults

FRIDAY, May 9, 2025 -- mRNA-1083 vaccine is noninferior and induces higher immune responses than recommended influenza and COVID-19 vaccines against several influenza strains and...

More news resources

Subscribe to our newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.