FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine
FDA approved Arexvy, the first RSV vaccine approved for use in the U.S. Arexvy is approved for the prevention of lower respiratory tract disease caused by RSV.
www.fda.govHere’s a concise update on the latest RSV vaccine news as of now.
Arexvy (GSK) and Abrysvo (Pfizer) are the leading RSV vaccines with approvals in various populations over recent years. Arexvy was the first RSV vaccine approved in the U.S. for adults 60+, aimed at preventing RSV-related lower respiratory tract disease, with initial approvals announced in March 2023; Abrysvo followed with broader indications including adults 18–59 at risk and pregnant individuals to protect infants, with initial approvals around 2023–2024. These milestones marked a historic shift in RSV prevention and have driven recommendations from health authorities for targeted use in high-risk groups.
In 2024 and 2025, approvals expanded for Abrysvo to broader age groups (including 18–59 at risk) and for use in pregnancy to protect newborns via maternal vaccination in later gestation. This broadened indication supports protection across more segments of the population, particularly older adults and infants.
WHO and other global health bodies have been evaluating and prequalifying RSV vaccines for maternal use and broader global deployment, signaling ongoing international adoption and recommendations pending country-specific regulatory decisions. This aligns with a growing push to reduce RSV hospitalizations worldwide, especially in low- and middle-income settings.
For the most current, jurisdiction-specific status (your location: Amsterdam, NL), local regulatory bodies or national immunization programs would publish the latest recommendations and availability, including any EU approvals or national rollouts that may differ from U.S. timelines. Check EU/EMA announcements and Dutch health authorities for latest guidance and scheduling.
If you’d like, I can pull the latest European or Netherlands-specific developments and summarize current recommendations, timelines, and eligibility.
FDA approved Arexvy, the first RSV vaccine approved for use in the U.S. Arexvy is approved for the prevention of lower respiratory tract disease caused by RSV.
www.fda.govFDA's approval is for use of the vaccine, called Abrysvo, at 32 to 36 weeks gestational age of pregnancy.
www.cidrap.umn.eduOn 12 March 2025, the World Health Organization (WHO) prequalified the first maternal respiratory syncytial virus (RSV) vaccine to protect infants against one of the most common causes of acute lower respiratory infections in children globally.
www.who.intFirst and only respiratory syncytial virus (RSV) vaccine indicated for adults younger than 50 Approval based on data from pivotal Phase 3 trial in adults at increased risk of lower respiratory tract disease caused by RSV Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO ® (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused...
www.pfizer.comGSK said Friday the US Food and Drug Administration expanded the approved age indication of Arexvy to adults aged 18 to 49 at heightened risk of lower respiratory tract disease from the...
www.marketscreener.comFDA’s decision is based on the data from the pivotal Phase 3 clinical trial in approximately 37,000 participants Each year in the U.S., it is estimated that between 60,000 and 160,000 older adults are hospitalized and between 6,000 and 10,000 die due to RSV infection1 ABRYSVO’s approval will help offer older adults protection in the anticipated RSV season this fall Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO™ ( Respiratory...
www.pfizer.com