FDA approves first vaccine to protect infants from RSV | CIDRAP
FDA's approval is for use of the vaccine, called Abrysvo, at 32 to 36 weeks gestational age of pregnancy.
www.cidrap.umn.eduHere’s the latest available overview on RSV vaccines, focusing on updates through 2024–2025 with context for 2026.
Direct answer
- As of early 2024, the first RSV vaccine for adults 60+ (Arexvy by GSK) was approved in the U.S., with subsequent approvals expanding indications to other groups and ongoing assessments of long-term protection. Pfizer’s Abrysvo followed with approvals that included use during pregnancy to protect infants and, later, broader adult indications in some jurisdictions. Public health bodies and regulatory agencies continue to evaluate uptake, safety, and real-world effectiveness as RSV seasons unfold each year.
Key recent developments and considerations
- Approvals for adults 60 and older: Arexvy’s initial approval established a template for RSV vaccination in older adults, showing meaningful reductions in RSV-related lower respiratory tract disease and severe disease in pivotal trials. This set expectations for impact in high-risk populations during RSV seasons. The approval was based on large trials and ongoing follow-up to assess durability and booster use.[2]
- Pregnant-person vaccination to protect infants: Abrysvo’s use during pregnancy (32–36 weeks gestation) aims to confer passive immunity to newborns in their first months of life, addressing the high RSV hospitalization risk in young infants. This indication was a landmark progression in RSV prevention strategies, gaining traction in clinical practice and ACIP considerations.[1][7]
- Expanded indications and ongoing monitoring: Some regulatory jurisdictions have evaluated extending RSV vaccine indications beyond the initial target groups, including older adults under certain conditions or clinical risk profiles. ACIP and other advisory bodies periodically review risk-benefit data and make recommendations on use in various populations, including timing relative to RSV seasons.[1][2]
What this means for you (practical takeaways)
- If you’re 60+, discuss Arexvy with your clinician about RSV risk and season timing, and consider vaccination ahead of the anticipated RSV season in your region.[2]
- If you’re pregnant or planning pregnancy, discussing Abrysvo with your obstetrician can provide protection for your newborn during the first months of life, a period of high RSV vulnerability.[1]
- For adults under 60 with certain chronic conditions or high-risk factors, be aware that some vaccines have expanded or alternative indications in different states or countries; check current local guidelines and FDA/ACIP recommendations for up-to-date eligibility in your area.[3][2]
Illustrative note
- RSV vaccines represent a shift from passive prevention (monoclonal antibodies given to infants) to active immunization strategies in older children and adults, with maternal vaccination also joining the prevention toolkit to shield newborns.[2][1]
Citations
- FDA approval and Arexvy (60+): FDA press release on Arexvy approval.[2]
- Abrysvo maternal vaccination and expanded adult indications: Pfizer press release on ABRYSVO and related regulatory discussions.[3][1]
- General context on RSV vaccine approvals and ACIP considerations: additional FDA/ACIP materials and coverage analyses.[2]
If you’d like, I can pull the most current local guidelines for Los Angeles/California and summarize what’s recommended for your specific age and pregnancy status, including any relevant state-specific eligibility or availability details.