FDA approves Pfizer RSV vaccine for high-risk adults under 60
- The FDA approved Pfizer's Abrysvo vaccine for adults 18-59 years at high risk of RSV on October 24, 2024.
- The approval comes after the pivot Phase 3 MONeT study showed encouraging safety and efficacy results.
- This decision is crucial as RSV vaccine uptake has declined, underscoring the need for effective immunization strategies.
On October 24, 2024, the FDA approved Pfizer's Abrysvo, a bivalent RSV vaccine, for adults aged 18 to 59 years at high risk of lower respiratory tract disease caused by RSV. This approval expands the vaccine's use, as it was previously approved only for those aged 60 and above. Abrysvo also remains the only RSV vaccine authorized for use in pregnant individuals to protect newborns from birth until six months of age. The FDA's decision was influenced by findings from the pivotal Phase 3 MONeT study, which assessed the vaccine's safety and effectiveness in individuals with chronic medical conditions prone to RSV-related disease. The CDC's Advisory Committee on Immunization Practices had already recommended routine RSV vaccinations for adults aged 75 and above, reflecting a growing concern over the RSV threat among vulnerable populations. However, the recommendation for adults aged 50-59 who are at increased risk has been postponed pending further data. The RSV vaccine market has faced challenges, as recent weeks have seen a decline in vaccination rates, with many opting for GSK's Arexvy, showing a preference for one brand over the other. Despite the challenges, Pfizer views RSV vaccines as crucial to developing new revenue streams amid looming generic competition for their leading products. This approval marks a significant step in addressing public health concerns surrounding RSV, particularly for high-risk groups.