Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO, its bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged 18 through 59 years who are at increased risk for the disease.
This approval significantly broadens ABRYSVO's indication, which previously covered adults aged 60 and older, and pregnant individuals to protect infants. ABRYSVO now offers the broadest RSV vaccine indication for adults, expanding its potential market reach.
The FDA's decision is based on inferred efficacy from the pivotal Phase 3 MONeT clinical trial, which evaluated the vaccine's safety, tolerability, and immunogenicity in adults at risk of RSV-associated disease due to chronic medical conditions. This expanded approval is expected to contribute to Pfizer's vaccine portfolio revenue.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.