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FDA Approves Pfizer’s RSV Vax ABRYSVO in Adults at Increased Risk

Decision is based on inferred efficacy from a Phase 3 trial in adults at higher risk of severe illness.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Pfizer received approval from the U.S. FDA for ABRYSVO (Respiratory Syncytial Virus Vaccine), a bivalent RSV prefusion F (RSVpreF) vaccine for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals who are at increased risk for LRTD caused by RSV, in individuals 18 through 59 years of age.    The FDA decision is based on inferred efficacy from the Phase 3 trial (NCT05842967) MONeT (RSV I M munizati ON Study for Adul T s at Higher Risk of Severe Illness), which in...

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