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FDA Approves Pfizer’s ABRYSVO Vax for RSV Prevention

Decision is based on the data from the pivotal Phase 3 clinical trial in approximately 37,000 participants.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Pfizer received approval from the FDA for ABRYSVO (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years and older. ABRYSVO is unadjuvanted and composed of two preF proteins selected to optimize protection against RSV A and B strains and was observed to be safe and effective.   The decision is based on data from the Phase 3 clinical trial RENOIR, a global, rando...

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