June 1, 2023 – Pfizer announced that the FDA has approved 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.
“A vaccine to help prevent RSV had been an elusive public health goal for more than half a century. Today’s approval is a monumental step forward in delivering on Pfizer’s commitment to help alleviate the significant burden of RSV in higher-risk populations, which includes older adults,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “ABRYSVO will address a need to help protect older adults against the potentially serious consequences of RSV disease. We are extremely grateful to the clinical trial participants, study investigator teams and our dedicated Pfizer colleagues for their roles in making this vaccine available.”
The FDA’s decision is based on the data from the pivotal Phase 3 clinical trial. RENOIR is a global, randomized, double-blind, placebo-controlled study designed to assess the efficacy, immunogenicity, and safety of a single dose of the vaccine in adults 60 years of age and older.
The approval of Pfizer’s vaccine comes after the recent approval of the world’s first RSV vaccine from GSK. Currently, these vaccines are designed for RSV prevention in adults.