FDA approves Abrysvo, vaccine for the prevention of respiratory syncytial virus (RSV) in older adults

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 III clinical trial (NCT05035212) RENOIR (RSV vaccine Efficacy study iNOlder adults Immunized against RSV disease). 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. RENOIR has enrolled approximately 37,000 participants, randomized to receive RSVpreF 120 ?g or placebo in a 1:1 ratio. The results were recently published in The New England Journal of Medicine. RENOIR is ongoing, with efficacy data being collected in the second RSV season in the study.

See - "Efficacy and Safety of a Bivalent RSV Prefusion F Vaccine in Older Adul":Edward E. Walsh, M.D., Gonzalo Pérez Marc, M.D., Agnieszka M. Zareba, M.D., Ph.D., et al., for the RENOIR Clinical Trial Group. April 20, 2023 .N Engl J Med 2023; 388:1465-1477 DOI: 10.1056/NEJMoa2213836.