Approvals

Abrysvo is a bivalent RSV prefusion F (RSVpreF) vaccine that is unadjuvanted and composed of two preF proteins that have been chosen to optimise protection against RSV A and B strains.

The FDA’s decision was based on data from the global, randomised, double-blind, placebo-controlled phase 3 RENOIR (NCT05035212) trial, designed to assess the efficacy, immunogenicity and safety of a single dose of the vaccine. The trial is still ongoing, with interim results having been published in The New England Journal of Medicine.

Annaliesa Anderson PhD, senior vice president and CSO of Vaccine Research and Development at Pfizer, commented: “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. 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.”

Edward E Walsh MD, professor of Medicine at University of Rochester Medical Center and principal RENOIR investigator, said: “This past RSV season demonstrated the serious consequences and potential health risks this virus poses for older adults. Today’s FDA approval of Abrysvo recognises significant scientific progress and importantly helps provide older adults potential protection against RSV and an opportunity to improve community health by helping prevent the disease.”