The US Food and Drug Administration (FDA) has approved Pfizer’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine Abrysvo in individuals 60 years and older.
Abrysvo is unadjuvanted and composed of two preF proteins selected to optimise 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, Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer.
The FDA’s decision is based on the data from the pivotal Phase III clinical trial RENOIR (RSV vaccine Efficacy study iNOlder adults Immunized against RSV disease).
“This past RSV season demonstrated the serious consequences and potential health risks this virus poses for older adults,” said Edward Walsh, Professor of Medicine, University of Rochester Medical Center, and principal RENOIR investigator. “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.”
The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet on June 21, 2023, to discuss recommendations for the appropriate use of RSV vaccines in older adults. Pending the outcome of this meeting, Pfizer anticipates supply availability in Q3 2023 ahead of the anticipated RSV season this fall.
Pfizer has also reported positive top-line results from a Phase III study evaluating the safety and immunogenicity of ABRYSVO co-administered with seasonal inactivated influenza vaccine (SIIV) in adults 65 years and older.