The FDA, on May 31, 2023, granted approval to ABRYSVO (Respiratory Syncytial Virus Vaccine), Pfizer’s bivalent RSV prefusion F (RSVpreF) vaccine, for safeguarding individuals aged 60 and above against lower respiratory tract disease resulting from RSV. ABRYSVO, which contains two preF proteins chosen to enhance protection against RSV A and B strains, is an unadjuvanted vaccine that has demonstrated both safety and effectiveness.
“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 approval is supported by data obtained from the pivotal Phase III clinical trial known as RENOIR. RENOIR enrolled approximately 37,000 participants who were randomly assigned in a 1:1 ratio to receive either RSVpreF 120 μg or a placebo.
“This past RSV season demonstrated the serious consequences and potential health risks this virus poses for older adults,” said Edward E. Walsh, MD, Professor of Medicine, University of Rochester Medical Center, and principal RENOIR investigator. “Today’s FDA approval of ABRYSVO recognizes 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.”
Pfizer is currently the sole company pursuing regulatory approvals for an investigational RSV vaccine candidate targeting both older adults and infants through maternal immunization. The FDA recently granted priority review to Pfizer’s Biologics License Application (BLA) for RSVpreF, seeking approval for preventing lower respiratory tract and severe lower respiratory tract diseases caused by RSV in infants aged up to six months via active immunization of pregnant individuals. Pfizer also received a positive vote from the FDA’s Vaccines and Related Biological Products Advisory Committee, affirming the efficacy and safety of RSVpreF for the maternal indication. The FDA has scheduled an action date in August 2023 under the Prescription Drug User Fee Act (PDUFA).
In February 2023, the European Medicines Agency (EMA) initiated an accelerated assessment of Pfizer’s Marketing Authorization Application (MAA) for RSVpreF, encompassing protection for both older adults and maternal immunization to safeguard infants against RSV. The formal review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP) is presently underway. Additionally, Pfizer Japan submitted an application to the Ministry of Health, Labor, and Welfare in February 2023 for RSVpreF as a maternal immunization to protect infants against RSV. In April 2023, Pfizer Canada announced that Health Canada accepted the review of RSVpreF for both individuals aged 60 and above and as a maternal immunization for infant RSV protection.
Source: Pfizer
