FDA approves Pfizer’s RSV vaccine for adults over age 60

Pfizer’s ABRYSVO vaccine for respiratory syncytial virus (RSV) received U.S. Food and Drug Administration (FDA) approval for use in adults over age 60 on May 31, Pfizer announced.

The Pfizer RSV vaccine is the second RSV vaccine approved for older adults this year. The FDA approved GSK’s Arexvy for older adults just weeks before, on May 3.

Before last month, there were zero approved RSV vaccines.

Why RSV vaccines matter

Respiratory syncytial virus (RSV) is a highly contagious upper respiratory disease that leads to approximately 60,000-120,000 hospitalizations and 6,000-10,000 deaths among adults 65 and older, according to the FDA.

The effectiveness of ABRYSVO in preventing RSV in older adults is outlined in a report in The New England Journal of Medicine.

“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 at 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 U.S. 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,” Pfizer said. “Pending the outcome of this meeting, Pfizer anticipates supply availability in Q3 2023 ahead of the anticipated RSV season this fall.”

Pediatric RSV vaccine next?

The race for an RSV vaccine for children, another group that is especially at risk from RSV, is still underway. Pfizer has already requested market approval for a maternal RSV vaccine to protect unborn infants, and the FDA is expected to make a decision on that vaccine candidate by August. 

Two RSV vaccines hitting the market in one year signals a significant shift when it comes to elderly and pediatric risk during the height of cold and flu season. Undoubtedly, this news is yet another bit of relief to stressed hospital systems. 

“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. “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.”

A number of other vaccines and immunizations are under development, meaning the threat of RSV may soon (and finally) be a thing of the past.

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