FDA approves second RSV vaccine for people older than 60

May 31 (UPI) -- The U.S. Food and Drug Administration approved Pfizer's respiratory syncytial virus vaccine on Wednesday.

The vaccine, called ABRYSVO, is the second RSV vaccine for people older than 60 to be approved by the FDA. Earlier in May, the agency approved Arexvy, made by pharmaceutical company GSK.

ABRYSVO was tested in a clinical trial with an estimated 37,000 participants, according to a press release from Pfizer. It is expected to be available ahead of the next peak RSV season in the fall.

"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," Annaliesa Anderson, Pfizer's senior vice president and chief scientific officer of research and development, said in a statement. "ABRYSVO will address a need to help protect older adults against the potentially serious consequences of RSV disease.

Anderson said the pharmaceutical industry has been seeking a vaccine for RSV for more than 50 years. With two approved in the last month, healthcare facilities will have new tools to combat an illness that hospitalizes more than 60,000 older adults each year.

Between 6,000 and 10,000 older adults die each year from RSV, according to Pfizer. The virus is highly transmissible, passing on through direct contact with droplets from coughs and sneezes. The Centers for Disease Control and Prevention warns that infants, children and adults with compromised immune systems and the elderly are at elevated risk of the most severe outcomes from the illness.

RSV cases tend to be the highest between December and February, but in 2022 there were a large number of pediatric cases earlier in the fall. For patients 65 and older, cases peaked at 6.4 per 100,000 early in December -- a higher rate than any other time since at least 2016.

This past RSV season demonstrated the serious consequences and potential health risks this virus poses for older adults," Edward E. Walsh, professor of medicine at Rochester Medical Center in New York, said in a statement.