FDA approved Pfizer’s RSV vaccine for older adults

More people may have protection against respiratory syncytial virus (RSV) this winter as new vaccines become available.

The FDA approved Pfizer’s Abrysvo vaccine, the second vaccine to treat RSV in adults over the age of 60, on May 31, the company announced last week. Abrysvo’s approval comes after the FDA greenlit the world’s first RSV vaccine for older adults earlier in May. The CDC will review both vaccines later this month for safety, efficacy, and recommended use. Both vaccines are expected to be available this fall in time for RSV season.

“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,” Annaliesa Anderson, Pfizer’s SVP and chief scientific officer of vaccine research and development, said in a statement.

RSV is a seasonal respiratory disease that usually causes mild, cold-like symptoms, but it can lead to more serious infections like pneumonia in high-risk groups including infants and older adults, according to the CDC.

Pfizer is also pursuing FDA approval for an RSV vaccine for infants through maternal immunization—making it the only company seeking regulatory reviews for vaccines that protect both groups, according to its announcement. 

Every year, RSV contributes to about 60,000–160,000 hospitalizations in adults 65 and older, and 58,000–80,000 hospitalizations for children under the age of 5 in the US, the CDC estimates. Most infants will have an RSV infection at least once before they turn 2, but those who are at higher risk (including preemies) are more likely to develop severe respiratory illness from the virus.

A rise in RSV, the flu, and Covid-19 cases overwhelmed children’s hospitals across the country last winter. Hospital admissions for older adults also surged during the so-called “tripledemic,” the New York Times reported.

Pfizer’s RSV vaccine was 67% effective in preventing infections with at least two symptoms, according to an 2022 study of 34,000+ patients aged 60 and over.

“This past RSV season demonstrated the serious consequences and potential health risks this virus poses for older adults,” Edward Walsh, University of Rochester Medical Center professor of medicine and principal investigator on Pfizer’s RSV vaccine clinical trials, said in Pfizer’s statement.

The market for RSV vaccines is expected to surpass $10 billion by 2030, as more vaccines gain FDA approval and hit the shelves, Reuters reported.

Last month, an FDA panel recommended full approval for RSVpreF, an RSV vaccine administered to pregnant people during the late second or third trimester to protect the fetus against RSV. The vaccine has the potential to prevent up to 20,000 RSV hospitalizations annually in infants younger than 6 months, according to the FDA.

The FDA is expected to make a final decision on the infant vaccine by August.