FDA gives priority review to Pfizer RSV vaccine for older adults

The Food and Drug Administration (FDA) accepted Pfizer’s application for an RSV vaccine for older adults, and is expected to make an approval decision by the spring. 

Pfizer in a statement on Wednesday said the FDA is going to review its application under the priority review program, which reduces the approval timeline by four months. The end of the review period is expected to be May 2023, Pfizer said.

In healthy adults and older children, RSV typically causes mild, cold-like symptoms that go away with moderate rest and self-care. But it can result in severe illness in infants and older adults.

Like the flu, RSV season usually occurs during colder weather, though it’s been hitting unusually hard and early this year, contributing to a wave of respiratory infections that is overwhelming hospitals nationwide.  

Centers for Disease Control and Prevention Director Rochelle Walensky said Monday there are record levels of flu and RSV infections and hospitalizations, and urged people to get flu shots and COVID-19 boosters. 

There is no vaccine for RSV in either adults or children. If approved, Pfizer’s candidate would become the first RSV vaccine for older adults.

“With no RSV vaccines currently available, older adults remain at-risk for RSV disease and potential severe outcomes, including serious respiratory symptoms, hospitalization, and in some cases, even death,” Annaliesa Anderson, head of Pfizer’s vaccine research and development, said in a statement. 

In August, Pfizer announced that the vaccine was more than 85 percent effective in preventing severe lower respiratory tract illness in older adults. 

The company is also testing a maternal vaccine for RSV that’s administered during pregnancy in order to protect newborns too young for vaccination.