Pfizer Pharmaceuticals announced Wednesday that the Food and Drug Administration (FDA) has accepted its biologics license application for RSVpreF – its new vaccine to prevent lower respiratory tract disease caused by the RSV virus in people ages 60 and up.
The decision followed the FDA’s Breakthrough Therapy Designation of RSVpreF in older adults this past March.
The welcome news comes as the United States faces a “tripledemic” – a combination of RSV, influenza and COVID-19 all slamming the population at the same time.
Rochelle Walensky, MD, director of the Centers for Disease Control and Prevention (CDC) on Monday urged Americans to wear masks and get a flu shot.
The FDA granted a priority review, meaning a final decision on approval of the vaccine will be made four months earlier than usual – around May 2023.
The decision to grant the approval was made in response to evidence submitted by Pfizer from a phase 3 trial (RENOIR) that found the vaccine outperformed a placebo in protecting against RSV-associated lower respiratory tract illness and severe forms of the disease.
“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,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research & Development, Pfizer.
“The FDA’s acceptance of the BLA for our RSV vaccine candidate is an important regulatory milestone in Pfizer’s efforts to help protect older adults against RSV and demonstrates additional progress toward what has been an elusive public health goal – reducing the overall burden associated with this infectious disease.”
If approved, RSVpreF will become the first RSV vaccine for older adults.