FDA Panel Backs Pfizer RSV Vaccine

FDA’s Vaccines and Related Biological Products Advisory Committee 2/28 voted (7 to 4) that Pfizer’s BLA data are adequate to support approval of respiratory syncytial virus bivalent vaccine RSVpreF (PF-06928316). The vaccine is being reviewed by FDA for preventing acute respiratory disease and lower respiratory tract disease caused by RSV in individuals 60 years of age and older. In clinical studies, the vaccine reduced the risk of illness caused by RSV by 86%, according to the company.

If approved, FDA noted that safety monitoring will be needed for Guillain-Barré Syndrome and other immune-mediated demyelinating conditions under a pharmacovigilance plan. The safety-related concern was raised in a briefing document released in advance of the meeting.

“In older adults, RSV can result in serious illness, hospitalization, or even death, so there is a significant need to protect this at-risk population,” Pfizer said after the meeting.