USFDA panel votes in support of Pfizer RSV maternal vaccine
New York: Pfizer Inc. has announced that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that the available data support the efficacy and safety of its unadjuvanted bivalent respiratory syncytial virus (RSV) prefusion F vaccine candidate RSVpreF or PF-06928316. The Committee voted 14 to 0 on effectiveness and 10 to 4 on safety. The vaccine candidate is currently under FDA review for the prevention of medically attended lower respiratory tract disease (MA-LRTD) and severe MA-LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals.
“We are encouraged by the outcome of the VRBPAC meeting as it is a critical step forward in the scientific community’s long-sought-after goal to help prevent RSV disease in infants during their most vulnerable first six months of life,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “If approved, our RSV vaccine candidate has the potential to be the first maternal immunization vaccine to help protect infants at first breath through their first six months of life from this potentially serious infection.”
The VRBPAC based its recommendation on the scientific evidence shared by Pfizer, including primary analysis results from the pivotal Phase 3 clinical trial (NCT04424316) MATISSE (MATernal Immunization Study for Safety and Efficacy) announced in November 2022. These results were also recently published in The New England Journal of Medicine.
The role of the VRBPAC is to provide recommendations to the FDA; however, these recommendations are not binding. The FDA’s decision on the potential approval of RSVpreF for the prevention of MA-LRTD and severe MA-LRTD caused by RSV in infants by active immunization of pregnant individuals is expected by the Prescription Drug User Fee Act (PDUFA) goal date in August 2023.
