Pfizer’s goal to offer a vaccine targeting the respiratory syncytial virus (RSV) for infants inched closer to reality Thursday during the Vaccines and Related Biological Products Advisory Committee meeting.
This committee – which offers recommendations to the U.S. Food and Drug Administration – voted that data support the efficacy and safety of Pfizer’s prefusion F vaccine candidate RSVpreF (or PF-06928316). This vaccine would be administered to pregnant people during their late second to third trimester.
According to a meeting summary, Pfizer submitted a Biologics License Application to the FDA in December. Its new vaccine candidate was formulated to “prevent lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age by active immunization of pregnant individuals,” it said.
RSV infections lead to 100 to 300 deaths annually in children under 5 years old, according to the U.S. Centers for Disease Control and Prevention. It also leads to 2.1 million outpatient visits among children younger than 5 years old as well as 58,000-80,000 hospitalizations among children younger than 5.
Adults age 65 and older are also vulnerable to complications and death related to RSV infection. Earlier this month, the FDA announced that it approved GSK’s Arexvy, “the first respiratory syncytial virus (RSV) vaccine,” cleared for use in the U.S. for adults age 60 and older.
Pfizer’s vaccine could be the first RSV vaccine for the younger cohort. Meeting documents said the RSV vaccine candidate is a “bivalent recombinant protein subunit vaccine which consists of equal amounts of stabilized prefusion F (preF) antigens from the two major RSV subgroups: RSV A and RSV B,” to be administered as a single intramuscular injection at the dose level of 120 micrograms.
Data from five clinical studies were submitted with the BLA application, including a study regarding use of the vaccine during pregnancy. Pfizer said the advisory committee voted 14 to zero on effectiveness and 10 to four on safety. Now, it is under FDA review.
“We are encouraged by the outcome of today’s 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 Pfizer Senior Vice President and Chief Scientific Officer for vaccine research and development Annaliesa Anderson. “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.”
Recommendations from the advisory board are not binding and he FDA’s decision on the potential approval of is expected in August.
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