FDA AdCom backs approval for Pfizer's RSV vaccine

Following positive briefing documents from the agency’s staff, the US 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 US pharma giant Pfizer (NYSE: PFE) 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.

Panel member Paul Offit, who was a no vote on safety, believes there is not enough information to support a "reassuring" safety profile. "If you're in any sense risking premature births with this vaccine, I think there'll be a big price to pay," he said.