The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) has voted in favour of Pfizer’s unadjuvanted bivalent respiratory syncytial virus (RSV) prefusion F vaccine candidate, RSVpreF or PF-06928316.
The committee voted in support of approval for the vaccine candidate to help prevent the virus in infants through maternal immunisation.
According to the committee, the available findings support the efficacy and safety of the vaccine candidate.
The VRBPAC’s recommendation, which is not binding, is based on the scientific evidence provided by Pfizer, including primary evaluation data from the Phase III MATernal Immunization Study for Safety and Efficacy (MATISSE) trial announced in November last year.
FDA is currently examining RSVpreF for preventing medically attended lower respiratory tract disease (MA-LRTD) and severe MA-LRTD triggered by RSV in new-borns and infants aged up to six months by active immunisation of pregnant ladies.
The regulator aims to offer its decision on the potential clearance of RSVpreF for these patients by the Prescription Drug User Fee Act (PDUFA) goal date in August this year.
Pfizer senior vice-president and Vaccine Research and Development chief scientific officer Annaliesa Anderson said: “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.”