FDA committee votes in favour of Pfizer’s RSV vaccine for maternal immunisation
Pfizer has announced that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) from the US Food and Drug Administration (FDA) has voted in favour of the company’s respiratory syncytial virus (RSV) vaccine for maternal immunisation.
The committee voted 14 to 0 on effectiveness and 10 to 4 on safety, however the vaccine is currently still 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 to six months of age through the immunisation of pregnant individuals.
The VRBPAC recommendation is based on Pfizer’s evidence including primary analysis results from the phase 3 clinical trial MATISSE (MATernal Immunisation Study for Safety and Efficacy) that were announced in November 2022, and have recently been published in The New England Journal of Medicine.
Annaliesa Anderson PhD, senior vice president and chief scientific officer, Vaccine Research and Development at Pfizer, commented: “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. If approved, our RSV vaccine candidate has the potential to be the first maternal immunisation vaccine to help protect infants at first breath through their first six months of life from this potentially serious infection.”