FDA Approved: Pfizer’s RSV Vaccine Can Now Be Administered During Pregnancy

FDA has approved Abrysvo, the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age.

Abrysvo is unadjuvanted and composed of two preF proteins selected to optimize protection against RSV A and B strains and was observed to be safe and effective.

“Abrysvo’s approval as the first and only maternal immunization to help protect newborns immediately at birth through six months from RSV marks a significant milestone for the scientific community and for public health,” comments Annaliesa Anderson, PhD, SVP and chief scientific officer, vaccine research and development, Pfizer. “ … Today, a long-sought-after goal to deliver a maternal vaccine that will help protect infants six months of age or younger— when they are at greatest risk of possible serious consequences from RSV— has been achieved.”