Posted by Michael Wonder on 02 Mar 2022
Pfizer granted FDA breakthrough therapy designation for respiratory syncytial virus (RSV) vaccine candidate for the prevention of RSV in infants from birth up to six months of age by active immunisation of pregnant women
2 March 2022 - Pfizer today announced that its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, received breakthrough therapy designation from the US FDA for prevention of RSV associated lower respiratory tract illness in infants from birth up to six months of age by active immunisation of pregnant women.
The FDA decision is informed by the results of the Phase 2b proof-of-concept study of RSVpreF , a global, double blinded, placebo controlled study that assessed the safety and immunogenicity of RSVpreF in healthy pregnant women ages 18 through 49 years old, who were vaccinated between 28- and 36-weeks gestation, and their infants.
