Pfizer has secured breakthrough therapy designation for its respiratory syncytial virus (RSV) vaccine candidate — PF-06928316 (RSVpreF) from the US Food and Drug Administration (FDA) for the prevention of RSV-associated lower respiratory tract illness in infants from the time of birth up to six months by active immunization of pregnant women.

According to Pfizer, the FDA decision has been driven by the findings of the phase 2b proof-of-concept study of RSVpreF. The global, double-blinded, placebo-controlled study evaluated RSVpreF’s safety and immunogenicity in healthy pregnant women aged 18 to 49, who were vaccinated between 28- and 36-weeks gestation, and their infants.

Kathrin U. Jansen — Pfizer Senior Vice President and Head of Vaccine Research and Development said: “Today’s decision is a pivotal next step in our path towards potential regulatory approval for our maternal RSV vaccine candidate and is an important milestone in our efforts to help address the detrimental impact RSV disease has on infants.

“If approved by the FDA, this maternal immunization has the potential to be the first vaccine candidate to help protect infants in their vulnerable first months of life from disease caused by this highly-contagious virus. We look forward to our ongoing dialogue with the FDA to accelerate the development of our maternal RSV vaccine candidate.”

The breakthrough therapy designation decision for RSVpreF follows its fast-track status from the FDA in November 2018.

  FDA, Kathrin U. Jansen, Pfizer, Pregnant Women, respiratory syncytial virus, RSVpreF, US FDA, US Food and Drug Administration