Pfizer said that PF-06928316 (RSVpreF), its respiratory syncytial virus (RSV) vaccine candidate, has been granted breakthrough therapy designation from the US Food and Drug Administration (FDA).
The breakthrough therapy designation is for the use of the vaccine candidate in the prevention of lower respiratory tract disease caused by RSV in patients aged 60 years or older.
According to Pfizer, FDA’s decision is mainly driven by the positive findings of a proof-of-concept, phase 2a trial that assessed the safety, immunogenicity, and efficacy of a single dose of 120µg RSVpreF in a human viral challenge model in healthy adults aged between 18 and 50 years.
Kathrin U. Jansen — Pfizer Senior Vice President and Head of Vaccine Research and Development said: “Today’s decision is a significant step forward in our efforts to help protect vulnerable populations, particularly older adults, against certain potentially serious respiratory illnesses, including RSV.
“The clinical and economic burden of RSV represents a critical need, and we look forward to our ongoing dialogue with the FDA to accelerate the development of our RSV vaccine candidate.”
Earlier this month, Pfizer had secured FDA breakthrough therapy designation for RSVpreF 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.
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