FDA Grants Breakthrough Therapy Designation for Pfizer Respiratory Syncytial Virus Vaccine Candidate

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Pfizer’s respiratory syncytial virus vaccine candidate has received Breakthrough Therapy Designation from FDA for the prevention of RS in older adults.

Pfizer announced on March 24, 2022 that its respiratory syncytial virus (RSV) vaccine candidate, RSVpreF, received Breakthrough Therapy Designation from FDA for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age or older.

FDA’s Breakthrough Therapy Designation is designed to accelerate the development and review of drugs and vaccines that are intended to treat or prevent serious conditions and demonstrate substantial improvement over available therapies.

RSV is a contagious virus that can affect the lungs and breathing passages and can be potentially life-threatening for infants, children with chronic medical conditions, and older adults. According to Pfizer, RSV infections in older adults account for approximately 177,000 hospitalizations and 14,000 deaths each year in the US alone. There are currently no prophylactic, therapeutic, or vaccine options for older adults with RSV.


“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,” said Kathrin U. Jansen, senior vice-president and head of vaccine research & development at Pfizer, in a press release. “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.”

Source: Pfizer