Pfizer RSV vax wins another breakthrough designation

March 25, 2022

Pfizer has chalked up another win in its trials of a respiratory syncytial virus (RSV) vaccine candidate, grabbing a breakthrough therapy designation for its use in older adults from the U.S. FDA.

The drug candidate, PF-06928316 or RSVpreF, received the designation for its ability to prevent lower respiratory tract disease caused by RSV in individuals 60 years of age or older, according to Pfizer. Lower respiratory tract infections can include conditions like bronchitis and pneumonia.

The FDA granted the tag after positive data from phase 2a of clinical trials of RSVpreF regarding safety, immunogenicity, and efficacy of a single dose in adults aged 18 to 50, according to Pfizer. This designation is the latest in a bout of good news for the pharma titan.

On March 2, the FDA granted RSVpreF breakthrough therapy designation for the prevention of RSV-associated illness in infants from birth to six months old via immunization of pregnant women. 

In September, Pfizer launched another study of RSVpreF, this time looking at the effects of the drug in adults aged 60 and older. This study is still ongoing.

Pfizer’s drug has the potential to strike big. RSV currently has no treatment or vaccine options for older adults and medical remedies are limited to offering only supportive care. Among older adults, the infections from the virus account for approximately 177,000 hospitalizations and 14,000 deaths each year in the U.S. There are about 58,000 hospitalizations per year in the U.S. for children under five because of RSV infection.

The breakthrough therapy designation will allow Pfizer to speed up the development and review of the drug.