RSV Vaccine Candidate Receives 2nd Breakthrough Therapy Designation

New York-based Pfizer Inc. today announced that its respiratory syncytial virus (RSV) vaccine candidate RSVpreF received its second Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) to prevent lower respiratory tract disease caused by RSV.

Confirmed on March 24, 2022, this designation is for individuals 60 years or older.

RSVpreF (PF-06928316) received an earlier Designation from the FDA on March 2, 2022, for the prevention of RSV-associated lower respiratory tract illness in infants from birth up to six months of age by active immunization of pregnant women.

Currently, the FDA has not Approved any RSV vaccine candidate.

“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, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer Inc., in a related 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.”

RSVpreF is based on the prefusion form of the RSV fusion protein. The vaccine candidate is composed of two preF proteins selected to optimize protection against RSV A and B.

The FDA’s Breakthrough Therapy Designation is designed to expedite the development and review of drugs and vaccines intended to treat or prevent serious conditions, and preliminary clinical evidence indicates that the drug or vaccine may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

Additional RSV vaccine candidate news is posted at PrecisionVaccinations.com/RSV.

Note: This news article edited Pfizer press releases and FDA information and was manually curated for mobile readers.