Pfizer gets USFDA Breakthrough Therapy Designation for RSV Vaccine

The FDA decision is primarily informed by the positive results of a proof-of-concept, Phase 2a study evaluating the safety, immunogenicity, and efficacy of a single dose of 120µg RSVpreF in a human viral challenge model in healthy adults 18 to 50 years of age.

"The 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. "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."

In September 2021, Pfizer announced the initiation of RENOIR (RSV vaccine Efficacy study iNOlder adults Immunized against RSV disease), a Phase 3 clinical trial (NCT05035212) evaluating the efficacy, immunogenicity, and safety of a single dose of RSVpreF, in adults ages 60 years or older. This study remains ongoing.

The FDA's Breakthrough Therapy Designation is designed to expedite the development and review of drugs and vaccines that are 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).

RSV is a contagious virus and a common cause of respiratory illness. The virus can affect the lungs and breathing passages of an infected individual and can be potentially life-threatening for young infants, children with chronic medical conditions, and older adults. In the United States alone, among older adults, RSV infections account for approximately 177,000 hospitalizations and 14,000 deaths each year. For children younger than five years old in the U.S., approximately 2.1 million outpatient visits and 58,000 hospitalizations occur each year.

RSV is a disease for which there are currently no prophylactic, therapeutic, or vaccine options for older adults and the medical community is limited to offering only supportive care for adults with the illness.