Pfizer’s respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for prevention of RSV-associated lower respiratory tract illness in infants from birth up to six months of age by active immunization of pregnant women.
The FDA decision is informed by the results of the Phase 2b proof-of-concept study of RSVpreF (NCT04032093), a global, double-blinded, placebo-controlled study that assessed the safety and immunogenicity of RSVpreF in healthy pregnant women ages 18 through 49 years old, who were vaccinated between 28- and 36-weeks gestation, and their infants. Pfizer will publish outcomes from this clinical trial at a future date.
“Today’s decision is a pivotal next step in our path towards potential regulatory approval for our maternal RSV vaccine candidate and is an important milestone in our efforts to help address the detrimental impact RSV disease has on infants,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer Inc.
“If approved by the FDA, this maternal immunization has the potential to be the first vaccine candidate to help protect infants in their vulnerable first months of life from disease caused by this highly-contagious virus. We look forward to our ongoing dialogue with the FDA to accelerate the development of our maternal RSV vaccine candidate.”
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).
This decision follows the FDA’s November 2018 decision to grant Fast Track status to RSVpreF. Fast Track status is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address a medical need.
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, the immunocompromised, and older adults. In the United States alone, approximately 2.1 million outpatient visits and 58,000 hospitalizations occur each year among children younger than five years old. For older adults in the U.S., RSV infections account for approximately 177,000 hospitalizations and 14,000 deaths each year. There is no vaccine to prevent RSV, and the medical community is limited to offering only supportive care for those with the illness.