FDA grants breakthrough therapy designation to RSV vaccine

pharmafile | March 3, 2022 | News story | Business Services, Medical Communications  

The FDA has granted a Breakthrough Therapy Designation to Pfizer’s respiratory syncytial virus (RSV) vaccine candidate, for the prevention of RSV-associated lower respiratory tract illnesses in infants from birth up to six months of age. The vaccine is also for active immunisation of pregnant people.

“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.”

RSV is a contagious virus and a common cause of respiratory illness. It is a viral infection of the respiratory tract and commonly affects children below the age of 2 years, and is one of the leading causes of hospitalisation among infants. 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.

The FDA’s designation is informed by data from the Phase IIb proof-of-concept study of RSVpreF (NCT04032093), a global, double-blinded, placebo-controlled study. The study 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.

Breakthrough Therapy Designations are designed to accelerate the development and review of drugs and vaccines that are intended to treat or prevent serious conditions.

In the US alone, approximately 2.1 million outpatient visits and 58,000 hospitalisations occur due to RSV among children younger than five years old. In older adults in the US, RSV infections cause 14,000 deaths each year. The medical community is limited to offering only supportive care for those with the illness.

Ana Ovey

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