U.S. FDA acknowledges Pfizer’s RSV vaccine as breakthrough therapy

The RSV vaccination is designed for maternal immunization to prevent RSV-related lower respiratory tract illness in infants up to 6 months of age

The U.S. Food and Drug Administration (FDA) has reportedly granted Pfizer’s RSV (respiratory syncytial virus) vaccine candidate, dubbed RSVpreF (PF-06928316) with Breakthrough Therapy Designation.

Clinically, RVSpreF is deemed as an investigational vaccine candidate – made of two preF proteins selected to strengthen protection against RSV A and B - allowed by the agency in clinical trials.

Designed as an active vaccine for pregnant women, maternal immunization is developed to avoid the risk of respiratory tract illness associated with RSV infection among infants from birth until six months of age.

The FDA grant comes after a thorough evaluation of the internationally led, placebo-controlled and double-blinded Phase IIb proof-of-concept clinical trial for RSVpreF analysis.

As a part of the trial, healthy pregnant women between the age of 18 to 49 years were vaccinated during their gestation period of 28 to 36 weeks to analyze the safety as well as immunogenicity of the vaccine in these women as well as their infants. 

Pfizer will soon publish the results from the clinical trial conducted on the novel candidate RSVpreF.

Notably, the latest grant of breakthrough status follows the agency’s decision in 2018 to designate the vaccine with Fast Track status.

Speaking on the FDA grant, Kathrin Jansen, Pfizer Vaccine R&D Senior VP and Head, mentioned that the latest decision is crucial in the efforts to gain regulatory approval for the company’s maternal RSV vaccine candidate.

More importantly, if FDA approves the maternal immunization, it could most likely become the first-ever vaccine candidate to protect infants during the first few months of vulnerability from the highly contagious virus.

By the end of last year, the U.S. FDA issued an emergency use authorization (EUA) for the pharma company’s oral antiviral Paxlovid to address mild-to-moderate Covid19 symptoms among adults and children above 12 years of age.

Source Credit: https://www.pharmaceutical-technology.com/news/fda-breakthrough-pfizer-rsv-vaccine/