FDA Grants Priority Review for Adult RSV Vaccine

If approved, GSK’s vaccine could be the first available to help protect adults over the age of 60. The Prescription Drug User Fee Act date is May 3, 2023.

The FDA has accepted a biologics license application (BLA) and granted priority review for GSK’s vaccine for respiratory syncytial virus (RSV) for older adults. The Prescription Drug User Fee Act date is May 3, 2023. If approved, GSK’s RSV older adult vaccine candidate has the potential to be the first vaccine available to help protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.

RSV is a common contagious virus affecting the lungs. There is currently no vaccine or specific treatment available for adults. Older adults are at high risk for severe disease due to age-related decline in immunity and underlying conditions. RSV can exacerbate conditions, including chronic obstructive pulmonary disease (COPD), asthma and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalization, and death.

The BLA is based on positive data from a prespecified interim analysis of the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase 3 trial, which showed high overall vaccine efficacy against RSV lower respiratory tract disease in adults aged 60 years and older. The vaccine was well tolerated with a favorable safety profile. The most frequent observed solicited adverse events were injection site pain, fatigue, myalgia, and headache.

“RSV remains one of the few major infectious diseases without a vaccine, and these data have the potential to meaningfully impact the treatment of RSV and may reduce the 360,000 hospitalizations and more than 24,000 deaths worldwide each year,” Hal Barron, M.D., former chief scientific officer and president of R&D, GSK, said in a press release in June when results were released. Barron is now CEO and co-founder of Altos Labs, a recently launched biotech company focused on cellular rejuvenation programming..