Respiratory virus vaccine receives breakthrough therapy designation

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to an investigational prophylactic vaccine for the prevention of respiratory syncytial virus (RSV)-mediated lower respiratory tract disease. The medication is intended for adults aged 60 years or older.

Janssen, the company that produces the treatment, held clinical trials that demonstrated substantial improvement compared to the current standard of care, promoting the designation.

“With no preventive vaccines or effective antiviral treatments currently available, RSV remains a significant cause of illness in at-risk populations, particularly older adults,” said Johan Van Hoof, MD, Global Therapeutic Area Head, Vaccines and Managing Director, Janssen Vaccines & Prevention BV, Janssen. “This breakthrough therapy designation represents clear recognition of the transformative potential of this investigational RSV preventive solution. We look forward to working closely with the FDA throughout the course of the prophylactic RSV senior vaccine development programme.”

The vaccine is currently in a Phase IIb proof-of-concept study to investigate the safety and efficacy of the treatment. It is formulated to contain the gene encoding for the fusion protein of the RSV virus as an antigen.