Breakthrough status for Janssen’s RSV vaccine

Janssen has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for its investigational prophylactic vaccine for the prevention of respiratory syncytial virus (RSV)-mediated lower respiratory tract disease in adults 60 or older. The designation was based on clinical data with Janssen’s prophylactic RSV senior vaccine that “may demonstrate substantial improvement compared to available standard of care on a clinically significant endpoint,” announced the company. The investigational prophylactic vaccine is currently in a Phase IIb proof of concept study to investigate the safety and efficacy of the vaccine against RSV in adults aged 65 years and older. “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, global therapeutic area head, vaccines, and managing director, Janssen Vaccines & Prevention.