Janssen Gets FDA Breakthrough Therapy Designation for RSV Vaccine

Published on: 

The company has received breakthrough therapy designation for its prophylactic respiratory syncytial virus vaccine candidate for treating adults aged 60 years or older.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced on Sept. 3, 2019 that FDA has granted breakthrough therapy designation for the company's investigational prophylactic vaccine for preventing respiratory syncytial virus (RSV)-mediated lower respiratory tract disease in adults aged 60 years or older. Older adults are among the populations at the highest risk of developing RSV.

The breakthrough therapy designation was based on clinical data with Janssen's prophylactic RSV senior vaccine that may demonstrate substantial improvement compared to the available standard of care on a clinically significant endpoint.

"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 B.V., Janssen Pharmaceutica N.V., in a company press release. "This [b]reakthrough [t]herapy [d]esignation represents clear recognition of the transformative potential of this investigational RSV preventive solution. We look forward to working closely with [FDA] throughout the course of the prophylactic RSV senior vaccine development program."

As a result of being granted breakthrough therapy designation, the prophylactic RSV vaccine candidate is now eligible for all associated FDA features. The 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.


This vaccine candidate leverages unique features of Janssen's adenovector platform (AdVac); it contains the gene encoding for the fusion protein of the RSV virus as an antigen.

Source: Johnson & Johnson