Bavarian Nordic ‘Breakthrough’ for RSV Vaccine

FDA has granted Bavarian Nordic A/S a breakthrough therapy designation for vaccine candidate MVA-BN RSV for preventing lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults aged 60 years or older. The designation was made based on preliminary clinical evidence showing that the vaccine candidate may “demonstrate substantial improvement over available therapy on a clinically significant endpoint,” according to the company.

Bavarian Nordic says the vaccine contains five RSV-specific antigens that are intended to stimulate a broad antibody and cellular immune response against the virus. “Based on the encouraging results demonstrated in a human challenge trial last year, we recently announced our plans to initiate a Phase 3 study this year and look forward to working closely with the FDA on our path towards licensure of the vaccine,” it says.