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Bavarian Nordic receives Breakthrough Therapy Designation

Paul Chaplin

The U.S. Food and Drug Administration has granted the designation for the company’s vaccine candidate for active immunization for prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults aged 60 years or older.

The designation has been granted upon the assessment of preliminary clinical evidence for the vaccine candidate, MVA-BN RSV, indicating that the vaccine candidate may demonstrate substantial improvement over available therapy on a clinically significant endpoint, states the company. The designation provides an option to work more closely with FDA for the development and review of MVA-BN RSV.

“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.”

“The development of an RSV vaccine is one of our main priorities that could help fulfill the significant unmet need for a preventative therapy, particularly for the elderly who may be at risk from serious complications from the disease. Our candidate has a clearly differentiated approach, as it employs five RSV-specific antigens with an aim to stimulate a broad antibody and cellular immune response against RSV. 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,” says Paul Chaplin, President and CEO of Bavarian Nordic.

Photo of Paul Chaplin: Bavarian Nordic