RSV Vaccine Candidate Granted Fast-Track Status for Seniors

Denmark-based Bavarian Nordic A/S announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for MVA-BN RSV, a vaccine candidate for active immunization to prevent lower respiratory tract disease caused by a respiratory syncytial virus (RSV) in people 60 years or older. 

The FDA's designation has been granted upon assessing preliminary clinical evidence for MVA-BN RSV, indicating that the vaccine candidate may demonstrate substantial improvement over available therapy on a clinically significant endpoint.

Currently, there is no approved vaccine against RSV. As such, RSV constitutes a significant and critical unmet medical need.

Bavarian Nordic stated in its press release it plans to initiate a large Phase 3 trial of MVA-BN RSV in 2022. 

The vaccine candidate is based on Bavarian Nordic's proprietary MVA-BN platform technology, also used in the Company's approved vaccines for smallpox and Ebola. 

In a recent phase 2 clinical study, the MVA-BN RSV vaccine demonstrated the efficacy of up to 79% in preventing symptomatic RSV infections.

The vaccine incorporates five distinct RSV antigens to stimulate a broad immune response against both RSV subtypes (A and B), thus mimicking the immune response observed following a natural response to an RSV infection.

Incorporating five antigens differentiates MVA-BN RSV from other RSV vaccine candidates currently in development.

Paul Chaplin, President and CEO of Bavarian Nordic, commented in a press release issued on February 14, 2022, "The development of an RSV vaccine is one of our main priorities that could help fulfill the significant unmet need for 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."

RSV is a common virus that usually causes mild, cold-like symptoms, but in serious cases can lead to severe lung infections, including bronchiolitis and pneumonia, which ultimately can lead to death.

At-risk individuals typically include infants and elderly/immunocompromised individuals.

It is estimated that each year RSV-induced infections lead to approximately 14,000 deaths in adults aged 65 years and older in the U.S., similar to influenza.

Accordingly, preventing RSV-induced infections is a top priority for governments and medical professionals globally. In addition, the designation provides an option to work more closely with the FDA to develop and review MVA-BN RSV. 

Bavarian Nordic is a fully integrated vaccines company located in Copenhagen, Denmark, focused on developing, manufacturing, and commercializing life-saving vaccines.