Bavarian Nordic announces RSV vaccine did not meet all primary endpoints in phase 3 trial

Betsy Goodfellow | July 25, 2023 | News story | Medical Communications |  Bavarian Nordic, Infections and infestations, RSV, Vaccine, clinical trial 

Bavarian Nordic has announced that its phase 3 clinical trial of MVA-BN, its respiratory syncytial virus (RSV) vaccine candidate for adults over the age of 60, did not meet all of its primary endpoints for preventing lower respiratory tract disease (LRTD) following RSV infection.

The study results showed that the vaccine has a 59% efficacy at preventing more than two pre-defined LRTD symptoms, meaning it met one of the efficacy criteria of the trial. However, the vaccine was only 42.9% effective at preventing severe LRTD based on more than three pre-defined symptoms, therefore missing the co-primary endpoint of the trial.

The company is now planning to discontinue its RSV programme, including its partnership with Nuance Pharma.

Paul Chaplin, president and chief executive officer of Bavarian Nordic, commented: “We are disappointed that our RSV vaccine candidate was not successful in this pivotal trial. While this outcome was unexpected and will impact our short-term growth expectations, we continue to have a unique commercial business and given the recent strong brand and market growth, this provides a solid foundation for profitable growth in the years to come.”

Betsy Goodfellow