A phase III clinical trial of MVA-BN RSV, a respiratory syncytial virus (RSV) vaccine candidate for adults over 60 years of age did not meet all the primary endpoints of preventing lower respiratory tract disease.- Bavarian Nordic.

The final study results showed that the vaccine candidate had a 59% efficacy in preventing at least 2 pre-defined LRTD symptoms meeting one of the efficacy criteria of the study. However, when measuring more severe LRTD based on at least 3 pre-defined symptoms, the vaccine candidate only demonstrated a 42.9% efficacy and missed the co-primary endpoint of the study.Based on this outcome, Bavarian Nordic will discontinue its RSV program, including its partnership with Nuance Pharma to develop and launch the vaccine for selected Asian markets.

“We are disappointed that our RSV vaccine candidate was not successful in this pivotal trial,” said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic. “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.”

About the Phase III trial: The global, randomized, placebo-controlled, double-blind Phase III VANIR clinical trial enrolled more than 20,000 adults over 60 years of age, who were randomized 1:1 to receive either a single dose of MVA-BN RSV or placebo. The primary objective of the study was to assess the efficacy of the vaccine candidate against lower-respiratory tract disease (LTRD) caused by RSV.