Bavarian Nordic A/S announced that its Phase 3 clinical trial of MVA-BN®? RSV, a respiratory syncytial virus (RSV) vaccine candidate for adults =60 years of age did not meet all the primary endpoints of preventing lower respiratory tract disease (LRTD) from RSV. 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. A continued strong growth in the Company's travel vaccine business is expected to absorb the loss incurred from the lack of milestone payments of DKK 195 million, that are no longer expected under the Nuance partnership, and thus no impact on the financial guidance for 2023 is expected from the RSV program discontinuation.

The global, randomized, placebo-controlled, double-blind Phase 3 VANIR clinical trial enrolled more than 20,000 adults =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.