Denmark-based drugmaker Bavarian Nordic announced this week that its RSV program will be coming to an end after disappointing phase 3 trial results.
The jab, MVA-BN RSV, was being assessed for efficacy in 20,000 adults 60 and older with a primary endpoint to prevent lower respiratory tract disease (LRTD) caused by RSV.
Overall, study results demonstrated that the vaccine had 59% of efficacy in preventing some LRTD symptoms. According to the World Health Organization, vaccines can be considered for approval if they demonstrate an efficacy of 50% or higher. But when researchers examined more severe LRTD symptoms, the jab's efficacy dropped to 42.9% missing the study endpoint.
Paul Chaplin, President, and CEO of Bavarian Nordic, commented on the results, stating optimistically, "While this outcome was unexpected and will affect our short-term growth expectations, we still possess a distinctive commercial business. Considering the recent robust brand and market growth, this lays a strong foundation for profitable expansion in the future."
Bavarian’s collaboration with Nuance Pharma to develop and release the vaccine in specific Asian markets will also be coming to an end.
Competitor RSV vaccines and preventatives have already begun securing U.S. approvals. After a heated race, GSK snagged the first FDA okay back in May for a vaccine in older adults. Pfizer followed close behind, securing approval for a vaccine for the same patient population in early June. Last week, partners AstraZeneca and Sanofi won U.S. approval for their single dose long-acting antibody, marking the first U.S. approved RSV preventive option for a broad infant population.
