Bavarian Nordic begins phase 3 clinical trial of MVA-BN RSV vaccine for older adults

A global, Phase 3 trial of approximately 20,000 older adult volunteers for the Bavarian Nordic A/S MVA-BN RSV vaccine candidate began this week and is expected to produce results by mid-2023.

The randomized, double-blind test will gather those aged 60 years and older in both the United States and Germany to assess the MVA-BN RSV vaccine’s efficacy against lower-respiratory tract disease caused by a respiratory syncytial virus (RSV). RSV is a common virus that can cause a range of symptoms, from mild, cold-like effects to more severe impacts such as bronchiolitis and pneumonia, which can lead to death, particularly among the very young or very old.

“RSV remains a significant cause of respiratory disease in older adults, and in severe cases, unfortunately leading to death,” Paul Chaplin, president and CEO of Bavarian Nordic, said. “Despite an estimated burden on the healthcare system which is similar to that of influenza, no vaccines are available yet. The initiation of this pivotal trial of our vaccine candidate is a significant contribution to the global efforts to develop a safe and effective vaccine against RSV and represents an important step for Bavarian Nordic towards fulfilling our ambition to become one of the largest pure play vaccine companies.”

Testing will be conducted across approximately 115 sites. The trial has been dubbed VANIR and follows results from a smaller Phase 2 trial last year that showed a significant reduction in viral load among subjects vaccinated with MVA-BN RSV. Its efficacy held at up to 79 percent in preventing symptomatic cases of RSV infection.

Currently, no approved vaccine for RSV exists.