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Bavarian Nordic initiates global Phase 3 trial

Bavarian Nordic Research

Bavarian Nordic has announced the dosing of the first subject in the Phase 3 VANIR clinical trial of its investigational respiratory syncytial virus (RSV) vaccine candidate, MVA-BN RSV in older adults.

The VANIR trial is a global, randomized, double-blind Phase 3 trial of the recombinant MVA-BN RSV vaccine in 20,000 adults aged 60 years and older. The primary objective of the study will assess the efficacy of the vaccine candidate against lower-respiratory tract disease caused by RSV compared to placebo.

“RSV remains a significant cause of respiratory disease in older adults, and in severe cases, unfortunately leading to death. 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,” says Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic.

The Phase 3 trial is being conducted at approximately 115 sites across the U.S. and Germany. The trial is designed to run through the RSV season 2022/2023 with topline results expected mid 2023 if the pre-defined number of lower-respiratory tract disease events has occurred.

Photo: Bavarian Nordic Research