RSV Vaccine Candidate Launches Phase 3 Study With Seniors

Denmark-based Bavarian Nordic A/S announced today 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 Phase 3 trial is conducted at approximately 115 sites across the U.S. and Germany. Its primary objective is to assess the vaccine candidate's efficacy against lower-respiratory tract disease caused by RSV compared to a placebo. 

The U.S. FDA has granted the MVA-BN RSV vaccine candidate Breakthrough Therapy Designation.

“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 similar to 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,” said Paul Chaplin, President and CEO of Bavarian Nordic, in a press release issued on April 20, 2022.

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.

RSV is a common virus that usually causes mild, cold-like symptoms but, in serious cases, can lead to severe lung infections, including bronchiolitis and pneumonia, which ultimately can lead to death.

Bavarian Nordic is a fully integrated vaccine company located in Copenhagen focused on developing, manufacturing, and commercializing life-saving vaccines.

Additional RSV vaccine news is posted at PrecisionVaccinations.com/RSV.

Note: This press statement was edited for clarity and manually curated for mobile readers.