Bavarian Nordic announces result of efficacy study
Bavarian Nordic announced today a key milestone in the development of IMVAMUNE™ with the publication of a study (K.J.Sittelaar et al. Journal of Virology, June 2005, pp 7845-7851), which demonstrates that IMVAMUNE™ protects monkeys from a lethal challenge with monkeypox, a closely-related virus to smallpox. IMVAMUNE™ induced the same level of protection as traditional smallpox vaccines, and demonstrated for the first time ever, that an MVA-based vaccine candidate could protect monkeys from a lethal monkeypox infection induced through the lungs, a natural route of infection. Other animal challenge models have introduced monkeypox via the blood but cannot be used to demonstrate efficacy for the natural occurrence of the infection through the lung.
The monkey model developed by Bavarian Nordic is a major step forward in the company’s goal to register IMVAMUNE™. Animal data is the only approved method to demonstrate efficacy of a smallpox vaccine against smallpox infection in humans.
Peter Wulff, President & CEO of Bavarian Nordic said, “This is an encouraging result in the development of IMVAMUNE™. Demonstration of efficacy in monkeys is vital in presenting to regulatory authorities that IMVAMUNE™ is efficacious against smallpox infection. Reaching this milestone comes at a pivotal point in time as the U.S Government decides to stockpile an MVA-based vaccine. IMVAMUNE™ clearly is the best-characterised MVA-based vaccine and now with these new results, is the only vaccine candidate in the RFP program with the critical efficacy data.”
