The company will receive $36 million for R&D of a prophylactic equine encephalitis virus vaccine.
Eastern equine encephalitis virus (EEEV) is a zoonotic alphavirus and arbovirus. It was first detected in horses in Massachusetts in 1831 and in humans in New England in 1938. It occurs today in North, Central and South America and the Caribbean. EEEV is only transmitted to through the bite of infected mosquitos. Most people infected with EEEV have no symptoms. In rare cases – approximately 7 per year in the US, and mostly in the Atlantic and Gulf Coast states - encephalitis, an inflammation of the brain, occurs, which leads to death or significant brain damage in a third of patients. There is currently no cure.
Danish vaccine company Bavarian Nordic has developed a vaccine candidate that has been shown to be effective against EEEV, as well as the Venezuelan and Western equine encephalitis viruses in preclinical models. The vaccine has been developed using the company’s proprietary MVA-BN platform.
A new $36-million grant from the US Department of Defense (DoD) will fund additional preclinical studies, production of clinical trial materials and demonstration of safety and immunogenicity in clinical studies for the vaccine candidate. Additional funding could be forthcoming to support the company in its efforts to gain US Food and Drug Administration (FDA) approval and implement cGMP production of the vaccine if this initial R&D stage is successful.
Bavarian Nordic already has other agreements in place with the US DoD for its smallpox vaccine Imvamune, which was also developed using its MVA-BN vaccine platform. The company currently has a stockpiling contract worth up to $539 million with the Health and Human Services agency Biomedical Advanced Research and Development Authority (BARDA), even though Imvamune is only approved in Europe and not in the US. The stockpiling is for emergency use.
Previously, Bavarian Nordic had delivered $233 million worth of liquid Imvamune doses, all of which have passed their three-year expiration date. The current BARDA contract is for lyophilized doses with a shelf life of 5 years, as well as simpler storage and shipping requirements. The company plans to seek FDA approval for the lyophilized smallpox vaccine later in 2018.