U.S. Government Expands Smallpox Vaccine Supply

Bavarian Nordic MVA-BN is a non-replicating smallpox vaccine distributed in liquid-frozen formulation

The U.S. Biomedical Advanced Research and Development Authority (BARDA) has exercised another option under an ongoing contract for freeze-dried MVA-BN® smallpox vaccine. 

Although not yet approved in the USA, MVA-BN is currently stockpiled by the U.S. Government for emergency use in people for whom replicating smallpox vaccines are contraindicated, such as people with HIV and atopic dermatitis. 

This option, valued at USD 44 million, will cover qualification of the new fill-finish facility, currently being established at the Bavarian Nordic A/S manufacturing site in Denmark, as well as transfer and validation of the freeze-drying process. 

This new facility has been designed with a potential annual capacity of up to 40 million doses of liquid vaccines and 8 million doses of freeze-dried vaccines. 

This is the 2nd option exercised under an existing contract. 

During 2017, BARDA exercised an option of USD 37 million to cover development costs associated with the Phase 3 study required for the eventual approval of the freeze-dried MVA-BN smallpox vaccine. 

This Phase 3 will be initiated in the first half of 2019. 

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Since 2010, Bavarian Nordic has manufactured its liquid-frozen MVA-BN smallpox vaccine for the U.S. government and has supplied 28 million doses to the U.S. Strategic National Stockpile (SNS) for emergency use. 

Concurrently, BARDA has supported the development of a freeze-dried version of the vaccine with longer shelf-life to replace the current stockpile that has expired. 

This project has been funded in whole or in part with federal funds from the HHS Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201700019C.

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MVA-BN is approved in Canada (marketed under the trade name IMVAMUNE®) and in the European Union (marketed under the trade name IMVANEX®). 

Bavarian Nordic is a fully integrated biotechnology company focused on the development of innovative and safer therapies against cancer and infectious diseases.