US Invests Additional 44 Million in Smallpox Vaccine Manufacturing

Bavarian Nordic A/S announced on Jan. 18 that the U.S. Biomedical Advanced Research and Development Authority (BARDA) has exercised another option under the ongoing contract for freeze-dried MVA-BN^® smallpox vaccine.

The option, valued at USD 44 million, will cover qualification of the new fill-finish facility, currently being established at the company’s manufacturing site in Denmark, as well as transfer and validation of the freeze-drying process. The majority of this contract option is expected to be revenue recognized in 2019 and 2020.

This is the second option exercised under the contract. In 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.

The new fill-finish 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.

The company is investing approximately USD 75 million in the project, and the newly awarded option from BARDA will support the process transfer and validation activities, required for finalizing the production of freeze-dried MVA-BN smallpox vaccine.

The construction began in March 2018, and the facility is expected to be fully operational in 2020, upon which qualification and validation of the process for freeze-dried MVA-BN will begin, before initiating commercial manufacturing in 2021.

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.

Manufacturing of bulk vaccine to support this transition was initiated in 2016 and by end of 2019, the Company will have manufactured and invoiced bulk vaccine worth USD 333 million. The fill-finish of this bulk will trigger additional contract options valued at USD 299 million. The ten-year contract, awarded in 2017, also includes pricing for additional orders of vaccine bulk and vaccine doses of either liquid-frozen or freeze-dried MVA-BN.

Source: Bavarian Nordic, edited for context and format by Global Biodefense.