Bavarian Nordic to supply smallpox vaccines to three European countries

Bavarian Nordic's manufacturing site at Kvistgaard, Denmark

The company hopes its newly built fill and finish facility will assume commercial manufacturing this year

Imvanex, the only EU-approved non-replicating smallpox vaccine, is manufactured at Bavarian Nordic’s Denmark-based commercial-scale facility, which has been producing the bulk smallpox vaccine for more than a decade.

Although the final drug product manufacturing has taken place with a contract manufacturer, Bavarian Nordic will soon commission its own fill and finish facility as part of the company’s expansion of the facility to become a center of excellence for live viral vaccine manufacturing.

The construction of the fill and finish facility has been completed in less than 2 years, and pending final validation and qualification, the facility will assume commercial manufacturing in 2021 with liquid-frozen Jynneos (US trade name for the smallpox vaccine) as the first product on the line.

The facility also houses lyophilization capabilities, and a freeze-dried version of the smallpox vaccine is currently in the final stages of development, anticipated ready for manufacturing in 2022.

In addition, construction work is currently ongoing for expansion of the facility to allow for simultaneous bulk manufacturing of multiple products. This investment will enable Bavarian Nordic to transfer the manufacturing of the two vaccines, Rabipur/RabAvert (against rabies) and Encepur (against tick-borne encephalitis) according to the planned schedule after having acquired the vaccines from GlaxoSmithKline (GSK) in 2019.