BARDA orders bulk supply of Bavarian Nordic’s non-replicating smallpox vaccine

The Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services (HHS), ordered a bulk supply of Bavarian Nordic’s non-replicating smallpox vaccine Imvamune on Friday.

Imvamune is being developed as a smallpox vaccine for individuals for whom traditional replicating vaccines are contraindicated, such as people with atopic dermatitis and HIV.

Under terms of the order, Bavarian Nordic will manufacture and store a bulk supply of Imvamune, which will then be freeze-dried and transferred to a commercial line, pending approval by the U.S. Food and Drug Administration (FDA).

Freeze-drying the supply is expected to reduce life cycle management costs based on a longer shelf life and will replace the frozen liquid version that is currently stored in the U.S. Strategic National Stockpile.

“We are pleased to announce our continued successful collaboration with the U.S. government, specifically BARDA and the NIH. This additional order of Imvamune will ensure that the preparedness of the U.S. government and the protection of its people will not wane,” Paul Chaplin, president and CEO at Bavarian Nordic, said. “It has been investments like this by BARDA, and the research at the NIH, which have allowed successful medical countermeasures to be stockpiled.”