The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, has awarded Bavarian Nordic, a Kvistgaard, Denmark-based biotechnology company, a contract for procuring freeze-dried Imvamune smallpox vaccine. The potential value of the initial base and optional awards is in excess of $539 million.

The initial award in the contract calls for the manufacturing and storage of $100 million of Imvamune bulk. This is the third such award to manufacture vaccine bulk; with the two prior orders totaling $233 million. The initial options in the contract are divided between two distinct areas, the first of which is the filling and freeze-drying of Imvamune from the three bulk awards, with total potential value of $299 million. The second part of the contract contains provisions for clinical development, regulatory commitments, and parts of the establishment and validation of fill/finish activities, with potential value of up to $140 million. The award also contains options to acquire additional vaccine bulk and/or freeze-dried doses of Imvamune in the future.

As part of Bavarian Nordic’s partnership with BARDA, a potential optional award of up to $33 million (part of the $140 million previously mentioned) is dedicated to process transfer, and validation of the new manufacturing line. Bavarian Nordic plans to invest approximately $75 million over the coming years in constructing a fill/finish manufacturing line at its facility in Denmark in order to secure the future Imvamune stockpile at the US Strategic National Stockpile, the US’ national repository of antibiotics, vaccines, chemical antidotes, antitoxins, and other critical medical equipment and supplies.

Source: Bavarian Nordic