Beginning in 2023 and 2024, Bavarian Nordic A/S will, for the first time, manufacture and invoice a freeze-dried version of its JYNNEOS smallpox vaccine to the U.S. government.
The announcement followed a decision by the Biomedical Advanced Research and Development Authority (BARDA) to exercise options under an existing contract with Bavarian Nordic. Valued at $119 million, this first set of options in the contract will include the conversion of the existing bulk vaccine to approximately 13 million JYNNEOS doses. If additional options on the contract are exercised, it would be valued at $180 million, though the overall contract is valued at approximately $299 million.
“We are pleased to announce the exercise of the first options under our contract with the U.S. government to deliver a freeze-dried version of the smallpox vaccine with an improved shelf-life, which will be manufactured at our new fill and finish facility,” Paul Chaplin, president and CEO of Bavarian Nordic, said. “This marks a significant milestone in our long-standing partnership with the U.S. government to ensure availability of life-saving vaccines for the entire population.”
The majority of the bulk vaccine has already been manufactured and dispatched to the government, but conversion will follow. Commercial manufacturing will likely wait until 2023 due to a pending Food and Drug Administration (FDA) inspection later this year at the new fill and finish plant to which Bavarian Nordic transferred its freeze-drying process last year.
Bavarian Nordic has worked with the U.S. government to develop, manufacture and supply a non-replicating smallpox vaccine since 2003. Since then, it has supplied nearly 30 million doses of a liquid-frozen version for largely emergency use before the vaccine’s FDA approval in 2019. A freeze-dried version has been under development since 2009 to give the vaccine a longer shelf-life for stockpiling.