FDA approves smallpox vaccine's delivery

Bavarian Nordic, a Danish biotechnology company, has announced that the FDA has decided that all requirements for delivery of the company's smallpox vaccine to the United States government have been met.

The FDA's announcement means that Bavarian Nordic will deliver 20 million doses of Imvamune to the U.S., which will fulfill a contract currently being held.

"What remains are some administrative procedures that need to get in place," Chief Executive Officer Anders Hedegaard told Reuters. "Our firm expectation is that we will start deliveries on this order in the first half of 2010."

Delivery on the contract was originally set to begin by the end of 2009 but was delayed while the Bavarian company made the required adjustments to its facilities. The FDA has now accepted the company's actions to address the observations.

"This was the last step along with the clinical and preclinical data that will be used to potentially support the use of Imvamune following a declared emergency," Bavarian told Reuters. "Subsequently, the company will scale-up the production as planned ... so the 20 million doses will be produced and delivered according to the contract."

Bavarian has said that it will deliver as many as five million doses of Imvamune to the U.S. this year.