Danish vaccine company Bavarian Nordic filled its order book for the next three years at a single stroke, when the US Food and Drug Administration (FDA) gave the final approval for the company's smallpox vaccine Imvamune, thereby putting into effect the first order of 20 million doses from the US government. The news is widely reported in the Danish media, and Bavarian Nordic has posted a company announcement on its website.
The green light to start manufacturing followed acceptance by the FDA of actions that Bavarian Nordic took to address observations made during an inspection of its manufacturing facilities in 2009. In the statement from the company, CEO Anders Hedegaard commented:
“This conclusion from the FDA concerning our manufacturing process as well as the data submitted in support of Imvamune to date, marks a major milestone for Bavarian Nordic, as we now complete the transformation into a fully industrial biotech company. With a full order sheet for the coming years, we are well positioned for future growth and success.”
In addition to the 20 million dose order now placed, the US authorities have an option for a further 60 million doses of Imvamune, which national daily newspaper Berlingske Tidende reports would make the total order worth DKK 9bn (USD 1.65bn).
The newspaper also writes that the US authorities consider smallpox to be the most dangerous biological weapon and has thus established that there is a need for a protective vaccine. Consequently they have invested USD 650m in the development of Bavarian Nordic's Imvamune vaccine, which is considered to have a superior side-effect profile to conventional vaccines.