The five-year contract is valued at more than $500 million, with options that if exercised extend the value to $1.6 billion and the performance period of the contract.
The department of health and human services (HHS) is procuring the vaccine for the protection of individuals considered to be at risk for exposure to smallpox. The contract options allow for the government to procure up to an additional 60 million doses and would support additional clinical studies for extending the license to include HIV-infected, pediatric, and geriatric populations.
This contract is the first next-generation, or completely new, product procured by HHS under the government’s BioShield program, enacted after the terrorist attacks of 9/11 to guard against bioterrorism.
Peter Wulff, Bavarian Nordic’s president and CEO, says that while the only way to prevent smallpox infection is through vaccination, traditional smallpox vaccines used or stockpiled today are live replicating viruses that can pose serious side effects and lead to complications in up to 25% of the population.
Imvamune, on the other hand, is based on the Modified Vaccinia Ankara (MVA) virus, which is also a live virus but one that does not replicate in the body and is expected to be safe for both healthy as well as immuno-compromised individuals. Additionally, the MVA virus cannot be accidentally transferred to others who might be immuno-compromised, because it is administered by injection.
According to Wulff, “Our Imvamune clinical development program consists of 10 completed or ongoing trials, which have investigated the vaccine in persons who are immuno-compromised as well as healthy individuals. Results in more than 1,500 persons (atopic dermatitis, HIV-infection and healthy subjects) vaccinated with Imvamune show that the vaccine was safe and well-tolerated.”
Bavarian Nordic has invested $60 million of its own financial capital to put into operation a manufacturing facility in Denmark that has the capacity to produce a minimum of 40 million doses of Imvamune per year, with the capacity of being expanded to 180 million doses per year.