Pharmaceutical Business review

Bavarian Nordic’s smallpox vaccine top for safety

New data has shown that Imvamune is expected to be effective in protecting against smallpox infection three days after just one vaccination compared to traditional vaccines, such as Wyeth’s DryVax, that show protection only after more than ten to 14 days after vaccination and have a known risk of severe complications.

“The ability for a smallpox vaccine to generate a fast immune response is critical in an emergency situation, where protection against smallpox is a top priority,” said Peter Wulff, president and CEO of Bavarian Nordic. “Imvamune has shown to be a safer smallpox vaccine than those currently available, and with this new data, now offers protection against smallpox significantly earlier than traditional vaccines that are stockpiled or under development.”

Imvamune has been shown to be safe in healthy volunteers and in HIV-infected patients in clinical trials to date and in a major step forward in 2004, the company began the first-ever trial investigating Imvamune in patients with atopic disorders (such as eczema).

Individuals with atopic disorders, those pregnant, the very young, and the elderly comprise more than 25% of the population who are at risk of severe side effects after vaccination with traditional smallpox vaccines.

In 2004, Bavarian Nordic was also awarded the largest single contract, worth more than $141 million, from the US government to develop and purchase a safe smallpox vaccine.

Bavarian Nordic’s manufacturing capacity for Imvamune is backed up by a global partnership with GlaxoSmithKline to produce and market the product. The two companies will also closely collaborate and act as commercial partners on future US government programs, including a forthcoming program expected to outline requirements for the purchase of up to 60 million doses of safe smallpox vaccine.