Danish firm expects to sell smallpox vaccine to US

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Apr 18, 2007 (CIDRAP News) – Bavarian Nordic, a Danish company, announced this week that the US government plans to buy 20 million doses of the company's Imvamune smallpox vaccine, but a US official said no decision has been made yet.

Imvamune is Bavarian's version of modified vaccinia Ankara (MVA), which is considered safer than the conventional smallpox vaccine, particularly for people with weakened immune systems, pregnant women, and children.

"Following a competitive RFP process, Bavarian Nordic has received notification from the US Department of Health and Human Services that it intends to procure 20 million doses of the company's third-generation IMVAMUNE smallpox vaccine for the strategic national stockpile," the company said in an Apr 16 statement.

But Holly Babin, an HHS spokeswoman in Washington, DC, said no decision has been made on the vaccine. "We can't comment on it now," she told CIDRAP News, but added that an announcement is expected within the next few weeks.

Bavarian Nordic and the British drug company Acambis each received an HHS contract in early 2003 to develop and test a vaccine based on MVA. In September 2004 HHS awarded each company a further contract calling for production of 500,000 doses of the vaccine and clinical trials. But Acambis announced in November 2006 that HHS had notified it that the company's vaccine was too expensive.

Bavarian said the expected HHS contract would require the company to win US Food and Drug Administration approval for use of the vaccine in healthy people and those with limited immunity.

Peter Wulff, Bavarian's chief executive officer, said the company plans to begin phase 3 clinical trials early in 2008 and expects to win a US license for the vaccine in 2010, according to an Apr 16 Bloomberg News story.

"While the principal terms of the agreement [with HHS] have been reached, the contract is currently being finalized," the company statement said. "It is expected to be the first procurement contract under the BioShield program since enactment of the Pandemic and All-Hazards Preparedness Act in December 2006."

Bavarian said it has built a facility that can produce at least 40 million doses of Imvamune annually.

The BioShield program was established in 2004 to promote the development of medical treatments for the effects of chemical, biological, and other unconventional weapons. But major drug companies showed little interest in the program. In passing the All-Hazards Preparedness Act in December, Congress tried to revitalize the program by authorizing partial payments to companies working under BioShield contracts before final delivery of their products.

Existing smallpox vaccines are made with live vaccinia virus—a cousin of the smallpox virus—which in rare cases can cause serious or life-threatening side effects such as a severe rash or encephalitis. MVA is a strain of vaccinia that cannot replicate inside human cells and therefore cannot cause a severe or spreading infection, HHS has said.

An MVA-based vaccine was found to be safe when it was given to 120,000 Germans in the 1970s, according to HHS. But research on MVA ended when smallpox was declared eradicated in 1980.

Although smallpox was eradicated, disease experts fear that terrorists may have supplies of the virus, which the Soviet Union made in large quantities during the Cold War. Since 2001, HHS has stockpiled enough doses of the conventional smallpox vaccine to immunize the entire US population. The United States and Russia still hold samples of the smallpox virus for research purposes.

See also:

Oct 4, 2004, CIDRAP News story "Further contracts awarded for weakened smallpox vaccine"

Feb 25, 2003, CIDRAP News story "HHS awards contracts to develop safer smallpox vaccine"

Dec 15, 2006, CIDRAP News story "Congress passes public health preparedness bill"

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