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U.S. Receives 1 Million Smallpox Vaccine Doses

The United States has received 1 million doses of a new smallpox vaccine for the Strategic National Stockpile, Danish manufacturer Bavarian Nordic announced yesterday (see GSN, July 2).

Imvamune was created under Project Bioshield, a federal program to boost U.S. defenses against biological weapons and other WMD agents by financing the development and acquisition of medical countermeasures (see GSN, July 13).

Bavarian Nordic is contracted through the Health and Human Services Department's Biomedical Advanced Research and Development Authority to manufacture 20 million Imvamune doses for the national stockpile. As many as 60 million additional doses could be ordered under the agreement.

"We are gratified that the U.S. government has added our vaccine to the Strategic National Stockpile," company president and chief executive officer Anders Hedegaard said in a released statement. "This represents a significant milestone for our company, our first major sale to the U.S."

Imvamune is dissimilar to traditional smallpox vaccines in that it does not produce copies of itself in human cells, which negates the possibility of unintended infection caused by the vaccine's strain of vaccinia virus, the company said.

Smallpox vaccines held in reserve today that do self-replicate are judged to be unsuitable for as many as one in four potential users who could have compromised immune systems or other ailments that would put them at risk for infection from the vaccinia virus. At this time, stockpiled Imvamune is designated for use during a crisis by individuals with weakened immune systems.

"Our partnership with [the National Institutes of Health], BARDA and HHS over the recent years is a case study in successful public-private partnerships to combat bioterrorism," Hedegaard said (Bavarian Nordic release, July 13).

NTI Analysis