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Smallpox Vaccine Approved for Wider Use in U.S.

Danish biotechnology firm Bavarian Nordic on Wednesday said its smallpox vaccine has been authorized for use across a broader section of the U.S. populace in the event of a crisis (see GSN, Feb. 4, 2011).

While the United States has enough standard smallpox vaccine on hand to safeguard all residents against a biological strike involving the virus, the product could cause serious side effects in people with immune system troubles, according to a Bavarian Nordic release. The company's vaccine, Imvamune, could be used to treat such victims of a smallpox strike.

However, prior rules allowed only some HIV-infected people to receive the vaccine. That has been broadened to encompass people who carry the AIDS virus or suffer from a skin condition called atopic dermatitis, no matter their age. In addition, "children, pregnant women and nursing mothers with HIV or AD are eligible to receive Imvamune, despite limited clinical data in these specific populations," Bavarian Nordic said.

The attenuated vaccine might be needed for 28 million people suffering from atopic dermatitis and 10 million with "compromised immune systems," along with millions more in those people's households, the release cites the U.S. Health and Human Services Department's Biomedical Advanced Research and Development Authority as saying in 2010.

The company intends by next year to deliver 20 million doses of the vaccine to the United States. In collaboration with the HHS agency, Bavarian Nordic is working on a version of the vaccine that could be freeze-dried and stocked for a longer period of time. It also could be more easily transported and held (Bavarian Nordic release, July 11).

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