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November 4, 2002

U.S. IMMUNIZATION NEWS

"FDA Grants License for Smallpox Vaccine"

Washington Post (www.washingtonpost.com) (11/02/02) P. A13; Connolly, Ceci

The Food and Drug Administration (FDA) has granted a license for the federal government's 30-year-old stockpile of the Dryvax smallpox vaccine.  According to Jerome M. Hauer, the Department of Health and Human Services' head of bioterrorism, most of the first 1.7 million doses, made by Wyeth, are to go to the Pentagon, while the other 13.7 million doses could be used to vaccinate emergency personnel or to respond to an attack using smallpox.  The granting of the license removes a number of informed consent and patient monitoring requirements, but President Bush has expressed concern about the vaccine's side effects and has not yet made a decision on who should receive it. The government also has 75 million doses of an Aventis Pasteur smallpox vaccine and has ordered 209 million more from Baxter International and Acambis, but it could take up to a year to get the latter two licensed.  FDA director of the Office of Vaccines Research and Review Karen Midthun explains that Dryvax was licensed when it was made, but Wyeth needed further approval for new needles and reconstituting fluid.

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