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Smallpox Vaccine Receives FDA Approval From Tuesday, September 4, 2007 issue.

Smallpox Vaccine Receives FDA Approval


The U.S. Food and Drug Administration announced Saturday that it had approved a new smallpox vaccine that could be produced quickly in the event of a bioterrorist attack involving the disease, the Associated Press reported (see GSN, Sept. 13, 2006).

“The licensure of ACAM2000 supplements our current supply of smallpox vaccine, meaning we are more prepared to protect the population should the virus ever be used as a weapon,” said Jesse Goodman, head of the agency’s Center for Biologics Evaluation and Research, in a press release.

The vaccine is produced by British drug maker Acambis Inc. and would be used to protect those considered at high risk for exposure to the disease.   Use of modern cell culture technology means that production could be ramped up quickly if necessary.

More than 192 million doses of the treatment, derived from the Dryvax vaccine that is no longer produced, have been stockpiled to date in the United States, AP reported.

Smallpox has been eradicated in nature.  However, the Centers for Disease Control and Prevention ranks it among the top public health threats (John Heilprin, Associated Press/Washington Post, Sept. 1).


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