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New Smallpox Vaccine Secures FDA Approval

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By JOHN HEILPRIN, The Associated Press

Published: September 2, 2007

WASHINGTON - The approval of a new vaccine against smallpox was announced Saturday by the Food and Drug Administration, which says the shots could be made quickly if the virtually extinct virus reappears.

The vaccine, ACAM2000, is intended to inoculate people at high risk of exposure to smallpox, a highly contagious disease. The FDA said the vaccine also could be used during a bioterrorism attack.

'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 L. Goodman, director of the FDA's Center for Biologics Evaluation and Research.

Goodman said the vaccine is made using modern cell culture technology that would allow for speedy manufacturing if large quantities were needed quickly.

ACAM2000 is made by Acambis of Cambridge, England and Cambridge, Mass. The federal Centers for Disease Control and Prevention has stockpiled 192.5 million doses of the vaccine.

The U.S. ended routine vaccination against smallpox in 1971, and world health authorities declared the disease eradicated from the wild in 1980. The last known case was reported in Somalia in 1977.

After the Sept. 11 attacks, concern arose that smallpox and other infections could be engineered as weapons. That led to the stockpiling of vaccines in case they are needed, and to vaccinate some military personnel and health care workers.

Two approved U.S. and Russian labs keep known stockpiles of smallpox, which the CDC considers among the greatest potential threats to public health.

'Smallpox could be a particularly dangerous biological threat to us that would kill or debilitate a high percentage of the population,' said W. Craig Vanderwagen, a rear admiral and assistant secretary for preparedness and response at the Department of Health and Human Services.

Smallpox is caused by the variola virus, which spreads through close contact with infected people or contaminated objects. It has no FDA-approved treatment.

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