AP News, May 18th, 2007
Government advisers backed a second-generation smallpox vaccine on Thursday as safe enough to be used if the virtually extinct virus ever reappears.
The vaccine maker, Acambis Plc, already has provided 192.5 million doses of the experimental vaccine to a U.S. stockpile. But future production may depend in part on whether the Food and Drug Administration formally approves the shots. The company failed to win a further government contract last fall.
An FDA advisory committee voted unanimously on Thursday that Acambis' vaccine works and is safe enough to use in special situations where people are deemed at high risk of smallpox exposure.
The FDA is not bound by its advisers' recommendations, but usually follows them.
The U.S. ended routine vaccination against smallpox in 1971 and world health authorities declared the disease official eradicated from the wild in 1980. But after the attacks of Sept. 11, 2001, concern arose that smallpox and other infections could be engineered as weapons. That led to the stockpiling of certain vaccines in case they ever are needed _ and to vaccinate some military personnel and health care workers.
The nation's old smallpox vaccine, called Dryvax, is no longer made, although there are leftover supplies.
Like Dryvax, the Acambis vaccine is made using a relative of the smallpox virus called vaccinia. FDA scientists who reviewed studies of the new version concluded that both pose similar risks of serious side effects. These include itch, rash and pain, and rare cases of inflammation of the heart and its surrounding sac.
Still, the FDA review concluded those risks would be acceptable for people deemed at high risk of exposure to smallpox.
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On the Net:
Acambis Plc: http://www.acambis.com/
Food and Drug Administration: http://www.fda.gov/
