Market Watch
September First 2007
http://www.marketwatch.com/news/story/fda-approves-acambis-smallpox-vaccine/story.aspx?guid=%7B48BFCB85-FE9D-4887-A3AB-CE6B6FEDF1DE%7DFDA approves Acambis smallpox vaccine
By Jennifer Corbett
WASHINGTON (MarketWatch) --
The Food and Drug Administration said Saturday it approved a smallpox vaccine by Acambis PLC
U.K.-based Acambis, with U.S. offices in Cambridge, Mass., has been making the vaccine for a U.S. strategic stockpile since being awarded a contract in late 2001 amid concerns of a bio-terrorism attack using the smallpox virus. The vaccine is considered a second-generation vaccine and is made using cell-culture lines. It was derived from Dryvax, an older vaccine made by Wyeth (WYE:wyeth com
Future U.S. contracts, however, partly hinge on FDA approval of the vaccine, which is known as ACAM2000.
Members of the U.S. military are routinely vaccinated against smallpox. While there are still stocks of the older Dryvax vaccine on hand, Wyeth has stopped making it.
The Acambis vaccine won't be sold commercially in the U.S. Routine vaccination of U.S. children stopped in 1972 and naturally occurring cases of the disease was eliminated in the 1970s after a global vaccination campaign. The last case of smallpox seen in the U.S. was in 1949. The virus causes a severe skin rash and is fatal in about 30% of cases.
The FDA said there are serious safety concerns associated with smallpox vaccines. In clinical studies, about 1 in 175 healthy adults who received the vaccine for the first time developed inflammation and swelling of the heart, or myopericarditis, and/or surrounding tissues, which can be fatal in severe cases. In the studies, however, there were no fatalities. In total 10 adults had myopericarditis and four had no symptoms and at the end of the study, all but one had their symptoms resolve, the agency said.