FDA approves smallpox vaccine from Acambis
FDA approves new smallpox vaccine from U.K.-based company — and a good thing, too, as current vaccine maker, New Jersey-based Wyeth, has stopped making its version of the vaccine
The Food and Drug Administration (FDA) on Saturday approved a smallpox vaccine by Cambridge, U.K.-based Acambis. The company has been making the vaccine, called ACAM2000, for a U.S. strategic stockpile since being awarded a contract in late 2001 amid concerns of a bioterrorism 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 Madison, New Jersey-based Wyeth. Members of the U.S. military are routinely vaccinated against smallpox. There are still stocks of the older Dryvax vaccine on hand, but Wyeth has stopped making it.
The Acambis vaccine will not be sold commercially in the United States. 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 United States was in 1949. The virus causes a severe skin rash and is fatal in about 30 percent 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, or surrounding tissues, which can be fatal in severe cases. In the studies, however, there were no fatalities. In total en 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.
