Health
Smallpox trial halted
NEWS IN BRIEF — Posted May 3, 2004
Enrollment in a phase III trial of a smallpox vaccine was suspended in early April when its manufacturer found that three cases of heart inflammation had developed in some volunteers in an earlier trial.
The manufacturer, Acambis, had already sold about 200 million doses of vaccine to the United States for use against a possible terrorist attack. No decision has been made on what to do with those doses and Acambis said it was reviewing the situation along with the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention.
The three cases of myopericarditis developed among 1,132 volunteers who received Dryvax, the traditional vaccine used against smallpox, as well as an updated version, ACAM2000, which was developed by Acambis.
As a precaution, the company halted a second phase III trial of 1,752 volunteers although no cases of the heart inflammation were discovered.
Findings from a U.S. smallpox vaccination program for civilians and the military also found a causal association between myopericarditis and vaccination, Acambis noted in a release.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2004/05/03/hlbf0503.htm.
