Smallpox
FDA clinical hold for ACAM2000 removed, BLA submission planned
Published in Vaccine Weekly, October 20th, 2004
In April 2004, Acambis announced that its two phase III trials of its investigational second-generation smallpox vaccine, ACAM2000, had been placed on clinical hold by the U.S. Food and Drug Administration (FDA) following the discovery of suspected cases of myocarditis in three subjects. Myocarditis is a condition involving inflammation of the heart muscle.
The two phase III clinical trials were designed to compare the safety, tolerability and efficacy of ACAM2000 with Dryvax, the currently licensed smallpox vaccine. The first phase...
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Source: Vaccine Weekly (2004-10-20)
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