ACAM2000: a newly licensed cell culture-based live vaccinia smallpox vaccine

The studies with ACAM2000 indicate that it closely matches the safety of Dryvax in both non-clinical and clinical trials. ACAM2000 met two of the four primary surrogate efficacy end point criteria established for the Phase III clinical trials. Concern over the incidence of myopericarditis with ACAM2000 and Dryvax exists. So far the cardiac events seem to be self-limited. There are no pediatric safety data for ACAM2000. Overall, clinical trial results were sufficient to convince the FDA that ACAM2000 is a suitable replacement for Dryvax in the event of bioterrorism involving variola (smallpox).