ACAM2000(TM): The New Smallpox Vaccine for United States Strategic National Stockpile
ARMY MEDICAL RESEARCH INST OF INFECTIOUS DISEASES FORT DETRICK MD
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Smallpox was eradicated more than 30 years ago, but heightened concerns over bioterrorism have brought smallpox and smallpox vaccination back to the forefront. The previously licensed smallpox vaccine in the United States, DryvaxRegistered Wyeth Laboratories, Inc., was highly effective, but the supply was insufficient to vaccinate the entire current US population. Additionally DryvaxR had a questionable safety profile since it consisted of a pool of vaccinia virus strains with varying degrees of virulence, and was grown on the skin of calves, an outdated technique that poses an unnecessary risk of contamination. The US government has therefore recently supported development of an improved live vaccinia virus smallpox vaccine. This initiative has resulted in the development of ACAM2000Trademarked Acambis, Inc.TM, a single plaque-purified vaccinia virus derivative of DryvaxR, aseptically propagated in cell culture. Preclinical and clinical trials reported in 2008 demonstrated that ACAM2000TM has comparable immunogenicity to that of DryvaxR and causes a similar frequency of adverse events. Furthermore, like DryvaxR, ACAM2000TM vaccination has been shown by careful cardiac screening to result in an unexpectedly high rate of myocarditis and pericarditis. ACAM2000TM received US Food and Drug Administration FDA approval in August 2007, and replaced DryvaxR for all smallpox vaccinations in February 2008. Currently, over 200 million doses of ACAM2000TM have been produced for the US Strategic National Stockpile. This review of ACAM2000TM addresses the production, characterization clinical trials, and adverse events associated with this new smallpox vaccine.
- Safety Engineering