ACAM2000(TM): The New Smallpox Vaccine for United States Strategic National Stockpile

Abstract

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, Dryvax(Registered) (Wyeth Laboratories, Inc.), was highly effective, but the supply was insufficient to vaccinate the entire current US population. Additionally Dryvax(R) 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of a pool of vaccinia virus strains with varying degrees of virulence, and was grown on the skin of calves, an outdated technique that poses an unnecessary risk of contamination.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 ACAM2000(Trademarked) (Acambis, Inc.(TM)), a single plaque-purified vaccinia virus derivative of Dryvax(R), aseptically propagated in cell culture. Preclinical and clinical trials reported in 2008 demonstrated that ACAM2000(TM) has comparable immunogenicity to that of Dryvax(R) and causes a similar frequency of adverse events. Furthermore, like Dryvax(R), ACAM2000(TM) vaccination has been shown by careful cardiac screening to result in an unexpectedly high rate of myocarditis and pericarditis. ACAM2000(TM) received US Food and Drug Administration (FDA) approval in August 2007, and replaced Dryvax(R) for all smallpox vaccinations in February 2008. Currently, over 200 million doses of ACAM2000(TM) have been produced for the US Strategic National Stockpile. This review of ACAM2000(TM) addresses the production, characterization clinical trials, and adverse events associated with this new smallpox vaccine.

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Document Details

Document Type
Technical Report
Publication Date
Jan 01, 2010
Accession Number
ADA524108

Entities

People

  • Aysegul Nalca
  • Elizabeth E. Zumbrun

Organizations

  • United States Army Medical Research Institute of Infectious Diseases

Tags

DTIC Thesaurus Topics

  • Cardiomyopathies
  • Clinical Trials
  • Culture Techniques
  • Diseases And Disorders
  • Health Care
  • Health Services
  • Immunity
  • Immunogenicity
  • Infectious Diseases
  • Medical Personnel
  • Poxviridae Infections
  • Public Health
  • Side Effects
  • Therapy
  • United States
  • Vaccines
  • Viruses

Readers

  • Critical Infrastructure Protection in CBRN and WMD Threats.
  • Strategic Security Studies
  • Virology (or Medical Virology).

Technology Areas

  • Biotechnology