Emerging Infectious Diseases (Dec 2001)

Developing New Smallpox Vaccines

  • Steven R. Rosenthal,
  • Michael Merchlinsky,
  • Cynthia Kleppinger,
  • Karen L. Goldenthal

DOI
https://doi.org/10.3201/eid0706.010602
Journal volume & issue
Vol. 7, no. 6
pp. 920 – 926

Abstract

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New stockpiles of smallpox vaccine are required as a contingency for protecting civilian and military personnel against deliberate dissemination of smallpox virus by terrorists or unfriendly governments. The smallpox vaccine in the current stockpile consists of a live animal poxvirus (Vaccinia virus [VACV]) that was grown on the skin of calves. Because of potential issues with controlling this earlier manufacturing process, which included scraping VACV lesions from calfskin, new vaccines are being developed and manufactured by using viral propagation on well-characterized cell substrates. We describe, from a regulatory perspective, the various strains of VACV, the adverse events associated with calf lymph-propagated smallpox vaccine, the issues regarding selection and use of cell substrates for vaccine production, and the issues involved in demonstrating evidence of safety and efficacy.

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