title: Developing new smallpox vaccines.
abstract: 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.
authors.affiliation: CBER/Food and Drug Administration, Rockville, MD 20852, USA. rosenthals@cber.fda.gov
authors.forename: S R
authors.initials: SR
authors.lastname: Rosenthal
authors.forename: M
authors.initials: M
authors.lastname: Merchlinsky
authors.forename: C
authors.initials: C
authors.lastname: Kleppinger
authors.forename: K L
authors.initials: KL
authors.lastname: Goldenthal
mesh_terms: D000818:Animals; D002460:Cell Line; D002986:Clinical Trials as Topic; D015195:Drug Design; D005544:Forecasting; D006801:Humans; D012899:Smallpox / Q000517:prevention & control*; D012900:Smallpox Vaccine / Q000009:adverse effects; D012901:Variola virus / Q000254:growth & development / Q000302:isolation & purification
chemical_list: D012900:Smallpox Vaccine