Development of vaccinia virus-based vaccines against smallpox

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Current effective version

Adopted guideline

Reference numberCPMP/1100/02
Published24/06/2002
Effective from01/07/2002
KeywordsSmallpox, second generation, vaccinia virus, first generation, smallpox vaccines, bioterrorism, tissue culture, eggs
DescriptionThis document addresses the manufacture and preclinical/clinical development of smallpox vaccines. It applies to vaccines produced by means of growing vaccinia virus in tissue culture or in emryonated hens' eggs. It provides guidance on the data to be submitted in an application for marketing authorisation.


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