Development of vaccinia virus-based vaccines against smallpox - Scientific guideline

This 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.

Keywords: Smallpox, second generation, vaccinia virus, first generation, smallpox vaccines, bioterrorism, tissue culture, eggs

Current effective version

Note for guidance on the development of vaccinia virus based vaccines against smallpox

AdoptedReference Number: CPMP/1100/02Legal effective date: 01/07/2002