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

Table of contents

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


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