Adjuvants in vaccines for human use - Scientific guideline

This document addresses the quality issues arising from the use of new or established adjuvants in vaccines. The applicability of this guideline to established adjuvants will vary on case-by-case basis. Adjuvants that are given separately and/or at a different time point from the vaccine antigens are not considered to be adjuvants and are called immunomodulators. Read together with the Explanatory note on immunomodulators for the guideline on adjuvants in vaccines for human use

EMA will not update this guideline as its clinical and non-clinical sections have been superseded by the: scientific guideline on the clinical evaluation of new vaccines; WHO guideline on non-clinical evaluation of vaccines. Applicants can still use the quality section of this guideline, as it remains valid.

Keywords: Immunomodulators, adjuvants, vaccines

Current effective version

Guideline on adjuvants in vaccines for human use (see also explanatory note)

AdoptedReference Number: EMEA/CHMP/VEG/134716/2004Legal effective date: 31/07/2005

Document history - First version (current)

Guideline on adjuvants in vaccines for human use (see also explanatory note)

AdoptedReference Number: EMEA/CHMP/VEG/134716/2004Legal effective date: 31/07/2005

Concept paper on the development of a committee for proprietary medicinal products (CPMP) note for guidance on requirements for the evaluation of new adjuvants in vaccines

Reference Number: CPMP/BWP/6622/02

Draft guideline on adjuvants in vaccines

Reference Number: EMEA/CPMP/VEG/17/03/2004v 5/ConsultationLegal effective date: 25/03/2004