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 PDF icon Explanatory note on immunomodulators

EMA will not update this guideline as its clinical and non-clinical sections have been superseded by the:

Applicants can still use the quality section of this guideline, as it remains valid.

Keywords: Immunomodulators, adjuvants, vaccines


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