This guideline addresses the quality aspects of mRNA vaccines. It addresses specific aspects regarding the manufacturing process, characterisation, specifications and analytical control of mRNA vaccines, as well as the definition of starting materials, active substance and finished product for mRNA vaccines. Additional regulatory considerations are provided for changes in existing mRNA vaccine strains, bivalent and multivalent vaccines, self-amplifying mRNA vaccines, other delivery systems and use of platform technology/prior knowledge. The scope of this guideline is applicable to mRNA vaccines against infectious diseases. Other mRNA-based medicinal products are out of scope of this guideline, although relevant parts of this guideline may be applicable to those. It is not intended to address specific requirements for mRNA vaccines to be used in clinical trials, however the scientific principles described may also be applicable during pharmaceutical development…
