Development of a guideline on the quality aspects of mRNA vaccines - Scientific guideline

This concept paper addresses the need to establish a guideline on the quality aspects of mRNA vaccines. The number of clinical trial applications for human products and marketing authorisation applications for mRNA containing products significantly increased over the last few years and is expected to increase further in the future. Furthermore, a lot of experience with mRNA vaccines was gained during the COVID-19 pandemic. From an analytical and regulatory perspective, mRNA vaccines are interesting since their classification depends on the target and/or whether they are obtained chemically or biologically.

mRNA vaccines against infectious disease have to align with the general guidance for human vaccines, however the new technology is not fully accounted for in the existing guidance. It is therefore proposed to establish a guideline addressing those specific aspects regarding the manufacturing process, characterisation, specifications and analytical control as well as the definition of active substance and finished product for mRNA vaccines for the prevention of infectious disease.

Keywords: mRNA, vaccine, development and manufacture, starting materials, active substance, finished product

Current version

Concept paper on the development of a guideline on the quality aspects of mRNA vaccines

Consultation dates: 23/06/2023 to 30/09/2023Draft: consultation closedReference Number: EMA/CHMP/BWP/211968/2023Summary:

This concept paper addresses the need to establish a guideline on the quality aspects of mRNA vaccines. The number of clinical trial applications for human products and marketing authorisation applications for mRNA containing products significantly increased over the last few years and is expected to increase further in the future. Furthermore, a lot of experience with mRNA vaccines was gained during the COVID-19 pandemic. From an analytical and regulatory perspective, mRNA vaccines are interesting since their classification depends on the target and/or whether they are obtained chemically or biologically.

mRNA vaccines against infectious disease have to align with the general guidance for human vaccines, however the new technology is not fully accounted for in the existing guidance. It is therefore proposed to establish a guideline addressing those specific aspects regarding the manufacturing process, characterisation, specifications and analytical control as well as the definition of active substance and finished product for mRNA vaccines for the prevention of infectious disease.

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