Guideline on quality aspects of mRNA vaccines for veterinary use

This concept paper addresses the need to establish a guideline on the quality aspects of mRNA vaccines. In the area of human medicinal products, the number applications for clinical trials and marketing authorisations for mRNA containing products significantly increased over the last few years and a lot of experience with mRNA vaccines was gained during the COVID-19 pandemic. It is expected that such developments will be seen in the field of vaccines for veterinary use, too. 

Keyword: mRNA, vaccine, development and manufacture, starting materials, active substance, quality, veterinary, finished product

Current effective version

Draft concept paper for the development of a guideline on quality aspects of mRNA vaccines for veterinary use

Draft: consultation closedConsultation dates: 08/01/2025 to 08/04/2025Reference Number: EMA/CVMP/IWP/189026/2024 Summary:

This concept paper addresses the need to establish a Guideline on the quality aspects of mRNA vaccines. In the area of human medicinal products, the number applications for clinical trials and marketing authorisations for mRNA containing products significantly increased over the last few years and a lot of experience with mRNA vaccines was gained during the COVID-19 pandemic. It is expected that such developments will be seen in the field of vaccines for veterinary use, too.

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