Plasmid DNA vaccines for veterinary use – Scientific guideline

This document addresses the quality, safety and efficacy aspects of nucleic acid vaccines for use in animals. It is applicable to vaccines consisting of plasmid DNA, non-amplifiable in eukaryotic cells.

Keywords: plasmid DNA vaccines, vaccines for veterinary use

Current effective version - effective from 17/07/2024

Guideline on plasmid DNA vaccines for veterinary use

Adopted Reference Number: EMA/CVMP/IWP/365817/2022 Legal effective date: 17/07/2024

Revision 1

Guideline on plasmid DNA vaccines for veterinary use

Adopted Reference Number: EMA/CVMP/IWP/365817/2022 Legal effective date: 17/07/2024

Overview of comments received on Draft guideline on plasmid DNA vaccines for veterinary use

Reference Number: EMA/CVMP/IWP/303516/2023

Draft guideline on plasmid DNA vaccines for veterinary use

Draft: consultation closed Consultation dates: 24/02/2023 to 23/06/2023 Reference Number: EMA/CVMP/IWP/365817/2022

First version

Concept paper on DNA vaccines non-amplifiable in eukaryotic cells for veterinary use

Draft: consultation closed Consultation dates: 29/04/2016 to 31/07/2016 Reference Number: EMA/CVMP/IWP/867401/2015 Summary:

The ‘Note for guidance on DNA vaccines non-amplifiable in eukaryotic cells for veterinary use’ was adopted in March 2000 and came into effect on 1st January 2001.

Note for guidance: DNA vaccines non-amplifiable in eukaryotic cells for veterinary use

Adopted Reference Number: CVMP/IWP/07/98-FINAL Legal effective date: 01/01/2001