The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on a series of three new general texts on mRNA vaccines, published in this quarter’s issue of Pharmeuropa 36.2 for comment.

The mRNA vaccine field has developed rapidly in the past few years and continues to evolve into an increasingly important technology tailored to fight different infectious diseases. The development and authorisation of COVID-19 mRNA vaccines provided an important impetus and is paving the way for the emergence of novel vaccines coding for a range of specific antigen(s). This has underscored the need for common quality standards for mRNA vaccines across Europe and beyond.

To help reach this goal, the Ph. Eur. has developed a series of three new general texts addressing key aspects related to the production and control of mRNA vaccines and their components, with the aim of supporting developers, manufacturers, regulatory agencies and national control laboratories worldwide:

• mRNA vaccines for human use (5.36), covering mRNA packaged in lipid nanoparticles, i.e. mRNA-LNP medicinal products;
• mRNA substances for the production of mRNA vaccines for human use (5.39), covering mRNA active substances used in the manufacture of mRNA vaccines;
• DNA template for the preparation of mRNA substances (5.40), covering the linear DNA template used as the starting material for the preparation of mRNA substances.

These new general texts are the result of the collaborative work and engagement of the Ph. Eur.’s mRNAVAC Working Party – a group consisting of a large number of specialists representing industry, academia, licensing authorities and national control laboratories from around the world.

The Ph. Eur. would like to encourage all stakeholders to provide their comments on the three draft texts via the appropriate channel. The commenting period runs until 30 June 2024.

More information on how to comment can be found here: “Comment on drafts (Pharmeuropa)”