Messenger RNA (mRNA) vaccines have been at the forefront of vaccine development efforts during the COVID-19 pandemic. With two authorised mRNA-based vaccines on the market, the mRNA vaccine field continues to evolve, as this increasingly important technology can be tailored to fight different infectious diseases. More products currently in development are expected to reach the market in a relatively short time and multivalent vaccines may also soon follow.
To support this emerging field, the European Pharmacopoeia Commission (EPC) agreed, at its 175th session in March 2023, to elaborate three new general texts addressing aspects related to the production and control of mRNA vaccines and their components, namely:
- mRNA Vaccines for human use (5.36), the mRNA packaged in lipid nanoparticles, i.e. mRNA-LNP medicinal product;
- mRNA Substances for the production of mRNA vaccines for human use (5.39), the mRNA active substances in the manufacture of mRNA vaccines;
- DNA Template for the preparation of mRNA transcript (5.40), the starting material for the preparation of the mRNA component.
Assigned to the newly established mRNAVAC Working Party – a group consisting of specialists representing industry, academia, licensing authorities and national control laboratories from around the world – the elaboration of these texts will take into account the experience gained with mRNA vaccines during the pandemic and also build upon stakeholders’ ideas and proposals put forward during the EDQM symposium held in 2022, entitled “Quality requirements for nanomedicines”. Addressing the quality of mRNA vaccines and their components has been identified as a significant ongoing project for the EPC in the field of nanomedicines, and preparing for a more comprehensive incorporation of these medicines in the European Pharmacopoeia (Ph. Eur.) is among its priorities for 2023-2025.