The European Directorate for the Quality of Medicines & HealthCare (EDQM) has introduced one new guideline and updated two existing guidelines to improve the safety and consistency of vaccines used in Europe. As of May 1st, these changes were officially adopted and published.
The new guideline focuses on mRNA vaccines that use lipid nanoparticles (LNPs) to deliver their instructions. This includes vaccines for COVID-19, COVID-19 combined with seasonal influenza, and respiratory syncytial virus (RSV). The guideline sets clear standards for testing these vaccines to ensure they meet strict quality requirements. It also provides a model document that vaccine manufacturers must complete for each batch they produce.
Once a vaccine batch passes these tests, it receives a special certificate called an OCABR certificate. This certificate is recognized across the European Union (EU) and European Economic Area (EEA), making it easier for people to access these vaccines. This approach also helps use resources more efficiently.
This new guideline applies to three specific sections of the European Pharmacopoeia (Ph. Eur.), which are technical standards for medicines:
1. Section 5.36: mRNA vaccines for human use
2. Section 5.39: mRNA substances used to produce mRNA vaccines for human use
3. Section 5.40: DNA templates used to prepare mRNA substances
In addition to the new guideline, two existing guidelines have been updated: one for the pertussis (whooping cough) vaccine and another for the herpes zoster (shingles) vaccine. These updates ensure that the batch release process remains independent and efficient, maintaining high safety standards.
Moderna, a company working on mRNA technology, has recently made progress in this area. The European Medicines Agency (EMA) has supported Moderna’s combined COVID-19 and flu mRNA vaccine. Earlier this year, Moderna also agreed to a $150 million partnership with Recordati to develop a potential treatment for a rare metabolic disorder called propionic acidemia. This treatment, called mRNA-3927, aims to modify the disease and improve patients’ lives.