One new guideline relevant to mRNA vaccines produced with LNPs and two revised guidelines for vaccines to treat infectious diseases.

DNA vaccine vial concept

Following its adoption on 1 May, the European Directorate for the Quality of Medicines & HealthCare (EDQM) has published a single guideline for mRNA vaccines produced with lipid nanoparticles (LNPs), supporting regulatory consistency and efficiency.

The new guideline establishes a harmonised framework for the co-ordinated, independent control of these EU-bound vaccines. Appliable products include COVID-19 (mRNA) vaccines, COVID-19 and seasonal influenza combined (mRNA) vaccines and respiratory syncytial virus (mRNA) vaccines.

It defines the tests that the Official Medicines Control Laboratories (OMCLs) and Official Control Authority Batch Release (OCABR) Network will conduct. Additionally, it offers a template for the summary protocol for batch release to be provided by vaccine manufacturers/marketing authorisation holders.

Vaccine batches that comply with the approved quality requirements are certified via an OCABR certificate and recognised in the EU/EEA region and beyond. This approach enhances medicine access and optimises use of resources”

Vaccine batches that comply with the approved quality requirements are certified via an OCABR certificate and recognised in the EU/EEA region and beyond. This approach enhances medicine access and optimises use of resources.

The new guideline applies to the following European Pharmacopoeia (Ph. Eur.) general chapters:

  • 5.36 mRNA vaccines for human use
  • 5.39 mRNA substances for the production of mRNA vaccines for human use
  • 5.40 DNA templates for the preparation of mRNA substances.

Also adopted on 1 May were two revised guidelines covering pertussis (acellular component, adsorbed) vaccine and herpes zoster (rDNA) vaccine (formerly the Varicella (rDNA) vaccine guideline), following approval of the vaccine products. The revisions—now published—are intended to ensure the efficient independent batch release, according to the EDQM.

Moderna has made progress in the mRNA space in recent months. This includes gaining backing from the European Medicines Agency (EMA)’s human medicine’s committee for its mRNA COVID-19/flu combination vaccine.

Several months earlier, through a potential $150 million license agreement with Recordati, the firm committed to developing mRNA-3927, a potential disease modifying therapy for the rare metabolic disorder propionic acidemia.

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