New guidelines for independent batch control of COVID-19 vaccines by EU laboratories

Three new Official Control Authority Batch Release (OCABR) guidelines outlining the tests to be performed by the EU’s Official Medicines Control Laboratories (OMCLs) will be part of the independent control of COVID-19 vaccine batches, when they become available in the EU.

The guidelines, which have just been published by the EDQM (European Directorate for the Quality of Medicines & HealthCare), are for:

· Pandemic COVID-19 vaccine (Non-Replicating Chimpanzee Adenovirus-Vectored Vaccine);
· Pandemic COVID-19 vaccine (Non-Replicating Human Adenovirus-Vectored Vaccine);
· Pandemic COVID-19 vaccine (mRNA Vaccine).

As part of OCABR, OMCLs will perform the prescribed tests and make a careful review of the batch release protocol from the manufacturer. COVID-19 vaccines are eligible for EU OCABR according to Article 114 of EU Directive 2001/83/EC, as amended.

Additional guidelines are under development to address other vaccine types which are under development for the COVID-19 pandemic and are intended for the European market (e.g. recombinant protein-based vaccines).