EDQM releases new guidelines for COVID-19 vaccine quality testing

The European Directorate for the Quality of Medicines & Healthcare (EDQM) has published three new Official Control Authority Batch Release (OCABR) guidelines outlining the tests to be performed by Official Medicines Control Laboratories (OMCLs) as part of the independent control of pandemic COVID-19 vaccine batches. They were adopted by the full OCABR Network and have been in force from 12 November 2020.

The guidelines will apply to the following COVID-19 vaccines: 

• Non-replicating chimpanzee adenovirus-vectored vaccines
• Non-replicating human adenovirus-vectored vaccines
• mRNA vaccines.

The guidelines are expected to address the vaccines currently predicted to arrive first on the European market. 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 (eg, recombinant protein-based vaccines).

The EDQM says that the availability of these guidelines at an early stage will help anticipate the launch of the first vaccines and allow OMCLs and manufacturers to take the necessary steps to prepare for OCABR, thus preventing delays in availability while still ensuring their quality and safety.

As part of OCABR, OMCLs will perform the prescribed tests and make a careful review of the batch release protocol from the manufacturer. The protocol will include data on all the quality control tests for batch release performed by the manufacturer, as approved in the marketing authorisation. Only batches that are compliant with the approved quality standards will be released.

Once the relevant marketing authorisations for COVID-19 vaccines have been approved, they will be reviewed and updated accordingly, including the addition of a model protocol for the manufacturer’s data submission.

“Independent control of each batch of COVID-19 vaccine, before it reaches the patient, is an important part of the EU regulatory network strategy to ensure the availability of vaccines that meet the appropriate quality requirements and to protect public health,” the EDQM said in a statement. 

The EDQM highlights that COVID-19 vaccines are eligible for EU OCABR according to Article 114 of EU Directive 2001/83/EC, as amended.