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) in the EU OCABR Network as part of the independent control of pandemic COVID-19 vaccine batches. They were adopted by the full OCABR Network and are in force from 12 November 2020.
The guidelines, which can be downloaded here, 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).
These 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 (e.g. recombinant protein-based vaccines).
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.
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. COVID-19 vaccines are eligible for EU OCABR according to Article 114 of EU Directive 2001/83/EC, as amended.
Presently, there are no COVID-19 vaccines with a marketing authorisation in the EU. The guidelines have been prepared based on current knowledge. Once the relevant marketing authorisations have been approved, they will be reviewed and updated accordingly, including the addition of a model protocol for the manufacturer’s data submission.
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.
- Press release: COVID-19 vaccines: release of guidelines critical for co-ordinated independent batch control by EU OMCLs
- The EDQM’s contributions to the protection of public health in the COVID-19 pandemic: latest information
- Batch Release for Human biologicals: vaccines, blood and plasma derivatives