COVID-19 vaccines: release of guidelines critical for co-ordinated independent batch control by EU OMCLs

The European Pharmacopoeia Commission - 12/22/2020 4:30:00 PM

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.

MORE about The European Pharmacopoeia Commission

The European Pharmacopoeia (Ph. Eur.) Commission is the decision-making body of the European Pharmacopoeia and is responsible for the elaboration and maintenance of its content. The Ph. Eur. Commission adopts all the texts to be published in the Ph. Eur. and takes technical decisions by consensus.

The Ph. Eur. Commission

evaluates proposals for inclusion, revision or suppression of monographs and general chapters,
allocates agreed work items to a Group of Experts or Working Party,
reviews overall progress made on the work programme, including revision work, on a yearly basis,
approves the terms of reference of Groups of Experts and Working Parties, defines criteria to be applied for the selection of experts and ad hoc specialists and appoints them.

Composition of the Ph. Eur. Commission

The Commission is composed of the delegations representing the contracting parties to the Convention on the Elaboration of a European Pharmacopoeia, currently 39 member states and the European Union (EU).

The up to three members of delegations are appointed by the Contracting Party based on their experience and competence in matters dealt with by the Commission. Each Contracting party can also appoint up to three similarly-qualified alternates.

Observership/Observer status

Observers can take part in the scientific work of the European Pharmacopoeia Commission and benefit from European experience in this area.

According to its Rules of procedure, the European Pharmacopoeia Commission may, by a unanimous vote of the delegations casting a vote admit technically qualified observers, such as:

observers from Member States of the Council of Europe that are not parties to the Convention;
observers from States that are not Members of the Council of Europe;
observers from international governmental organisations;
observers from international non-governmental organisations.

Sessions of the Commission

The Commission meets three times a year (usually in March, June and November) at the EDQM premises in Strasbourg. Sessions are held in private.

Ph. Eur. Commission sessions are attended by the delegations of the contracting parties. Observers to the Ph. Eur. Commission (see above) are also always welcome.