Independent control contributes to ensuring vaccine quality

Since 1994, the EU Official Control Authority Batch Release (OCABR) network has played a key role in ensuring vaccine quality. This network of state laboratories, Official Medicines Control Laboratories (OMCLs), is part of the General European OMCL network, which is supported by the EU Commission and the Council of Europe (CoE) and co-ordinated by the European Directorate for the Quality of Medicines and HealthCare of the CoE.

OCABR, which is also applied to human blood-derived medicinal products, is an integrated part of the medicines regulatory system in the European Economic Area (EEA) as foreseen by the codified EU Directive for Human Medicines, 2001/83/EC, as amended. The Directive includes provisions for marketing authorisation, obligations to comply with good manufacturing practice and oversight through inspection, pharmacovigilance and market surveillance by the authorities.

Specifications for the quality of medicines, including vaccines, are defined in their marketing authorisation dossiers, which are assessed by experts at the European Medicines Agency or national competent authorities as part of the licensing procedure. They should comply with the monographs of the European Pharmacopoeia, which sets the legally binding quality standards for medicines in its member states, including the EEA.

OCABR (article 114 of the Directive) allows a member state to verify through testing at an OMCL that the quality of each licensed batch of vaccine conforms to the approved specifications, independently from the release tests performed by the manufacturer and before the batch reaches the patient.

OCABR is therefore an additional guarantee of the quality of these important products. It includes a review of the manufacturer’s batch documentation and testing of a pre-defined set of critical quality parameters that have been agreed by the network experts.

To avoid impacting the timing for availability on the market the procedure is generally done in parallel to the manufacturer’s own production and release procedures.

Article 114 specifies that OCABR results from one member state must be recognised in all the others, thus avoiding the duplication of work, conserving vaccine samples for use in patients and reducing the burden on manufacturers.

Compliant batches, which have been evaluated by an OMCL according to codified procedures and under an externally audited quality system, receive an EU OCABR certificate which is then recognised throughout the EEA to allow release to market.

These certificates are also recognised outside the EEA as a sign of quality. If a batch is not compliant, all member states are informed to ensure that the batch is not placed on the market.

Since OCABR is carried out in real time on every batch, the OMCLs can monitor trends in results and take preventive action if needed. Thanks to this surveillance, OMCLs regularly identify issues which, with the input of the regulatory authorities and manufacturers involved, can be corrected so only the batches with conformant quality reach the patient.

One strength of the OCABR network is communication.

The information gained during the OCABR process is available to the responsible authorities in all member states and can be used to help ensure the continued high quality of these medicines. Maintenance of experimental testing at OMCLs secures expertise independent from the manufacturers.

Since OMCLs have hands-on experience with vaccines from different manufacturers, they have a unique insight and contribute to the establishment of common methods and standards which helps both authorities and manufacturers to provide the best quality products. OCABR also allows the authorities to have an overview of the products that will be available, or not, on the market and thus potentially help them to anticipate possible shortages.

In 2018, through efficient work sharing, OMCLs from 12 different member states tested over 4000 final lots of vaccines to the benefit of patients in all member states. OMCLs are constantly evolving to face new challenges, such as vaccines with an ever-higher number of components and complex and sophisticated new testing methods, as well as the logistical challenges linked to manufacturers’ increasingly global production strategies.

According to the World Health Organization an estimated 2-3 million lives are saved ever year thanks to vaccines. Despite the accumulated evidence of the benefit of vaccines, vaccination coverage in the EEA is sub-optimal. In April 2018 the European Commission communicated (COM(2018) 245/2) a strategy to address this issue, highlighting vaccine hesitancy as one of a complex set of contributing factors, amongst other issues including vaccine supply management.

The Council recommendation of 7 December 2018 on strengthened cooperation against vaccine-preventable diseases (2018/C 466/01) sets out a number of important recommendations. Support for the EU OMCL Network to ensure that vaccines placed on the market are of high quality is among them.

The quality of vaccines is important both for the individual patient and for public confidence to foster adherence to vaccination programs. OCABR is an independent control system that helps to ensure that no matter where a patient is in the EEA, they benefit from the same high standards.

OCABR certificates facilitate the movement of vaccines within Europe, which is beneficial for vaccine supply management.

The contribution that OMCLs and the OCABR system make to ensuring good quality vaccines merits support. Like vaccination, OCABR is a preventive measure that is good for public health.