06 / 2023
The rapid authorisation of the first carefully developed and tested COVID-19 vaccine products posed major challenges for official control laboratories in Europe. Through proactive preparation, work-sharing, and close cooperation between all parties involved, the first batches with a large number of COVID-19 vaccine doses were immediately released to the market post-authorisation after having completed batch testing independent of the manufacturer. Employees of the European Directorate for the Quality of Medicines & HealthCare (EDQM) and various national medicines authorities and control laboratories, including an expert from the Paul-Ehrlich-Institut, reported on the success of the operation.
The independent quality control of vaccines post-production is regulated in the European Union (EU) by guidelines on federal batch release, known as the OCABR guidelines (Official Control Authority Batch Release). The issuance of a certificate for each individual batch is subject to testing within the Official Medicines Control Laboratories (OMCL) network, followed by federal batch release. The OMCL network includes official control laboratories within the EU, the European Economic Area (EEA), and Switzerland. The Paul-Ehrlich-Institut is an OMCL within the network, i.e. it acts as an official control laboratory with the task of batch testing and batch release. Only in the case of a successfully tested batch does the manufacturer receive an EU OCABR certificate.
The EU OCABR system is coordinated by the European Directorate for the Quality of Medicines and HealthCare (EDQM).
Since the beginning of the SARS-CoV-2 pandemic, COVID-19 vaccine products around the world have been rapidly brought to the authorisation stage. The goal was to make a very large number of high-quality, safe, and effective vaccine doses available as quickly as possible to protect the population, without neglecting due diligence in vaccine development and authorisation.
In parallel to the development of vaccines, the existing European Official Control Authority Batch Release network was preparing for the batch testing of a large number of various COVID-19 vaccine product batches.
The most promising candidates for early authorisation were vaccine products based on platform technologies. These vaccines included mRNA vaccines and viral vector vaccines. Appropriate testing procedures had to be determined and described in the OCABR guidelines for these new vaccine types. Three new guidelines were published in November 2020.
OMCLs prepared for batch testing through measures such as purchasing new equipment and materials, establishing new methods, increasing staff capacity, and training staff. Preparation was made more difficult by the necessary compliance with pandemic protective measures: closed borders led to supply shortages and problems in logistics. The risk of SARS-CoV-2 infections spreading among personnel also made the implementation of preparatory measures more challenging.
Although it was not possible to predict which vaccine candidates would receive authorisation, preparations were made for a wide variety of vaccine candidates. In order to identify the correct official control laboratory as the OMCL responsible for each of the vaccines, the OCABR network informed the manufacturers of the different testing methods provided by the OMCLs in the network. It must be possible to batch test each vaccine product in at least two official control laboratories in case of a testing failure at one of the laboratories.
The quality tests were carried out under tremendous time constraints due to the high demand for COVID-19 vaccine doses. Valid results were requested and delivered within days, sometimes even within hours, instead of the usual 60-day period. At the same time, just as before the pandemic, the laboratories continued testing the quality of batches of other vaccine products and of medicines made from human blood and plasma – this work continued without interruption. The OMCLs worked seven days a week and were thus able to meet demands.
The EU-wide system for batch testing and quality assurance of vaccines proved itself to be successful even in such a difficult situation. The existing network of OMCLs coordinated by the EDQM, the process of EU certificate issuance and recognition, and the requirement to routinely test each batch in just one OMCL proved robust in the crisis. A large number of vaccine batches could thus be tested in a very short time and still meet the strict criteria. All vaccine batches released to the market met the required quality standards.
The World Health Organization (WHO) also established a network of national control laboratories (WHO-National Control Laboratory Network for Biologicals, NNB). The WHO's aim was to promote confidence in batches released by national control laboratories and authorities through communication and the exchange of information between members. The WHO-NNB aims to facilitate access to vaccines on the global market, avoiding duplication of quality checks. Most European OMCLs that carry out vaccine batch tests according to the OCABR guidelines are also full members of the WHO-NNB.
More than half of the batches tested by European OMCLs were placed on the market outside the EU/EEA and were used in 160 non-EU countries. The high levels of transparency and communication within the OCABR system and the support of the WHO led many non-EU countries to also trust the EU certificate, preventing redundant batch checks from being carried out.
These successes were made possible through close cooperation between medicines authorities, OMCLs and manufacturers. The Coalition for Epidemic Preparedness Innovations (CEPI/COVAX) provided its support to this cooperation.
The detailed report was published by npj Vaccines:
Updated: 07.06.2023
