Koen Brusselmans : Quality control of vaccines

24 septembre 2022 - Symposium conjoint avec l'Académie nationale de Pharmacie de France
Vaccins : de la conception à la pharmacovigilance
Quality control of vaccines : role of manufacturers, regulatory authorities and official control laboratories

Koen BRUSSELMANS (Sciensano QA vaccines, AFMPS, KULeuven)

Vaccination has a huge impact on the reduction of infectious diseases worldwide. As vaccines are intended to prevent disease, they are administered to the broad population including newborns, children and elderly. Therefore, it is of utmost importance that the quality of vaccines is strictly controlled during their development and production.

Each vaccine needs to be approved by the regulatory authorities before it can be marketed. A marketing authorisation file of a vaccine should contain all the details on the manufacturing process, vaccine characteristics, vaccine testing, vaccine stability, as well as information from toxicology studies in animals and data from safety and efficacy studies in humans. Only when found acceptable and sufficient by the regulatory authorities, a license is granted for a vaccine.

In addition, vaccine manufacturers are inspected by the authorities on a regular base, to verify if vaccine production occurs in accordance with the marketing authorisation file and in agreement with the ‘good manufacturing practices’ (GMP) legislation.

A vaccine batch is defined as the yield of a single production run in a fermentor that is further purified and filled in vials or syringes. The manufacturer has to test each new vaccine batch according to its specifications: a fixed set of test methods for the essential quality parameters with strict acceptance criteria which are included in the marketing authorisation file. In Europe, a unique additional level of quality control exists for vaccines: they also need to be tested by an independent official medicines control laboratory (OMCL) that is part of the EDQM network. An OMCL will repeat the most important specification tests on each vaccine batch. To release a vaccine batch to the market, the test results from both the manufacturer and the OMCL must comply with the acceptance criteria of the vaccine specifications.

Due to this unique control strategy at different levels, vaccines have the most stringent quality control of all medicinal products in Europe.