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Control Testing


at a glance


Control Testing


01 March 2016 to 28 February 2022


European Vaccine Initiative


IMI2 Innovative Medicines Initiative, European Union and EFPIA


16 Mio Euro


Vaccine batch to vaccine batch comparison by consistency testing

VAC2VAC is a wide-ranging collaborative research project funded by IMI2 which aims to develop and validate quality testing approaches for both human and veterinary vaccines using non-animal methods. The initiative that started on 1 March 2016 aims to provide the data to support the "Consistency Approach" for quality control of established vaccines, where current quality control approaches are often relying on in vivo methods.

VAC2VAC is a public-private consortium, involving experts from veterinary and human vaccine industry in a partnership with official medicines control laboratories, academia, translational research organisations, and vaccinology alliances. To achieve their goal, the project partners will develop, optimise and evaluate physico-chemical and immunochemical methods, cell-based and other assays for routine batch quality, safety and efficacy testing of vaccines. This will be done in collaboration and consultation with regulatory agencies. The ultimate goal of the project is to develop tests and approaches that will allow acceptance of the "Consistency Approach" for established vaccines by the regulatory agencies and thereby significantly reducing in the future the use of animals for batch testing in routine vaccine production.



Bavarian Nordic (Denmark); Biomedical Primate Research Centre (BPRC) (Netherlands); Boehringer Ingelheim (BI) (Germany); College ter Beoordeling van Geneesmiddelen (CBG/ MEB) (Netehrlands); Joint Research Centre (JRC) - European Commission (Belgium); European Vaccine Initiative (EVI) (Germany); GSK Biologicals (GSKBio) (Belgium); Institute for Translational Vaccinology (Intravacc BV) (Netherlands); International Alliance for Biological Standardization for Europe (IABS-EU) (France); Istituto Superiore di Sanità (ISS) (Italy); Merck Sharp & Dohme (MSD) (Netherlands); Merial, National Institute for Biological Standards and Control (DH-NIBSC) (UK); National Institute for Public Health and the Environment (RIVM) (Netherlands); Austrian Agency for Health and Food Safety: AGES (Austria); Paul-Ehrlich Institute (PEI) (Germany); Pfizer (Austria); Sanofi Pasteur (France); Sciensano (Belgium); University Medical Center Groningen (UMCG) (Netherlands); University of Applied Sciences Utrecht (HU) (Netherlands); University of Utrecht (Netherlands); Zoetis Belgium SA. (Belgium).

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 115924. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA. This communication reflects the authors' view(s) and that neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained therein.

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