Vaccine lot to vaccine lot comparison by consistency testing


Developing and validating alternative, non-animal testing approaches for both human and veterinary vaccines is the main goal of the VAC2VAC project. In routine vaccine production, the current quality control approach requires large numbers of laboratory animals. VAC2VAC aims to provide data to support the ‘consistency approach’ for quality control that promotes the use of in vitro, analytical, non-animal based systems. The project brings together scientists from both the human and veterinary pharmaceutical industry along with academia and regulators. Together they plan to develop and validate non-animal tests; generate vaccine specific toolkits of consistency tests; increase our scientific understanding of vaccine quality; and contribute to the regulatory acceptance and routine use of non-animal tests during vaccine quality control testing.

Achievements & News

Safe, potent and consistent vaccine batches – no routine animal testing required

Every single batch of human or animal vaccines that is manufactured must undergo a series of rigorous tests to ensure it meets certain standards for safety and potency. Today, many of these batch tests involve large numbers of laboratory animals. In addition to raising ethical questions, the testing process tends to be slow and expensive and the results are not always relevant and reproducible. In an interview with the IMI Programme Office, the VAC2VAC project explains how it is working to develop alternative batch tests that do not involve animals.###

One highlight concerns a test for pyrogens (contaminants that could cause a fever) in a vaccine against tick-borne encephalitis virus (TBEV). The traditional test uses rabbits, but VAC2VAC further developed the monocyte activation test (MAT), a cell-based assay. The method was validated in GSK, the manufacturer of the vaccine, and implemented following approval by the competent authorities.

‘This is the first method within VAC2VAC to reach regulatory acceptance and implementation and thus represents an important milestone in our effort to implement the consistency approach,’ the project explains.

The project is also busy developing tests to assess the quality and quantity of antigens in a number of vaccines - antigens are a key component of vaccines as they trigger the immune response.

The project has generated a lot of interest globally, as evidenced during conferences where scientists from a developed as well as low and middle-income countries highlighted the widespread commitment towards the replacement of in vivo (animal) testing.

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EFPIA companies
  • Boehringer Ingelheim Animal Health France, Lyon, France
  • Boehringer Ingelheim Vetmedica GMBH, Ingelheim am Rhein, Germany
  • Glaxosmithkline Biologicals SA, Rixensart, Belgium
  • Intervet International BV, Boxmeer, Netherlands
  • Pfizer Limited, Sandwich, Kent , United Kingdom
  • Sanofi Pasteur SA, Lyon, France
  • Zoetis Belgium SA, Louvain la Neuve, Belgium
Universities, research organisations, public bodies, non-profit groups
  • Academisch Ziekenhuis Groningen, Groningen, Netherlands
  • Agentschap College Ter Beoordeling Van Geneesmiddelen, Utrecht, Netherlands
  • Ages - Osterreichische Agentur Fur Gesundheit Und Ernahrungssicherheit GMBH, Vienna, Austria
  • Association Internationale De Standardisation Biologique Pour L'Europe(Iabs-Eu), Lyon, France
  • Bundesinstitut Fur Impfstoffe Und Biomedizinische Arzneimittel, Langen, Germany
  • Department of Health, Leeds, United Kingdom
  • European Commission - Directorate General Joint Research Centre - JRC, Brussels, Belgium
  • European Vaccine Initiative E.V, Heidelberg, Germany
  • Istituto Superiore Di Sanita, Roma, Italy
  • Rijksinstituut Voor Volksgezondheid En Milieu, Bilthoven, Netherlands
  • Sciensano, Brussels, Belgium
  • Stichting Biomedical Primate Research Center, Rijswijk, Netherlands
  • Stichting Hogeschool Utrecht, Utrecht, Netherlands
  • Universiteit Utrecht, Utrecht, Netherlands
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
  • Intravacc BV, Bilthoven, Netherlands
Non EFPIA companies
  • Bavarian Nordic As, Kvistgaard, Denmark

NameEU funding in €
Academisch Ziekenhuis Groningen400 500
Ages - Osterreichische Agentur Fur Gesundheit Und Ernahrungssicherheit GMBH512 487
Association Internationale De Standardisation Biologique Pour L'Europe(Iabs-Eu)493 187
Bundesinstitut Fur Impfstoffe Und Biomedizinische Arzneimittel1 000 000
Department of Health631 405
European Commission - Directorate General Joint Research Centre - JRC228 647
European Vaccine Initiative E.V1 060 437
Intravacc BV26 051
Istituto Superiore Di Sanita509 000
Ministerie Van Volksgezondheid, Welzijn En Sport (left the project)1 052 105
Rijksinstituut Voor Volksgezondheid En Milieu247 464
Sciensano505 625
Stichting Biomedical Primate Research Center305 090
Stichting Hogeschool Utrecht325 000
Universiteit Utrecht553 000
Total Cost7 849 998