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VAC2VAC, ‘Vaccine batch to vaccine batch comparison by consistency testing,’ successfully completed

The VAC2VAC project (1 March 2016 - 28 February 2022) was dedicated to developing quality control testing approaches for human and veterinary vaccines using non-animal methods. It was a large public-private collaborative research initiative funded by Innovative Medicines Initiative 2 (IMI2) and European and Federation of Pharmaceutical Industries and Associations (EFPIA).

The initiative provided data to support the “Consistency Approach” for quality control of established vaccines, where current quality control approaches are often relying on in vivo methods. This means that physicochemical, immuno-chemical, cell-based and/or multiparametric tests - instead of animal tests - can be used to ensure that each vaccine batch produced is consistent with a batch already proven to be safe and efficacious.


With a total duration of six years, the project has allowed the validation of two in vitro assays the monocyte activation test (MAT) and the Tetanus Neurotoxin (TeNT) LC-MS/MS assay.

The MAT, used for pyrogenicity testing of a vaccine against tick-borne encephalitis virus (TBEV) produced by GSK, has been introduced to industry, validated, authorised by the appropriate regulatory bodies, and used to replace the rabbit pyrogen test.

The TeNT LC-MS/MS is an antibody-free approach that can recognise and measure how much TeNT is present in the bacterial medium at various stages of synthesis of diphtheria, tetanus and acellular pertussis (DTaP) and monovalent veterinary tetanus vaccines.



The quantity and quality of vaccine antigens can also be determined through immunochemical methods, such as Luminex and Enzyme-Linked Immunosorbent assay (ELISA). Seven ELISA assays have been qualified during the project, and diphtheria, tetanus, and TBEV ELISAs are being further developed by industry partners for product-specific optimisation and validation. Moreover, another 11 in vitro tests have achieved proof of concept and have been given to business partners, to be applied to quality control of four veterinary vaccines and three human vaccines.


Importantly, monoclonal antibodies for the DTaP ELISA and Luminex assays developed in VAC2VAC will be made available to the public by VAC2VAC partner, National Institute for Biological Standards and Control (NIBSC, UK).


“The VAC2VAC project has demonstrated that concerted and collaborative efforts between industry, academia, regulators, and public researchers can deliver concrete progress towards replacing animals with in vitro assays. This is an important achievement and the conclusion of the VAC2VAC project should be seen as a beginning rather than an end towards reducing the use of experimental animals for routine testing of vaccines”. - Ole Olesen, EVI Executive Director

At the time of completion, the project has produced 21 peer-reviewed open access articles, and more publications are anticipated. Over 13 young scientists were able to advance their education and refine their skills through graduate degree and internships at consortium members.

For regulatory acceptance and wide-ranging outreach, general awareness of the methods developed, a coordinated outreach has been implemented to stakeholders and regulatory agencies, such as NC3Rs, WHO, EDQM, USDA, FDA, OIE, ICH/VICH* and national regulatory bodies from 22 countries. A key outcome from this effort was the widespread acceptance of a need for global harmonisation of in vitro batch control in a consistency approach.


Learn more and visit VAC2VAC website: https://europevaccine.wixsite.com/vac2vac-eu

Read more: https://www.imi.europa.eu/news-events/newsroom/safe-potent-and-consistent-vaccine-batches-no-routine-animal-testing-required


*

NC3Rs: National Centre for the Replacement, Refinement and Reduction of Animals in Research

WHO: World Health Organization

EDQM: European Directorate for the Quality of Medicines & HealthCare

USDA: United States Department of Agriculture

FDA: Food and Drug Administration

OIE: Organisation for Animal Health

ICH/VICH: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use/ International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products.