VAC2VAC is pleased to announce that one year after its start it has already created enough interest to have the Medicines Evaluation Board (MEB), a regulatory agency and an independent administrative body residing under the Government of the Netherlands, joining its membership.
For VAC2VAC, that aims to establish ‘Vaccine batch to vaccine batch comparison by consistency testing’, i.e. replacing animal test with non-animal assays, having regulatory agencies as partners is an important contribution towards its goal. Dr Odile Leroy, Executive director of European Vaccine Initiative and coordinator of the VAC2VAC project highlights “One of the success criteria of this endeavour is to have new robust, sensitive, and reproducible assays to convince the regulators to accept the replacement of the existing animal-based quality control assays. To have regulators participating in the different steps of the development of those assays is therefore critical.” Marcel Hoefnagel, Senior Assessor Biopharmaceuticals at MEB:
“It is great for a regulator to contribute to the development and acceptance of innovative methods to replace animal tests, especially in a project that aims at replacing specific release tests that are recurrently performed. This may really impact the number of animals used, which is one of the ambitions of the MEB. Replacement can only be successful if it is accepted by all regulators around the globe. Another challenge that I can contribute to.”
MEB will contribute to establishing those non-animal assays, more specifically by working on cell-based assays for assessment of novel biomarkers. Furthermore, the MEB will contribute by proposing rational arguments for regulatory acceptance based on analysis and comparison of information obtained from the animal testing and the information from the proposed alternative test/s.
The overall objective of the “Vaccine batch to vaccine batch comparison by consistency testing” project (acronym: VAC2VAC) is to demonstrate proof of concept of the consistency approach for batch release testing of established vaccines. This means that non-animal assays - instead of animal tests - shall be used to ensure that each vaccine batch produced is consistent with a batch already proven to be safe and efficacious in registration studies or clinical use. Hence the name “consistency approach”. Due to the nature of the non-animal assays, the consistency approach will speed up the batch release process and help ensure that vaccine batches are available for vaccination.
The project’s first objective is to develop, optimise and evaluate non-animal assays to demonstrate that the critical quality attributes of each vaccine batch remain consistent. Assays will be developed that can be used to test several types of human and/or veterinary vaccines currently on the market as well as for different adjuvants that are included in some vaccine formulations to enhance the immune response.
The project’s second objective is to work with regulatory authorities to develop guidance for regulatory approval and implementation of the newly developed assays. You can find more information about last year’s progress here.
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