Safe, potent and consistent vaccine batches – no routine animal testing required
July 2021

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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