The European Pharmacopoeia has announced a major decision to phase out the use of rabbit pyrogen testing in its monographs, marking a pivotal step towards reducing the use of experimental animals in pharmaceutical testing.
July 2024
This initiative marks a progressive shift in pharmacopeial standards, paving the way for broader acceptance and implementation of in vitro methods in the industry and in the pursuit of more humane and sustainable scientific practices.
The EVI-led VAC2VAC project played a pivotal role in this achievement by providing the necessary evidence to support the replacement of the traditional rabbit pyrogen (contaminants that could cause a fever) test with a reliable in vitro alternative.
During the project, the monocyte activation test (MAT), a cell-based assay, was validated for ENCEPUR, a vaccine against tick-borne encephalitis virus (TBEV) by project partner Instituto Superiore di Sanità (Etna et al. Altex 2020). In 2019, GSK, the vaccine manufacturer, implemented the method following approval by the German competent authorities in May 2020. This marked a significant milestone in advancing the consistency approach for replacing animal testing with in vitro methods. The approval of MAT for ENCEPUR by the authorities demonstrated the essential role that effective collaboration between academic partners, industry and national regulatory agencies played in the success of VAC2VAC, a project conceived and funded by the 2nd programme of the Innovative Medicines Initiative (IMI2).
In 2015, at the start of VAC2VAC, almost 50,000 rabbits were used for pyrogen testing in 14 Member States of the European Union. The discontinuation of the rabbit pyrogen test underscores the importance and concrete results of collaborative research when validating and introducing new approaches in pharmaceutical research.
For more details, visit EUROPEAN Pharmacopeia Announcement.
More on VAC2VAC’s contributions.
The VAC2VAC project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement N- 115924. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA.
Photo credit: Photo by Travis Grossen on Unsplash
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