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3Rs implementation in veterinary vaccine batch-release testing: Current state-of-the-art and future opportunities. A
Laura Viviani1, Elisabeth Balks2, Sonja Beken3
1SciethiQ, under contract with Humane Society International, Basel, Switzerland.
Summary
Veterinary vaccine safety testing is moving away from animal use. Stakeholders are collaborating to advance non-animal methods for regulatory acceptance and improve vaccine quality control.
Area of Science:
- Veterinary Medicine
- Toxicology
- Vaccinology
Background:
- Regulatory authorities mandate veterinary batch-release testing for vaccine potency and safety.
- Traditional testing methods heavily rely on laboratory animals, posing ethical and practical challenges.
- Advancements in vaccine research present opportunities to replace in vivo testing with alternative methods.
Purpose of the Study:
- To outline the state-of-the-art non-animal approaches for veterinary batch-release testing.
- To discuss the implementation of the 3Rs (Replacement, Reduction, Refinement) in quality control.
- To identify barriers and opportunities for advancing alternative methods in veterinary vaccine testing.
Main Methods:
- A three-part event series (two webinars, one workshop) was organized.
- The events focused on the state-of-the-art non-animal approaches for veterinary batch-release testing.
- Discussions included the deletion of obsolete safety testing and current stakeholder initiatives in Europe, North America, and Asia-Pacific.
Main Results:
- The events fostered a better understanding of barriers to implementing the 3Rs in veterinary vaccine testing.
- Participants identified the need for open communication, collaboration, and international regulatory harmonization.
- Commitments were shared by represented countries to advance the acceptance of alternative methods.
Conclusions:
- Accelerating the acceptance of non-animal testing methods requires concerted efforts in communication and harmonization.
- Stakeholder collaboration is crucial for overcoming challenges in implementing the 3Rs for veterinary vaccines.
- There is a global commitment to advancing alternative methods, despite existing implementation barriers.

