Discussions from the Animal Testing Replacement for Vaccines: A One Health View – Global Outlook and Future Strategy conference have been summarised in a recent report, highlighting progress towards non-animal vaccine testing alongside the regulatory and operational challenges that remain.
A conference report, published in Biologicals, has assessed recent progress towards replacing animal-based methods in vaccine quality control, while highlighting the scientific, regulatory and practical considerations that will shape the adoption of alternative approaches.
The report summarises discussions from the Animal Testing Replacement for Vaccines: A One Health View – Global Outlook and Future Strategy conference, held in Bangkok, Thailand, in December 2025. The event brought together stakeholders from regulatory authorities, industry and public health institutions to discuss developments in non-animal vaccine testing and strategies for their future implementation.
The conference builds on an International Alliance for Biological Standardization (IABS) meeting held in 2019, which identified scientific, regulatory and implementation barriers to replacing animal-based methods in vaccine quality control. The latest meeting considered how the field has evolved since then and the priorities for further progress.
Discussions from the meeting emphasised new WHO guidelines, pharmacopoeial revisions and international collaborative validation initiatives as key frameworks to support the transition. Alongside these developments, advances in in vitro and analytical methods were highlighted as expanding the potential for non-animal approaches to vaccine potency, safety and pyrogenicity testing.
However, the report identified a gap between scientific readiness and regulatory and operational readiness. This gap is particularly apparent in jurisdictions where legacy products and established regulatory requirements continue to rely on animal-based assays, highlighting the need for a phased transition without compromising supply continuity or regulatory confidence.
Key takeaways from the meeting included the need for more flexible, science-driven regulatory frameworks, alongside coordinated international validation, greater data sharing and broader use of reliance and work-sharing models. The discussions also highlighted the importance of access to reference materials, laboratory infrastructure and workforce training, as well as early dialogue between developers and regulators, to support implementation.
To view the full report and read more about the conference, click here.
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