Challenges and opportunities for the implementation of the Three Rs in Canadian vaccine quality control

Area of Science:

• Veterinary medicine
• Toxicology
• Biotechnology

Background:

• The Three Rs principles aim to minimize animal use in scientific research and testing.
• Vaccine testing traditionally relies on animal models, raising ethical and scientific questions.
• Implementing alternative methods in vaccine quality control is a growing global trend.

Purpose of the Study:

• To identify opportunities and challenges in implementing the Three Rs in Canadian vaccine testing.
• To understand stakeholder perspectives on adopting alternative methods in vaccine quality control.

Main Methods:

• A case-study approach was employed.
• Data collected through interviews with 16 Canadian stakeholders in vaccine production, testing, and evaluation.

Main Results:

• Key challenges include inconsistent regulatory requirements, limitations of in vitro methods, benchmarking issues, and resistance to change.
• Opportunities identified: harmonization of test methods, collaborative development, poor performance of traditional animal methods, regulatory acceptance, and ethical concerns for animal welfare.
• Stakeholders express openness to the Three Rs, provided methods are reliable and biologically relevant.

Conclusions:

• Canadian industry and government are receptive to implementing the Three Rs in vaccine quality control.
• Successful implementation hinges on the reliability and biological relevance of alternative methods.
• Harmonizing regulatory requirements is crucial for advancing the adoption of alternative methods in vaccine testing.