GLOBAL REGULATORY ALIGNMENT

The need for global regulatory alignment

Every year, about 10 million animals are still used globally in batch-release testing for vaccines, while scientific consensus has grown steadily regarding the inadequacies of animal testing in vaccine production, and the need to transition to animal-free methods.

The majority of testing relies on old procedures that are both painful and obsolete (some dating back almost a century), hampered by poor reproducibility and limited reliability, being costly and time-consuming, and often forcing producers and national control laboratories to additional re-testing, increasing costs and time to market of vaccines.

Due to their scientific, methodological and ethical shortcomings, most of these animal-based techniques would not be considered today, yet having served as a ‘gold standard’ for decades, they are still widely in use, and their acceptance seems to go without question.

Alternative methods that can replace, reduce or refine animal-based testing have been developed – and adopted in some regions – and others are being developed right now through cutting0edge international projects.

Establish a climate conducive to the use of non-animal methods

With animal-based methods so deeply rooted in vaccine regulatory culture, moving beyond them will require more than scientific input; work is needed to establish a climate that is conducive, and fertile, to the use of non-animal methods. Such a result can only be achieved through a synergistic approach, one involving all stakeholders in an exercise of mutual transparent cooperation and trust-building. This approach will be using the virtuous examples of the most advanced countries/regions to promote what is possible everywhere else, with specific attention to developing countries and markets, leveraging the benefits in terms of costs, time and safety to stimulate regulatory attention to available non-animal methods, easing the rigidity related to requiring only, and absolutely, old animal tests for vaccine batch release.

AFSA's objectives

Willing to be part of this momentous change, AFSA is putting itself at the service of all the involved stakeholders, with a view of helping them dialogue, exchange information, experiences, training and materials, and offering them instruments to autonomously step forward in their quest to overcome legacy animal methods.

AFSA’s resources will also be directed at overcoming one of the key barriers to the acceptance of alternative methods, the regulatory fragmentation whereby each country/region has specific, and often incompatible, regulations for vaccine quality control. AFSA will work to see that those disparate regulations are made to converge as much as possible, in a harmonization of great benefit for manufacturers and consumers.

AFSA is already at work on key projects focused on the worldwide elimination of legacy animal-based safety tests, the General Safety Test (GST) for human and veterinary vaccines, and the Rabbit Pyrogen Test for human vaccines, and it welcomes the cooperation and the interest of all the parties that share its vision of a more advanced, efficient, safer and animal free vaccine sector.

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