The majority of testing is performed with procedures that are both painful and obsolete (some dating back almost a century). They suffer from poor reproducibility and limited reliability, can be very costly and time-consuming, and their limited reliability often causes manufacturers and national control laboratories to re-test vaccine batches, having a negative impact on costs and time to market.
Due to their technical and scientific limitations, and ethical shortcomings, no animal test would be sanctioned today. And yet they often represent the accepted and only standard, and their use goes unquestioned.
New methods and approaches that can substituTe animal-based testing have been already developed – and adopted in a number regions – and others are being developed right now in cutting-edge international projects.
AFSA’s resources are being invested in overcoming the regulatory fragmentation, whereby each country/region has specific, and often different enough, regulations for vaccine quality control. Regulatory fragmentation is one of the key barriers to the acceptance and use of alternative methods. AFSA will work for the alignment and convergence of those regulations, which will benefit both manufacturers, regulatory authorities themselves, people, animals and the environment.
AFSA is already at work on key projects focused on the worldwide elimination of legacy animal-based safety tests for human and veterinary vaccines, and it welcomes the interest and values the cooperation of all the parties that share its vision of a more advanced, efficient, safe and animal free vaccine sector.
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 the synergistic approach presented in our roadmap: 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. Read more about the 2019 Symposium “Global harmonization of vaccine testing requirements: Making elimination of the ATT and TABST a concrete global achievement”.
HSI via the AFSA Collaboration has engaged a number of international stakeholders for an ambitious 3-years project dedicated to accelerating the implementation and regulatory acceptance of non-animal approaches for legacy human vaccine batch-release testing, with a specific focus on developing countries.
The project is intended to advance the dialogue toward global regulatory alignment while at the same time generating local competencies, direct experience and confidence in change.
Through the creation of local forums for discussion of key stakeholders, and the support of an International Steering Committee formed by some of the most recognized experts of the field, the project participants will work on the creation of country-tailored roadmaps, that could guide the introduction of non-animal methods in the manufacturers testing strategies and in regulations and pharmacopoeias of the various countries involved. Participants constitute a global community of renown experts and key stakeholders, all agreeing on the urgency of transitioning away from animal-based methods in vaccines’ batch release testing.
Brazil, India, China, South Korea, Indonesia are the key targeted countries, while others are being gauged for interest and the possibility to be involved.
Project Event presentation: https://www.afsacollaboration.org/sciencex_event/toward-implementation-plans-for-replacement-of-animal-testing-for-human-vaccines/ (in the future we’ll publish our reports)
AFSA is committed to seeing the widest implementation of the Monocyte Activation Test (MAT) as a replacement for the obsolete animal-based Rabbit Pyrogen Test (RPT), and is engaging stakeholders from a number of countries, in particular in Brazil and India, to see that the test is uptaken, embedded in pharmacopoeias, and the RPT finally retired.
AFSA/HSI Event on MAT in collaboration with the Italian Institute of Health: https://www.afsacollaboration.org/sciencex_event/monocyte-activation-test-the-experience-of-the-italian-institute-of-health/
AFSA is engaged in the introduction of recombinant Factor C as alternative non-animal derived assay for the Bacterial Endotoxin Test (BET). As an artificial compound mimicking the extraordinary capabilities of the lysate from the horseshoe crabs, rFC can be used in bacterial endotoxin testing with the same results, without the need to exploit and endanger the horseshoe crabs ecosystem.
rFC ensures sustainable supply and consistency because it is based on recombinant production. Its adoption would safeguard the entire supply chain linked to the execution of the BET insulating its cost and viability from external events, safeguarding the citizens’ access to quality biopharmaceutical products.
With AFSA’s collaboration, Korea has approved its use in 2022, and AFSA is working in various countries, in particular Brazil and India, to secure its recognition as alternative to LAL for the BET, engaging stakeholders in the regulatory and manufacture sectors, and fostering exchange of information with areas/countries that have already succeeded.