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 cutting-edge international projects.
AFSA’s objectives and roadmap
Wanting to be part of this momentous change, AFSA is helping involved stakeholders exchange information, experience, training and materials, and assisting them in their move away from animal methods.
Harmonize vaccine testing requirements
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.
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 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”.
Our progresses and achievements
- Complete and partial deletion of the Abnormal Toxicity Test for human vaccines in:
- Brazil (2019); India (2021); South Korea (2022); Indonesia (2022; product specific waivers after company’s request)
- Russia (eased position toward test waiver, deletion and reduction, and established channels for communications and exchange till February 2022)
- Implemented regulatory requirement for the waiver of the Animal Batch Safety Tests (Veterinary vaccines):
- Brazil (2022)
- India (2022; eased position toward test waiver; ongoing cooperation)
- Organized dedicated local and global multi-stakeholders’ meetings and workshops:
- Rome (2019): “Global harmonization of vaccine testing requirements: making elimination of the ATT and TABST a concrete global achievement” (Biologicals 2020; AFSA Roadmap).
- Bangkok (2019): Support in the organization of the IABS Conference “Animal testing for vaccines. Implementing replacement, reduction and refinement: challenges and priorities” (Biologicals, 2020).
- India (2021, online workshop): “Future of TABST and LABST in the Indian Pharmacopoeia Monographs. A Humane Society International/India Workshop” (manuscript under review in Biologicals). The workshop was attended by 20 local and international stakeholders from the Indian Pharmacopoeia Commission (IPC), the Central Drugs Standard Control Organisation (CDSCO), industry representatives from the Indian Federation for Animal Health Companies (INFAH), the Asian Animal Health Association (AAHA) and HealthforAnimals, and from EDQM and VICH.
- Global (2021, online workshop): “Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. Planning common next steps” (Biologicals, 2022). The online workshop had speakers from the regulatory authorities from Europe, USA, Canada, India, South Korea, Indonesia, Japan, Russia, from EFPIA and IFPMA companies, from the WHO and the Bill & Melinda Gates foundation. Over 100 people participated from all over the world. The materials and recording of the workshop are publicly available (link).
- Brazil (2022, 2 online workshops in Portuguese): “Monocyte Activation Test: A Replacement for the Pyrogen Test in Rabbits / Teste de Ativação de Monócitos: A Substituição Para o Teste de Pirogênio em Coelhos” in collaboration with BraCVAM and Fiocruz (link). Reports to be published in Portuguese and English soon.
- South Korea (2022): Ministry of Food And Drug Safety committed to amend the pharmacopoeia introducing the recombinant Factor C as non-animal based method for the Bacterial Endotoxin detection, in 2023.
- Global (2022): event series in collaboration with the Global Veterinary Industry Association (HealthforAnimals) and the International Alliance for Biologicals Standardization dedicated to the implementation of non-animal methods for veterinary vaccines batch release testing. Over 300 representatives from industry and regulators participated to 2 regional webinars (Europe & Americas – October 6th; Asia – October 20th) and an hybrid workshop (Brussels and online, November 16th) and set the scene for future collaborations and a possible project (materials and recordings available here; publication in Biologicals in preparation).