This webinar is part of the Humane World for Animals Project “Accelerate non-animal batch release testing for human vaccines”[1] funded by the Gates Foundation.
The objective of the webinar is to explore the complexity of the substitution of the monkey neurovirulence test, which is still required as a safety test (at master and working seed lot and in some situations also for the release of the products) of live attenuated viral vaccines.
Stakeholders have been trying to find alternative tests: using different species (e.g. mice, rats, hamsters), investigating the use of in vitro approaches or use of high-throughput sequencing technology that has been successfully used for the novel Oral Polio Virus Vaccine.
The presentations will provide concrete insights on explored opportunities, including their shortcomings, the perspective from manufacturers and regulators, and suggestions about possible directions for further methods development, investments, projects and collaborations.
Scientific Organizing Committee
- Kutub Mahmood, PATH
- Robin Levis, US FDA
- Tong Wu, HealthCanada
- Catherine Milne, EDQM
- Dean Smith, HealthCanada
- Emmanuelle Coppens, Sanofi
- Pradip Das, Biological E
- Javier Martin, MHRA
- Gautam Sanyal, Vaccines Analytics
- Blaise Descampe, consultant
- Laura Viviani, consultant
Target audience: regulators and assessors, pharmacopoeias’ experts and committees, national control laboratories, international organizations, vaccine manufacturers and associations.
Agenda
- Welcome remarks, Laura Viviani, SciEthiQ and Jan Turner, Humane World for Animals/AFSA (5 minutes) PRESENTATION SLIDES
- Introduction on the neurovirulence test – historical overview and future perspective, Konstantin Chumakov (20 min + 5 min Q&A) PRESENTATION SLIDES
- Yellow Fever Vaccine and the challenges of neurovirulence, Carine Logvinoff, Sanofi (20 min +5 min Q&A) PRESENTATION SLIDES
- Whole-genome next generation sequencing as an alternative to neurovirulence tests in animals for the quality control of live-attenuated viral vaccines, Javier Martin, MHRA (20 min + 5 min Q&A) PRESENTATION SLIDES
- Monkey Neurovirulence testing of Yellow fever vaccine and nOPV and its refinement and replacement opportunities, Panduranga Pavuliri and Pradip Das, Biological E (20 min +5 min Q&A) PRESENTATION SLIDES
- Scientific and Regulatory Considerations for Controlling Residual Neurovirulence of Viral Vaccines. Tong Wu, HealthCanada (20 min +5 min Q&A) PRESENTATION SLIDES
- Overview of the next steps and panel discussion with all the speakers, moderated by Kutub Mahmood (PATH)
- Closing remarks and launch of the survey, Laura Viviani, SciEthiQ and Jan Turner, Humane World for Animals/AFSA (5 minutes)
TAKE OUR MNVT REPLACEMNET SURVEY (open until October 31, 2025)
[1] Humane World for Animals/AFSA’s project: https://www.afsacollaboration.org/new-assays-implementation-and-acceptance/