Animal neurovirulence tests (NVT) have historically been required for release of oral polio vaccine virus seeds and monovalent bulks. The improvement in knowledge about the genetics of attenuation, the development of next-generation sequencing capabilities, and the advancement of genetically stabilized vaccine strains allow this requirement to be revisited, considering the latest WHO OPV Technical Report Series guidance. This presentation will detail how PATH’s Center for Vaccine Innovation & Access team helped develop and implement a strategy for a LMIC manufacturer to be the first oral polio vaccine manufacturer to establish NGS as an alternative to monkey neurovirulence testing, and how we leverage our learnings to support other manufacturers to achieve the same goals through the Sustaining Vaccine Manufacturing Program.
