Disease X is a “placeholder name” that was first used by the World Health Organization (WHO) in a 2018 on their shortlist of blueprint priority diseases of pandemic concern requiring R&D. The term was used to represent a hypothetical, unknown pathogen that could cause a future epidemic or pandemic. The term was used to encourage the infectious disease R&D community to develop broad approaches to planning for future pandemic, with technology being sufficiently flexible to adapt to an unknown pathogen (e.g., broader vaccines and manufacturing facilities). The emergence of SARS-coronavirus 2 and resulting the COVID-19 global pandemic was the first pathogen to meet the definition of a ‘Disease X’ emergence.
CSIRO has a current focus on preparedness for future emergence of pandemic pathogens, focussing in the areas of pre-clinical testing and manufacturing. The development of appropriate animal models for vaccine and therapeutic testing is a bottle-neck that is often faced prior to the assessment of vaccine and therapeutic candidates, with this being a more challenging issue when it comes to emergence. The talk will focus on the aspects that must be considered when developing animal models to generate data required by regulators for vaccine approvals, and what can be done now to be better prepared for the next Disease X emergence.