Infectious disease experts have been predicting a new emerging or re-emerging pandemic for some time. Indeed, the mantra had been, “not if, but when”. In the aftermath of the Ebola (2014) and Zika (2015) virus outbreaks, the WHO undertook a rigorous review of their policy approach, dramatically shifting from a reactive to proactive preparedness model. The concept of a Blueprint list of priority diseases was born, a list that included seven known potential threats, and an unknown pathogen, referred to as Disease X. SARS-CoV-2 emerged in China in late 2019 as Disease X ver1.0, and has presented the world with a pandemic challenge requiring both novel and rapid national and global responses.
The functional arm of the new WHO preparedness model is the Coalition for Epidemic Preparedness Innovations, CEPI who have funded a raft of programs aimed at the development of targeted vaccines and platform technologies that could also be applied to Disease X, in readiness for this expected pandemic. We were one of the groups funded by CEPI to prepare for such an outbreak and this presentation will provide some insights into the journey we took in applying our Molecular Clamp platform to the development of a COVID-19 vaccine candidate from initial development through to clinical trials in under 6 months. Our vaccine did not progress to Phase 2/3 clinical trials owing to the induction of a low immune response that interfered with some front-line HIV diagnostics. However, the very promising Phase 1 data has validated the underlying technology and has allowed us to progress the development of a re-engineered Molecular Clamp based vaccine.