saRNA SARS-CoV-2 vaccine

This COVID-19 Rapid Response award is jointly funded (50:50) between the Medical Research Council and the National Institute for Health Research. The figure displayed is the total award amount of the two funders combined, with each partner contributing equally towards the project. This project aims to rapidly progress a self-amplifying RNA (saRNA) vaccine against the 2019 novel Coronavirus (SARS-CoV-2) to first in human studies (phase I) within a matter of months. Within 14 days of accessing the sequence we have already designed and constructed a candidate saRNA vaccine expressing a pre-fusion stabilised conformation of the native surface glycoprotein (S-protein). This design maximises the potential for induction of neutralising antibodies while minimising the induction for off-target responses to post-fusion conformations. We have engaged key manufacturing partners able to generate GMP material not only for phase I/II studies according to a very tight schedule but also with the capability to rapidly scale to millions of doses should this be required. This cutting-edge nucleic acid vaccine platform has been specifically designed for rapid manufacture and deployment in the event of an outbreak. SaRNA offers significant advantages over other nucleic acid vaccine platforms yielding exponentially higher levels of protein expression than messenger RNA (mRNA) or DNA. The self-amplifying properties of saRNA mean that much lower doses are required to induce protective immunity, providing a significant advantage to manufacturing costs and speed. Additionally, saRNA is not limited by anti-vector immunity and is safe to administer to individuals unable to receive live attenuated vaccines (e.g. children and the immunocompromised). The Target Product Profile (TPP) is a vaccine that can be rapidly manufactured at low cost and elicit protective immunity across all at risk populations within 6 weeks of administration, with the potential for repeat boosting as required.