Rapid development of manufacturing processes for future production of adenovirus-vectored COVID19 vaccine at million-dose scale

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. We aim to provide, in <6 months and probably c. 4 months -A GMP process to produce the University of Oxford's (UOXF's) simian adenovirus-vectored COVID-19 vaccine at 200L/ c. 1m-dose scale -With MHRA engagement, a contingency plan (subject to funding) to make available 1m doses of GMP-like UK-cleanroom-produced material for clinical use as soon as possible. -Development of options for 1000L-scale (>5m dose) manufacturing in UK & abroad. Small-batch GMP and clinical trials of the UOXF vaccine are already planned. Supported by the extensive human safety/ immunogenicity record of these vectors, and anticipating supportive primate efficacy/ immunopathology safety data in April, we are contingency planning an emergency clinical trial programme. With a £0.25m in-kind contribution from PallBiotech, including access to a fully-equipped process development (PD) facility, and starting from our existing GMP 3L-scale process, we are already performing scale-up preparation experiments and anticipate a 50L run at Pall's facility and then 200L runs as needed, within funds requested here. With Co-I J Humphreys (VMIC), we are contingency planning near-immediate access to 200L-capable cleanrooms at two CDMOs, both partners in this application (Cobra in Keele, UK & Halix in Leiden NL). We have requested an emergency meeting with MHRA to discuss regulatory mechanisms to make vaccine available for large-scael use as soon as possible.