GMP Manufacture of a vaccine targeting a viral hemorrhagic fever

Marburg virus disease is indistinguishable from disease caused by Ebolaviruses and is associated with a high case fatality rate. Marburg virus has caused disease outbreaks predominantly in Eastern and Central Africa, with eleven incidences of outbreaks on record between 1975 and 2021\. The location of the most recent Marburg virus outbreak has caused concern regarding viral spread into Western Africa as previous outbreaks have been limited to Kenya, Uganda and the Democratic Republic of the Congo. Marburg virus has been identified as a virus of pandemic and epidemic potential. There are no clinically available vaccines that can protect against disease caused by Marburg virus. Our vaccine modality of choice, for vaccine manufacture, is a chimpanzee adenoviral vector (ChAdOx1). ChAdOx1 regimens are highly immunogenic, and we have demonstrated they can induce protection against disease (e.g. the Oxford/AstraZeneca ChAdOx1 nCOV-19 protects against COVID-19). Of note, the emergency response against COVID-19 has led to large-scale manufacture of this vaccine technology and there is now an accumulated manufacturing experience to generate vaccines at scale and at a price which can be used in low and middle income countries. We have started to generate a vaccine against Marburg virus and in this application we will progress this vaccine through GMP (Good Manufacturing Practice) production - generating a vaccine that can be used in humans to protect against viral haemorrhagic disease. We now wish to progress the ChAdOx1 Marburg to allow for release of the ChAdOx1-Marburg vaccine which is of utmost importance given the outbreak of Marburg virus in Equatorial Guinea and Tanzania and the selection of ChAdOx1-Marburg vaccine by the WHO prioritization committee.