GMP Manufacture of a vaccine targeting a viral hemorrhagic fever

马尔堡病毒病与埃博拉病毒引起的疾病难以区分，并与高病死率相关。马尔堡病毒造成的疾病暴发主要发生在东非和中非，在1975年至2021年期间有记录的暴发发生了11次。最近马尔堡病毒暴发的地点引起了人们对病毒传播到西非的担忧，因为以前的疫情仅限于肯尼亚、乌干达和刚果民主共和国。马尔堡病毒已被确定为具有大流行和流行潜力的病毒。目前还没有临床可用的疫苗可以预防马尔堡病毒引起的疾病。我们选择的疫苗生产方式是黑猩猩腺病毒载体（ChAdOx1）。ChAdOx1方案具有高度的免疫原性，我们已经证明它们可以诱导对疾病的保护（例如牛津/阿斯利康ChAdOx1 nCOV-19可以预防COVID-19）。值得注意的是，针对COVID-19的紧急应对措施导致了这种疫苗技术的大规模生产，现在已经积累了生产疫苗的经验，可以按规模和价格生产疫苗，供低收入和中等收入国家使用。我们已经开始生产一种针对马尔堡病毒的疫苗，在这种申请中，我们将通过GMP（良好生产规范）生产来推进这种疫苗，即生产一种可用于人类预防病毒性出血性疾病的疫苗。我们现在希望在ChAdOx1马尔堡问题上取得进展，以便放行ChAdOx1马尔堡疫苗，鉴于赤道几内亚和坦桑尼亚暴发了马尔堡病毒，以及世卫组织重点委员会选择了ChAdOx1马尔堡疫苗，这一点至关重要。

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.