Manufacturing research hub for a sustainable future: Vaccines for pandemic preparedness

新冠肺炎疫情继续造成巨大损失，估计已有630万人死亡，其中英国有17.8万人。全球有16亿学生失学，2.5亿人将陷入极端贫困，经济损失估计达12万亿英镑。历史表明，流行病和大流行威胁不断出现，而SARS-CoV-2随着流行而不断变异。显然，国内对公共卫生的持续投资可以防止重大损失。Vax-Hub1在响应技术和加速质量控制方法方面开展的工作使针对SARS-CoV-2的ChAdOx1载体疫苗得以快速开发和生产（通过与阿斯利康的非营利性合作伙伴关系，于2020年12月获得紧急使用许可）。目前已在180个国家发放了超过29亿剂疫苗。英国在大流行期间发挥了主导作用，拟议中的中心将在这一成功的基础上推进更广泛技术的新研究。Vax-Hub将与利益攸关方密切合作，使英国能够更好地为下一次大流行做好准备。这项对未来疫苗制造中心的投资将实现我们的愿景，使英国成为全球疫苗发现、开发和制造中心。疫苗制造中心汇集了世界一流的多学科团队，在疫苗设计和制造研究的各个方面积累了数十年的经验。该中心将把学术界、工业界、非营利组织和决策者聚集在一起，在技术创新文化的基础上提出疫苗开发和制造技术的根本变革。该中心将通过以下方式加强未来的疫苗生产：(i)通过对选定的一系列最有前途的平台技术（既有和新颖/颠覆性）进行战略性创新，降低新疫苗生产的风险；（ii）开发可提高产品质量和免疫原性的生产方案；（iii）通过新颖的响应性解决方案和先进的数字化战略简化制造工艺开发；（iii）注重加强稳定性和无针管理路线，使其在中心的生命周期内成为现实。在项目转移到GMP生产设施之前，拟议的中心将是早期研究的自然地点。这项工作的重点是开发改进的疫苗平台，这些平台可以足够灵活，用于多种产品的生产。这些改进的疫苗技术被用作案例研究，以测试快速和反应迅速的开发工具，以创建模拟疫苗生产的整个过程，在发生流行病/大流行的情况下可以轻松快速地部署。最后，研究重点是标准和新型佐剂，使粘膜递送成为现实，从而允许替代注射途径进行大规模给药。该中心将使英国成为端到端疫苗研究和生产的全球中心。此外，疫苗应被视为国家安全的优先事项，因为疾病显然不受国际边界的限制，因此开展能力建设和快速反应方面的工作具有重大优势。由于联合王国重申其在全球卫生领域的领导地位，并努力确保该中心的产出惠及全球社会和最弱势群体，特别是儿童，因此将在国际上感受到该中心的影响。

The Covid-19 pandemic continues to take a huge toll - an estimated 6.3m people have died including 178,000 in the UK. Globally 1.6bn students have missed school, 250m people will be pushed into extreme poverty and economic losses are estimated at £12tr. History shows that epidemic and pandemic threats constantly emerge, whilst SARS-CoV-2 continues to mutate as it becomes endemic. It is clear that major losses could be prevented by sustained domestic investment in public health. Work undertaken within Vax-Hub1 on responsive technologies and accelerated quality control methods enabled rapid development and manufacture of the ChAdOx1 vectored vaccine against SARS-CoV-2 (licensed for emergency use in December 2020 via a non-profit partnership with AstraZeneca). Over 2.9bn doses have now been released in 180 countries. The UK had a leading role during the pandemic and the proposed Hub builds on this success to advance novel research on a broader range of technologies. Working closely with stakeholders, Vax-Hub will enable the UK to be better prepared for the next pandemic.This investment into The Future Vaccine Manufacturing Hub will enable our vision to make the UK the global centre for vaccine discovery, development and manufacture. The Vaccine Manufacturing Hub brings together a world-class multidisciplinary team with decades of cumulative experience in all aspects of vaccine design and manufacturing research. This Hub will bring academia, industry, not-for-profit organizations and policy makers together to propose radical change in vaccine development and manufacturing technologies, building on a technological innovation culture.The Hub will enhance future vaccine manufacturing through (i) de-risked manufacture of new vaccines by strategically innovating for a selected range of the most promising platform technologies (established and novel/disruptive); (ii) developing manufacturing options that improve the product quality and so immunogenicity; (iii) streamlined manufacturing process development with novel responsive solutions and advanced digitalisation strategies; (iii) a focus on enhancing stability and needle-free administration routes so they become a reality within the lifetime of the Hub. The proposed Hub would be the natural location for early-stage research before projects are transferred to a GMP manufacturing facility.The work focuses on development of improved vaccine platforms which can be flexible enough to be used for multiple product manufacture. These improved vaccine technologies are used as case studies to test rapid and responsive development tools to create a whole process mimicking vaccine manufacture, which could be easily and quickly deployed in case of epidemic/pandemic scenario. Finally the research focuses on standard and novel adjuvants to make mucosal delivery a reality, thus allowing alternative route to injection for mass administration.The Hub will establish the UK as the global centre for end-to-end vaccine research and manufacture. Additionally, vaccines should be considered a national security priority, as it is evident that diseases do not respect international boundaries, thus this work into capacity building and rapid response is a significant advantage. The impact of this Hub will be felt internationally, as the UK reaffirms its leadership in Global Health and works to ensure that the outputs of this Hub reach the global community and the most vulnerable, especially children.