Farlow Andrew, Torreele Els, Gray Glenda, Ruxrungtham Kiat, Rees Helen, Prasad Sai, Gomez Carolina, Sall Amadou, Magalhães Jorge, Olliaro Piero, Terblanche Petro
Nuffield Department of Medicine, University of Oxford, Broad St., Oxford OX1 3BD, UK.
Oxford Martin School, University of Oxford, Broad St., Oxford OX1 3BD, UK.
Vaccines (Basel). 2023 Mar 17;11(3):690. doi: 10.3390/vaccines11030690.
This Review initiates a wide-ranging discussion over 2023 by selecting and exploring core themes to be investigated more deeply in papers submitted to the Special Issue on the "Future of Epidemic and Pandemic Vaccines to Serve Global Public Health Needs". To tackle the SARS-CoV-2 pandemic, an acceleration of vaccine development across different technology platforms resulted in the emergency use authorization of multiple vaccines in less than a year. Despite this record speed, many limitations surfaced including unequal access to products and technologies, regulatory hurdles, restrictions on the flow of intellectual property needed to develop and manufacture vaccines, clinical trials challenges, development of vaccines that did not curtail or prevent transmission, unsustainable strategies for dealing with variants, and the distorted allocation of funding to favour dominant companies in affluent countries. Key to future epidemic and pandemic responses will be sustainable, global-public-health-driven vaccine development and manufacturing based on equitable access to platform technologies, decentralised and localised innovation, and multiple developers and manufacturers, especially in low- and middle-income countries (LMICs). There is talk of flexible, modular pandemic preparedness, of technology access pools based on non-exclusive global licensing agreements in exchange for fair compensation, of WHO-supported vaccine technology transfer hubs and spokes, and of the creation of vaccine prototypes ready for phase I/II trials, etc. However, all these concepts face extraordinary challenges shaped by current commercial incentives, the unwillingness of pharmaceutical companies and governments to share intellectual property and know-how, the precariousness of building capacity based solely on COVID-19 vaccines, the focus on large-scale manufacturing capacity rather than small-scale rapid-response innovation to stop outbreaks when and where they occur, and the inability of many resource-limited countries to afford next-generation vaccines for their national vaccine programmes. Once the current high subsidies are gone and interest has waned, sustaining vaccine innovation and manufacturing capability in interpandemic periods will require equitable access to vaccine innovation and manufacturing capabilities in all regions of the world based on many vaccines, not just "pandemic vaccines". Public and philanthropic investments will need to leverage enforceable commitments to share vaccines and critical technology so that countries everywhere can establish and scale up vaccine development and manufacturing capability. This will only happen if we question all prior assumptions and learn the lessons offered by the current pandemic. We invite submissions to the special issue, which we hope will help guide the world towards a global vaccine research, development, and manufacturing ecosystem that better balances and integrates scientific, clinical trial, regulatory, and commercial interests and puts global public health needs first.
本综述开启了一场贯穿2023年的广泛讨论,通过挑选和探讨核心主题,以便在提交给“满足全球公共卫生需求的流行病和大流行疫苗的未来”特刊的论文中进行更深入的研究。为应对新冠疫情,不同技术平台的疫苗研发加速,使得多种疫苗在不到一年的时间内获得紧急使用授权。尽管速度创纪录,但许多局限性也浮出水面,包括产品和技术获取不平等、监管障碍、疫苗研发和生产所需知识产权流动的限制、临床试验挑战、未能减少或预防传播的疫苗的研发、应对病毒变种的不可持续策略,以及资金分配扭曲以偏袒富裕国家的主导公司。未来应对流行病和大流行的关键将是基于公平获取平台技术、分散化和本地化创新以及多个开发者和制造商,尤其是在低收入和中等收入国家(LMICs),实现可持续的、由全球公共卫生驱动的疫苗研发和生产。人们谈论着灵活、模块化的大流行防范,基于非排他性全球许可协议并给予公平补偿的技术获取池,世界卫生组织支持的疫苗技术转让中心和分支,以及创建准备好进行I/II期试验的疫苗原型等。然而,所有这些概念都面临着巨大挑战,这些挑战受到当前商业激励措施、制药公司和政府不愿分享知识产权和技术诀窍、仅基于新冠疫苗建设能力的不稳定状况、专注于大规模生产能力而非小规模快速反应创新以在疫情发生时和发生地阻止疫情爆发,以及许多资源有限的国家无力为其国家疫苗计划购买下一代疫苗等因素的影响。一旦当前的高额补贴消失且兴趣减弱,在两次大流行之间维持疫苗创新和生产能力将需要基于多种疫苗,而不仅仅是“大流行疫苗”,在世界所有地区公平获取疫苗创新和生产能力。公共和慈善投资将需要利用可执行的承诺来分享疫苗和关键技术,以便世界各地的国家能够建立并扩大疫苗研发和生产能力。只有当我们质疑所有先前的假设并吸取当前大流行带来的教训时,这才会发生。我们邀请大家向特刊投稿,希望这将有助于引导世界走向一个全球疫苗研究、开发和生产生态系统,该系统能更好地平衡和整合科学、临床试验、监管和商业利益,并将全球公共卫生需求放在首位。
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