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比较 18 种疫苗的研发、上市和扩大规模的时间表:从 COVID-19 中吸取的经验教训及其对其他传染病的影响。

Comparing research and development, launch, and scale up timelines of 18 vaccines: lessons learnt from COVID-19 and implications for other infectious diseases.

机构信息

Duke Global Health Innovation Center, Duke Global Health Institute, Durham, North Carolina, USA

Innovations in Healthcare, Durham, North Carolina, USA.

出版信息

BMJ Glob Health. 2023 Sep;8(9). doi: 10.1136/bmjgh-2023-012855.

Abstract

Over the next decade, millions of deaths could be prevented by increasing access to vaccines in low-income and middle-income countries (LMICs). The COVID-19 pandemic has demonstrated that the research and development (R&D), launch and scale up timelines of vaccines can be drastically shortened. This study compares such timelines for eighteen vaccines and identifies lessons and implications for accelerating the R&D, launch and scale up process for other vaccine candidates. To replicate the rapid R&D process of the COVID-19 vaccines, future vaccine R&D should capitalise on public-private knowledge sharing partnerships to promote technology innovation, establish regional clinical trial centres and data sharing networks to optimise clinical trial efficiency, and create a funding mechanism to support research into novel vaccine platforms that may prove valuable to quickly developing vaccine candidates in future global health emergencies. To accelerate the launch timeline, future efforts to bring safe and efficacious vaccines to market should include LMICs in the decision-making processes of global procurement and delivery alliances to optimise launch in these countries, strengthen the WHO prequalification and Emergency Use Listing programs to ensure LMICs have a robust and transparent regulatory system to rely on, and invest in LMIC regulatory and manufacturing capacity to ensure these countries are vaccine self-sufficient. Lastly, efforts to accelerate scale up of vaccines should include the creation of regional pooled procurement mechanisms between LMICs to increase purchasing power among these countries and an open line of clear communication with the public regarding pertinent vaccine information to combat misinformation and vaccine hesitancy.

摘要

在未来十年,通过增加低收入和中等收入国家(LMICs)获得疫苗的机会,可以预防数百万人死亡。COVID-19 大流行表明,疫苗的研究和开发(R&D)、推出和扩大规模的时间表可以大大缩短。本研究比较了这 18 种疫苗的时间表,并确定了为其他疫苗候选物加速 R&D、推出和扩大规模过程的经验教训和影响。为了复制 COVID-19 疫苗的快速 R&D 过程,未来的疫苗 R&D 应利用公私知识共享伙伴关系来促进技术创新,建立区域临床试验中心和数据共享网络,以优化临床试验效率,并创建一个为支持研究新型疫苗平台提供资金的机制,这些平台可能对快速开发未来全球卫生紧急情况下的疫苗候选物有价值。为了加快推出时间表,未来将安全有效的疫苗推向市场的努力应包括将 LMICs 纳入全球采购和交付联盟的决策过程,以优化这些国家的推出,加强世界卫生组织的预认证和紧急使用清单计划,以确保 LMICs 拥有健全和透明的监管系统,投资于 LMIC 的监管和制造能力,以确保这些国家能够自给自足疫苗。最后,加快疫苗扩大规模的努力应包括在 LMIC 之间创建区域集中采购机制,以增加这些国家的购买力,并与公众就相关疫苗信息保持公开透明的沟通渠道,以打击错误信息和疫苗犹豫。

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