DCVMN International, Route de Crassier 7, 1262 Eysins-Nyon, Switzerland.
DCVMN International, India.
Vaccine. 2022 Nov 28;40(50):7288-7304. doi: 10.1016/j.vaccine.2022.10.044. Epub 2022 Nov 2.
The sustainable manufacturing of vaccines in developing countries is critical to increasing equitable access to vaccines and pandemic preparedness globally. Sustainable manufacturing requires that organizations engaged in the development, production and supply of vaccines have viable business models and incentives to manufacture vaccine products. The expanding manufacturing capabilities and capacities of developing countries vaccine manufacturers (DCVMs) are increasingly positioning these organizations to meet the national and regional public health needs in developing countries; however, key industry challenges such as regulatory barriers, low prices and demand uncertainty for vaccine products, and limited R&D funding threaten the long-term viability of vaccine manufacturers. This study assesses the technical capabilities, manufacturing capacities, and aspirational plans of DCVMs, exemplifying the business models and strategies undertaken to sustainably manufacture vaccines in developing countries. The public health importance of a healthy vaccine industry which enables manufacturers is discussed throughout. Vaccine manufacturers reported diverse product portfolios and R&D pipelines and utilized an array of vaccine technology platforms. Large manufacturing capacities were reported, a critical factor in manufacturers achieving economies of scale and supplying large volumes of vaccine doses to the world's most populous regions. Partnerships and collaboration within the industry and with international organizations along the vaccine value-chain were cited with high frequency. Manufacturers also reported aspirational plans to enter new markets, acquire new technologies and invest in the development of novel and improved vaccines. As DCVMs aim to have an increasing impact on the global vaccine ecosystem, a coordinated multi-stakeholder approach is required alleviate critical industry barriers to ensure that all efforts produce vaccines are sustainable and enable developing countries to realize the public health benefit of vaccines.
发展中国家可持续生产疫苗对于增加疫苗的公平可及性和全球大流行防范至关重要。可持续生产要求参与疫苗开发、生产和供应的组织拥有可行的商业模式和生产疫苗产品的激励措施。发展中国家疫苗制造商（DCVM）的制造能力不断扩大，这些组织越来越有能力满足发展中国家的国家和地区公共卫生需求；然而，监管障碍、疫苗产品价格低和需求不确定以及研发资金有限等关键行业挑战，威胁着疫苗制造商的长期生存能力。本研究评估了 DCVM 的技术能力、生产能力和抱负计划，举例说明了在发展中国家可持续生产疫苗所采用的商业模式和战略。贯穿全文讨论了健康的疫苗行业对制造商的重要性。疫苗制造商报告了多样化的产品组合和研发管道，并利用了一系列疫苗技术平台。报告了大量的生产能力，这是制造商实现规模经济并向世界上人口最多的地区供应大量疫苗剂量的关键因素。业内以及疫苗价值链上的国际组织之间的伙伴关系和合作被频繁提及。制造商还报告了进入新市场、收购新技术以及投资开发新型和改良疫苗的抱负计划。随着 DCVM 旨在对全球疫苗生态系统产生更大的影响，需要采取协调的多方利益相关者方法来缓解关键的行业障碍，以确保所有努力生产的疫苗都是可持续的，并使发展中国家能够实现疫苗带来的公共卫生效益。
