Biomedical Advanced Research and Development Authority, Administration for Strategic Preparedness and Response, US Department of Human and Health Services, Washington, District of Columbia, USA.
J Infect Dis. 2024 Jul 25;230(1):e1-e3. doi: 10.1093/infdis/jiae017.
Infectious disease outbreaks have become increasingly common and require global partnership for adequate preparedness and response. During outbreaks, medical countermeasures (MCMs)-vaccines, therapeutics, and diagnostics-need to reach patients quickly. Recent outbreaks exemplify that products with regulatory approval can expand access and reach patients quicker than investigational products. Unfortunately, insufficient funding globally and differences in funders' prioritization puts gains and future efforts at risk. Of primary concern is (1) lack of a feasible regulatory path and clinical capability to achieve regulatory approval for new MCMs for many diseases; and (2) the need for partners with the mandate, funding, and capabilities to support long-term sustainment of manufacturing capability and stockpiling of licensed products. Without collaboration, the global community runs the risk of losing the capabilities built through years of investment and being underprepared to combat future threats. Synergies between funders are critical to create long-term sustainment of products to ensure access.
传染病的爆发越来越频繁，这需要全球合作以充分做好准备和应对。在疫情爆发期间，医疗对策（MCMs）——疫苗、疗法和诊断方法——需要迅速提供给患者。最近的疫情爆发表明，具有监管批准的产品可以比研究性产品更快地扩大获得途径并接触到患者。不幸的是，全球资金不足以及资助者优先事项的差异使收益和未来的努力面临风险。主要关注点是：（1）缺乏可行的监管途径和临床能力，无法为许多疾病的新的 MCMs 获得监管批准；（2）需要有授权、资金和能力的合作伙伴，以支持长期维持生产能力和储备许可产品。如果没有合作，全球社会就有可能失去多年投资所建立的能力，并为应对未来的威胁做好准备。资助者之间的协同作用对于确保获取途径的产品的长期可持续性至关重要。
