Kim June, Sabet-Azad Ramin, Patel Dimki, Malin Gene, Askary Syed Hassan, Särnefält Anna
Manufacturing & Supply Chain, Coalition for Epidemic Preparedness Innovations, Askekroken 11, 0277 Oslo, Norway.
Regulatory Affairs, Coalition for Epidemic Preparedness Innovations, Askekroken 11, 0277 Oslo, Norway.
Vaccines (Basel). 2025 Aug 11;13(8):849. doi: 10.3390/vaccines13080849.
CEPI (the Coalition for Epidemic Preparedness Innovation)'s CMC rapid response framework is developed to support accelerated vaccine development, manufacturing, and roll-out for various outbreak scenarios to achieve the 100 Days Mission. The framework outlines coordinated deliverables across five functional areas: manufacturing processes, formulation, analytics, supply chain, and facilities. It could serve as a tool to streamline CMC and the related activities for rapid vaccine development, identify areas for improvement and innovation, and assess preparedness for the outbreak response. The framework emphasizes the importance of thorough preparation during interpandemic periods as the foundation for the 100 Days Mission and for gaining the confidence of health authorities and the public in vaccines.
流行病防范创新联盟（CEPI）的化学、生产和控制（CMC）快速响应框架旨在支持针对各种疫情爆发情况加速疫苗研发、生产和推广，以实现“百日任务”。该框架概述了五个功能领域的协调交付成果：生产工艺、配方、分析、供应链和设施。它可作为一种工具，简化CMC及相关的快速疫苗研发活动，识别改进和创新领域，并评估疫情应对的准备情况。该框架强调在大流行间期进行充分准备的重要性，这是“百日任务”的基础，也是赢得卫生当局和公众对疫苗信任的基础。
