Center for Drug Evaluation, National Medical Products Administration, 128 Jianguo Road, Chaoyang District, Beijing, China.
Center for Drug Evaluation, National Medical Products Administration, 128 Jianguo Road, Chaoyang District, Beijing, China.
Biologicals. 2023 Nov;84:101700. doi: 10.1016/j.biologicals.2023.101700. Epub 2023 Sep 12.
In recent years, urgent unmet medical needs due to the COVID-19 pandemic have accelerated the application of mRNA technology in vaccine development, leading to some of the first approvals of mRNA vaccines in human history by regulatory agencies around the world. For market authorization, comprehensive chemistry, manufacturing and control (CMC) information is required to assure the safety and quality consistency of mRNA vaccines. Evaluating mRNA vaccines for new virus variants poses a challenge for regulators, given the rapid optimization and development based on prior platform knowledge to accelerate the development process, which is traditionally limited for biological products. Here we summarize the current regulatory considerations of CMC evaluation on mRNA vaccines based on the scientific knowledge available, which will be updated with the advance of mRNA biology and pharmaceutical science.
近年来，由于 COVID-19 大流行而产生的紧迫的未满足的医学需求加速了 mRNA 技术在疫苗开发中的应用，导致世界各地的监管机构首次批准了一些 mRNA 疫苗。对于市场授权，需要全面的化学、制造和控制（CMC）信息，以确保 mRNA 疫苗的安全性和质量一致性。鉴于基于先前平台知识的快速优化和开发以加速开发过程，对于监管机构来说，评估针对新病毒变体的 mRNA 疫苗是一个挑战，而这在传统上是生物制品所受到的限制。在这里，我们根据现有的科学知识总结了 CMC 评估对 mRNA 疫苗的当前监管考虑因素，随着 mRNA 生物学和药物科学的进步，这些考虑因素将不断更新。
