Ju Jung Hun, Lee Naery, Kim Sun-Hee, Chang Seokkee, Yang Misook, Shin Jihyun, Lee Eunjo, Sung Sunhwa, Kim Jung-Hwan, Hong Jin Tae, Oh Ho Jung
Emerging Infectious Disease Vaccines Division, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju, Korea.
College of Pharmacy and Medical Research Center, Chungbuk National University, Cheongju, Korea.
Osong Public Health Res Perspect. 2022 Feb;13(1):4-14. doi: 10.24171/j.phrp.2021.0311. Epub 2022 Feb 8.
Due to the global public health crisis caused by the coronavirus disease 2019 (COVID-19) pandemic, the importance of vaccine development has increased. In particular, a rapid supply of vaccines and prompt deployment of vaccination programs are essential to prevent and overcome the spread of COVID-19. As a part of the vaccine regulations, national lot release is regulated by the responsible authorities, and this process involves the assessment of the lot before a vaccine is marketed. A lot can be released for use when both summary protocol (SP) review and quality control testing are complete. Accelerated lot release is required to distribute COVID-19 vaccines in a timely manner. In order to expedite the process by simultaneously undertaking the verification of quality assessment and application for approval, it is necessary to prepare the test methods before marketing authorization. With the prolonged pandemic and controversies regarding the effectiveness of the COVID-19 vaccine against new variants, public interest for the development of a new vaccine are increasing. Domestic developers have raised the need to establish standard guidance on the requirements for developing COVID-19 vaccine. This paper presents considerations for quality control in the manufacturing process, test items, and SP content of viral vector vaccines.
由于2019冠状病毒病（COVID-19）大流行引发的全球公共卫生危机，疫苗研发的重要性日益增加。特别是，快速供应疫苗和迅速部署疫苗接种计划对于预防和克服COVID-19的传播至关重要。作为疫苗监管的一部分，国家批签发由负责当局进行监管，这一过程涉及在疫苗上市前对批次进行评估。当总结方案（SP）审查和质量控制测试均完成后，批次方可放行使用。为了及时分发COVID-19疫苗，需要加快批签发。为了通过同时进行质量评估验证和批准申请来加快这一过程，有必要在上市许可前准备好测试方法。随着疫情的持续以及关于COVID-19疫苗对新变种有效性的争议，公众对新型疫苗研发的兴趣与日俱增。国内研发人员提出了制定COVID-19疫苗研发要求标准指南的必要性。本文介绍了病毒载体疫苗生产过程中的质量控制、测试项目和SP内容的相关考量。
