Accelerated national lot release on COVID-19 vaccines in Republic of Korea

Independent quality testing of samples from vaccine lots is part of quality assurance, especially to ensure the consistency of production lot by lot. Effective national lot release system that ensures the quality of each lot of vaccine before it is on the market is important because vaccines are int...

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Bibliographic Details
Published in:Biologicals 2022-06, Vol.77, p.24-27
Main Authors: Yang, Misook, Lee, Naery, Ju, Jung Hun, Park, In-Sook, Hong, Jin Tae, Oh, Ho Jung
Format: Article
Language:English
Subjects:
Accelerated national lot release
Adenovirus-vectored
COVID-19
COVID-19 vaccine
mRNA
Pandemic
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Summary:Independent quality testing of samples from vaccine lots is part of quality assurance, especially to ensure the consistency of production lot by lot. Effective national lot release system that ensures the quality of each lot of vaccine before it is on the market is important because vaccines are intended to healthy people. In order to respond more quickly to public health crises such as the COVID-19 pandemic, the MFDS implements accelerated national lot release for rapid vaccination in Republic of Korea. For the accelerated system, improvement has been made in terms of timing of application for lot release and required documents. In addition, the processing period has been shortened and sampling method and test items have been streamlined. A thorough preparation for accelerated lot release has been developed by establishing test methods for a new platform in advance. As a result, a total of 43.88 million doses have been released within eight days on average. The accelerated lot release system has contributed significantly to rapid COVID-19 vaccination in Korea.
ISSN:1045-1056
1095-8320
DOI:10.1016/j.biologicals.2022.05.002