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KMID : 1142220210160020135
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Regulatory Research on Food, Drug & Cosmetic
2021 Volume.16 No. 2 p.135 ~ p.141
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Points to Consider on the National Lot Release and Summary Protocol for COVID-19 mRNA Vaccines
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Kim Sun-Hee
Kim Na-Ri
Choi Jung-Yun
Kim Jung-Hwan
Lim Jong-Mi
Jo Mi-Ran
Kwak Min-Young
Choi Ko-Woon
Moon Myung-Sook
Cho Jeung-Gue
Cho Yoon
Kim Jin-Ho
Oh Ho-Jung
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Abstract
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It has been used various platforms for vaccines, like as virus-like particle vaccines, recombinant viral-vectored vaccines, toxoids, polysaccharides or protein-based vaccines. And one mRNA-based COVID-19 vaccine has received EUA(Emergency Use Authorization) in 2020 for the first time. Because of its advantages, such as rapid vaccine manufacturing and mass production within a short period time, mRNA-based vaccines are regarded as a very useful technique, in particular, in this unprecedented emergence of infectious disease like as SARS-CoV- 2. Biologicals including vaccines must be confirmed by ‘National Lot Release’ before it is released on the market in order to verify the consistency for manufacturing and quality. ‘National Lot Release’ is a system that the NRA(National Regulatory Authority) or NCL(National Control Laboratory) verifies the quality of vaccines by performing the test for the final drug products and reviewing the summary protocol(SP). It is mandatory to get an approval for the summary protocol template first followed by submission of the National Lot Release application along with summary protocol filled with results and signed by the responsible person of the manufacturing company. MFDS provides the standard template to facilitate the preparation of summary protocol for each vaccine. In this article, we reviewed the manufacturing steps and principal quality control parameters of mRNA-based vaccines and referred to guidelines issued by OMCL(European Network of Official Medicines Control Laboratories). Here, we suggest standard template of summary protocol for COVID-19 mRNA vaccines to help manufacturers.
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KEYWORD
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Vaccine, COVID-19 vaccine, mRNA, National Lot Release, Summary Protocol
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