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KMID : 1142220180130020143
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Regulatory Research on Food, Drug & Cosmetic
2018 Volume.13 No. 2 p.143 ~ p.153
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Study on Establishment and Management of Reference Lab for Clinical Evaluation of Vaccines
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Kim Jae-Ouk
Chun June-Young
Yang Jae-Seung
Ayan Dey
Bae Joon-Ik
Song Man-Ki
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Abstract
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National efforts are being made to develop vaccines for National Immunization Program and emerging infectious diseases such as MERS-coronavirus, Zika virus, Ebola virus, etc. As the demand for vaccine clinical evaluation increases, the international standardization of evaluation is required. In this study, we conducted a questionnaire from vaccine experts to investigate the national demand of Reference Lab for vaccine clinical evaluation. As a result, 85% of the respondents confirmed that demand of Reference Lab for vaccine clinical evaluation was very high. In order to investigate the Reference Labs in other countries, we have searched the internet and literature, and visited 4 laboratories conducting vaccine evaluation. However, there is no designated Reference Lab for only vaccine clinical evaluation. Nonetheless, it was found that the reliability of clinical evaluation can be improved by academic achievement, international joint research, and GCLP (good clinical laboratory practice) implementation. On the other hand, there is no basis for designating or establishing a Reference Lab for vaccine clinical evaluation under the current legislation. Therefore, it is desirable to support projects to carry out the role as a kind of Reference Lab. In conclusion, we suggest that it is necessary to determine the priority that needs standardization of materials and assay among vaccines with high national demand. Also, it is recommended to support laboratories with expertise in specific vaccines to encourage the standardization and dissemination of the clinical evaluation of those vaccines.
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KEYWORD
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Vaccine, Clinical Evaluation, Reference Lab, Reference Materials, Standard Operating Protocol
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