Establishment of the 1st National Reference Standard for Sabin Inactivated Poliomyelitis Vaccine in Korea

Misook Yang, Jung-Min Jung, Naery Lee, Yanghyun Kim, Eunjeong Park, Jong Won Kim, Jin Tae Hong

doi:10.4167/jbv.2021.51.4.189

All Issue

2021 Vol.51, Issue 4 Preview Page Next Page

Original Article

Establishment of the 1^st National Reference Standard for Sabin Inactivated Poliomyelitis Vaccine in Korea

31 December 2021. pp. 189-199

PDF XML

Abstract

In 2019, the first Sabin strain inactivated poliomyelitis vaccine was approved in Korea. It was necessary establishment of national reference standards of that vaccine for consistent quality control and standardization since international standards are provided only in small quantities per year. Therefore, Sabin strain inactivated poliomyelitis vaccine standard candidate was produced in 2019. In this study, we tried to establish the D-antigen content of the candidate standard through collaborate study with five institutions and six laboratories participated in the collaborate research. The candidate standard was set up value of DU/mL with Salk strain International Standard (12/104, NIBSC) and the SDU/mL value was established with the Sabin International Standard (17/160, NIBSC). The D-Ag contents (DU/mL and SDU/mL) derived from each laboratory were calculate using the CombiStat program and analyzed for statistical significance. Earlier this year, the candidate standard was registered as the 1st national reference standard of Sabin strain inactivated poliomyelitis vaccine and the D-Ag contents of the standard was assigned 47, 129, 262 DU/mL and 48, 106, and 193 SDU/mL by each type (Type 1, 2, 3,). Because of established of national standard, it will help consistent quality control and standardization of the Sabin strain inactivated poliomyelitis vaccines.

Keywords

Poliovirus vaccine

Sabin strain

Inactivated vaccine

National reference standard

D-antigen content assay

Quality control

References

World Health Organization. Polio vaccines: WHO position paper-March 2016. Wkly Epidemiol Rec 2016;91:145-68.

Burns CC, Diop OM, Sutter RW, Kew OM. Vaccine-derived polioviruses. J Infect Dis 2014;210(suppl. 1):S283-93. doi:10.1093/infdis/jiu295.

10.1093/infdis/jiu29525316847

World Health Organization. WHO Global Action Plan to minimize poliovirus facility-associated risk after type-specific eradication of wild polioviruses and sequential cessation of oral polio vaccine use. GAPIII. https://apps.who.int/iris/ handle/10665/208872.

Chumakov K, Ehrenfeld E. New Generation of Inactivated Poliovirus Vaccines for Universal Immunization After Eradication of Poliomyelitis. Clin Infect Dis 2008;47:1587-92.

10.1086/59331018990066PMC2596976

MFDS, 2020 Annual Report of National Lot Release). 11-1471057-000122-10, 2021. https://www.mfds.go.kr/brd/ m_231/view.do?seq=33049&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1.

World Health Organization. Recommendations for the preparation, characterization and establishment of international and other biological reference standards, Annex 2, WHO Technical Report Series, No 932. 2004. https://www.who.int/publications/m/item/annex2-trs932.

Martin J, Daas A, Milne C. European Pharmacopoeia biological reference preparation for poliomyelitis vaccine (inactivated): collaborative study for the establishment of batch No. 3. Pharmeur Bio Sci Notes 2016;2016:135-50.

MFDS, 2021National Standard Guidebook. 11-1471057-000380-10, 2021.7. http://www.nifds.go.kr/brd/m_522/list.do.

Crawt L, Atkinson E, Tedcastle A, Pegg E, Study participants (see Appendix 2), Minor P, et al. Report on the WHO collaborative study to establish the 1st International Standard for Sabin inactivated polio vaccine (sIPV). WHO/BS/2018.2338.

Martin J, Dougall T, Stephens L, Cooper G, Minor PD, Heath A, et al. Report on the WHO collaborative study to establish the 3rd International Standard (replacement) for inactivated polio vaccine. WHO/BS/2013.2217.

Crawt L, Atkinson E, Tedcastle A, Elaine Pegg, the sIPV Study Group, Minor P, et al. Differences in Antigenic Structure of Inactivated Polio Vaccines Made From Sabin Live-Attenuated and Wild-Type Poliovirus Strains: Impact on Vaccine Potency Assays. J Infect Dis 2020;221:544-52.

10.1093/infdis/jiz07630788503

WHO Expert Committee on Biological Standardization. WHO manual for the preparation of secondary reference materials for in vitro diagnostic assays designed for infectious disease nucleic acid or antigen detection: calibration to WHO International Standards. Annex 6, WHO Technical Report Series, No. 1004, 2017. https://www.who.int/ bloodproducts/norms/SecStandManWHO_TRS_1004_web_Annex_6.pdf.

European Pharmacopoeia 10.0, General section, Vaccines, Poliomyelitis Vaccine(Inactivated), 01/2019:0214, Assay, D-antigen content. 2019. p.1025.

World Health Organization. Recommendations to assure the quality, safety and efficacy of poliomyelitis vaccines (inactivated), Annex3, WHO Technical Report Series, No.1024, https://www.who.int/publications/m/item/ poliomyelitis-vaccines-annex-3-trs-no-1024.

Information

Publisher :The Korean Society for Microbiology
Publisher(Ko) :대한미생물학회
Journal Title :JOURNAL OF BACTERIOLOGY AND VIROLOGY
Volume : 51
No :4
Pages :189-199
Received Date :2021. 10. 06
Revised Date :2021. 12. 06
Accepted Date : 2021. 12. 07
DOI :https://doi.org/10.4167/jbv.2021.51.4.189

JOURNAL OF BACTERIOLOGY AND VIROLOGY ISSN:1598-2467(Print) 2093-0429(Online)

All Issue