WHO International Standard for evaluation of the antibody response to COVID-19 vaccines: call for urgent action by the scientific community

被引:108
作者
Knezevic, Ivana [1 ]
Mattiuzzo, Giada [3 ]
Page, Mark [3 ]
Minor, Philip
Griffiths, Elwyn
Nuebling, Micha [4 ]
Moorthy, Vasee [2 ]
机构
[1] WHO, Dept Hlth Prod Policy & Stand, Access Med & Hlth Prod, CH-1211 Geneva, Switzerland
[2] WHO, Sci Div, Res Hlth Dept, Geneva, Switzerland
[3] Natl Inst Biol Stand & Controls, Potters Bar, Herts, England
[4] Paul Ehrlich Inst, Langen, Germany
关键词
D O I
10.1016/S2666-5247(21)00266-4
中图分类号
R51 [传染病];
学科分类号
100401 ;
摘要
The first WHO International Standard and International Reference Panel for anti-SARS-CoV-2 immunoglobulin were established by the WHO Expert Committee on Biological Standardization in December, 2020. The WHO International Antibody Standards are intended to serve as global reference reagents, against which national reference preparations or secondary standards can be calibrated. Calibration will facilitate comparison of results of assays (eg, of the neutralising antibody response to candidate COVID-19 vaccines) conducted in different countries. Use of these standards is expected to contribute to better understanding of the immune response, and particularly of the correlates of protection. This Personal View provides some technical details of the WHO Antibody Standards for SARS-CoV-2, focusing specifically on the use of these standards for the evaluation of the immune response to COVID-19 vaccines, rather than other applications (eg, diagnostic or therapeutic). The explanation with regard to why rapid adoption of the standards is crucial is also included, as well as how funders, journals, regulators, and ethics committees could drive adoption in the interest of public health.
引用
收藏
页码:E235 / E240
页数:6
相关论文
共 29 条
[1]  
Centers for Disease Control and Prevention, 2021, INT LAB BIOS GUID HA
[2]   Genomic characterization of the 2019 novel human-pathogenic coronavirus isolated from a patient with atypical pneumonia after visiting Wuhan [J].
Chan, Jasper Fuk-Woo ;
Kok, Kin-Hang ;
Zhu, Zheng ;
Chu, Hin ;
To, Kelvin Kai-Wang ;
Yuan, Shuofeng ;
Yuen, Kwok-Yung .
EMERGING MICROBES & INFECTIONS, 2020, 9 (01) :221-236
[3]   Emerging coronaviruses: Genome structure, replication, and pathogenesis [J].
Chen, Yu ;
Liu, Qianyun ;
Guo, Deyin .
JOURNAL OF MEDICAL VIROLOGY, 2020, 92 (04) :418-423
[4]   Viral targets for vaccines against COVID-19 [J].
Dai, Lianpan ;
Gao, George F. .
NATURE REVIEWS IMMUNOLOGY, 2021, 21 (02) :73-82
[5]   Investigation into Low-Level Anti-Rubella Virus IgG Results Reported by Commercial Immunoassays [J].
Dimech, Wayne ;
Arachchi, Nilukshi ;
Cai, Jingjing ;
Sahin, Terri ;
Wilson, Kim .
CLINICAL AND VACCINE IMMUNOLOGY, 2013, 20 (02) :255-261
[6]   Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial [J].
Folegatti, Pedro M. ;
Ewer, Katie J. ;
Aley, Parvinder K. ;
Angus, Brian ;
Becker, Stephan ;
Belij-Rammerstorfer, Sandra ;
Bellamy, Duncan ;
Bibi, Sagida ;
Bittaye, Mustapha ;
Clutterbuck, Elizabeth A. ;
Dold, Christina ;
Faust, Saul N. ;
Finn, Adam ;
Flaxman, Amy L. ;
Hallis, Bassam ;
Heath, Paul ;
Jenkin, Daniel ;
Lazarus, Rajeka ;
Makinson, Rebecca ;
Minassian, Angela M. ;
Pollock, Katrina M. ;
Ramasamy, Maheshi ;
Robinson, Hannah ;
Snape, Matthew ;
Tarrant, Richard ;
Voysey, Merryn ;
Green, Catherine ;
Douglas, Alexander D. ;
Hill, Adrian V. S. ;
Lambe, Teresa ;
Gilbert, Sarah C. ;
Pollard, Andrew J. .
LANCET, 2020, 396 (10249) :467-478
[7]  
Government of Canada, 2020, BIOS ADV SARS COV 2
[8]   Comparison of Serologic Assays for Middle East Respiratory Syndrome Coronavirus [J].
Harvey, Ruth ;
Mattiuzzo, Giada ;
Hassall, Mark ;
Sieberg, Andrea ;
Mueller, Marcel A. ;
Drosten, Christian ;
Rigsby, Peter ;
Oxenford, Christopher J. ;
Caly, L. ;
Li, C. ;
Zhao, L. ;
Tan, W. ;
Peiris, M. ;
Perera, M. ;
Mueller, M. ;
Drosten, C. ;
Kang, C. ;
Wang, J-S ;
Haagmans, B. ;
Okba, N. M. A. ;
Gopal, R. ;
Myhill, S. ;
Mattiuzzo, G. ;
Thornburg, N. .
EMERGING INFECTIOUS DISEASES, 2019, 25 (10) :1878-1883
[9]  
Health and Safety Authority, 2020, RISK GROUP CLASS SER
[10]   WHO international standard for anti-rubella: learning from its application [J].
Kempster, Sarah L. ;
Almond, Neil ;
Dimech, Wayne ;
Grangeot-Keros, Liliane ;
Huzly, Daniela ;
Icenogle, Joseph ;
El Mubarak, Haja Sittana ;
Mulders, Mick N. ;
Nubling, C. Micha .
LANCET INFECTIOUS DISEASES, 2020, 20 (01) :E17-E19