1Emerging Infectious Disease Vaccines Division, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju, Korea
2College of Pharmacy and Medical Research Center, Chungbuk National University, Cheongju, Korea
© 2022 Korea Disease Control and Prevention Agency.
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Ethics Approval
Not applicable.
Conflicts of Interest
The authors have no conflicts of interest to declare.
Funding
None.
Availability of Data
All data generated or analyzed during this study are included in this published article. Other data may be requested from the corresponding author.
Authors’ Contributions
Conceptualization: JHJ, JTH; Data curation: NL, SHK, SC, MY, JS, EL, SS, JHK; Writing-original draft: JHJ, NL, HJO; Writing-review & editing: JTH, HJO.
Available from regulatory authority websites as of October 2021 (sources: FDA, https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19; EMA, https://www.ema.europa.eu/en; PMDA, https://www.pmda.go.jp/english/about-pmda/0002.html; Health Canada, https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/vaccines.html; Swissmedic, https://www.swissmedic.ch/swissmedic/en/home.html).
COVID-19, coronavirus disease 2019; ICH, International Council for Harmonization; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; FDA, Food and Drug Administration; MA, marketing authorization; EUA, emergency use authorization; EC, European Commission; CMA, conditional marketing authorization; MHLW, Ministry of Health, Labour and Welfare; PMDA, Pharmaceuticals and Medical Devices Agency; SAFE, special approval for emergency; HC, Health Canada; ISAD IO, interim order pathway for COVID-19-related drugs and vaccines; TPA, temporary authorization; -, unauthorized or unapproved.
COVID-19, coronavirus disease 2019; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.
Available from Ministry of Food and Drug Safety website (source: https://nedrug.mfds.go.kr).
COVID-19, coronavirus disease 2019.
Data as of December 3, 2021 (source: https://www.who.int).
Category |
United States (USP) |
Europe (EDQM) |
Korea (MFDS) |
Japan (NIID)a) |
|
---|---|---|---|---|---|
Item | Attribute | Possible test methods | |||
Identity | Sequence confirmation | DNA extraction & sequencing (USP 1125, 1126) restriction analysis (USP 1129, 1126) | Immunochemical methods (EP 2.7.1), NAT (EP 2.6.21), LC (EP 2.2.29) | Immunochemical methods. NAT, LC | Suitable methods |
Vector detection | qPCR, ddPCR, RT-PCR (USP 1125, 1126, 1127), ELISA (USP 1103) | ||||
Purity | Vector aggregates | Light-scattering (USP 1430.2, 1430.3, 1430.5, 1430.6, 1430.7), SEC-MALS (USP 621, 1430.1) | Light-scattering | Light-scattering | - |
Potency | Infectious vector titer | Plaque assays (USP 111, 1235, 1237), CCID50, cell-based qPCR (USP 1032, 1033, 1034) | Plaque assays or CCID50 assay by immunostaining, qPCR, flowcytometry/FACS, fluorescent focus assay | Plaque assays or CCID50 assay by immunostaining, qPCR, flowcytometry, fluorescent focus assay | Immunostaining |
Transgene expression | Western blot (USP 1104), ELISA (USP 1103), LC-MS (USP 621, 736, 1736), RP-HPLC (USP 621) | Immunochemical assay (EP 2.7.1), biochemical assay, flow cytometry (EP 2.7.24) | Immunochemical assay, biochemical assay, flow cytometry | - | |
Quantity | Virus particle (vector concentration) | Light-scattering & DLS (USP 1430.2, 1430.6), CZE (USP 1053), qPCR (USP 1125, 1126, 1127) | qPCR (EP 2.6.21) | qPCR | LC |
Appearance | Compendial test | USP 1, 790 | EP 2.7.1, 2.6.21, 2.2.29 | Visual observation | Criteria specified |
pH | Compendial test | USP 791 | EP 2.2.3 | KP general test | JP general test |
Container content for injections (includes extractable volume) | Compendial test | USP 697 | EP 2.9.17 | KP general test | - |
Sterility | Compendial test | USP 71 | EP 2.6.1 | KP general test | JP general test |
Endotoxin | Compendial test | USP 85 | EP 2.6.14 | KP general test | JP general test |
Osmolality | Compendial test | USP 785 | EP 2.2.35 | KP general test | - |
USP, United States Pharmacopoeia; EDQM, European Medicines Quality Committee; MFDS, Ministry of Food and Drug Safety; NIID, National Institute of Infectious Diseases; EP, European Pharmacopoeia; NAT, nucleic acid test; LC, liquid chromatography; qPCR, quantitative polymerase chain reaction; ddPCR, droplet digital PCR; RT-PCR, reverse transcription PCR; ELISA, enzyme-linked immunosorbent assay; SEC, size exclusion chromatography; MALS, multi-angle light-scattering; CCID50, cell culture infectious dose 50%; FACS, fluorescence-activated cell sorting; MS, mass spectrometry; DLS, dynamic light-scattering; CZE, capillary zone electrophoresis; RP, reverse phase; HPLC, high-performance liquid chromatography; KP, The Korean Pharmacopoeia; JP, Japanese Pharmacopoeia; -, not applicable.
a) Chimpanzee adenoviral vector vaccine only.