aBlood Products Division, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju, Korea
bWorld Health Organization, Regional Office for the Western Pacific, Manila, Philippines
cNational Institute of Infectious Diseases, Tokyo, Japan
dNational Institutes for Food and Drug Control, China Food and Drug Administration, Beijing, China
eDepartment of Pharmacology and Therapeutics, University of Melbourne, Parkville, VIC, Australia
fDepartment of Statistics, Sookmyung Women’s University College of Science, Seoul, Korea
gDepartment of Emergency Medicine, Hanyang University College of Medicine, Seoul, Korea
hNational Institute for Control of Vaccine and Biological, Ministry of Health Vietnam, Hanoi, Vietnam
iDepartment of Manufacturing Pharmacy, Chungbuk National University College of Pharmacy, Cheongju, Korea
Copyright © 2017 Korea Centers for Disease Control and Prevention
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Establishing a snake venom NRS for use in an antivenom potency test;
Studying international harmonization and establishing a test method for thrombin generation; and,
Establishing an in vitro potency test for anti-tetanus immunoglobulin as an alternative to animal tests.
Evaluating the efficacy of the pertussis vaccine in different mouse strains;
Evaluating the use of an antibody titre test as an alternative to the MICA for pertussis vaccines;
Investigating adenylate cyclase toxin in the aP vaccine by ELISA;
Evaluating novel methods for testing pertussis toxicity (enzymatic high performance liquid chromatography [HPLC], Chinese hamster ovary [CHO] clustering, fetuin-binding ELISA); and,
Researching the polymer content of toxoid by HPLC.
Evaluating a single radial immune-diffusion (SRID) assay to accurately measure the hemagglutinin (HA) content of two influenza B virus components of the quadrivalent influenza vaccine (QIV);
Developing an antigen ELISA as an alternative to the in vivo potency test for the inactivated Japanese encephalitis vaccine;
Evaluating a D-antigen ELISA as an alternative to the in vivo potency test in rats for the Sabin-based inactivated poliomyelitis vaccine;
Developing an antigen ELISA as an alternative to the in vivo potency test in mice for hepatitis A & B vaccines;
Developing a sensitive in vitro assay to detect residual viable rabies virus in the inactivated rabies vaccine; and,
Refining the histamine sensitization test (HIST) and developing alternatives to the HIST for aP vaccines.
Strengthening the ability of the NICVB/NCL to participate in the NCL network;
Implementing an NICVB-Lab system reaching the WHO-GLP, ISO 17025, 15189 supported by the Ministry of Health;
Improving the ability to research, establish, and manage NRSs; implementing NRS projects; and collaborating with the regional NCLs to develop RWRS for vaccines and biologics;
Establishing a training plan for new staff about proper research techniques, the quality management system, and QC techniques in new vaccines;
Organizing an annual harmonization workshop on lot release and QC testing methods between the NICVB and the manufacturers; and,
Ensuring that all equipment will be calibrated and maintained by NICBV staff.
Updates to lists of medically important snakes to reflect the discovery of new species and changes to nomenclature;
Revision of methodologies for serpentariums producing venoms to emphasize traceability and QC, including the recommendation to discontinue the use of wild-caught snakes for ethical and QC reasons;
Need for national reference venom collections that are independent of manufacturers;
A recommendation for research into new adjuvants;
Updates to tables of known equine viruses;
Greater emphasis on the specific health controls of donor animals prior to and during bleeding sessions;
Redrafting QC and preclinical testing chapters to eliminate redundancy in describing lethality testing in animal models, strengthen messages regarding the ethical use of animals in experiments, and update stability study recommendations;
Inclusion of antivenomics as an additional preclinical testing methodology that can supplement conventional approaches; and,
Updates to the clinical assessment chapter and expanded information on the role of regulatory authorities in antive-nom production.
CONFLICTS OF INTEREST
No potential conflict of interest relevant to this article was reported. The authors alone are responsible for the views expressed in this report and they do not necessarily represent the views, decisions or policies of the institutions with which they are affiliated. The mention of specific companies or of certain manufacturers’ products dose not imply that they are endorsed or recommended by the participating national control laboratories in preference to others of a similar nature that are not mentioned.
Reused from Lim et al (J Korean Med Assoc 2013;56:1091–103) [7].
Period | Patient (n) | Grade | Antivenom complication | Death | Reference | |||||
---|---|---|---|---|---|---|---|---|---|---|
|
|
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0 | I | II | III | IV | Skinb | Serum sickness | ||||
2008–2010 | 62 | 6 | 47 | 9 | 0 | 0 | 2 | 1 | 0 | You et al (2013) [9] |
|
||||||||||
2006–2008 | 32 | 0 | 13 | 15 | 2 | 2 | – | – | 0 | Kim et al (2009) [10] |
|
||||||||||
1999–2008 | 170 | 2 | 39 | 75 | 53 | 1 | – | – | 0 | Park et al (2009) [11] |
|
||||||||||
2000–2006 | 169 | 4 | 78 | 66 | 19 | 2 | – | – | 0 | Jin et al (2008) [12] |
|
||||||||||
2000–2004 | 108 | 4 | 58 | 34 | 10 | 2 | 0 | 0 | 0 | Jun et al (2004) [13]c |
|
||||||||||
1995–1999 | 97 | 2 | 36 | 39 | 20 | 0 | – | – | 0 | Kim and Choi (2000) [14] |
|
||||||||||
1991–1996 | 71 | 15 | 25 | 26 | 5 | 0 | 3 | – | 0 | Cho and Park (1996) [15] |
|
||||||||||
1995–1996 | 100 | 3 | 47 | 37 | 13 | 0 | – | – | 0 | Jang et al (1996) [16]d |
|
||||||||||
1990–1993 | 105 | 44 | 31 | 15 | 15 | 0 | 17 | 0 | 0 | Kim et al (1995) [17] |
|
||||||||||
Total | 914 | 80 | 374 | 316 | 137 | 7 | 22 | 1 | 0 |
Modified from Lim et al (J Korean Med Assoc 2013;56:1091–103) [7].
a Traditional Snakebite Severity Grading Scale (The classification proposed by Parrish, McCollough, and Gennard).
Grade 0 (No envenomation): Local or systemic signs or symptoms absent;
Grade I (Minimal): Local swelling, absence of systemic sign, normal laboratory findings;
Grade II (Moderate): Swelling extending past bite site (6–12 inches), ≥ 1 systemic signs or symptoms, abnormal laboratory findings;
Grade III (Severe): Marked swelling (> 12 inches), tissue loss, multiple or severe systemic symptoms, immediate systemic signs, rapid progression of symptoms;
Grade IV (Very severe): Rapid development of local reaction, ecchymosis, necrosis, blebs, blisters, swelling severe enough to obstruct venous or arterial flow, swelling may involve ipsilateral trunk.
b Rash, urticarial, etc.
c Sixteen antivenom users with fever and urticaria and 1 Viken user with urticaria.
d Antivenom administrate from grade II.