International regulatory requirements for vaccine safety and potency testing: A WHO perspective &

Procedia in Vaccinology

Volumn 5, Issue , 2011, Pages 164-170

  Shin, Jinho ^a   Lei, Dianliang ^a   Conrad, Christoph ^a   Knezevic, Ivana ^a   Wood, David ^a  

^a WORLD HEALTH ORGANIZATION   (Switzerland)

Author keywords

Alternatives; Animal use; Vaccines; World Health Organization

Indexed keywords

MEASLES MUMPS RUBELLA VACCINE; POLIOMYELITIS VACCINE; RABIES VACCINE; SMALLPOX VACCINE; YELLOW FEVER VACCINE;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TESTING ALTERNATIVE; ANIMAL WELFARE; ARTICLE; CONTROLLED STUDY; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG POTENCY; DRUG SAFETY; MEASLES; MUMPS; NONHUMAN; POLIOMYELITIS; PRACTICE GUIDELINE; PRIORITY JOURNAL; RABIES; RUBELLA; SMALLPOX; WORLD HEALTH ORGANIZATION; YELLOW FEVER;

EID: 84555196680     PISSN: None     EISSN: 1877282X     Source Type: Journal    
DOI: 10.1016/j.provac.2011.10.015     Document Type: Article

References (33)

1. World Health Organization. Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks: Proposed replacement of TRS 878, Annex 1. WHO/BS/10.2132.
2. [Anonymous]. IABs scientific workshop on neurovirulence tests for live virus vaccines, January 31-February 1, 2005, Geneva. Biologicals 2006 Sep;34(3):233-236.
3. World Health Organization. Recommendations for the production and control of poliomyelitis vaccine (oral). In: WHO Expert Committee on Biological Standardization. Fiftieth report. Geneva, World Health Organization, 2002, Annex 1 (WHO Technical Report Series, No. 904) [http://www.who.int/biologicals/publications/trs/areas/vaccines/polio/WHO_TRS_904_A1polio_oral.pdf].
4. Dunn G, O'Brien J, Heath A, Chumakov K. Report of the WHO collaborative study to establish a new International Standard and three new International Reference Preparations for the MAPREC test of poliovirus Type 1 (Sabin). WHO/BS/09.2103.
5. Amexis G, Oeth P, Abel K, Ivshina A, Pelloquin F, Cantor CR, et al. Quantitative mutant analysis of viral quasispecies by chip-based matrix-assisted laser desorption/ionization time-of-flight mass spectrometry. Proc Natl Acad Sci USA 2001 Oct 9;98(21):12097-12102.
6. Grachev VP, Karganova GG, Rumyantsev AA, Ivanova OE, Eremeeva TP, Drozdov SG. Evaluation of the new control methods for oral poliomyelitis vaccine. Dev Biol (Basel) 2001;105:211-217.
7. Proudnikov D, Kirillov E, Chumakov K, Donlon J, Rezapkin G, Mirzabekov A. Analysis of mutations in oral poliovirus vaccine by hybridization with generic oligonucleotide microchips. Biologicals 2000 Jun;28(2):57-66.
8. Cherkasova E, Laassri M, Chizhikov V, Korotkova E, Dragunsky E, Agol VI, et al. Microarray analysis of evolution of RNA viruses: evidence of circulation of virulent highly divergent vaccine-derived polioviruses. Proc Natl Acad Sci USA 2003 Aug 5;100(16):9398-9403.
9. Shin J, Wood D, Robertson J, Minor P, Peden K. WHO informal consultation on the application of molecular methods to assure the quality, safety and efficacy of vaccines, Geneva, Switzerland, 7-8 April 2005. Biologicals 2007 Mar;35(1):63-71.
10. Victoria JG, Wang C, Jones MS, Jaing C, McLoughlin K, Gardner S, et al. Viral nucleic acids in live-attenuated vaccines: detection of minority variants and an adventitious virus. J Virol 2010 Jun;84(12):6033-6040.
11. Neverov A, Chumakov K. Massively parallel sequencing for monitoring genetic consistency and quality control of live viral vaccines. Proc Natl Acad Sci USA Nov 16; 107((46): 20063-20068.
12. World Health Organization. Requirements for yellow fever vaccine (Requirements for biological substances no.3). In: WHO Expert Committee on Biological Standardization. Forty-sixth report. Geneva, World Health Organization, 1998, Annex 2 (WHO Technical Report Series No. 872) [http://www.who.int/biologicals/publications/trs/areas/vaccines/yellow_fever/WHO_TRS_872_A2.pdf].
13. World Health Organization. Requirements for measles, mumps and rubella vaccines and combined vaccines (live) (requirements for biological substance no. 47). In: WHO Expert Committee on Biological Standardization. Forty-third report. Geneva, World Health Organization, 1994, Annex 3 (WHO Technical Report Series, No. 840) [http://www.who.int/biologicals/publications/trs/areas/vaccines/mmr/WHO_TRS_840_A3.pdf].
14. World Health Organization. Recommendations for the production and quality control of smallpox vaccine, revised 2003. In: WHO Expert Committee on Biological Standardization. Fifty-third report. Geneva, World Health Organization, 2004, Annex 1 (WHO Technical Report Series No. 926) [http://www.who.int/biologicals/publications/trs/areas/vaccines/smallpox/Annex%201%20(27-64)TRS926Smallpox2003.pdf].
15. Ferguson M, Shin J, Knezevic I, Minor P, Barrett A. WHO Working Group on Technical Specifications for Manufacture and Evaluation of Yellow Fever Vaccines, Geneva, Switzerland, 13-14 May 2009. Vaccine 2010 Nov 2;28:8236-8245.
16. World Health Organization. Recommendations to assure the quality, safety and efficacy of live attenuated yellowfever vaccines - Proposed replacement of: TRS 872, Annex 2 and Amendment to TRS 872, Annex 2, TRS (in press) (ECBS 2008). WHO/BS/102131.
17. World Health Organization. WHO guidelines on nonclinical evaluation of vaccines. In: WHO Expert Committee on Biological Standardization. Fifty-fourth report. Geneva, World Health Organization, 2005, Annex 1 (WHO Technical Report Series, No. 927) [http://www.who.int/biologicals/publications/trs/areas/vaccines/nonclinical_evaluation/ANNEX%201Nonclinical.P31-63.pdf].
18. World Health Organization. Guidelines for the production and quality control of candidate tetravalent dengue virus vaccines (live). In: WHO Expert Committee on Biological Standardization. Fifty-fifth report. Geneva, World Health Organization, 2006, Annex 1 (WHO Technical Report Series No. 932) [http://www.who.int/biologicals/publications/trs/areas/vaccines/dengue/TRS932Annex%201_Dengue%20virus%20vacc%20live.pdf].
19. Guy B, Guirakhoo F, Barban V, Higgs S, Monath TP, Lang J. Preclinical and clinical development of YFV 17D-based chimeric vaccines against dengue, West Nile and Japanese encephalitis viruses. Vaccine 2010 Jan 8;28(3):632-649.
20. Trent D, Shin J, Hombach J, Knezevic I, Minor P. WHO Working Group on technical specifications for manufacture and evaluation of dengue vaccines, Geneva, Switzerland, 11-12 May 2009. Vaccine 2010 Jul 29;28:8246-8255.
21. World Health Organization. Recommendations for diphtheria, tetanus, pertussis and combined vaccines (Amendments 2003). In: WHO Expert Committee on Biological Standardization. Fifty-fourth report. Geneva, World Health Organization, 2005, Annex 5 (WHO Technical Report Series No. 927) [http://www.who.int/biologicals/publications/trs/areas/vaccines/dtp/ANNEX%205%20DTPP138-147.pdf].
22. World Health Organization. Recommendations for whole-cell pertussis vaccine. In: WHO Expert Committee on Biological Standardization. Fifty-sixth report. Geneva, World Health Organization, 2007, Annex 6 (WHO Technical Report Series No. 941) [http://www.who.int/biologicals/publications/trs/areas/vaccines/whole_cell_pertussis/Annex%206%20whole%20cell%20pertussis.pdf].
23. Meslin F-X KM, Koprowski H., eds. Laboratory techniques in rabies. 4th edition. Geneva, World Health Organization, 1996.
24. World Health Organization. Recommendations for inactivated rabies vaccine for human use produced in cell substrates and embryonated eggs (Revised 2005). In: WHO Expert Committee on Biological Standardization. Fifty-sixth report. Geneva, World Health Organization, 2007, Annex 2 (WHO Technical Report Series, No. 941) [http://www.who.int/biologicals/publications/trs/areas/vaccines/rabies/Annex%202%20inactivated%20rabies%20vaccine.pdf].
25. Ferguson M, Heath A. Collaborative study to assess the suitability of a candidate International Standard for yellow fever vaccine. Biologicals 2004 Dec;32(4):195-205.
26. Seagroatt V, Magrath DI. A W.H.O. collaborative study of in vitro and in vivo methods for the assay of yellow fever vaccines. J Biol Stand 1983 Jan;11(1):47-54.
27. World Health Organization. Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks: Proposed replacement of TRS 878, Annex 1. WHO/BS/10.2132.
28. World Health Organization. Guidelines for independent lot release of vaccines by regulatory authorities. In: 2010, WHO/BS/10.2128.
29. Rubin SA, Snoy PJ, Wright KE, Brown EG, Reeve P, Beeler JA, et al. The mumps virus neurovirulence safety test in Rhesus monkeys: a comparison of mumps virus strains. J Infect Dis 1999 Aug;180(2):521-525.
30. Afzal MA, Marsden SA, Hull RM, Pipkin PA, Bentley ML, Minor PD. Evaluation of the neurovirulence test for mumps vaccines. Biologicals 1999 Mar;27(1):43-49.
31. Rubin SA, Afzal MA, Powell CL, Bentley ML, Auda GR, Taffs RE, et al. The rat-based neurovirulence safety test for the assessment of mumps virus neurovirulence in humans: an international collaborative study. J Infect Dis 2005 Apr 1;191(7):1123-1128.
32. World Health Organization. Recommendations for Japanese encephalitis vaccine (inactivated) for human use, adopted 2007. [http://www.who.int/biologicals/publications/trs/areas/vaccines/jap_encephalitis/Japanese%20Encephatis%20guidelines%202007%20revised%20211207%20rev07.pdf].
33. World Health Organization. Guidelines for the production and control of the cellular pertussis component of monovalent or combined vaccines. In: WHO Expert Committee on Biological Standardization. Forty-seventh report. Geneva, World Health Organization, 1998, Annex 2 (WHO Technical Report Series No. 878).[http://www.who.int/biologicals/publications/trs/areas/vaccines/acellular_pertussis/WHO_TRS_878_A2.pdf].