Twenty-five years of the WHO vaccines prequalification programme (1987-2012): Lessons learned and future perspectives

Vaccine

Volumn 33, Issue 1, 2015, Pages 52-61

  Dellepiane, Nora ^a   Wood, David ^a  

^a WORLD HEALTH ORGANIZATION   (Switzerland)

Author keywords

Global public health; International supply chains; National immunization programme; Vaccine prequalification programme; Vaccines of assured quality

Indexed keywords

VACCINE;

CAPACITY BUILDING; CLINICAL TRIAL (TOPIC); COST EFFECTIVENESS ANALYSIS; DECENTRALIZATION; DRUG EFFICACY; DRUG INDUSTRY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; GOOD MANUFACTURING PRACTICE; HEALTH CARE DELIVERY; HEALTH PROGRAM; HUMAN; IMMUNIZATION; QUALITY CONTROL; REVIEW; RISK ASSESSMENT; VACCINE PREQUALIFICATION PROGRAMME; WORLD HEALTH ORGANIZATION; ADVERSE EFFECTS; HEALTH; HISTORY; IMMUNOLOGY; ORGANIZATION AND MANAGEMENT; PREVENTIVE HEALTH SERVICE; PROCEDURES; STANDARDS; SUPPLY AND DISTRIBUTION; VACCINATION;

GLOBAL HEALTH; HISTORY, 20TH CENTURY; HISTORY, 21ST CENTURY; HUMANS; IMMUNIZATION PROGRAMS; VACCINATION; VACCINES; WORLD HEALTH ORGANIZATION;

EID: 84919416181     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2013.11.066     Document Type: Review

References (42)

1. World Health Organization Procurement of vaccine for public-sector programmes. WHO/IVB/03.16 2003.
2. The World Health Organization Constitution Official Records of the World Health Organization 1946, 2:100.
3. World Health Organization Constitution Amendment. Basic documents October 2006, [accessed 20.03.13]. http://www.who.int/governance/eb/who_constitution_en.pdf, 45th ed. Supplement.
4. Establishment of the WHO Expert Committee on Biological Standardization 2013, http://www.who.int/biologicals/expert_committee/en/ [accessed 20.03.13].
5. Anonymous The PAHO revolving fund. EPI Newsletter 1979, I(May (1)):3.
6. Anonymous EPI revolving fund vaccines prices. EPI Newsletter 1983, V(June (3)):8.
7. Anonymous Control of vaccines for the EPI program. EPI Newsletter 1979, I(July (2)):6.
8. Anonymous Quality control of biologicals. EPI Newsletter 1982, IV(August (4)):5.
9. Anonymous The importance of testing. EPI Newsletter 1980, II(June (3)):8.
10. WHO Expert Committee on Biological Standardization Procedure for evaluating the acceptability in principle of vaccines proposed to United Nations agencies for use in immunization programmes. Technical Report Series 760 1987, [Annex 1].
11. WHO Expert Committee on Biological Standardization Modification for lyophilized BCG vaccines of the procedure for evaluating the acceptability in principle of vaccines proposed to United Nations agencies for use in immunization programmes. Technical Report Series 771 1988, [Annex 2].
12. WHO Expert Committee on Biological Standardization The national control of vaccines and sera. Technical Report Series 658 1981, [Annex 11].
13. GPV Policy Statement Statement on vaccine quality. WHO/VSQ/GEN/96.02 REV.1 1996.
14. WHO Expert Committee on Biological Standardization Forty second report. Guidelines for national authorities on quality assurance for biological products. Technical Report Series 822 1992, [Annex 2].
15. WHO Expert Committee on Biological Standardization Forty-fifth report. Regulation and licensing of biological products in countries with newly developing regulatory authorities. Technical Report Series 858 1995, [Annex 1].
16. Belgharbi L., Dellepiane N., Wood D. Regulation of vaccines in developing countries. Vaccines 2013, 1454-1463. Elsevier. 6th ed. S.A. Plotkin, W.A. Orenstein, P.A. Offit (Eds.).
17. World Health Organization Vaccine supply and quality. National Control Authority, Guidelines for assessment of vaccine quality in non-producing countries. WHO/VSQ/95.1 1995.
18. World Health Organization Vaccines and biologicals. Regulation of vaccines: building on existing drug regulatory authorities. WHO/V&B/99.10 1999.
19. Perez Cristiá R., Sánchez González C. Capacity building: benchmark system and institutional development plan 2008, Experience of the Cuban National Regulatory Authority, [accessed 20.03.03]. http://www.who.int/(/2_Cuba_ImpactVaccineAssessment.
20. Milstien J., Dellepiane N., et al. Assuring vaccine quality by strengthening regulatory agencies: the work of the World Health Organization. New generation of vaccines 2010, 121-130. Informal Healthcare USA, Inc., New York. 4th ed. M.M. Levine (Ed.).
21. WHO Expert Committee on Biological Standardization Procedure for evaluating the acceptability in principle of vaccines proposed to United Nations agencies for use in immunization programmes. Technical Report Series 786 1989, [Annex 1].
22. Procedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies. WHO/VSQ/97.06 1997.
23. Procedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies. WHO/V&B/02.08 2002.
24. Procedure for assessing the acceptability of vaccines for purchase by United Nations agencies. WHO/IVB/05.19 2005.
25. World Health Organization Procedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies. WHO/BS/10.2155 2010.
26. World Health Organization Assessing the programmatic suitability of vaccine candidates for WHO prequalification. WHO/IVB/12.10 2012.
27. European Medicines Agency Guideline on procedural aspects regarding a CHMP Scientific opinion in the context of cooperation with the World Health Organisation (WHO) for the evaluation of medicinal products intended exclusively for markets outside the community 2005, EMEA/CHMP/5579/04 Rev.1, London.
28. WHO 37th WHO Expert Committee on Specifications for Pharmaceutical Preparations Procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies. Technical Report Series 908 2003, [Annex 8]. 37 ed.
29. World Health Organization Overview of the prequalification of diagnostics assessment process - prequalification of diagnostics, PQDx_007 v4 22 March 2011, [accessed 17.05.13]. http://www.who.int/diagnostics_laboratory/evaluations/110322_pqdx_007_pq_overview_document_v4.pdf.
30. WHO, UNICEF, World Bank State of the world's vaccines and immunization 2009, World Health Organization, Geneva, [accessed 17.05.13]. http://www.who.int/immunization/sowvi/en/, 3rd ed.
31. Global Vaccine Action Plan (2011-2020) WHO 2013. [accessed 05.06.13]. http://www.who.int/immunization/global_vaccine_action_plan/GVAP_doc_2011_2020/en/index.html.
32. Global alliance for vaccines and immunization. Its mission 2013, http://www.gavialliance.org/about/mission/ [accessed 5.06.13].
33. Milstien J.B., Kaddar M. The role of emerging manufacturers in access to innovative vaccines of public health importance. Vaccine 2010, 28:2115-2121.
34. Milstien J.B., Kaddar M., Kieny M.P. The impact of globalization on vaccine development and availability. Health Affairs 2006, 25(4):1061-1069.
35. Vaccines prequalification priority list 3013-2014 2013, http://www.who.int/immunization_standards/vaccine_quality/pq_priorities/en/ [accessed 5.06.13].
36. List of WHO contracted laboratories performing tests on behalf of the WHO vaccine prequalification programme 2013, http://www.who.int/immunization_standards/vaccine_quality/contracted_labs_vaccines/en/index.html [accessed 5.06. 13].
37. Parasuraman A., Zeithaml V.A., Berry L.L. SERVQUAL: a multiple-item scale for measuring customer perceptions of service quality. Journal of Retailing 1988, 64(Spring (1)):12-40.
38. Guide to master formulae 2013, http://www.who.int/immunization_standards/vaccine_quality/guide_to_master_formulae_final_2012.pdf [accessed 17.05.13].
39. Environmental monitoring of clean rooms in vaccine manufacturing facilities 2013, http://www.who.int/immunization_standards/vaccine_quality/env_monitoring/en/index.html [accessed 17.05.13].
40. Format requirements for product summary files 2013, http://www.who.int/immunization_standards/vaccine_quality/PQ_vaccine_manufacturers_guidance/en/index.html [accessed 10/05/13].
41. The Pan American Health Organization revolving fund 2013, http://new.paho.org/hq/index.php?option=com_content&view=article&id=1864&Itemid=4135&lang=en [accessed 13.06.13].
42. Mirza Z. Pooled procurement of medicines and allied commodities. Joint WHO, WIPO, WTO technical symposium access to medicines: pricing and procurement practices 2013, [accessed 03.06.13]. http://www.wto.org/english/tratop_e/trips_e/techsymp_july10_e/mirza_e.pdf.