Prequalification progress - Vaccines

1. Prequalification progress - Vaccines Dr David Wood, Coordinator, Quality Safety and Standards (QSS), Department of Immunization, Vaccines and Biologicals (IVB)

2. Outline • Review of progress • Current and future synergies

3. Review of progress

4. Vaccines prequalified by WHO: Status 2010 (assured quality) 15 industrialized country mfrs 7 emerging economy country mfrs 24 manufacturers 36 Sites 106 pre-qualified vaccines used in 124 countries 64% total population

5. 100 meetings in 2009 with manufacturers and other stakeholders 31 new vaccine tests available through WHO contracted labs

6. Revision of vaccines PQ procedure • The vaccines prequalification procedure (WHO/IVB/05.19) was last revised in 2005 • WHO plans to update the vaccines prequalification procedure in 2010 to take into account technical, communication and policy revisions • The revision process is described in a concept paper available to meeting participants

7. Prequalification of immunization related equipment – the Performance, Quality & Safety (PQS) scheme A defined scope - 3 functions • Identify requirements & develop and maintain performance specifications and verification protocols. • Pre-qualify products and accredit test laboratories • Monitor products post-market & Prospect innovations A structured organization • Secretariat hosted at WHO • Inter-agencies and intersectoral Steering Committee • Ad hoc working groups according to categories • Involvement of experts from: industry, laboratories, standard bodies, institutions, freelance experts. A PQS Web based database At its final phase of development

8. Performance, Quality & Safety Online published documentation • Published SOPs for all functions • Guidelines for manufacturers (published 6) • Performance specifications & Verification protocols for all product sub-categories • Information sheets on laboratories • Product information sheets for all prequalified products • Soon online catalogue • Online search • Downloadable • Printing option

9. Increase the number of products by category to ensure fair competition Institute a functional user-feedback system Build up on existing active partnerships Develop a tool to assist NRAs in strengthening their role of overseeing the equipment for immunization. Establish a reality check hub for needs assessments and field test of newly developed/introduced devices and equipment. Performance, Quality & Safety The way forward …. Financing of the project Annual cost: US$ 500.000 Cost recovery US$ 150.000 Gap US$ 350.000

10. Current and future synergies

11. Partners (UNICEF, GAVI, BMGF, PATH, manufacturers) More and faster prequalification of vaccines Synergies with/between countries (1) 100% of vaccines used in national immunization programmes are of assured quality by 2013 (SO11 MTSP indicator) • Countries • crisis management for vaccine safety events

12. Synergies with/between countries (2) Functionality of NRA's in key developing countries that supply affordable priority vaccinesis sustained and increased • Observed audits • Regulatory Mentoring to Strengthen Capacity – Health Canada/CDSCO India case study • Networking – Developing Country Vaccine Regulator's Network - Developing Country Vaccine Manufacturer's Network

13. Global Advisory Committee on Vaccine Safety Vaccine prequalified Product licensed by functional NRA Procurement by UN Agencies Industry application Expert Committee on Biological Standardization Synergies with countries (3)Policy coherence WHO policy recommendations (SAGE, vaccine position papers,..) on control of disease through vaccination; schedules for developing countries Prequalification process Global Advisory Committee on Vaccine Safety Functional NRA Expert Committee on Biological Standardization Functional NRA Critical step Interaction/influence

14. Synergies with countries (4) Blueprint for a 21st century system for global vaccine safety Global capacity building and harmonized tools Global analysis and response GACVS Other global or regional advisory bodies WHO and partners** National AEFI surveillance, investigation and response Global signal detection and evaluation Brighton Collaboration Immunization programme Regulatory authority Uppsala Monitoring Centre CIOMS/WHO working group AEFI review committee Other support groups* Global vaccine safety data link Product monitoring Other partners** Vaccine manufacturers Licensing authorities in countries of manufacture Procurement agencies

15. Synergies between PQ programmes • Joint audits of NRA's (2009) - Egypt: review and strengthening of components of the regulatory system -Bangladesh: Joint review of Medicines and Vaccines - Led to joint development plan for support to core activities • Common functions of NRA's (examples) -Marketing authorisation and licensing - Oversight of clinical trials • Internal Working Group - Comparison between the WHO PQ procedures

16. Challenges

17. Vaccine prequalification resource gaps • Relative modest budget (capped at 19.3 million$) given scope of work to service all WHO Member States • Funding gap from 2010 onwards (due to sun-setting of some existing grants, plus high dependency on 1 major donor) • Flexible funds are being lost -disproportionately affects core activities, eg normative work • Ways forward: (a) increase awareness of need for flexible funding of critical core functions (b) business plan to be developed

19. Further information • www.who.int/immunizations • www.who.int/biologicals • www.who.int/vaccine_safety

20. Spare slides

21. PQS Guidelines for Manufacturers A guideline for manufacturers of waste management equipment, WHO/PQS/E10/GUIDE.1.3 A guideline for manufacturers of cold rooms and freezer rooms, WHO/PQS/E01/GUIDE.1.2 A guideline for manufacturers of vaccine refrigerators, vaccine freezers and icepack freezers, WHO/PQS/E03/GUIDE.1.2 A guideline for manufacturers of solar power systems, WHO/PQS/E03/GUIDE.2.2 Guidelines for manufacturers of temperature monitoring devices PQS/E06, WHO/PQS/E06/GUIDE.1.2 Prequalification of single-use injection devices under the PQS system: A guideline for manufacturers, WHO/PQS/E08-E13/GUIDE.1.3

22. PQS categories: progress overview

23. New initiatives Regulatory oversight on the management of time and temperature sensitive pharmaceutical products Harmonized guidelines 2008 ECBS 2009 ECBS ECSPP Landscape analysis of regulatory oversight on PQS items Guidelines United Kingdom, Australia Tunisia, Senegal?, Thailand/Indonesia, Bolivia?

24. New initiatives WHO-PDA Pharmaceutical Cold Chain Management on Wheels Experiential learning Berlinger, LogTag, Blowkings, ColdPack 2010 course 7-12 June 2010, TURKEY

25. Prequalification – vaccines model Procure by UN agencies (UNICEF SD; PAHO RF) Functional National Regulatory Authority List of products of assured quality Global supply base for a product Prequalification by WHO for UN Self-procurement by countries

26. WHO activities that support vaccine, and related equipment, prequalification From Headquarters Regional/Country Offices Norms and Standards for Biologicals (Knezevic) REGULATORY BENCHMARKS New or replacement standards established through ECBS Promotion and implementation of WHO standards Vaccine Quality and Regulation (Dellepiane) REGULATORY SUPPORT Strengthen regulatory systems for vaccines Develop and promote new regulatory pathways for priority vaccines Efficient prequalification of vaccines and immunization equipment Global Vaccine Safety(Zuber) REGULATORY RESPONSE Global Advisory Committee on Vaccine Safety (GACVS) Strengthened global capacity to monitor and manage AEFIs Assessment of and response to global vaccine safety issues