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The African Vaccine Regulatory Forum (AVAREF): Potential to Meet Africa's Needs

African Regulatory Conference (ARC) 10-13 December 2012 . The African Vaccine Regulatory Forum (AVAREF): Potential to Meet Africa's Needs. B.Dicky Akanmori RIN/IVD. Why build vaccine regulatory capacity?. - To ensure the quality, safety, and effectiveness of vaccines.

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The African Vaccine Regulatory Forum (AVAREF): Potential to Meet Africa's Needs

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  1. African Regulatory Conference (ARC) 10-13 December 2012 The African Vaccine Regulatory Forum (AVAREF): Potential to Meet Africa's Needs B.Dicky Akanmori RIN/IVD

  2. Why build vaccine regulatory capacity? • - To ensure the quality, safety, and effectiveness of vaccines. • - Improve access to vaccines and medicinal products in general. • - Minimize/prevent counterfeiting • - Accelerate product development • - Increase confidence of public in vaccines

  3. Drivers for WHO Capacity Building for Regulators • 3. Increase in R&D • Many Sponsors • Support of other regulators • Prioritization of regulation • 4. Initiatives – GAVI, GIVS & GVAP • 5. Young and highly motivated regulators 1. Legal/regulatory framework • Specific legislation • Mandated institutions 2. Regulatory Capacity • Review, approval & oversight of clinical trials. • Guidelines, procedures and documentation • Human resource capacity • Quality Management systems • Enforcement Maiga, Akanmori & Chocarro, Vaccine 2009, 27: 7249-7252

  4. Survey of Legal Framework & Regulatory Capacity (19 Countries of AVAREF) Weak Legal Framework and Regulatory Capacity • Availability of Legal framework (64%) • Clear Mandates for NRA & ECs (64%) • Comprehensive training programme (53%) • Review of Tb, HIV and Malaria vaccine CTs (53%) • Formal communication between ECs and NRAs (3%) • Requirement for registration of CTs– No country • Strategy for capacity building – No country • Quality management system– very few countries. Source: Survey of 19 AVAREF countries conducted by COHRED, 2009

  5. Increase in R&D 2005 2012 Phase One (0) Phase Two (2) Phase Three (0) Phase One (4) Phase Two (7) Phase Three (1) - Phase 1 clinical trials - Challenge studies - Phase 3 clinical trials - More & diverse sponsors – AERAS, TB vaccine alliance, MANET, SANARIA etc. - More clinical trials and field sites

  6. Availability of New Vaccines *4 new vaccines available to NIPs in 4 years!

  7. Prioritization of regulatory issues by product developers

  8. WHO Approach to Capacity Building Network approach – Networking NRAs & ECs Focus on initially identified target countries (19) Vaccine Clinical trials as entry point Innovation Country stewardship and Sustainability Reliance on local expertise Ensuring autonomy of Regulators

  9. Brief History of AVAREF Birth of AVAREF (Accra, Sept 06) Managed by WHO HQ/AFRO January 2005 2005/6 2006 -Development of model regulatory procedures for countries to adapt/adopt Joint reviews of CTAs & joint GCP inspections of phase II CT of Conj. Men A vaccine Using procedures -Identification of Gaps -Network approach for strengthening regulation of clinical trials Annual meetings (2007, 08, 09,10, 11) RegulatorsRecognized Potential strength of networking • Capacity building • Information Sharing • Harmonization Activities Joint Review of RTS,S CTA GCP inspections Dev. & adoption of ACCTD PACTA Project An African Registry - PACTR Currently underway Formalization and expansion of network Secretariat in WHO/AFRO Newsletter & Virtual community

  10. AFRICAN VACCINE REGULATORY FORUM (AVAREF)

  11. AVAREF ACTIVITIES 2. Information sharing – approvals and registrations 1. Linkages with DCVRN, AMRH, PANDRH And other networks 6. Strategy & Guidelines (Pan-African Clinical Trials Alliance, African Common Clinical Trial Guidelines, GCP inspection) NRA EC 3. Training & course Development -HC-Mentorship -WHO/TDR Fellowship -WHO GLO Courses 5. Communication & collaboration – Health Canada, USFDA, European Medicines Agency 4. Joint reviews & inspections

  12. EC/IRBs NRA AVAREF AMAREF PACTA (Pan African Clinical Trial Alliance) PACTA Sharing + Strengthening + Harmonization PACTR Pan African Clinical Trial Registry PACTA= Pan African Clinical Trial Alliance ATM registry

  13. Registered Clinical Trials Source: Pan-African ClinicalTrial Registry (www.pactr.org

  14. Web-based Communication Platform - The AVAREF VIRTUAL COMMUNITY Pillars Enhanced Collaboration 2. Enhance exchange of ideas 1. Cost-effective supplement to face-to-face meetings 3. Frequent continuous communication Botswana Burkina Faso Cameroon Central Africa Republic Ethiopia Gabon Gambia Ghana Kenya Malawi Mali Mozambique Nigeria Rwanda Senegal Sierra Leone South Africa Tanzania Uganda Zambia Zimbabwe

  15. Snapshot of AVAREF Virtual Community

  16. The Potential/Opportunities • Excellent communication platform, apart from face-to-face meetings (AVAREF Virtual Community) • Unique network of ECs and NRAs • Global recognition by sponsors, regulators (HC, EMA FDA) and partners (BMGF Grant 2012 - 2015) • Rapid collective needs identification and dynamic response • Willingness to collaborate and share information

  17. The Potential/Opportunities • Clear strategy and innovations (Joint reviews & Joint inspections) • Training opportunities – WHO/TDR Fellowships (Mozambique NRA – ANVISA Brazil), HC Mentorship, GLO courses • 22 countries with potential to expand to 46 • Vaccines with potential to expand to medicines • Clinical trials but expanding to post-market surveillance and licensure

  18. Partners • EDCTP • Bill & Melinda Gates Foundation • Path/MVI • CBER FDA • Health Canada • EMA

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