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Malaria Diagnostics and Medicines. WHO/UNICEF Technical Briefing Seminar Essential Medicines Policies 1 November 2011 - Geneva. Silvia Schwarte Diagnosis, Treatment and Vaccines Global Malaria Programme. Diagnosis: RDTs. Proportion of malaria cases
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Malaria Diagnostics and Medicines WHO/UNICEF Technical Briefing Seminar Essential Medicines Policies 1 November 2011 - Geneva Silvia Schwarte Diagnosis, Treatment and Vaccines Global Malaria Programme
Proportion of malaria cases in Africa confirmed by RDTs Suspected malaria cases tested by microscopy or RDT Preliminary analysis: WHO WMR 2011
Scaling-up RDTs: The example of Senegal (2007-2009) Suspected cases Tested cases Positive cases Treated cases
WHO product testing for malaria RDTs: Round 1 to 3 results for P. falciparum
WHO product testing for malaria RDTs: round 1 to 3 results for P. vivax
RDT improvement from Round 1 to Round 3 for the 23 re-submitted products P. falciparum Mean PDS: 61.3 to 74.7 Median PDS: 63.1 to 83.8 P. vivax Mean PDS: 31.1 to 60.7 Median PDS: 30.0 to 62.9 PDS increase at 200 parasites/ml ‘Test 1’ = 2009, ‘Test 2’ = 2011
Malaria RDT product testing: market impact and funding requirements Funding secured Pledge (soft) No funding secured Response to WHO malaria RDT Product Testing Expression of Interest (EOI) in Rounds 1-4 Funding status for product testing, lot testing and recombinant antigen development
1st-line antimalaria treatment policies in 80 countries with CQ-resistant falciparum malaria Artemether-lumefantrine (AL) Artesunate-amodiaquine (AS-AQ) Artesunate-mefloquine (AS-MQ) Artesunate sulfadoxine-pyrimethamine (AS-SP) Dihydroartemisinin-piperaquine (DHA-PPQ) DHA-PQP 1st-line treatment: - China (or AS-AQ or other) - Cambodia (specific areas) - Ghana (or AL or AS-AQ) - Nigeria (or AL or AS-AQ) - Indonesia - Myanmar (or AL or AS-MQ) - Viet Nam Source: http://www.who.int/malaria/publications/treatment-policies/en/index.html (last updated February 2011)
701.2 million ACT treatment courses suppliedfor public sector use up to 2010 9.1 million treatment courses of DHA-PQP in 2007-10 6-24 months from adoption to implementation GF appeal on ACTs Cumulative number of countries Millions of ACT treatment courses Supply shortage WHO policy on ACTs
Tightening relation between global ACT supply and demand Total orders confirmed: 135.7 million (as of 29.6.11) Warning signs since July 2011: • Longer lead times for ACT orders, i.e. >> 2-4 months • Limited capacity of major ACT manufacturers to accept additional large orders for delivery in 2011 • Increased price of artemisinin on the “spot” market Contributing factors: • Increased volume and number of ACT orders from First-Line-Buyers to AMFm in May - June 2011 ("levers" recently introduced)
Malaria Vaccine (I)RTS,S/AS01 Phase 3 Trial ongoing enrolling over 15,000 African infants RTS,S/AS01 • RT: Malaria protein (Segment of P. falciparum sporozoite surface protein) • S,S: Hepatitis B protein • AS01: Adjuvant system 01 (most potent of many adjuvants tested) • Developed by GSK with funding from BMGF through PATH Malaria Vaccine Initiative (MVI) • Phase 2 data shows 40-60% efficacy over up to 18 months against clinical malaria in 2 recent field trials • Currently in Phase 3 trials, at least 5 years ahead of other candidates • WHO Malaria Vaccine Technical Expert Group constituted in 2009, joint between Vaccine and Malaria Departments (JTEG)
Malaria Vaccine (II)Timing for WHO policy recommendations • First interim data became publicly available on 18 Oct 2011 (NEJM), in a non-target population (5-17 months olds without co-administration of other EPI vaccines): these data will not lead to WHO policy recommendation. • JTEG has advised WHO to base policy recommendation on the review of: • full Phase 3 data in the target population (infants 6 weeks old at first vaccination in co-administration with EPI vaccines) with 30 months follow-up, • site-specific clinical malaria efficacy, • severe malaria efficacy, and • impact of booster dose at 18 months. • WHO policy recommendation may occur in 2015, if Phase 3 data supports it. Policy-makers should be aware that WHO has defined its policy process and does not expect a policy recommendation before 2015 for RTS,S/AS01. • For specific queries contact Dr Vasee Moorthy (e-mail: moorthyv@who.int)