Diagnostics and Medicines 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

Suspected malaria cases tested by microscopy or RDT Proportion of malaria cases in Africa confirmed by RDTs 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 PDS increase at 200 parasites/ml 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 ‘Test 1’ = 2009, ‘Test 2’ = 2011 7

Malaria RDT product testing: market impact and funding requirements 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 Funding secured Pledge (soft) No funding secured

Treatment: ACTs

(last updated February 2011) 1st-line antimalaria treatment policies in 80 countries with CQ-resistant falciparum malaria 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 Artesunate sulfadoxine-pyrimethamine (AS-SP) Dihydroartemisinin-piperaquine (DHA-PPQ) Artesunate-amodiaquine (AS-AQ) Artesunate-mefloquine (AS-MQ) Artemether-lumefantrine (AL) Source: http://www.who.int/malaria/publications/treatment-policies/en/index.html (last updated February 2011)

701.2 million ACT treatment courses supplied for 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 Millions of ACT treatment courses Cumulative number of countries Supply shortage WHO policy on ACTs

Tightening relation between global ACT supply and demand 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) Total orders confirmed: 135.7 million (as of 29.6.11)

Vaccines

Malaria Vaccine (I) RTS,S/AS01 Phase 3 Trial ongoing enrolling over 15,000 African infants 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)

Thank you