1. Diagnostics and Medicines
Malaria
Diagnostics and Medicines
WHO/UNICEF Technical Briefing Seminar
Essential Medicines Policies
1 November Geneva
Silvia Schwarte
Diagnosis, Treatment and Vaccines
Global Malaria Programme

2. Diagnosis: RDTs

3. Suspected malaria cases tested by microscopy or RDT
Proportion of malaria cases
in Africa confirmed by RDTs
Preliminary analysis: WHO WMR 2011

4. Scaling-up RDTs: The example of Senegal (2007-2009)
Suspected cases
Tested cases
Positive cases
Treated cases

5. WHO product testing for malaria RDTs:
Round 1 to 3 results for P. falciparum

6. WHO product testing for malaria RDTs:
round 1 to 3 results for P. vivax

7. 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

8. 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

9. Treatment: ACTs

10. (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:
(last updated February 2011)

11. 701.2 million ACT treatment courses supplied for public sector use up to 2010
9.1 million treatment courses of DHA-PQP in
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

12. 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 )

13. Vaccines

14. 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)

15. 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 (

16. Thank you