Malaria Diagnostics and Medicines Malaria Diagnostics and Medicines Silvia Schwarte Diagnosis,...

Malaria Diagnostics and

Medicines

Malaria Diagnostics and

Medicines

Silvia Schwarte Diagnosis, Treatment and VaccinesGlobal Malaria Programme

WHO/UNICEF Technical Briefing SeminarEssential Medicines Policies1 November 2011 - Geneva

2 Global Malaria Programme

WHO/UNICEF TBS | 1 November 2011

Diagnosis: RDTs



Suspected malaria cases tested by microscopy or RDT

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Africa

Americas

Eastern Mediterranean

Europe

South-East Asia

Western Pacific

Preliminary analysis: WHO WMR 2011

Proportion of malaria cases in Africa confirmed by RDTs



Scaling-up RDTs: The example of Senegal (2007-2009)

Suspected cases

Tested cases

Treated cases

Positive 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

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 securedPledge (soft)No funding secured



Treatment: ACTs


WHO/UNICEF TBS | 1 November 2011 (last updated February 2011)

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

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



0.5 0.6 2.1 5

31.3

82.7

97

130

165

182

0

50

100

150

200

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

0

10

20

30

40

50

60

70

80

ACT procured No countries: ACT 1st line No countries deploying

6-24 months from adoption to implementation6-24 months from adoption to implementation

Mil

lio

ns

of

AC

T t

reat

men

t c

ou

rses

Cu

mu

lati

ve n

um

ber

of

cou

ntr

ies

WHO policy on ACTsWHO policy on ACTs

GF appeal GF appeal on ACTson ACTs

GF appeal GF appeal on ACTson ACTs

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

Supply shortageSupply

shortage



Tightening relation between global ACT supply and demand

Warning signsWarning 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” marketContributing factorsContributing 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

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: [email protected])



Thank you

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