th WHO Vector Control Advisory Group Meetingof pathway Assess public health value Assess product...
Transcript of th WHO Vector Control Advisory Group Meetingof pathway Assess public health value Assess product...
11th WHO Vector Control Advisory Group Meeting
VCAG update
Anna Bowman, VCAG Project Manager
Why evaluate new tools?
• Without evidence WHO can’t develop well informed policies
• “WHO’s legitimacy and technical authority lie in its rigorous adherence to systematic use of evidence as the basis for all policies” 12th
GPW
Evaluation Pathway for vector control products
Assess product safety, quality and efficacy
Inspect manufacturing facilities to ensure quality
Academia, developers, manufacturers and PDPs VCAG PQ
GMP and NTD with support of MPAC/STAG
Outcome
1. Consisting of staff from PQT, GMP and NTD
Pre-qualify product
(product listing)
Intervention class with WHO policy recommendation
Intervention class without WHO policy
recommendation
Submit request for
determination of pathway
Assess public health value
Assess product safety, quality and efficacy
Inspect manufacturing facilities to ensure quality
Develops policy recommendation
Pre-submission
Coordination Committee1
PH value confirmed
Safety, quality and efficacy confirmed
PH value confirmed
WHO policy recommendation
Efficacy, safety and quality confirmed
Within WHO, VCAG assesses the public health (PH) value of new intervention classes
The role of VCAG
Functions
1. To provide guidance to applicants, through WHO, on the generation of epidemiological data and study designs to enable assessment of the public health value of new vector control interventions
2. to assess the public health value of new vector interventions submitted to WHO
3. to provide advice to WHO, for submission to the Malaria Policy Advisory Committee (MPAC) and the Strategic and Technical Advisory Group for neglected tropical diseases (STAG), on the public health value of new interventions.
• Public health value is defined as: proven protective efficacy to reduce or prevent infection and/or disease in humans.
Updated VCAG Terms of Reference
• Core role to assess public health value (epi impact) of new interventions has remained the same
• The scope of VCAG has changed over time
VCAG Prequalification and VCAG
Assessment of public health value (epi studies and associated entoendpoints)
Also provided advice to product developers on topics such as:• efficacy and safety, • economic feasibility • user acceptability.
VCAG ToRs revised to focus role on assessment of public health value (epi studies and associated ento endpoints)
VCAG improvement plan
• Independent assessment of VCAG sustainability conducted by BCG (Nov 2017 – March 2018)
• Process involved consultation with 21 stakeholders and identification of areas for improvement
• Taking into account feedback WHO VCAG Secretariat developed an improvement plan that was shared at the 8th VCAG meeting in May 2018
Results from VCAG Improvement Plan
High-level achievements:
• Roles and responsibilities of WHO departments defined
• VCAG ToRs updated to clarify role of VCAG
• SoPs developed to clarify processes
• VCAG membership diversified: gene drive, regulatory and ex-industry
• Off-cycle reviews implemented, which improve timeliness
• Feedback loops improved, regularly seek input
• Communications improved: new website, updates through vector control mailing list, WebEx, transparency of interventions under review
Improvements made since May 2019
• VCAG SoPs updated to include off-cycle review processes and procedures
• Action taken based on feedback from VCAG 10 applicants (e.g. increased timing of interactions, clarified processes, etc.).
• VCAG Information sheet
• Improved processes to onboard new members and ad hoc experts • Continuing practice of VCAG 101
• Pre-calls for each working group
VCAG: next steps
• Update / revise two key documents to align with revised GMP policy-making process:• The evaluation process for
vector control products
• How to design vector control efficacy trials
VCAG portfolio overview
10Intervention
types
16 Intervention
classes
69%Planning or
conducting epi trials
38% conducting studies
11 tools for malaria (incl. 5 new nets)5 tools for Aedes-borne diseases1 tool for Leishmaniasis control
Intervention type
DescriptionIntervention
classPrototype / product
Status in WHO evaluation process
Target Disease
Insecticide-treated nets
Mosquito nets treated with chemicals either as single products or as combinations
Non-pyrethroid insecticide net
Yorkool LN (OP) Safety assessment by PQ Malaria
Pyrethroid plus non-pyrethroid insecticide net
Interceptor® G2 (pyrethroid-chlorfenapyr)
Field trial in progress Malaria
Pyrethroid plus insect growth regulator net
Royal Guard LN (pyrethroid-pyriproxifen)
Field trial in progress Malaria
Pyrethroid plus piperonylbutoxide (PBO) net*
Olyset® Plus Field trial in progress Malaria
Spatial Repellents Devices that release volatile chemicals in the air and prevent human/vector contact within the treated space
Spatial Repellents Transfluthrin passive emanator
Results from one trial shared at VCAG 10. Planning further field trials.
Malaria and dengue
Attractive Targeted Sugar Baits
Devices that attract and kill disease vectors
Attractive Targeted Sugar Bait (ATSB)
ATSB®, mosquitoes’ bait station
Field trials in planning Malaria
Peri-domestic combined repel and lure devices
Devices placed around a house and/or its surrounding (push and pull/repel and lure)
Repel and lure strategy for malaria control
The approach consists of two devices: 1) repels mosquitoes from houses and immediate surroundings (the “push”) and 2) lures mosquitoes towards odor-baited traps (the “pull”)
Concept and preliminary elements of an RCT reviewed by VCAG
Malaria
Genetic manipulation of vectors for disease control
Reduction or alteration of vector populations through genetic manipulation
Population reduction –gene-drive approach
CRISP/Cas9 - suppression construct in An. gambiae
Initial lab data reviewed by VCAG
Malaria
Population alteration –gene-drive approach
Cas9- based gene drive -anti-P. falciparum and/or anti-P. vivax constructs
Initial lab data reviewed by VCAG
Malaria
Systemic insecticides and endectocides
MDA of an endectocide to humans +/- livestock to reduce malaria transmission
Endectocides Ivermectin repurposed for malaria
Field trials in planning Malaria
Housing modification
Modification to housing to decrease exposure of inhabitants to vectors
Lethal House Lures In2Care®EaveTube with electrostatically charged coating for delivery of powder formulations
Results from one trial to be shared at VCAG 11
Malaria
Malaria-focused tools
Aedes-focused toolsIntervention
typeDescription
Intervention class
Prototype / productStatus in WHO
evaluation processTarget
Disease
Spatial Repellents Devices that release volatile chemicals in the air and prevent human/vector contact within the treated space
Spatial Repellents Transfluthrin passive emanator
Field trials in progress Malaria and dengue
Vector traps for disease management
Devices that lure and kill vectors Adulticidal oviposition and larvicidal traps
Vector traps including AGO trap, Trap-N-kill ® trap and ALO
ALO concept review May 2019
Aedes-borne viral disease
Auto-dissemination devices
In2Care® Mosquito Trap Field trials in planning Aedes-borne viral disease
Sterile insect technique (SIT) combined with microbial infection
Radiation-based sterility for mosquito population reduction and bacterial infection to prevent virus transmission
Sterile Insect Technique / Incompatible InsectTechnique
Sterilized male Ae. aegypti and Ae. albopictus infected with Wolbachia spp.
VCAG reviewed RCT protocol
Aedes-borne viral disease
Microbial control of human pathogens in adult vectors
Introduction of micro-organisms into vectors to alter target phenotypes
Wolbachia-based population alteration
wMel strain Wolbachia in Aedes aegypti
Field trial in progress Aedes-borne viral disease
Interventiontype
DescriptionIntervention
classPrototype / product
Status in WHO evaluation process
Target Disease
Systemic insecticides and endectocides
Systemic insecticide treatment of livestock to reduce or prevent transmission of pathogens transmission to humans
Systemic cattle treatment for vector control
Fipronil bolus VCAG reviewed protocol in 2017
Leishmaniasis
Leishmaniasis
At this meeting
Protocol reviews
• Spatial Repellents
• Endectocides
• Wolbachia Suppression
• PBO nets – Uganda trial (Statistical Analysis Plan)
Results from one trial
Lethal House Lures