Vector Control Product Development Pathway: 

Phase-Dependent Evidence Gathering 

A Workshop Organized by the 

Division of Microbiology and Infectious Diseases 

National Institute of Allergy and Infectious Diseases/National Institutes of Health 

June 24-25, 2019 

Meeting Report 
 

 

 

 

 

 

 

 

 

 

Table of Contents 

EXECUTIVE SUMMARY..............................................................................................................3 

BACKGROUND .................................................................................................................................3 

Stakeholder Environment & Regulatory Requirements..............................................................3 

MEETING SUMMARY...................................................................................................................5 

INTRODUCTION ................................................................................................................................5 

VECTOR CONTROL PRODUCT DEVELOPMENT LANDSCAPE..............................................................6 

Stakeholder Environment ...........................................................................................................6 

Regulation in the U.S..................................................................................................................6 

WHO Prequalification Process ..................................................................................................7 

WHO Evaluation Pathway for New Products ............................................................................8 

Perspectives from Disease-Endemic Countries..........................................................................9 

GENERATING EVIDENCE AT EACH PHASE........................................................................................9 

Laboratory and Pre-Field Studies (Phase I) ..............................................................................9 

Semi-Field and Small-Scale Studies (Phase II)........................................................................10 

Large-Scale Studies (Phase III)................................................................................................12 

GAPS, CHALLENGES, AND LESSONS LEARNED...............................................................................14 

APPENDIX 1: WORKSHOP AGENDA ............................................................................................17 

APPENDIX 2: PARTICIPANT LIST.................................................................................................20 

APPENDIX 3: RESOURCES...........................................................................................................23 

APPENDIX 4: VECTOR CONTROL PRODUCT DEVELOPMENT PATHWAYS DRAFT DIAGRAM ........25 

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Executive Summary 

Background 

As global progress toward malaria eradication stalls and other vector-borne disease outbreaks 

continue to pose substantial public health threats, there is an urgent need for new and improved 

vector control tools. At the same time, the evidence base for evaluating vector control tools is 

extremely limited. Many developers rely on the World Health Organization (WHO) to evaluate 

and recommend vector control interventions. This workshop was organized to address the need to 

better understand the data requirements for each phase of product testing, including laboratory and 

pre-field studies (Phase I), small-scale field studies (Phase II), and large-scale field studies (Phase 

III). The workshop goals were to: 

• Gather perspectives from industry, regulators, and academia on the process for gathering 

the evidence required to drive novel vector control product development and use. 

• Gain a better understanding of and identify gaps and challenges related to the safety, 

efficacy, quality, and regulatory evidence required to move novel vector control products 

through the different phases of development. 

• Stimulate an ongoing dialogue among different stakeholders involved in vector control 

product development. 

Stakeholder Environment & Regulatory Requirements 

During the final session of the workshop, participants discussed gaps, challenges, and lessons 

learned for each phase of the product development pathway. The following were the main themes 

from these discussions. 

Overall: 

• There is a need to better define the stages of vector control product development and to 

harmonize terminology across agencies and institutions. 

• Building understanding and use of Target Product Profiles (TPPs) and Preferred Product 

Characteristics (PPCs) is a critical need. 

• Better understanding within the research community of WHO’s prequalification process is 

a need and a gap. 

• Engagement with regulators should span the product development process, starting prior to 

Phase I (lab studies) through Phase III (large field trials). 

• It is beneficial to engage local government agencies early and at multiple levels (Ministry 

of Health and local officials). 

• It was noted that the academic mindset is different from the corporate mindset with respect 

to the decision process. In industry, design criteria are used to determine what is working; 

in academia there is a more open-ended mindset. For example, having a TPP is routine in 

industry but could also be important in academia. 

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Laboratory and Pre-Field Studies (Phase I): 

• Phase I studies provide confidence that the product has a chance at succeeding in later 

phases. 

• Bioassays should be related to mosquito behavior, use field-relevant mosquitoes, and 

researchers should take into consideration the effect of the proposed method on other 

regional vectors. 

• In terms of conducting studies that will potentially be in the product’s regulatory dossier, it 

is important to consider the design of the study in the context of the proposed 

implementation of the intervention. 

• With respect to assessing product quality for regulatory approval, there is a need to 

describe the product by its physical and chemical characteristics in the laboratory and to 

consider the methods by which these characteristics will be verified by field testing. 

• Basic research investigators need more resources and information on the factors that they 

should consider before moving forward with the development of a vector control product. 

• In terms of field-relevant mosquitoes, there is concern about how representative laboratory 

colonies are of the situation in the field as some unexpected genetic drifts may take place in 

colonized species. 

• Methods for control and evaluation of other vectors (sand flies, tsetse flies, etc.) may not be 

as developed as those for mosquitoes. 

• Risk assessment and risk management are considerations needed before the in-country 

regulatory agencies will allow field testing of an intervention. These factors typically are 

part of the dossier required by regulatory agencies. 

Small-Scale Field Studies (Phase II): 

• The Phase II stage is the assessment under real world, but contained, environments. It 

involves collaboration with stakeholders, regulatory agencies, and local expertise. It is 

important to identify challenges early and to address them quickly. The design should be 

robust, but not so defined as to prevent flexibility. 

• Resistance monitoring is crucial for defining susceptibility and must take into account the 

mechanism involved. In designing trials, there is an opportunity to learn from other 

industries, e.g., pharmaceutical, agricultural and others. Phenotypic markers and bioassays 

may not always translate to functional resistance and/or product failure or success. 

Diagnostic doses are intended to serve as an early warning of resistance. 

• The design of semi-field and Phase II studies should consider long-term public health 

impacts and opportunities to inform future studies. 

• It is important to think about the mechanistic basis for a failure in Phase I as there can be a 

disconnect between Phase I and Phase II, in that work on a product may have been 

discontinued based on results in the laboratory that might work in the field. For example, a 

product that is sub-lethal in the laboratory may be functionally lethal in the field. In 

considering the experiments and experimental design, it is important to consider how the 

evidence obtained from the work would contribute to the overall approval package. 

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Large-Scale Field Studies (Phase III): 

• A Phase III trial is more likely to be successful when there is high community acceptance, 

early engagement with the Ministry of Health and regulatory authorities, and knowledge of 

the entomology and epidemiology of the local area. 

• In terms of selecting field sites, it is best to focus on hotspots for prevention approaches; 

however, for outbreaks, flexibility is necessary. Consideration should be given to 

complementary activities at sites that could be built upon for the proposed study. 

• Assembly of a multidisciplinary team is very important for success and should include a 

range of expertise, including areas such as epidemiology, modeling, clinical medicine, 

entomology, and social sciences. 

• There is a need for more emphasis on the value of clinical evaluation in the context of 

Phase III trials for vector products. 

• It is important to consider how a new intervention can be integrated into an existing control 

program and work with other interventions. In some local contexts, the emphasis is on 

incorporating new interventions into ongoing work rather than sticking with a single 

intervention. 

• It is important and sometimes a challenge to select both appropriate entomological and 

epidemiological endpoints of public health significance. 

• Regarding WHO prequalification, it is important to keep in mind the target market, as this 

informs the requirements. For example, WHO prequalification is required if the product is 

procured by Global Fund. In other cases, WHO prequalification may not be required, but 

many Ministries of Health find it desirable. 

Meeting Summary 

Introduction 

The purpose of this workshop was to bring together experts in vector control product development 

to discuss the data and evidence requirements along the translational pathway for laboratory/prefield (Phase I), semi-field and small-scale (Phase II), and field/large-scale (Phase III) trials. 

National Institute of Allergy and Infectious Diseases (NIAID) program officers, Drs. Adriana 

Costero-Saint Denis and Ghiorghis Ghenbot, opened the meeting by describing the need to specify 

the evidence base required for novel vector control interventions to move forward through the 

different phases. The goals of the workshop were to: 

• Gather perspectives from industry, regulators, and academia on the process for gathering 

the evidence required to drive novel vector control product development. 

• Gain better understanding and identify gaps and challenges on the safety, efficacy, quality. 

and regulatory evidence required to move novel vector control products through the 

different phases of development. 

• Stimulate an ongoing dialogue among different stakeholders involved in vector control 

product development. 

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Vector Control Product Development Landscape 

Stakeholder Environment 

Dr. Helen Jamet of the Bill and Melinda Gates Foundation (BMGF) provided an overview of the 

product development pipeline and stakeholder environment to emphasize the need for considering 

market segmentation before beginning to develop a product. The product development process 

differs for private market products and those intended for a public/country market. For the private 

market, one would start with user-centered market research to determine what is available and 

what is needed, followed by country registration, consideration of available distribution networks, 

and marketing. For community-based interventions, one would assess the policy evidence for the 

intervention and work with WHO for product evaluation and listing. For country registration, 

consideration should be given to the developmental stage of the country’s system, as some systems 

are less well developed, especially for new products. After country registration, public health 

organizations often work with WHO on scale-up and procurement. In this sense, WHO is a 

doorway to the country market. 

To illustrate the difference in private vs. country markets, Dr. Jamet offered the following 

example: The 2018, global private retail market for mosquito control products was approximately 

$10 billion, including products for disease control and nuisance biting mosquitoes. By contrast, 

the 2017 public health market for mosquito control products was $3.1 billion – much lower than 

the private retail market – and was mostly for malaria control. Major funders included The Global 

Fund, the President’s Malaria Initiative (PMI), endemic country governments, and other country 

governments. In the 2014-2017 Global Fund budget cycle, 83 percent of vector control funding 

was for long-lasting insecticidal nets (LLIN) and 14 percent was for indoor residual spraying 

(IRS). Any new category of intervention in this market must therefore compete for a finite amount 

of funds. 

Those involved in vector control product development should aim to: 1) understand the market 

segment; 2) plan ahead by identifying commercial partners, providing evidence for product claims, 

providing evidence for appropriate policy, developing assays and having them approved, preparing 

regulatory dossiers, defining the product’s pathway through WHO, and addressing the economics 

of acceptable cost-of-goods (COGs) from the donor and user perspective; and 3) achieve good 

communication in terms of donor awareness, driving country demand and creating an enabling 

environment. The latter should include ensuring that the prospective country knows how or why 

the product is to be used and knows the groups that may specifically benefit from the product or be 

at risk from it. 

Regulation in the U.S. 

Dr. Susan Jennings of the U.S. Environmental Protection Agency (EPA) provided an overview of 

the regulation of vector control products in the United States. The specific roles of the U.S. Food 

and Drug Administration (FDA) and the EPA in regulating vector control are defined in “The Final 

Guidance for Industry #236 – Clarification of FDA and EPA Jurisdiction over Mosquito-Related 

Products”, October 2017 (https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/cvm-gfi-236-clarification-fda-and-epa-jurisdiction-over-mosquito-related-products). 

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The guidance states that mosquito-related products intended to function as pesticides by 

preventing, destroying, repelling, or mitigating mosquitoes for population control purposes are not 

“drugs” under the Federal Food, Drug, and Cosmetic Act, and are regulated by the EPA under the 

Federal Insecticide, Fungicide, and Rodenticide Act. By contrast, the FDA has jurisdiction over 

mosquito-related products that are intended to prevent, treat, mitigate, or cure a disease (including 

by an intent to reduce the level, replication, or transmissibility of a pathogen within mosquitoes). 

However, since the release of this guidance, new methods of vector control have been developed 

that do not easily fit into one of these distinct categories, and, in those circumstances, decisions are 

currently being made on a case-by-case basis. 

There are several unique data considerations related to mosquitoes: 1) dissemination is mosquitodependent in that the application rate needs to be defined and the release point does not equal the 

treatment area; 2) the health of the released mosquitoes will depend on several factors including 

their age at time of release, handling conditions during shipping, and fitness costs of the new trait; 

3) the density of the existing wild mosquito population will affect the release numbers needed; 4) 

the potential for accidental female release needs to be addressed by its likelihood, species of 

mosquito, and potential human health and ecological implications. 

Risk assessment and risk management should be considered and addressed. While not all studies 

are required for all submissions, issues that need to be considered include: 1) toxicity for terrestrial 

and aquatic organisms; 2) exposure to workers, bystanders, and ecological species through oral, 

dermal, or inhalation routes; and 3) environmental fate of the product (e.g., degradation in soil, 

water, or air). 

In terms of satisfying data requirements, there are several approaches. If a study is needed, it 

should be conducted in accordance with EPA guidelines. However, it may be possible to cite 

existing data from similar active ingredients/products, in which case “bridging” rationale or studies 

may be needed. Submitters can provide a scientific rationale to address the requirement, such as 

citing scientific literature or providing physical and/or biological characterization of the active 

ingredient and product formulation. Submitters can request a data waiver based on lack of 

exposure or on the relevance of the study to the use patterns of the pesticide. The basis for this 

request must be scientifically defensible. 

With respect to efficacy data for public health pests, Pesticide Registration Notice (PRN) 

(https://www.epa.gov/pesticide-registration/pesticide-registration-notices-year) 2002-1 includes a 

list of pests of significant public health importance, defined broadly to include pests that “pose a 

widely recognized risk to significant numbers of people” (https://www.epa.gov/pesticideregistration/prn-2002-1-lists-pests-significant-public-health-importance). The purpose of such data 

is to promote the control of invertebrate pests of concern and to ensure that labeling provides 

consumers with accurate information concerning how long and how quickly the product works. 

WHO Prequalification Process 

Dr. Marion Law (WHO) described the steps in the WHO evaluation process for vector control 

products. She noted that the WHO is undergoing a major transformation from the WHO Pesticide 

Evaluation Scheme (WHOPES) system to the WHO Prequalification Team (PQT)-Vector Control 

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(VC) framework for registration (https://apps.who.int/iris/bitstream/handle/10665/255644/WHOHTM-GMP-2017.13-eng.pdf). 

The first step is the determination of the relevant pathway. This process enables the WHO to 

provide manufacturers with the most applicable guidance regarding the data requirements and 

specific process to reach prequalification. The two outcomes are the Prequalification Pathway or 

the New Intervention Pathway. 

The Prequalification Pathway involves assessment of the quality, safety, and efficacy of the 

product, as well as the inspection of manufacturing facilities. These issues continue throughout the 

lifetime of the product. The responsibility of the manufacturer involves the development and 

submission of the dossier. The dossier format has six modules: 

• Module 1: Administrative information and labelling 

• Module 2: Discipline summaries 

• Module 3: Quality dossier- Physical/Chemical Data; Declaration of Product Formulation; 

Description of Manufacturing Process; Declaration of Manufacturing Sites; Confidential 

Appendices 

• Module 4: Safety dossier- Acute Toxicology (Acute Inhalation, Acute Oral, Acute Dermal, 

Primary Eye Irritation, Primary Skin Irritation, Dermal Sensitization); Product Risk 

Assessment (Occupational and Residential Exposure); A.I. Specific Hazard Assessment (or 

summary of publicly available information) 

• Module 5: Efficacy dossier- Laboratory Studies (Characterize the efficacy, residual 

activity, and cross-resistance of the active ingredient, and analyze in a controlled 

environment using well-characterized colonies; assess endpoints measuring efficacy; 

conduct testing to estimate efficacy); Semi-Field Studies (Integrate mosquito behavior and 

human dwelling into a more realistic assessment of efficacy in a still relatively controlled 

experimental settings to assess endpoints measuring efficacy; conduct testing to estimate 

efficacy); Field studies (Assess the effectiveness of vector control products in variable 

environments and communities; measure endpoints such as vector longevity, infectivity 

rate, entomological inoculation rate and vector capacity; conduct field studies testing 

households in communities) 

• Module 6: Inspection dossier- Site Master File(s), and an inspection report following the 

manufacturing site inspection. This process involves back-and-forth interaction with the 

manufacturer for information and assessment to reach a decision point. 

Dr. Law indicated that the prequalification format is no longer divided into Phase I, Phase II and 

Phase III. All information is received at one time and the evaluation integrates all factors, with an 

emphasis on the labeling claims of the product. The process ends with a Decision Document 

addressing the approval or disapproval of the submission. 

WHO Evaluation Pathway for New Products 

Dr. Anna Bowman of WHO’s Vector Control Advisory Group (VCAG) 

(https://www.who.int/groups/vector-control-advisory-group) described the WHO’s process for 

evaluating new interventions. WHO’s guidance document, “The Evaluation Process for Vector 

Control Products,” describes the revised evaluation process following the 2017 transition from the 

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WHOPES to the WHO Prequalification Team (PQT), details the role of the VCAG as part of this 

process, and outlines the two pathways and their associated components. It is meant to guide 

interactions between product developers/manufacturers and WHO 

(https://apps.who.int/iris/bitstream/handle/10665/255644/WHO-HTM-GMP-2017.13-eng.pdf). 

Both the prequalification pathway and new intervention pathway involve the VCAG confirming 

the public health value of the proposed product, with the public health value defined as proven 

protective efficacy to reduce or prevent infection and/or disease in humans. VCAG is a crossdepartmental collaboration of the WHO Global Malaria Program (GMP), the Department of 

Control of Neglected Tropical Diseases (NTDs), and the WHO Prequalification Team (PQT) for 

vector control products. For any new vector control tools in new product classes, the WHO 

requires evidence from at least two well conducted, randomized controlled trials (RCT) with 

epidemiological outcomes, and follow-up over at least two transmission seasons. 

Perspectives from Disease-Endemic Countries 

Researchers from local institutions in Mexico, Kenya, and Peru discussed the challenges for 

product development and implementation in their countries. Dr. Pablo Manrique-Saide of the 

Universidad Autónoma de Yucatán described that in Mexico the regulatory framework for vector 

control products is overseen by COFEPRIS (Federal Commission for the Protection against 

Sanitary Risk), through which companies can apply to register products for public health use. The 

Ministry of Health through CENAPRECE (the National Center of Preventive Programs and 

Disease Control) issues an annual call for registered products for use in public health programs. 

Dr. Eric Ochomo of the Kenya Medical Research Institute stated that public health insecticides 

are regulated by the Pest Control Products Board (PCPB) in Kenya. The challenges to registration 

in Kenya include: the process of obtaining funding for the evaluation of vector control products; 

the lack of infrastructure and intellectual capacity; the effect of political influence versus scientific 

evidence on decisions; and the lack of transparency and clarity in the evaluation process. 

Dr. Gissella Vazquez of the U.S. Naval Medical Research Unit No. 6 (NAMRU-6) stated that in 

Peru vector control is focused on malaria and dengue vectors. Each state has its own public health 

directorate which reports to the national Ministry of Health. Peru adheres to the WHO vector 

control guidelines. If a product is not listed by WHO, then permits are required from three 

different local level agencies. One challenge for new products in Peru is the lack of a clear 

communication channel between local public health directorates and the national Ministry of 

Health. 

Generating Evidence at Each Phase 

Laboratory and Pre-Field Studies (Phase I) 

Phase I studies take place in the laboratory and can include pre-field studies of prototypes on a 

small scale. These studies generate crucial data required to proceed with product development. 

Phase I evaluation of LLINs – Dr. Philip McCall of the Liverpool School of Tropical Medicine 

noted the need for new insecticides and control methods to deal with the rapid spread of pyrethroid 

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resistance in Africa. The assays currently used to evaluate new insecticides are often carried out 

under artificial conditions that that have little similarity to natural exposure, focus on short-term 

knockdown, are not always representative of true LLIN action, and provide limited insight into 

slow-acting chemicals or to sub-lethal effects. 

Dr. McCall described three new tests to evaluate active ingredients (AIs) in LLINs. All tests use 

mosquito strains with appropriate insecticide-resistant phenotypes and all are repeated by two 

operators. Rapid impact product measures include: excito-repellency (i.e., behavioral avoidance), 

knockdown, and mortality. Delayed/sub-lethal effects can be measured by follow-up of survivors 

and include longevity, blood-meal inhibition, blood-meal volume, egg batch size, and egg hatch 

rate. 

1. The Video Cone Test Analyzer (ViCTA) is a rapid screen done at close range to assess 

interaction at a treated surface and measures repellency, irritancy, knockdown, and 

mortality. This 3-minute simple test is not dependent on responsive mosquitoes. Its 

disadvantages are 1) that it is forced; 2) net contact is assumed, which can be potentially 

misleading if the netting has repellent or irritant properties which result in reduced contact, 

and thus an underestimation of net efficacy; 3) if no host is present, there may be no 

attraction for some mosquito species and the repellency estimate could be inflated; and 4) 

minimal data are developed from the test. The two main behaviors assessed are flying or 

resting on the net. Resting on the cone is rare. 

2. The Thumb-Test or Baited-box Test is a 20-minute test that details behavior during final 

net approach, landing, contact and exit. The test provides for quantifying net 

repellency/irritancy and other immediate effects; assesses mosquito probing, blood-feeding, 

persistence, success, and duration; and, through follow-up, allows measurement of sublethal impacts on individual mosquitoes. 

3. Room-scale video tracking is a technology that maps how/where nets alter basic responses 

and the location and duration of net contact. It also has the potential to capture effects of 

LLIN over eight hours (i.e., one night). It uses a scan at five seconds and assigns each 

mosquito to one behavior. Dr. McCall showed examples of the kind of data and visuals that 

can be obtained. 

Increasing the value of Phase I testing – Dr. Matthew Thomas of Pennsylvania State University 

described research on the development of a fungal biopesticide for control of adult mosquitoes to 

illustrate three points related to Phase I testing: 1) the need for defining a clear use case; that is, 

why a particular product is needed and what it brings to the table; 2) the need to consider the full 

TPP to guide evaluation and key decision points; and 3) the value of being creative in the design of 

Phase I studies to answer as many questions as possible with respect to an ultimate product. 

Semi-Field and Small-Scale Studies (Phase II) 

Phase II is the transition of an intervention into a semi-field or small-scale field study. The 

following are examples of data needs and considerations for these studies. 

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Assessing Insecticide Resistance – Insecticide resistance is a major challenge in the fight against 

vector-borne diseases. Dr. Audrey Lenhart of the U.S. Centers for Disease Control and 

Prevention (CDC) addressed how insecticide resistance can be assessed along the three phases of 

the developmental pathway. Either in laboratory or semi-field settings of Phase I studies, there 

should be a determination of how effective the AIs in the product are against insecticidesusceptible and insecticide-resistant mosquito strains. This includes the need to understand how the 

mosquito response to the insecticide occurs. The components of such studies include bioassays and 

characterization of the resistance mechanisms of the strains used (e.g., molecular markers, 

synergist assays, etc.). 

For Phase II studies, the key issue is how effective the product is against wild mosquito strains in 

field settings. The components of such studies include: 1) longitudinal monitoring of product 

efficacy against strains of differing resistance phenotypes, including monitoring of residual 

efficacy and bioavailability of the AIs over time; 2) longitudinal monitoring of changes in 

resistance phenotypes of local mosquito strains; and 3) monitoring changes in insecticide 

resistance mechanisms in the mosquitoes (i.e., resistance allele frequencies, gene transcription 

differences, etc.). Phase III studies consider how effective the product is at preventing disease 

and/or pathogen transmission in field trials. The same measurement components are needed as for 

Phase II studies. Data collected on resistance in the field trial settings can allow for the estimation 

of the effect that insecticide resistance may have on epidemiological endpoints. 

For products with multiple AIs, one challenge is disentangling the differential impacts of the AIs 

on resistance – that is, is one AI primarily responsible for mortality while another continues to 

select for resistance? For other approaches, challenges include understanding how genetic markers 

of resistance move through populations; developing assays and identifying molecular markers for 

behavioral resistance; determining if there are behavioral modifications by vectors to avoid contact 

with interventions (i.e., exophily/exophagy); and determining the basis for the lack of an excitorepellency response to spatial repellents. With respect to non-chemical interventions, an important 

issue is determining if there is “resistance’ to harboring Wolbachia or “resistance” to 

entomopathogenic fungi. 

Autocidal Methods against Aedes Mosquitoes – Dr. Stephen Dobson of MosquitoMate, Inc., and 

the University of Kentucky described two new autocidal vector control tools. The first approach is 

based on Wolbachia, an endosymbiotic bacterium that is common in many invertebrate species. 

This method uses repeated inundative releases of Wolbachia-infected male mosquitoes to cause a 

form of conditional sterility, as eggs laid by females don’t hatch. This approach received EPA 

approval for use on Aedes aegypti and Aedes albopictus. The second approach, “AutoDissemination Augmented by Males” (ADAM), employs repeated inundative introductions of 

male Aedes mosquitoes to distribute pyriproxyfen as an inhibitor of Aedes development. 

Dr. Dobson described a small field study in South Miami that used the first approach. The research 

area was a district with two zones, one treated and one untreated, with each area containing 160 

acres and about 460 homes per area and of equal demographics. The choice of the locations was 

acceptable both to the government officials as well as the regulators. In the treated area, there were 

75 release sites, with about 1000 mosquitoes per release event and five events per week. Thus, 

about 370,000 Aedes aegypti per week were released in the treated areas or a total of 6.8 million 

males released over six months. The study design recognized that female mosquitoes from 

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adjacent areas could fly into the study areas. Since females are monogamous and after mating 

carry the sperm with them for life, it was anticipated that there would be some “immigration” from 

non-treated areas and that such female mosquitoes would be resistant to the Wolbachia approach. 

For this reason, the treated area was studied as containing a core area (which was outside the flight 

range for female mosquitoes to fly into) and edge areas that were inside the flight range. The 

results were encouraging. In the untreated areas, Dr. Dobson saw the usual seasonal increase in 

female mosquitoes and a reduced number of females in the treated areas. The “immigration” effect 

was seen along the edges. Overall, there was a 75% reduction of female mosquitoes in the treated 

areas. 

Large-Scale Studies (Phase III) 

Testing Ivermectin for Malaria Control – Ivermectin is an endectocide that is used in animals and 

humans for helminth and ectoparasite control, but researchers are also investigating ivermectin’s 

potential as a malaria intervention. Dr. Brian Foy of Colorado State University summarized a 

Phase III RCT testing ivermectin for malaria control in Burkina Faso. The goals of Dr. Foy’s 

research are to target adult malaria vectors through blood meals, to primarily affect their daily 

probability of survival, but also to affect other variables of vectorial capacity if possible. 

Dr. Foy summarized some of the studies that laid the groundwork for the Phase III trial. For 

observational field data studies, Dr. Foy’s group followed a single ivermectin mass drug 

administration (MDA) that was given by health authorities during the rainy season for the control 

of onchocerciasis or lymphatic filariasis in West Africa. Participants were given pills based on a 

minimum height of ≥90 cm as a surrogate for weight over 15kg. It was estimated that about 75% 

of the population of a “treatment” village’s mosquitoes were collected from homes and 

measurements were done for mortality, parity, and sporozoite rate before and after the MDA and 

compared with control villages that did not participate in the MDA. The results demonstrated that 

the number of older mosquitoes was reduced, and that there were more young mosquitoes and 

fewer sporozoites. 

The Phase III trial in Burkina Faso led by Dr. Foy’s team was a cluster-randomized controlled trial 

with four villages in each arm. The primary outcome of the intervention was a reduced incidence 

of malaria in children in the treatment arm. Assessing a salivary marker in blood as a measure of 

exposure to Anopheles found that children in the ivermectin MDA group received fewer bites 

overall (https://www.sciencedirect.com/science/article/pii/S0140673618323213?via%3Dihub). 

Dr. Foy currently has an NIH-funded cooperative agreement (U01AI138910) to support a doubleblind cluster randomized clinical trial for integrated malaria control using ivermectin. The study 

will integrate repeated high dose ivermectin MDA into the existing monthly seasonal malaria 

chemoprevention (SMC) delivery plan in Burkina Faso, combined with LLIN distribution. The 

broad goal is to develop an evidence base that ivermectin MDA can be easily and safely integrated 

with current measures to significantly enhance malaria control, as well as to preserve the efficacy 

of current tools by adding another synergistic product that targets both vectors and parasites in 

unique ways. The three aims of his study are to: 1) assess the impact of a combined approach of 

repeated ivermectin MDA and SMC on malaria; 2) characterize the entomological, 

pharmacokinetic, and parasitological indices associated with the primary outcome; and 3) define 

the trial’s impact on markers of insecticide and drug resistance in both vectors and parasites. 

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Dr. Foy noted that challenges for this kind of study include safety, resistance development, product 

and regimen development, feasibility, and regulatory issues. He stated that the key lessons are 

embracing the risk, convincing others (reviewers, funders) to do so too, and being open to inviting 

others into your research area, as the Phase III stage and beyond is too big for one research group. 

A product concept is more likely to be embraced by others if more than one group shows positive 

results. 

Targeted Indoor Residual Spraying (TIRS) for Control of Aedes aegypti – Dr. Gonzalo VazquezProkopec of Emory University described his experience testing targeted indoor residual spraying 

(TIRS) for dengue control. The underlying behavior related to the dengue vector Ae. aegypti is that 

the vector spends most of its time resting, is a lazy flyer, preferentially a daytime human biter, and 

seeks blood on an average of every 1.5 days. Prior studies on Aedes behavior showed that there 

was a 17-fold greater chance of finding Ae. aegypti resting in areas below 1.5 meters in height, 

with the mosquitoes resting principally in bedrooms (44%), living rooms (25%), bathrooms (20%), 

and kitchens (9%). 

Studies in Cairns, Australia in 2002 showed that TIRS led to a significant reduction in dengue 

cases. However, the dengue control environment in Cairns is different from endemic settings in 

that it is well-resourced and features a compliant human population, as well as a susceptible Aedes 

population. One major hurdle for using TIRS in other endemic environments, such as Latin 

America, is pyrethroid resistance and the availability of non-pyrethroid formulations. Another 

issue is whether a modified IRS protocol with the right chemistry would offer a sustainable tool in 

the medium term. In this regard, there was a need for information about the epidemiological 

impact of TIRS in endemic settings, ideally generated by randomized trials. 

Dr. Vazquez-Prokopec described the design and results of the first Phase II entomological 

clustered randomized controlled trial (CRCT) in Mexico to evaluate the effectiveness of TIRS 

against pyrethroid-resistant Ae. aegypti. Fourteen clusters of homes were involved with three arms: 

untreated; IRS with bendiocarb (susceptible population); and IRS with deltamethrin (resistant 

population). Entomological measurements were done at 15 days, and at one, two, and three 

months. 

Dr. Vazquez-Prokopec described a second Phase II entomological CRCT in Merida to measure the 

effectiveness of preventive (preseason) TIRS on Ae. aegypti. There were 14 clusters of homes in 

two arms: untreated; and TIRS with pirimiphos-methyl on a susceptible population of mosquitoes. 

The study showed a significant (60-70%) reduction in entomological indices for up to seven 

months. Importantly, Dr. Vazquez-Prokopec found that there was community acceptance of the 

intervention. Additional studies found that a 10 to 20-minute application may protect the home 

environment for up to four (bendiocarb) or seven (pirimiphos-methyl) months. He is currently 

evaluating new formulations and modes of action. 

Dr. Vazquez-Prokopec described further studies and plans in preparation for a two-armed Phase III 

CRCT to estimate the epidemiological impact of a TIRS. The trial would evaluate two paradigms: 

TIRS and prevention control. It would need an international consortium and local Ministry of 

Health participation. The target population would be children 2-15 years of age at the time of 

13 
 

 

 

 

 

 

 

 

 

 

enrollment living within the assigned clusters in the city of Merida, Yucatan, Mexico. The primary 

epidemiological endpoint will be laboratory-confirmed Aedes-borne disease. 

In summary, TIRS appears to be effective at preventing dengue in Australia. Information generated 

from Phase II semi-field and field trials have paved the way to evaluate the epidemiological impact 

in endemic settings. Dr. Vazquez-Prokopec hypothesized that performing preemptive control with 

TIRS will significantly reduce Aedes-borne disease burden in comparison to routine reactive 

vector control strategies. If efficacious, TIRS could drive a paradigm shift in Aedes control by 

incorporating preventive control within the operational toolbox for effective prevention. 

Gaps, Challenges, and Lessons Learned 

During the final session of the workshop, participants discussed gaps, challenges, and lessons 

learned for each phase of the product development pathway. The following were the main themes 

from these discussions. 

Overall: 

• There is a need to better define the stages of vector control product development and to 

harmonize terminology across agencies and institutions. 

• Building understanding and use of TPPs and PPCs is a critical need. 

• Better understanding within the research community of WHO’s prequalification process is 

a need and a gap. 

• Engagement with regulators should span the product development process, starting prior to 

Phase I through Phase III. 

• It is beneficial to engage local government agencies early and at multiple levels (Ministry 

of Health and local officials). 

• It was noted that the academic mindset is different from the corporate mindset with respect 

to the decision process. In industry, design criteria are used to determine what is working; 

in academia there is a more open-ended mindset. For example, having a TPP is routine in 

industry but could also be important in academia. 

Laboratory and Pre-Field Studies (Phase I): 

• Phase I provides confidence that the product has a chance at succeeding in later phases. 

• Bioassays used should be related to mosquito behavior, use field-relevant mosquitoes, and 

researchers should consider the function of the proposed method on other regional vectors. 

• In terms of conducting studies that will potentially be in the product’s regulatory dossier, it 

is important to consider the design of the study in the context of the proposed 

implementation of the intervention. 

• With respect to assessing product quality for regulatory approval, there is a need to 

describe the product by its physical and chemical characteristics in the laboratory and to 

consider the methods by which these characteristics will be verified by field testing. 

• Basic research investigators need more resources and information on the factors that they 

should consider before moving forward with the development of a vector control product. 

• There is a need for laboratory testing to improve consideration of insect behavior. 

14 
• In terms of field-relevant mosquitoes, there is concern about how representative laboratory 

colonies are of the situation in the field as some unexpected genetic drifts may take place in 

colonized species. 

• Methods for control and evaluation of other vectors (sand flies, tsetse flies, etc.) may not be 

as developed as those for mosquitoes. 

• Risk assessment and risk management are considerations normally needed before the incountry regulatory agencies will allow field testing of an intervention. These factors are 

part of the dossier required by regulatory agencies. 

Small-Scale Field Studies (Phase II): 

• The Phase II stage is the assessment under real world, but contained, environments. It 

involves collaboration with stakeholders, regulatory agencies, and local expertise. It is 

important to identify challenges early and to address them quickly. The design should be 

robust, but not so defined as to prevent flexibility. 

• Resistance monitoring is crucial for defining susceptibility and must take into account the 

mechanism involved. In designing trials, there is an opportunity to learn from other 

industries, e.g., pharmaceutical, agricultural and others. Phenotypic markers and bioassays 

may not always translate to functional resistance and/or product failure or success. 

Diagnostic doses are intended to serve as an early warning of resistance. 

• The design of semi-field and Phase II studies should consider long-term public health 

impacts and opportunities to inform future studies. 

• It is important to think about the mechanistic basis for a failure in Phase I as there can be a 

disconnect between Phase I and Phase II, in that work on a product may have been 

discontinued based on results in the laboratory that might work in the field. For example, a 

product that is sub-lethal in the laboratory may be functionally lethal in the field. In 

considering the experiments and experimental design, it is important to consider how the 

evidence obtained from the work would contribute to the overall approval package. 

Large-Scale Field Studies (Phase III): 

• A Phase III trial is more likely to be successful when there is high community acceptance, 

early engagement with the Ministry of Health and regulatory authorities, and knowledge of 

the entomology and epidemiology of the local area. 

• In terms of selecting field sites, it is best to focus on hotspots for prevention approaches; 

however, for outbreaks, flexibility is necessary. Consideration should be given to 

complementary activities at sites that could be built upon for the proposed study. 

• Assembly of a multidisciplinary team is very important for success and should include a 

range of expertise, including areas such as epidemiology, modeling, clinical medicine, 

entomology, and social sciences. 

• There is a need for more emphasis on the value of clinical evaluation in the context of 

Phase III trials for vector products. 

• It is important to consider how a new intervention can be integrated into an existing control 

program and work with other interventions. In some local contexts, the emphasis is on 

incorporating new interventions into ongoing work rather than sticking with a single 

intervention. 

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• It is important and sometimes a challenge to select both appropriate entomological and 

epidemiological endpoints of public health significance. 

• Regarding WHO prequalification, it is important to keep in mind the target market, as this 

informs the requirements. For example, WHO prequalification is required if the product is 

procured by Global Fund. In other cases, WHO prequalification may not be required, but 

many ministries of health find it desirable. 

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APPENDIX 1: Workshop Agenda 

Vector Control Product Development Pathway: Phase-Dependent Evidence Gathering 

June 24-25, 2019 

5601 Fishers Lane, Rockville, MD 

Purpose: Bring together experts in vector control product development to discuss the 

data/evidence requirements along the translational path for laboratory/pre-field (Phase I), semifield and small-scale field trials (Phase II), and large-scale field (Phase III) trials. 

Expected outcomes: 1) Gather perspectives from industry, regulators and academia on the 

processes for gathering the evidence required for novel vector control product development and 

use; 2) Gain better understanding and identify gaps and challenges on the safety, efficacy, quality 

and regulatory evidence required to move novel vector control products through the different 

phases of development; and 3) Stimulate an ongoing dialogue among different stakeholders 

involved in vector control product development. 

DAY 1 - June 24, 2019 

Date/Time Presentation Speaker Topic 

7:45-8:45 AM Registration 

8:45-9:00 AM Welcome and 

Introduction 

Ghiorghis Ghenbot and 

Adriana Costero-Saint Denis 

(NIAID/NIH) 

Background and Expectations 

Session 1: Overview - Vector Control Product Development Landscape 

Chair Adriana Costero-Saint Denis 

(NIAID/NIH) 

9:00 – 9:30 AM Helen Jamet 

BMGF 

Vector Control Product Development 

and the Stakeholder Environment 

9:30 – 10:00 AM Susan Jennings 

EPA 

Regulation of Vector Control Products 

for Use in the U.S. 

10:00 – 10:30 AM Marion Law 

WHO/Evaluation 

WHO Prequalification Process for 

Vector Control Products 

10:30 – 11:00 AM Anna Bowman 

WHO/Policy 

WHO Evaluation Pathway for New 

Vector Control Interventions 

11:00 – 11:15 AM BREAK 

Perspectives from Disease-Endemic Countries (DEC) on Vector Control Product Development: Panel 

Discussion 

Chair Jennifer Armistead 

(USAID) 

11:15 – 11:45 AM Panel 

members 

Pablo Manrique-Saide 

UADY/Mexico 

Challenges for Product Implementation 

in Mexico 

Eric Ochomo 

KEMRI/Kenya 

Challenges for Product Implementation 

in Kenya 

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Gissella Vazquez 

NAMRU-6/Peru 

Challenges for Product Implementation 

in Peru 

11:45 – 12:00 PM Discussion ALL 

12:00 – 1:00 PM LUNCH 

Session 2: Generating Evidence for Phase I and Phase II Studies 

1:00 – 2:00 PM Laboratory/ 

pre-field 

Efficacy, Safety and 

Regulatory Aspects 

Process for established product classes 

(Phase I), challenges for new products 

and product classes 

Chairs Dave Malone (Sumitomo) 

Pablo-Manrique-Saide 

(UADY) 

1:00 – 1:20 PM Philip McCall 

LSTM 

Generating an Evidence Base for 

Evaluating LLINs 

1:20 – 1:40 PM Matthew Thomas 

Pennsylvania State Univ. 

Increasing the Value of Phase 1 Testing 

1:40 – 2:00 PM Discussion ALL Gaps and Challenges 

2:00 – 2:15 PM BREAK 

2:15 – 3:15 PM Semi-field 

and smallscale field 

Efficacy, Safety and 

Regulatory Aspects 

Process for established product classes 

(Phase II), challenges for new products 

and product classes 

Chairs Kurt Vandock (Bayer) and 

Gissella Vasquez (NAMRU6) 

2:15 – 2:35 PM Audrey Lenhart 

CDC 

Assessing Insecticide Resistance Along 

the Translational Pathway 

2:35 – 3:55 PM Stephen Dobson 

MosquitoMate, Inc. and 

University of Kentucky 

Autocidal Methods Against 

Aedes Mosquitoes 

3:55 – 4:15 PM Discussion ALL Gaps and Challenges 

4:15 – 4:30 PM Wrap up 

Preparation 

for Day 2 

Adriana Costero-Saint Denis 

and Ghiorghis Ghenbot 

NIAID/NIH 

4:30 PM Adjourn 

DAY 2- June 25, 2019 

Date/Time Presentation Speaker Topic 

9:00 – 9:15 PM Welcome 

back 

Ghiorghis Ghenbot and 

Adriana Costero-Saint Denis 

NIAID/NIH 

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Session 3: Generating Evidence for Phase III Studies 

Chairs Melinda Hadi (Vestergaard) 

Eric Ochomo (KEMRI) 

Process for established product classes 

(Phase III), challenges for new 

products and product classes 

9:15 – 9:45 AM Brian Foy 

Colorado State Univ. 

Phase III studies Testing Ivermectin for 

Malaria Control 

9:45 – 10:15 AM Gonzalo Vazquez-Prokopec 

Emory University 

Targeted Indoor Residual Spraying 

(TIRS) for the Control of Aedes 

aegypti: Evidence from Phase-I/II to 

Inform a Phase-III Trial 

10:15 – 10:45 AM Discussion ALL participants Gaps and Challenges 

10:45 – 11:00 AM BREAK 

Session 4: Integration and Identification of Gaps and Challenges 

Chair Ghiorghis Ghenbot 

NIH/NIAID 

11:00-11:15 AM Phase I: Dave and Pablo 

11:15 – 11:30 AM Phase II: Kurt and Gissella 

11:30 – 11:45 AM Phase III: Melinda and Eric 

11:45 AM – 12:15 

PM 

Discussion ALL participants What are the gaps/challenges at each 

phase of development? 

How can these gaps/challenges be 

addressed? 

12:15 – 12:30 PM Wrap up and 

Next Steps 

Adriana Costero-Saint Denis 

and Ghiorghis Ghenbot 

12:45 PM Adjourn 

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APPENDIX 2: Participant List 

Jennifer Armistead 

U.S. Agency for International 

Development 

Roberto Barrera 

U.S. Centers for Disease Control and 

Prevention 

John Beier 

University of Miami 

Eric Bohnenblust 

U.S. Environmental Protection Agency 

Anna Bowman 

World Health Organization 

Eric Caragata 

Johns Hopkins Bloomberg School of Public 

Health 

Cristina Cassetti 

National Institute of Allergy and Infectious 

Diseases 

Adriana Costero-Saint Denis 

National Institute of Allergy and Infectious 

Diseases 

Brinda Dass 

Foundation for the National Institutes of 

Health 

Gregory Deye 

National Institute of Allergy and Infectious 

Diseases 

Stephen Dobson 

MosquitoMate, Inc. 

Molly Duman Scheel 

Indiana University School of Medicine 

and University of Notre Dame 

Sally Eatmon 

National Institute of Allergy and Infectious 

Diseases 

Noel Elman 

GearJump Technologies 

Joseph Fireman 

Verily Life Sciences 

Brian Foy 

Colorado State University 

Ghiorghis Ghenbot 

National Institute of Allergy and Infectious 

Diseases 

Melinda Hadi 

Vestergaard 

Catherine Hill 

Purdue University 

Steve Huang 

National Institute of Allergy and Infectious 

Diseases 

Audrey Hutter 

Bill and Melinda Gates Foundation 

Maliha Ilias 

National Institute of Allergy and Infectious 

Diseases 

Stephanie James 

Foundation for the National Institutes of 

Health 

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Helen Jamet 

Bill & Melinda Gates Foundation 

Susan Jennings 

U.S. Environmental Protection Agency 

Chung-Yan Koh 

Defense Advanced Research Projects 

Agency 

David Larsen 

Syracuse University 

Marion Law 

World Health Organization 

Audrey Lenhart 

U.S. Centers for Disease Control and 

Prevention 

Erica Lindroth 

Armed Forces Pest Management Board 

Michael Macdonald 

Innovative Vector Control Consortium 

Hannah MacLeod 

Johns Hopkins Bloomberg School of 

Public Health 

David Malone 

Sumitomo Chemical Co. 

Pablo Manrique Saide 

Universidad Autónoma de Yucatán 

Jeannette Martinez 

World Health Organization 

martinezjea@who.int 

Philip McCall 

Liverpool School of Tropical Medicine 

philip.mccall@lstmed.ac.uk 

Christina McCormick 

National Institute of Allergy and Infectious 

Diseases 

Gunter Muller 

USTTB Bamako University Mali 

Effie Nomicos 

National Institute of Allergy and Infectious 

Diseases 

Douglas Norris 

Johns Hopkins Bloomberg School of Public 

Health 

Eric Ochomo 

Kenya Medical Research Institute 

Jean Patterson 

National Institute of Allergy and Infectious 

Diseases 

Amanda Pierce 

U.S. Environmental Protection Agency 

Sarah Rees 

Innovative Vector Control Consortium 

Alan Reynolds 

U.S. Environmental Protection Agency 

Jennifer Saunders 

U.S. Environmental Protection Agencys 

Nicole Scott 

Cybele Microbiome Inc. 

Colleen Sico 

National Institute of Allergy and Infectious 

Diseases 

Nigel Snoad 

Verily Life Sciences 

Susan Spring 

Freelance Science Writer 

21 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Dan Stoughton 

National Institute of Allergy and Infectious 

Diseases 

Wiebke Striegel 

U.S. Environmental Protection Agency 

Matthew Thomas 

Penn State University 

Karen Tountas 

Foundation for the National Institutes of 

Health 

Kurt Vandock 

Bayer U.S. LLC 

Gissella Vasquez 

U.S. Naval Medical Research Unit 

No.6 

Gonzalo Vazquez Prokopec 

Emory University 

Andre Wilke 

University of Miami 

Gabriela Zollner 

Armed Forces Pest Management Board 

22 
 

 

 

 

 

 

 

APPENDIX 3: Resources 

National Institute of Allergy and Infectious Diseases (NIAID): 

• Resources for Researchers: https://www.niaid.nih.gov/research/resources 

• Preclinical Services: https://www.niaid.nih.gov/research/resources 

• Reagents: https://www.beiresources.org/Home.aspx 

• Live vectors: https://www.beiresources.org/Catalog/VectorResources.aspx 

World Health Organization (WHO): 

• Vector Control Advisory Group: https://www.who.int/groups/vector-control-advisorygroup 

U.S. Environmental Protection Agency (EPA): 

Product Registration: 

• https://www.epa.gov/ingredients-used-pesticide-products 

• https://www.epa.gov/pesticide-registration/registration-requirements-and-guidance 

• https://www.epa.gov/pesticide-registration 

• Pesticide Registration Manual: Chapter 12 - Applying for an Experimental Use Permit (EUP) 

Pesticides and Biotechnology: 

• https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/epas-regulationbiotechnology-use-pest-management 

• https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/modernizing-regulatorysystem-biotechnology-products 

U.S. Food and Drug Administration (FDA): 

• Regulation of Mosquito-Related Products (GFI #236) (January 2017) 

• Regulation of Intentionally Altered Genomic DNA in Animals (GFI #187) (January 

2017) 

Environmental Assessment Explained: 

• EPA: Testing Requirements to Assess Risks to Human Health and the Environment 

• Guidance on the environmental risk assessment of genetically modified animals 

Modernizing the Regulatory System for Biotechnology Products: 

Final Version of the 2017 Update to the Coordinated Framework for the Regulation of 

Biotechnology - 2017_coordinated_framework_update 

U.S. Agency for International Development (USAID): 

• Combating Zika and Future Threats: A Grand Challenge for Development 

https://www.usaid.gov/grandchallenges/zika 

23 
 

 

 

U.S. Centers for Disease Control and Prevention (CDC): 

• Preparing the Nation to Address Vector-Borne Disease Threats 

https://www.cdc.gov/ncezid/dvbd/about/prepare-nation.html 

• Vector-Borne Disease Regional Centers of Excellence 

https://www.cdc.gov/ncezid/dvbd/about/prepare-nation/coe.html 

• Division of Vector-Borne Diseases 

https://www.cdc.gov/ncezid/dvbd/index.html 

Armed Forces Pest Management Board (DoD): https://www.acq.osd.mil/eie/afpmb/ 

Publications of Interest: 

• Global Vector Control Guidelines – The Need for Co-Creation (2019) 

https://www.sciencedirect.com/science/article/pii/S1471492218302708?via%3Dihub 

• Intersectoral Collaboration for the prevention and control of vector-borne diseases to 

support the implementation of a global strategy: A systematic review (2018) 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6179246/pdf/pone.0204659.pdf 

• Developing multi-sectoral approaches to prevent and control vector-borne diseases 

(2017) 

https://www.who.int/tdr/news/2017/multi-sectoral-approaches-to-prevent-vbd/en/ 

• Evidence-based vector control? Improving the quality of vector control trials (2015) 

https://reader.elsevier.com/reader/sd/pii/S1471492215000975?token=021ACBF1513AE3 

0D343B13087F6BFD0B2977381ED575BCA393A0B8176730AB5C68C287DBE35574 

127DF28C9F9FC65CF9 

• Framework for rapid assessment and adoption of new vector control tools (2014) 

https://reader.elsevier.com/reader/sd/pii/S1471492214000348?token=7A2CB3CC6AC35 

B340D2DD1190E428F54FF72431FA2C03807068AA17E4946E36D50A33CBE5A7C0 

105F433808E355AEB41 

24 
 

 

 

APPENDIX 4: Vector Control Product Development Pathways Draft Diagram 

PQT: Prequalification Team, VCAG: Vector Control Advisory Group, GMP: Global Malaria Program, NTD: Neglected tropical diseases, 

MPAC: Malaria Policy Advisory Committee, STAG: Strategic and Technical Advisory Group 

25