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Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=ierv20 Download by: [University of Michigan] Date: 17 April 2016, At: 04:31 Expert Review of Vaccines ISSN: 1476-0584 (Print) 1744-8395 (Online) Journal homepage: http://www.tandfonline.com/loi/ierv20 International Dengue Vaccine Communication and Advocacy: Challenges and Way Forward Ana Carvalho, Rebecca Van Roy & Jon Andrus To cite this article: Ana Carvalho, Rebecca Van Roy & Jon Andrus (2016) International Dengue Vaccine Communication and Advocacy: Challenges and Way Forward, Expert Review of Vaccines, 15:4, 539-545, DOI: 10.1586/14760584.2016.1152187 To link to this article: http://dx.doi.org/10.1586/14760584.2016.1152187 Accepted author version posted online: 08 Feb 2016. Published online: 17 Mar 2016. Submit your article to this journal Article views: 93 View related articles View Crossmark data Citing articles: 1 View citing articles

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Page 1: Ana Carvalho, Rebecca Van Roy & Jon Andrussrisawat/temp/International.pdf · dengue vaccines. Waiting to plan and advocate for the intro-duction of new vaccines until licensure, as

Full Terms & Conditions of access and use can be found athttp://www.tandfonline.com/action/journalInformation?journalCode=ierv20

Download by: [University of Michigan] Date: 17 April 2016, At: 04:31

Expert Review of Vaccines

ISSN: 1476-0584 (Print) 1744-8395 (Online) Journal homepage: http://www.tandfonline.com/loi/ierv20

International Dengue Vaccine Communication andAdvocacy: Challenges and Way Forward

Ana Carvalho, Rebecca Van Roy & Jon Andrus

To cite this article: Ana Carvalho, Rebecca Van Roy & Jon Andrus (2016) International DengueVaccine Communication and Advocacy: Challenges and Way Forward, Expert Review ofVaccines, 15:4, 539-545, DOI: 10.1586/14760584.2016.1152187

To link to this article: http://dx.doi.org/10.1586/14760584.2016.1152187

Accepted author version posted online: 08Feb 2016.Published online: 17 Mar 2016.

Submit your article to this journal

Article views: 93

View related articles

View Crossmark data

Citing articles: 1 View citing articles

Page 2: Ana Carvalho, Rebecca Van Roy & Jon Andrussrisawat/temp/International.pdf · dengue vaccines. Waiting to plan and advocate for the intro-duction of new vaccines until licensure, as

REVIEW

International Dengue Vaccine Communication and Advocacy: Challenges andWay ForwardAna Carvalho, Rebecca Van Roy and Jon Andrus

Sabin Vaccine Institute, Washington, DC, USA

ABSTRACTDengue vaccine introduction will likely occur soon. However, little has been published on interna-tional dengue vaccine communication and advocacy. More effort at the international level is requiredto review, unify and strategically disseminate dengue vaccine knowledge to endemic countries’decision makers and potential donors. Waiting to plan for the introduction of new vaccines untillicensure may delay access in developing countries. Concerted efforts to communicate and advocatefor vaccines prior to licensure are likely challenged by unknowns of the use of dengue vaccines andthe disease, including uncertainties of vaccine impact, vaccine access and dengue’s complex patho-genesis and epidemiology. Nevertheless, the international community has the opportunity to applyprevious best practices for vaccine communication and advocacy. The following key strategies willstrengthen international dengue vaccine communication and advocacy: consolidating existing coali-tions under one strategic umbrella, urgently convening stakeholders to formulate the roadmap forintegrated dengue prevention and control, and improving the dissemination of dengue scientificknowledge.

ARTICLE HISTORYReceived 20 October 2015Accepted 5 February 2016

KEYWORDSDengue; dengue vaccine;vaccines; vaccineintroduction;communication; advocacy;internationalcommunication andadvocacy; decision making;dengue-endemic countries;strategic communication;framing; social marketing

Introduction

Dengue is a vector-borne vaccine-preventable disease.Approximately eight dengue vaccine candidates are under-going clinical studies of which one candidate received limitedmarketing authorization in three countries (Mexico, thePhilippines, and Brazil) in December 2015. A vaccine will beavailable in the near future to help reduce dengue burden ofdisease (Box 1) [1–5].

However, uncertainties remain regarding the use of denguevaccines. Although nearly half of the world’s population is atrisk [2], many countries are unaware of the disease burden. A2015 survey showed that only 9% of Americans know aboutthe danger of dengue in the United States [6]. Further, entireregions suffer from economic, physical, and emotional distresscaused by dengue. Informed citizens in many dengue-ende-mic countries are capable of pressuring Ministries of Health toprevent the disease. As a result, dengue is a priority in suchcountries as India, Sri Lanka, Thailand, Vietnam, Brazil,Colombia, Mexico, and Nicaragua [7–10].

Public health officials and other dengue stakeholders grap-ple with multiple complex issues. These issues include

● dengue’s low mortality and high morbidity, compared toother health threats;

● varied efficacies by serotype, i.e. the lack of tetravalentefficacy, of the currently most advanced vaccine candi-date, Sanofi’s CYD-TDV (a potential safety concern);

● the unknown price per dose;● duration of vaccine-induced immunity;

● the number of doses that will be required to significantlyreduce disease burden (if three doses are required toachieve a certain efficacy and the immunization programfails to deliver all three, efficacy and disease impact willbe affected);

● the benefits of introduction in regions where dengueburden is still unknown;

● the potential use of dengue vaccines for people travelingto endemic countries;

● the date of market availability of vaccines, including thedevelopment timeline for the dengue vaccine pipeline.

The eight candidates in clinical trials include: CYD-TVD(Dengvaxia®) by Sanofi Pasteur, which has been approved inMexico, the Philippines and Brazil for people between theages of 9 and 45 years, living in dengue endemic areas;TV003 by Butantan Institute and the National Institute ofAllergy and Infectious Diseases at the National Institutes ofHealth (NIH) in Phase III; TDV by Takeda in Phase II; and TDENVPIV by GlaxoSmithKline (GSK)/Walter Reed Army Institute ofResearch (WRAIR)/Fiocruz, TDENV – LAV + TDENV – PIV byWRAIR, TVDV by the Naval Medical Research Center, TV005by Panacea Biotec and V180 by Merck, in Phase I (see Figure 1and Box 2 for more information).

Dengue-endemic countries need accessible informationabout dengue vaccines that is grounded in scientific evidence.While global and regional strategies for dengue preventionand control already exist [11–14], as does literature on denguedisease communication and advocacy [10], little has beenpublished on dengue communication and advocacy regarding

CONTACT Ana Carvalho [email protected]

EXPERT REVIEW OF VACCINES, 2016VOL. 15, NO. 4, 539–545http://dx.doi.org/10.1586/14760584.2016.1152187

© 2016 Taylor & Francis

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dengue vaccines. Waiting to plan and advocate for the intro-duction of new vaccines until licensure, as routinely occurs,may unnecessarily delay access in developing countries byyears [15]. In order to reduce suffering more quickly, planningneeds to begin now. Communication and advocacy focusingon dengue vaccines must be designed and implementedproactively [14]. By doing so, dengue-endemic countries can

more swiftly provide vaccines to their citizens once the deci-sion is made to introduce them. As suggested by the Academyof Educational Development and UNICEF in ‘Why Invest inCommunication for Immunization:’

Knowing about vaccination, although important, does not neces-sarily lead to immunization acceptance. The impact of informationon immunization behavior is mediated by socio-cultural and

Box 1. During the review of this article, Dengvaxia®, Sanofi Pasteur’s dengue vaccine, received approval for limited marketing in Mexico onDecember 9, the Philippines on 22 December and Brazil on 28 December 2015. The national regulatory agency of each country granted theapproval, which applies specifically to individuals between the ages 9 and 45 years living in dengue-endemic areas in these three countries.

Figure 1. Dengue Vaccine Candidates in Clinical Development as of March 3, 2016.

box 2. 3TDENV – LAV + TDENV – PIV is being developed for immunological assessment, as opposed to vaccine development like all othercandidates listed.4Panacea Biotech is using NIH’s vaccine formulation. NIH has licensed its strains to several manufacturers in developingcountries, like Panacea Biotech in India. Other manufacturers using NIH vaccine formulation include Butantan Institute in Brazil (currently inPhase III trials), Serum Institute of India, in India, and Vabiotech, in Vietnam (both currently in preclinical trials).

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political influences, a situation that calls for locally appropriatecommunication responses. [. . .] Without well-planned, adequatelyfunded strategic communication, immunization programs fall shortof meeting and sustaining coverage goals [16].

This article reviews from an international perspective denguecommunication and advocacy; describes current dengue com-munication and advocacy in relation to vaccines and identifiescurrent challenges; offers recommendations based on lessonslearned from past vaccine introductions; and provides a viewof dengue vaccine communication and advocacy for the nextfive years.

Dengue communication and advocacy

Most dengue-related communication and advocacy hasfocused on the individual, neighborhoods, schools, andhouses near areas where dengue cases have been confirmed.Little attention has been given to creating and sustaining adialogue at the decision-making level [13]. Media coverage ofdengue countries also varies substantially. Additionally, den-gue communication strategies that reinforce advocacy effortsare often lacking, resulting in short-term campaigns and ad-hoc activities as reactions to outbreaks [12].

Nevertheless, the increasing spread of the disease coupledwith recent achievements in the vector-control and vaccinefields has resulted in dengue being relatively higher on theglobal health agenda. A recent example is the World HealthOrganization’s campaign for World Health Day in 2014, whichfocused on the message ‘small bite, big threat:’ ‘A globalhealth agenda that gives higher priority to vector controlcould save many lives and avert much suffering’ [17]. Thecampaign highlighted dengue as one of the fastest-spreadingvector-borne diseases [18]. But, more needs to be done.

International organizations and partnerships have recog-nized the need for a better structured and inclusiveapproach to dengue communication and advocacy. In2003, for example, the Pan American Health Organizationlaunched the ‘Integrated Management Strategy for DenguePrevention and Control’ (EGI Dengue), which included theWorld Health Organization’s ‘Communications for BehavioralImpact’ (COMBI) framework and risk communications, pri-marily focused on vector and outbreak control [10]. In 2004,WHO published ‘Planning Social Mobilization andCommunication for Dengue Prevention and Control: AStep-by-Step Guide’ to assist program managers in develop-ing effective mobilization and communication strategies topromote behavioral change as part of vector control pro-grams [13–22].

Effective communication and advocacy activities aregrounded in four key factors. First, communication and advo-cacy are crucial for raising awareness and mobilizing resourcesfor disease prevention and control [16]. Public health technol-ogies are public goods, serving the interest of the populationat large. It is every individual’s responsibility to safeguardhealth, but the reality is that competing demands, interests,perceptions, behaviors, and limited resources can constitutemajor barriers to reaching this goal. Strategic communicationand advocacy are crucial to position health issues as relevantcauses, political priorities, and investment cases [13,16,20].

Second, effective public health decisions and interventionsrely on the accuracy of health data, such as disease burdenand epidemiology [21]. Because of their technical nature,health data lend themselves to misinterpretation by the aver-age lay person. Targeted communication and advocacy areparamount to transmit health data in a language that iscomprehensible to expert and nonexpert audiences in orderto transform scientific evidence into specific, actionable poli-cies with timelines and measurable indicators [22,23].

Third, effective communication and advocacy are essentialcomponents of the strategy to respond to epidemics andother crises, such as medicine recalls, natural disasters, andthe spread of new infectious diseases.

Lastly, communication and advocacy help ensure thathealthy behaviors are sustained over time [24,25].

Dengue vaccine communication and advocacy

Currently, there is little published on effective dengue vaccinecommunication and advocacy. An online search across differentscientific journals yielded few publications when compared toinformation on dengue communication and advocacy in gen-eral. Clearly, more effort at the international level is required toreview, consolidate, and strategically disseminate dengue vac-cine knowledge to decision-makers in endemic countries.

Nevertheless, some stakeholders are spearheading efforts todevelop and/or strengthen vaccine communication and advo-cacy. Currently, stakeholders’ leading efforts to promote denguevaccine communication and advocacy range from governmentsin dengue-endemic countries, international organizations suchas the World Health Organization and the Pan American HealthOrganization, the donor community such as the Bill and MelindaGates Foundation, independent research organizations, and vac-cine advocates like the Dengue Vaccine Initiative or DVI. All theseparties constitute a diverse communication and advocacy envir-onment, which at times results in conflicting messages.

Disjointed dengue communication and advocacy raise doubtsabout partnership dynamics. Communication must be transpar-ent. In a competitive environment where large profits are at stake,governments are under pressure to provide fast and effectivehealth solutions. Transparency might not always be a priority.Effective partnerships should help garner trust and ensure trans-parency, particularly for the best interests of endemic countries.

In the case of DVI, which works at aligning the interests ofthese different stakeholders to reduce suffering in dengue-endemic countries, actions are being taken by members topromote international and regional dengue communicationand advocacy strategies. For example, DVI joins dengue expertsfocusing on critical aspects of dengue vaccines, including epi-demiologists, economists, regulatory, strategic communicationand advocacy specialists. With this model, communication andadvocacy are not applied ad hoc, but integrated from thebeginning in the process of dengue vaccine knowledge gen-eration. Through this approach, knowledge is strategically dis-seminated in a language that is understandable to decision-makers in endemic countries. Social mobilization and capacitybuilding are seen as an integral part of the process of fightingdengue, not as an enhancer. As Dr. Ciro de Quadros said duringhis tenure as a core member of the DVI consortium, for the first

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time we are seeing communication and advocacy efforts beingmade before a vaccine is available. ‘These steps will enablecountries to introduce vaccines faster and more effectively’ [26].

The lack of more concerted efforts to communicate andadvocate for vaccines prior to licensure is likely related to thenumerous unknowns of the use of dengue vaccines and thedisease. Understanding these unknowns would contribute tomore informed decisions regarding the introduction of denguevaccines and more effective communication and advocacy thatanticipates contentious topics and knowledge gaps. The follow-ing section explains how several of these challenges pose athreat to effective dengue vaccine communication andadvocacy.

Uncertainties of vaccine impact

The mechanism of protective immunity against dengue is notfully understood [27]. Only one of the vaccine candidatescurrently under clinical trial, Sanofi’s CYD-TDV, has completedPhase III trials and has been approved for use in Mexico, thePhilippines, and Brazil. The results demonstrate that a vaccinethat reduces dengue cases and hospitalizations is possible.However, these results have shown varying efficacies, depen-dent on serotype and age.

Regarding serotype, Sanofi Pasteur’s first Phase III trial con-ducted in Asia-Pacific demonstrates moderate overall efficacybut statistically insignificant protection against serotype two,corroborating results from a previous Phase IIb trial. The lackof immunity for serotype two in these two studies remainsunclear [1]. A follow-up study of the long-term efficacy andsafety of the vaccine pooled data from the two CYD-TDVPhase III studies showed moderate overall efficacy and statis-tically significant efficacy against all serotypes [28]. Still, sero-type coverage continued to vary and efficacy remained lowestagainst serotype two. The lack of equipotent efficacy is note-worthy because while infection by one serotype confers last-ing protection against re-infection by the same serotype, itprovides only transient protection against infection caused byany of the remaining three dengue serotypes [27]. As Schmitzet al. (2011) explain: ‘the potential risk of immune enhance-ment of infection and disease underscores the importance ofdeveloping dengue vaccines which produce balanced, long-lasting immunity to all four DENV serotypes’ [27].

The long-term efficacy and safety study also demonstratedvarying vaccine efficacy by age. While results show that thevaccine reduced hospitalizations for individuals nine years ofage and above, they suggest that CYD-TDV may be associatedwith increased risk of hospitalization for children under nineyears of age during the third year of the study [28]. Theseuncertainties, added to the geographic inconsistencies of thedata, pose challenges for producing effective communicationand advocacy around dengue vaccine introduction.

Uncertainties on vaccine accessibility

There is little information regarding timelines for the develop-ment of the dengue vaccine pipeline. In terms of the CYD-TDVdengue vaccine candidate, currently the most advanced, accu-rate dates for availability and supply remain unknown.

Sanofi Pasteur representatives and media outlets have dis-cussed the company’s new ‘flipping the model’ approach onvaccine introduction, by which for the first time the pharma-ceutical company directly reaches out to the interested countryinstead of waiting for international regulation and licensure.The flip approach raises the question of whether resource-poor countries in which Sanofi seeks to introduce the CYDvaccine candidate have the technical and financial regulatoryexpertise and capability to deal with new vaccine approval andlicensing. The uncertainty regarding CYD-TDV’s potential priceadds to the difficulty of planning for dengue vaccine introduc-tion. This situation calls for increased efforts in communicationand advocacy that highlights the knowns and unknowns andoffers spaces for dialogue among different stakeholders.

There are also questions about vaccine supply, given thatSanofi has limited capacity, while the predicted demands forthe vaccine in specific dengue-endemic countries may be high[29]. The question remains of who will be vaccinated given alimited supply of dengue vaccines, which can lead to equityand ethical dilemmas and could spark negative perspectiveson the role of immunization programs. While supply limitationis largely associated with the manufacturing companies, part-nerships of the global health community with vaccine manu-facturers and dengue-endemic countries would beinstrumental in addressing limited supply and its implicationfor effective strategies of vaccine introduction.

Complex dengue pathogenesis and epidemiology

Dengue pathogenesis and epidemiology are complex. Manydengue cases are under-reported, which challenges the accu-rate measurement of dengue burden on society. Dengue canresult in hemorrhagic fever and other more severe forms ofthe disease that if not clinically well managed can cause death.Death from dengue hemorrhagic fever can increase dramati-cally if not treated quickly, which is common in countries withpoor health care infrastructure and access.

Dengue affects different age groups across regions, coun-tries, and even within countries, as in the case of Brazil. Suchvariance in epidemiology challenges the consistency of den-gue language to raise awareness, producing a range of possi-bilities, with few unifying characteristics [30]. The lack ofunifying characteristics complicates the harmonization of den-gue communication and advocacy across regions. Messagesmust therefore be tailored to specific locations.

Challenge of framing dengue to secure support frompartners

The lack of a unified communication and advocacy strategyconcerning these unknowns presents challenges to framingdengue in a consistent way. The use of conceptual frameworksby which issues are portrayed is crucial in garnering supportfrom partners given that social context, not only scientificevidence, can affect how individuals and organizations per-ceive the importance of an issue [31,32].

While several efforts are underway to quantify the burdenof dengue, there has not been a systematic international effortto portray the impact of the disease to the layman and

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potential donors. Dengue prevention and control advocatesneed to identify frames for communication that resonate withthese audiences. The first step in this process will be todevelop universally agreed-upon messages to address uncer-tainties about dengue and dengue vaccines. Frames alone,however, are not enough: they must be reinforced by trustedvoices in the global health community [31]. To this end,strengthening the coalitions through which these messagescan be communicated will be vital.

In this context, the global health community has the oppor-tunity to apply best practices from partnerships focusing oncommunication and advocacy from previous vaccine introduc-tions [30]. Two examples stand out: vaccine communicationand advocacy for rotavirus and pneumococcal disease. Thebiannual International Rotavirus Symposium, for example,brings together global health experts to discuss challengesand new advances in rotavirus vaccines. The meeting is a toolfor communication and advocacy, social mobilization, and capa-city building that can contribute to informing and stimulatingexchange with experts in endemic countries. The Rota Council,an international organization of rotavirus specialists and healthadvocates, works to provide technical evidence to policymakersto accelerate rotavirus vaccine introduction.

Similarly, the Pneumococcal Awareness Council of Experts(PACE) focused on pneumococcal disease awareness and preven-tion and worked through a variety of media to promote pneu-mococcal awareness and advocacy efforts. PACE worked withmore than 100 professional medical societies around the globe,promoting initiatives including media campaigns, new research,in-country events, discussion forums, and calls to action.

Applying these best practices would benefit dengue vac-cine communication and advocacy, despite the questions thatremain to be answered. The key is laying the groundwork nowfor countries to be better positioned to access dengue vac-cines as they become available, and when the evidence sup-ports their introduction.

Expert commentary

Recommendations

Based on the above discussion, we believe the following keystrategies will strengthen global dengue vaccine communica-tion and advocacy:

(1) Consolidate existing coalitions under one strategicumbrella. We need a unifying strategy at the interna-tional level to effectively communicate and advocatethe need to prevent and control dengue at the regionaland national levels. The direction of such a strategyshould be based on an assessment study involvinginternational dengue stakeholders and endemic

countries. The aim of the assessment would be toaccurately identify the gaps in investments and imple-mentation for supporting dengue-endemic countries.

(2) Urgently convene stakeholders to formulate the road-map for integrated dengue prevention and control.This annual meeting should provide ongoing mon-itoring and evaluation of dengue vaccine communi-cation and advocacy campaigns in endemiccountries.

(3) Improve dissemination of dengue scientific knowledge. Ofthe several approaches to strengthening communica-tion, one key opportunity is to strengthen relationshipswith journalists. The scientific community can provideexpert insight to journalists on highly technical infor-mation about dengue vaccines. Conversely, the journal-ists’ perspective can help scientists better understandthe challenges in reporting about dengue vaccines.Strategic training and capacity building involving bothscientists and journalists should improve reporting thatis based on scientific evidence.

Five-year view

Way forward: dengue communication and advocacy

Dengue vaccine introduction in some countries will likelyoccur in the near future. The experiences of first-introducingcountries will influence policy decisions of other dengue-endemic countries. The international health communityshould continue to support countries to be adequately pre-pared with scientific knowledge before a first dengue vaccineis available, while the clinical trials of other candidates con-tinue to progress.

During first-generation dengue vaccine introduction, therewill be greater pressure from endemic countries for capacitybuilding and sharing best practices on how to effectivelycommunicate and advocate for dengue vaccines, when theevidence supports vaccine introduction. This experience willbe not only instrumental for the fight against dengue, but alearning opportunity for the communication and advocacy ofthe public health strategies that will help fight dengue andother emerging vector-borne diseases as chikungunya andZika. We must seize this opportunity now.

Financial and competing interests disclosure

The authors have no relevant affiliations or financial involvement withany organization or entity with a financial interest in or financial con-flict with the subject matter or materials discussed in the manuscript.This includes employment, consultancies, honoraria, stock ownership oroptions, expert testimony, grants or patents received or pending, orroyalties. Sabin Vaccine Institute is a member of DVI.

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References

Reference annotations• Of interest•• Of considerable interest

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Key issues

● Dengue is a vector-borne vaccine-preventable disease.● However, uncertainties remain regarding the use of dengue vaccines and the disease.● Dengue-endemic countries need factual and accessible information about dengue vaccines that is grounded in scientific evidence.● While global and regional strategies for dengue prevention and control already exist, as does literature on dengue disease communication and advocacy,

little has been published on dengue communication and advocacy regarding dengue vaccines.● Waiting to plan and advocate for the introduction of new vaccines until licensure, as routinely occurs, may delay access in developing countries by years.● Some stakeholders are spearheading efforts to initiate, develop and strengthen vaccine communication and advocacy, such as the Dengue Vaccine

Initiative.● The lack of other concerted efforts to communicate and advocate for vaccines prior to licensure is likely related to unknowns of the use of dengue

vaccines and the disease: uncertainties of vaccine impact and accessibility and dengue’s complex physiology and epidemiology.● Furthermore, the lack of a unified communication and advocacy strategy concerning these unknowns presents challenges to framing dengue in a

consistent way to secure sustainable support from partners.● Dengue prevention and control advocates need to identify frames for communication that resonate with audiences. The first step in this process will be

to develop universally agreed-upon messages to address uncertainties about dengue and dengue vaccines. Strengthening the coalitions through whichthese messages can be communicated will be vital.

● The global health community has the opportunity to apply previous best practices from partnerships focusing on communication and advocacy forprevious vaccine introductions, particularly those from rotavirus and pneumococcal vaccine introductions.

● We believe the following key strategies will strengthen international dengue vaccine communication and advocacy:● consolidating existing coalitions under one strategic umbrella.● urgently convening stakeholders to formulate the roadmap for integrated dengue prevention and control.● improve dissemination of dengue scientific knowledge.

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