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                              February 28 - March 1, 2022, TBDWG Meeting (online)
                              Tick-Borne Disease Working Group Virtual Meeting 20 Summary - Day 1


    

    

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Tick-Borne Disease Working Group Virtual Meeting 20 Summary - Day 1








  
  
    

  
      





February 28th, 2022

*Note: For context and clarity, speaker credentials will be included upon first mention in each meeting’s summary. Subsequently, individuals will be referenced by their first names to equalize expertise across the many diverse disciplines represented in this document. All perspectives and expertise, including patient-lived experience, is valued equally. Speaking on a first-name basis helps the Tick-Borne Disease Working Group ensure that all voices are heard and valued based on merit and without the bias of titles, eminence, or prestige.*

Welcome and Roll Call: Day 1

Linden Hu, MD, Tufts University School of Medicine, Professor Microbiology and Medicine; Vice Dean for Research; Working Group Co-Chair, thanked the Working Group members for working effectively and diligently as the Tick-Borne Disease Working Group begins to prepare its report to Congress.

Holiday Goodreau, Executive Director, LivLyme Foundation; Co-creator, TickTracker; Working Group Co-Chair, echoed Linden’s comment and introduced James (Jim) Berger, MS, MT (ASCP), SBB, Senior Blood and Tissue Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services (HHS); Designated Federal Officer for the Tick-Borne Disease Working Group, to call the meeting to order and conduct the roll call (see Appendix 1: Tick-Borne Disease Working Group Members and HHS Support Staff).

Overview of the Working Group’s Mission Statement, Vision Statement, and Values

Jim reviewed the Working Group’s Mission Statement, as follows:

The Tick-Borne Disease Working Group’s mission, as mandated through the 21st Century Cures Act, is to provide expertise and to review all efforts within the Department of Health and Human Services related to all tick-borne diseases, to help ensure inter-agency coordination and minimize overlap, and to examine research priorities. As part of this mandate, and in order to provide expertise, we will ensure that the membership of the Working Group represents a diversity of scientific disciplines and views and is comprised of both Federal and non-Federal representatives, including patients, and family members or caregivers, advocates of non-profit organizations in the interest of the patient with tick-borne illness, scientists, and researchers. A major responsibility of our mission will be to develop and regularly update the action of HHS from the past, present, and the future.

Jim then reviewed the Working Group’s Vision Statement, as follows:

**SHARED VISION:** A nation free of tick-borne diseases where new infections are prevented and patients have access to affordable care that restores health.

Finally, Jim gave an overview of the Working Group’s Core Values, the complete versions of which are provided below.

**RESPECT: Everyone is valued**

We respect all people, treating them and their diverse experiences and perspectives with dignity, courtesy, and openness, and ask only that those we encounter in this mission return the same favor to us. Differing viewpoints are encouraged, always, with the underlying assumption that inclusivity and diversity of minority views will only strengthen and improve the quality of our collective efforts in the long term.

**INNOVATION: Shifting the paradigm, finding a better way**

We strive to have an open mind and think out of the box. We keep what works and change what doesn’t. We will transform outdated paradigms when necessary, in order to improve the health and quality of life of every American.

**HONESTY and INTEGRITY: Find the truth, tell the truth**

We are honest, civil, and ethical in our conduct, speech, and interactions with our colleagues and collaborators. We expect our people to be humble, but not reticent, and to question the status quo whenever the data and the evidence support such questions, to not manipulate facts and data to a particular end or agenda, and to acknowledge and speak the truth where we find it.

**EXCELLENCE: Quality, real-world evidence underlies decision-making**

We seek out rigorous, evidence-based, data-driven, and human-centered insights and innovations—including physician and patient experiences—that we believe are essential for scientific and medical breakthroughs. We foster an environment of excellence that strives to achieve the highest ethical and professional standards, and which values the development of everyone’s skills, knowledge, and experience.

**COMPASSION: Finding solutions to relieve suffering**

We listen carefully with compassion and an open heart in order to find solutions which relieve the suffering of others. We promise to work tirelessly to serve the greater good until that goal is achieved.

**COLLABORATION: Work with citizens and patients as partners**

The best results and outcomes won’t be created behind closed doors but will be co-created in the open with input of the American public working together with these core values as our guide. We actively listen to the patient experiences shared with us, respect the lived experiences of patients and their advocates, and learn from their experiences in our pursuit of objective truth. Across diverse audiences, we communicate effectively and collaborate extensively to identify shared goals and leverage resources for maximum public health impact.

**ACCOUNTABILITY: The buck stops here**

We, as diligent stewards of the public trust and the funds provided by our fellow citizens, pledge to be transparent in all of our proceedings and to honor our commitments to ourselves and others, while taking full responsibility for our actions in service to American people.

Objectives, Update, and Goals of Meeting 20

Objectives

Jim briefly reviewed the Working Group’s objectives, which are to provide expertise and review all efforts within HHS related to all tick-borne diseases, to help ensure interagency coordination and minimize overlap, and to examine research priorities. He outlined the Working Group’s duties, as follows:

No later than two years after the date of enactment of the authorizing legislation, review a summary of:
	Ongoing tick-borne disease research, including research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, duration of illness, and intervention;
		Advances made pursuant to such research;
		Federal activities related to tick-borne diseases, including (a) epidemiological activities related to tick-borne diseases and (b) basic, clinical, and translational tick-borne disease research related to the pathogenesis, prevention, diagnosis, and treatment of tick-borne diseases;
		Gaps in tick-borne disease research described in clause 3b;
		The Working Group’s meetings; and
		The comments received by the Working Group.
	Make recommendations to the Secretary regarding any appropriate changes or improvements to such activities and research.
	Solicit input from States, localities, and non-governmental entities, including organizations representing patients, health care providers, researchers, and industry regarding scientific advances, research questions, surveillance activities, and emerging strains and species of pathogenic organisms.Update on Subcommittee Activities

Linden highlighted progress made by the Working Group since the last public meeting (Meeting 19), including establishing six subcommittees; assembling 54 subcommittee members; holding 69 subcommittee meetings since October 2021; and writing five reports containing findings that align with each subcommittee’s objectives.

What We Hope to Accomplish Today

Linden noted that today the Working Group will hear findings from each subcommittee, provide an opportunity to learn and ask questions, and create the foundation for an initial discussion that will inform next steps.

Public Comments

Holiday welcomed public commenters and reminded the public of the three ways to engage with the Working Group: (a) providing oral public comments at public meetings, (b) submitting written public comments for a public meeting by email to tickbornedisease@hhs.gov, and (c) sending comments any time by email to tickbornedisease@hhs.gov.

*Grace Shults*: Grace is a 21-year-old college student. She described becoming very ill at age 17 and receiving a late diagnosis of Lyme disease. She explained her odyssey of seeking treatment from many physicians as her health declined. She described being constantly ignored by physicians. She said she eventually found a Lyme-literate clinician who diagnosed her with *Babesia*, *Bartonella*, *Mycoplasma*, and mold illness. She explained that she now volunteers for Lyme disease support groups and has learned that her difficulty accessing treatment is shared by many tick-borne disease patients. Grace noted that tick-borne disease affects many vulnerable populations, who deserve better access to care.

*Nicole Malachowski*: Nicole is an Air Force colonel who was medically retired after 20 years of service due to tick-borne illness. She stated that these diseases present a unique risk to members of the military, veterans, and their families due to global military service, and they are a military readiness issue. Nicole noted that the Centers for Disease Control and Prevention (CDC) does not include tick-borne illness statistics from the military in its surveillance data, which has led to an undercount of cases. She explained that she advocates for other medically discharged personnel and has observed that tick-borne diseases are common and often undiagnosed or misdiagnosed. Nicole stated it took four years for her to receive a diagnosis, and she has been diagnosed with post-traumatic stress disorder for her experiences being denied access to care. She called for a whole-government approach to addressing this problem.

*Bonnie Crater*: Bonnie co-founded the Bay Area Lyme Foundation and the Center for Lyme Action, both of which fund tick-borne disease research. She reported that advocates from these groups have doubled funding from $55M to $108M. She lauded the work of the Tick-Borne Disease Working Group and made five recommendations for its upcoming report to Congress: (a) make Lyme disease a priority for government agencies, including the Office of the Assistant Secretary for Preparedness and Response and Biomedical Advanced Research and Development Authority (BARDA); (b) help the National Institutes of Health (NIH) implement its 2019 plan for tick-borne diseases; (c) require CDC to conduct surveillance for chronic Lyme disease cases; (d) authorize the LymeX Innovation Accelerator program to improve diagnostics; (e) and establish new academic centers for Lyme disease through NIH. Bonnie also requested reauthorization of the Tick-Borne Disease Working Group.

*Jody Hudson*: Jody is the founder of the Alex Hudson Lyme Foundation. Jody stated that her daughter visited more than 40 doctors before her diagnosis of Lyme disease, and then continued to struggle to received treatment. She said that doctors dismissed her daughter, who passed away in 2018. Jody has dedicated her advocacy work to her daughter’s memory. She stated that too many Lyme disease patients must become experts in their illness because they lack access to care.

*Betty Gordon*: Betty advocates on behalf of the National Disease Research Interchange. She explained that, after her husband Jack passed away in 2014, she sought brain autopsies, which revealed chronic Lyme disease and *Bartonella*. Betty described her disappointment in being ignored by the research community; however, she noted that new researchers at Columbia University may publish their observations of her husband’s donated tissue. Betty added that she also tested positive for Lyme disease and *Bartonella* and will donate tissue to researchers, as well. Betty expressed frustration at the lack of clinician education for tick-borne diseases and advocated for its improvement. She lauded the Tick-Borne Disease Working Group for engaging patient advocates as leaders in the group.

*Alex Bamberry*: Alex noted that she is a chronic Lyme disease patient and did not feel well. She stated that she has struggled with access to care since her diagnosis in 2012. Alex highlighted the issue of tick-borne disease transmission from mother to baby and advocated for more research to help this vulnerable population. According to Alex, inaccurate official guidelines that deny this transmission harms patients and leads to misdiagnoses and delayed treatment. She held a moment of silence for individuals who have lost their lives to this illness.

*Cortney McCord*: Courtney is a registered nurse from Mississippi who was bitten by a tick in 2021 and developed symptoms of tick-borne disease. She stated that, despite being told by her provider that Lyme disease does not exist in her area, she was diagnosed with several tick-borne diseases, including Lyme disease, *Bartonella*, *Babesia*,andultimately Alpha-gal Syndrome (AGS), which sent her to the emergency room. Her doctor, she noted, denied that AGS was the cause of her reactions. Courtney expressed frustration that local doctors were unavailable to help her with AGS and advocated for more research on the syndrome, as well as more education for health care providers. She also called for more labeling of medicine with animal products, which can trigger AGS allergic responses, and a database of medicines to avoid.

*Julie Salzbrunn*: Julie noted that she recently tested positive for COVID-19. She described working in 2021 at an Arkansas summer camp, where she was bitten by at least 10 ticks, soon after which she experienced cardiovascular and neurological symptoms. These symptoms, she noted, were dismissed by local providers. Julie stated that she drove home to Illinois to seek care after severe joint swelling, but her concerns about tick-borne illness were also dismissed there. In addition to her previous symptoms, she described suffering from headaches and nausea over several months, with repeated visits to the emergency room. Eventually she was diagnosed with Rocky Mountain spotted fever but had severe reactions to antibiotics due to AGS. Julie said that Soliman Auricular Allergy Treatment (SAAT) helped her, and she advocates for research and awareness of AGS.

*Amanda Warren*: Amanda is a school nutrition director who suffers from AGS. She explained that the number of children with AGS is unknown, and she advocates for changing child nutrition standards. Amanda observed that many children are at risk of malnutrition and are often ignored or stigmatized for having food allergies. She provided several accounts of children experiencing severe allergic reactions due to AGS in multiple states. Amanda called for making AGS a reportable condition, clear labeling of mammalian ingredients in all products, adding Alpha-gal to the allergens list, and promoting more research on the syndrome.

Public Comment Subcommittee Update

Analysis of Commentary

Lauren Overman, MPH, CPH, Public Health Analyst, OIDP, HHS, provided an analysis of public comments as requested by the Co-Chairs of the 2021-2022 Tick-Borne Disease Working Group. The goal of the analysis was to apply both quantitative and qualitative measurements to assess the various elements of the commentary and identify common themes for the Working Group to consider in preparation for writing the 2022 Report to Congress.

Between November 2017 and December 2021, the subcommittee received at least 1,371 emails and 459 public comments through its *Federal Register*notice. The subcommittee utilized qualitative analyses to help formulate research questions, define sources of material and parameters for inclusion (excluding verbal comments), identify categories or features to focus research or qualitative themes, measure the occurrence of pre-established categories, and use coding to measure the prevalence of themes. The methodology for analysis incorporated NVivo and was conducted by a single researcher with the help of Allison Petkoff and Debbie Seem of OIDP. Case coding was conducted for various themes, which were visualized by Tableau and Excel. Limitations for the analysis included redaction in accordance with Federal Advisory Committee Act (FACA) rules; requests from commenters to keep certain information private; and lack of determination of the exact number of unique emails. Lauren noted that more reporting will become available because the third cycle is not yet complete.

Themes

The majority of comments were about *Borrelia* with the greatest percentage focused on *Borrelia burgdorferi*followed by *B. miyamotoi*and other *Borrelia* species. The other major focal point was tick-borne diseases in general. These comments involved tick ecology and calls for more research and resources. The next largest group involved AGS, and smaller groups were primarily for other, less common tick-borne diseases.

Within these groups of comments, the subcommittee identified the following seven categories.

Challenges, including climate change, conflict, and regulations
	Epidemiology, including geography, incidence, sexual transmission, and vertical transmission
	Ethics, including autonomy, conflicts of interest, consent, mishandling, and weaponization
	FACA business, including nominations and transparency
	Morbidities, including death, disability, mental health, pain, safety, and vaccine injury
	Patient experience, including abandonment, delayed diagnosis, diagnostic criteria, diagnostic sensitivity, disregard, exasperation, finance, insurance, invasive procedures, misclassification, misdiagnosis, protracted treatment for chronic disease, and sacrifice
	Resources, including clinical education, novel diagnostics, public education, research, surveillance, vaccines, and vector controlThe subcommittee also identified themes by infection and disease. Those related to borreliosis were protracted treatment, delayed diagnosis, and misdiagnosis. For tick-borne diseases generally, disregard, delayed diagnosis, and research were the major themes. For AGS, misdiagnosis, disregard, and clinical education were the most prominent themes. For *Babesia*, protracted treatment, delayed diagnosis, and disregard were most common. For rickettsial diseases, delayed diagnosis, diagnostic criteria, and disregard were the major themes.

Patient experience of feeling disregarded was a major theme across many groups and categories. Patients reported not being listened to or understood, being ignored, or dismissed, having the existence of their disease denied, being told the illness was imagined, and a disregard for their quality of life. Patients’ interest in diagnostic criteria was another major theme, primarily that surveillance data are inappropriately applied to a clinical case definition, leading to disregard of symptoms and illness. Geography was another major theme, as patients reported provider disregard for their illness, particularly when they have moved from an area where tick-borne disease is endemic to other places. Many patients described experiencing personal sacrifices and loss of finances, relationships, employment, health, hobbies, as well as legal problems related to insurance coverage. Another major theme involved significant impacts on patient mental health, including depression, anxiety, and suicidal thoughts. A prominent theme from commentors included mishandling of Lyme disease by providers and demands for accountability. Finally, a significant portion of comments were about vaccines; some commenters described them as a tool to fight tick-borne disease, while others expressed their distrust of vaccines.

Jennifer Platt, co-founder, Tick-Borne Conditions United, asked whether the Working Group would be able to examine the evolution of comments over the past three cycles. Lauren responded affirmatively.

Subcommittee Presentations

On Day One, three of the six subcommittees presented their reports to the Tick-Borne Disease Working Group. The co-chairs of each subcommittee outlined subcommittee membership (see Appendix 2 for complete subcommittee membership), provided background information, reported the subcommittee’s evidence and findings, and presented potential actions for the Working Group to consider.

Changing Dynamics of Tick Ecology, Personal Protection, and Control Subcommittee

Subcommittee Co-Chair Kirby C. Stafford III, PhD, Chief Scientist and State Entomologist, Department of Entomology, Center for Vector Biology & Zoonotic Diseases, The Connecticut Agricultural Experiment Station, identified fellow members and their expertise, and reported the subcommittee’s priorities, evidence, findings, and proposed potential actions.

Goals, Evidence, and Findings

Kirby explained that the subcommittee’s three main goals were to identify the causes for tick and tick-borne disease expansion, identify current and future strategies for managing tick-borne diseases, and examine barriers to the development and commercialization of tick bite prevention and tick control. The subcommittee believed that priorities and actions of the previous Working Groups remain valid, and agreed to build upon this work with this objective: Minimize the public health threat of Lyme disease and other tick-borne diseases with changing climates through surveillance, effective ecologically-based tick management strategies, and personal protection measures. Through expert presentations and a gap analysis, the subcommittee identified four focus areas that were not substantiated in previous reports:

Tick ecology, environmental change, and range expansion
	Tick bite prevention and tick control
	Host behavior and host-targeted control methods
	New innovations and commercial translation for tick controlBased on previously identified priority areas, public comments, and input from other subcommittees, the Changing Dynamics of Tick Ecology, Personal Protection, and Control Subcommittee identified and addressed four priorities and proposed a total of 13 potential actions for the Working Group to consider.

Priorities and Potential Actions

Priority 1: Minimize roadblocks and streamline the process for getting new tick bite prevention and tick control products to market.
Kirby noted that roadblocks exist to implementing new tick bite prevention and tick control products because of the absence of public health tick management programs. Thus, the subcommittee’s proposed potential actions are meant to foster long-term research as well as commercial product development, including associated costs, patent or licensing issues, registration approvals, marketing, and acceptance of and use by the public or pest management professionals.

**Potential Action 1.1:**Expand the remit of the Biomedical Advanced Research and Development Authority (BARDA) to include vector-borne diseases and provide BARDA with funding to bring new tick bite prevention and tick control products to market.

**Potential Action 1.2:**Charge federal entities (including EPA [Environmental Protection Agency], FDA [Food and Drug Administration], USDA [U.S. Department of Agriculture], CDC, DoD [Department of Defense], and NIH) to work with industry to streamline regulatory pathways and target solutions for getting new tick bite prevention.

**Potential Action 1.3:**Enhance existing federal proposal, review, and funding for research, development, and evaluation of new tick bite prevention and tick control products (for example, Small Business Innovative Research Program; and other federal funding mechanisms which are open to academic institutions and all industry entities).

Priority 2: Accelerate efforts to define and deploy tick bite prevention and tick control approaches and strategies.
Kirby explained that observed evidence for reduction of human tick bites and associated disease by existing personal protection and tick control measures is weak. Potential actions in Priority 2 are, therefore, meant to address the critical need for development of novel concepts and approaches to prevent tick bites and reduce tick-borne disease. The subcommittee’s focus was on new approaches for host-targeted methodologies and genomic advances, including the genetic manipulation of ticks.

**Potential Action 2.1:**Fund research to validate the scale and degree of effectiveness of existing tick bite prevention and tick control strategies to reduce human tick bites and tick-associated disease.

**Potential Action 2.2:**Support development of novel concepts to prevent human tick bites or suppress ticks and their associated pathogens in the environment (for example, acaricide products such as nootkatone capable of killing undetected human feeding ticks, anti-tick vaccines for humans or wildlife, or transgenic ticks to suppress population growth).

**Potential Action 2.3:**Define tick control strategies suitable for residential properties and lands (for example schools, parks, and high-use recreation areas) or entire communities.

Priority 3: Define the primary drivers of tick populations, tick pathogen prevalence, and geographic expansion of ticks and tick-associated diseases.
Kirby stated that the United States is currently experiencing an emergence, resurgence, and geographic spread of native ticks and tick-borne diseases. Although some diseases, such as tick-borne encephalitis and Crimean Congo hemorrhagic fever, are not currently present in the United States, they do represent a significant biosecurity concern. Introductions of foreign ticks, exemplified by the invasive Asian longhorned tick (*Haemaphysalis longicornis*) demonstrate the potential for establishment of new tick species and tick-borne pathogens. Priority 3 is meant to address the ecological, environmental, and social factors that contribute to increased risk of tick bites and all potential tick-borne diseases.

**Potential Action 3.1:**Fund critical research on the effects of environmental variables on tick biology and ecology (e.g., survival, reproduction, and ability of ticks to transmit pathogens that impact public health).

**Potential Action 3.2:**Fund capacity for rapid identification of tick species and discovery of the pathogens they may transmit to allow early detection and rapid response.

**Potential Action 3.3:**Create browsable maps of current and forecasted distributions of tick species and tick-borne pathogens of public health significance so stakeholders can assess risk.

Priority 4: Expand knowledge and increase adoption of tick bite prevention and tick control methods.
Kirby noted that this priority was elevated from a similar action item in the 2020 Tick Ecology, Biology, and Control Subcommittee Report to provide education and training to all stakeholders with an increased focus on minority, inequity, and occupational issues. The subcommittee acknowledged that some members of the public take action to prevent tick bites, and education has helped increase knowledge of personal protection measures, with mixed results. Kirby also noted the lack of national workplace hazard assessment requirements for employees in outdoor workplaces to prevent tick bites.

**Potential Action 4.1:**Clarify the reasons behind the public’s limited use of tick bite prevention methods (such as repellents) and tick control methods (such as backyard treatments to kill ticks) and pursue solutions to overcome roadblocks.

**Potential Action 4.2:**Charge the U.S. Occupational Safety and Health Administration (OSHA) to work with employers to develop standards to mitigate occupational risk for ticks and tick-borne disease and educational requirements for occupational physicians.

**Potential Action 4.3:**Develop information materials for tick bite prevention and tick control targeted to high-risk groups for tick bites (for example, children, animal health professionals, hunters, farmers, park rangers, and other outdoor workers) in multiple languages and styles to reach underserved communities.

**Potential Action 4.1:**Incorporate tick-borne disease prevention strategies in livable environment design considering health equity issues and climate adaptation.

*Challenges*

The subcommittee identified four significant challenges:

Streamlining regulatory pathways from novel concept to finished product that involve several Federal research and regulatory agencies and finding solutions to move new tick bite prevention and tick control products to market
	Fostering support for concepts and approaches that incorporate basic, translational, and applied research (for example, Centers of Excellence, Small Business Innovation Research grants)
	Addressing the lack of a local public health workforce engaged in protecting the United States from tick-borne disease, serving as a stable market for tick control products, and acting as a conduit to the tick control industry
	Providing research support to address the urgent need for studies to clarify how existing personal protection measures should be used and environmental tick control methods should be implemented to reduce human tick bites*Opportunities*

The Subcommittee identified three significant opportunities:

Empowering BARDA to (a) expedite the development of promising new intervention technologies and (b) facilitate commercialization of new intervention products for tick and tick-borne disease control
	Developing novel, more targeted methodologies, and products with advances in basic science or proof-of-concept studies in areas such as new application methods for wildlife tick control, anti-tick vaccines, and genetically modified ticks
	Increasing cooperation and collaboration available through the Centers for Excellence in Vector-Borne Diseases to advance research and training*Discussion*

After the presentation, Kirby responded to questions and comments from Working Group members. The main discussion points are summarized below.

The Working Group discussed the reasons why the public is not adopting tick mitigation strategies, such as repellents. Kirby noted that this topic warrants further research and added that in the Northeast United States, tick bites often occur in residential areas rather than during activities in less developed, recreational areas where the public might otherwise engage in mitigation measures. Members also discussed the expansion of so-called “natural” products, which may not be effective. Kirby observed that the issue is primarily a lack of testing for these products.

The Working Group considered genetic controls that are effective for other insects such as mosquitos but are more challenging for ticks because they have a multi-year life cycle and bite multiple hosts. Kirby acknowledged the important need for additional research on the fundamental science before such an approach could be implemented. Several members commented that tick repellents, such as Nootkatone, show great promise but are not yet on the market. Public control measures that use chemicals to reduce mosquito populations could be applicable to ticks, but require additional research.

The aggressive nature of the Lone Star tick was another discussion topic, particularly how to deal with mitigation strategies as its habitat expands. The spread of *Amblyomma americanum*contributes to additional public health concerns because these ticks harbor rickettsial diseases. In its report, the subcommittee acknowledged that deer are also an important factor in tick control, because many tick species feed on them; however, more research is needed to determine the ways to utilize deer in a mitigation strategy. Charles Benjamin (Ben) Beard, PhD, Deputy Director, Division of Vector-Borne Diseases, CDC, U.S. Department of Health and Human Services, Associate Editor*, Emerging Infectious Diseases*, added that deer do not respect property boundaries, raising the need for community-oriented tick control measures.

Finally, Working Group members considered OSHA training, acknowledging its importance in changing behaviors and promoting more safety precautions against tick bites. According to Kirby, communicating the consequences of illness and promoting specific tick education and prevention is key. He cited the example of Connecticut’s state OSHA guidelines, which address tick-borne illnesses. The Working Group also addressed the education of mothers and children as effective agents of behavioral change, as well as of school personnel about the risk factors associated with tick bites in outdoor settings.

Diagnostics Subcommittee

Subcommittee Co-Chair Monica E. Embers, PhD, Director of Vector-Borne Disease Research, Division of Immunology, Tulane National Primate Research Center, reported on the subcommittee’s membership, priorities, evidence, findings, and proposed potential actions.

Acting Subcommittee Co-Chair Amanda B. Elam, PhD, CEO and Co-founder, Galaxy Diagnostics also reported on proposed potential actions.

*Goals, Evidence, and Findings*

Monica explained that the subcommittee’s three main goals were to assess the current status of diagnostic testing for tick-borne diseases in the United States, identify current and future strategies for advancing diagnostics for tick-borne disease, and examine barriers to the development and commercialization of tick-borne disease diagnostics. The subcommittee believed that priorities and actions in the previous Tick-Borne Disease Working Groups remain valid. Therefore, the subcommittee focused on areas that still require consideration while building on the previous reports and recommendations. Given the increase in tick-borne disease, the subcommittee’s primary objective was to identify the challenges to and opportunities for development and commercialization of new diagnostic solutions for Lyme disease and other tick-borne diseases.

The six focus areas identified by the subcommittee incorporated topics that were not substantially covered in previous reports:

Diagnostic testing for multiple tick-borne diseases
	Potential for advances in serodiagnostic “-omics” and molecular testing
	Availability of patient samples for testing and validation
	Vector testing for endemicity and patient exposure
	Opportunities for personalized medicine
	Challenges to commercial translation of novel diagnostic solutionsBased on the proceedings of the Working Group’s August 2021 public meeting, the Diagnostics Subcommittee was charged with addressing the following issues: consideration of diagnostics for all tick-borne pathogens; assessment of the process for development and validation of new tests; identification of the gaps and limitations in current testing; familiarization with the most promising techniques on the horizon; evaluation of the approval and standardization processes; and consideration of the roadblocks to moving better tests to market.

After reviewing relevant literature, public comments, and current Federal activities; identifying gaps in knowledge; and hearing from expert presenters, the Diagnostics Subcommittee formulated three priorities with 10 potential actions for the Working Group to consider.

*Priorities and Potential Actions*

*Priority 1: Charge the Tick-Borne Disease Working Group to designate an Advisory Panel of experts in Lyme disease and tick-borne disease diagnostics to promote evaluation and development of current and promising new diagnostic approaches**.***

Monica noted that many promising new tests have been developed since the first Diagnostics Subcommittee Report in 2018. The subcommittee did not find an absence of new technologies or interest, but rather a *major gap in future**investment in these tests*, hindering the transition of novel research findings into improved patient outcomes. The subcommittee observed a disconnect between product development, testing and validation, and commercial development. This observation led the subcommittee to prioritize the formation of an advisory panel to facilitate performance of the potential actions presented here.

**Potential Action 1.1:**Charge the Tick-Borne Disease Working Group members to designate seven individuals to serve on the panel, under the Office of the Assistant Secretary for Health (OASH), HHS, comprised of stakeholders from the academic, clinical, industry, government, and advocacy sectors. This panel will convene from February 2023 through January 2025 with the goal of promoting the recommendations set forth in this report.

**Potential Action 1.2:**Fund the advancement of diagnostics or tick-borne disease through targeted requests for applications (RFAs), Small Business Innovation Research/Small Business Technology Transfer, Congressionally Directed Medical Research Programs, and other Federal funding mechanisms which are open to academic institutions and all industry entities.

**Potential Action 1.3:**Host an HHS-sponsored scientific conference to review promising proof-of-principle studies and applications of promising diagnostic technologies, including direct and indirect detection of methods, as well as host immune biomarkers that may facilitate diagnosis.

**Potential Action 1.4:**Mandate Federal funding for: (1) the Centers for Disease and Prevention to build a national biorepository of human samples supported by a network of qualified labs and physician clinics, and (2) the Center for Lyme and tick-borne disease to build a clinical research program involving a network of clinical academic centers with standardized case definitions and evaluation tools which will facilitate future research and development of diagnostic tests and outcome measures.

*Priority 2: Educate policymakers, reviewers, researchers, and clinicians on the unique challenges of diagnostic test development and the innovation pipeline for tick-borne disease diagnostics.*
Monica explained that the two previous subcommittee reports (2018 and 2020) clearly stated the need for better testing for tick-borne diseases, especially direct testing and FDA-approved testing. Monica stated that, although advances have occurred, few have reached the point of commercialization, and most are indirect methods that have not improved in sensitivity. The subcommittee believes an improved understanding of the challenges of advanced diagnostics for tick-borne diseases is needed, from the technical challenges presented by pathobiology of each pathogen, to those inherent in the development and commercialization of new diagnostic approaches.

**Potential Action 2.1:**Charge the National Academies of Sciences, Engineering, and Medicine (NASEM) to host webinars to educate researchers, doctors, and disease advocates on the latest science, working hypotheses, and future needs.

**Potential Action 2.2:**Charge the Centers for Disease Control and Prevention to revise their web pages on tick-borne disease diagnostics in consultation with the Advisory Panel to reflect fully the advantages and limitations of currently recommended tests, and to provide more timely information about tests under development or not currently recommended.

**Potential Action 2.3:**Accelerate efforts by the Centers for Disease Control and Prevention to better engage the American public, clinicians, and relevant patient groups via an outreach program on the benefits of participating in clinical studies for tick-borne disease diagnosis.

*Priority 3: Minimize roadblocks and streamline the process for getting new tick-borne disease diagnostics to market.*
Amanda observed that despite recent progress in the development of tick-borne disease diagnostics, few innovations are advancing beyond research labs. The subcommittee believes this is due to poor understanding of the prevalence of disease and poor funding in development and commercialization. Amanda noted that this priority was meant to create a national initiative to stimulate interest and funding for tick-borne disease testing, particularly acknowledging chronic disease, which is independent from diagnostics for infections that kill quickly and affect large populations. The subcommittee formulated this priority to build on existing programs and initiatives.

**Potential Action 3.1:**Expand the purview of BARDA to include vector-borne diseases and provide funding to bring new tick-borne disease diagnostics to market. Build on existing initiatives to stimulate interest and funding for tick-borne disease diagnostic development and early commercialization, including multiphase funding for promising new diagnostic approaches.

**Potential Action 3.2:**Charge Federal entities (including the Centers for Medicare & Medicaid Services, U.S. Food and Drug Administration, Centers for Disease Control and Prevention, U.S. Department of Defense, and National Institutes of Health) to work with industry to streamline regulatory pathways and target solutions for getting new tick-borne disease diagnostic offerings to market.

**Potential Action 3.3:**Charge federal agencies to acknowledge that different testing methodologies may be required for different types and stages of Lyme disease, and other elusive tick-borne infections, similar to the model provided by tuberculosis guidelines.

At the end of presentation, Monica reiterated the pressing need to address tick-borne diseases and improve diagnostic testing through Federal support and investments in commercialized solutions.

Discussion

After the presentation, Monica responded to questions and comments from Working Group members. The main discussion points are summarized below.

The Working Group discussed reasons why AGS was not mentioned in the subcommittee’s report. Monica noted that the 2020 report had an extensive review of AGS, along with recommendations for diagnostic improvements; as such, the Diagnostics Subcommittee was primarily focused on new innovations in the current iteration of the report. Linden highlighted the need for the Working Group to ensure incorporation of items from past cycles into the current report. Amanda also noted that current testing measures in the United States typically support only domestically reportable diseases, which limits the tools available for individuals who may become infected abroad.

Members further explored some of the roadblocks to test development. Monica confirmed that the lack of resources for test validation, including a lack of biorepositories, is a barrier to bringing new tests to stages where they may get approval for clinical or commercial use. She noted that samples of coinfections are also lacking. Monica cited BARDA’s work as an example of fast tracking new diagnostics with Federal support. Amanda noted that Galaxy has submitted numerous high scoring applications that did not receive funding due to a lack of resources; competition is high, and reviewers may not understand the field. Moreover, large testing companies wait to see commercial potential and do not invest in early commercialization of novel diagnostics. Dennis Dixon, PhD, Chief of Bacteriology and Mycology Branch, National Institute of Allergy and Infectious Diseases, NIH noted that it is difficult to develop diagnostics with the sensitivity and specificity needed for Food and Drug Administration (FDA) clearance. Monica commented that the lack funding is a significant barrier, and there have been few awards for tick-borne disease diagnostics over the past two decades. The group agreed that more can be done to bring together the large and small players from the private sector to foster test development.

The Working Group also discussed the reliance on commercial entities, instead of Federal agencies, for test development, particularly in light of recent emergency use authorizations for COVID-19 tests and therapeutics. Ben noted that emergency use typically happens under a specific set of circumstances. Leith Jason States, MD, MPH (FMF), Deputy Chief Medical Officer, OASH, HHS, proposed bridge funding as a means to obtain promising diagnostics from the lab to commercialization.

Prevention and Treatment Subcommittee

Subcommittee Co-Chair Dennis Dixon, reported on the subcommittee’s membership, priorities, evidence, findings, and proposed potential actions.

Subcommittee Co-Chair Sunil Sood, MD, South Shore University Hospital Attending Physician, Cohen’s Children’s Medical Center, Professor of Pediatrics and Family Medicine, Zucker School of Medicine and Hofstra/Northwell, also reported on proposed potential actions.

*Goals, Evidence, and Findings*

Dennis explained that the Prevention and Treatment Subcommittee established a goal to build upon the previous work of Working Group members and subcommittees, rather than reiterate previous findings. To that end, the subcommittee responded to three charges from the Working Group:

Identify key advances, remaining gaps, and areas to be reinforced beyond the two reports
	Generate broadly-focused, actionable final recommendations
	For prevention, exclude vector-control or reservoir target measures, because these were under the purview of another subcommitteeWith these charges in mind, the subcommittee identified the following focus areas: Rickettsiales, *Bartonella*, babesiosis, relapsing fever, *B. miyamotoi*infections, tick-borne viruses, AGS, and Lyme disease prevention and treatment.

*Priorities and Findings*

*Priority 1: Prevention and treatment for infections by Rickettsiales*
Sunil noted that the 2018 Report to Congress did not appreciably address non-Lyme tick-borne diseases except in the context of Lyme disease coinfections. Furthermore, the 2020 Report to Congress reviewed the biology of rickettsial pathogens but did not provide specific treatment or prevention recommendations. Two subcommittee reports to the 2020 Working Group, *Ehrlichia/Anaplasma*and *Rickettsia*, provided in-depth updates and general treatment and prevention recommendations; those reports were published in peer-reviewed journals. Sunil observed that current treatments are effective and widely available; however, hesitancy in prescribing doxycycline for children remains an outdated concept, necessitating enhanced education for frontline health care practitioners. Moreover, improved surveillance and reporting is needed, and clinicians must be informed of the risks of suspected rickettsial infections, which requires prescribing an appropriate therapy quickly. Sunil stated that the best chance for commercial success lies in preventive approaches targeting ticks or reservoirs, possibly with a multi-pathogen vaccine.

*Priority 2: Prevention and treatment for babesiosis and relapsing fever/Borrelia miyamotoi infections*
Sunil stressed that more research and surveillance is needed for these pathogens; *B. miyamotoi*is relatively new to the research community and can cause life-threatening complications. Babesiosis is a concern because subcommittee members believe case numbers are significantly underreported. Sunil observed that physicians and the public are often unfamiliar with these diseases and their complications. Immunocompromised patients also have increased risks of infection and lengthy courses of treatment. One Health approaches recognize the connections between people, animals, and plants and may be effective against these pathogens.

*Priority 3: Prevention and treatment for tick-borne viruses*
Dennis identified Powassan, Heartland, and Bourbon viruses in this category. Documented infections are rare, and little is known about these viruses. Antiviral drugs are unavailable, and only supportive treatment is available. Powassan virus is the most significant tick-borne virus, which causes encephalitis and has a 10% mortality rate. There are few reports of the other tick-borne viruses; however, the range of tick vectors is expanding. Lack of funding and regulatory recognition poses challenges for academic research. Dennis stated that stakeholders should prepare for the possibility of future exposures, and the subcommittee recommends the development of antivirals and vaccine candidates. The subcommittee also recommends evaluating vaccine use in specific geographic areas. Existing vaccines may be of use for other tick-borne encephalitis viruses and should be studied. Dennis also highlighted the challenge of evaluating the possibility of antibody-dependent enhancement of infection.

*Priority 4: Prevention and treatment for Alpha-gal Syndrome*
AGS is an allergic reaction to a carbohydrate in non-primate mammals, and there is strong evidence that ticks play a causal role. Incidence is increasing with expansion of tick ranges, and AGS is the leading cause of anaphylaxis in a southeastern patient registry. Dennis underlined the importance of educating physicians about AGS. Genetically edited “Alpha-gal safe” pigs have already been approved by FDA to reduce risk. Potential treatments include omalizumab monoclonal antibodies, and more research is needed to determine whether they help AGS patients. Allergen desensitization studies have not been attempted. Dennis noted that improved surveillance is needed to help inform physicians of the risks. The subcommittee believes that preventative approaches targeting ticks have the best chance of success.

*Priority 5: Lyme Disease Prevention*
Dennis noted that personal protection measures can help prevent infection. The subcommittee recommends a safe and effective vaccine; previously-introduced Lymerix vaccine was removed in 2002 and was not replaced. One promising development is a next-generation vaccine, VLA15, which is based on recombinant OspA proteins and is in Phase 2 clinical trials. Human monoclonal antibodies also show promise in preclinical studies, and one is in Phase 1 preclinical studies now. Dennis noted that these monoclonal antibodies could also be used for prophylaxis in endemic areas. Current gaps in knowledge about B and T cell responses and correlates of long-lasting immunity, which may inform vaccine development, present a challenge for researchers. Antibiotics can also be used as prophylaxis, but there are known concerns about resistance and microbiome issues. Identification of small molecules and natural products could inform new preventative measures.

*Priority 6: Lyme Disease Treatment*
Sunil commented that treatment with appropriate antibiotics is effective for most patients in early stages of Lyme disease. However, following acute cases of infection, a subset of patients (10-20%) experience persistent symptoms. Pathogenesis of these symptoms remain largely unknown. Sunil noted that coinfection with other tick-borne diseases may contribute to symptoms, meriting further study. A gap exists regarding the etiology of neuropsychiatric illnesses in children, which may be due to exposure to tick bites in endemic areas. The subcommittee also expressed a need for better understanding of the incidence and outcome of tick-borne diseases during pregnancy.

Based on these priorities the Prevention and Treatment Subcommittee presented the following findings:

**Finding 1.1:**Improve regional surveillance and reporting of tick-borne diseases, including Alpha-gal Syndrome, and expand physician and public education to ensure that health care providers consider the potential for tick-borne diseases in their patients.

**Finding 1.2:**Understand the full spectrum of clinical manifestations of Lyme disease and other tick-borne diseases, to include microbial, immunologic, allergic (e.g., alpha-gal), and other biological determinants of outcomes of these diseases, including coinfections.

**Finding 1.3:**Support research to better understand the magnitude of outcomes of coinfections and vertical transmission of tick-borne diseases.

**Finding 2.1:**Improve treatment and management options for Alpha-gal Syndrome, including methods to desensitize patients to tick salivary factors and the use of alpha-gal deficient livestock for use as sources of food and pharmaceutical products.

**Finding 2.2:**Develop antimicrobial compounds and antibody therapies with therapeutic potential for acute and persistent infections with domestic tick-borne pathogens. Establish a plan for identifying top candidates and carrying development at least through animal models.

**Finding 2.3:**Increase research into the causes of persistent post-treatment symptoms attributed to tick-borne diseases, including Lyme disease, and identify or develop appropriate therapeutic approaches, including non-pharmaceutical interventions, to improve treatment outcomes.

**Finding 3.1:**Increase development of “anti-tick” human vaccines and novel tick-control methods to provide protection against multiple tick-borne diseases.

**Finding 3.2:**Establish correlates of protection and assess putative vaccine antigens for potential use in multivalent, multi-pathogen vaccines. Access cross-protective potential of existing tick-borne encephalitis vaccines against Powassan virus.

**Finding 3.1:**Require labeling of foods and food products for ingredients that are of non-primate mammal origin to prevent alpha-gal IgeE response in sensitized individuals.

Discussion

After the presentation, Dennis and Sunil responded to questions and comments from Working Group members. The main discussion points are summarized below.

The Working Group discussed the potential for occupational hazards for tick-borne disease, particularly risks to animal workers. Amanda noted that risk and treatment guidelines are not formalized, which can create barriers to access to care.

Elizabeth (Betty) Maloney, MD, President, Partnership for Tick-borne Disease Education, questioned whether the subcommittee was excluding persistent infection as potential pathogenesis of ongoing symptoms in patients with Lyme disease. Dennis noted that NIH is interested in persistent infection, and an upcoming solicitation will become available to study persistence in Lyme disease. The subcommittee, he added, consider this topic as an unanswered question. Dennis and Betty discussed multiple Lyme disease studies of persistence, and the efficacy of long-term microbial treatments. Betty noted that some studies showed improvement in some patients given longer courses of antibiotics. Dennis cited clinical trials that did not have such promising results; ultimately, however, he underscored that the lack of conclusive results demands more study. Betty highlighted the importance of individualized care and emphasized the need for other, perhaps more effective, antibiotic treatments. The Working Group agreed that research exploring the pathogenesis of persistent illness is sorely needed.

Linden stressed the importance of diagnostics that enable the categorization of patients who have heterogeneous expressions of disease. New fields of study, particularly related to long-haul COVID-19, have helped researchers think differently about how to address persistent disease. Dennis noted the difficulty of enrolling participants in clinical trials when the patient population has varying degrees of illness and reiterated the importance of effective diagnostics. Monica stressed the need for more antimicrobial combination treatments. Sunil noted that doxycycline treatment for pregnant patients is still considered questionable, except in the case of rickettsial disease, and more treatment options are needed for this population. The Working Group acknowledged the importance of more study to understand the pathogenesis of tick-borne disease.

Adjournment

The meeting was adjourned at 3:20 pm.

Appendix 1: Tick-Borne Disease Working Group Members and HHS Support Staff

Tick-borne Disease Working Group

**In alphabetical order:**

**Co-Chair***Holliday Goodreau*, Executive Director, LivLyme Foundation, Co-creator, TickTracker (Present)

**Co-Chair***Linden Hu*, MD, Professor of Microbiology and Medicine, Vice Dean for Research, Tufts University School of Medicine (Present)

*Charles Benjamin (Ben) Beard*, PhD, Deputy Director, Division of Vector-borne Diseases, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, Associate Editor, *Emerging Infectious Diseases* (Present)

*CAPT Rebecca Bunnell*, MPAS, PA-C, Senior Advisor, Learning and Diffusion Group, *Center for Medicare & Medicaid Innovation**,* Centers for Medicare & Medicaid Services, U.S. Department of Health and Human Services (Present)

*Dennis Dixon*, PhD, Chief, Bacteriology and Mycology Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, U.S. Department of Health and Human Services (Present)

*Monica E. Embers*, PhD, Associate Professor and Director of Vector-borne Disease Research, Tulane National Primate Research Center (Present)

*Elizabeth Maloney*, MD, President, Partnership for Tick-borne Diseases Education (Present)

*Robert J. Miller*, PhD, National Program Leader, Agricultural Research Service, U.S. Department of Agriculture (Present)

*CDR Todd Myers,* PhD, HCLD (ABB), MB (ASCP), Office of Counterterrorism and Emerging Threats, Office of the Chief Scientist, Office of the Commissioner, U.S. Food and Drug Administration, U.S. Department of Health and Human Services (Present)

*Jennifer Platt*, DrPH, Co-founder, Tick-borne Conditions United (Present)

*Sunil K. Sood*, MD, Chair of Pediatrics, South Shore University Hospital, Attending Physician, Infectious Diseases, Cohen Children’s Medical Center, Professor of Pediatrics at Hofstra/Northwell (Present)

*Kirby C. Stafford III*, PhD, Chief Scientist and State Entomologist, Department of Entomology, Center for Vector Biology & Zoonotic Diseases, The Connecticut Agricultural Experiment Station (Present)

*Leith Jason States*, MD, MPH (FMF), Deputy Chief Medical Officer, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services (Present)

*Gabriella Zollner (Romero)*, PhD, Program Manager, Deployed Warfighter Protection Program, U.S. Department of Defense (Present)

HHS Support Staff

**In alphabetical order:**

*James (Jim) Berger*, MS, MT (ASCP), SBB, Designated Federal Officer, Tick-Borne Disease Working Group, Senior Blood and Tissue Policy Advisory, Office of Infectious Disease and HIV/AIDS Policy, U.S. Department of Health and Human Services

*B. Kaye Hayes*, MPA, Alternate Designated Federal Officer, Tick-Borne Disease Working Group, Deputy Director, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services

*Chinedu Okeke*, MD, MPH-TM, MPA, Senior Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy, U.S. Department of Health and Human Services

*Lauren Overman*, MPH, CPH, Public Health Analyst, Office of Infectious Disease and HIV/AIDS Policy, U.S. Department of Health and Human Services

*Allison Petkoff*, Public Health Analyst, Office of Infectious Disease and HIV/AIDS Policy, U.S. Department of Health and Human Services

Appendix 2: TBDWG Subcommittees

**In alphabetical order:**

Access to Care and Education

**Co-Chair***Elizabeth (Betty) Maloney*, MD, President, Partnership for Tick-borne Diseases Education

**Co-Chair***CAPT Rebecca Bunnell*, MPAS, PA-C, Senior Advisor, Division of Model Learning Systems, Learning and Diffusion Group, The Center for Medicare and Medicaid Innovation, Centers for Medicare and Medicaid Services

*Holly Ahern*, MS, MT(ASCP), Associate Professor of Microbiology; Educator, patient advocate, researcher, and scientific advisor for Focus on Lyme Foundation

*Megan DuLaney*, MS, Senior Advisor in support of U.S. Department of State; Patient Advocate; Subject Matter Expert in military health, global health, and policy development and analysis

*Lorraine Johnson,* JD, MBA, Principal Investigator, MyLymeData; Subject Matter Expert in patient-centered health care policy, big data, patient registries, and innovative research; Chief Executive Officer, MyLyme.Org*David Roberts*, MD, Associate Professor of Medicine; Dean for External Education, Harvard Medical School; Educator for clinicians, trainees, and the public

*Ginger Savely*, DNP, Provider specializing in the treatment of Lyme disease; Member, International Lyme and Associated Diseases Society; Speaker and author with a focus on Lyme disease

*Leith J. States*, MD, MPH, MBA, FACPM, Chief Medical Officer, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services

*Beatric Szantyr*, MD, Physician educator on Lyme disease and other tick-borne diseases; Member, Maine Center for Disease Control and Prevention Vectorborne Workgroup

Changing Dynamics of Tick Ecology, Personal Protection, and Control

**Co-Chair**

*Robert J. Miller*, PhD, National Program Leader, NP104 Veterinary, Medical, and Urban Entomology, Agricultural Research Service, U.S. Department of Agriculture

**Co-Chair***Kirby C. Stafford III*, PhD, Chief Scientist and State Entomologist, Department of Entomology, Center for Vector Biology & Zoonotic Diseases, The Connecticut Agricultural Experiment Station

*Jill Auerbach*, Chairperson, Hudson Valley Lyme Disease Association, Coordinator; Tick Research to Eliminate Diseases: Scientist Coalition

*Lars Eisen*, PhD, Research Entomologist, Division of Vector-Borne Diseases, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention

*Amanda Elam*, PhD, CEO and Co-Founder, Galaxy Diagnostics, Inc.

*Dina Fonseca*, PhD, Professor and Director of the Center for Vector Biology, Department of Entomology, Rutgers, The State University of New Jersey, New Brunswick

*Rebecca Trout Fryxell*, PhD, Associate Professor, Medical and Veterinary Entomology, Department of Entomology and Plant Pathology, The University of Tennessee Institute of Agriculture

*Holly Gaff*, PhD, Professor, Department of Biological Sciences, Old Dominion University

*Erika T. Machtinger*, PhD, Assistant Professor of Entomology, College of Agricultural Sciences, The Penn State University

*Lonnie Marcum*, PT, BSHCA, Physical Therapist; Health and Science Writer for LymeDisease.org

*Daniel Salkeld*, PhD, Research Scientist, Department of Biology, Colorado State University

*Pete D. Teel*, PhD, Regents Professor, Department of Entomology, Texas A&M University

*Stephen K. Wikel*, PhD, Professor and Chair Emeritus of Medical Sciences, St. Vincent’s Medical Center, Quinnipiac University

Clinical Presentations and Pathogenesis

**Co-Chair***Charles Benjamin (Ben) Beard*, PhD, Deputy Director, Division of Vector-Borne Diseases, Centers for Disease Control and Prevention

**Co-Chair***Jennifer Platt*, DrPH, Co-founder, Tick-Borne Conditions United

**Co-Chair***Leith Jason States*, MD, MPH (FMF), Deputy Chief Medical Officer, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services

*Meghan Bradshaw*, Patient Advocate, Global Lyme Alliance, Center for Lyme Action

*Sue Faber*, RN, BScN, Co-Founder, LymeHope

*Brian Fallon*, MD, MPH, Director, Lyme and Tick-Borne Diseases Research Center, Columbia University

*Alison Hinckley*, PhD, Epidemiologist, Bacterial Vector-Borne Disease Branch, Centers for Disease Control and Prevention

*Jacob Lemieux*, MD, DPhil, Clinician and Researcher, Division of Infectious Diseases, Massachusetts General Hospital

*Tina Merritt*, MD, Provider, Allergy and Asthma Clinic of Northwest Arkansas

*Rhisa Parera*, Patient Advocate, Lyme360

Diagnostics

**Co-Chair***Monica E. Embers*, PhD, Associate Professor of Microbiology and Immunology, Director, Vector-Borne Disease Research, Tulane National Primate Research Center

**Co-Chair***CDR Todd Myers*, PhD, HCLD (ABB), MB (ASCP), Office of Counterterrorism and Emerging Threats, Office of the Chief Scientist, Office of the Commissioner, U.S. Food and Drug Administration

**Acting Co-Chair**(during CDR Todd Myers’s deployment)*Amanda Elam*, PhD, CEO and Co-Founder, Galaxy Diagnostics, Inc.

*John Aucott,* MD, Director, Johns Hopkins Lyme Disease Clinical Research Center; Associate Professor of Medicine, Johns Hopkins Medicine

*John Belisle*, PhD, Principal Investigator, Belisle Lab; Professor, Co-Director, Center for Metabolism and Infectious Diseases, Colorado State University

*John Branda*, MD, Associate Professor of Pathology, Harvard Medical School; Associate Pathologist, Associate Director, Microbiology Laboratory, Massachusetts General Hospital

*Tammy Crawford*, Founder and Executive Director, Focus on Lyme

*Liz Horn*, PhD, MBI, Principal Investigator, Lyme Disease Biobank; Principal, LHC Biosolutions

*Robyn Nadolny*, PhD, Chief, Molecular Biology Section and Tick-Borne Disease Laboratory, Laboratory Sciences Directorate, U.S. Army Public Health Center

*Rafal Tokarz*, PhD, Assistant Professor of Epidemiology, Center for Infection and Immunity, Columbia University Medical Center

Disease Prevention and Treatment

**Co-Chair***Dennis Dixo*n, PhD, Chief, Bacteriology and Mycology Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health

**Co-Chair***Sunil Sood*, MD, Chair of Pediatrics, South Shore University Hospital; Attending Physician, Cohen Children’s Medical Center; Professor of Pediatrics and Family Medicine, Zucker School of Medicine and Hofstra/Northwell

*Scott P. Commins*, MD, PhD, Associate Professor of Medicine and Pediatrics, Section Chief, Allergy and Immunology, University of North Carolina School of Medicine

*Gregory Ebel*, ScD, Professor, Colorado State University

*Erol Fikrig*, MD, Professor of Medicine (Infectious Diseases) and Epidemiology (Microbial Diseases) and Microbial Pathogenesis, Yale University for Global Health; Section Chief, Infectious Diseases

*Tony Galbo*, Advocate for Gabby’s Law; Member, Congressionally Directed Medical Research Programs Tick-Borne Disease Programmatic Panel, U.S. Department of Defense

*Peter J. Krause*, MD, Senior Research Scientist, Department of Epidemiology of Microbial Diseases, Yale University School of Public Health

*Charlotte Mao*, MD, MPH, Researcher and Physician, Dean Center for Tick-Borne Illness, Spaulding Rehabilitation Hospital

*Luis A. Marcos*, MD, MPH, Director, Infectious Diseases Fellowship Program, Stony Brook University; Associate Professor of Medicine, Microbiology, and Immunology, Stony Brook University Health Sciences Center School of Medicine

*Christopher Paddock*, MD, MPHTM, Pathologist, Rickettsial Zoonoses Branch, Centers for Disease Control and Prevention

*Paul Mead*, MD, MPH, Chief, Bacterial Diseases Branch, Division of Vector-Borne Diseases, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention

*Sam Perdue*, PhD, Section Chief, Basic Sciences and Program Officer, Rickettsial and Related Diseases, Bacteriology and Mycology Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health

*Mark Soloski*, PhD, Professor of Medicine, Lyme Disease Research Center, Johns Hopkins University School of Medicine

*Charlie Stockman*, Patient Advocate

Public Comment

*Holiday Goodreau*, Executive Director, LivLyme Foundation; Co-creator, TickTracker

*Linden Hu*, MD, Professor of Microbiology and Medicine, Vice Dean of Research, Tufts University School of Medicine

*Lauren Overman*, MPH, CPH, Public Health Analyst, Office of Infectious Disease and HIV/AIDS Policy, Health and Human Services*Jenifer Platt*, DrPH, Co-founder, Tick-Borne Conditions United

*Gabriella Zollner (Romero),* PhD, Program Manager, Deployed Warfighter Protection Program, U.S. Department of Defense

                    
  


Content created by Office of Infectious Disease and HIV/AIDS Policy (OIDP) Content last reviewed April 8, 2022Back to top
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