LDA NEWS & UPDATES
February 2021
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As part of the LymeX public-private partnership between Health & Human Services (HHS) and the Cohen Foundation, HHS has published an RFI in the Federal Register, 2.11.21 that seeks information on the current state of the science and technology to accelerate “innovative solutions” for Lyme disease diagnosis.
The RFI contains a series of questions it encourages responders to answer including types of technologies being developed, any emerging technologies that could be used to characterize stages of Lyme, what sample
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type is optimum for a detection test, and challenges in clinical practice. Read more.
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The study, “A murine model of Lyme disease demonstrates that Borrelia burgdorferi colonizes the dura mater and induces inflammation in the central nervous system,” was published in the journal PLOS Pathogens by Timothy Casselli, et |
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al. Prior to this, studies using inbred laboratory mice to observe B. burgdorferi infection and host immune responses in the central nervous system (CNS) were lacking, creating a major barrier to understanding the neuropathologies associated with Lyme disease.
RNA-sequencing and quantitative RT-PCR showed B. burgdorferi infection to be associated with increased expression of inflammatory cytokines and a robust interferon (IFN) response in the dura mater. Read more.
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Dr. Montgomery McFate, Professor, U.S. Naval War College, published, “The Myths of Lyme Disease: Separating Fact from Fiction for Military Personnel,” in Joint Force Quarterly, 100, Feb. 16, 2021.
Dr. McFate addresses, in the well-cited article, many damaging myths regarding Lyme that have proliferated in the medical system since its discovery 40+ years ago. She describes how myths harm military personnel, a population particularly at risk for exposure to Lyme. She presents several stories of military personnel harmed by Lyme & tick-borne diseases. Read more.
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SrA Dennis Sloan Joint Base Charleston Public Affairs |
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The study, "Diagnosis, Treatment, and Prevention Practices for Lyme Disease by Clinicians, United States, 2013-2015," by Alyssa R. Beck, MPH, et al., Public Health Report, Feb. 4, 2021, presents a study which objective “was to better understand factors associated with clinical practices related to tick bites and Lyme disease.” The study used a survey of health care providers, with 4,517 respondents across a three-year timeframe, and provided analyses of responses based on the provider's license type and the level of
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Lyme disease in high-low incidence states in 2019. Read more.
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The Centers for Disease Control and Prevention (CDC) has provided an update in the federal agency’s Morbidity and Mortality Weekly Report (MMWR) on February 19, 2021, regarding the first month of COVID-19 vaccine safety monitoring in the US from December 14, 2020, through January 13, 2021. The report covers the two COVID-19 vaccines, developed by Pfizer BioNTech and Moderna that have received Emergency Use Authorization for administration in the US. Read more.
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Johns Hopkins Lyme Disease Research Center’s recently released Winter 2021 Newsletter addresses the confusing new IDSA guidelines and calls attention to the similarities between common COVID-19 long hauler symptoms and persistent Lyme disease symptoms. It also provides insights into significant advances made by their Lyme disease clinical research program, despite challenges brought by the COVID-19 pandemic.
Drawing on the similarities between COVID-19 long haulers and persistent symptoms in Lyme disease, such as severe fatigue, cognitive symptoms, and pain, the Hopkins authors call attention to potential common mechanisms of illness, such as infection-induced changes in the autonomic nervous system and immune system. Read more.
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Adaptive Phage Therapeutics (APT) announced the US Food and Drug Administration (FDA) clearance of the Expanded Access IND for PhageBank™ treatment for pneumonia or bacteremia/septicemia due to Acinetobacter baumannii, Pseudomonas aeruginosa or Staphylococcus aureus in COVID-19 patients.
APT’s PhageBank™ therapy has been used to treat 9 COVID-19 patients in South Texas with co-infections due to multi-drug resistant Acinetobacter baumannii under the emergency IND mechanism since September 2020. Read more.
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The Tick-Borne Disease Working Group 2020 Report to Congress (Report) is now available. The Report was presented to the Secretary of Health & Human Services in December 2020 by the Working Group (WG). The Secretary sent the Report to the Energy & Commerce Committee in the House of Representatives and the Health, Education, Labor, and Pensions Committee in the Senate at the end of January 2021. As required, the Report is now on the HHS website. The above process is required by the portion of the 21st Century Cures Act that created the WG.
This second term of the WG often had contentious meetings primarily focusing on chronic Lyme disease (CLD) material and the problems with patients who have CLD in obtaining treatment and reimbursement in Chapter 7. Read more.
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How this happened on the Working Group
The Access to Care Subcommittee unanimously recommended the following Potential Action.
WG Access to Care Subcommittee Report
Potential Action 4: Recommend that CDC provide input to the Council of State and Territorial Epidemiologists, CSTE, that the
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Lyme disease surveillance case definition be revised such that it abandons the use of geographic parameters for Lyme disease. Read more.
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According to the US Department of Agriculture (USDA), the most recent tick to come into the US is now found in 15 states. The information is published in the USDA’s National Haemaphysalis longicornis Situation Report, February 3, 2021. The states are VA, WVA, PA, NC, NJ, TN, NY, KY, MD, CT DE, SC, AR, OH, RI. Read more.
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Longhorned Ticks. Photo by James Occi, (PhD cand.) LDA Scientific & Professional Advisory Board |
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On Feb. 24, 2021, the Food & Drug Administration (FDA) indicated Johnson & Johnson’s COVID-19 vaccine has met requirements for emergency use authorization (EUA). The report from staff will be used to brief the Vaccines & Related Biological Products Advisory Committee meeting, Feb. 26, to review Johnson & Johnson’s application for EUA of the single-shot vaccine. Read more,
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A study by Mikhail, et al., in Open Forum Infectious Diseases, Feb. 2021, from 2006 to 2017 showed 19,469 beneficiaries had babesiosis recorded, a substantial increase. The highest states by rates were Massachusetts (62), Rhode Island (61), Connecticut (51), New York (30), and New Jersey (19). States previously considered nonendemic saw increases: New Hampshire, Maine, Vermont, Pennsylvania, and Delaware. Read more.
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