Pfizer Gets Priority Review for Tick-Borne Encephalitis Vaccine
Pfizer has received priority review for their vaccine, TicoVac, which protects against tick-borne encephalitis. This tick-borne virus can cause meningitis and trigger long-term neurological symptoms in humans. If approved, the vaccine would potentially protect travelers and members of the United States military that are deployed to regions where the virus is common, such as Europe and parts of Asia.
TicoVac is an inactivated virus vaccine that has been highly effective at preventing tick-borne encephalitis throughout Europe for four decades. With this FDA fast-pass, it is hoped that a US approval would occur by August and would simplify the process for US military members to get the vaccine.
Pfizer is also developing a vaccine for another tick-borne illness: Lyme disease.
In this newly published review, Emerging Human Babesisosis with “Ground Zero” in North America, authors address the geographic distribution of the human-infecting Babesia spp., their phylogenetic relationship, and their tick vector worldwide. Species reviewed for human infection include, but are not limited to, B. microti, B. divergens, B. venatorum, B. duncani, B. crassa, and two yet unnamed Babesia species needing further investigation.
Authors found that the number of human Babesiosis cases appearing in the literature has increased exponentially in the last 10 years. Babesiosis has been a nationally notifiable disease in the United States (US) since 2011. Though cases of Babesiosis have been reported from all continents except Antarctica, the US leads the world in case numbers of human Babesiosis with more than 20,000 total cases reported since 2006.
The authors state several factors which may have contributed to this rapid increase in human case numbers of Babesiosis including increased awareness of the disease in the medical community, active monitoring and survey studies, global warming, transfusion transmissions and vertical transmission from an infected mother to child.
In Vitro Study: Botanical Medicines Against Babesia Duncani
The use of botanical medicines in the fight against Babesia duncani is explored in Frontiers in Cellular and Infection Microbiology by Johns Hopins’ Yumin Zhang and a research team.
The article states that although Babesia duncani was first described almost 30 years ago, due to treatment failures and undesirable side effects, the current treatment for human babesiosis has remained inadequate.
By examining a panel of herbal medicines that included Cryptolepis sanguinolenta, Artemisia annua, Scutellaria baicalensis, Alchornea cordifolia, and Polygonum cuspidatum, the research team determined the botanical remedies as having good in vitro inhibitory activity against B. duncani in the hamster erythrocyte model. Potential bioactive compounds, cryptolepine, artemisinin, artesunate, artemether, and baicalein, also demonstrated good activity against B. duncani.
The researchers propose that these botanicals be considered as candidates for clinical development due to their low cost, satisfactory toxicity and pharmacokinetic profiles, and history of safe and effective use in clinical trials and/or traditional medicine. Additional research is needed to distinguish bioactive components and determine their efficacy against other Babesia species in vitro and in vivo.
Phase 2 Study for Lyme Disease Vaccine Candidate Begins
Valneva and Pfizer announced that they have initiated a Phase 2 study for their Lyme disease vaccine candidate. This is currently the only active Lyme disease vaccine in clinical development.
This new study builds on previous studies, including new dose regimens as well as being the first clinical study to include children between the ages 5-17 years. Advancement to Phase 3 studies will depend on the outcome of this study.
Six serotypes prevalent in both North America and Europe will be covered by this vaccine and the vaccine targets one of the most dominant surface proteins expressed by Borrelia the pathogen when present in a tick, the outer surface protein A (OspA).
Note: The Lyme Disease Association Inc. has not taken a position on this vaccine but presents current information so consumers take actions relating to any information presented or can make informed decisions on issues presented.
Read the full article here. Read articles on vaccines from LDA here.
Research Trial Seeks Participants: Fluvoxamine for Early COVID Treatment
A randomized research study sponsored by Washington University School of Medicine seeks participants age 30 and older, who have tested positive for COVID-19, and are currently experiencing mild symptoms.
The purpose of the study is to determine if the drug fluvoxamine can be used during the early onset of COVID-19 infections to prevent more severe symptoms such as shortness of breath. Fluvoxamine is an anti-depressant drug approved by the US Food and Drug Administration (FDA) for the treatment of obsessive-compulsive disorder. The FDA has not approved fluvoxamine for COVID-19 treatment and therefore its use for the treatment of COVID-19 is considered investigational.
The study will be entirely remote, meaning that there will be no face-to-face contact. Materials, including the study drug, will be shipped to participants’ houses. All communication and interactions will be done via videoconferencing, email, or phone. People living in the United States and Canada can participate.
Hopkins Looks at Other Conditions Including Lyme to Understand Long Haul COVID 19
Dr. John Aucott, Director of The Lyme Disease Research Center, Division of Rheumatology, Department of Medicine at Johns Hopkins University School of Medicine, et al. published the article, “Long-haul COVID: heed the lessons from other infection-triggered illnesses” in The Lancet.
According to Aucott, explanations of the long-term effects of COVID-19 are beginning to appear in medical literature, the first significant cohort study with a 6-month follow-up has been published, with more data expected to emerge.
Similarities have been observed in persistent imaging and testing abnormalities across several organ systems in the post-acute period, as well as the frequent occurrence of patient-reported complaints including fatigue, insomnia, anxiety and depression, autonomic disturbances, cognitive difficulties, pain, and others.
The research team specifies, “Although the frequency, severity, and potentially the etiology of persistent symptoms can vary, sequelae after COVID-19 appears poised to join the range of other postinfectious syndromes described in the field of infectious diseases.”
It is the hope of the Hopkins team that researchers and clinicians will draw on other conditions such as myalgic encephalomyelitis/chronic fatigue syndrome, fibromyalgia, and post-treatment Lyme disease, as they continue efforts to advance scientific understanding of “long-haul” or “persistent COVID-19.” The researchers emphasize that there are important lessons to learn, as well as pitfalls to avoid and point to the ways post-treatment Lyme disease has remained a highly controversial illness for over 30 years.
HHS Chief Data Scientist Interview on Lyme Initiative
Health and Human Services Department (HHS) Chief Data Scientist and Senior Advisor to the Assistant Secretary for Health, Kristen Honey, recently gave an interview on HHS’s Lyme Innovation initiative with Nextgov. In the interview, Honey discusses various difficulties associated with Lyme disease and offered insights into the department’s continuing initiative to accelerate new advancements for patients.
@CovidAnalysis, a group of Ph.D. researchers and scientists, has put together a database of all ivermectin COVID-19 studies. The database includes 65 studies, 31 peer-reviewed, 44 with results comparing treatment and control groups. Click here to view the database on c19early.com.
Disclaimer: The Lyme Disease Association Inc. (LDA) provides this information as a public service. LDA does not necessarily endorse any of the studies or other articles in this section. Viewers need to consult with physicians or other professionals on any healthcare issues.
Read more about ivermectin treatment for COVID-19 on LDA’s website.
COVID Pre-Exposure Prophylaxis for Pregnant Women
COVID pre-exposure prophylaxis for pregnant women is a critical issue as pregnant women are at higher risk for developing severe complications of COVID infections including preterm delivery, fetal demise, respiratory failure and maternal death. As pregnant women initially may not be eligible to receive COVID-19 vaccines due to the unknown effects on mother and fetus, these women urgently need an option for protection from COVID when vaccine candidates are not available to them.
A peer-reviewed report, co-authored by Melissa C. Fesler and Raphael B. Stricker, has been published in the International Journal of General Medicine which evaluates pre-exposure prophylaxis (PrEP) with medications approved for use in pregnant women to prevent gestational problems and severe illness in this high-risk population.
This report evaluates pre-exposure prophylaxis medications with findings that hydroxychloroquine (HCQ) may provide the safest most effective means to reduce effects of or prevent SARS-CoV-2 infection in pregnancy.
HHS Request for Information (RFI): Diagnostic Testing for Lyme
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 the types of technologies being developed, any emerging technologies that could be used to characterized stages of Lyme, what sample type optimum for a detection test, and challenges in clinical practice.
Responses need to be submitted no later than 5:00 PM ET, March 15, 2021.