https://www.linkedin.com/pulse/many-100s-subjects-participating-valneva-vla15-lyme-luche-thayer/

Many 100s of Subjects Participating in Valneva VLA15 Lyme Vaccine Trials

Published on December 16, 2018

Jenna Luche-Thayer

 

FRIENDS,

The OspA based LYMErix vaccine was problematic with 1000+ adverse reactions and ongoing severe complications. According to the US government, the LYMErix vaccine had many health risks and was quite ineffective. Nevertheless, the biotech company Valneva appears to be using a similar OspA-based technology for their VLA15 Lyme vaccine.

TO NOTE: On December 3, 2018, the US federal Tick Borne Diseases Working Group stated they would be addressing Lyme vaccine safety concerns in their 2020 Report to Congress. This 2020 Report to Congress coincides with the end of the most experimental and riskier phases of the VLA15 trials.

US GOVERNMENT MESSAGE ON LYMERIX

The Directorate of Technical Support of the Department of Labor’s (USDOL) Occupational Safety and Health Administration’s (OSHA) issues Hazard Information Bulletins in accordance with OSHA instruction CPL 2.65 to provide relevant information regarding unrecognized or misunderstood health hazards. Hazard Information Bulletins are initiated based on information provided by the field staff, studies, reports and concerns expressed by safety and health professionals, employers and the public. Bulletins are developed based on thorough evaluation of available facts in coordination with appropriate parties.

Excerpted from the USDOL/OSHA Hazard Information Bulletin [1] regarding the LYMErix Vaccine:

“Communications with the Vaccine Adverse Events Reporting System Hotline during September 1999 indicated some reports of adverse events relating to LYMErix have been made”

“Lyme disease vaccine does not protect all recipients against infection with B. burgdorferi (Lyme)”

“Consequently, vaccinated persons, as well as the unvaccinated, should continue to practice good prevention and personal protective measures to prevent tick bites, and they should seek medical attention for early diagnosis and treatment of suspected tickborne infections”

“The duration of protection with LYMErix is not known …”

“LYMErix is not recommended for certain groups of people [including] Pregnant Women, Persons with Immunodeficiency and Persons with Musculoskeletal Disease [such as] persons with diseases associated with joint swelling (including rheumatoid arthritis) or diffuse musculoskeletal pain”

Safety and efficacy are unknown for persons with chronic joint or neurological illness related to Lyme disease and for persons with second-or third-degree atrioventricular block.”

In a memorandum for Regional Administrators from former Director Ruth McCully [2], of OSHA’s Directorate of Science, Technology and Medicine,

“Workers should be advised of the signs and symptoms of Lyme disease, as well as the primary and secondary preventive measures for decreasing the risk of Lyme disease transmission, acute illness, and chronic health effects. If recognized early, Lyme disease can be easily treated with antibiotic medication. However, if the disease goes unrecognized and untreated, chronic conditions may ensue, including varying degrees of permanent damage to the joints or the nervous system … “

“… In fact, the majority of infected persons do not recall being bitten by a tick … It is very important that the infection be diagnosed and treated with appropriate antimicrobial medication as early as possible because untreated Lyme disease may result in symptoms that are severe, chronic, and disabling. These disorders include chronic inflammatory arthritis, chronic muscle pain, heart disease, and/or neurological (brain and peripheral nerves) disorders. In addition, Lyme disease in a later stage is more difficult to diagnose, and treatment may be more prolonged and costly.”

VALNEVA VLA15 LYME VACCINE

Valneva, a biotech firm, plans to launch a Lyme vaccine. See studies:

—Assessing the Safety, Immunogenicity and Dose Response of VLA15, A New Vaccine Candidate Against Lyme Borreliosis—ClinicalTrials.gov Identifier: NCT03010228

—Immunogenicity and Safety Study of a Vaccine Against Lyme Borreliosis, in Healthy Adults Aged 18 to 65 Years. Randomized, Controlled, Observer-blind Phase 2 Study—ClinicalTrials.gov Identifier: NCT03769194

In both study phases, the target is to enroll approximately 10 percent or more of subjects that are baseline seropositive for Borrelia burgdorferi sensu latu (Lyme).

Valneva announced in an October 2018 article that the:

“Vaccination with OspA was already proven to work in the 1990s” —Valneva is referring to the LYMErix vaccine.

“The safety profile is expected to be similar to other vaccines using the same technology that have been approved for active immunization in adults and children.”

“European Medicines Agency (EMA) provided positive feedback on the Company’s general development approach for its Lyme disease vaccine candidate, VLA15 [and] is largely aligned with previous discussions with the US Food and Drug Administration (FDA) on the strategy for the VLA15 development”

“It is planned to include both study participants that have previously been exposed to Lyme as well as study participants that have not experienced previous infection.”

“Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. Phase 2 is underway and may include 800 subjects at more than 10 study sites in Lyme endemic areas in the U.S. and Europe.”

QUESTIONS

  1. Has the LYMErix vaccine health risk been disclosed to these Valneva Lyme vaccine study subjects?
  2. How will VLA15 accommodate the health risks particular to children?
  3. Will Valneva provide access to all Lyme treatment options from guidelines that meet international standards to those subjects —including children— who develop Lyme infection from the VLA15 studies? Including the: 10 percent or more persons recruited who are seropositive for Lyme infection?  Persons recruited who are seronegative for Lyme infection?
  4. How will the Tick Borne Diseases Working Group 2020 Report to Congress influence the VLA15 Lyme vaccine safety concerns—particularly those regarding children?
  5. Will the Tick Borne Diseases Working Group 2020 Report to Congress promote VLA15, which is a commercial venture by Valneva?
  6. Does the US federal government —e.g. HHS, CDC, NIH, DOD, or any of their employees— own patents related to VLA15?
  7. Do any members of the Tick Borne Diseases Working Group —and/or its Subcommittees— have conflicts of interests related to VLA15?
  8. Other questions? Other concerns?

Faithfully,

Jenna

Jenna Luché-Thayer. 30+ years working globally on the rights of the marginalized. Former Senior Advisor to the United Nations and the US Government. Director, Ad Hoc Committee for Health Equity in ICD11 Borreliosis Codes. Founder, Global Network on Institutional Discrimination, Inc. —Holding institutions accountable for political and scientific solutions. Email jennaluche@gmail.com

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For more:  https://madisonarealymesupportgroup.com/2018/06/06/valneva-seeking-partner-for-350m-lyme-disease-vaccine-effort-prepping-for-phase-2/

https://madisonarealymesupportgroup.com/2017/01/26/lyme-vaccine-to-be-tested-on-humans/

https://madisonarealymesupportgroup.com/2018/07/10/new-effort-for-lyme-disease-vaccine-draws-early-fire/

https://madisonarealymesupportgroup.com/2018/07/01/lyme-vaccine-fail-safety-ignored/

https://madisonarealymesupportgroup.com/2018/06/07/the-lyme-vaccine-russian-roulette/

https://madisonarealymesupportgroup.com/2018/07/22/why-we-care-so-strongly-about-a-potential-lyme-vaccine/

This vaccine should draw early fire, middle fire, and late fire.  The problems with it are endless.