Archive for the ‘Lyme Vaccine’ Category

Michigan Study Finds Anti-Zika Chemicals Impact Infant Motor Skills

http://www.ns.umich.edu/new/releases/24890-chemicals-used-to-combat-zika-agricultural-pests-impact-motor-skills-in-infants

June 8, 2017  Laurel Thomas Gnagey:  Michigan News

Researchers at the U-M School of Public Health and U-M Center for Human Growth and Development tested children in China and found exposure to the chemical naled via their mothers during pregnancy was associated with 3-4 percent lower fine motor skills scores at age 9 months for those in the top 25 percent of naled exposure, compared to those in the lowest 25 percent of exposure. Infants exposed to chlorpyrifos scored 2-7 percent lower on a range of key gross and fine motor skills.

Girls appeared to be more sensitive to the negative effects of the chemicals than boys.

Naled is one of the chemicals being used in several U.S. states to combat the mosquito that transmits Zika. Chlorpyrifos, around since the 1960s, is used on vegetables, fruit and other crops to control pests.

Both are insecticides called organophosphates, a class of chemicals that includes nerve agents like sarin gas. They inhibit an enzyme involved in the nerve signaling process, paralyzing insects and triggering respiratory failure. However, they may adversely impact health through other mechanisms at lower exposure levels that are commonly encountered in the environment.

“Motor delays in infancy may be predictive of developmental problems later in childhood,” said first author Monica Silver, graduate student research assistant and research fellow in the School of Public Health Department of Environmental Health Sciences. “The findings may help inform policy as the debate over use of these chemicals continues.”

The only studies to date on naled health impacts have taken place in occupational settings, not with exposure in the general population, Silver says. Previous chlorpyrifos research has found ties to delayed motor development in children and a host of health issues for those who handle the chemical, including nausea, dizziness and convulsions.

**Comment**

This is another great example of a myopic view on a problem to the detriment of public health.  Much like the Lyme vaccine which uses OspA and causes chronic Lyme symptoms in many people, many pesticides are wrecking havoc on public health as noted by the University of Michigan. and many, many other sources.

Why?

http://www.naturalnews.com/055293_Zika_virus_birth_defects_profits.html  Scott Adams, author of Natural News, has come up with five industries with agendas that stand to gain from a Zika scare including: chemical companies, vaccine makers, biotech industry (GMO mosquitoes), and Planned Parenthood and the condom industry since the disease is believed to be spread sexually.

Let us not forget governmental agencies and researchers as they typically obtain grant money for their research that is highly dependent upon what I call “curb appeal.”  In other words, the best way to get money in the 21st century is to whoop something up using the media to obtain funding as well as career advancement, prestige, and essentially power.  http://www.pewinternet.org/2015/02/15/how-scientists-engage-public/  Even though nearly 80% of scientists acknowledge that science news coverage doesn’t distinguish between well-founded and not well-founded findings.

For a refresher of how it all went down with Zika:  https://madisonarealymesupportgroup.com/2016/12/21/how-zika-got-the-blame/ Despite the CDC initially denying a causal link between Zika and microcephally, CDC authors then plopped one paper into a formula of which the paper only met 3 of 7 criteria and they did an about face.  

For more on Zika: https://madisonarealymesupportgroup.com/2016/03/08/fixation-on-zikapolio/
https://madisonarealymesupportgroup.com/2016/07/17/zika-in-the-land-of-oz/
https://madisonarealymesupportgroup.com/2016/10/26/zika-puzzling-scientists/
https://madisonarealymesupportgroup.com/2016/03/04/health-policy-recap/
https://madisonarealymesupportgroup.com/2016/04/08/zika-ebola-zombies-and-the-cdc/

What can really cause microcephally, not to mention cancer?

https://madisonarealymesupportgroup.com/2016/11/14/naled-causes-microcephaly/  

Naled’s breakdown product DICHLORVOS (another organophosphate insecticide) interferes with prenatal brain development. In laboratory animals, exposure for just 3 days during pregnancy when the brain is growing quickly reduced brain size 15 percent. https://www.ncbi.nlm.nih.gov/pubmed/8065512

DICHLORVOS also causes cancer, according to the International Agency for Research on Carcinogens. In laboratory tests, it caused leukemia and pancreatic cancer. Two independent studies have shown that children exposed to household “no-pest” strips containing dichlorvos have a higher incidence of brain cancer than unexposed children.

Aerial applications of naled can drift up to one-half mile. According to the U.S. Environmental Protection Agency, naled is moderately to highly toxic to birds and fish. It also reduced egg production and hatching success in tests with birds and reduced growth in tests with juvenile fish. convulsions, paralysis, and death.”

LDA President Pat Smith on Contagion Live


Patricia Smith, President of the Lyme disease Association, discusses Lyme disease has spread throughout the United States in the past decade. Part 1

Lyme Disease: What Makes Diagnosis & Treatment Difficult? Part 2

How Have Tick-Borne Diseases Grown in the United States? Part 3

What Do I Need to Know About Lyme Transmission Time? Part 4

Are Patients Facing Difficulties in Accessing Treatment for Lyme? Part 5

Why is May Lyme Disease Awareness Month? Part 6

How Does Government Acknowledgement of Lyme Affect Patient Care? Part 7

The Current State of Lyme Disease Prevention. Part 8

Lyme Disease Legislation May Advance Patient-Centered Research. Part 9

Medicine is Behind the Times When it Comes to Treating Lyme

http://www.contagionlive.com/news/is-the-medical-community-behind-the-times-when-it-comes-to-treating-lyme

MAY 24, 2017 | PAT SMITH

Is the Medical Community Behind the Times When It Comes to Treating Lyme?

 Lyme disease has been recognized in the United States for more than 40 years, with about 400,000 new cases occurring in 2015, according to the Centers for Disease Control and Prevention (CDC). Nineteen tick-borne diseases now affect Americans, and one tick bite can cause more than one disease. A recent CDC study uncovered that ticks that cause Lyme disease are found in 50% of continental US counties.1 In addition, according to the results of a large Johns Hopkins University study, as many as 36% to 63% of patients with Lyme disease go on to develop chronic symptoms (posttreatment Lyme disease).2
Major problems surrounding Lyme disease today include reliance upon dogma, promoting beliefs people are expected to accept without questioning or doubting, and the use of selective science by many in the medical community, the Lyme “experts,” who often blame the patient, the internet, and treating doctors with divergent opinions for their own lack of successful patient outcomes. They continue to approach Lyme with a “cookbook” approach. Patients are told the symptoms are “in their head,” that they need to stop reading the internet, or parents of patients are accused of Munchhausen by proxy syndrome (ie, making their children sick). These experts neither want to understand why their approach does not work, nor do they want to take the necessary time to understand the disease by researching and reading all the science, not just that which supports their unsuccessful treatment approach. Steeped in dogma, they ignore the fact that Lyme is meant to be a clinical diagnosis using testing as an adjunct.

Lyme clinical practice guidelines (CPGs) (eg, Infectious Diseases Society of America [IDSA] guidelines) often used by these physicians to treat Lyme are outdated and not posted on the National Guidelines Clearinghouse (NGC) These guidelines are most often used to deny treatment to patients with chronic disease, and so their current absence from the NGC is beneficial to patients who may need long-term antibiotic therapy and have been denied this through use of these guidelines. The only Lyme CPGs available on the NGC are those adhering to newly revised National Academy of Medicine, formerly Institute of Medicine, standards for guidelines− the International Lyme and Associated Diseases Society (ILADS) Lyme Guidelines,3 which address the usefulness of antibiotic prophylaxis for tick bites, the effectiveness of erythema migrans (EM) treatment, and antibiotics’ role in retreatment of persistent Lyme disease symptoms.

Many physicians solely rely on the two-tiered indirect Lyme tests recommended by the CDC and the outdated guidelines. These recommendations include a positive/equivocal enzyme-linked immunosorbent assay (ELISA) followed by western blot (WB), and the tests that are US Food and Drug Administration (FDA)-cleared (substantially equivalent to a predicate test),4 yet not necessarily approved. To date, the FDA has not been able to provide Lyme Disease Association, Inc., with any information on any FDA-approved test for Lyme, including the original predicate test.  According to research in BMJ,5 the two-tiered system, although very specific for Lyme disease (99%)—yielding few false-positives—has a uniformly low sensitivity (56%), missing 88 of 200 patients with Lyme. The current archaic Lyme tests remain unreliable decades later. By comparison, AIDS tests have a sensitivity of 99.5%, missing only one of 200 infected patients.

Additionally, there is no test for active Lyme disease infection, and test interpretation, especially the use of specific bands in the WB (IgM 2/3; IgG 5/10), developed at the 1994 CDC/Association of State and Territorial Public Health Laboratory Directors Dearborn meeting,6 is problematic. Some doctors and researchers believe those bands were selected only to protect the then-in-development Lyme disease vaccine (subsequently licensed and withdrawn over 4 years). Furthermore, the Lyme ELISA used for screening may not react with serum antibodies if at least a month has not elapsed between the tick bite and the test. If antibodies do develop, research in the Journal of the American Medical Association7 has shown that the antigen and the antibody produced by the patient can form a complex. Current commercial tests can only test for a free antibody, not an antibody in a complex, so patients can remain undiagnosed despite having produced antibodies.

Perhaps most noteworthy is that FDA-cleared commercial serological tests are based on one strain of Borrelia burgdorferi bacteria in contrast, for example, to a 2-strain Lyme test developed by one independent Clinical Laboratory Improvement Amendments-approved lab.  The recent discovery by Mayo Clinic/CDC of the Borrelia mayonii species in the Midwest, which can also cause Lyme, and the acknowledgement that Borrelia miyamotoi, a spirochete closely related to the relapsing fever bacteria and more distantly related to the Lyme bacteria, causes a Lyme-like disease in the United States, means Ixodes scapularis ticks transmit all three of those bacteria, further clouding the diagnostic picture.

There has been considerable research over the past several years supporting the existence of chronic Lyme, including the discovery at Northeastern University that persister cells are formed by B. burgdorferi.8 These cells go dormant when treated with antibiotics, but can grow again after treatment stops. Persisters are found in other diseases as well. Work at Johns Hopkins has also been done on persisters: research in Emerging Microbes & Infections,9 “…identified 165 agents approved for use in other disease conditions that had more activity than doxycycline and amoxicillin against B. burgdorferi persisters. The top 27 drug candidates from the 165 hits were confirmed to have higher persister activity than the current frontline antibiotics.” Additionally, work on biofilms in Lyme, by researchers from the University of New Haven, and published in European Journal of Microbiology & Immunology,10 demonstrated for the first time “…the presence of Borrelia biofilm in human infected skin tissue.”

The results of several animal studies have shown that the Lyme spirochete survives antibiotic treatment for Lyme disease, including a University of California mouse study,11 a Tulane monkey study,12 a Cornell dog study,13 and a National Institutes of Health human xenodiagnosis study.14

As new research continues to unlock persistence mechanisms used by B. burgdorferi, the medical community needs to avail itself of those scientific findings by attending continuing medical education conferences and grand rounds and partaking in preceptorships that foster divergent views. The medical community needs to support further research on why some individuals remain sick. It is imperative that healthcare professionals learn how to change that outcome rather than relying on outdated methodologies that have not benefited patient health.

**Patricia Smith (Pat), President of the Lyme Disease Association, Inc., graduated from Monmouth University. She has been involved with Lyme disease issues for 33 years and is a Member of the Columbia Lyme & Tick-Borne Diseases Research Center Advisory Committee, the Congressionally Directed Medical Research Programmatic Panel on Tick-Borne Diseases, and the Environmental Protection Agency Pesticide Environmental Stewardship Program. She has twice testified before US House Subcommittees on Lyme and is former Chair of the NJ Governor’s Lyme Disease Advisory Council. She has published on and been interviewed for broadcast, electronic, and print media on Lyme and tick-borne diseases.  

Lyme Vaccine to be Tested on Humans

http://www.thevaccinereaction.org/2017/01/fda-gives-green-light-to-test-lyme-disease-vaccine-on-humans/  by Patrice La Vigne and Barbara Loe FisherPublished January 25, 2017

Reprinted here:

Valneva’s preclinical study on mice reveal protection against Lyme disease transmitted by ticks among the majority of Borrelia bacteria strains.
Clinical trials for a new Lyme disease vaccine will be conducted in the U.S. and Belgium after the U.S. Food and Drug Administration (FDA) and European Union’s Clinical Trial Application gave Biotech firm Valneva of France clearance to begin Phase I testing.1

Valneva is developing VLA15, a hexavalent, protein subunit-based vaccine for protection against Lyme’s disease, a tick-transmitted bacterial infection characterized by fever, headache, fatigue and skin rash that, if left untreated, can spread to the joints, heart and nervous system and cause severe, chronic health problems.2 The vaccine targets the outer surface protein A (OspA), one of the most dominant antigens expressed by the Borrelia bacteria transmitted by a tick.1

The serotypes expressed by the U.S. species of the Borrelia bacteria differ from the European version of the bacteria. In fact, there are six types of the proteins. Valneva’s vaccine aims to target all different strains of OspA and teach the body’s immune system to recognize the bacteria and launch an attack.3

First Lyme Vaccine Withdrawn After Injury Claims
This is not the first time a company has pursued a Lyme disease vaccine candidate, although there are no vaccines currently on the market.

In 1998, the FDA approved LYMErix, manufactured by SmithKline Beecham (now GlaxoSmithKline) of the United Kingdom. Patients received three doses of the vaccine, which was manufactured using a recombinant Borellia burgdorferi outer surface protein (OspPA). The company claimed an effectiveness rate of 80 percent.

However, almost immediately after the vaccine was licensed and distributed, there were complaints that LYMErix vaccine was causing Lyme disease symptoms and in some cases was causing permanently disabling brain and immune system damage, including treatment resistant autoimmune arthritis.The biological mechanism hypothesis was that the outer surface protein A (OspA), which was the antigenic component of the LYMErix vaccine, induced autoimmunity in genetically susceptible individuals, including high levels of autoantibody to OspA in their synovial fluid. On Jan. 31, 2001, the FDA advisory committee held a public meeting to review the evidence for the vaccine’s safety and public comments were made by physicians, research scientists, individuals alleging LYMErix injury and attorneys.4

GSK voluntarily withdrew LYMErix vaccine from the market in 2002 citing uncertainty about risk of the disease and low public demand. However, they stopped producing the vaccine soon after a class action lawsuit involving hundreds of patients, who claimed they were injured by LYMErix, was settled out of court. GSK denied the vaccine caused harm and the vaccine industry and public health officials placed blame on the media for publicizing reports of vaccine reactions.

Other Lyme Vaccines Failed to Materialize
Pasteur Merieux Connaught of France moved its vaccine through to Phase III testing with positive results, however the company never sought licensure, citing a small market size.5 Baxter of Deerfield, IL was also recently developing a potential vaccine candidate against Lyme, but similarly abandoned the initiative.6

Seeing an experimental vaccine through to Phase III testing can cost a company more than $1 billion. About 86 percent of experimental drugs do not clear Phase I and II studies.

Valneva Vaccine Targets Six OspA Serotypes
Valneva’s preclinical study on mice reveal protection against Lyme disease transmitted by ticks among the majority of Borrelia bacteria strains.7

Phase I human trials at a U.S. site and a Belgium site will enroll 180 patients aged 18 to 40 years. The single-blind, partially randomized, dose escalation study will focus on evaluating VLA15’s safety and tolerability among different dose and formulation groups and time points. Researchers will measure immunogenicity by observing IgG antibodies against six OspA serotypes.

Call for Extensive Safety Testing of New Lyme Vaccine
According to the U.S. Centers for Disease Control and Prevention, approximately 300,000 Americans and 85,000 Europeans develop Lyme disease annually. The CDC states that Lyme disease is one of the fastest growing vector-borne infections in the U.S. and Congress made development of a new Lyme disease vaccine a funding priority in the 21st Century Cures Act passed at the end of 2016.8 9

Two researchers warned several years ago that new Lyme disease vaccines using the outer surface protein (OspA) must be thoroughly tested for safety. They said, “Any new Lyme vaccine will need extensive safety testing, more transparency about side-effects, and improved patient communication to allay patient concerns about safety. Let’s hope that history does not repeat itself because Lyme vaccine manufacturers, regulators, and promoters once again underestimate or ignore justified patient concerns about Lyme vaccination risks.”10

Please read Dr. Stricker’s comment about the vaccine:

Raphael Stricker2017 Feb 08 1:33 p.m.edited

Another Lyme OspA Vaccine Whitewash

The meta-analysis by Zhao and colleagues comes to the conclusion that “the OspA vaccine against Lyme disease is safe and its immunogenicity and efficacy have been verified.” The authors arrive at this sunny conclusion by excluding 99.6% of published articles that demonstrate potential problems with the OspA vaccine. Furthermore, the authors ignore peer-reviewed studies, FDA regulatory meetings and legal proceedings that point to major problems with OspA vaccine safety (1-3). This whitewash bodes ill for future Lyme vaccine candidates because it fosters disregard for vaccine safety among Lyme vaccine manufacturers and mistrust among potential Lyme vaccinees.

References 1. Stricker RB (2008) Lymerix® risks revisited. Microbe 3: 1–2. 2. Marks DH (2011) Neurological complications of vaccination with outer surface protein A (OspA). Int J Risk Saf Med. 23: 89–96. 3. Stricker RB, Johnson L (2014) Lyme disease vaccination: safety first. Lancet Infect Dis. 14(1):12.

 

For more on Lyme Vaccines:  https://madisonarealymesupportgroup.com/2016/08/04/vaccine-injuries-and-the-lyme-connection/

 

Lyme/MSIDS and Psychiatric Illness

  Uploaded on Dec 24, 2016
Lecture to American Psychiatric Association NY Branch, Lenox Hill Hospital

This excellent video has Dr. Jane Marke discussing psychiatric illness in TBI patients, and while the technical lecture is given to psychiatrists it will be highly illuminating to patients.  If you only want to know about psychiatric symptoms associated with Lyme, skip to around minute 28.

Marke states,

“Many doctors are convinced that after a short course of antibiotics patients should be well. The huge number of people still ill years after a course of antibiotics belie this assertion.”

http://www.janemarkemd.com/services-provided/lyme-psychiatry/  Her website states:

Patients with Lyme, and related tick-borne disease, can have symptoms which mimic every known psychiatric syndrome.  Treatment aimed directly at symptoms can relieve suffering rather quickly.  These symptoms include insomnia, anxiety, “brain fog”, obsessive-compulsive symptoms, depersonalization, depression, and rages.  But antibiotics are needed to undermine the root cause of the illness: the bacteria that causes Lyme: Borrelia burgdorferi.”

Other noteworthy comments:

15:12 – Marke describes the flagella of borrelia is more like the winged arms on a wine bottle opener which powerfully propels the organism.

15:40 – She questions if psychiatric disorders are inflammatory diseases.  She lists: Autism, Alzheimer’s, Schizophrenia, Bipolar, PTSD, Depression, Stress, Sleep Deprivation, Self-harm, and Suicid Attempts.  She also describes a study in England observing children for over a decade in which children with a high IL-8 at age 8 have an 81% change of developing depression by age 18 and a 2-fold chance of becoming psychotic.

18:04 – She states that TBI’s (Tick Borne Illness) causes an impaired Hypopituitary Axis (HPA) which on a chronic basis decreases cortisol and increases inflammation.  

20:40 – Neurotoxins in the brain contribute to mental illness by causing problems with Homosysteine metabolism, which supresses remethylation, but that apoptosis (cell death) which can be reversed by supplementing with SamE.

21:30 – She says Post Treatment Lyme Syndrome (PTLS) is like a “dog whistle,” and usually demonstrates a bias on behalf of the authors who believe that 3 weeks of antibiotics cures LD.  She then goes on to tell of a study that revealed that nearly 50% of those labeled as PTLS (with persistent symptoms) had anti-brain antibodies compared to 16.5% of Post Treatment Healthy Controls (no symptoms).

23:15 – She points out that the Lyme vaccine was taken off the market due to people getting sick from it not from “poor sales” as the cabal keeps saying.  http://www.nytimes.com/2002/02/28/business/sole-lyme-vaccine-is-pulled-off-market.html

25:34 – Babesia and Bartonella are of extreme interest to psychiatrists.

*Bartonella produces most of the psychiatric problems as well as photophobia, floaters, blurred vision, bone pain, pain in the soles of the feet, headaches, the hallmark rash that looks like stretch marks, migratory polyneuropathy (burning, weakness, and numbness, on both sides of the body that moves around) and POTS (a fast heart-rate when one goes from a lying position to a standing position).  Patients tend to exhibit OCD, self-mutilating behaviors, seizures, rage attacks, and psychosis (bipolar under this).  

https://madisonarealymesupportgroup.com/2011/09/25/the-bartonella-checklist-copyrighted-2011-james-schaller-md-version-11/  Dr. Schaller’s Bartonella Checklist

https://madisonarealymesupportgroup.com/2016/01/03/bartonella-treatment/

*Babesia patients present with day/night sweats, severe fatigue, and low blood pressure and exhibit anxiety, panic disorders, and depression.

https://madisonarealymesupportgroup.com/2011/09/25/the-babesia-checklist-copyrighted-2011-james-schaller-md-mar-version-20/  Dr. Schaller’s Babesia Checklist

https://madisonarealymesupportgroup.com/2016/01/16/babesia-treatment/

26:35 Persisting atypical and cystic forms drive local inflammation

28:23 Shows an excellent slide of the percentage of patients with late Lyme and various impairments such as Encephalopathy, memory issues, cognitive impairment, motor issues, and more.

31:15 She sites a study in which researchers set out to prove that there is no such thing as Late Lyme causing psychiatric problems.  Compared to controls, chronic lyme patients met criteria for adult onset ADHD (both inattentive type and hyperactive/impulsive types combined) more frequently.  She encourages doctors to take “syndromes,” and try to find an etiology, rather than the reverse, which is what is typically done.  In this specific case, she’s asking doctors to question and try to find solid reasons (etiology) why an adult would all of a sudden have ADHD.

33:30 She says TBI patients are the worst sleepers she’s encountered.  This is important because it is when toxins are cleared in the brain.

35:30 Depression is common in TBI patients.

36:50 She has an informative slide on suicides from those with Lyme collected from newspapers.

38:55 Shows a slide on Case studies of Intrusive Symptoms such as musical hallucinations, intrusive thoughts, Cognitive Tics, catastrophising, OCD.

40:00 Pediatric Auto-Immune Neurological Disorder (PANDAS) – caused by a lot of different organisms, including TBI’s, and it can also occur in adults.  These folks do extremely well on antibiotics or Immunoglobulin.  http://www.mercurynews.com/2014/04/19/misdiagnosed-bipolar-one-girls-struggle-through-psych-wards-before-stanford-doctors-make-bold-diagnosis-and-treatment/

http://www.pandasnetwork.org/understanding-pandaspans/ivig/

41:00 Depersonalization, Violence, self-harm, and schizophrenia can be a part of the picture with TBI’s. At 41:20 she tells the story of a little girl who would throw horrific temper tantrums in which she would destroy her room and then feel absolutely horrible after the fact.  She also had a psychotic episode.  Her MSIDS testing came back flagrantly positive.

42:21 Autism – There is vertical transmission of Lyme from mother to fetus.  Those with Bb in a study made remarkable improvement taking antibiotics.

42:56 Finding Spirochetes in Alzheimer’s patients as well as other pathogens.

https://madisonarealymesupportgroup.com/2016/04/10/bugs-causing-alzheimers/

https://madisonarealymesupportgroup.com/2016/08/09/dr-paul-duray-research-fellowship-foundation-some-great-research-being-done-on-lyme-disease/

https://madisonarealymesupportgroup.com/2016/06/03/borrelia-hiding-in-worms-causing-chronic-brain-diseases/

http://www.huffingtonpost.com/david-michael-conner/man-diagnosed-with-als-di_b_8891262.html

45:18 She points out the CDC guidelines and controversies, including the very poor testing and the vilification of small labs.  She recommends CLIA certified labs and that there is NO SUCH THING AS AN FDA APPROVED LAB.  She recommends IGeneX labs as they report the bands to you and uses more than 1 strain of Bb.

For more on IGeneX:  https://madisonarealymesupportgroup.com/2016/12/07/igenex-presentation/

48:17 She shows a SPECT scan with marked improvement after treatment with antibiotics for Encephalopathy.  She also states that minocycline probably crosses the blood brain barrier the best.

49:02 is a slide with supplements that directly help detoxification, inflammation, and more.  (vitamins, glutathione, LDN, herbs, diet, and compounds such as NAC, etc).  For info on LDN:  https://madisonarealymesupportgroup.com/2016/12/18/ldn/ and on NAChttp://www.lifeextension.com/magazine/2010/5/n-acetyl-cysteine/page-01

50:40 Marke asks psychiatrists with treatment resistant patients to consider microbes.

For more information on psychiatric Lyme: https://madisonarealymesupportgroup.com/2015/10/18/psychiatric-lymemsids/

Lyme Vaccine Heads to Clinical Testing

This is lengthy, but please read.  Lots of info here.  Chronically infected people need to carefully weigh vaccinations as their immune systems are already compromised.  Every person I know with MSIDS who got a vaccination suffered relapse.

http://www.4-traders.com/VALNEVA-SE-54466/news/VALNEVA-Valneva-Receives-FDA-and-European-Approvals-to-Start-Clinical-Testing-of-Lyme-Disease-Vacc-23531380/

12/10/2016 | 09:13am CET

(GlobeNewswire) – Valneva SE (“Valneva” or “the Company”), a fully integrated, commercial stage biotech company focused on developing innovative life-saving vaccines, today announced that its vaccine candidate VLA15 against Lyme disease is now progressing into clinical testing (Phase I) following the Investigational New Drug application (IND) clearance from the Food & Drug Administration (FDA) and the approval of the Clinical Trial Application (CTA) in Europe (Belgium).
Currently, there is no licensed vaccine available to protect humans against Lyme disease, a multi systemic tick-transmitted infection that can cause serious health problems and disabilities. Each year, an estimated 300,000 Americans and 85,000 Europeans develop Lyme disease and according to the CDC (Centers for Disease Control and Prevention), it is the fastest growing vector-borne infectious disease in the United States.
Valneva is developing a new hexavalent, protein subunit-based vaccine targeting the Outer Surface Protein A (OspA) of Borrelia. OspA is, one of the most dominant proteins expressed by the bacteria when present in a tick. Pre-clinical data showed that Valneva`s vaccine candidate can provide protection against the majority of Borrelia species pathogenic for humans[1].
Thomas Lingelbach, President and CEO, and Franck Grimaud, Deputy CEO of Valneva, commented, “We are very pleased to be able to advance our Lyme vaccine candidate which is intended to address such an important unmet medical need. We are committed to finding ways to accelerate the clinical development path to licensure, given that we are conducting the only active vaccine program in the industry.”
Valneva`s Phase I trial VLA15-101 is being conducted at two sites – one in the U.S. and one in Europe (Belgium) and will enroll 180 subjects, aged 18-40 years. The primary objective of the single-blind, partially randomized, dose escalation study will be to evaluate the product candidate`s safety and tolerability. Immunogenicity, measured by observing IgG antibodies specific against six OspA serotypes, will also be monitored for different dose groups and formulations at different time-points.

Investor Meeting and Live Webcast in New York, December 12th, 12pm Eastern Time.
Considering the strong interest shown on the disease by investors, shareholders and the general public, Valneva is hosting a conference on Lyme disease in New York on December 12, 2016 to provide more detailed information on the disease and the opportunity to develop a vaccine. The conference will be co-presented by Prof. Stanley A. Plotkin, Emeritus Professor, University of Pennsylvania, and Valneva`s Lyme R&D experts led by CEO Thomas Lingelbach. To register for the conference, please visit Valneva`s website:  http://www.valneva.com/en/

Valneva SE (Euronext Paris: VLA:EPA) is hosting a webcasted Key Opinion Leader Lunch on Developing a Vaccine for Lyme Disease TODAY, Monday, December 12, 2016, from 12:00-1:30 pm ET.
A live webcast and subsequent replay of the event will be available at: http://lifesci.rampard.com/20161212/. If you would like to ask a question during the live Q&A, please submit your request via email to questions@lifesciadvisors.com.
A Q&A session with the featured experts and management will follow the presentations.

About Valneva SE
Valneva is a fully integrated, commercial stage biotech company focused on developing innovative life-saving vaccines.
The Company seeks financial returns through focused R&D investments in promising product candidates and growing financial contributions from commercial products, striving towards financial self-sustainability.
Valneva`s portfolio includes two commercial vaccines for travelers: IXIARO/JESPECT indicated for the prevention of Japanese encephalitis and DUKORAL indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. The Company has proprietary vaccines in development including candidates against Clostridium difficile and Lyme Borreliosis. A variety of partnerships with leading pharmaceutical companies complement the Company`s value proposition and include vaccines being developed using Valneva`s innovative and validated technology platforms (EB66 vaccine production cell line, IC31 adjuvant).
Valneva is listed on Euronext-Paris and the Vienna stock exchange and has operations in France, Austria, Great Britain, Sweden, Canada and the US with over 400 employees. More information is available at www.valneva.com.
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Forward-Looking Statements
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[1] http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0113294
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(c) 2016 palestinechronicle.com Provided by SyndiGate Media Inc. (Syndigate.info)., source Middle East & North African Newspapers

***Please know that the first Lyme vaccine, LYMErix, caused many folks to develop Chronic Lyme.  https://madisonarealymesupportgroup.com/2016/08/04/vaccine-injuries-and-the-lyme-connection/

The CDC Fraud with vaccines and lyme (OspA) connection:

“The LYMEerix vaccine was manufactured with ‘outer surface protein A’ (OspA). OspA is fungal and therefore has an immunosuppressive effect – causing post-sepsis syndrome. People injected with this vaccine were effected similarly to those bitten by a tick -which injects spirochetes (toxic fungi). Ironically, this vaccine was making people sick with the exact thing it was supposed to prevent!
The LYMErix vaccine gave people the same disease we know of as chronic neurologic Lyme, so then what is the disease? What is OspA?
The LYMErix vaccine was patented by the U.S. Centers for Disease Control and prevention (CDC). The synthetic OspA injected into subjects in the trial for the vaccine were getting sick. They were injected with a fungal type antigen which is toxic to humans.
LYMErix was pulled off the market when this fact was revealed to the FDA. But was anyone prosecuted like with the NECC scandal? Did anyone go to jail for racketeering? Was a fund set up for the victims?
Petition for a Congressional Investigation
It’s time to hold the CDC, Merck, Yale, IDSA (and others) responsible for the lives they have destroyed. Carl Tuttle started a petition with over 34k signatures so far – “Calling for a Congressional investigation of the CDC, IDSA and ALDF”
https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf”

LYMERix Vaccine Victim’s Stories – FDA: http://www.fda.gov/ohrms/dockets/ac/01/briefing/3680b2_17.pdf

http://cid.oxfordjournals.org/content/52/suppl_3/s253.abstract

Please read Dr. Sticker’s (a prominent LLMD) comments on the vaccine:

Raphael Stricker2017 Feb 08 1:33 p.m.edited

Another Lyme OspA Vaccine Whitewash

The meta-analysis by Zhao and colleagues comes to the conclusion that “the OspA vaccine against Lyme disease is safe and its immunogenicity and efficacy have been verified.” The authors arrive at this sunny conclusion by excluding 99.6% of published articles that demonstrate potential problems with the OspA vaccine. Furthermore, the authors ignore peer-reviewed studies, FDA regulatory meetings and legal proceedings that point to major problems with OspA vaccine safety (1-3). This whitewash bodes ill for future Lyme vaccine candidates because it fosters disregard for vaccine safety among Lyme vaccine manufacturers and mistrust among potential Lyme vaccinees.

References 1. Stricker RB (2008) Lymerix® risks revisited. Microbe 3: 1–2. 2. Marks DH (2011) Neurological complications of vaccination with outer surface protein A (OspA). Int J Risk Saf Med. 23: 89–96. 3. Stricker RB, Johnson L (2014) Lyme disease vaccination: safety first. Lancet Infect Dis. 14(1):12.

 

If you want to know more about vaccines in general:

https://madisonarealymesupportgroup.com/2016/03/19/a-dozen-collapse-after-vaccine/

https://madisonarealymesupportgroup.com/2015/06/19/a-word-on-vaccines/

https://madisonarealymesupportgroup.com/2016/12/08/mercury-and-autism/

https://madisonarealymesupportgroup.com/2015/11/08/flu-vaccine-causes-the-flu/

https://madisonarealymesupportgroup.com/2016/04/24/gardasil-and-bartonella/

https://madisonarealymesupportgroup.com/2016/07/19/motor-and-sensory-findings-in-girls-who-received-gardasil/

https://madisonarealymesupportgroup.com/2016/11/07/connection-of-acute-flaccid-myelitis-and-vaccinations/

 

Lyme Cryme Video – Powerful

Cryme Disease: The Lyme Cryme Against Humanity
TRUTH from the LYMErix whistleblower

https://youtu.be/f8DU1Z6R-ms  Published on Sep 2, 2016.  Powerful hour long video explaining how the CDC purposely rigged the case definition of Lyme so cases would be missed.

Stress is placed on the fact that spirochetes are fungal shedders not bacteria.  This is important in semantics because unless you are using the same linguistics you will never come to an agreement, and that’s right where we are:  NO AGREEMENT IN THE MEDICAL COMMUNITY.