Archive for the ‘Lyme Vaccine’ Category

The Lyme Disease Vaccine – Separating Fact And Fiction

https://www.lymedisease.org/lyme-vaccine-fact-vs-myth/

The Lyme disease vaccine–separating fact and fiction

By Lonnie Marcum

Aug. 29, 2023

The latest version of a Lyme disease vaccine, “VLA15” made by Pfizer and Valneva, is in phase 3 clinical trials and is due to hit the market in 2026.

A recent Bloomberg article reviews some of the history of the previous failed Lyme vaccine called LYMErix. However, they missed some critical elements of how and why LYMErix was pulled from the market 20 years ago—and believe me, it wasn’t anti-vaxxer conspiracy theories.

Let me be clear, I am not anti-vaccine. In fact, because I’ve worked in various aspects of healthcare for the past 30 years, I am fully vaccinated against most everything. There is no doubt, a vaccine that protects against Lyme disease would be highly valuable. Better yet, a vaccine that would protect against all tick-borne diseases.

According to the Centers for Disease Control (CDC), the incidence of reported vector-borne diseases (caused by ticks, mosquitos, and fleas) tripled during 2004-2016, with 75% of those infections coming from ticks. Lyme disease accounted for 82% of the tick-borne disease reports and is overall one of the top three “nationally notifiable” infectious diseases in the United States. (Rosenberg 2018)

The “discovery” of Lyme disease

In fact, evidence of Borrelia was found  in 5,300-year-old human remains from Europe (Keller 2012) and in fossilized 15-20 million-year-old amber from the Dominican Republic. Thus, disease caused by Borrelia, aka Lyme disease, is not a new phenomenon. (Poinar 2015)

However, it wasn’t until 1977 that Dr. Allen Steere first described an “epidemic” of arthritis occurring in patients living in Lyme, Connecticut. By 1982, researchers had identified a spirochete in blood samples from those patients and determined it to be the cause of this cluster of illnesses.

The bacterium was later named Borrelia burgdorferi after Wilhelm “Willy” Burgdorfer, the scientist who identified it. The illness was named Lyme disease, after the community in which it was discovered. (Burgdorfer 1982)

Complex bacteria

Borrelia burgdorferi is one of the most complex bacteria known to man. Its unique genomic structure contributes greatly to its ability to survive and maintain an extremely difficult life cycle that alternates between warm-blooded animals and cold-blooded ticks. (Brock 1994; Porcella 2001)

While there are many similarities between Borrelia and other spirochetes (eg. Leptospira, Treponema) the primary difference is their genomic structure. Where Treponema contains only one linear chromosome, Borrelia contains one linear chromosome, plus 21 extrachromosomal elements, including 12 linear and nine  circular plasmids—by far the largest number of plasmids ever found in any bacterium. (Frasier 1997)

It’s now known that Lyme disease can be caused by different strains and species of Borrelia bacteria, though most commonly by Borrelia burgdorferi in the US and Borrelia afzelii or Borrelia garinii in Europe. (Cutler 2016)

Today there are five known subspecies of Lyme disease causing Borrelia burgdorferi and over 52 species of Borrelia worldwide. Twenty-one species belong to the Lyme disease group and 29 are members of the relapsing fever group.

Furthermore, each of those species can develop genetic variants or subtypes.  In all, there are over 300 known strains of Borrelia worldwide, with over 100 found in the US alone. (Cerer 2016)

How do you develop a vaccine to protect against 300 strains of Borrelia?

Challenges of making a Lyme vaccine

Because of their genetic complexity, all Borrelia can alter their outer surface proteins when conditions change—a process known as antigenic variation. This complexity allows Borrelia to adapt to a variety of hosts, avoid immune detection, widely disseminate throughout the body, and support chronic or persistent infection. Borrelia has also been shown to survive standard antibiotic therapy in several animal and primate studies. (Hodzic, Barthold 2014; Elsner, Baumgarth 2015; Embers 2017)

Many of the reasons we do not have a vaccine for Lyme disease are the same reasons we do not have vaccines for other complex bacterial diseases like syphilis and tuberculosis.

The demise of LYMErix

The first vaccine for Lyme disease, drugmaker SmithKline Beecham’s LYMErix, was FDA-approved in 1998. In 2002, shortly after Lyme Disease Association President Pat Smith and others met with the FDA to discuss reports of adverse reactions to the vaccine, the manufacturer withdrew LYMErix from the market.

On that January day in 2002, Donald H Marks, MD, PhD, presented evidence of adverse events associated with the LYMErix vaccine. These included long-lasting arthritis and complicated neurological problems.

Dr. Marks has decades of clinical practice, research, and regulatory affairs experience in the pharmaceutical industry. While serving as director of clinical research at Aventis Pasteur, a pharmaceutical company, he oversaw its OspA Lyme disease vaccine program which was stopped due to adverse events.

In compelling testimony, Marks told the FDA, “The Company (the vaccine maker) dismissed the significance” and did not inform physicians of the potential for adverse events. “As a result of these actions, GPs in the US were kept in the dark about the life-threatening side effect of Lymerix.”

Furthermore, Marks told FDA officials, “In my opinion, there is sufficient evidence that Lymerix is causally related to severe rheumatologic, neurologic, autoimmune, and other adverse events in some individuals. This evidence is such as to warrant a significantly heightened degree of warnings and possible limitations or removal from marketing of Lymerix.”

One month later, February 2002, SmithKline Beecham (now GlaxoSmithKline) withdrew LYMErix from the market claiming poor sales potential.

See the full LYMErix Safety Data Reported to the Vaccine Adverse Event Reporting System (VAERS) here.

Lyme vaccine fact check

Fact: LYMErix did not provide immunity to humans. The LYMErix vaccine was derived from a single outer-surface protein of Borrelia burgdorferi known as OspA. The vaccine relied on the tick to feed on the vaccinated human, ingest a human byproduct of the vaccine (OspA antigen), that would then kill the Borrelia spirochete in the midgut of the tick. In order to work, this process needed to take place prior to the tick injecting the live spirochetes into the human—a process that the makers of LYMErix admitted was only partially successful. (Sheller 2013)

The new Lyme vaccine, VLA15, also uses the OspA protein, with some structures removed to reduce the number of adverse reactions, in theory.

Fact: LYMErix required patient/doctor compliance and had limited effectiveness. The LYMErix vaccine required three doses within a 12-month period in order to obtain enough OspA antigen to kill the Borrelia in the tick. The vaccine was reported to be 50% effective after the second dose and only 73-78% effective after the third dose. (Smith 2022) Meaning 20% of people who were fully vaccinated could still acquire Lyme disease.

Unfortunately, there were no studies to show what would happen to a patient if they were bitten by an infected tick during the LYMErix vaccine series, and there were no studies demonstrating whether or not the vaccine would provide long-term protection.

The new VLA15 vaccine will also require three doses within a nine-month period followed by annual boosters.

Fact: LYMErix caused auto-immune reactions in some people.  Just prior to FDA approval of LYMErix, Dr. Allen Steere and others published research describing potential auto-immune responses to OspA in a subset of patients who are born with a genetic defect known as HLA-DR4. Approximately 30% of the population carries HLA-DR4 genetic defects. (Gross 1998)

We do not yet know if the VLA15 OspA vaccine will cause the same adverse reactions as the LYMErix. (Comstedt 2017)

Fact: LYMErix caused adverse events that ranged from mild to life-threatening illness, including symptoms of Lyme disease. In the FDA’s 2001 Safety Data Report there were 1,048 reports of injury following the vaccine, including four deaths, and 85 serious events. (Ball 2001; Latov 2004; Rose 2001)

The VAERS data is not available for VLA15. Pfizer states, “The VLA15-221 trial is ongoing to assess the safety and immunogenicity of VLA15 in a pediatric population aged 5 years and above.”

Fact: LYMErix caused hyper immune reactions in some people. A subset of the vaccinated population had extreme immune responses to the vaccine, causing them to test positive for Lyme disease. Using the currently available test, there was no way to determine if the patient had contracted a new case of Lyme, reactivated a subclinical infection, or if they were having an auto-immune reaction to the vaccine. Note: 20-30% of the vaccinated had no protection from Lyme. (Fawcett 2001)

Fact: LYMErix caused severe neurological complications in some patients. These may have been related to asymptomatic pre-existing Lyme disease infections and/or HLA-DR defects. (Marks  2011)

Dr. Marks told the FDA in 2002:

  • “Many of these people may have had prior exposure and clinical or subclinical infection. In these cases, Lymerix could be triggering or reactivating the damage caused by old and presumably cured Lyme disease.”
  • “Pattern of symptoms experienced after Lymerix mimicked pattern of prior infections in many individuals. In these patients, Lymerix-related symptoms seemed to respond to antibiotics, as did the initial infection, bolstering the theory of disease reactivation.”

Fact: LYMErix resulted in multiple class-action lawsuits. After reports of injury the FDA requested GlaxoSmithKline, the makers of LYMErix, to expedite the reporting of their Phase IV trial, including all adverse events. Shortly after a study was published documenting injury, LYMErix was pulled off the market citing “poor sales.” (Stricker, Johnson 2014)

The challenge of establishing trust

Because the history of the previous Lyme vaccine is so muddied, Pfizer will face an uphill battle establishing trust amongst the Lyme community for its new vaccine. As LymeDisease.org’s Lorraine Johnson points out, “without transparency about the issues with the past vaccine, there would be no trust in the patient community for a new vaccine.”

As Pat Smith says in the recent Bloomberg article, “We are interested in the possibility of a vaccine. The issue is the safety and efficacy.”

One way we might get that trust is for Pfizer and Valneva to make their VAERS data easily available for all to see!

In March 2020, I submitted written comments to the federal Tick-borne Disease Working Group on the history of the Lyme vaccine along with my suggestions on how to move forward. You can see those comments here.

And in July 2019, I composed a long thread on Twitter pointing out Myth vs Fact on the LYMErix vaccine in response to an article in The Guardian that got several details wrong. You can see that thread here.

LymeSci is written by Lonnie Marcum, a Licensed Physical Therapist and mother of a daughter with Lyme. She served two terms on a subcommittee of the federal Tick-Borne Disease Working Group. Follow her on Twitter: @LonnieRhea  Email her at: lmarcum@lymedisease.org.

References

1      Ball R. (2001) Powerpoint on the Lymerix Vaccine, LYMErix® Safety Data Reported to the Vaccine Adverse Event Reporting System (VAERS), https://www.lymediseaseassociation.org/images/NewDirectory/Government/Vaccines/2001_fda_powerpoint_RobertBall.pdf

2      Brock TD, et al. (1994) Biology of Microorganisms, 7th ed. Prentice Hall, NJ, USA. Introduction to Spirochètes. University of California Museum of Paleontology.

3      Burgdorfer W, Barbour AG, Hayes SF, Benach JL, Grunwaldt E, Davis JP. (1982). Lyme disease-a tick-borne spirochetosis? Science, 216(4552), 1317-1319.

4      Cerar T, et al. (2016) Differences in Genotype, Clinical Features, and Inflammatory Potential of Borrelia burgdorferi sensu stricto Strains from Europe and the United States. Emerging Infectious Diseases. 2016,22(5):818-827. doi:10.3201/eid2005.151806

5      Comstedt P, et al. (2017) The novel Lyme borreliosis vaccine VLA15 shows broad protection against Borrelia species expressing six different OspA serotypes. Plos. https://doi.org/10.1371/journal.pone.0184357

6      Cutler SJ, Ruzic-Sabljic E, Potkonjak A (2016). “Emerging borreliae – Expanding beyond Lyme borreliosis”. Molecular and Cellular Probes. doi:10.1016/j.mcp.2016.08.003. PMID 27523487.

7      Eisen RJ, Kugeler KJ, Eisen L, Beard CB, & Paddock CD. (2017) Tick-Borne Zoonoses in the United States: Persistent and Emerging Threats to Human Health. ILAR J, 1-17. doi:10.1093/ilar/ilx005

8      Elsner R, Hastey CJ, Baumgarth N. (2015) Suppression of long-lived immunity following Borrelia burgdorferi induced Lyme disease. PloS Pathogens, 11: e1004976.

9      Embers M, et al. (2017) Variable manifestations, diverse seroreactivity and post-treatment persistence in non-human primates exposed to Borrelia burgdorferi by tick feeding. PlosOne, https://doi.org/10.1371/journal.pone.0189071

10    Embers M, Narasimhan S. (2013) Vaccination against Lyme disease: past, present, and future. Frontiers in Cellular and Infection Microbiology 3(6):6 · DOI: 10.3389/fcimb.2013.00006

11    Fawcett PT, Rose CD, et al. (2001) Effect of Immunization with Recombinant OspA on Serologic Tests for Lyme Borreliosis. Clin Vaccine Immunol vol 8, no 1 79-84 doi: 10.1128/CDLI.8.1.79-84.2001

12    Frasier CM, et al. (1997) Genomic sequence of a Lyme disease spirochaete, Borrelia. Nature volume 390, pages 580–586

13    Gomes-Solecki, M. (2014) Blocking pathogen transmission at the source: reservoir targeted OspA-based vaccines against Borrelia burgdorferi. Front Cell Infect Microbiol. 2014; 4: 136 doi: 10.3389/fcimb.2014.00136

14    Gross DM, et al. (1998) Identification of LFA-1 as a Candidate Autoantigen in Treatment-Resistant Lyme Arthritis Science  31 Jul 1998: DOI: 10.1126/science.281.5377.703

15    Hodzic E, Imai D, Feng S, Barthold SW. (2014) Resurgence of persisting non-cultivable Borrelia burgdorferi following antibiotic treatment in mice. PLoS One, Jan 23;9(1):e86907. doi:  10.1371/journal.pone.0086907.

16    Hu LT, et al. (2006) Protective efficacy of an oral vaccine to reduce carriage of Borrelia burgdorferi (strain N40) in mouse tick reservoirs. Vaccine. doi:  10.1016/j.vaccine.2005.10.044

17    Keller A, Graefen A, et al (2012) New insights into the Tyrolean Iceman’s origin and phenotype as inferred by whole-genome sequencing. Nature Communications vol 3, Article number 698

18    Latov N, et al. Neuropathy and cognitive impairment following vaccination with the OspA protein of Borrelia burgdorferi. J Peripher Nerv Syst. 2004 Sep;9(3):165-7. DOI: 10.1111/j.1085-9489.2004.09306.x

19    Marconi RT, et al. (2017) Identification of a defined linear epitope in OspA protein of the Lyme disease spirochetes that elicitis bactericidal antibody responses: Implications for vaccine development. Science Direct. https://doi.org/10.1016/j.vaccine.2017.04.079

20   Marks DH. Neurological complications of vaccination with outer surface protein A (OspA). Int J Risk Saf Med 2011; 23: 89–96.

21    Poinar G. (2015) Spirochete-like cells in a Dominican amber Ambylomma tick (Arachnida: Ixodidae) Historical Biology. Jan 2014, Volume 27,2015-Issue 5

22    Porcella SF, Schwan TG. (2001) Borrelia burgdorferi and Treponema pallidum: a comparison of functional genomics, environmental adaptations, and pathogenic mechanisms. J. Clin Invest, 10.1172/JCI12484

23    Rose CD, Fawcett PT, Gibney KM. (2001) Arthritis following recombinant outer surface protein A vaccination for Lyme disease. J Rheumatol. Nov;28(11):2555-7.

24    Rosenberg R, et al. (2018) Vital Signs: Trends in Reported Vectorborne Disease Cases — United States and Territories, 2004–2016 Weekly / 67(17);496–501

25    Sheller S. (2013) “It’s Time to Develop a Vaccine for Lyme Disease, Doctor Says” Op-Ed. Philladelphia Enquirer. https://www.lymediseaseassociation.org/images/NewDirectory/Government/Vaccines/2013_LymeOp_Ed_Sheller.pdf

26    Stricker R, Johnson L. (2014) The Lancet. Lyme disease vaccination: safety first. DOI: https://doi.org/10.1016/S1473-3099(13)70319-0

27    Smith P, Gaito A, Marks, DH. (2002) Transcript of FDA Lymerix meeting, Bethesda, MD. https://www.lymediseaseassociation.org/about-lyme/controversy/vaccine/261-lymerix-meeting

28    Sprong H, Seemann I, et al. (2014) ANTIDotE: anti-tick vaccines to prevent tick-borne diseases in Europe. Parasites and Vectors. https://doi.org/10.1186/1756-3305-7-77

Category:

Activism, Lyme Vaccine, Testing, Ticks

Dog Dies Minutes After Lyme Vaccine & OspA mRNA “Vaccine” in the Works for Humans

http://

Dog Dies Minutes After Lyme Vaccine

June, 2020

WDIV Detroit

Meanwhile, all over planet earth: vaccines are ‘safe and effective’.

Dr. John Robb, a Connecticut vet with other 34 years of experience testified about that over vaccination is killing our pets.  Vets are bound legally to do what the ‘vaccine’ manufacturer says even if they are injecting a tiny dog with the same amount of deadly poison as a massive dog.  He also said current dose is even far too much for the larger K9s.  He states a simple titre check would show if they are immune to a disease – but titre checks aren’t done.  He submitted 45 articles showing that vaccines are dose dependent and that titres indicate immunity.

The ‘vaccine’ religion at work.

http://

Dangerous Pet Vaccines

The vaccine safety has been debated since inception, and doctors and veterinarians disagree on many points.  Interestingly, the vets in the news story acknowledge that each case is different, yet ‘the powers that be’ want everyone, despite age, risk factors, pregnancy status, or health status to get the COVID jab.

And now they are developing an OspA mRNA-Lipid Nanoparticle “vaccine” Against Lyme Disease for humans.

RIP Greg the dog

For more:

Do not be fooled.  Each and every vaccine has the potential to damage and or kill you and our pet.

Category:

Lyme, Lyme Vaccine, vaccines

Lyme Cabalist Develops Test for Pfizer Lyme Vaccine Trials: Yet More Proof of a Conspiracy

https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/31520021

To: The FDA… What shenanigans are taking place here?

Carl Tuttle

Hudson, NH, United States

APR 23, 2023 — 

Please see the following inquiry/complaint sent to the FDA.

Dr. Gary Wormser has developed diagnostics for Pfizer’s Lyme vaccine trial?

What shenanigans are taking place here? This is a huge red flag! Controlling the Lyme disease narrative for the past 30yrs and now the outcome of a vaccine trial?

I believe the FDA will refuse to respond to my complaint so PLEASE demand an answer to this citizens complaint by sending an email to  the Center for Biologics Evaluation and Research at ocod@fda.hhs.gov referencing my letter below. Everyone has permission to cut and paste my correspondence.

Complaint sent to the Center for Biologics Evaluation and Research at the FDA:

———- Original Message ———-
From: CARL TUTTLE <runagain@comcast.net>
To: ocod@fda.hhs.gov
Cc: Brennan, Patti (NIH/NLM) [E], Schor, Nina (NIH/OD) [E], Gregurick, Susan (NIH/OD) [E], michael.lauer@nih.gov, lyric.jorgenson@nih.gov
Date: 04/18/2023 11:34 AM
Subject: Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15)

An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15) (VALOR)
https://clinicaltrials.gov/ct2/show/NCT05477524

Apr 18, 2023

Food and Drug Administration
Center for Biologics Evaluation and Research (CBER)
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

Re: ClinicalTrials.gov Identifier: NCT05477524

To whom it may concern,

For the past thirty years there has been a handful of academics controlling the Lyme disease narrative who have a vested interest in bringing an “OspA-Based” Lyme disease vaccine to market. Most of these individuals hold patents on technology that would pay out handsomely in royalties.  It would be a flagrant conflict of interest if these individuals reside on Pfizer’s Endpoint Adjudication Committee deciding who has or does not have Lyme disease.

There is another concern here as discovered through the Open Payments Search Tool.

“The Open Payments Search Tool is used to search payments made by drug and medical device companies to physicians, physician assistants, advanced practice nurses and teaching hospitals.”

Dr. Gary Wormser received $156,000 in 2021 and in one of his recent publications he claims to have developed “Lyme diagnostics for a Lyme vaccine trial” for Pfizer:

Lack of Convincing Evidence that Borrelia burgdorferi Infection Causes Either Alzheimer’s Disease or Lewy Body Dementia
https://doi.org/10.1093/cid/ciab993
Gary P Wormser, Adriana Marques, Charles S Pavia, Ira Schwartz, Henry M Feder, Jr, Andrew R Pachner

COI Statement….

Disclosures: Dr. Wormser reports receiving research grants from the Institute for Systems Biology for exploring biomarkers for outcome of Lyme disease, Pfizer, Inc for developing Lyme diagnostics for a Lyme vaccine trial, NIH/Tufts for Xenodiagnosis to assess persistence of Borrelia, and CSU/NIH. He has been an expert witness in malpractice cases involving Lyme disease and was an expert witness regarding babesiosis; employed by New York Medical College; and is an unpaid board member of the non-profit American Lyme Disease Foundation. He reports no money paid to anyone for U.S. Patent No. 10,669,567 B2 ( HIGH SENSITIVITY METHOD FOR EARLY LYME DISEASE DETECTION Issue Date: June 2, 2020 Inventors: John T. Belisle, Claudia R. Mollins, Gary P. Wormser).

Dr. Marques has a patent US 8,926,989 B2 and 9310367 for compositions and methods for screening for Lyme disease; and is an unpaid Scientific Advisor to the Global Lyme Alliance and to the American Lyme Disease Foundation. Dr. Schwartz has been on the External Advisory Committee for Oklahoma InBRE. Other None

End of COI statement

______________________________

The CDC requires “new tests” to be cleared by the FDA. Is Wormser’s Lyme diagnostics for this clinical trial FDA approved? What behind the scenes shenanigans are going on here?

From the CDC website:

CDC supports the development of new tests
https://www.cdc.gov/lyme/diagnosistesting/index.html

“New tests may be developed as alternatives to one or both steps of the two-step process. Before CDC will recommend new tests, they must be cleared by the Food and Drug Administration (FDA).”

Additional concerns:

There were neurological complications with the previous “OspA-Based” Lyme vaccine (LYMErix) as published in the International Journal of Risk & Safety in Medicine. Reports of cerebral ischemia, transient Ischemic attacks, demyelinating events, optic neuritis, transverse myelitis, and non-specific demyelinating conditions are evaluated in this paper. To my knowledge, there were no studies to determine why LYMErix caused these serious complications.

Neurological complications of vaccination with outer surface protein A (OspA).
Marks DH.
http://www.ncbi.nlm.nih.gov/pubmed/21673416

REPORT ON LYMErix prepared for the 2001 Advisary Committee Meeting:(personal Dropbox storage area)
https://www.dropbox.com/s/sodqs3pdeeesktf/Sheller%20Lymerix.pdf?dl=0

Excerpt

“The people who have contacted us were, prior to vaccination with LYMErix, healthy, active and energetic. Indeed, the very reason they sought the LYMErix vaccine was their desire to preserve their healthy, active lifestyle. However, what they experienced was a dramatic degradation of their health and quality of life. As will be described below, these previously healthy individuals are now afflicted with painful, at times debilitating arthritic symptoms, including joint pain and swelling, as well as extremely severe Lyme-disease-like symptoms which have persisted to this day.”

Below is the link to the Final Judgement and Approval of the class action against SmithKline Beecham as a settlement was awarded to these individuals.

JUDGEMENT, FINAL ORDER AND DECREE GRANTING FINAL APPROVAL OF THE CLASS ACTION SETTLEMENT: (personal Dropbox storage area)
https://www.dropbox.com/s/v3gyw4fv8nst9bz/2003_Vaccine_Judgement_Final_Sttle_Apprvl..pdf?dl=0

Summary of this inquiry:

  1. Who are the individuals residing on the Endpoint Adjudication Committee in North America?
  2. Is Wormser’s “Lyme diagnostics for a Lyme vaccine trial” FDA approved?
  3. Through informed consent have the study participants been advised of Neurological Complications from the previous “OspA-Based” Lyme vaccine and are they made aware of the class action settlement?

Let us not forget that Pfizer paid the largest fine for health care fraud in 2009:

Justice Department Announces Largest Health Care Fraud Settlement in Its History Pfizer to Pay $2.3 Billion for Fraudulent Marketing  https://www.justice.gov/opa/pr/justice-department-announces-largest-health-care-fraud-settlement-its-history

Please provide a prompt reply to this inquiry/complaint and answer all three questions.

Respectfully submitted,

Carl Tuttle
Hudson, NH

Cc: Patricia Flatley Brennan, RN, PhD Director National Library of Medicine

Nina F. Schor, MD, PhD, NIH Deputy Director for Intramural Research
Susan K. Gregurick, PhD, NIH Associate Director for Data Science
Michael Lauer, MD, NIH Deputy Director for Extramural Research
Lyric Jorgenson, PhD, Acting NIH Associate Director for Science Policy

________________

**Comment**

It’s all right here in purple crayon, and is yet more proof the government uses people, social media, mainstream media, and “vaccine” manufacturing companies as subsidiaries for their own nefarious purposes.

For more on Wormser:

  • Immunetics, Inc. (the developer of the insensitive C6 Lyme test, which he promotes).
  • Abbott, Institute for Systems Biology
  • Rarecyte, Inc.
  • Quidel Corporation
  • Insurance companies, by serving as an expert witness in court cases against doctors for treating outside IDSA guidelines
  • NIH: by receiving large shares of grants for Lyme-related research and by being influential in the selection of grant recipients.
  • IDSA – by being chairman of the Lyme guidelines revision panel which is opposed toand biased against chronic/persistent Lyme
Wormser serves the commercial interests of profit-making companies, and trivializes the effects of Lyme on patients as proven by his appearance in Under Our Skin, a documentary on the ravages of chronic Lyme disease

Category:

Activism, Lyme, Lyme Vaccine, Testing

Human Trials Begin for Shot Against Lyme Disease

http://  Approx. 3 Min.

Human Trials Begin For Shot Against Lyme Diease

March 23, 2021

Lyme PrEP still uses OspA, the outer surface protein connected to Lyme-like symptoms caused by the previous Lymerix vaccine.

Excerpts:

Safety concerns began to emerge soon after people began getting LYMErix. Some recipients began to report joint pain and other effects that they attributed to the vaccine. Within a year of the vaccine’s approval, a class action lawsuit was filed against SmithKline Beecham on behalf of 121 people. Although the suit was eventually settled — it provided no compensation to the plaintiffs — publicity about it dampened interest in the vaccine.

Meanwhile, growing distrust of vaccines may have compounded LYMErix’s struggles.

But there is another possible point of contention: VLA15 and Lyme PrEP both target the same protein on Borrelia bacteria that LYMErix did — outer surface protein A (OspA).

The approach used to target OspA in LYMErix was linked to concerns that arose about potential side effects. While studies have not confirmed the connection, VLA15 uses a slightly modified vaccine approach and Lyme PrEP delivers a single antibody directly — both of which could circumvent the purported issue. But Telford said some people might still take issue with a vaccine that targets OspA.

“I anticipate Valneva is going to have a problem with activists,” he said, noting that he had informally spoken with some community groups. “The broad statement was ‘No OspA vaccine, no how.’”

Klempner, similar to other Lyme Cabal players has a history with biological weapons as both Director and investigator of a bioweapons lab.  He’s been accused of research fraud, and single-handedly has convinced mainstream medicine that extended treatment doesn’t help Lyme/MSIDS patients. The “Klempner” Report has ruled Lyme-land for over 20 years.

Further, I’m with Lyme advocate Carl Tuttle in that we don’t want a vaccine until the issue of chronic/persistent infection is acknowledged. As you can see from this article, there are those who still believe what we are suffering from is a “scam that should be condemned”.

Excerpt:

The Lyme disease controversy keeps on getting bigger, with an hypothetical presentation of “chronic Lyme disease” that some believe to be responsible for late subjective symptoms experienced by patients who are supposedly victims of this chronic infection despite negative examination results and unrelated clinical signs.

This irrational diatribe has been picked up by the media and orchestrated by sectarian supporters of such syndrome – i.e., off-the-rails physicians, associations proclaiming to “defend” the patient’s interests, and even political figures – and has grown into an absurd and troubling polemic. Untruths told by Lyme pseudo-specialists (i.e., the Lyme doctors) and assertions made by people convinced to have chronic Lyme disease are indeed picked up by the media – too eager to disseminate fake news and happy to see the medical authorities flouted – and work to the disadvantage of patients. Patients are fooled, taken advantage of, betrayed, and even encouraged to physically threaten physicians contesting the existence of such syndrome!

Tick-borne illness has been ruled by a Cabal doing pseudoscience, just as COVID has.

In fact, for those paying attention, there are many similarities between how Lyme/MSIDS & COVID have been handled.

For more:

Category:

Activism, Lyme, Lyme Vaccine, vaccines

Lyme Disease Vaccine For Humans: Would You Trust It?

https://danielcameronmd.com/lyme-disease-vaccine-for-humans-would-you-trust-it/

LYME DISEASE VACCINE FOR HUMANS: WOULD YOU TRUST IT?

Lyme disease vaccine for humans being given to male patient

It has been 18 years since GlaxoSmithKlein pulled its preventative Lyme disease vaccine for humans, known as LYMErix, from the market. Now, a new vaccine is currently in Stage 2 clinical trials. This vaccine is also derived, in part, from the same OspA bacterial protein found in LYMErix. This begs the question: Will a new Lyme disease vaccine succeed or suffer the same fate as LYMErix?

By

LYMErix was reportedly effective at preventing a Lyme disease rash. But the vaccine was only 50% effective at preventing other manifestations of Lyme disease, according to the LYMErix package insert. LYMErix was voluntarily removed from the market due to low demand.

In a survey of 1,015 adults in the U.S., author Matt Motta¹ addresses the question of whether growing concern over climate change and the spread of tick-borne illnesses could increase public acceptance and use of a new Lyme disease vaccine for humans.

Survey respondents were asked, “how likely they are to request to be vaccinated when a Lyme vaccine becomes available for public use?”

The results indicated that “climate change concern is positively and significantly (B = 1.36, p < 0.01) associated with increased vaccination intentions,” the author writes.

Not surprisingly, survey findings showed, “Individuals who live in the Northeast, where Lyme is most prevalent, are more likely to intend to vaccinate (B = 1.35, p < 0.01), while people who place less trust in scientific authorities like the CDC are less likely to do so (B = À1.81, p < 0.01).”

Survey results, however, don’t guarantee the new Lyme disease vaccine for humans will be embraced by the public, writes Mott.

He describes several reasons why LYMErix was removed from the market:

“Low demand for LYMErix may have arisen from several factors, including its cost and the fact that it must be administered in two or three doses to reach high levels of effectiveness.”

“Misinformation about the vaccine’s safety – including the scientifically disputed claim that it can have adverse autoimmune effects – have also been linked to the vaccine being discontinued.”

References:
  1. Motta M. Could concern about climate change increase demand for a Lyme disease vaccine in the U.S.? Vaccine. 2020.

______________________

**Comment**

Another great example of important research tagged with the unimportant moniker ‘climate change’ regarding the spread of ticks and the diseases they transmit.  For the millionth time:  https://madisonarealymesupportgroup.com/2018/11/07/ticks-on-the-move-due-to-migrating-birds-and-photoperiod-not-climate-change/

According to tick researcher John Scott, TICKS ARE IMPERVIOUS TO WEATHER.

Please spread the word and don’t be duped by another money grab.

Please note the continuing emphasis on clearance of the rash, which does NOT equate to clearance of a systemic infection, so while the vaccine appears to clear the rash, (which it often does of its own accord anyway) it is only 50% effective against other manifestations of Lyme disease.  My guess is they also did not study these patients for long enough to determine if they developed other manifestations.

Regarding Lymerix:   https://madisonarealymesupportgroup.com/2018/01/28/the-secret-x-files-the-untold-history-of-the-lymerix-vaccine/

Excerpt:

Quotes from the patients affected by the LYMErix VACCINE:

“…..Smithkline should not be able to destroy people’s lives as they have destroyed mine …”

“… As of May 8, 2000 there were 467 adverse reactions reported to VAERS, and of them 144 had complained of some sort of joint pain. Please do not let this vaccine hurt anymore people. I know SmithKline is trying to get it approved for children, PLEASE DO NOT LET THEM HURT ANYMORE KIDS…”

“….. The FDA let them put this on the market without fully testing it. The longer that this is left on the market, the more people are going to get hurt. Please stop this madness and take it off the market…”

“….. No one else should ever suffer such profound life changes through the administration of a “safe” vaccine. He would have been far better off to get Lyme Disease than to be incapacitated by something we counted on to protect his health!…”

“….Please stop this vaccine from wrecking more lives! !Respectfully submitted…”

Dr. Lapenta also lists 13 patient stories of adverse reactions due to Lymerix that will curl your hair.

Further, this astute article reveals OZ behind the curtain.  A shady meeting at Dearborn, Michigan changed Lyme testing criteria so they could make their lucrative, adverse reaction riddled vaccine. Due to this, the sickest patients no longer meet the standard:   https://madisonarealymesupportgroup.com/2020/02/10/the-bitter-feud-over-lymerix/

So in answer to Dr. Cameron’s question: “Would you trust a Lyme vaccine?”, the answer isn’t just a “No,” it’s a “Hell No”. 

I’m with Weiler:  https://madisonarealymesupportgroup.com/2020/09/01/it-is-time-to-reboot-public-health-time-for-a-cdc-niaid-fda-walk-away-movement/

For more:  https://madisonarealymesupportgroup.com/2019/10/19/no-lyme-vaccine-until-persistent-infection-is-acknowledged-and-fully-addressed-period/

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

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

https://madisonarealymesupportgroup.com/2020/08/12/what-is-life-like-for-the-vaccine-injured/

The issue regarding vaccines is quite similar to an issue surrounding COVID-19.  Unfortunately due to fear, many put so much emphasis on ONE issue they remain blind to 1,000 others.  For example, vaccines have injured, maimed and actually killed people.  Should fear of disease outweigh these people and their negative outcomes, which includes death, in the annuls of history?  Regarding COVID-19, should fear of a virus negate the suffering of people with other issues that are not COVID-19? 

We are being told daily that vaccines and COVID-19 trump all other issues.  I flat-out disagree.

This lie is a form of bullying.

Vaccination – What’s Trust Got to Do With It?

http://

NVIC co-founder and president Barbara Loe Fisher discusses questions the public is asking about infectious disease and vaccines and changes in public perceptions during the 2020 debate about vaccine science, policy and law. 

If you would rather read the commentary:  https://www.nvic.org/NVIC-Vaccine-News/September-2020/vaccination-whats-trust-got-to-do-with-it.aspx

 

 

 

 

 

Category:

Lyme Vaccine, research