Archive for the ‘vaccines’ Category

Tickborne Diseases – Confronting a Growing Threat

https://www.nejm.org/doi/full/10.1056/NEJMp1807870

Tickborne Diseases — Confronting a Growing Threat

Catharine I. Paules, M.D., Hilary D. Marston, M.D., M.P.H., Marshall E. Bloom, M.D., and Anthony S. Fauci, M.D.

July 25, 2018, at NEJM.org.

Every spring, public health officials prepare for an upsurge in vectorborne diseases. As mosquito-borne illnesses have notoriously surged in the Americas, the U.S. incidence of tickborne infections has risen insidiously, triggering heightened attention from clinicians and researchers.

nejmp1807870_f1

Common Ticks Associated with Lyme Disease in North America.

According to the Centers for Disease Control and Prevention (CDC), the number of reported cases of tickborne disease has more than doubled over the past 13 years.1 Bacteria cause most tickborne diseases in the United States, and Lyme disease accounts for 82% of reported cases, although other bacteria (including Ehrlichia chaffeensis, Anaplasma phagocytophilum, and Rickettsia rickettsii) and parasites (such as Babesia microti) also cause substantial morbidity and mortality. In 1982, Willy Burgdorfer, a microbiologist at the Rocky Mountain Laboratories of the National Institute of Allergy and Infectious Diseases, identified the causative organism of Lyme disease, a spirochete eponymously named Borrelia burgdorferi. B. burgdorferi (which causes disease in North America and Europe) and B. afzelii and B. garinii (found in Europe and Asia) are the most common agents of Lyme disease. The recently identified B. mayonii has been described as a cause of Lyme disease in the upper midwestern United States. Spirochetes that cause Lyme disease are carried by hard-bodied ticks (see graphic), notably Ixodes scapularis in the northeastern United States, I. pacificus in western states, I. ricinus in Europe, and I. persulcatus in eastern Europe and Asia. B. miyamotoi, a borrelia spirochete found in Europe, North America, and Asia, more closely related to the agents of tickborne relapsing fever, is also transmitted by I. scapularis and should be considered in the differential diagnosis of febrile illness occurring after a tick bite.

Patterns of spirochete enzootic transmission are geographically influenced and involve both small-mammal reservoir hosts, such as white-footed mice, and larger animals, such as white-tailed deer, which are critical for adult tick feeding. The rising incidence and expanding distribution of Lyme disease in the United States are probably multifactorial, but increased density and range of the tick vectors play a key role. The geographic range of I. scapularis is apparently increasing: by 2015, it had been detected in nearly 50% more U.S counties than in 1996.

Lyme disease’s clinical manifestations range from relatively mild, nonspecific findings and classic erythema migrans rash in early disease to more severe manifestations, including neurologic disease and carditis (often with heart block) in early disseminated disease, and arthritis, which may occur many months after infection (late disease). Although most cases are successfully treated with antibiotics, 10 to 20% of patients report lingering symptoms after receiving appropriate therapy.2 Despite more than four decades of research, gaps remain in our understanding of Lyme disease pathogenesis, particularly its role in these less well-defined, post-treatment symptoms.

Meanwhile, tickborne viral infections are also on the rise and could cause serious illness and death.1 One example is Powassan virus (POWV), the only known North American tickborne encephalitis-causing flavivirus.3 POWV was recognized as a human pathogen in 1958 after being isolated from the brain of a child who died of encephalitis in Powassan, Ontario. People infected with POWV often have a febrile illness that can be followed by progressive and severe neurologic manifestations, resulting in death in 10 to 15% of cases and long-term sequelae in 50 to 70% of survivors.3 An antigenically similar virus, POWV lineage II, or deer tick virus, was discovered in New England in 1997. Both POWV subtypes are linked to human disease, but their distinct enzootic cycles may affect their likelihood of causing such disease. Lineage II seems to be maintained in an enzootic cycle between I. scapularis and white-footed mice — which may portend increased human transmission, because I. scapularis is the primary vector of other serious pathogens, including B. burgdorferi. Whereas only 20 U.S. cases of POWV infection were reported before 2006,3 99 were reported between 2006 and 2016. Other tickborne encephalitis flaviviruses cause thousands of cases of neuroinvasive illness in Europe and Asia each year, despite the availability of effective vaccines in those regions. The increase in POWV cases coupled with the apparent expansion of the I. scapularis range highlight the need for increased attention to this emerging virus.

The public health burden of tickborne pathogens is considerably underestimated. For example, the CDC reports approximately 30,000 cases of Lyme disease per year but estimates that the true incidence is 10 times that number.1 Multiple factors contribute to this discrepancy, including limitations in surveillance and reporting systems and constraints imposed by available diagnostics, which rely heavily on serologic assays.4 Diagnostic utility is affected by variability among laboratories, timing of specimen collection, suboptimal sensitivity during early infection, imperfect use of diagnostics (particularly in persons with low probability of disease), inability of a single test to identify coinfections in patients with acute infection, and the cumbersome nature of some assays. Current diagnostics also have difficulty distinguishing acute from past infection — a serious challenge in diseases characterized by nonspecific clinical findings. Moreover, tests may remain positive even after resolution of infection, leading to diagnostic uncertainty during subsequent unrelated illnesses. For less common tickborne pathogens such as POWV, serologic testing can be performed only in specialized laboratories, and currently available tests fail to identify novel tickborne organisms.
Such limitations have led researchers to explore new technologies. For example, one of the multiplex serologic platforms that have been developed can detect antibodies to more than 170,000 distinct epitopes, allowing researchers to distinguish eight tickborne pathogens.4 In addition to its utility in screening simultaneously for multiple pathogens, this assay offers enhanced pathogen detection, particularly in specimens collected during early disease. Further studies are needed to determine such assays’ applicability in clinical practice.

Nonserologic platform technologies may also improve diagnostic capabilities, particularly in identifying emerging pathogens. Two previously unknown tickborne RNA viruses, Heartland virus and Bourbon virus, were discovered by researchers using next-generation sequencing to help link organisms with sets of unexplained clinical symptoms. The development and widespread implementation of next-generation diagnostics will be critical to understanding the driving factors behind epidemiologic trends and the full clinical scope of tickborne disease. In addition, sensitive, specific and, where possible, point-of-care assays will facilitate appropriate clinical care for infected persons, guide long-term preventive efforts, and aid in testing of new therapeutics and vaccines.

In the United States, prevention and management of tickborne diseases include measures to reduce tick exposure, such as avoiding or controlling the vector itself, plus prompt, evidence-based treatment of infections. Although effective therapies are available for common tickborne bacteria and parasites, there are none for tickborne viruses such as POWV.

The biggest gap, however, is in vaccines: there are no licensed vaccines for humans targeting any U.S. tickborne pathogen. One vaccine that was previously marketed to prevent Lyme disease, LYMErix, generated an immune response against the OspA lipoprotein of B. burgdorferi, and antibodies consumed by the tick during a blood meal targeted the spirochete in the vector.5 Nonetheless, the manufacturer withdrew LYMErix from the market for a combination of reasons, including falling sales, liability concerns, and reports suggesting it might be linked to autoimmune arthritis, although studies supported the vaccine’s safety. Similar concerns will probably affect development of other Lyme disease vaccines.5

Historically, infectious-disease vaccines have targeted specific pathogens, but another strategy would be to target the vector.5 This approach could reduce transmission of multiple pathogens simultaneously by exploiting a common variable, such as vector salivary components. Phase 1 clinical trials are under way to evaluate mosquito salivary-protein–based vaccines in healthy volunteers living in areas where most mosquito-borne diseases are not endemic. Since tick saliva also contains proteins conserved among various tick species, this approach is being explored for multiple tickborne diseases.5

The burden of tickborne diseases seems likely to continue to grow substantially. Prevention and management are hampered by suboptimal diagnostics, lack of treatment options for emerging viruses, and a paucity of vaccines. If public health and biomedical research professionals accelerate their efforts to address this threat, we may be able to fill these gaps. Meanwhile, clinicians should advise patients to use insect repellent and wear long pants when walking in the woods or tending their gardens — and check themselves for ticks when they are done.
________________

**Comment**

While this article repeats much of the same verbiage that’s been repeated for years, particularly the vaccine push, they are ignoring the following:

  1. Many TBI’s are congenitally transmitted:  https://madisonarealymesupportgroup.com/2018/06/19/33-years-of-documentation-of-maternal-child-transmission-of-lyme-disease-and-congenital-lyme-borreliosis-a-review/, https://madisonarealymesupportgroup.com/2018/07/24/congenital-transmission-of-lyme-myth-or-reality/, https://madisonarealymesupportgroup.com/2018/02/26/transplacental-transmission-fetal-damage-with-lyme-disease/
  2. There is a real probability of sexual transmission:  https://madisonarealymesupportgroup.com/2018/02/06/lyme-in-the-southern-hemisphere-sexual-transmission/, https://madisonarealymesupportgroup.com/2017/02/24/pcos-lyme-my-story/
  3. While they mention Ehrlichia, Anaplasma, Rickettsia, and Babesia, there are many other players that are hardly getting a byline.  For a list to date:  https://madisonarealymesupportgroup.com/2017/07/01/one-tick-bite-could-put-you-at-risk-for-at-least-6-different-diseases/.  This is an important issue because to date the medical world is looking at this complex illness as a one pathogen one drug illness when nothing could be further from the truth.  No one has done any research on the complexity of being infected with more than one pathogen.  It will reveal the CDC’s guidelines of 21 days of doxy to be utter stupidity.
  4. Also, worth mentioning is that only a few of these are reportable illnesses so there is absolutely no data on how prevalent any of this is.  Surveillance is a real problem.
  5. Regarding what ticks are where….this ancient verbiage needs to change.  Ticks are moving everywhere.  This is on record in numerous places:  https://madisonarealymesupportgroup.com/2018/07/16/ticks-that-carry-lyme-disease-are-spreading-fast/, https://madisonarealymesupportgroup.com/2018/07/10/we-have-no-idea-how-bad-the-us-tick-problem-is/, https://madisonarealymesupportgroup.com/2018/07/22/citizen-scientists-help-track-tick-borne-illness-exposure/
  6. No tick is a good tick.  They all need blood meals and have the potential to transmit disease.  
  7. This article is silent about the Asian Longhorned tick that propagates itself by cloning and can drain cattle of their blood.  Found in six states so far it was recently found on a child in New Jersey:  https://www.northjersey.com/story/news/environment/2018/07/24/bergen-county-nj-child-may-first-carrying-longhorned-tick-us/825744002/.  Word in the tick world is it had NOT bitten the child and tested negative for pathogens.  What is concerning is that it is known to transmit SFTS virus and Japanese spotted fever in Asia. This story is a reminder that this tick is NOT just a livestock problem and that a normal child going about a normal day with NO contact with livestock had this tick on her.  Another clear reminder that it is foolish to put any of this in a box.
  8. They need to emphasize that the “classic erythema migrans rash” while indicative of Lyme, is unseen or variable in many patients.
  9. Constraints in testing is a true problem but an even bigger problem is untrained and uneducated medical professionals.  This stuff may never test clearly.  Get over it.  Get trained to know what to look for!
  10. The Lyme vaccine was a bust.  It still is.  Unless safety concerns are dealt with we want nothing to do with any vaccine.
  11. All I know is that mosquitoes and Zika get more attention that this modern day 21st century plague that is creeping everywhere and is a true pandemic.  It still isn’t being seriously dealt with or researched.  What research is being done is same – o – same -o stuff we already know.  Study the tough stuff – the unanswered questions or things that are just repeated as a mantra for decades.
We need answers out here not repeated gibberish that isn’t helping patients.
Afterthought:

The one thing I didn’t deal with that I will point out now is this regurgitated number in the NEJM article of 10-20% of patients moving on to chronic/persistent Lyme. The following informative article written by Lorraine Johnson points out this number to be considerably higher which corresponds to my experience as a patient advocate: https://madisonarealymesupportgroup.com/2018/07/22/lyme-costs-may-exceed-75-billion-per-year/. Excerpt below:

Besides the staggering financial cost to this 21st century plague, this paper, based on estimates of treatment failure rates associated with early and late Lyme, estimates that 35-50% of those who contract Lyme will develop persistent or chronic disease.

Let that sink in.

And in the Hopkins study found 63% developed late/chronic Lyme symptoms.

For some time I’ve been rankled by the repeated CDC statement that only 10-20% of patents go on to develop chronic symptoms. This mantra in turn is then repeated by everyone else.

While still an estimate, I’d say 35 to over 60% is a tad higher than 10-20%, wouldn’t you? It also better reflects the patient group I deal with on a daily basis. I can tell you this – it’s a far greater number than imagined and is only going to worsen.

 

 

Category:

Anaplasmosis, Babesia, Borrelia Miyamotoi (Relapsing Fever Group), Lyme, Lyme Vaccine, Parasites, Testing, Ticks, Treatment, vaccines, Viruses

Why We Care So Strongly About A Potential Lyme Vaccine

https://www.lymedisease.org/touchedbylyme-why-we-care-lyme-vaccine/

TOUCHED BY LYME: Why we care so strongly about a potential vaccine

by Dorothy Kupcha Leland

I was recently contacted by a reporter for a national news organization. She was blunt: why is your organization so opposed to a vaccine for Lyme disease?

Note, she didn’t say “what is your organization’s opinion about it?” or “are you opposed to it?” She re-stated several versions of this basic question: “why would an organization that is supposed to help Lyme patients be opposed to a vaccine that would protect people from Lyme disease?”

Sigh.

On the fast track

This comes as the French company Valneva SE is preparing for Phase 2 trials of its proposed Lyme vaccine, VLA-15. It has received fast-track designation from the FDA, which is a way of expediting the development of new drugs that are deemed to be especially needed.

It also comes on the heels of plenty of news coverage framing any discussion of a Lyme vaccine like this: A Lyme vaccine—any Lyme vaccine—is automatically a good thing. Anybody who raises any questions about it is a wicked “anti-vaxxer.” After all, look what those terrible people did to LYMErix.”

So, let me clarify a few points for the record.

LymeDisease.org is not “anti-vaccine.” Rather, we think important questions should be answered about the last Lyme vaccine before a new one is approved.

Safety first

Plain and simple, we care about safety. The last vaccine, LYMErix, was introduced in 1998 and withdrawn from the market in 2002, after a number of serious problems cropped up.

Among them:

  • Over 1000 adverse events related to LYMErix were reported to the FDA, including death, strokes, musculoskeletal effects and neurologic effects.
  • Over 400 people who felt they had been injured by the vaccine were preparing a class-action lawsuit against the manufacturer
  • The last vaccine was not very effective. It required three doses given over the span of a year, to achieve less than 80% effectiveness.
  • Furthermore, it was unclear whether booster shots would be required.
Osp A

According to Valneva, VLA15 targets outer surface protein A (Osp A) of Borrelia, and

“the anticipated safety profile is expected to be similar to other vaccines using the same technology.”

Guess what? LYMErix was also based on Osp A. And its safety issues have never been appropriately addressed.

Here’s our bottom line: we want these concerns investigated and resolved before any new Lyme vaccine comes on the market.

Co-infections

There’s another matter as well. It’s becoming ever clearer that tick-borne diseases include many strains of Borrelia (not just Borrelia burgdorferi—what might be considered “classic” Lyme) along with other pathogens such as Babesia, Anaplasma/Ehrlichia, and Powassan virus.

An Osp A vaccine won’t do diddly-squat for co-infections.

Thus, we’re also concerned that a vaccine that only targets classic Lyme will give a false sense of security to those who receive it.

The market for a Lyme vaccine is projected to be between $800 million to $900 million a year.

I would think a company that stands to make that kind of money would cross their t’s and dot their i’s, in preparing the way for their product.

Yet, the manufacturers have not been forthright about safety issues with the previous vaccine. Nor have they reached out to the Lyme community in connection with this new one.

Here’s a thought: Valneva, why don’t you change your approach, starting right now? Answer our questions. See if you can allay our fears. It’s the right thing to do.

TOUCHED BY LYME is written by Dorothy Kupcha Leland, LymeDisease.org’s Vice-president and Director of Communications. She is co-author of When Your Child Has Lyme Disease: A Parent’s Survival Guide. Contact her at dleland@lymedisease.org .

________________

**Comment**

Unfortunately, this infantile attack ploy against anyone who raises ANY questions about ANY vaccine is occurring as I write this sentence.  It blows my mind how any professional gets away with name calling and bullying those questioning the safety of vaccines.

After all, much vaccine fraud has been uncovered recently, not to mention conflicts of interest.

Not to mention the fact only 1% of vaccine injuries are reported,  of which independent researchers have stated the reporting system is “utterly inadequate,” and the CDC has even further thwarted the reporting process.

More on the Lyme vaccine:

Category:

Activism, Lyme Vaccine, vaccines

HHS Vaccine Fraud Proven

  Real News With David Knight  Approx. 20 Min

Published July 13, 2018

Del Big Tree explains on “Real News With David Knight”  that in exchange for giving vaccine companies immunity from prosecution for adverse reaction & medical harm, the Federal government said it would take measures to monitor & improve vaccine safety. A new lawsuit by Del Bigtree shows HHS never looked at ANY safety or adverse reactions for ANY vaccine for the 31 years since they were given oversight.

Big Tree has this fact in bright purple crayon on a legal document.  This isn’t speculation.  This is fact.

For the proof:  http://icandecide.org/government/ICAN-HHS-Stipulated-Order-July-2018.pdf

Excerpt:

Whereas, on June 27, 2018, HHS sent ICAN the following response to the FOIA Request:

The [Department]’s searches for records did not locate any records responsive to your request.  The Department of Health and Human Services (HHS) Immediate Office of the Secretary (IOS) conducted a thorough search of its document tracking systems.  The Department also conducted a comprehensive review of all relevant indexes of HHS Secretarial Correspondence records maintained at Federal Records Centers that remain in the custody of HHS.  These searches did not locate records responsive to your request, or indications that records responsive to your request and in the custody of HHS are located at Federal Records Centers.  

Time to get rid of the 1986 Act 

(The 1986 Act grants economic immunity to pharmaceutical companies for injuries caused by vaccines.  (42 U.S.C. 300a a-11.)  It also makes HHS directly responsible for nearly every aspect of vaccine safety.  (42 U.S.C. 300a a-2, 300a a-27.) 

And we think HHS isn’t going to solve the Lyme/MSIDS problem?

https://madisonarealymesupportgroup.com/2018/07/18/hhs-not-to-be-trusted-with-lyme/

Go to icandecide.org for more info.

For more:  https://madisonarealymesupportgroup.com/2018/06/21/u-s-government-continues-to-pay-millions-in-vaccine-injuries-death-settlements/

https://madisonarealymesupportgroup.com/2018/03/21/congress-receives-vaccine-safety-project-details-since-the-cdc-fda-ignore-their-own-data-and-proclaim-vaccines-do-not-cause-autism/

https://madisonarealymesupportgroup.com/2018/07/10/pediatricians-state-new-who-aefi-guidelines-put-childrens-lives-at-risk-200-evidence-based-reasons-not-to-vaccinate/

https://madisonarealymesupportgroup.com/2017/09/19/autism-aluminum-adjuvant-link-corroborated/

https://madisonarealymesupportgroup.com/2018/06/01/immunoexcitotoxicity-as-the-central-mechanism-of-etiopathology-treatment-of-autism-spectrum-disorders-a-possible-role-of-fluoride-aluminum/

https://madisonarealymesupportgroup.com/2018/06/15/canadian-data-more-autism-where-vaccine-coverage-is-highest/

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

 

Category:

Activism, Lyme, Lyme Vaccine, vaccines

New Effort For Lyme Disease Vaccine Draws Early Fire

https://www.msn.com/en-us/health/medical/new-effort-for-lyme-disease-vaccine-draws-early-fire/ar-AAzNCA7

New Effort for Lyme Disease Vaccine Draws Early Fire

By Sumathi Reddy

Efforts to bring a vaccine for Lyme disease to the market have run aground amid heated debate over the years.

Now, a European company is in the early stages of creating a vaccine for the increasingly common tick-borne disease. Lyme disease patient-advocacy groups—who disagree with the protocols used by most doctors for the diagnosis and treatment of Lyme disease—are already raising concerns.

The Centers for Disease Control and Prevention estimate that there are more than 300,000 new cases of Lyme a year, about triple the rate from two decades ago. Most cases are in the Northeast, mid-Atlantic region and Upper Midwest states, but the disease is spreading across the country.

When blacklegged or deer ticks infected with the Borrelia burgdorferi bacterium bite humans, they can transmit Lyme disease, which typically causes flu-like symptoms such as a fever, headache, muscle and joint aches, and sometimes a ring-like skin rash. If untreated, the infection can spread and cause more serious health problems, including arthritis, heart palpitations and brain inflammation.

Ticks that transmit Lyme disease can also transmit other pathogens causing less-common diseases such as anaplasmosis and babesiosis.

In March, Valneva SE, a company based in France, announced initial Phase 1 clinical trial results after testing its proposed vaccine in 180 healthy adults who took the vaccine with no serious side effects. The study also showed that the vaccine stimulated an immune response, says David Lawrence, chief financial officer of the company.

Later this year it intends to start a Phase 2 clinical trial to determine the dosing of the vaccine. The U.S. Food and Drug Administration granted the vaccine candidate a fast-track status last year. Still, Mr. Lawrence estimates that it will take at least five years for a product to be commercially available.

The vaccine is similar to Lymerix, the vaccine that was manufactured by SmithKline Beecham, now GlaxoSmithKline, from 1998 until it was withdrawn from the market in 2002. The vaccine had a 78% efficacy rate after three doses were taken. The company voluntarily withdrew it after class-action lawsuits that alleged it caused side effects such as arthritis. The lawsuits were settled in 2003 with the company agreeing to pay attorney fees and costs associated with the cases.

“Lymerix was approved by FDA in December 1998 and was voluntarily discontinued in February 2002 due to low demand,” says a spokeswoman for GSK. “Currently there are no plans to bring it back.”

The data evaluated by the FDA supported the safety and effectiveness of Lymerix, the agency says.

Mr. Lawrence of Valneva says there are two main differences with the French company’s proposed vaccine. One, it protects against six strains of Lyme disease, whereas the old vaccine protected against only one, he says. And, to assuage concerns about side effects, the company cut a gene sequence in the vaccine that had been identified in some scientific papers as possibly related to arthritis—though no evidence emerged of arthritis related to the vaccine.

The company intends to test the vaccine in children as well as adults.

Lyme disease patient-advocacy groups—a powerful lobby that experts say has stopped previous vaccine efforts—are raising doubts.

“The last Lyme vaccine that came out had significant safety concerns,” says Lorraine Johnson, CEO of LymeDisease.org, a nonprofit patient advocacy group. “The feeling in the community is that whoever is going to be putting together [a vaccine] ought to be dialoguing with the community and ought to be transparent about the process.”

Ticks can cause co-infections and other diseases and the vaccine may offer a false sense of complacency, she says.

“We don’t feel that there has been enough research done to answer the questions as to what occurred with the prior vaccine,” says Patricia Smith, president of the Lyme Disease Association Inc., a New Jersey-based national nonprofit group, which raises money for Lyme research, education and patient support. “The vaccine that is now in development is something with the same base. There were a lot of patients that thought they were harmed from that vaccine. It’s very problematic.”

Many doctors and medical experts say there was never any evidence that the old vaccine caused serious side effects such as arthritis or neurological problems. They say a vaccine would greatly limit the spread of Lyme disease.

“There’s a lot of general tick prevention advice, such as using DEET and other insect and tick repellent, doing tick checks, and wearing long trousers and long sleeves. But despite that we still have abundant cases of Lyme disease every year,” says Paul Auwaerter, a professor of medicine at Johns Hopkins University School of Medicine and president of the Infectious Diseases Society of America.

It makes sense to have a vaccine for people in parts of the country where Lyme disease rates are high and for people who are outdoors a lot, he says.

Gregory Poland, director of the vaccine research group at Mayo Clinic in Rochester, Minn., published a 2011 study in the journal Clinical Infectious Diseases detailing what happened with the previous Lyme vaccine and lessons learned from it.

Lymerix, he says, “was actually very effective” but multiple factors led to its withdrawal.

The vaccine required taking three shots over a year and took two tick seasons to become effective, he says, and then would require periodic booster shots. Also, it couldn’t be used in children. The recommendations for taking the vaccine were vague, so it was unclear who should get it and insurance companies weren’t required to cover its cost. But anti-vaccine sentiments ultimately did it in, he says.

“In this country you can protect your dog with a vaccine for Lyme disease but you can’t protect yourself or your child,” says Dr. Poland. “We have a public health problem in this country with a disease that has short-, mid- and long-term consequences and for which all other prevention methods are wholly inadequate.”

Several Lyme disease vaccines similar to Lymerix are available for dogs.

Sam Telford, a professor of infectious disease and global health at Tufts University, helped discover the mechanism that led to the development of Lymerix and ran one of the clinical trials that tested it.

He is now part of a group of biotech professionals who have formed an alliance and want to bring back the vaccine and distribute it as a nonprofit.

“There’s a lot of legal issues that may prevent reviving the product as a generic,” he says. “There are many things that we can do to prevent Lyme disease but there’s nothing like a vaccine to reduce the incidence of any infection.”

Write to Sumathi Reddy at sumathi.reddy@wsj.com

____________

**Comment**

Death Count listed here (number of each in parenthesis):

  1. Hypertensive Cardiovascular Disease (54) 1 DAY AFTER THE SECOND DOSE
  2. Hypertensive & Cardiovascular Arteriosclerotic Disease (63) 3 DAYS AFTER THE FIRST DOSE
  3. Arthritis, Neurological Symptoms, and Suicided (43) 7 MONTHS AFTER THE 2nd DOSE
  4. Anemia, Thrombocytopenia, with Myelofibrosis diagnosis (69) 7 MONTHS AFTER THE FIRST DOSE AND DIED 6 MONTHS LATER AN UNKNOW TIME AFTER THE 3rd DOSE
  1. ARTHRALGIA (322)
  2. MYALGIA (227)
  3. PAIN (196)
  4. ASTHENIA (167)
  5. FEVER (126)
  6. FLU SYNDROME (124)
  7. INJECTION SITE PAIN (117)
  8. RASH (85)

One doctor stated that 21 patients developed severe arthritis after receiving the LYMERIX vaccine:  http://www.yourlawyer.com/topics/overview/lymerix

Dr. Marks lead the clinical trials for Lymerix’s competitor, the OspA vaccine produced and then abandoned by Aventis Pasteur.  He states:

“In my opinion,” he told FDA officials, “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.”  http://www.lymediseaseassociation.org/index.php/about-lyme/controversy/vaccine/261-lymerix-meeting  (Go to link for an entire dirty laundry list of shenanigans)

Dr. Stricker writes about the problem with the research here:
https://madisonarealymesupportgroup.com/2018/07/01/lyme-vaccine-fail-safety-ignored/

Lyme Advocate Carl Tuttle writes about how antibody tests were deliberately stripped of important bands to facilitate vaccine development, leaving many patients unable to ever test positive:  https://madisonarealymesupportgroup.com/2018/06/07/the-lyme-vaccine-russian-roulette/  He also points out how principle investigators of Lyme vaccines (Allen C. Steere & Gary Wormser) have flagrant conflicts of interest by sitting on the CDC Lyme guideline panel and purposely matching the definition of the disease to vaccine development.

In a vile cesspool of conflicts of interest are university patent holders, drug companies, and the FDA itself as another patent holder. It generated 40 million dollars before it was yanked. (2008, Drymon)  https://madisonarealymesupportgroup.com/2017/07/01/pbs-lyme-vaccine/

  • The article states that ticks can transmit other pathogens that cause “less-common” diseases such as anaplasmosis and babesiosis.  Yes, they can but no, they are NOT less common.  Frankly, no one really knows because as this article states, only 6 are required to be reported.  There are 18 and counting diseases transmitted by ticks:  https://madisonarealymesupportgroup.com/2018/07/10/we-have-no-idea-how-bad-the-us-tick-problem-is/
  • Interestingly, “to assuage concerns about side effects,” they cut a gene sequence that had been identified in some scientific papers as possibly related to arthritis—though no evidence emerged of arthritis related to the vaccine…..yet, VAERS reported 322 people with arthralgia, or JOINT PAIN.  I also listed one doctor who personally reported that 21 patients developed arthritis after the vaccine.  Hello?  Then, 227 reported Myalgia (muscle pain) and another 196 reported generalized pain.  
That’s a whopping 745 people with PAIN after the vaccine!  322 with specific joint pain.
  • Let’s talk about Sam Telford of Tufts for just a moment.  Please see that he regularly publicly speaks out and has vested interests as delineated above by running a clinical trial for Lymerix as well as by forming an alliance to bring the vaccine back.  In this rebuttal Zubcevik rebutted by Telford to a talk given by Dr. Nevena Zubcevik,  http://www.mvtimes.com/2016/07/13/visiting-physician-sheds-new-light-lyme-disease/ he remarks that there is no research that negates the validity of the “well-known” grace period of 24 hours of tick attachment before the transmission of Lyme Disease.  He also believes that two doses of doxy will do the trick and then goes on to remark that ILADS has no expertise with tick biology or tick-pathogen interactions and that their recommendations are opinions with no factual basis.  He goes on to talk about things like “negative fitness factor” and that pathogens “go to sleep” during winter months, and that “very elegant, peer-reviewed molecular analysis” exists about heat pulses to bacteria in test tubes.
A wonderful reminder that scientists can be quite guilty of myopia.
It’s also a clear reminder that the Lyme Wars still exist for good reasons.

First, I’m no “tick expert,” but one thing I do know:  ticks don’t understand the word “grace.”  We also know for sure that some tick-borne viruses can be transmitted in mere minutes.  There has NEVER been a study showing minimum attachment time to transmit Lyme or many other pathogens:  https://madisonarealymesupportgroup.com/2017/04/14/transmission-time-for-lymemsids-infection/  Also, within that link is the fact that a little girl couldn’t walk or talk within 6 hours of tick attachment.  (She’s far from alone)

SIX HOURS.

As to the two doses of doxy:  https://madisonarealymesupportgroup.com/2017/03/24/one-pill-of-doxy-only-reduces-prevalence-of-rash-not-lyme-disease/

Dr. Cameron states:  “Only been one study (Nadelman et al) on the effectiveness of 1 pill of doxycycline and only found a reduction in the number of erythema migraines (EM) rashes compared to the placebo group. According to him, the IDSA 1 pill of doxy approach started in 2006 despite the fact that three previous prophylactic antibiotic trials for a tick bite had failed.”

According to Cameron, Nadelman’s study had several other limitations:

  • “It was not designed to detect Lyme disease if the rash were absent.
  • The six-week observation period was not designed to detect chronic or late manifestations of Lyme disease.
  • It was not designed to assess whether a single dose of doxycycline might be effective for preventing other tick-borne illnesses such as Ehrlichia, Anaplasmosis, or Borrelia miyamotoi.”

I highly, highly doubt that adding one more pill is going to be any different.

For a great read on why the Lyme Wars exist:  https://madisonarealymesupportgroup.com/2018/06/28/the-science-isnt-settled-on-chronic-lyme/

 

Category:

Activism, Lyme, Lyme Vaccine, vaccines

Pediatricians State New WHO AEFI Guidelines Put Children’s Lives at Risk & 200 Evidence-based Reasons Not to Vaccinate

https://www.moneylife.in/article/new-guidelines-from-who-put-childrens-life-at-risk-paediatricians/54601.html

New Guidelines from WHO Put Children’s Life At Risk: Paediatricians

Moneylife Digital Team
06 July 2018

Two leading paediatricians in India have urged the World Health Organization (WHO) to urgently revise its manual on classification of Adverse Events Following Immunization (AEFI), warning that the new guidelines put children’s life at risk.

This needs to be done “urgently in the interest of child safety,” Doctors Jacob Puliyel at St Stephen’s Hospital in Delhi, and Pathik Naik of Children Hospital in Surat, say in a report published in the prestigious journal ‘F1000Research’

Under WHO’s revised manual on AEFI, only those adverse reactions observed during clinical trials of a vaccine, should be classified as vaccine related. All new serious adverse reactions including deaths seen during post-marketing of the vaccine should be considered as ‘coincidental’ or ‘unclassifiable’, and the vaccine should not be blamed.

The WHO has also changed the definition of “causal association,” the doctors say. Under the revised guidelines, if there is an alternate explanation for the adverse event, or another factor is involved, causative association with vaccine should not be made.

“In other words, if after vaccination, a child with an underlying congenital heart disease develops cardiac failure, it would not be considered causally related to the vaccine.”

The revised classification by WHO “is a major step backward for patient safety,” the authors say, adding, “This could embolden vaccine manufacturers to be more reckless with regard to adverse reactions.”.

Puliyel and Naik note that the Global Advisory Committee on Vaccine Safety has documented many deaths in children with pre-existing heart disease after they were administered the pentavalent vaccine (combined diphtheria, tetanus, pertussis, Hib, and hepatitis-B vaccine).

“Under WHO’s new definition of causal association, these deaths would not be acknowledged as related to vaccination.”

Both Sri Lanka and Vietnam governments withdrew the pentavalent vaccine following the deaths of five children in Sri Lanka and 12 in Vietnam soon after vaccination.

But WHO investigating teams declared that the deaths were ‘unlikely’ to be related to vaccination, the report says. 

The authors point out that a new study in India, showed that the switch from DPT (diphtheria, tetanus, pertussis) to pentavalent vaccine almost doubled the deaths following vaccination.

“A large number of these deaths could have been avoided had the AEFI manual not been revised.”

According to their report, the consequence of India adopting WHO’s new classification can be seen from the causality assessment of 132 serious AEFI cases uploaded on the website of the Ministry of Health and Family Welfare. Of the total AEFI cases, 54 babies died and 78 survived,

“but not even one death was classified as vaccine-related. Nearly all the deaths were simply classified as unclassifiable or coincidental.”

Vaccines are drugs used as a preventive measure, given to healthy persons.  Adverse events following immunization must be monitored more carefully than other drugs, the authors note.

“A credible immunization safety evaluation and monitoring system is essential for the success of immunization programmes.”

Adverse reaction and deaths may not show up as significantly increased in small safety studies. However, records of all deaths and serious adverse events following vaccinations should be maintained and periodically reviewed for safety signals.

According to the authors, WHO’s new AEFI classification scheme “that allows for an outright denial of any new causative association with vaccination” could fall foul of Article 2 of the European Convention on Human Rights. Adverse reaction and deaths may not show up as significantly increased in small safety studies. However, records of all deaths and serious adverse events following vaccinations should be maintained and periodically reviewed for safety signals.

“Paradoxically, the AEFI algorithm is said to be for vaccine safety,” says Puliyel. “Perhaps we need a scheme for public safety rather than vaccine safety.”

Please see:

200 Evidence-Based Reasons NOT To Vaccinate – FREE Research PDF

http://cdn.greenmedinfo.com/sites/default/files/gmipub_58635_anti_therapeutic_action_vaccination_all.pdf  Written By:  GreenMedInfo Research Group

Also, Lyme/MSIDS patients need to consider vaccinations very carefully as vaccines have reactivated latent infections:  https://madisonarealymesupportgroup.com/2017/12/02/scottish-doctor-gives-insight-on-lyme-msids/…..young women who fell ill after their HPV vaccination, which seems to have stimulated a latent Lyme infection to reactivate.

https://madisonarealymesupportgroup.com/2016/04/24/gardasil-and-bartonella/   Asymptomatic girls after receiving Gardasil activated dormant Bartonella which was confirmed by testing.

Dr. Klinghardt in this article states that many patients improve after dealing with retroviruses which can be acquired from vaccines:  https://madisonarealymesupportgroup.com/2018/06/23/the-role-of-retroviruses-in-chronic-illness-a-clinicians-perspective/  An unintended source of retroviruses are some vaccines as reported in Frontiers in Microbiology in January 2011.

Since retroviral contaminated vaccines was first reported to the CDC, NIH, FDA, and other government agencies in 1991 by American immunologist Elaine DeFreitas, the government did absolutely nothing for over two decades until the FDA approved technologies developed by the Cerus Corporation in 2014 to clean up the problem.

Microbiologist Judy Mikovitz sounded the alarm and was viciously persecuted:  https://madisonarealymesupportgroup.com/2017/10/15/vaccines-and-retroviruses-a-whistleblower-reveals-what-the-government-is-hiding/

But unless your ear is to the ground, you probably didn’t even hear about it.  Yet many are probably dealing with it.

Data suggests that 6% of the U.S. population is harboring a retrovirus in their bodies that can develop into an acquired immune deficiency. It began with trials of polio vaccines and yellow fever vaccines given in the early 1930s. This is when the first recorded cases of Chronic Fatigue Syndrome and autism appeared. It involved the use of laboratory mice to prepare vaccines for human use. Retrovirus exposure intensified in the 1970s as new vaccines and pharmaceutical products were developed. These retroviruses and related infectious agents are now associated with dozens of modern chronic illnesses – perhaps nearly all of them. In these diseases, infection leads to inflammation — and unresolved inflammation can lead to chronic disease.

Even though 20 million Americans are likely to be infected, not everyone will develop serious illness.  Retroviruses in the human body are like sleeping giants. They are quiet until they are activated in immune deficient people.  Once activated, they create diseases such as Myalgic Encephalomyelitis, also called Chronic Fatigue Syndrome (ME/CFS), Chronic Lyme disease, Chronic Lymphocytic Leukemia, autism spectrum disorder (ASD), numerous cancers, and a wide range of other autoimmune, neuroimmune, and central nervous system diseases. 

These retroviruses can be passed between family members through body fluids.

It is not unusual to find a family where everyone tests positive for a retrovirus, but only one person is experiencing a retrovirus-related illness. Symptom free carriers are common in human retroviral infections.
And our government hid it.

Do your research on vaccines and think long and hard about it as acquiring Lyme/MSIDS can be the trigger that activates retroviruses and vice a versa.

 

Category:

Activism, research, vaccines, Viruses