Archive for the ‘vaccines’ Category

Beyond the Measles Scare: Facts, Myths, & Effective Strategies

https://worldcouncilforhealth.substack.com/p/measles-facts?

Going Beyond the Measles Scare: Facts, Myths & Effective Strategies

Immunity depends upon a lot more than just antibodies.

Dr Jayne Donegan practiced as a Medical Doctor for 40 years. In 1990 she began her studies in homeopathy and naturopathy and is now a registered Homeopathic and Naturopathic Practitioner. She is a member of the British Society of Ecological Medicine and a patron of the College of Naturopathic Medicine. In July 2023, after applying unsuccessfully for four years, she was eventually deregistered from the General Medical Council. She is now free to continue working as a holistic practitioner without having to adhere to NHS policies that she believes were not in the best interests of her patients.

In 2011, Dr Donegan wrote a comprehensive articleMeasles Outbreaks: The Song Remains the Same, for The Informed Parent. Christoph Plothe DO, Health and Science Lead for the World Council For Health, asked Dr Donegan to share her insights regarding recent measles scares on Better Way Today on 25 March 2024.

Watch the full episode now

What’s causing the measles scare?

In the UK we are told that the recent measles scare is due to lower rates of vaccine uptake. These low rates are not surprising: during the Covid event doctors’ surgeries were closed, reducing access to these services. We also saw during Covid that making people afraid is one of the best ways to ensure compliance – so now the health authorities are trying to increase vaccination rates by threatening that children are going to die of measles. Dr Donegan denies that there is a measles emergency, but notes that – just like during Covid – nobody is informing the public about effective ways of managing measles or other diseases that result in fevers.

Were vaccines really the cure?

Dr Donegan points out that there is a lot more to immunity than antibodies generated by vaccines, and long before vaccines were developed, death rates from measles had been plummeting. This is not the story we have been told – or that doctors have been educated to believe. Instead we have learnt that the MMR vaccine is a lifesaving intervention that will protect us all from measles.

Measles deaths in England and Wales, 1940-1991. Source: Immunisation Against Infectious Diseases Handbook

In the Immunization Against Infectious Diseases Handbook, which provides guidance on vaccination to doctors, is a graph showing measles-related deaths in England and Wales. The graph starts in 1940, with the zigzag pattern reflecting the fact that measles epidemics normally occur about every two years. After introduction of the original measles vaccine in 1968 cases do appear to decline; and they continue to do so after introduction of the MMR vaccine.

Looking at this graph, it is clear why people believe that the measles vaccine was responsible for the decrease in measles-related deaths, but we need to look more deeply into the evidence. For instance, what the graph actually indicates is an association in time – not causality. Also, what is not stated is that, when the measles vaccine was first introduced, there was only a 30% uptake. Most parents didn’t see the point of the vaccine as measles was just a normal childhood disease, like chickenpox. Uptake of the vaccine only exceeded 50% in 1980, and it was only in the 1990s that uptake rates for all vaccines rose above 90%.

Dr Donegan herself had accepted without question graphs such as this in her medical textbooks. It was only once she started studying homeopathy and hearing that death rates had started to decline before the vaccines were introduced, that she started questioning her assumptions and researching the issue more deeply. Eventually, on an old CD-ROM from the Office for National Statistics (ONS), she found data that enabled her to produce a graph of measles mortality for the whole of the 20th Century.

Measles Deaths per Million, England and Wales, 1901-1999. Source: https://www.jayne-donegan.co.uk/measles-outbreaks/

Even before antibiotics became widely available, measles deaths were declining precipitously. By 1940 (the starting point of the graph in the medical textbook) – and certainly by the time the vaccine was introduced in 1968 – the number of deaths was almost negligible. Of course, sometimes people with underlying medical conditions, or those not properly treated (e.g. for fever) do die of measles and other infectious diseases. But they are the exceptions.

In developed regions, a great many diseases have declined not due to vaccines but due instead to the provision of clean water, removal and treatment of sewage, better nutrition, and improved indoor air quality. Indeed, in countries lacking these services, many children do still die of measles because these conditions undermine their general health and weaken their immune systems. Emeritus Professor Thomas McEwan, a past Chair of WHO’s Health Research Strategy Committee, stated that the radical decline in child mortality between the 1850s (approx. 1,000 per million) and 1960s (almost zero) in England and Wales was due not to physicians, but to surgeons and hygiene.

Making an informed decisions

As we know, governments use fear to pressurize parents to have their children vaccinated, even though graphs like the one above clearly show that the risk of death and the efficacy of vaccines have been exaggerated. Over the past 30 years it has become more difficult for parents to make the decision not to vaccinate their children but to allow them to contract a disease and develop strong, long-lasting natural antibody immunity. In the case of a future mother, natural immunity will also confer immunity onto her child for the first 18 months of life by means of transplacental antibodies! Insights such as these help parents make choices based on science rather than fear.

Something else that can help us decide whether or not to have ourselves or our children vaccinated is to research what is in the vaccines, and their adverse effects (which are generally highly underreported). In the UK, the Electronic Medicines Compendium provides access to information on drugs and vaccines used to treat various diseases. By typing into your search engine ‘EMC’ plus the name of a disease, you will find the patient information leaflet (PIL) and the summary of product characteristics (SmPC) for the relevant medication, for example MMRVAXPRO for measles.

Knowing how to manage a fever – which is what people did to protect their children before the measles vaccine was introduced – can also empower parents who would prefer not to vaccinate their children. This makes sense when you consider that the risks of a serious vaccine adverse effects may be underreported by a factor greater than 100, and that babies and young children are subjected to multiple vaccines and boosters, increasing their individual risks.

Unlike babies born to mothers who themselves had measles as children, and whose long-lasting immunity protects the infant until 18 months of age, vaccine-derived antibodies are short-lived and not passed on from mother to baby. Prior to Covid, there was a measles scare in Europe; most of the children who died were actually babies below the age of 18 months born to MMR-vaccinated mothers.

It’s about more than antibodies

It is important to recognize that immunity depends upon more than antibodies, which (with the lymphocytes) are part of the adaptive immune system that protects against specific pathogens and changed body cells. The innate immune system is the body’s first line of defence operating at the skin and mucous membranes to protect against germs in general entering the body.

Something that few of us recognize is the importance of fever itself. In the 1950s, a General Practitioner, Dr Fry, reported that mothers were observing that their children did better after “a good dose of measles”. People at the time regarded diseases like measles and chickenpox as developmental steps. Ironically, going through these infections appropriately results in improvements, but avoiding them means that you miss out. Dr Donegan referred to an editorial in the British Medical Journal that stated that “autoimmunity is the price one pays for the eradication of infectious disease.” The author explained to Dr Donegan that the human immune system developed under the ‘insult’ of common childhood diseases; without having to deal with these challenges, the immune system doesn’t learn. 

Dr Donegan feels that we should let children have their normal childhood diseases and manage them properly – and this means not bringing down all their fevers with paracetamol or ibuprofen. According to a WHO bulletin from 2000, “fever is an ancient adaptive response for which there are a few, if any, good reasons to suppress.” As long as the patient remains alert, can communicate clearly, and sleep peacefully, the fever should be allowed to run its course. Indeed, the rise in body temperature increases the rate of detoxification by the liver, filtration of blood by the kidneys, and the immune response. And while the patient must drink enough during a fever, the natural tendency not to eat is a logical response, as it allows the gut to prioritize production of immune cells rather than focus on digestion.

This article is a taste of a fascinating discussion. We hope you will visit the World Council for Health’s Video Library to watch the whole episode … including Health Coach Linda Rae’s short video on how to boost your immunity!

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**Comment**

  • The CDC obfuscates vaccine data is by classifying 95% of measles cases as ‘unvaccinated or unknown’two fundamentally different categories.  Truth be told, measles cases with unknown vaccination status may in fact be vaccinated.
  • The CDC purposely merges unknown cases with unvaccinated ones maximizing the association between measles cases and non-vaccination while obscuring uncertainty in the data.  It purposely does not apply the same logic in reverse – merging ‘unknown cases with vaccinated cases maximizing the association between measles cases and vaccination, which very well could be true.
This allows them to smugly reinforce a predetermined narrative which the media regurgitates.
  • The MMR vaccine contains a live measles virus that was created through a laboratory process U.S. military biodefense experts state “could be considered, by current definitions, gain-of-function research.” 
  • Peer-reviewed studies further document vaccine-strain replication and shedding, measles-like illness following vaccination, and frequent inability to distinguish vaccine-strain illness from wild measles in symptomatic cases.

Please share this information with those around you.  We desperately need to return to sanity and wisdom.  The past four years have attempted to change everything previously known about disease.

Go here for the new Children’s Health Defense e-book, “A Parents’ Guide to Healthy Children: From Preconception to Early Childhood.”

For more:

https://madisonarealymesupportgroup.com/2024/02/27/is-any-vaccine-worth-getting/

Go here to listen to doctor after doctor discussing the very real problems surrounding vaccinations. Vaccine information is being censored from nearly every platform.  ‘Authorities’ simply don’t want you to know the following truths about vaccines:

  • They contain toxic ingredients
  • The CDC has been lying about vaccine injuries and deaths for decades
  • The vaccine given in trials are often not what is given to the public
  • Vaccines are used in lieu of a true placebo making them appear safer than they are
  • Trials often do not have a true control group
  • Infant deaths due to vaccines are NEVER listed on death certificates but are listed as SIDS due to a lack of ICD code
  • Vaccines can reactivate latent infections
  • Vaccines have contained retroviruses and other cancer and disease causing viruses
  • Corrupt ‘public health’ has never done a study comparing the vaccinated to the unvaccinated
  • Corrupt ‘public health’ has never done a study looking at the cumulative effect of vaccines – particularly looking at metal accumulation
  • Corrupt ‘public health’ never admits vaccines can cause the very disease they are supposed to cure
  • Doctors get kickbacks for pushing vaccines on their patients
  • Go here for more shenanigans ‘public health’ plays

AMA President Opposing Free Speech As COVID ‘House of Cards Collapsing’

https://petermcculloughmd.substack.com/p/ama-president-opposes-free-speech?

AMA President Opposes Free Speech

Dr. Jesse M. Ehrenfeld believes vaccine orthodoxy must be preserved at all costs

Dr. Jesse Ehrenfeld was inaugurated president of the American Medical Association in 2023. He and his colleague—Dr. Benjamin Hoffman, an Oregon-based pediatrician—just wrote a very foolish editorial in MEDPAGE TODAY titled: Medical Misinfo Runs Rampant Online. The Gov’t Must Retain the Right to Intervene.—Combating vaccine falsehoods and other inaccurate claims protects public health

According to Dr. Ehrenfeld’s bio that is posted on the AMA website, he has a distinguished career in anesthesiology. His bio also states:

Upon his inauguration, Dr. Ehrenfeld made AMA history as the first openly gay president of the organization. For the past two decades, he has been a nationally recognized advocate for lesbian, gay, bisexual, transgender and queer (LGBTQ+) individuals. In 2018, in recognition of his outstanding research contributions, he received the inaugural Sexual and Gender Minority Research Investigator Award from the director of the NIH.

I’m immediately struck by the combination of anesthesiologist and gay rights activist, as both endeavors have been matters of great controversy since the mid 19th century.

Imagine if—following Friedrich Sertürner’s discovery of morphine in 1805—medical boards in the United States (affiliated with the British East India Company) insisted that ONLY opioid-based analgesics could be used, and that no one could use ether to anesthetize patients. To understand just how much disagreement, discussion, and debate there was around the use of ether, take a look at this history of the Ether Controversy.

Imagine if a medical board in Boston established a censorship apparatus to prevent anyone from challenging the supremacy of morphine as an analgesic, so that William Morton, Crawford Long, and Oliver Wendell Holmes, Sr. couldn’t publish about the value of ether for surgical anesthesiology.

Fast forward to the end of the 20th century. Imagine if no one was allowed to publish any criticism of the promotion and marketing of OxyContin by Purdue Pharma.  (See link for article)

The AMA is entirely corrupt, instructs doctors to deceive, and has caused untold thousands of deaths due to their banning of early treatments for COVID.

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https://expose-news.com/2024/03/27/dr-fullmich-statement-from-prison-their-house-of-cards-is-collapsing/

Dr. Füllmich Statement From Prison – ‘Their House of Cards is Collapsing’

Dr. Reiner Füllmich has continued to analyze evidence of the crimes against humanity from prison. that he and the Corona Committee had been working to expose since 2020. The corruption is being increasingly seen worldwide and “Their house of cards is collapsing” according to Reiner, “and we as international attorneys will do our best to speed up that process and make sure that Justice is done.” He adds ‘The windows of truth that are opening worldwide and the light that shines through these windows is in the process of identifying all of those who are responsible, no one will escape Justice.

Reiner Füllmich made this statement in a a break from the his trial due to the Easter holidays which has followed eight days in court. He has now been able to summarize the criminal proceedings against him and concludes that Hoffman and Antonia Fischer were only interested in ‘getting their hands on the Corona Committees donation. He claims that ‘through ‘fraud and extortion’, they had gotten their hands on roughly 1.5 million euros of his and his client’s money.’

Viviane Fischer, however, has confirmed in court that they both took loans in order to secure the Corona Committee’s donations which were at risk from “government attack, but they were both able to pay the monies back.

What this means is accusations that Reiner had embezzled committee funds are unfounded. In fact, there seems to be no reason for the man to have been kept in jail at all, and he believes, as many others do, that the criminal proceedings are an effort to shut him up and put him in jail and can see that the ‘DA’s case, is dead in the water.’

Reiner therefore, seems to be more positive for the future, which can be heard in his statement which you can listen to in full in the video of the audio below. However, I have also transcribed the audio recording verbatim and have added it underneath the video for those unable to play videos. (See link for article and 10 Min video)

For more:

Ivermectin Win: FDA Must Remove Controversial Verbiage From its Website While DOJ Attempts to Shut Down Pfizer Fraud Case

**UPDATE**

Besides bad-mouthing ivermectin, a U.S. government ‘cartel’ bribed large pharmacy chains like Walgreens and CVS with billions of dollars in contracts to promote COVID-19 vaccines and not fill prescriptions for ivermectin.  See:  The FDA’s War Against America’s Health

https://petermcculloughmd.substack.com/p/breaking-dr-mary-talley-bowden-reacts

Agency Capitulates by Removing False Claims on Ivermectin from Social Media and Internet

By Peter A. McCullough, MD, MPH

Thursday evening March 21, 2024, in an unprecedented court case, the US FDA led by  Commissioner Robert Califf, MD, a previously respected Duke Cardiologist, has settled a court case and taken down all of its false and misleading claims on ivermectin. The drug has been part of community standard of care for the treatment of COVID-19 with an excellent safety profile and signals of benefit in 101 studies.

During 2021, in what has been called “A War on Ivermectin” the US FDA engaged in false and misleading tweets and public messaging to dissuade doctors, pharmacists, and patients from using the drug in The McCullough Protocol and similar multi-drug regimens for acute COVID-19.  (See link for article and video)

According to an Epoch Times article , a court ordered the FDA to walk-back its negative posts about using ivermectin for COVID:

  • Studies show ivermectin works against COVID the FDA itself cites, but it’s webpage currently states it is not authorized or approved for use in preventing or treating COVID.
  • The court settlement requires the FDA to delete multiple social media posts that are strongly against ivermectin.
  • For doing this, doctors who sued the agency are dismissing their claims.
  • According to one of the doctors who sued, “This landmark case sets an important precedent in limiting FDA overreach into the doctor-patient relationship.”
  • Another ivermectin prescribing doctor who saw lives saved states that due to FDA interference, “we will never know how many lives were affected because patients were denied access to a lifesaving treatment because their doctor was ‘just following the FDA.’”
  • The three-judge panel of the U.S. Court of Appeals for the Fifth Circuit found that the law did not authorize the FDA to give medical advice.
  • Numerous doctors have chronicled the highly coordinated and timed actions between the FDA, CDC, AMA, APHA, and corporate controlled media to squash ivermectin – an extremely safe, cheap drug on the WHO’s essential list of medicines that has been used for decades without a prescription in many countries, including Africa which had essentially ZERO COVID due to the prolific use of the drug.

FDA can inform, but it has identified no authority allowing it to recommend consumers ‘stop’ taking medicine,” U.S. Circuit Judge Don Willett, wrote for the court. The appeals court remanded the case back to the district court.

Predictably, the FDA didn’t get the memo:
  • and has not “admitted any violation of law or any wrongdoing, disagrees with the plaintiffs’ allegation that the agency exceeded its authority in issuing the statements challenged in the lawsuit, and stands by its authority to communicate with the public regarding the products it regulates.”
  • and has not changed its position that currently available clinical trial data do not demonstrate that ivermectin is effective against COVID-19. The agency has not authorized or approved ivermectin for use in preventing or treating COVID-19.”
Welcome to the Twilight Zone.

For a quick flashback, watch this video of a doctor being forcibly removed by police from a hospital board meeting simply for endorsing ivermectin that he used in his own private practice, and for evidently breaking protocol by whispering a “thanks” to a politician who questioned hospital policy. He shared at about 7:00 that doctors on staff at the hospital would come and see him to get ivermectin but would not speak their mind or prescribe it for fear of retribution from hospitals or their own medical groups. He states that 99% of doctors now have a contract with the hospital and are beholden to it, and that ‘brutal’ COVID treatment protocols, which one nurse blamed for 90% of hospital deaths, were followed to the letter due to government financial incentives.  Hospitals were simply not interested in early treatment which have saved lives and freed up hospital beds.

This video shows how the CARES Act signed into law in 2020 waived patient rights, and made hospitals rich (approx. 100K per COVID patient) due to these government incentives.

The ivermectin-prescribing doctor was unable to eat in the hospital employee lounge because he didn’t take the COVID shot.

And the reason the suit was brought in the first case was due to doctors suffering repercussions after prescribing ivermectin to patients with COVID.  Pharmacists refused to fill prescriptions.

The FDA is certainly guilty, as well as other government agencies.  But so are hospitals, medical groups like the AMA, APHA, ASHP, mainstream media, and doctors themselves.

Unless action is taken, this can and will happen again.

________________

https://www.naturalnews.com/2024-03-22-department-of-justice-intervenes-pfizer-fraud-case.

Collusion coverup: Department of Justice intervenes in Pfizer fraud case, in a corrupt attempt to shut the case down

03/22/2024  Lance D Johnson
Story at a glance: (summary by “Neo” LLM via Brighteon.AI)- The United States Department of Justice (DOJ) is attempting to shut down the Pfizer fraud case scheduled for April 17.- The lawsuit alleges that Pfizer-BioNTech violated the False Claims Act during their clinical trials and knowingly delivered a defective product to the world.- Former employee Brook Jackson, who worked at Ventavia Research Group (a company that conducted some of Pfizer’s COVID-19 vaccine clinical trials), is suing Pfizer, her former employer Ventavia, and another Pfizer contractor, ICON plc.- The DOJ asked the court to dismiss the lawsuit, claiming it would be inconsistent with their public health policy.- The DOJ’s motion to dismiss cites a flimsy hypothesis authored by the FDA, which supports the faulty vaccines and contradicts Jackson’s claims of fraud and negligence.  (See link for article)

Pfizer sunk to unbelievable lows to peddle their gene therapy shots including using children in ads
The shot not only flopped, it caused more COVID infections & an inflammatory syndrome

For more:

WEF Planning to ‘Relaunch’ COVID ‘Pandemic’ Insider Warns

https://newsaddicts.com/wef-planning-relaunch-covid-pandemic-insider-warns/  Video Here (Approx. 9 Min)

WEF Planning to ‘Relaunch’ Covid Pandemic, Insider Warns

A bioweapons industry insider has blown the whistle to warn the public that the World Economic Forum (WEF) is planning to “relaunch” the Covid pandemic in order to finalize its “Great Reset” agenda.

According to Dr. Harvey Risch, a bioweapons expert and Yale University professor and epidemiologist, the “next pandemic” is about to erupt “seemingly out of nowhere.”

Risch warns that globalist elites are not finished with Covid yet, despite the appearance that the pandemic is “over.”

While the last pandemic may have failed to fully usher in the WEF’s “Great Reset,” another, more deadly Covid outbreak would surely complete the transition.

Both the “virus,” so-called, and the “vaccine,” so-called, were the perfect excuse for America’s bioweapons industry to boost itself as something the nation requires in order to serve the public good by protecting We the People against disease – or so it claims.

Dr. Risch is now alerting top trusted lawmakers in the hope of blocking the plans.  (See link for article and video)

_______________

**Comment**

Risch is not alone.  Seems it came stright from the horses mouth and Benzinga reported that WHO Director-General Tedros Ghebreyesus sounded the alarm that its a “matter of when not if” a new pandemic, infamously called ‘Disease X,’ will strike.  This sounds similar to billionaire Bill Gates’s recent public concerns that “we’re making the same mistakes again” by failing to adequately prepare.

But researchers are preparing by using breakthroughs in artificial intelligence (AI) to further speed up future vaccine development against Disease X. The Coalition for Epidemic Preparedness Innovations is providing up to $4.98 million to the Houston Methodist Research Institute to use AI to do just that. They aim to use AI to analyze the structures of potential viruses that may be the eventual Disease X and then identify specific parts of their proteins that cause an immune response. For now, their efforts focus on viruses such as Nipah and Lassa, but their goal is to get the time to develop a vaccine against a pandemic down to just 100 days.

Gee, what could go wrong?

Meanwhile, Politico reported that a growing dependence on artificial intelligence could pose a danger to the U.S. financial system, and regulators need to rethink their siloed approach to rule-making to minimize the risk, Securities and Exchange Commission Chair Gary Gensler said.

I’m sure trusting AI to create a ‘vaccine’ in 100 days to be put in human bodies is much safer, right?

Patients Question CDC About Pfizer Lyme ‘Vaccine’

https://www.lymedisease.org/lyme-vax-essential-questions/

Patients question CDC about Pfizer Lyme vaccine

3/13/24
By Lonnie Marcum

On March 6-7, I was one of seven Lyme disease advocates selected to attend the “Lyme Disease Vaccine—Technical Consultation” at the CDC in Atlanta.

The purpose of this meeting was to bring together experts and advocates to develop a list of questions about the potential arrival of the new Pfizer/Valneva Lyme disease vaccine candidate called VLA-15.

Let me be clear, attending this meeting was not an endorsement of VLA-15. Quite the opposite—it was a chance for the Lyme advocacy community to raise our serious concerns.

Other advocates in attendance were Wendy Adams, Bonnie CraterBruce FriesHoliday GoodreauOlivia Goodreau and Patricia Smith. (Click links to find out more about them.)

My goal in this column is to share the theme of the questions we developed so that the public can at least know what was presented to Pfizer during our technical consultation. My next task will be to help gather answers to those questions and share them with the public.

And something I simply must state at the outset: I worry that a vaccine is being developed when there STILL is no accurate test for Lyme disease. How will they know someone does or doesn’t have Lyme, to begin with? How can Pfizer prove the vaccine even works? Honestly, if you want ALL the controversy to go away, develop an accurate test!

What I learned before the meeting

Prior to the meeting, I spoke with many scientists, researchers and entomologists who work with Borrelia and the ticks that transmit Lyme disease. Most of them had seen scientific presentations on VLA-15, and told me they likely would have designed the vaccine differently (eg. using mRNA or adding another protein like OspC) or gone for an anti-tick vaccine instead.

One researcher who had tested the vaccine in their animal lab told me “it worked” and while they maybe would have designed it differently, “something that reduces the number of Lyme cases is better than nothing” at this point.

I also reached out to several members of the Lyme community to get their input. I arrived at the meeting with a long list of questions, which I have included below.

The week before the meeting, we were given copies of Valneva/Pfizer press releases, which I will link to below for anyone interested in reading them. I was disappointed that we were not given anything more recent, nor access to the scientific presentations that the researchers I spoke with had seen.

In addition to the press releases (which had already been published) I read several of Pfizer’s references as I tried to drill down into the science. Among many things, I learned that VLA-15 is an aluminum-containing adjuvant formulation. (Adjuvants increase the immune response to the vaccine. Many people with Lyme and/or mast cell activation syndrome are highly sensitive to certain additives. They need to know all the ingredients to avoid a serious reaction.)

How VLA-15 reportedly works

The VLA-15 vaccine does not create a traditional immunity to Lyme disease. The vaccine is based off of a single outer-surface protein of Borrelia burgdorferi known as OspA. OspA is primarily expressed by Borrelia spirochetes when they are attached within the midgut of the blacklegged tick. The vaccine relies on the tick to feed on a fully vaccinated human and thus to ingest a human byproduct of the vaccine (OspA antibody). In theory that antibody will kill the Borrelia spirochetes in the midgut of the tick before it can be transmitted to the human. In order for this to work, Pfizer will likely recommend that people get three vaccines within the first year and annual boosters thereafter.

Let me say, I am not anti-vaccine. However, due to the history of the previous Lyme vaccine, called LYMErix, I came with a lot of questions about the safety of VLA-15. (You can read my recap of the Lyme disease vaccine—separating fact from fiction here.)

Who from the CDC met with us

There were several high-ranking members of the CDC present during both days of the meeting, including Dr. Susanna VisserDr. Lyle PetersonDr. Paul Mead, and Dr. Grace Marx. (There was also a team of kind women who worked behind the scenes to arrange for our travel, hotel, meals, taking notes of our meeting and allowing Pat Smith to participate virtually, as she was not able to attend in person.)

Dr. Nirav Shah, Principal Deputy Director of the CDC, started the first day’s meeting by reiterating that 90% of vector-borne disease in the U.S. are transmitted by ticks, with the majority (80%) of tick-borne infections being Lyme disease. One goal of the CDC’s Division of Vector-Borne Diseases latest National Strategy to Protect People is to reduce the number of Lyme disease cases (laboratory confirmed) 25% by 2035, compared to 2022. Part of their strategy to reduce Lyme is to find a safe and effective vaccine.

Just for background, the CDC has not been involved in the clinical trials and has no intellectual property tied to the Pfizer Lyme vaccine candidate. However, if the vaccine is approved by the FDA, and if the Advisory Committee on Immunization Practices (a panel within the CDC) recommends it, the CDC will take the lead for developing and implementing the Lyme disease vaccination program.

Later, Drs. Marx and Mead gave presentations on the government’s relative roles in vaccine development and monitoring for adverse events.

Then, the Lyme advocates presented our many questions (summarized below) and grouped them into logical categories. It was a long, worthwhile process.

After the meeting, we got to see the CDC museum, one of the only places at the complex where you are allowed to take photographs. We then headed to dinner where we continued our deep discussions about vector-borne diseases and why we each have a passion for why we do what we do.

From left: Lonnie Marcum, Olivia Goodreau, Bruce Fries, Holiday Goodreau, Wendy Adams, Bonnie Crater. Not shown: Pat Smith, who attended remotely.

Day 2

The next day, we met Pfizer representative Christine Hanson. She is not a scientist and thus could not answer any of our technical questions. She was there to hear and document our concerns and then get back to us with answers at a later date.

Sue Visser asked each of us to give our full personal stories of how we or a family member were affected by Lyme and/or co-infections. All of us had stories about missed and delayed diagnoses.

Pat Smith’s recollection was the most detailed—going back to the 80s when the cause of Lyme disease was first discovered. She documented her real-life experience as community members reported serious side effects of the LYMErix vaccine as it rolled out in the late 90s until it was taken off the market in 2002.

See here for more on the complicated history of the LYMErix vaccine.

Summary of Questions

Many of my technical questions (besides those in my vaccine Fact/Fiction recap) came after reading the publication entitled “Broadly Protective Multivalent OspA Vaccine against Lyme Borreliosis, Developed Based on Surface Shaping of the C-Terminal Fragment.”

The paper details how Valneva designed the vaccine off of six different outer surface protein A (OspA) derived from the five most common species of Borrelia found in Europe and one species found in the U.S.

Being from California, I immediately had several specific questions about whether this vaccine would offer any protection to the many species of Borrelia we have on the West Coast (see my question #7 below).

I asked Pfizer if they could explain why, in the above paper, the vaccine appeared to be roughly three times better against the five European strains (3.2 fold) versus the single U.S. strain which showed only a 1.9 fold increase in antibodies as compared to baseline.

Wendy Adams and I also wanted to know how (or if) Pfizer had modified the OspA proteins to prevent auto-immune reactivity to HLA-DR4, as was theorized with the previous OspA vaccine, LYMErix.

We all wondered how Pfizer is testing patients for Lyme disease considering the standard laboratory tests for Lyme miss approximately 50% of cases.

We all had concerns about whether a Lyme vaccine might create a false sense of security regarding tick bites. After all, Lyme disease is only one of nearly 20 tick-borne pathogens transmitted to humans in the U.S.

We asked how quickly it takes for someone to develop antibodies following the vaccine, and how long those “protective” antibodies last. And what is the overall effectiveness of this vaccine? Reportedly, the prior vaccine was only 70% effective, if everything went right. Would this one be any better?

The absolute need for transparency

We asked about the inclusion/exclusion criteria for their phase 2 and 3 clinical trials, which did not include pregnant women. We also wanted access to the detailed reports of adverse events (VAERS).

I wanted to know specifically why both of the VALOR clinical study sites located in Nantucket and Marthas Vineyard were shut down during the Phase 3 clinical trial.

And we all stressed the need for 100% transparency.  Without it, we warned both the CDC and Pfizer, you’ll never gain trust from the Lyme community. Complete transparency is a must!

Above all, we want to know if the proposed Lyme vaccine is safe.

It was an intense couple of long days. I am honored to have been invited and I hope that I am able to make the Lyme community proud by reporting my experience as the facts roll in.

Once the CDC has compiled our questions in written form, I will share them with you. Stay tuned for updates as I learn more.

Pfizer/Valneva Press Releases

Sept. 28, 2021: Valneva and Pfizer Report Further Positive Phase 2 Results, Including Booster Response, for Lyme Disease Vaccine Candidate

Feb. 4, 2022: Valneva and Pfizer Report Further Positive Phase 2 Data for Lyme Disease Vaccine Candidate

April 28, 2022: Pfizer, Valneva Report Positive Phase 2 Pediatric Date for Lyme Disease Vaccine Candidate

Aug. 8. 2022: Pfizer and Valneva Initiate Phase 3 Study of Lyme Disease Vaccine Candidate VLA15

Dec. 1, 2022: Valneva and Pfizer Report Six-Month Antibody Persistence Data in Children and Adults for Lyme Disease Vaccine Candidate

Aug, 8, 2022: Pfizer and Valneva Initiate Phase 3 Study of Lyme Disease Vaccine Candidate VLA15

Feb. 17, 2023: Pfizer and Valneva Issue Update on Phase 3 Clinical Trial Evaluating Lyme Disease Vaccine Candidate VLA15

Sept. 7, 2023: Valneva and Pfizer Report Positive Pediatric and Adolescent Phase 2 Booster Results for Lyme Disease Vaccine Candidate

Dec 4, 2023: Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial for Lyme Disease Vaccine Candidate, VLA15

Full List of My Personal Questions to Pfizer

Vaccine development requires a clinically testable disease definition to pass clinical trials and garner FDA approval.

  1. What testing method is Pfizer using to find a patient population free of Lyme disease, vaccinate it, and then prove the vaccine has worked by retesting those patients?
  2. Have you followed up with VLA15 vaccinated patients who’ve been bitten by ticks to see if they were in fact protected from Lyme disease? How are you determining efficacy considering standard laboratory tests for Lyme miss approximately 50% of actual cases?
  3. Lyme disease is the most common vector-borne disease in the US. How do people who’ve already had Lyme disease react to VLA15?
  4. Growing evidence suggests that Borrelia can be present at subclinical levels leading to mild symptoms or asymptomatic infection. Similarly, people may have been previously exposed to the bacteria and have a resolved infection. This infection status and immune history could dramatically impact vaccine response. How will you determine if trial participants have a past or present infection?

A similar question holds for other subclinical co-infections. How will you assess infection status for common Lyme co-infections?

Are Pfizer scientists aware of advances in direct detection that may help stratify patients for clinical trials? E.g., Nanotrap, digital PCR, etc.

Will Pfizer/Valneva release raw data from the clinical trials and be transparent about adverse reactions?

Why exactly were the two VALOR VLA15 study sites at Nantucket and Martha’s Vineyard halted “representing approximately half of the total recruited”? At the time thoses sites were shut down, how many US. patients versus how many European patients were enrolled in the trial? How many US patients remained in the trial after Nantucket and Martha’s Vineyard were shut down? 

How was OspA “modified” to prevent auto-immune reactivity with HLA-DR4?

What modifications were made to better stimulate protective immunity? Can you provide any evidence pointing to improved efficacy in children and seniors, a short-coming of the previous vaccine?

Valneva began the research for VLA15 in Europe utilizing “four Borrelia species presenting six different outer surface protein A (OspA) serotypes (ST) that are responsible for the majority of human clinical cases: Borrelia burgdorferi (OspA ST1), Borrelia afzelii (OspA ST2), Borrelia garinii (OspA ST3, OspA ST5, and OspA ST6), and Borrelia bavariensis (OspA ST4).” In VLA15 “The protein backbones of all six chimeric variants were based on the sequence of the C-terminal fragment of afzelii OspA ST2, which represents the most prevalent OspA ST causing LB in Europe.” My questions:

  1. How protective will VLA15 be against other forms of Borrelia found in the United States? (eg. B. mayonii, americana, CA5, CA382, CA-11-2A, CA8 and B. miyamotoi a relapsing fever species found in the same blacklegged ticks that carry Lyme).
  2. According to Bob Lane’s research significant variations exist in the major outer surface proteins (OspA and OspB) and other proteins (21kDa to 25kDa) in fresh tick-derived isolates of B.burgdorferi from Northern California. Isolate CA5 possessed abundant proteins with relative mobilities of ca.21.5 and 24 kDa that were not present in several other fresh isolates from ticks or in the B31 strain. How effective is VLA15 against the many strains of Borrelia found on the West Coast of North America?
  3. One “study of California patients who were tested for tick-borne disease suggests there may be similar exposure risks for Lyme disease and relapsing fever borrelia (33% vs. 27%), and evidence for dual exposure to Lyme disease and relapsing fever borrelia (RFB) was found in 11% of patients.” How is Pfizer going to educate the public about the lack of protection to RFB?
  4. In your phase 2 clinical trial, patients produced three times as many antibodies to the European strain ST2 versus the US strain ST1 (Geometric mean fold rise 3.2 fold increase over baseline, versus 1.9 respectively). Can you explain this?

How long does it take for human antibodies to OspA to develop after VLA15?

How long do human antibodies to OspA continue after VLA15 last?

What happens if someone is only partially vaccinated? For instance,

  1. What happens if someone is infected with Lyme disease between the first and second vaccine?
    • Will the patient be more or less prone to infection?
    • Will the patient be more or less prone to false positive or false negative testing?
    • Will the patient be more or less prone to auto-inflammatory reactions?
    • What testing methods are you using to prove the above?
  2. What happens if someone is bitten by a tick and infected with Lyme disease prior to receiving the third VLA15 vaccine? (same followup questions)
  3. What happens if someone is infected with Lyme disease between annual boosters? (same followup questions)

According to the previous LYMErix vaccine package insert, it was 70% effective at preventing a rash but only 50% effective at preventing chronic Lyme. How effective is VLA15 at preventing chronic Lyme? What testing method are you using to prove this?

In your mouse model studies following vaccination with VLA15, all of the challenge tick inoculation was with B. afzelii, while all of the B31 challenge was via needle inoculation using cultured B31. Borrelia have a unique response to tick guts and tick saliva that does not occur in culture. In fact, approximately 90% of Borrelia burgdorferi die with needle inoculation, In addition, B31 does not produce OspA in culture. How can you prove VLA15 is truly effective against B31 when you did not include tick inoculation in your B31 vaccine challenge?

Have you done any non-human primate studies with VLA15?

VLA15 is expected to disable the outer surface protein A (OspA) of the Borrelia burgdorferi bacteria within the tick gut prior to transmission to humans.

  1. Most Lyme infections are a result of bites from nymphal ticks. “Outer surface proteins A and B are two antigens coded on a bicistronic operon and abundantly expressed on the surface of spirochetes within unfed (flat) ticks. When nymphs feed, the majority of B. burgdorferi clear OspA and OspB from their surface and instead express OspC, a protein which is not expressed on spirochetes before tick engorgement.” How long does Bb continue to express OspA in the tick gut once it is exposed to human blood? How long does Bb continue to express OspA once it has migrated to the tick salivary glands?
  2. In partially fed ticks Borrelia has migrated to the salivary glands and is no longer expressing OspA. Partially fed infected ticks are capable of transmitting infection in as little as 12 hours. Have you done any studies to demonstrate VLA15 works against partially fed ticks?

Some have expressed concern that a Lyme vaccine might promote a false sense of security against Lyme and other tick-borne diseases [See Understanding consumer and clinician perceptions of a potential Lyme disease vaccine]

The COVID pandemic has created a lot of anti-vaccine sentiment and will likely be a barrier for broad Lyme vaccine acceptance. How will you gain trust?

Since patient compliance was low with the previous OspA vaccine LYMErix, even outside of the fears related to autoimmunity, why was the decision made to continue with a 3-shot, plus annual boosters regimen? 

How will you convince patients and providers that this vaccine is a significant improvement over its predecessor?

Will the vaccine be safe for patients with pre-existing autoimmune conditions?

Will the vaccine be safe for patients with acquired immune deficiency (from AIDS, COVID, Lyme and co-infections or otherwise)?

Will the vaccine be safe for pregnant women? If so, to what extent have pregnant women been included in the clinical trials?

In VLA15 mouse studies, aluminum hydroxide increased the efficacy of the vaccine. What adjuvants are being used in the VLA15 human trials? Will this be the same adjuvant used when the vaccine goes public?

LymeSci is written by Lonnie Marcum, a 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.

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**Comment**

Kudos to these advocates who obviously spent a lot of their precious time studying this and focusing important concerns into an intelligent, logical presentation.

Sadly, despite their herculean efforts, I WILL NEVER TRUST PFIZER for anything, let alone a ‘vaccine’ for Lyme.  The company is completely and hopelessly corrupt and does not deserve our trust.

The fact that these advocates were handed press releases rather than real science should tell you everything you need to know.

Further, the CDC, FDA, and other governmental agencies in charge of ‘vaccines’ are also completely and hopelessly corrupt and dishonest. They don’t need to be involved in the clinical trials or have intellectual property with this particular ‘vaccine’ to be untrustworthy because the CDC is squarely behind the fraudulent Lyme testing which hasn’t changed in 40 years.  This is a MAJOR problem that sits untouched.  I WILL NEVER TRUST them either – for anything.  

The past four years should have proved to the world that these agencies need to be disbanded. The long and sordid history of conflicts of interests has only worsening with time.