Author Archive

Patients Having “Viral Rebound” After Paxlovid, Which Failed to Show Improvement Over Placebo For Prophylaxis

https://www.bloomberg.com/news/newsletters/2022-04-30/coronavirus-daily-urgent-data-sought-on-pfizer-s-paxlovid-for-covid

U.S. Seeks Data on Post-Paxlovid Rebound

Tourism On Rebound As More Americans Vaccinated
Photographer: Roger Kisby/Bloomberg

Urgent data sought on Pfizer’s Covid pill

Pfizer’s Paxlovid has become the go-to drug for people who get Covid and are at higher risk of developing a severe case. Now U.S. government researchers are planning studies of how often and why coronavirus levels rebound in some patients who have completed a course of the pill treatment.

“It is a priority,” Clifford Lane, deputy director for clinical research at the National Institute of Allergy and Infectious Diseases, told Bloomberg in an interview this week. He called the issue “a pretty urgent thing for us to get a handle on.” The agency is discussing a variety of possible epidemiological and clinical studies to examine the rebound phenomenon, he said.

(See link for article)

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SUMMARY:

  • In an apparent marriage scuffle, Pfizer CEO Albert Bourla suggested people just take more of the treatment, contrary to established protocol. This prompted a FDA official to contradict Bourla.  I wonder if he’ll be forced to sleep on the couch now?
  • While only one case is found in medical literature, many doctors and social media posts are also describing the phenomenon.
  • Predictably, Pfizer states it’s unlikely to be related to their drug and that those given a placebo also experienced rebounds.
  • Interestingly, the NIH states that due to this effect, some may need longer treatment than the standard five days. The same institute soundly denies extended treatment for Lyme/MSIDS.
  • A virologist personally experienced this viral rebound. Symptoms went away quickly while on the drug but then came back after the drug was stopped.
  • Despite these problems, the Biden administration plans to make it more widely available at pharmacies (directly from the federal government) as well as expanding its “test to treat” program. Predictably, a senior official warned that “securing more and even better treatments will require additional funding from Congress,” despite the fact cheap, safe, effective treatments already exist but are censored and banned.  Also worth mentioning is the inability of PCR to diagnose COVID because it cannot rule out diseases caused by other bacterial or viral pathogens.  Further, it is not a validated test, produces far too many false positives, and cannot identify active infection or measure contagiousness.  Similarly for Lyme/MSIDS, government testing is worthless.
  • To my knowledge I have not heard of anyone having viral rebound utilizing HCQ or ivermectin treatments.

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https://www.pfizer.com/news/press-release/press-release-detail/pfizer-shares-top-line-results-phase-23-epic-pep-study

Pfizer Shares Top-Line Results from Phase 2/3 EPIC-PEP Study of PAXLOVID™ for Post-Exposure Prophylactic Use

NEW YORK, April 29, 2022 Pfizer Inc. (NYSE: PFE) today shared top-line results from the Phase 2/3 EPIC-PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) study evaluating PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for post-exposure prophylactic use.

In this trial, compared to placebo, Pfizer observed risk reductions of 32% and 37% in adults who received PAXLOVID for five and ten days, respectively, to prevent infection.
These results, however, were not statistically significant and, as such, the primary endpoint of reducing the risk of confirmed and symptomatic COVID-19 infection in adults who had been exposed to the virus through a household contact was not met.

According to this, the trial data used to obtain EUA designation showed:

  • 89% relative risk reduction of progression to severe COVID for a high risk group.
  • For those with COVID immunity absolute risk reduction was only 1%.
  • The trial was done at a time when Delta was predominant and when fewer people had naturally acquired or vaccine-induced immunity to COVID-19, raising questions about whether the $530 five-day treatment is even effective against the newer variants predominant today.
  • It is unknown how it will perform with other variants.
Pfizer foresees $54 billion in global sales this year — $32 billion from its COVID-19 vaccine and $22 billion from Paxlovid.

Please see Full Emergency Use Authorization (EUA) Prescribing Information available at www.fda.gov and www.COVID19oralRx.com

IMPORTANT SAFETY INFORMATION

PAXLOVID is contraindicated in patients with a history of clinically significant hypersensitivity reactions (eg, toxic epiderma necrolysis [TEN] or Stevens-Johnson syndrome) to its active ingredients (nirmatrelvir or ritonavir) or any other components of the product.

PAXLOVID is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions:

•    Alpha1-adrenoreceptor antagonist: alfuzosin
•    Analgesics: pethidine, propoxyphene
•    Antianginal: ranolazine
•    Antiarrhythmic: amiodarone, dronedarone, flecainide, propafenone, quinidine
•    Anti-gout: colchicine
•    Antipsychotics: lurasidone, pimozide, clozapine
•    Ergot derivatives: dihydroergotamine, ergotamine, methylergonovine
•    HMG-CoA reductase inhibitors: lovastatin, simvastatin
•    PDE5 inhibitor: sildenafil (Revatio®) when used for pulmonary arterial hypertension
•    Sedative/hypnotics: triazolam, oral midazolam

PAXLOVID is contraindicated with drugs that are potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance. PAXLOVID cannot be started immediately after discontinuation of any of the following medications due to the delayed offset of the recently discontinued CYP3A inducer:

•    Anticancer drugs: apalutamide
•    Anticonvulsant: carbamazepine, phenobarbital, phenytoin
•    Antimycobacterials: rifampin
•    Herbal Products: St. John’s Wort (hypericum perforatum)

There are limited clinical data available for PAXLOVID. Serious and unexpected adverse events may occur that have not been previously reported with PAXLOVID use.

Risk of Serious Adverse Reactions Due to Drug Interactions: Initiation of PAXLOVID, a CYP3A inhibitor, in patients receiving medications metabolized by CYP3A or initiation of medications metabolized by CYP3A in patients already receiving PAXLOVID, may increase plasma concentrations of medications metabolized by CYP3A. Initiation of medications that inhibit or induce CYP3A may increase or decrease concentrations of PAXLOVID, respectively. These interactions may lead to:

•    Clinically significant adverse reactions, potentially leading to severe, life-threatening, or fatal events from greater exposures of concomitant medications
•    Clinically significant adverse reactions from greater exposures of PAXLOVID
•    Loss of therapeutic effect of PAXLOVID and possible development of viral resistance

Hypersensitivity reactions have been reported with PAXLOVID including urticaria, angioedema, dyspnea, mild skin eruptions, and pruritus. Cases of anaphylaxis, TEN, and Stevens-Johnson syndrome have also been reported with components of PAXLOVID (refer to NORVIR labeling). If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue PAXLOVID and initiate appropriate medications and/or supportive care.

Hepatotoxicity: Hepatic transaminase elevations, clinical hepatitis, and jaundice have occurred in patients receiving ritonavir. Therefore, caution should be exercised when administering PAXLOVID to patients with pre-existing liver diseases, liver enzyme abnormalities, or hepatitis.

Because nirmatrelvir is co-administered with ritonavir, there may be a risk of HIV-1 developing resistance to HIV protease inhibitors in individuals with uncontrolled or undiagnosed HIV-1 infection.

 Please see this powerful FLCCC graphic comparing Paxlovid vs ivermectin.

The True Cost of Lyme Treatment

https://www.globallymealliance.org/blog/cost-of-treatment

Patients with Lyme disease not only suffer from debilitating symptoms, but also have to pay enormous amounts in medical bills. This blog discusses the financial impact of having Lyme on individuals and their families.  

Lyme disease can take an incredible toll on patients and families. Beyond feeling physically sick—wrestling with symptoms ranging from fatigue, to joint pain, to neurological manifestations—there are emotional, psychological, and financial costs that come with a diagnosis of Lyme. If the patient is lucky enough to get treated right away for early localized Lyme disease, these effects may only impact them for a few short weeks.

But for many Lyme disease patients, the story is not as simple. Roughly 40% aren’t diagnosed until a later stage of the disease [i], and 10-20% of those who are diagnosed early go on to experience persistent symptoms. Many of these people also have other tick-borne diseases, so the road to the recovery is long and circuitous. In these cases, patients can suffer for years, and the financial impact can be severe.

Research by the Johns Hopkins University Bloomberg School of Public Health found that Lyme disease costs the U.S. health care system between $712 million and $1.3 billion a year [I]. Despite these staggering numbers, some Lyme disease patients find themselves shelling out their life savings to cover medical costs. Part of the problem is that long term antibiotic treatment is often not covered by insurance (for more information on this issue, please see “Why Isn’t My Lyme Disease Treatment Covered by Insurance?”). Because of this quagmire, many Lyme Literate Medical Doctors (LLMDs) don’t take insurance, so patients need to pay out-of-pocket and hope for some level of reimbursement. Then there’s the cost of adjunct therapies, supplements, and alternative treatments, most of which are also not covered by insurance. A recent Business Insider article tells the story of one Lyme disease patient who paid $100,000 out-of-pocket over a three-year period. Unfortunately, her plight is all too common.

These costs can be especially difficult to cover when patients are too sick to work. In a 2015 lymedisease.org study of more than 6,000 chronic Lyme disease patients, 42% reported having to quit or cut back on work. Less than half of that number reported receiving disability at some point. Losing the ability to provide for oneself or one’s family—and in many cases having to depend on family or friends while sick—can be a real blow to a patient’s sense of self-worth. Moreover, loss of finances can negatively affect relationships. “Active and upbeat people lose the capacity to perform their jobs; athletes lose their ability to play sports for recreation or profession; the emotional turmoil within family life roils to the point of divorce or separation as the Lyme victim—and in many families, more than one person is afflicted—stresses the climate of the household with constant symptoms, financial demands, and psychological changes that boomerang throughout both immediate family and extended relationships,” [iv] write Denise Lang and Kenneth Leigner, M.D. in their book Coping With Lyme Disease: A Practical Guide to Dealing with Diagnosis and Treatment.

In spite of the bleak reality of the costs of Lyme disease, there are resources available to help alleviate the burden. Many foundations offer financial assistance for people with Lyme disease. For example, the Lymelight Foundation provides grants for treatment and medication for people up to 25 years of age, while Ride Out Lyme and Ticked Off Foundation provide grants for adults ages 26 and older. And those are just a few of the many resources available; check out GLA’s detailed list. Lyme is expensive, but help is available!

[i] Bobe, Jutras, B. L., Horn, E. J., Embers, M. E., Bailey, A., Moritz, R. L., Zhang, Y., Soloski, M. J., Ostfeld, R. S., Marconi, R. T., Aucott, J., Ma’ayan, A., Keesing, F., Lewis, K., Ben Mamoun, C., Rebman, A. W., McClune, M. E., Breitschwerdt, E. B., Reddy, P. J., … Fallon, B. A. (2021). Recent Progress in Lyme Disease and Remaining Challenges. Frontiers in Medicine8, 666554–666554. https://doi.org/10.3389/fmed.2021.666554

[ii] https://publichealth.jhu.edu/2015/lyme-disease-costs-more-than-one-billion-dollars-per-year-to-treat-study-finds

[iii] Zhang, X., et al., Economic impact of Lyme disease. Emerg Infect Dis, 2006. 12(4): p. 653-60

[iv] Lang, Denise with Liegner, Kenneth, M.D. Coping with Lyme Disease: A Practical Guide to Dealing with Diagnosis and Treatment. New York: Henry Holt and Company, 2004 (21-22).

Global Lyme Alliance
Admin at Global Lyme Alliance

Global Lyme Alliance

Email: info@globallymealliance.org

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**Comment**

Digging back a number of years, I estimated we were spending approximately $15K per person per year for Lyme/MSIDS treatment. I’m sure it’s increased by now. We only tested once so saved money on testing.  We also utilized mainly antibiotics which are fairly inexpensive as a rule.  I also planned ahead and used Canadian pharmacies which are much cheaper for the more expensive drugs.  You need to allot about a month when you do this as the drugs often come from India and take longer to get.  Herbal treatments (which we’ve also used) are approximately $280-$300 per month unless you buy the ground herbs in bulk and either swig them down or make your own capsules.  So “natural” options aren’t cheaper.  We also used IV blood ozone ($100-$170 per time) and required many supplements (and still do). 

For more:

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.

Time for every number on the CDC website to be adjusted.

Lyme Disease Call to Action

https://www.truthcures.org/post/call-to-action

Call to Action

By Laura Hovind, TRUTHCURES

Are you looking for a way you can help spread Lyme disease awareness this month? Look no further!

TRUTHCURES has made significant progress in proving that Lyme diagnostics have not been valid for 27 years. This has caused immense suffering due to missed diagnoses and denial of care. We met with FDA investigators in person on October 18, 2021. We told them they have a responsibility to protect the public by recalling every Lyme disease test currently on the market by way of FDA clearance.

The FDA has confirmed there is an open investigation but they are withholding all other information. Therefore we have asked our U.S. Senators for assistance. The most likely path forward is a hearing of the Senate Health, Education, Labor & Pensions (HELP) Committee. Support among the other members, and especially the Committee Chair (Patty Murray-WA) and Ranking Member (Richard Burr-NC) is critical to obtain a hearing.

If you are a constituent of any of the Senate HELP Committee members, please contact them immediately. See the list here, and click through for their contact information.

Tell them:
  • I am requesting Senator _______’s support for a HELP Committee hearing on faulty Lyme disease diagnostics. The issue has been forwarded to the Committee by Senator Ed Markey’s office, and Senator Roger Marshall’s office can provide details.

  • The FDA last October was given data proving that there is not a single valid FDA-cleared Lyme disease test. There hasn’t been one for 27 years because the diagnostic standard was manipulated by corporate interests and then perpetuated by the FDA’s 510(k) clearance pathway. Refer to our press release and feel free to forward it. Six months after our meeting the FDA is supposedly investigating but has done nothing to rectify the problem, and seem to be withholding information. Meanwhile, we are kicking off another horrendous tick season.

  • If you need guidance, additional information, or our contact info to pass along, please email Laura at truth@truthcures.org. I am happy to speak with your elected representatives and their staffers if they would like firsthand information. We can also connect them with our Senators’ staffers who are working on this issue.

Thank you, and happy May!

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**Comment**

Senator Tammy Baldwin is on this committee representing Wisconsin. 

For more on testing:

Kids, Hepatitis, & COVID Shots: Is There a Connection?

http://  Approx. 15 Min

April 26, 2022

Hepatitis Hell: 111 Known Cases of Sudden Onset Hepatitis in Children

Retired Consultant Pediatrician Dr Ros Jones joins Mark Steyn to discuss the sudden rise in hepatitis in children.  The reports are 4 times the normal rate.  Steyn states the number is 114 while the video states it is 111.

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This recent report states:

Over 100 cases of pediatric hepatitis of unknown cause are under investigation in 25 states, and five children in the U.S. have died in the past seven months from the condition, CDC researchers said on Friday.

Cases were severe:  over 90% were hospitalized, and 14% required liver transplants.  Adenovirus was detected in more than half of the cases and remains suspect.

https://childrenshealthdefense.org/defender/kids-hepatitis-covid-shots-cola

Kids, Hepatitis and COVID-19 Shots: Is There a Connection?

As of April 8, health officials reported 74 unexplained cases of severe hepatitis in children up to 10 years old. Researchers found COVID-19 vaccines trigger innate immune suppression that could cause liver disease, but it’s unclear if the children with hepatitis received the vaccine.

Story at a glance:

  • As of April 8, 74 cases of severe hepatitis that health officials can’t explain have been reported in children up to 10 years old.
  • In October 2021, a case report involving a 47-year-old, previously healthy man demonstrated conclusive evidence that COVID-19 shots may trigger hepatitis.
  • A Journal of Hepatology paper noted that seven additional cases of suspected immune-mediated hepatitis were reported following COVID-19 shots.
  • Researchers have uncovered innate immune suppression triggered by COVID-19 shots and other disturbances that could cause liver disease.
  • Recently released Pfizer documents also show that in the first week after the shot, people of all ages experienced a temporary weakening of the immune system; could this increased susceptibility to infection also be playing a role in hepatitis and other cases of liver disease?

A strange outbreak of severe hepatitis in young children has been reported in the U.S. and Europe, puzzling public health officials. The children were tested for common hepatitis viruses, but they were not to blame, leaving the cause unknown.

In a news release, Graham Cooke, a professor of infectious diseases at Imperial College London, suggested that if the hepatitis was caused by COVID-19, “it would be surprising not to see it more widely distributed across the country given the high prevalence of (COVID-19) at the moment.”

Potential links to COVID-19 injections appear not to have been widely explored yet, even though the shots have been previously associated with the development of hepatitis. British health officials did state, however, that none of the affected children had received a COVID-19 shot.

Young children developing mysterious liver disease

In the U.S., nine children in Alabama have developed severe hepatitis, or inflammation of the liver, that health officials can’t explain. All of the children were ages 6 years and younger and were previously healthy.

Symptoms of the liver disease include diarrhea, nausea and vomiting, along with jaundice in some. Liver enzymes were also elevated.

Five of the children tested positive for adenovirus type 41, which are respiratory viruses that can cause the common cold. Health officials have suggested that adenovirus type 41 could be to blame.

But, Dr. Wes Stubblefield, district medical officer for the Alabama Department of Public Health, said, “This is unusual. This virus hasn’t, in the past, been associated with this constellation of signs, symptoms and injury.”

Others have also discounted this theory, as adenoviruses are extremely common in children, meaning that it’s quite possible they could test positive for adenoviruses without them being the cause of hepatitis.

As of April 8, 74 cases of hepatitis had been reported in children up to 10 years old. Some of the children required hospitalization and six have undergone liver transplants, but no deaths were reported as of April 11.

With the increase in cases reported over the last month, the World Health Organization (WHO) expects that more cases of the mysterious hepatitis illness will be uncovered in children. So far, laboratory testing has ruled out hepatitis type A, B, C and E viruses, along with hepatitis D where applicable.

WHO reported, “Overall, the etiology of the current hepatitis cases is still considered unknown and remains under active investigation. Laboratory testing for additional infections, chemicals and toxins is underway for the identified cases.”

COVID-19 shots may trigger hepatitis

A case report involving a 47-year-old previously healthy man demonstrates conclusive evidence that COVID-19 shots may trigger hepatitis.

“Immune-mediated hepatitis with the Moderna vaccine,” researchers wrote in the Journal of Hepatology in October 2021, “[is] no longer a coincidence but confirmed.”

The man featured in the case report received his first Moderna COVID-19 shot on April 26, 2021. Three days later, he developed malaise and jaundice, a yellowing of the skin that can occur if the liver isn’t processing red blood cells efficiently; it’s a hallmark of hepatitis, and a symptom being experienced by some of the children noted above.

The man had his liver function tested four years earlier, with tests coming back normal, and had no history of acetaminophen usage, which can cause liver damage, and only minimal alcohol usage.

Yet, three days after the shot, liver tests showed concerning results according to the Journal of Hepatology:

“Investigations on the 30th April showed serum bilirubin 190 μmol/L (normal 0-20), alanine aminotransferase (ALT) 1,048 U/L (normal 10-49), alkaline phosphatase (ALP) 229 U/L (normal 30-130) …”

By the end of June, the man’s jaundice and liver function tests improved, but then he received a second dose of the Moderna shot on July 6, 2021. Within days, the jaundice returned and liver function tests declined.

The researchers explained:

“The pattern of injury on histology was consistent with acute hepatitis, with features of autoimmune hepatitis or possible drug-induced liver injury (DILI), triggering an autoimmune-like hepatitis.

“This case illustrates immune-mediated hepatitis secondary to the Moderna vaccine, which on inadvertent re-exposure led to worsening liver injury with deranged synthetic function. This occurred in a well man with no other medical problems. The onset of jaundice associated with the mRNA vaccine was unusually rapid.”

Hepatitis cases reported following shots

The case report above isn’t an isolated one. The Journal of Hepatology paper noted that seven additional cases of suspected immune-mediated hepatitis have been reported following COVID-19 shots, including both Pfizer’s and Moderna’s.

They hope to raise awareness so that vaccination centers will routinely check for signs of immune-mediated hepatitis prior to administering second doses and state, “Long-term follow up of identified individuals will be essential in determining the prognosis of this immune-mediated liver injury.”

In a separate letter to the editor, published in the Journal of Hepatology in June 2021, researchers again raised concerns that COVID-19 shots could cause hepatitis. In this case, a 56-year-old woman developed severe autoimmune hepatitis following her first dose of Moderna’s COVID-19 shot.

Prior to this, in April 2021, researchers also described a case of autoimmune hepatitis that developed after a COVID-19 shot, this time in a 35-year-old woman who was three months postpartum. In autoimmune hepatitis, the body’s immune system mistakenly attacks the liver, causing inflammation and damage, and it’s possible the shot triggered the autoimmunity via spike-directed antibodies.

Researchers explained:

“To our knowledge, this is the first reported episode of autoimmune hepatitis developing post-COVID-19 vaccination, raising concern regarding the possibility of vaccine-induced autoimmunity. As causality cannot be proven, it is possible that this association is just coincidental.

“However, severe cases of SARS-CoV-2 infection are characterized by an autoinflammatory dysregulation that contributes to tissue damage. As the viral spike protein appears to be responsible for this, it is plausible that spike-directed antibodies induced by vaccination may also trigger autoimmune conditions in predisposed individuals.”

Is immune suppression to blame?

Researchers from Ireland noted in November 2021, “It is speculated that SARS-CoV-2 can disturb self-tolerance and trigger autoimmune responses through cross-reactivity with host cells and that the COVID-19 mRNA vaccines may trigger the same response.”

They also reported the cause of autoimmune hepatitis that developed after a COVID-19 injection in a 71-year-old woman with no risk factors for autoimmune disease.

She noticed jaundice four days after the shot and had “markedly abnormal” liver function tests. The researchers raised the possibility that this was a case of vaccine-related drug-induced liver injury and, like the other teams that reported similar cases, noted:

“These findings raise the question as to whether COVID-19 mRNA vaccination can, through activation of the innate immune system and subsequent non-specific activation of autoreactive lymphocytes, lead to the development of autoimmune diseases including AIH or trigger a drug-induced liver injury with features of AIH.

“The trigger, if any, may become more apparent over time, especially following withdrawal of immunosuppression. As with other autoimmune diseases associated with vaccines the causality or casualty factor will prove difficult to tease apart … But it does beg the question of whether or not these individuals should receive the second dose of an mRNA COVID-19 vaccine.”

Stephanie Seneff, a senior research scientist at the Massachusetts Institute of Technology, and colleagues have also highlighted the innate immune suppression triggered by COVID-19 shots.

The mRNA COVID-19 shots teach the body’s cells to produce a protein, or piece of protein, that triggers an immune response, including the production of antibodies. However, because natural mRNA is easily broken down, this means the experimental gene therapy needs a special delivery system to make it to the body’s cells.

The shots use lipid nanoparticles that contain polyethylene glycol (PEG)17 for this purpose. The mRNA is wrapped in lipid nanoparticles that carry it to the cells, and the lipid nanoparticles are “PEGylated” — that is, chemically attached to PEG molecules to increase stability.

Usually, if you were to inject RNA into your body, enzymes would immediately break it apart, but the COVID-19 shots are specifically designed so that doesn’t happen.

As such, “mRNA vaccines promote sustained synthesis of the SARS-CoV-2 spike protein,” Seneff and colleagues wrote in Food and Chemical Toxicology.

The spike protein is not only neurotoxic but also impairs DNA repair mechanisms, while suppression of type I interferon responses results in impaired innate immunity, they explained.

COVID-19 shot disturbances could cause liver disease

Seneff’s research suggests genetic modifications introduced by COVID-19 shots may induce immune cells to release large quantities of exosomes into circulation. Exosomes are extracellular vesicles that contain protein, DNA, RNA and other constituents, and may contain mRNA along with spike protein.

According to Seneff and colleagues:

“[W]e present evidence that vaccination induces a profound impairment in type I interferon signaling, which has diverse adverse consequences to human health. Immune cells that have taken up the vaccine nanoparticles release into circulation large numbers of exosomes containing spike protein along with critical microRNAs that induce a signaling response in recipient cells at distant sites.

“We also identify potential profound disturbances in regulatory control of protein synthesis and cancer surveillance. These disturbances potentially have a causal link to neurodegenerative disease, myocarditis, immune thrombocytopenia, Bell’s palsy, liver disease, impaired adaptive immunity, impaired DNA damage response and tumorigenesis.”

In one example noted in their study, the shot appears to have caused a case of viral reactivation that led to liver failure. The case involved an 82-year-old woman who had hepatitis C (HCV) in 2007. Just days after she received a Pfizer COVID-19 shot, “a strong increase in HCV load occurred,” along with jaundice. She died from liver failure three weeks after the injection.

They also report that the release of exosomes containing microRNAs following COVID-19 shots could interfere with IRF9 synthesis, leading to reduced synthesis of sulfatide in the liver. This cascade, they believe, could represent a “plausible factor” in the multiple case reports that have found liver damage following COVID-19 shots.

When they reviewed data from the Vaccine Adverse Event Reporting System or VAERS, including symptoms that “clearly represent serious liver problems,” they identified 731 events following COVID-19 shots — representing more than 97% of cases out of all vaccines in 2021.

Pfizer documents released by the U.S. Food and Drug Administration this month must also be taken into account. Buried in one of the documents is the statement, “Clinical laboratory evaluation showed a transient decrease in lymphocytes that was observed in all age and dose groups after Dose 1, which resolved within approximately one week …”

What this means is Pfizer knew that in the first week after the shot, people of all ages experienced transient immunosuppression — or put another way, a temporary weakening of the immune system — after the first dose. Could this increased susceptibility to infection also be playing a role in hepatitis and other cases of liver disease following the shots? An investigation is warranted to find out.

Originally published by Mercola.

The views and opinions expressed in this article are those of the authors and do not necessarily reflect the views of Children’s Health Defense.

© [4/27/22] Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.

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https://aflds.org/news/post/whats-causing-acute-pediatric-hepatitis/

What’s causing acute pediatric hepatitis?

Posted by Moshe Tokayer

May 02, 2022

Hundreds of adverse liver events reported on VAERS

There has been a spate of reports regarding pediatric hepatitis of unknown origin around the world.  According to the World Health Organization (WHO) as of April 21 “Cases have been reported in the United Kingdom of Great Britain and Northern Ireland (the United Kingdom) (114), Spain (13), Israel (12), the United States of America (9), Denmark (6), Ireland (<5), The Netherlands (4), Italy (4), Norway (2), France (2), Romania (1), and Belgium (1). . . .

“The common viruses that cause acute viral hepatitis (hepatitis viruses A, B, C, D and E) have not been detected in any of these cases.” In many but not all the cases, adenovirus type 41 was detected.  But adenovirus type 41 is not known to cause hepatitis and adenovirus type 41 presents with more mild symptoms.

The WHO article continues, “Hypotheses related to side effects from the COVID-19 vaccines are currently not supported as the vast majority of affected children did not receive COVID-19 vaccination.”

It should be noted, though, that adverse liver events are a side effect of the COVID-19 vaccines.  In fact, hundreds of adverse liver events have been reported on the Vaccine Adverse Event Reporting System (VAERS) following COVID-19 vaccinations.

There are two possibilities that, to the best of our knowledge, are not being explored.

Face Masks

It is possible that face masks are causing liver damage in children.  Consider this:

A recent report published on the Science Direct website posits that,

  • Face masks can release large numbers of nanoplastics and microsplastics
  • Mask microplastics were detected in the nasal mucus of mask wearers suggesting they can be inhaled while wearing a mask.
Image 1

In another report published on the Science Direct website, the authors conclude “that the 0.1 μm microplastic could enter hepatocytes (cells that make up 80% of the liver’s mass) from circulation and result [in] liver damage even at a low concentration.”

Studies have shown that children are more susceptible to air pollutants than adults.  “. . . children take in more air per unit body weight at a given level of exertion than do adults. When a child is exercising at maximum levels, such as during a soccer game or other sports event, they may take in 20 percent to 50 percent more air — and more air pollution — than would an adult in comparable activity.”

Spike Protein Shedding

Another possibility is unvaccinated children who are living in proximity with vaccinated adults getting vaccine side effects through a process of spike protein shedding. 

Spike protein shedding affecting the unvaccinated gained traction following thousands of reports of vaccine-free women experiencing irregular menstrual cycles after being in proximity with the vaccinated.

Dr. Lawrence Palevsky, board certified pediatrician practicing in New York said, “. . . what we’ve been seeing is a massive increase in those who’ve been given the injection of blood clotting problems, miscarriages, stillborns, infertility, stroke, heart attack, autoimmune diseases, and death, just to name a few, and that’s in those who been injected.  So certainly there should be a suspicion when you see people around the injected people who have not been injected getting the typical symptoms of COVID in addition to miscarriages, bleeding, irregular menstrual cycles; it should raise a very, very strong suspicion.”  Dr. Palavsky continued, “. . . what we’re seeing is women who are around others who’ve been injected are having the same experience [miscarriages and stillbirths], which has to raise the suspicion that not only does that messenger RNA make the body produce spike protein on an ongoing basis, but that spike protein is probably shedding out of the breath of saliva, the skin . . .”

In a position statement, America’s Frontline Doctors wrote, “Worldwide cases of pericarditis, shingles, pneumonia, blood clots in the extremities and brain, Bell’s Palsy, vaginal bleeding, and miscarriages have been reported in persons who are near persons who have been vaccinated.”

So, it is possible that we are seeing vaccine-caused adverse events in unvaccinated children living with vaccinated parents.

All possible causes of the unprecedented outbreak of acute hepatitis in otherwise healthy children need to be further explored instead of just those that are “politically correct”.

https://mobile.twitter.com/JamesMelville/status/1518478733958647808

Watch Justin Trudeau broadcast to four year olds in Canada:

“You’re gonna be able to get your vaccine as soon as you turn five. I know you’re excited, I know you’re eager.”

Smarmy, creepy and disturbingly manipulative in equal measure, but not more so than the fact our government has paid the media $1 BILLION to promote COVID shots, and this Pfizer ad directed at kids claiming those that children in the ‘vaccine’ trials are “super heroes”:  

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Please also read about why they want shots mandated for children.

News Cycle to Shock and Distract You From What’s Important: FDA Decision on COVID Shots For Kids & The Great Reset

https://rumble.com/v136kzm-the-ultimate-goal-of-the-great-reset-is-one-world-government-dr.-reiner-fue  Video Here (Approx. 2 Min)  May 1, 2022

The Ultimate Goal of The Great Reset Is ‘One World Government’ – Dr. Reiner Fuellmich

Dr. Reiner Fuellmich describes the ultimate goal of the Great Reset is “keeping us in panic mode for as long as it takes to install this one world government”. This will be achieved through the United Nations, under complete control by the World Economic Forum, a creation of Klaus Schwab. Feullmich argues that causing “as much chaos as possible” is part of the method to influence mass obedience.

For more:

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https://popularrationalism.substack.com/p/the-news-cycles-to-shock-and-distract

The News Cycles to Shock and Distract You. Why You Need to Stay Hyperfocused on FDA for One Month. This Month.

As FDA works with Pfizer/Moderna to Find Excuses to Approve of COVID-19 Vaccines for Kids Under 5 (An Impossible Task) we are about to be peppered with distracting news stories designed to distract

One month ago, I emailed close associates inviting them to join an FDA Watchdog Group bent on keeping a laser-beam-like focus on the FDA as it moves toward reconsidering approval of COVID-19 vaccines for kids under 5 years of age.

I predicted that the news cycles would be peppered with jaw-dropping distracting headlines.

Today’s is “In a stunning breach of confidentiality and secrecy, Politico obtained what it calls a draft of a majority opinion that would strike down Roe v. Wade” (CNN).

IMPORTANT CONNECTION NEXT PARAGRAPH

Don’t be distracted. Stay on focus: The move to approve COVID-19 vaccines for kids under 5 is necessary for the states to begin to mandate COVID-19 vaccines, and then all vaccines, for all children under the age of 5 – before parents begin comparing notes on vaccines for school entry.

FDA postponed the decision given insufficient (unconvincing) data. But there cannot be any convincing new data that shows individual benefit for kids under five from the COVID-19 vaccines… they do not stop transmission; under any reality-based analysis, vaccines do not stop COVID-19; kids do not get COVID-19 or die from COVID-19.

What type of evidence of individual benefit could Pfizer/Moderna/FDA cook up in two months’ time?
  • Will they show that individual children have decreased risk of death from COVID-19?
    • No, the vaccines being studied are targeting an extinct virus.
  • Will they show that Will they show that individual children have decreased risk of hospitalization from COVID-19?
    • No.
  • Will they show decreased transmission in this population?
    • No, Dr. Fantini’s results show INCREASED transmission due to vaccination against Wuhan-1 since the emergence of Beta, Gamma, Delta and Omicron.

The FDA will be able show data on antibodies. Period. Antibodies against an extinct variant, Wuhan-1.

  • The participants in the study will likely not be screened for prior immunity to COVID-19 from either natural infection, or from prior infection to viruses that confer cross-protection.
  • And the study will be adjusted for outcomes-related confounders, if necessary (p-hacking).
And we know that antibodies do not tell the full story.

Students in my Immunology course have created a visually stunning, fact-filled fact sheet showing that antibodies do not tell the entire story of our immune response to COVID-19 or to COVID-19 vaccines.

To sign up to receive information about the Fact Sheet, and how to interact with IPAK-EDU to have information sheets made for your organization, email info@ipak-edu.org subject line “Fact Sheet Zoom Meeting”.

I’m still unable to Tweet due to my sharing of Dr. Fantini’s results. That information is too dangerous. So please share this post everywhere on social media and have an impact.

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The Discussion section of Fantini’s work states:

“Given the global scale and magnitude of the ongoing pandemic, including case reports of reinfection, it is clear that viral evolution will continue.”

Sign and send a petition to your governor to protect children from federal agencies & catastrophic COVID shots.

For more: