How Safe Are the Nanoparticles in Moderna's Vaccine?

Both the Pfizer-BioNTech and Moderna COVID-19 vaccines are made with messenger RNA (mRNA) know-how, which works by turning your physique’s cells into veritable drug factories. The mRNA vaccines train your cells to provide a protein, or piece of protein, that triggers an immune response, together with the manufacturing of antibodies.1

However, as a result of pure mRNA is well damaged down, this implies the experimental gene remedy wants a particular supply system to make it to the physique’s cells.

Moderna and Pfizer are utilizing lipid nanoparticles that comprise polyethylene glycol (PEG)2 for this objective. The mRNA is wrapped in lipid nanoparticles (LNPs) that carry it to your cells, and the LNPs are “PEGylated” — that’s, chemically hooked up to PEG molecules to extend stability.3

This experimental mRNA gene remedy and its lipid nanoparticle-based supply system have by no means been authorized to be used in a vaccine or drug.4 This consists of Pfizer’s and Moderna’s COVID-19 vaccines, which have been solely “authorized” for emergency use by the U.S. Food and Drug Administration — not “approved.”5

Significant issues have been raised over the know-how, together with the lipid nanoparticles, and Moderna truly deserted it in 2017 after research revealed a excessive price of hostile results.

Moderna Abandoned mRNA Project in 2017

Moderna partnered with the National Institute of Allergy and Infectious Diseases (NIAID) headed by Dr. Anthony Fauci to create its COVID-19 vaccine. In February 2020, its inventory value elevated 78.1% when it introduced that its messenger RNA vaccine was prepared for medical trials,6 propelling its CEO Stéphane Bancel into the billionaire’s club.

In 2016, Bancel had talked up one other of the firm’s up-and-coming merchandise, a drug therapy for a uncommon illness referred to as Crigler-Najjar syndrome. Those with Crigler-Najjar syndrome are lacking a liver enzyme wanted to interrupt down bilirubin. Moderna’s experimental therapy used mRNA to encode for the lacking enzyme, and was encased in LNPs as the supply agent.

But, as STAT reported in 2017, the therapy was “indefinitely delayed” as a result of it “never proved safe enough to test in humans.”7 According to STAT:8

“… mRNA is a difficult know-how. Several main pharmaceutical firms have tried and deserted the thought, struggling to get mRNA into cells with out triggering nasty unwanted effects … The indefinite delay on the Crigler-Najjar venture alerts persistent and troubling security issues for any mRNA therapy that must be delivered in a number of doses …

… And for its chemists, these nanoparticles created a frightening problem: Dose too little, and you aren’t getting sufficient enzyme to have an effect on the illness; dose an excessive amount of, and the drug is simply too poisonous for sufferers … Moderna couldn’t make its remedy work, former staff and collaborators stated. The secure dose was too weak, and repeat injections of a dose robust sufficient to be efficient had troubling results on the liver in animal research.”

Moderna Says LNPs Could Trigger ‘Significant Adverse Events’

In their company prospectus9 launched in 2018 at the time of their inventory market launch, Moderna acknowledged that their LNPs carried dangers.10 They said:11

“No mRNA drug has been approved in this new potential category of medicines, and may never be approved as a result of efforts by others or us. mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new category of medicines.”

They additionally laid out the many potential dangers associated to mRNA or its LNP supply system. Among them:

  • “Gene therapies and mRNA based medicines may activate one or more immune responses against any and all components of the drug product (e.g., the mRNA or the delivery vehicle, such as a lipid nanoparticle (LNP)) as well as against the encoded protein, giving rise to potential immune reaction related adverse events.”12
  • “Most of our investigational medicines are formulated and administered in an LNP which may lead to systemic side effects related to the components of the LNP which may not have ever been tested in humans.”13
  • “While we have continued to optimize our LNPs, there can be no assurance that our LNPs will not have undesired effects. Our LNPs could contribute, in whole or in part, to one or more of the following: immune reactions, infusion reactions, complement reactions, opsonation reactions, antibody reactions including IgA, IgM, IgE or IgG or some combination thereof, or reactions to the PEG from some lipids or PEG otherwise associated with the LNP.”14
  • “Certain aspects of our investigational medicines may induce immune reactions from either the mRNA or the lipid as well as adverse reactions within liver pathways or degradation of the mRNA or the LNP, any of which could lead to significant adverse events in one or more of our clinical trials.”15

LNPs May Enter Your Brain

In a letter to Dr. Peter Marks,16 director of the FDA’s Center for Biologics Evaluation and Research, the Informed Consent Action Network (ICAN) questioned whether or not LNPs are secure, as analysis exhibits they readily enter the mind:

“A 2018 study titled Lipid Nanoparticles: A Novel Approach for Brain Targeting17 states, ‘… lipid nanoparticles are taken up readily by the brain because of their lipophilic nature. The bioacceptable and biodegradable nature of lipid nanoparticles makes them less toxic and suited for brain targeting.’ The article also states, ‘these nanostructures need to be investigated intensively to successfully reach the clinical trials stage.'”

The research’s authors advised lipid nanoparticles like these in COVID-19 vaccines could also be excellent for drug supply techniques due to their means to bypass the blood mind barrier and “reach the target site due to their small size and ability to dodge the reticular endothelial system.”18

I just lately interviewed Judy Mikovits, Ph.D., a mobile and molecular biologist, and he or she agreed that LNPs can enter the mind can contribute to pathologic neuroinflammation, probably resulting in hostile results like a number of sclerosis or ALS. Additionally, these LNPs carrying the mRNA final for lengthy intervals of time, forcing your cells to repeatedly produce the SARS-CoV-2 spike protein. I encourage you to review my article and interview with Judy.

The mRNA vaccine triggers your physique to provide antibodies towards the SARS-CoV-2 spike protein, and spike proteins in flip comprise syncytin-homologous proteins which can be important for numerous features in your physique, together with the formation of the placenta in pregnant ladies.

“Syncytin is the name given to the endogenous gamma retrovirus envelope,” Mikovits stated, “and we know if it’s expressed overtly in the body in different places … for instance, in the brain, where these lipid nanoparticles will go, then you’ve got multiple sclerosis.” She continued:

“So the expression of that gene alone enrages microglia, actually inflames, and dysregulates the communication between the mind microglia, that are important for clearing toxins and pathogens in the mind, and the communication with the astrocytes that dysregulates not solely the immune system however the endocannabinoid system …

We’ve already seen in the medical trials … a number of sclerosis as an hostile occasion, and we’re being lied to. ‘Oh, these individuals had that.’ No, they did not. And we additionally see myalgic encephalomyelitis, irritation of the mind and the spinal twine.”

A petition to the European Medicine Agency additionally referred to as for a halt to Phase 3 medical trials of Pfizer’s mRNA vaccine, in half attributable to the concern that if a lady’s immune system begins reacting towards syncytin-1, there’s the risk she might change into infertile.19

Immune Reactions Are Another Key Concern

According to ICAN in their letter to the FDA,20 the first dose of COVID-19 vaccine might prime the physique to have an immune response to LNPs, such that when the second dose is acquired, a stronger probability for hostile occasions exists:

“An article titled Side Effects and COVID-19 Vaccines: What to Expect, published by Johns Hopkins states, ‘Side effects were more frequent after the second dose in the vaccine trials.’21

This occasion is demonstrated in Exogenous nanoparticles and endogenous crystalline molecules as hazard alerts for the NLRP3 inflammasomes, which offers help that more and more inflammatory side-effects noticed in the vaccine arm of the trial are attributable to LNPs and that they worsen with repeated injection.

This elevated reactogenicity is clearly illustrated in COVID-19 Clinical Trials for each the Pfizer22 and Moderna.”23

Moderna’s report of medical security to the FDA’s Vaccines and Related Biological Products Advisory Committee additionally famous, “In Study 301, solicited local and systemic ARs [adverse reactions] were more common in participants who received mRNA-1273 compared with placebo, and systemic ARs were more common after the second injection.”24

Their information present that Grade 3 systemic hostile reactions, that are extreme sufficient to forestall each day actions, rose from 2.9% after the first dose to fifteen.7% after the second dose. Grade 4 reactions, which require emergency room visits or hospitalizations, additionally elevated, from 5 instances after the first injection to 14 instances after the second.25

At least eight individuals have additionally had extreme allergy-like reactions to Pfizer’s COVID-19 vaccine, prompting NIAID to convene a number of conferences to debate the hostile occasions with officers from Pfizer and Moderna, together with the FDA and impartial scientists.26

Many suspect the PEG discovered in each Pfizer’s and Moderna’s vaccines is likely to be the offender inflicting allergic reactions and anaphylaxis. PEG has by no means been used in an authorized vaccine, however is used in sure medication identified to trigger anaphylaxis.27 According to Robert F. Kennedy Jr., “studies show that 1 in 7 Americans28 may unknowingly be at risk of experiencing an allergic reaction to PEG.”29

He believes “everyone should be screened for anti-PEG antibodies before getting the Pfizer and Moderna vaccines,” including that “It is unconscionable that, instead, the FDA and CDC are encouraging people to go ahead and risk a life-threatening anaphylactic reaction and just assume that someone will be on hand to save them.”30

Moderna’s Vaccine Facing Legal Troubles?

It’s additionally value noting that Moderna has no authorized rights to a key patent for its vaccine supply system, and firm executives are amongst those that have dumped their stock. Both Moderna and the NIH are primarily engaged in patent infringement, as a core a part of the know-how — the LNP know-how that’s a part of the vaccine supply system — belongs to a small Canadian biotech firm referred to as Arbutus.31

Moderna sought to invalidate the patent owned by Arbutus Biopharma, however misplaced the problem at the finish of July 2020.32 After shedding the problem, Moderna stated their LNP know-how is definitely much more superior than Arbutus’ and claimed “the LNP used to make mRNA-1273, its Covid-19 vaccine candidate, is not covered by the Arbutus patent.”33

“Whatever happens on the intellectual property front, it is highly unlikely that a patent issue will get in the way of the development or distribution of a Covid-19 vaccine,” Forbes famous in July 2020.34

Indeed the vaccine has already been rolled out, however earlier than making your resolution on whether or not or to not obtain it, make certain you are knowledgeable about the many unanswered questions and dangers surrounding it, together with not solely these associated to LNPs but additionally one other important challenge often called antibody‐dependent enhancement (ADE).

What to Do if You or Someone You Know Received the Vaccine

The major motive why I wished to interview Mikovits was to seek out out her suggestions for many who selected to get the vaccine and now remorse it. Interestingly, what I discovered is that you’d use the identical methods that you’d use to deal with the precise SARS-CoV-2 an infection.

I’ve written many articles over the previous 12 months detailing easy methods to enhance your immune system, and with a wholesome immune system, you may get via it with out incident even when you find yourself getting sick. Below, I’ll summarize a few of the methods you should use each to forestall COVID-19 and tackle any unwanted effects it’s possible you’ll encounter from the vaccine.

First of all, you may need to eat a “clean,” ideally natural eating regimen. Avoid processed meals of every kind, as they’re loaded with damaging omega-6 linoleic acid that wrecks your mitochondrial operate. Also think about dietary ketosis and time-restricted consuming, each of which can show you how to optimize your metabolic equipment and mitochondrial operate. As famous by Mikovits:

“We have to think about detoxing metal, we have to think about glyphosate … We have to prevent inflammation in all tissue sites and we have to keep our immune system healthy … You’re going to want to be burning ketones instead [of sugar] for the neuroinflammation, so you’re going to want to get into ketosis and take the stress off the mTOR pathway.”

With regard to glyphosate, a easy option to block glyphosate uptake is to take glycine. Approximately 3 grams, about half a teaspoon, just a few occasions a day ought to be ample, together with an natural eating regimen, so that you simply’re not including extra glyphosate with every meal.

To enhance cleansing, I like to recommend activating your pure glutathione manufacturing with molecular hydrogen tablets. All of those methods ought to assist enhance your resilience towards SARS-CoV-2, and will even assist your physique detoxify should you’ve made the mistake of getting this experimental gene remedy.

Another useful technique is to keep up a impartial pH. You need your pH to be proper round 7, which you’ll be able to measure with a reasonable urine strip.

The decrease your pH, the extra acidic you might be. A easy option to elevate your pH if it is too acidic (and most of the people are) is to take one-fourth teaspoon of sodium bicarbonate (baking soda) or potassium bicarbonate in water just a few occasions a day. Improving your pH will enhance the resiliency of your immune system and scale back the mineral loss out of your bones, thereby lowering your danger of osteoporosis.

Helpful Supplements

Nutritional supplementation will also be useful. Among the most vital are:

Vitamin D Vitamin D dietary supplements are available and one among the least costly dietary supplements on the market. All issues thought of, vitamin D optimization is probably going the best and most useful technique that anybody can do to reduce their danger of COVID-19 and different infections, and might strengthen your immune system in a matter of some weeks.

N-acetylcysteine (NAC) NAC is a precursor to lowered glutathione, which seems to play a vital position in COVID-19. According to at least one literature evaluation,35 glutathione deficiency may very well be related to COVID-19 severity, main the writer to conclude that NAC could also be helpful each for its prevention and therapy.

Zinc Zinc performs an important position in your immune system’s means to keep at bay viral infections. Like vitamin D, zinc helps regulate your immune operate36 — and a mix of zinc with a zinc ionophore, like hydroxychloroquine or quercetin, was in 2010 proven to inhibit SARS coronavirus in vitro. In cell tradition, it additionally blocked viral replication inside minutes.37 Importantly, zinc deficiency has been proven to impair immune operate.38

Melatonin Boosts immune operate in quite a lot of methods and helps quell irritation. Melatonin might also stop SARS-CoV-2 an infection by recharging glutathione39 and enhancing vitamin D synthesis, amongst different issues.

Vitamin C Quite a lot of research have proven vitamin C will be very useful in the therapy of viral diseases, sepsis and ARDS,40 all of that are relevant to COVID-19. Its primary properties embody anti-inflammatory, immunomodulatory, antioxidant, antithrombotic and antiviral actions. At excessive doses, it truly acts as an antiviral drug, actively inactivating viruses. Vitamin C additionally works synergistically with quercetin.41

Quercetin A strong immune booster and broad-spectrum antiviral, quercetin was initially discovered to supply broad-spectrum safety towards SARS coronavirus in the aftermath of the 2003 SARS epidemic,42,43,44 and proof suggests it might be helpful for the prevention and therapy of SARS-CoV-2 as nicely.

B vitamins B nutritional vitamins may also affect a number of COVID-19-specific illness processes, together with45 viral replication and invasion, cytokine storm induction, adaptive immunity and hypercoagulability.

Mikovits additionally recommends Type 1 interferons.

“The kind 1 [interferon] — the major supply of interferon, alpha and beta — is the plasmacyte dendritic cell. We know that is dysregulated in individuals with HIV, with XMRVs, with aberrant retroviral expression. Those individuals cannot make interferon.

Type 1 interferons will be offered in a sprig that you may spray immediately into your throat, your nostril, and that gives you the safety you want in order that the virus would not [replicate]. It degrades it straight away … Should you’re feeling cough or fever, headache, instantly up your Type 1 interferon. Take a few sprays of that per day prophylactically as nicely, and that can hold the viral load down.

We know [SARS-CoV-2] is not a pure virus, we all know that is lab-created, but it surely’ll calm the expression, it will degrade the RNA for many who cannot degrade the RNA, and that is the job of Type 1 interferon — to have your macrophages be these little Pac-Men that merely degrade the RNA.”

Nebulized Peroxide — My Favorite Treatment Choice

My private alternative for the therapy of COVID-19 signs is nebulized peroxide. It’s a house treatment I like to recommend everybody familiarize themselves with, as in many instances it will probably enhance signs in mere hours. You may also use it as a preventive technique if you recognize you’ve got been uncovered to somebody who’s ailing.

Nebulizing hydrogen peroxide into your sinuses, throat and lungs is a straightforward, simple option to increase your physique’s pure expression of hydrogen peroxide to fight infections and can be utilized each prophylactically after identified publicity to COVID-19 and as a therapy for delicate, average and even extreme sickness.

Dr. David Brownstein, who has efficiently handled over 100 COVID-19 sufferers with nebulized peroxide, printed a case paper46 about this therapy in the July 2020 challenge of Science, Public Health Policy and The Law. He additionally opinions its advantages in “How Nebulized Peroxide Helps Against Respiratory Infections.”

Nebulized hydrogen peroxide is extraordinarily secure, and all you want is a desktop nebulizer and food-grade hydrogen peroxide, which you may have to dilute with saline to 0.1% power. I like to recommend shopping for these things beforehand so that you’ve all the things you want and might start therapy at residence at the first indicators of a respiratory an infection.

peroxide dilution charts

In the video above, I am going over the fundamentals of this therapy. Be certain to purchase a nebulizer that plugs into {an electrical} outlet, as battery-driven ones are too low-powered to be actually efficient. Also ensure that your nebulizer comes with a face masks, not only a mouth piece. If it would not include a face masks, you possibly can decide one up individually. Just search Amazon for “nebulizer face mask for adults.”


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