Components of mRNA “Could Lead to Significant Adverse Events in One or More of Our Clinical Trials”

August 06, 2020

Components of mRNA Technology “Could Lead to Significant Adverse Events in One or More of Our Clinical Trials,” says Moderna

By the Children’s Health Defense Team

Summary:

  • mRNA vaccines undergoing Covid-19 clinical trials, including the Moderna vaccine, rely on a nanoparticle-based “carrier system” containing a synthetic chemical called polyethylene glycol (PEG).
  • The use of PEG in drugs and vaccines is increasingly controversial due to the well-documented incidence of adverse PEG-related immune reactions, including life-threatening anaphylaxis.
  • Roughly seven in ten Americans may already be sensitized to PEG, which may result in reduced efficacy of the vaccine and an increase in adverse side effects.
  • If a PEG-containing mRNA vaccine for Covid-19 gains FDA approval, the uptick in exposure to PEG will be unprecedented—and potentially disastrous.
  • Moderna documents and publications indicate that the company is well aware of safety risks associated with PEG and other aspects of its mRNA technology but is more concerned with its bottom line.

A dozen Covid-19 vaccines are undergoing clinical trials, leading a crowded field that now numbers approximately 170 candidates. Several of the U.S. contenders—Moderna, Pfizer/BioNTech and Arcturus Therapeutics—are deploying never-before-approved messenger RNA (mRNA) technology, an experimental approach designed to turn the body’s cells into viral-protein-making factories.

A key technical challenge is to get the vaccines’ bulky RNA “payload” into the cells intact—without it breaking down prior to arriving at its destination. In other words, mRNA vaccines will not work without an in-built delivery mechanism that enables the mRNA to shove its way into a cell’s cytoplasm. The chosen solution is to use trendy biotech “carrier systems” involving lipid nanoparticles (LNPs). LNPs “encapsulate the mRNA constructs to protect them from degradation and promote cellular uptake” and, additionally, rev up the immune system (a property that vaccine scientists tamely describe as LNPs’ “inherent adjuvant properties”). The LNP formulations in the three Covid-19 vaccines are also “PEGylated,” meaning that the vaccine nanoparticles are coated with a synthetic, nondegradable and increasingly controversial polymer called polyethylene glycol (PEG).

In the corporate prospectus supporting Moderna’s stock market launch in late 2018 (an initial public offering that set a record for the biotech industry), the company was frank that its technical approach has numerous risks. Specifically, Moderna acknowledged the potential for its proprietary LNPs—and PEG—to produce “systemic side effects,” particularly given the scientific literature’s documentation of these types of side effects for other LNPs. In comments not generally seen by the public, Moderna stated (p. 33):

[T]here 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 . . . or reactions to the PEG from some lipids or PEG otherwise associated with the LNP. 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. [Emphases and links added]

Far from expressing concern over clinical trial participants’ welfare, that section of the prospectus concluded that any one of these problems “could materially harm [the company’s] business, financial conditions, and prospects” […]

Via https://childrenshealthdefense.org/news/components-of-mrna-technology-could-lead-to-significant-adverse-events-in-one-or-more-of-our-clinical-trials-says-moderna/

© Aug 7 2020 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.

5 thoughts on “Components of mRNA “Could Lead to Significant Adverse Events in One or More of Our Clinical Trials”

  1. If I remember clearly there was a scandal many years ago of glycol being introduced into wine, particularly north African wine though I think Spain might have been involved as well. Glycol ( a major component of antifreeze compounds ) is seriously toxic.

    I have no idea whether PEG is as toxic as glycol, but, my immediate reaction is to see masses of red fla

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  2. I suspect, Lowell, the the response to PEC is idiosyncratic (ie just some people are extremely allergic to it). However 70% is an extremely high proportion for a severe allergy that can cause anaphylaxis (and death). I find it extremely concerning that authorities aren’t requiring animal trials, at least, for a medical intervention that is clearly very experimental.

    Like

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