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

By Children's Health Defense Team

6th August 2020

As the race to find a vaccine gathers pace, this report from "Children's Health Defence" highlights some of the challenges involved.

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).

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