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

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.

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in recent years, however, PEG has come under increasing scrutiny. Investigators who once assumed that the polymer was largely “inert” are now questioning its biocompatibility and warning about PEGylated particles’ promotion of tumor growth and adverse immune responses that include “probably underdiagnosed” life-threatening anaphylaxis (also called hypersensitivity).

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PEG-specific immune responses can actually reduce the efficacy of PEG-containing therapeutics. It must have worried many in the pharmaceutical industry when a 2016 study in Analytical Chemistry reported detectable and sometimes high levels of anti-PEG antibodies (including first-line-of-defense IgM antibodies and later-stage IgG antibodies) in approximately 72% of contemporary human samples and about 56% of historical specimens from the 1970s through the 1990s. The researchers confessed that the results were entirely unexpected. They also confirmed that sensitization to PEG could be induced through exposure to PEGylated drugs or could be “pre-existing” in individuals never treated with PEGylated drugs but “most likely . . . exposed to PEG through other means.”

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The population’s increased exposure to PEG-containing products makes it “natural to assume” that anti-PEG antibodies will continue to be both widespread and “inevitable.” However, if one of the PEGylated mRNA vaccines for Covid-19 gains FDA approval, the uptick in exposure to PEG will be unprecedented—and potentially disastrous.

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