The toxicity risks include “lipid nanoparticle structural components, production methods, route of administration and proteins produced from complexed mRNAs,” the authors of the paper wrote.

Authors of the paper include Moderna employees Eric Jacquinet and Dimitrios Bitounis and Maximillian Rogers, who was working at Moderna when the paper was being done.

Moderna didn’t respond to a request for comment.

The mRNA vaccines have multiple known side effects, including heart inflammation and severe allergic shock. Those may stem from hypersensitivity reactions, which can be elicited by “any LNP-mRNA component” but are most likely triggered by PEGlyated lipid nanoparticles, which is “the most potentially reactogenic component,” according to the scientists.

Polyethylene glycol, or PEG, an ingredient in the Pfizer and Moderna COVID-19 vaccines, is known to cause allergic reactions. Outside scientists are divided over the mechanism behind the heart inflammation, while Pfizer has posited that the LNPs are behind the issue.

The new paper drew from prior publications and other data. The authors didn’t carry out any new experiments.

Some of the papers cited included those that have found mRNA and the spike protein delivered by Moderna’s vaccine in various parts of human beings weeks or months after vaccination, despite health officials claiming when the vaccines were rolled out that such materials would exit the body within days.

The scientists said that Moderna’s COVID-19 vaccine is “safe and effective” and hailed the development of an updated vaccine as “[demonstrating] the rapid timeline for modifications with mRNA technology in the clinic.” Due to the “transient nature of mRNA,” however, “repeat administration may be necessary,” they said.

The scientists later noted that reducing risks of toxicities with mRNA-based vaccines and drugs is necessary but “complicated.” That can be accomplished through a multipronged approach that includes advanced testing in laboratories and adjusts preclinical, animal trials to better account for “differences in human and animal physiology.”

Moderna and other companies are currently testing a number of new mRNA products, including influenza vaccines and cancer treatments.

“Thanks to the mRNA platform we built, we have an exciting pipeline, with up to 15 launches in the next five years,” Stephane Bancel, Moderna’s CEO, told investors in the company’s most recent earnings call.

The paper’s corresponding author, Mansoor Amiji of Northeastern University’s Departments of Pharmaceutical Sciences and Chemical Engineering, referred a request for comment to Mr. Bitounis, who didn’t provide any answers.

Dr. Malone Reacts

Dr. Robert Malone, who helped invent the mRNA technology, said the paper downplayed the range of risks that have been linked to the mRNA-based vaccines and may be part of a limited hangout, or a propaganda technique.

That technique, a form of misdirection, involves people offering some information to obscure or prevent the discovery of other information.

“My most generous interpretation of the overall intent of the article is that this article summarizes and represents information concerning risks and toxicities of this platform technology which Moderna wishes to have disclosed in a manner which puts the firm, its activities and the underlying platform technology in the best possible light,” Dr. Malone, who wasn’t involved with the paper, wrote in his review.

“A less generous interpretation of intent is that this article represents a subtle form of propaganda strategy commonly referred to as a limited hangout.”

 

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