A healthy 74-year-old man died from toxic shock syndrome during Moderna’s Phase 1/2 clinical trial of its experimental mRNA-1018 pandemic influenza vaccine, according to a study published in April in Clinical Infectious Diseases by scientists from Moderna and collaborating institutions.
The Moderna and collaborating scientists claim the death was unrelated to the Moderna shot, but without explaining how that determination was made.
The findings come as Moderna advances its mRNA-1018 pandemic bird flu vaccine with up to $54.3 million in support from the Bill Gates-backed Coalition for Epidemic Preparedness Innovations (CEPI), after the U.S. Department of Health and Human Services terminated its previous funding for the program.
A January 2023 Nature Reviews Drug Discovery paper co-authored by Moderna scientists bluntly admits that avoiding “unacceptable toxicity” in mRNA vaccines remains a major challenge, warning that “lipid nanoparticle structural components, production methods, route of administration and proteins produced from complexed mRNAs all present toxicity concerns” and that the way these vaccines spread through the body can cause harm due to “cell tropism and tissue distribution… and their possible reactogenicity.”
Moderna submitted data in November 2017 proving their mRNA vaccine lipid nanoparticles (LNPs) accumulate in mammalian liver, spleen, plasma (blood), kidneys, heart, and lungs.
Toxic shock syndrome is typically attributed to toxins produced by certain bacterial infections, but the paper provides too little clinical information to independently assess whether another mechanism, like LNPs or vaccine-induced immune system damage, may have contributed to the participant’s death.
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