Moderna’s Non-Clinical Summary for Spikevax – Evidence of Scientific and Regulatory Fraud

Findings:

1. Moderna’s nonclinical summary contains mostly irrelevant materials.
2. Moderna claims that the active substance mRNAs of Spikevax does not need to be studied for toxicity and can be replaced with any other mRNA without further testing.
3. Moderna’s nonclinical program consisted of studies of other unapproved mRNAs, and only one non-GLP toxicology study of mRNA-1273 (active substance of SPIKEVAX).
4. There are two separate Investigational New Drug numbers for mRNA-1273: one held by Moderna, the other – by DMID (NIH), representing a serious conflict of interest.
5. Vaccine induced antibody-enhanced disease was identified as a serious risk and was not excluded by Moderna due to absence of positive control and unvalidated methods used.
6. FDA and Moderna lied about reproductive toxicology studies in public disclosures and product labeling.