- Moderna’s nonclinical summary contains mostly irrelevant materials.
- 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.
- 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).
- 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.
- 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.
- FDA and Moderna lied about reproductive toxicology studies in public disclosures and product labeling.