From Malone's Substack:
in the FDA’s Guidance for Industry: “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology” does not mention “lipids” anywhere within its text. While lipids are a common component in multiple pharmacological preparations, this seems to be the first market authorized vaccine product with bioengineered lipid nanoparticles.
It should have been obvious to mRNA manufacturers and/or the FDA that both LNPs and liposomes can be highly and similarly programmable to target specific cell receptors, and that LNPs should have been subject to special attention and testing for safety prior to their extensive implementation. Yet, it remains unknown if any such safety tests occurred during “warp speed” development, followed by the aforementioned profanely lucrative mRNA injection rollout.
“Safe and Effective?” LNPs and Spike Proteins and Life-Threatening Inflammatory-Related Adverse Events
Several studies have shown that spike proteins from either the mRNA shots or infection are toxic in a dose-dependent manner. The mRNA injections can turn one’s own cells into manufacturing machines compulsively replicating just the toxic engineered SARS-CoV-2 spike protein at a potentially greater rate than what would be via a community acquired COVID infection. While a healthy immune system will build antibodies and fight SARS-CoV-2 viral particles, attenuating replication, an mRNA injection has the potential to produce more coronavirus spike proteins, and at a higher rate, depending on the number/load of mRNA strands in the “vaccine” injection. As of now, we still don’t have transparency on the number of mRNA strands in a single injection or lot-to-lot variability.
In addition to the independent toxicity of spike proteins, there is a history showing that certain LNPs by themselves have independent toxicity and are known to activate the complement (inflammatory) system. In fact, Dr. Robert Malone, the inventor of mRNA delivery in animal models has written about how he was never able to overcome toxicity of any lipid-based delivery mRNA or DNA, eventually shuttering lipids as a delivery vehicle – and that was back in the 1990s. Was the FDA not aware of that history?