Questioning Lipid Nanoparticles

 Since there isn’t a good article which 1) scientifically, 2) clinically and 3) regulatorily address Lipid Nanoparticles (LNPs) and the FDA’s role in assuring and regulating novel technologies and ingredients, I am writing one.

In addition to often discussed spike proteins, there is a published history describing LNPs by themselves as having independent toxicity and studies showing that nanoparticles have the potential to independently activate the complement system.

Because novel nano-biotechnology is being used, and has been shown in studies to have independent clinical effects, should the LNPs combined with mRNA have been reviewed or received scrutiny as an FDA combination product? If those discussions took place, what data led to the final decision? Are LNP configurations contained in mRNA shots considered inactive components of mRNA shots? What discrete studies were conducted with the LNP component alone to establish them as inactive components? Are LNPs an un-regulated biotechnology? There appears to be a "Regulatory void" in FDA guidance when it comes to LNPs, excluding them from guidance oversight and specific FDA safety testing recommendations.

Could LNPs be considered biologically active via cell-targeting or other mechanisms related to the design/engineering of LNPs such as charge or ligand substrates? Were the specific LNPs employed for mRNA injections ever separately evaluated by developers for clinical or safety effects based on literature reports detailing toxicities, dating back to decades? What about those LNPs with ligand substrates?

Prior to their release under EUA, regulators seemingly neglected to examine the potential safety issues of LNPs themselves, instead implying them to be an inactive "Vehicle" or simple lipid "Just along for the ride" for mRNA delivery.

Purification, charge, substrate attachments, and size-based separation of nanoparticles varying by vial or lot are some of the things that may potentially affect LNP clinical or non-clinical activity.

LNPs are known to only have a lipid monolayer, thereby seemingly excluding LNPs from that guidance.

Since the judge's order didn't specify that any particular pages would be given priority or should be released sequentially, the most critical parts of the application, such as LNP safety, LNP configurations, mRNA LNP binding sites, the actual mRNA strands, or milligram/LNP quantity and sequence per 0.3mL injection could be the last pages to be released. 

https://brownstone.org/articles/questioning-lipid-nanoparticles/