Questions Regarding Lipid Nanoparticle Delivery of mRNA
When COVID first became evident in early 2020, a lot of us were scrambling around using what we had learned to handle cases the best way we knew how. I got the virus in late January (thought it was the flu), had the fever, wheezing, and felt like hell for over a week. By March, everyone was in a full-blown panic, grotesquely encouraged by every doctor who could find a TV camera. I expressed my disdain then, and haven’t backed off, even when respondents on this site were scandalized that I was making fun of mass masking, as I still do. Before some of you pearl owners start clutching, know that I am not an idiot COVID denier. I lost patients, lost a colleague that I had worked with for over a decade, and lost my favorite family member, all to that virus. The mRNA “vaccines” rolled out, we had a rough Delta Summer, and my naturally-earned immunity sailed me through it despite having it coughed in my face every day. By Fall, 2021 I was starting to send my CV to various telehealth companies for fear that I would lose my position for refusing to comply with the antiscientific, and in my view, dangerous CMS jab mandate. To this day I am grateful that I hung tough, grateful that my significant other supported me, grateful that I had already had the virus, and grateful that I had just enough medical training to be very skeptical of a new treatment.
Okay, full-disclosure time: In the volume press of first-year med school, I struggled with biochemistry, and had to get a classmate of mine who actually had a PhD in same to help me. I passed, but didn’t win any medals. By Spring, 2021 I was online and downloading basic biochemistry training apps to relearn the basics of RNA and DNA mechanics, because I never, ever used that stuff. I wanted to know how the new shot worked, and I was a little worried about the mechanism of action. By tricking cells to express a spike protein on their surfaces, you are by definition inviting cytotoxicity. Of course, the mechanism would rapidly run its course, and turn itself off, leaving an insignificantly few cells sacrificed to gain immunity. But what if it didn’t turn off? What if somehow this led to auto-immune complications? It was enough for this naturally immunized cat to avoid the risk.
Robert Malone, MD, MS helped to develop the mRNA/lipid nanoparticle technology on which the COVID “vaccine” is based. He has been excoriated by the usual establishment suspects as being a crank, a fraud, ignorant, and a vax denier. Read up on him, and judge for yourself. I follow him on Substack, and his latest piece deserves your consideration. Rather than regurgitating what he has published, I will give a bullet summary, but I strongly encourage you to read, and share this essay with colleagues and lay people, and discuss. Make up your own mind.
Lipid Nanoparticles and mRNA Shots
Did You Take Them Without Knowing What Was in Them?
David Gortler, Robert Malone
- “ …haste and the associated regulatory compromises enabled by lax EUA requirements yielded products with high rates of avoidable existing and emerging treatment-associated serious adverse events including hospitalizations, permanent disabilities and deaths…”
- This rush “resulted in avoidable damage to both public trust in government and regulatory authority integrity.”
- A good explanation of what “nanotechnology” does and does not entail, and why using it for an inoculation is both “Novel and Experimental.” Particularly, a good lay explanation as to what a “self-assembling lipid nanoparticle” actually is, and some of the quality control pitfalls that might be expected.
- A VERY important explanation as to the lack of product consistency, and the failure of the FDA to either demand or disclose such.
- “RNA biologicals, and relatively unpredictable and non-homogeneous self-assembling components” have been given en masse (mandated?), yet it is unknown whether “there is relevant expertise within the FDA. These pharmaceuticals have no natural analogs.”
- A good explanation of electrical charging as a method of cell targeting, and how lipid nanoparticles (LNP) could be introduced into a cell.
“Most Basic FDA Structure/Dosage Information Lacking” This one made me take notice. “The actual the dose/number of mRNA strands per injection hasn’t been provided by manufacturers or the FDA.” Given the high potential for LNP structural variation and aggregation, different inoculations could contain significantly different amounts of mRNA. Don’t know about you, but that seems kind of important. Months after the shot was released, the package insert was published, saying, ““Each 0.3 mL dose … contains 30 mcg of a nucleoside-modified messenger RNA (mRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2.” More practically, if I read Dr. Malone correctly, neither the pharmacist nor the physician actually knows how much of the mRNA is in that dose, or in what form(s) it exists. Shouldn’t that have been pretty important to an FDA that was not a captive organization of Pfizer, Moderna, and Fauci?
- “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.”
- Despite a judge’s order, it may be as long as two more years before we can see the data on “LNP safety, LNP configurations, mRNA LNP binding sites, the actual mRNA strands or milligram/LNP quantity and sequence per 0.3mL injection.” Why not full disclosure yesterday??
- “The current labeling additionally doesn’t specify pharmacologically/toxicologically active versus inactive ingredients, and genotoxicity and carcinogenicity studies have yet to be done.” Because emergency, y’know.
“LNP Standalone Safety/Toxicity in mRNA Shots Have Never Been FDA Tested” Either Malone is a liar with less credibility than the latest booster, or this is beyond troubling. “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?”
Again, please read this, chew on it, pass it around. It is devoid of politics, as I hope this column has been. If you have an opposing view, or find error AFTER reading Gortler’s essay, I hope you will share it on this site. Physicians who see patients, recommend treatments, and speak publicly have the obligation to know what they are talking about.
Thanks for the response Bill. Do we believe the million deaths were “from” or “with”? To date I don’t think we really have a refined morality or case fatality rate.
Pat, I compared flu and covid early on. Covid is single strand +RNA or equivalent to mRNA so can be expressed as protein directly. Flu is also single stranded but -RNA. Both must package a viral RNA-dependent-RNA polymerase to replicate and flu needs this to make mRNA, There is a eukaryotic defence against double stranded RNA called PTGS – a sort of RNA immunity with memory. PTGS is another possile avenue for immunizartion and many ther things but is not yet ready. The alternative was an adenovirus vaccine infecting cells and expressing the covid antigen but there were some issues probably associated with previous virus exposure. None of the protein based covid vaccines (used for fllu for example) made it to prime time here. PTGS is present but some viruses express an inhibitor so can overcome bodily defenses. Virus infection expression also leads to a protein based immune response but you get all the proteind expressed so immunity may not be as targeted as a single exposure. FYI I came by this honestly but only be reading up. Seems the current RNA vaccines are the lowest possible exposure method and most targeted. They cannot replicate ot become DNA and incorporate into the cell. That said, this was a venture capital reasearch effort until suddenly it wasn’t.
Great info, and I really appreciate your response. There are many reports of vaccine contamination with varying amounts of DNA, and spike proteins expressed in tissues very distant from the injection site. Are these bogus, or real? I think we should all cheer honest skepticism and inquiry from any direction.
Got the latest mRNA booster yesterday! Thank goodness for Pfizer, the FDA, and all the scientists involved in mRNA vaccine technology. After a million deaths in the US it still boggles my mind that there should be skepticism over a vaccine.