What did lipid/LNP scientists and Kariko say about intramuscular injection and reaction risk when the mRNA vaccine rollout adverse reactions initiated a safety signal? What did animal studies show?
Adverse reactions were linked to the lipids (LNPs). The lipids have a 20-year history of adverse events that the consumers were not warned of. Why is our Federal government not investigating?
This article is an excerpt from my work that was sent to state AGs and other investigators this summer. The full Executive Brief with links and references starts here: The LNP Files…
N. After The mRNA Vaccines Were Approved and “Anaphylaxis” Adverse Reactions Were Seen, What Did The Pfizer LNP Experts Say? What Can be Found in the Animal and Medical Studies?: When “anaphylaxis” reactions initiated a safety signal in the Pfizer Covid-19 vaccines just after they were released to the consumers, Science magazine interviewed officials and experts in this field who spoke on the matter as seen here, “Katalin Karikó (Kariko), a senior vice president at BioNTech who co-invented the mRNA technology underlying both vaccines, says she discussed with Szebeni whether PEG in the vaccine could be an issue. (The two know each other well; both are Hungarian, and in the 1980s, Karikó taught Szebeni how to make liposomes in her lab.) They agreed that given the low amount of lipid and the intramuscular administration, the risk was negligible.”[6] “Karikó emphasizes that based on what we know so far, the risk is still low. "All vaccines carry some risk. But the benefit of the vaccine outweighs the risk," she says.[6] However, according to the medical data, these statements are missing several material aspects that are pointed out in many of the articles on nanomedicine and nano lipids that are crucial to understanding the risks in the Covid-19 mRNA vaccines as follows:
1. First-Time Use of the LNP Formulation Intramuscularly: It should be noted that this is the first time in medical history that the use of these Covid-19 mRNA therapies and these LNP shells are administered to the general human population intramuscularly. As seen in the literature pre-pandemic and post Covid-19 vaccine EUA, the use of these lipids had many unanswered questions.
2. It should also be noted that it is unclear how the Covid-19 mRNA therapies are comparable to a traditional vaccine in the safety and warning labeling: Pfizer’s Covid-19 mRNA-LNP vaccine “Comparative Safety Claims” (typically found within the “Contradictions” section of FDA drug labeling) are not provided in the FDA EUA. However, in February 2022, Pfizer provided similar drug information internally when they compared the lipids to Onpattro (an Oligonucleotide gene therapy) in their internal White Paper. [2][Also see table 4 in Pfizer’s internal White Paper reference as well where Onpattro is listed a second time in this internal paper as a “Relevant RNA Drug” to the Covid-19 mRNA-LNP vaccine LNP lipids. [2] See section [DD, AA, EE.7, 10 and 12] for comparison of Covid-19 mRNA-LNP vaccine with traditional vaccines, as seen here and below where, regarding approval for newer vaccines, the WHO indicates “traditional vaccines are not likely to be applicable to newer products”. [87] To say that all vaccines carry risks, it seems from the medical literature, the FDA and the WHO, that the risk assessment of this vaccine likely should have included warnings based on lipid carrier drugs lipid components and not solely traditional vaccines. See section [DD] for details.
3. A “safe dose” of LNPs in humans has not been established within a regulatory agency: Remembering that PEG is used in the Pfizer Covid-19 mRNA LNP formulations, the literature shows that these lipids are variable in several ways that affect safety, as seen here in the “Biomolecular Corona” study which states, “even the same LNP tested in different animals, in different patients, or in the same individual over time might acquire different coronas, with potentially important implications for LNP clearance, target tissue accumulation, and efficacy.” [72]
4. Reactions occur upon first contact: According to Szebeni in 2014 and re-iterated in 2022 by Padin- Gonzalez et al. 2022, “These non-IgE-mediated hypersensitivity reactions are known as complement activation-related pseudoallergy (CARPA), with symptoms very similar to the type I hypersensitivity reaction, though they occur upon first contact without prior exposure and lack a specific allergen, which is why it is called “pseudoallergy”…” [4][5]. CARPA reactions are known to take place due to reactions brought about by the lipids.[4][5]
5. Immediate Reactions: Considering that these reactions can take place upon first contact with these drugs, and something that has not been noted above by Kariko but is found from most of the reading on CARPA and these C- mediated reactions (IRs, pseudoallergy and anaphylactoid reactions) such as in the case of infusion lipid carrier drugs, it is seen that reactions can take place within minutes of administration. This would mean that in an infusion, a reaction takes place before a full dose of LNP formulation is administered, in other words, when a “low dose” or “low amount” of the lipid formulation is given, and the full dose is not yet administered. For infusion drugs, the first fifteen or so minutes of the dose is sometimes given at a minimal dose or lower dose than the rest of the dose, to help prevent reactions. This is the case for Onpattro, where the Onpattro FDA fact sheet states, “The diluted solution of Onpattro should be infused intravenously over approximately 80 minutes at an initial infusion rate of approximately 1 mL/min for the first 15 minutes, followed by an increase to approximately 3 mL/min for the remainder of the infusion…[3])
*For reference (and because the names of the reactions matter to human lives) from The Journal of Allergy and Clinical Immunology :
Anaphylaxis is defined as an immediate systemic reaction caused by rapid, IgE-mediated immune release of potent mediators from tissue mast cells and peripheral blood basophils. [True allergy is in this category.]
Anaphylactoid reactions are immediate systemic reactions that mimic anaphylaxis but are not caused by IgE-mediated immune responses. [Pseudo allergy brought on by complement system are in this category.]
6. American Cancer Society on immediate non-allergic hypersensitivity reactions: Further, the American cancer society and several other medical institutions and medical literature state that non allergic hypersensitivity reactions/ IRs (infusion reactions) can take place within the first few minutes of the infusion. They write, “Infusion reactions can be immediate or delayed. Immediate reactions happen within minutes of beginning to receive your infusion. Delayed reactions can happen up to a few days or weeks after receiving your infusion. Infusion reactions can be mild, moderate, or severe.” [101] IR infusion reactions or pseudo allergy (CARPA) are also brought on by the lipids, according to the FDA fact sheet for Onpattro and Doxil. [3][14]
7. Minimal amount of the lipid in the body/circulation with delayed reactions: Consider that delayed reactions that take place weeks after the infusion, (as we are shown in the animal studies for infused lipid drugs that) much of the LNP formulation would have been excreted by this timeframe and the remaining amount would be low or lower than when first administered, thus, a “low” amount of the LNP can seemingly can bring about a CARPA like non IgE mediated reaction and this should be considered.
8. Unpredictable lipids: The Onpattro FDA Fact Sheet and literature also explains these reactions can occur on the first or second infusion session. And the articles on IRs in this section also explain that CARPA and infusion reactions can also be delayed, or they can take place when the consumer is being infused, or as we see above, within the first minutes of the infusion. Several articles describe this unpredictability of the lipid reactions, including articles co-authored by Janos Szebeni (mentioned above and in the first sections). [6]
9. Szebeni- unknowns in lipid shell drugs: In 2018, Szebeni et al. stated, “Despite decades of research suggesting that the incidence of IRs depends on both pharmacodynamics and pharmacogenetics, it is largely unknown why some patients develop these reactions while others do not. The lack of uniform terminology and classification of the reactions further complicates the issue..”[9]
10. Despite the “low dose,” reactions persist: Please note that both Moderna and Pfizer Covid-19 mRNA vaccines have different amounts of LNP lipids but both vaccines saw CARPA reactions as well as Pfizer and Moderna consumers also suffered myocarditis reactions. [6][21] These reactions are of interest as CARPA reactions are attributed to the lipids in lipid drugs and the LNPs (lipids) are also looked at as a factor in Myocarditis by scientists, including Pfizer scientists in their internal White Paper. Despite the lower dose of lipid in the Pfizer vaccine, these reactions were seen in both Covid-19 mRNA-LNP vaccines. This article called “Higher Incidence of Myocarditis, Pericarditis Found After COVID-19 Vaccination,” studies the myocarditis cases in these vaccines. It states, “The analysis included 11 studies with 58,620,611 subjects in which COVID-19 vaccination correlated with an increased risk of myocarditis or pericarditis. The increased incidence of pericarditis or myocarditis was noted mainly in those who received BNT162b2 [Pfizer] and mRNA-1273 [Moderna] vaccines, and no increased risks were found in other types of COVID-19 vaccines.” [21]
11. Dose (or the amount of lipid given) may not be the issue (according to the LNP co- creator and Pfizer studies): Comparing Pfizer and Moderns Covid-19 vaccines, with one vaccine having a higher dose of lipids and one vaccine having a lower dose of lipids, but both vaccines experiencing adverse anaphylactoid reactions that are known to take place with the lipids (and that likely take place with the lipids in the myocarditis cases [2]), the dosage or amount of the lipids do not seem to be the only cause of lipid adverse reactions, according to much of the literature in this highly studied but previously little known field of science, it is often stated that the reaction to the lipids is due to the biophysical features and the body’s reaction to lipids as they circulate in the body, and this is the case for the co-developer of the Covid-19 vaccine LNPs (Peter Cullis) in his co-authored 2020 “Biomolecular Corona” study [72] this factor of the biophysical features and lipid reactions is also pointed out by Pfizer in their internal White Paper.[2]
12. A closer look at Onpattro LNP “low doses”: In the Onpattro clinical trials, it can be seen that 20.8 % of the trial participants had a reaction to the lower dose drug compared to 7.7% who had a reaction to the higher dose of the drug. [100]
Note in the first sections of the LNP Files, Onpattro is discussed as Pfizer lists Onpattro (also known as Patisiran) lipids as “similar” and relevant” lipids to the Pfizer COVID-19 mRNA vaccine lipids in their internal documents (see section 1 and 2 of The LNP Files)- in fact, the Onpattro makers are suing Pfizer due to the curious similarity of the lipids.
13. No adverse event increase with increased PK exposure: Also, see here in the Onpattro clinical trial study, where it states, “Likewise, the frequency of AEs and SAEs did not increase with increasing PK exposure to ALN‐18328, DLin‐MC3‐DMA, or PEG2000‐C‐DMG, indicating that the incidence of these events was independent of the PK concentrations of the 3 analytes. Furthermore, the lack of relationship between PK exposure and AE or SAE incidence was consistent with the similar incidence of AEs and SAEs observed in the patisiran and placebo arms of APOLLO.” [100] [Note: DLin‐MC3‐DMA and PEG2000‐C‐DMG are the lipids. PK= Pharmacokinetics. Analytes are analyzed substances (the three substances mentioned).]
14. Pfizer- immune responses to the lipids are not yet fully understood: Repeated for context, Pfizer’s 2022 internal White Paper quoted reference states, “…the immune responses to these lipids has not yet been fully understood.”[2] [See section Y for similar information and sections R for coagulation factors and more.]
15. Peter Cullis (Co-creator of the Pfizer LNPs) co-authored “Biomolecular Corona” study- once the LNPs are injected, this can trigger an immune response that can affect toxicity and more: This study states, “However, once injected in a physiological environment, NPs interact with biological components and are surrounded by a protein corona (PC). This can trigger an immune response and affect NP toxicity and targeting capabilities.” [72]
16. Covid-19 mRNA-LNP vaccine animal studies show wide distribution (outside of the arm muscle) and an absence of non-clinical reactions: The Covid-19 mRNA-LNP animal studies did not predict/detect myocarditis [2] or the anaphylaxis and anaphylaxis-like Complement reaction CARPA cases seen post-EUA authorization. [6] They also did not detect autoimmune findings. [2][91] The animal studies showed that the formulation did not stay at the site of intramuscular injection. [See item 9 below] Thus, many questions remain within the scientific community regarding safety as seen in medical journals on the subject of the lipids post Covid-19 vaccine approval. Many references on this subject are found within this document, here are a few [6][21][63][72].
More can be seen here:
17. A reminder - pre-pandemic study shows mRNA-LNP distribution varies outside of the muscle to the liver with intramuscular injection depth: Katalin Kariko also co-wrote the 2015 “Expression Kinetics” study which described how the depth of the intramuscular injection of an mRNA-LNP formulation can be altered or variable based on the depth of the needle in the muscle tissue, including how the formulation distributes. [58] This Expression Kinetics study is referenced by other scientists in medical studies on the lipids, but it was not disclosed in the Pfizer FDA EUA. See sections C and D and the diagram in section D.
18. First, a look into the Pfizer non-clinical animal studies and past studies for answers: For the reasons above, questioning the safety in the “low” amount of the lipids, and the distribution of the Pfizer Covid-19 mRNA-LNP vaccine in the body (outside of the muscle/arm as the studies show it did not stay at the site of the injection), knowing from the referenced medical studies and FDA guidelines, that biodistribution of the lipids and the findings in the animal studies provide safety data (information on where the lipids go and how long they remain in the body and more) that not only determines safety of the LNP, but also is dependent on the EUA approval of the Covid-19 mRNA-LNP vaccines; the Pfizer animal studies, findings on the animal studies and literature discussing these studies, start below. Please pay special attention to items M. N. especially M.10-19 for injection site information. [Continued in my series: The LNP Files part 3 of 10.]
Again, why are our Federal agencies not investigating?
2023 Heather Hudson
Please credit my work and link to this source if you repost any part of my work. Thank You.
Click here: Full details with references can be found in my LNP Files Series, which starts here. The alarming LNP history you haven't been shown- The LNP developer's own studies dating back 20 years: Part 1 of 10, Introduction and Executive Brief sent to lawmakers & state investigators this summer.
About the author: Many may know me from my SubStack, media appearances, or testimony. I am the mother of Cody Hudson, who has a published medical case study and was significantly vaccine-injured at age 21. My research on the COVID-19 vaccine LNP has been published and is used in investigations into the COVID-19 mRNA vaccines. I write to bring awareness to these issues as I care for Cody. Please consider contributing to support my work or to help with his medical and educational expenses. Thank you.
