Shedding Part 4 - Evidence of Placental and Breast Milk Transmission of Covid mRNA Vaccine Components

The first three posts ( Part 1 , Part 2 , Part 3 ) in this series provided evidence of the following:
 The FDA and the EMA define the mRNA vaccines as gene therapies.

 The FDA requires that gene therapy products undergo human shedding studies given the known risks of shedding

 One nanoparticle gene therapy (Luxterna), already on the market, warns that the product can be excreted in tears and nasal discharge

 All three vaccine components (mrNA, the lipid nanoparticle, and the spike protein) distribute widely in the human body (contrary to promises of remaining localized in the arm) and for prolonged periods.

 Numerous studies have demonstrated that synthetic LNP’s containing genetic material or drugs can be absorbed by various routes including intranasal, transcutaneous, transfollicular, transdermal and inhalation via the lungs.

 LNPs retain their biologic activity after being absorbed no matter what route is used.

 Now we will move towards assembling evidence of transmission of Covid mRNA vaccine components which then cause illness in others.
 The title of this review paper is concerning: “Toxicity of Nanoparticles on the Reproductive System in Animal Models: A Review.” This paragraph raises serious questions:
 Nanoparticles (NPs) are associated with different disorders in animals, including pulmonary injury, hepatotoxicity, immuno-nanotoxicity neurotoxicity, renal toxicity, and irreversible testis damage ( Derfus et al., 2004 ; Chou et al., 2008 ; Lin et al., 2008 ; Schipper et al., 2008 ; Wu et al., 2011 ; Bartneck et al., 2012 ; Vance et al., 2015 ).
 Similarly, NPs present a potential threat to the susceptible female population, and their toxicity has been studied in different models of female reproductive health ( Tsuchiya et al., 1996 ; Wang et al., 2011 ). Both short- and long-term toxicities in animals and humans have been documented. Additionally, several reports demonstrate the biological effects of NPs on isolated physiological systems, such as organs, biomolecules, and primary cells. Overall, such studies have raised as many questions as they have answered, and it is clear that more studies are needed to determine the mechanisms by which NPs affect particular organ systems. NPs can also cross the biological barriers shielding various parts of the human body, such as the blood-testes barrier and enter the testes in animal models ( Araujo et al., 1999 ).
 Trans-placental Transmission/Shedding
 First, lets start with asking whether a vaccinated mother can transmit spike or mRNA to a developing fetus in the womb, i.e “trans-placentally.” Animal studies clearly indicate that nanoparticles can transit through ordinary placental transcellular transport. In that paper, they wrote:

 So, from the above, they found that nanoparticles under 240 nanometers can pass readily to the placenta? Lets again review the size of the Pfizer and Moderna lipidnanoparticles (LNP’s). Chat GPT (sorry) states “These LNPs generally fall within a range of approximately 80 to 200 nanometers in diameter.” However, another paper reported that the LNP’s range from 100 to 400, however, that still leaves a significant proportion being small enough to cross to the fetus via the placenta.
 The above study must be interpreted in the context of the evidence I presented in Part 2 whereby all vaccine components can be detected in the blood with studies reporting various time periods of one week, 14 days, 4 months, and up to 187 days (or longer). Thus, based on the study above and the fact that the vaccine products enter and remain in the bloodstream, trans-placental transmission must be occurring.
 Now, to be fair, PEG-coated LNPs (like in the vaccines) are reported to have less diffusion across the placental barrier than liposome-based formulations, but are still able to deliver some of their cargo to the fetus.
 To wit, in one mouse study , they developed a PEG-ylated LNP similar to the COVID mRNA vaccines that could get to the uterus as a therapeutic delivery mechanism. Apparently they succeeded. The study conclusion: “These LNPs may provide a platform for in utero mRNA delivery for protein replacement and gene editing.”
 But even if PEG limits the crossing of the placenta, that just means it would limit the transmission of the synthetic LNP’s, not the natural exosomes which contain spike or free spike (which we also know is in the blood).
 Now although all the animal papers emphasize that it is difficult to extrapolate to humans, these data cannot rule out that the components and products of the mRNA vaccines are capable of reaching the fetus of a vaccinated mother during pregnancy.
 So, i s there data showing risks to fetuses in pregnancy?
 Unsurprisingly and unfortunately, the answer is a resounding yes. Let’s start, again, with this document obtained by FOIA from Pfizer and their (P)FDA:

 To summarize the above, Pfizer received 458 reports of mothers “exposed’ (what an odd word) to the vaccine while pregnant. In 248 (54%) reports, an adverse event was reported.
 53 of the 248 adverse events involved spontaneous abortion, which they then “excluded” 17 due to having comorbidities or history of spontaneous abortion (not cool but whatever). This left them with 39 of the 248 adverse events (8.5%) resulting in spontaneous abortion. Now, although this rate of spontaneous abortion is consistent with traditional rates in pregnancy, the temporal association with vaccination in many of the reports is, to me as a clinician, highly concerning.
 For instance, there are an uncomfortable amount of spontaneous abortion reports within 1-10 days of the vaccine, and then a large number where the temporal association is left quite vague, i.e. “received vaccination in first trimester and abortion occurred at 6 weeks.” This suggests vaccination occurred right before the spontaneous abortion (given that the average time that women realize they are pregnant is at 5.5 weeks from conception). Take some time to peruse the below list of events:

 But beyond this Pfizer data, is there any other evidence of the reproductive harms of the mRNA vaccines?
 There is actually a mountain of data to contend with.
 One team of researchers performed a survey study after one of them observed “my period after dose one was one of the heaviest I remember having ever in my life.” So she and a colleague elicited reports of menstrual abnormalities from Covid vaccinated women. They were quickly deluged with 140,000 reports. Published in Science , they found that 42% of women reported menstrual abnormalities related to the vaccine. 42%. Let that sink in
 It was so troubling, it brought out a team of credentialed fact checkers as in this article from the “Science Media Center ”:

 They assembled a team of “experts” with quotes similar to this one below, all trying to dismiss the importance of the study:
 Dr Michelle Wise, Senior Lecturer, Department of Obstetrics and Gynaecology, University of Auckland, comments:
 “Unfortunately, this is not high quality research and I would not put a lot of credence on its findings. In the introduction, they call it an exploratory study, and that is all it is, they are exploring the effect of the vaccine on menses. It is a descriptive study, where they describe a large case series of almost 40,000 people who got the vaccine, and the key finding was that you were equally likely to have no change in your next period as you were to have a heavier next period.
 No comment.
 Now, although not published, I have been informed by a colleague in communication with an anonymous whistleblower working at a fertility clinic that they have been seeing not only large declines in successful fertilization but also “strange embryos” forming.
 The national expert on the risks of the mRNA vaccines in pregnancy is Jim Thorpe, a friend, colleague, and highly accomplished national expert in maternal-fetal medicine. He is also one of the only Ob-Gyn’s in the country who immediately spoke out publicly against the CDC’s decision to recommend injecting pregnant women with mRNA vaccines. A recent quote of his is a particularly sobering reminder of how unprecedented the actions of public health agencies were in regards to pregnant women:
 “the CDC is breaking the “golden rule” of pregnancy. “The golden rule of pregnancy is you don’t ever, ever use a novel substance in pregnancy, ever,” he said. “And you don’t have to be a physician or nurse, you don’t have to have any education, to know that.”
 He, like me, also lost his job due to his common sense advocacy. The American Board of Ob-Gyn even tried to go after him but now is backing off since the publication of his study finding unprecedented signals of harm from the Covid mRNA vaccines.
 In that study, Thorp et al analyzed the VAERS database using a CDC established method for detecting vaccine danger signals called “the proportional reporting ratio” (PRR). The PRR is calculated by comparing Covid mRNA vaccine adverse event report rates compared to the influenza vaccine adverse event report rates (i.e. the flu vaccine is used as the baseline standard for “safety”). The CDC states that a PRR of two or greater is a safety signal “that requires further study.”
 The two figures below show the PRR’s for eleven pregnancy related outcomes. The first on the left calculates it by number of doses given and the second to the right by number of persons vaccinated. Note how “off the charts” the PRR’s are. Depending on comparator method, having “abnormal menses” ranges from an RR of 298 to 4927 (i.e. well over the threshold of 2) . With miscarriages, the PRR ranges from 15-57.

 Note the conclusion by his team of authors: “These results necessitate a worldwide moratorium on the use of COVID-19 vaccines in pregnancy.”
 The finding of PRR’s far exceeding 2 for every pregnancy related outcome should have, per the CDC’s words, “warranted further study.” So maybe they should have immediately stopped recommending them to pregnant women while they did that?
 Apparently not. Fierce, unstoppable regulatory capture on display again as recently as a month ago:

 Recall that Thorp is an actively practicing maternal fetal medicine specialist and has seen firsthand the toxicity in pregnancy. In an article from the Defender, Thorpe is quoted as saying
 “The mRNA COVID-19 vaccines are the deadliest drug in the history of medicine, whether you call it a vaccine, a drug, a gene medicine, a medical intervention, whatever you call it. And they knew it. The CDC knew it. HHS knew it. Pfizer knew it and tried to bury the data, which showed 1,223 deaths from its vaccine in the first 10 weeks, for 75 years.”
 Finally, the investigative journalist Mary Beth Pfeiffer (and my sometime Op-Ed writing partner here and here ) reported on suddenly dropping birth rates across many European countries timed 9 months after the ramping up of their respective vaccine campaigns.
 But again, although it is abundantly clear how toxic the mRNA vaccine is to pregnant women, I cannot definitively state that it is solely from transmission of vaccine contents or spike product to the fetus. The reason for this uncertainty is that there are several other pathologic mechanisms which could explain these outcomes like hypercoagulable blood/”microclotting,” endothelial damage, autoimmune responses, hyperinflammation to name just a few of the many identified mechanisms of injury in the new, as yet unrecognized field of “ spikeopathy. ”
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 Breast Milk Transmission/Shedding
 So, although the devastating outcomes in pregnancy are not definitive proof of shedding/transmission, when we start to look at reports of infants and babies falling ill after breast feeding, the reality of the transmission of gene therapy products from mother to baby via breast milk is easier to identify.
 This study found that the vaccine mRNA was found in the milk of 1/10 women studied (4/40) in the first week after vaccination with mRNA vaccine (either after dose 1 or dose 2). Amounts can reach 2 ng/mL of milk.
 Although the authors did not think this represented a “significant” amount, in Banoun’s masterful review paper on shedding, she explains:
 This amount may seem small compared to the 30 micrograms of mRNA injected with the vaccine, but it can be enough to produce a significant amount of spike.
 Indeed, an infant makes several feedings per day, for approximately 240 to 360 mL per day and a total over a week of 1680 to 2,520 mL in the first week. The newborn, weighing between 2 and 5 kg, could therefore be exposed to a dose of 5 μg of mRNA in its first week. This seems disproportionate compared to the 10 μg injected into children aged 5 to 11 years who weigh approximately 18 to 35 kg respectively [39]. The method used in the latter study is more sensitive than that of Golan et al. who did not find mRNA in milk [40].
 This study in the Lancet reported on the breast milk of 11 women who were vaccinated with mRNA within 6 months of delivery. They found trace amounts of mRNA in 7 samples from 5 different participants at various times up to 48 hours post vaccination. The vaccine mRNA appeared in higher concentrations in the extracellular vesicles (i.e. exosomes/nanoparticles) than in whole milk. Uh oh.
 Their conclusion: “Our findings demonstrate that the COVID-19 vaccine mRNA is not confined to the injection site but spreads systemically and is packaged into breast milk extracellular vesicles.”
 Another study found PEG (a component of the mRNA vaccine) as well as Covid vaccine mRNA in breast milk as shown below.

 Note they say “Of note, PEGylated proteins concentration is higher in mRNA-1273 compared to BNT-162b2 which also stand in line with mRNA concentration in each vaccine (ready for administration vaccines were used).” So, a dose-response relationship was found which is particularly damning - the more you give, the more you get (in breast milk).
 Despite this, like in the paper above, they say without explaining what should be considered significant, “PEGylated proteins were not found at significant levels in milk after vaccination.”
 The one reassurance here is that in the first study, no Covid vaccine mRNA was found in breast milk after 48 hours from the jab. However, it would have been nice for American mothers to know this before being told to get vaccinated, i.e. they could have been instructed to take the first couple of days off of breastfeeding (easier said than done I am told). Instead, the CDC continues to recommend offering the COVID-19 mRNA vaccines to breastfeeding individuals.
 So, we know mRNA can be transmitted to breastfed babies in breast milk. I used to dismiss the importance of this finding by reasoning that the stomach acid of the baby would destroy the mRNA it and render it inert. But then I found these papers ( here , here , and here ), one of which stated:
 It has been known for some years that mRNA encapsulated in extracellular vesicles is protected from gastric juices and can transfect intestinal cells. A recent review by Melnik and Schmitz confirms that milk EVs survive the extreme conditions of the gastrointestinal tract, are internalized by endocytosis, are bioavailable, reach the bloodstream, and penetrate peripheral tissue cells. Beyond integration into the genome, other concerns should arise such as provoking an “immunogenic” reaction to mRNA.
 Clinical evidence suggesting that the mRNA and/or spike in breast milk can survive in the stomach and cause illness in the baby lies in the below list from an eight-page confidential document of reports made to Pfizer by lactating women who were vaccinated. Pfizer was aware of and tracking adverse events in babies “exposed” to the mother’s vaccination via breast milk.
 While medical journal propagandized OB/GYNs all over the world were lecturing their pregnant patients to get the experimental shots, Pfizer was observing what was graded as non-severe adverse events (AEs) in a whopping 20% of the 215 lactating women reporting “exposure” to the vaccine.
 The report also documents 10 serious AEs, including facial paralysis (not listed under “serious” interestingly), lymphadenopathy (swelling of lymph nodes that could be associated with cancer), and blurred vision. Note these are all side effects of the vaccines reported by adults. Among infants, reports included skin exfoliation, rashes, swollen skin, and unspecified sickness. That’s a high percentage of serious AEs in babies for any therapy.

 More evidence: A study published a year ago in JAMA revealed that 3.5% of women reported a decrease in breast milk supply and 1.2% reported “issues with their breastmilk-fed infant after vaccination.” This latter stat is truly troubling - 1.2% of moms reported a temporal association between vaccination and “issues with their infant.” As I have said throughout my career, mothers (and some fathers) are the best “clinicians” that I have ever seen in that they are highly keen observers and recorders of both the timing, pattern, triggers, and alleviators of their children’s symptoms and illness. Taking a history of illness from a keenly observant mother is a pleasure actually as you can gather all the truly critical information you need to make diagnoses and decide on treatment. But forgive me for I digress.
 Now, it only leaves the question whether the babies are falling ill from the LNP/mRNA in breast milk or the resulting spike in breast milk. I believe that, in most cases, it is the spike that is being transmitted and causing illness rather than the LNP or modified mRNA given that the symptoms caused are not only common to Long Vax, but to Long Covid as well (the latter syndrome does not involve lipid nano-particles or modified mRNA). However, the well described pro-inflammatory properties of LNP ’s suggest that just the LNP’s could cause illness itself.
 Here is one vivid VAERS entry which could represent spike or the LNP in breast milk:

 Further, the investigative reporter Sonia Elijah combed through the EU’s Periodic Safety Update reports and discovered that Pfizer documented numerous cases of strokes, convulsions, and respiratory failure among nursing babies. Ironically, appallingly, and counterintuitively, Pfizer refused to investigate further because these AEs were automatically dismissed as unrelated to the vaccine. Why? Because Pfizer simply removed them from the analysis!
 In the words of the Pfizer investigator, these serious AEs were “determined to be non-contributory and were not included in the discussion since these cases involved exposures to the vaccine during the mother’s pregnancy or through breastfeeding.” Absurd:

 Pharma and its (P)FDA does what it does and little consequences follow.
 Links to all the other posts in this series is after the subscribe button below.

 P.S. I just want to say thanks to all my subscribers, especially the paid ones! Your financial support is greatly appreciated as it allows me to devote what is often large amount of time I spend researching and writing my posts, so again, thanks. - Pierre
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 “Shedding” Part 1 - Shedding of Covid mRNA Vaccine Components and Products From The Vaccinated to the Unvaccinated - Part 1
 “ Shedding” Part 2 - The Bio-Distribution and Excretion Potential of Covid mRNA Vaccine Products
 “ Shedding” Part 3 - Can You Absorb Lipid Nanoparticles From Being Exposed To a Vaccinated Person?
 “ Shedding” Part 4 - Evidence of Placental and Breast Milk Transmission of Covid mRNA Vaccine Components
 "Shedding" Part 5 - Evidence of Shedding Causing Illness In Others
 “Shedding Part 6 - Clinical Case Notes Describing Shedding Phenomena Among Leading Edge Clinic Patients
 “Shedding” Part 7 - Shedding Via Sexual Intercourse - Clinical Reports
 “Shedding” Part 8 - A Deluge of Clinical Reports Pour In
 “Shedding” Part 9 - More and More Clinical Case Descriptions of Shedding Pour In

 P.P.S - Proud to report that my book is gaining Best Seller status on Amazon in several countries and is climbing up the U.S Amazon rankings… Link:


Shedding Part 3 - Can You Absorb Lipid Nanoparticles From Being Exposed To a Vaccinated Person?

In this post, I will review the ways in which the synthetic lipid nanoparticles (LNPs), used in the Covid mRNA vaccines (as well as natural LNPs called exosomes) can be absorbed into the body.
 First, a summary of the data presented in my first 2 posts here and here :
 The Covid mRNA vaccines meet the regulatory definition of a gene therapy product

 Gene therapy products are required to undergo both animal and human shedding studies (the latter were not done and the results of the former have not been made public by Pfizer).

 Shedding studies are required because the mRNA is delivered to the cell via lipid nano-particles and LNP’s are distributed widely in the body

 Pfizer specifically excluded subjects who could be closely exposed to a trial subject that had already received the vaccine.

 The gene therapy product called Luxterna has a warning on its insert that the product can be shed via tears and nasal secretions.

 Where is the evidence that LNP’s from vaccinated folks can be transmitted to and subsequently enter our bodies? From this review of nanoparticles (i.e LNPs/exosomes) they state:
 As far as the exposure of humans to NPs is concerned, they can enter the body through inhalation, ingestion, skin uptake, injection, or implantation. It is also interesting to note that NP uptake could be intentional or non-intentional.
 Non-intentional? From the article: “Some exposures are unintentional, such as pulmonary inhalation of NPs in the environment or at manufacturing sites.”
 This figure illustrates the various routes of absorption and dissemination throughout the body:

 Here is where we are: synthetic LNP’s like the Covid vaccines contain modified mRNA. Natural exosomes can take up released modified mRNA as well as the spike protein. LNP’s and exosomes distribute widely throughout the body. But can they be released from the body? If released via body fluids or exhaled breath, can they then be absorbed by others who are exposed to these fluids/vapor?
 A major concern is that this study found that vaccine mRNA is present from day one and persists in the bloodstream for at least 2 weeks after injection; its concentration starts to decrease after 4 days. Note this is much longer than was claimed by the manufacturers on the basis of brief studies in rats.
 From the conclusion of the study:
 In conclusion, we showed that BNT162b2 vaccine mRNA remains in the systemic circulation of vaccinated individuals for at least 2 weeks, during which it likely retains its ability to induce S-protein expression in susceptible cells and tissues.
 So mRNA can stay in the blood for up to two weeks. However, in my now almost two year clinical experiences treating both Long Vax and Long Covid, it is clear that the spike protein is the most worrisome given its severe pathogenicity and toxicity .
 Let’s start with what we know about distribution of spike protein to organs and body fluids (this would be required in order to support the fact that shedding can occur):
 In July of 2021 a page on the website of the Infectious Disease Society of America noted that the lifespan of spike in the bloodstream is “unknown and may be a few weeks.” That page no longer exists. This might be because of the publication of numerous studies showing not only wide dissemination but also the persistence of spike protein in the body:
 For example, this research team reported that the spike protein persists for a long time in free form: full-length spike is detected up to day 15, with a peak at 62 pg/mL. After the 2nd dose, free spike is no longer detected as it would be bound to antibodies (but the study did not look for antibody-spike immune complexes ).
 Another study found that vaccination with mRNA and translation of the mRNA induces the production of exosomes carrying the spike protein and circulating in the blood 14 days after injection and up to 4 months after .
 Another group similarly found that the spike protein concentration rapidly increases in blood after vaccination (within 1 to 3 days) and persists in the bloodstream for more than a week. Although they report that the spike is completely eliminated within 1 month a more recently published study  which looked much more carefully, found spike protein circulating in the blood up to 187 days after vaccination (after which they stopped testing and finished their study).
 In the Parry et al review paper on “spikeopathy”, they include a table summarizing the persistence of various vaccine products in various organs as in the below bottom left (image taken from William Makis’s review of the paper on his Substack called Covid Intel):

 Clinical and pathologic evidence abound as well: a case report of an autopsy done in a man who died of multifocal necrotizing encephalitis three weeks after the vaccine found vaccine spike in numerous organs (heart, brain, muscles, germinal centers etc.). Further, they emphasized the finding of high concentrations in the walls of capillaries. One sentence in that report jumped out at me:
 “The family of the deceased requested an autopsy due to ambiguous clinical signs before death.”
 That is exactly the patient population autopsied by a team of pathologists led by senior German pathologist Arne Burkhart (unfortunately he is recently deceased but many of us Covid dissidents co-lectured at conferences with him - he was a brilliant, courageous, and kind man).
 Know that in order to establish the vaccine as the cause of death on autopsy, you have to use a special stain to identify the spike protein embedded in the organs or vessels, something that nearly all “system” coroners across the world did NOT do. As the independent pathologist Ryan Cole has said “you can’t find what you don’t look for.” It was clear to all of us Covid “dissidents” that from the outset there was a concerted, global effort to avoid looking for disseminated spike protein in the bodies of the deceased.
 This is why the findings of Burkhart’s team are so alarming (and censored) They began systematically performing “2nd opinion” autopsies staining for the presence of spike protein in people who died where the family was convinced the vaccine was the cause (and the primary coroner had not performed these special stains).
 Although not yet published, he has presented their findings in multiple invited lectures . He reported that out of the first 50 autopsies performed, in 80% of cases where the family suspected the vaccine as the cause of death, spike induced organ damage was determined to be the proximate cause of death.
 In that lecture, Burkhart showed slides of properly stained tissues demonstrating not only widespread dissemination of the spike protein, but also widespread spike-induced damage to tissues and vessels (i.e. vessel walls, heart muscle, brain tissue, kidneys etc).
 More recently, another group of publicly vocal Covid “dissident” scientists including Peter McCullough, Harvey Risch, Mark Trozzi, and others performed a systematic review of autopsies where the spike protein was stained for. The spike was found to be the cause of death in 74% of cases. Unsurprisingly,  the paper was nearly immediately retracted off of a… pre-print server. It just doesn’t stop.
 So, LNPs, naked mRNA, naked spike and spike containing exosomes are disseminated in the bloodstream and to tissues as long as 187 days from vaccination (know this is not a limit, it is just the longest they followed the patient for). The dissemination of spike protein can cause immense organ damage leading to death.
 Now, are the vaccine product containing exosomes/LNP’s capable of being transmitted (“shed”) and then absorbed by the bodies of unvaccinated individuals in contact with freshly vaccinated individuals? In this paper they state:

 … "these ultrafine particles are capable of entering the body through skin pores, debilitated tissues, injection, olfactory, respiratory and intestinal tracts. These uptake routes of NPs may be intentional or unintentional. Their entry may lead to various diversified adverse biological effects. Until a clearer picture emerges, the limited data available suggest that caution must be exercised when potential exposures to NPs are encountered.
 These nanosized particles are likely to increase unnecessary infinite toxicological effects on animals and environment; although their toxicological effects associated with human exposure are still unknown.
 Again, based on the above, it is apparent that we humans are again proliferating novel technologies without fully understanding their risks.
 There is a large and growing body of research in the development of a rapidly increasing amount of “LNP nanoparticle therapeutics” (i.e. using LNP’s to deliver drugs and/or corrective genes). Reviewing these studies, it becomes quickly apparent that the LNP’s can be delivered into the body via numerous routes and successfully impact biologic activity (i.e. they have confirmed the successful impact on biologic activity by measuring production of the desired gene product and/or the therapeutic effect of the drug cargo or the achievement of an immune response in nanoparticle vaccine experiments).
 Currently, therapeutic nanoparticles have been successfully administered transcutaneously ( here , here , and here ), transdermally ,   transfollicularly , intranasally , via inhalation and then excreted via urine, feces , saliva, breast milk , exhaled breath, and sweat . About that last one, Banoun points out:
 What is unfortunate about that is an increase in sweating after the COVID vaccine has been noted [33] and people who have received the vaccine have complained of increased sweating, particularly at night [34].
 In regards to nasal absorption, a close colleague of mine who is a clinical expert in exosome therapy, reported a case of rapid return of smell after intranasal administration of cord blood derived stem cell secreted exosomes.
 In my original draft of this post, I explored the studies behind each of the transmission routes above in a too-long yet detailed manner, I subsequently decided to focus almost solely on the science behind respiratory (inhalational) transmission of LNP’s. Why did I do that?
 Two reasons; the first is that although LNP’s/exosomes can be absorbed by all of the above routes, in each study or example, the researchers were treating with therapeutic doses and/or using designed applicators (concentrated fluids, creams, or nebulizers containing the LNP’s).
 Thus I used to think it was doubtful that in routine, daily, social life, sufficient body fluids could be exchanged between the vaccinated and unvaccinated outside of sexual intercourse, kissing (saliva), or accumulated exhaled breath vapor in close proximity.
 Although no study on sexual transmission/shedding exists, in Part 7 of this series, I provide two examples of typical vaccine adverse effects which developed after one form of sexual intercourse. Although I placed Part 7 behind a paywall due to their sensitive nature, in Parts 6 and 8, I present over two dozen clinical descriptions of shedding events from both our practice and from people who have written to me or posted in the comments section. Two of them describe symptoms and/or focal bruising developing in an extremity placed in proximity to a vaccinated persons extremity for a prolonged period. So, ultimately, I don’t know if their are limits to transmission.
 Thus it is my opinion that based on our clinical observations and treatment of shedding “injuries” that the lungs would be the primary (but not only) route of transmission (i.e. the inhalation of exhaled breath from a vaccinated person which contains free spike/free mRNA, and/or natural or synthetic LNP/exosomes containing spike or mRNA).
 (*Here I will break to make an appeal for paid subscribers to support my time and work, thanks for considering).
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 ABSORPTION VIA INHALATION
 The findings in this paper from 2005 are terrifying in my view:
 When inhaled, specific sizes of NSPs (nano-sized particles, i.e. LNP’s/exosomes) are efficiently deposited by diffusional mechanisms in all regions of the respiratory tract. The small size facilitates uptake into cells and transcytose across epithelial and endothelial cells into the blood and lymph circulation to reach potentially sensitive target sites such as bone marrow, lymph nodes, spleen, and heart.
 This randomized, double-blind controlled trial in The Lancet found that in humans, liposomal DNA gene therapy loaded nanoparticles administered locally by nebulization transfected airway cells. This was validated by the fact the cystic fibrosis patients treated in this manner experienced a stabilization of lung function, while the placebo group experienced a decline.
 So this study found that DNA encased in the LNP integrated and became active in the recipient. Again, the LNPs were nebulized using a therapeutically sufficient dose which may not mimic real world risks. However it certainly does not exclude the possibility.
 Clinical trials for influenza prevention have shown the efficacy and safety of inhaled mRNA vaccines:

 The paper above reported that bare mRNA or mRNA enveloped in lipid particles (especially PEG-based as in the anti-COVID mRNA vaccines), are able to be inhaled in an aerosol and transfect lung epithelial cells.
 Finally, extracellular vesicles by inhalation (ongoing trial against Alzheimer's disease) is being studied .
 Finally, from Banoun:
 Nebulization of exosomes for inhalation therapy has been tested against COVID-19. Clinical trials are underway to deliver aerosolized anti-viral therapies in EVs in COVID-19. Currently, over sixty clinical trials are underway to study the effects of MSCs (mesenchymal stem cells) and EVs (containing these MSCs) in COVID-19 patients. A phase 1 clinical trial to evaluate the safety and efficacy of inhaled exosomes derived from MSCs for the treatment of COVID-19 pneumonia has been completed.
 At this point of my deep dive into shedding, I find the above propositions insane - unless in a hermetically sealed room or waring a P100 respirator (does that even filter out nanoparticles?), anyone administering the aerosolized nanoparticle vaccine or in proximity will unwittingly receive the “vaccine.”
 Also t his study reported 3 clinical trials that used aerosol as the route of administration. In 2022, this study showed that exosomes were effective via nebulization therapy in COVID-19 patients:

 Similarly, in our private practice specializing on both Long Covid and the treatment of Covid mRNA vaccine injury syndromes (Long Vax), my partner Scott Marsland and I have treated a select cohort of (generally refractory) patients with stem cell derived exosomes delivered via nebulizer, intranasal spray, and intravenously. Since we used multiple routes simultaneously, we cannot clinically differentiate which routes had the most impact.
 It is important to note that the Covid mRNA vaccines were injected and not inhaled. This presents a higher risk of mRNA and/or DNA to be transmitted given the amounts of mRNA that were injected. From Banoun:
 “ Huge amounts of mRNA are injected compared to the circulation of a virus during a natural infection: up to 7 to 10 times more, according to Professor Jean-Michel Claverie [27].”).
 This is likely not a good time to remind us of the DNA plasmids contaminating the vials.
 Links to all the other already active posts in this series is after the subscribe button below.

 P.S. I just want to say thanks to all my subscribers, especially the paid ones! Your financial support is greatly appreciated as it allows me to devote what is often large amount of time I spend researching and writing my posts, so again, thanks. - Pierre
 Subscribe now
 “Shedding” Part 1 - Shedding of Covid mRNA Vaccine Components and Products From The Vaccinated to the Unvaccinated - Part 1
 “ Shedding” Part 2 - The Bio-Distribution and Excretion Potential of Covid mRNA Vaccine Products
 “ Shedding” Part 3 - Can You Absorb Lipid Nanoparticles From Being Exposed To a Vaccinated Person?
 “ Shedding” Part 4 - Evidence of Placental and Breast Milk Transmission of Covid mRNA Vaccine Components
 "Shedding" Part 5 - Evidence of Shedding Causing Illness In Others
 “Shedding Part 6 - Clinical Case Notes Describing Shedding Phenomena Among Leading Edge Clinic Patients
 “Shedding” Part 7 - Shedding Via Sexual Intercourse - Clinical Reports
 “Shedding” Part 8 - A Deluge of Clinical Reports Pour In
 “Shedding” Part 9 - More and More Clinical Case Descriptions of Shedding Pour In

 P.P.S - Proud to report that my book is gaining Best Seller status on Amazon in several countries and is climbing up the U.S Amazon rankings… Link:

Summary: I review all the routes of entry into the human body that mRNA vaccine nanoparticles can take.. and the ease in which they do so. The most troubling is via inhalation.


Shedding Part 2- The Bio-Distribution and Excretion of Covid mRNA Vaccine Components and Products

OK, so in Part 1 of this series on Covid mRNA vaccine shedding, I provided evidence that:
 The FDA and the EMA define the mRNA vaccines as gene therapies.

 The FDA requires that gene therapy products undergo human shedding studies given the known risks of shedding

 Shedding studies were not done because, even though the vaccines are gene-therapies, they legally fell under the legal definition of a “countermeasure” in a public health emergency. Countermeasures do not require shedding or other types of safety studies before mass use.

 All we know is that from a FOIA obtained document, Pfizer did a shedding study on rats but we don’t know what they found.

 HOW DOES SHEDDING OCCUR AND IS THERE ANY EVIDENCE OF IT OCCURRING WITH THE COVID mRNA VACCINES?
 In order for the vaccine or spike to be shed, it would first require distribution of the vaccine components or spike protein product to the lungs (to then be exhaled) and other body fluids (to then be excreted)
 To explore this possibility, it is important that we define what a lipid nanoparticle LNP) is, along with their natural, biological counterparts which are called exosomes or extracellular vesicles (EVs).
 The papers I reviewed used the terms exosomes, LNP’s, EV’s, and even nanoparticles somewhat interchangeably although there are some differences. For instance, exosomes are a subset of extracellular vesicles (EV’s). From this paper in Molecular Therapy, they state:
 Exosome-like nanovesicles (ELNVs) are biological nanostructures of 40–150 nm, are secreted by most types of cells and relay information between cells and organisms across all three kingdoms of life. 1 , 2 Although earlier perceived to be cellular debris and hence undervalued, ELNVs are now acknowledged as crucial entities to regulate physiological functions of multicellular organisms in an intercellular transmission manner.
 From another paper in Science:
 Exosomes are EVs with a size range of ~40 to 160 nm (average ~100 nm) in diameter with an endosomal origin. For instance, the LNP’s in the Covid MRNA vaccines are approximately 100 - 400 nm in size .
 The most important fact to remember is that the smaller the size, the more widely they distribute and the more easily they can enter the body (more on the latter later).
 For context, the length of the SARS-Cov2 virus is about 9-12 nm in size. Further, as Banoun points out in her masterful review of the topic of shedding:
 “ Huge amounts of mRNA are injected compared to the circulation of a virus during a natural infection: up to 10 to 7 times more, according to Professor Jean-Michel Claverie [27].”
 Further, there are different biologic materials that can be used to make the outer membrane enclosing the contents of a nanoparticle. Lipids (i.e. liposomes or LNP’s) are one of the most commonly used for drug delivery. Early conventional “liposomes” (yet another term) had limitations such as short half-life and rapid systemic clearance following their clearance by the reticuloendothelial system (RES). However, the conjugation of polymers such as polyethylene glycol (PEG) resulted in the generation of sterically stabilized liposomes with prolonged half-life and increased stability.
 To wit, the Covid mRNA vaccines used PEG to stabilize the LNP carrying the modified mRNA.
 So what are nanoparticles/LNPs/exosomes, what is inside them, and what do they do?
 Basically, they are tiny sacs enclosed by a lipid membrane which can contain any of the following: proteins, metabolites, enzymes, growth factors, and nucleic acids . You can also package drugs (and synthetic mRNA) into them in order to deliver their contents into recipient cells to effectively alter their biological response.
 Natural, endogenous exosomes are associated with immune responses, viral pathogenicity, pregnancy, cardiovascular diseases, central nervous system–related diseases, and cancer progression. Such exosome-mediated responses can be disease promoting or restraining . Exosomes can be engineered to deliver diverse therapeutic payloads, including short interfering RNAs, antisense oligonucleotides, chemotherapeutic agents, and immune modulators, with an ability to direct their delivery to a desired target.
 Importantly, synthetic mRNA vaccine LNPs have the same structure as the natural exosomes they seek to mimic.
 So what do we know about human biodistribution of synthetic LNP’s??
 From this article by Sonia Elijah, regulators knew LNP’s distribute widely in the human body:
 In the recent leaked letter by the EMA, Executive Director, Emer Cooke, to the Chair of COVID-19 Special Committee, MEP Kathleen Van Brempt, Cooke begrudgingly admitted, “that the lipid nanoparticles can distribute rather non-specifically to several organs such as liver, spleen, heart, kidney, lung and brain, with the liver appearing to be the organ where the lipid nanoparticles distribute most.”
 Her admission was made on the heels of the Therapeutics Goods Administrations (TGA) of Australia’s evaluation report on Pfizer’s nonclinical biodistribution study, which alarmingly revealed that the lipid nanoparticles which encase the mRNA, travel to the liver, spleen, brain, eyes, bone marrow, adrenal glands, ovaries and testes– nearly every organ tissue.
 Further, beyond the mRNA encased in synthetic LNP’s, “naked” mRNA as well as mRNA encased in natural LNP’s (called exosomes) and spike protein in free form or encapsulated in exosomes can be found in the bloodstream and breast milk .
 More worryingly, LNP’s or their natural equivalent, exosomes (a.k.a. extracellular vesicles (EVs)) are able to be excreted through body fluids (sweat, sputum, breast milk) and to pass the transplacental barrier. These exosomes are also able to penetrate by inhalation and through healthy or injured skin as well as orally through breast milk.
 This figure from a review paper on nanoparticle therapies is illuminating:

 If that isn’t concerning enough, it gets worse.

 The above paper from 2017 states:
 Due to their unique characteristics, nanoparticles are widely used in biomedical and industrial applications ( Lee et al., 2007 ; Zhang et al., 2008 ; Das et al., 2009 ; Vance et al., 2015 ). Currently, there are 1,814 marketed consumer products containing nanoparticles , including antibiotics, food items, textiles, sports tools, and electronic materials, and the number is increasing steadily.
 Good to know (and unsurprising) that as of 2017, the human race has 1,814 consumer products out there relying on the use of nanoparticles and we have no comprehensive understanding of what the short or long term risks of both the absorption into our bodies and or the risk of secondarily shedding the nanoparticles onto other humans, in particular our families, friends, and others.
 It is shocking that in a number of review papers on nanoparticle technology, in each one, statements like this appear: “ it is clear that more studies are needed to determine the mechanisms by which NPs affect particular organ systems.”
 Equally prevalent are statements such as the below from this review paper :
 Despite the potential for clinical application, some studies have suggested that NPs can be toxic . These studies have demonstrated the ability of NPs to accumulate in cells and induce organ-specific toxicity. These studies, combined with the ever-increasing human exposure, demonstrate an urgent need for the design of safe NPs and the development of strict guidelines for their development with regards to toxicity testing.
 Urgent need to design safe nanoparticles? Strict guidelines needed for development in regards to testing for toxicity? Bit late for that now given “we” injected transmissable nanoparticles into the bodies of billions of people of all ages across the world.
 The reason for so many papers on nanoparticle technology constantly calling out for safety and shedding studies is that the researchers all are fully aware that there is a distinct paucity of studies confirming safety and/or risks of nanoparticles/LNP’s - the red bars in the chart below refers to the number of studies on nanoparticles found with titles containing the words “risks, safety or toxicity”

 I find it highly troubling that the nanoparticle technology industry is expanding so rapidly yet the potential for biologic toxicity to others has been so little studied. Almost all the studies have been in animals and they are not reassuring. At all.
 Ed: Sorry to interrupt but if you like (and enjoy learning from) this Substack, please consider supporting with a paid subscription (my time is under increasing strain and I need to prioritize - support will help me do that!) Thanks.
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 Before we get into the studies demonstrating the passing of spike protein and/or mRNA from vaccinated to the unvaccinated via various routes, know that Pfizer knew that shedding was a possibility given that they specifically excluded people “exposed” to the vaccine via inhalation (not subtle) or skin contact:
 Starting on p. 67 of the protocol the investigator is instructed to report various "environmental exposures."
 1)A male participant who is receiving or has discontinued study intervention exposes a female partner prior to or around the time of conception."
 2) "A female family member or healthcare provider reports that she is pregnant after having been exposed to the study intervention by inhalation or skin contact."
 3) "A male family member or healthcare provider who has been exposed to the study intervention by inhalation or skin contact then exposes his female partner prior to or around the time of conception."
 4) "A female is found to be breastfeeding while being exposed or having been exposed to study intervention (ie, environmental exposure). An example of environmental exposure during breastfeeding is a female family member or healthcare provider who reports that she is breastfeeding after having been exposed to the study intervention by inhalation or skin contact."trial who had close contact to a vaccinated person:
 From Banoun:
 The protocol for the Pfizer Phase I/II/III trial of COVID-19 mRNA vaccines (which began in May 2020) mentions the possibility of passage of the study product through inhalation or skin contact and passage through semen from a man exposed through inhalation or skin contact and passage through breast milk; the possibility of an adverse vaccine reaction from these exposures is also mentioned [15]. Pfizer's data clearly indicate that a pregnant woman may be exposed to “the intervention studied due to environmental exposure.”
 Environmental exposure can occur through “inhalation or skin contact.” Examples of environmental exposure during pregnancy include: A female family member or health care provider reports that she is pregnant after being exposed to the study intervention through inhalation or skin contact. A male family member or health care provider who was exposed to the study intervention by inhalation or skin contact subsequently exposes his female partner before or around the time of conception.
 Please re-read that last sentence again as I think it is critically important to understand what they are describing, i.e. “secondary shedding,” meaning someone can be “exposed” via inhalation or skin contact and then secondarily “expose” someone else. This will be important to remember in later posts where I provide clinical case examples of such “secondary shedding” events causing symptoms.
 Banoun further interprets the section as follows:
 This clearly means that any contact, including sexual contact with someone who has received the vaccines, exposes those who have not received the vaccines to the “intervention”, i.e. mRNA. Exposure during breastfeeding had also to be immediately notified during the trial: it is assumed that the investigator is concerned that a breastfeeding mother could transmit the experimental mRNA to her baby if she received the vaccines directly or if she is “exposed to the study intervention by inhalation or skin contact.”
 Also remember the mention of sexual contact. Part 7 of this series describes two clinical reports of symptoms occurring immediately after a particular type of sexual intercourse (although a short post, for sensitive reasons I put it behind a paywall however numerous other clinical examples are provided in other posts in this series).
 Unsurprisingly, numerous fact check articles were published to refute the above interpretations of the trial protocol language. This Chicago Tribune article argues that the language does not mean that Pfizer is suggesting that shedding can occur. To make this argument, they found this completely random, unknown professor who explained it away as follows:
 Dr. Shobha Swaminathan, an associate professor of medicine at Rutgers New Jersey Medical School, referred to the document’s language as “generic” meant to cover cases of “any potential exposures, including possible accidental ones.”
 Swaminathan said that “exposure” through inhalation or skin contact could refer to incidents where a pregnant woman was near a syringe of the product that accidentally broke. But in the case of COVID-19 vaccines, the degree of absorption from spilling the vaccine on your skin is “probably going to be negligible to non-existent,” Swaminathan said.
 “ Absorption will probably be negligible. ” I am not reassured by Professor Swaminathan’s confidence. “ In case a syringe accidentally broke .” I didn’t know that glass syringes were still in widespread use. The fact checkers are having a tough time here.
 Sasha Latypova recently sent me another piece of evidence that Pharma knows that gene therapy product shedding occurs. The following is from an insert of a drug called Luxterna , an adenovirus vector gene therapy injected into the retina (IMO a terrible drug given that serious injuries impacting vision occurred in over 5% of subjects). Read on:

 Links to all the other already active posts in this series is after the subscribe button below.

 P.S. I just want to say thanks to all my subscribers, especially the paid ones! Your financial support is greatly appreciated as it allows me to devote what is often large amount of time I spend researching and writing my posts, so again, thanks. - Pierre
 Subscribe now
 “Shedding” Part 1 - Shedding of Covid mRNA Vaccine Components and Products From The Vaccinated to the Unvaccinated - Part 1
 “ Shedding” Part 2 - The Bio-Distribution and Excretion Potential of Covid mRNA Vaccine Products
 “ Shedding” Part 3 - Can You Absorb Lipid Nanoparticles From Being Exposed To a Vaccinated Person?
 “ Shedding” Part 4 - Evidence of Placental and Breast Milk Transmission of Covid mRNA Vaccine Components
 "Shedding" Part 5 - Evidence of Shedding Causing Illness In Others
 “Shedding Part 6 - Clinical Case Notes Describing Shedding Phenomena Among Leading Edge Clinic Patients
 “Shedding” Part 7 - Shedding Via Sexual Intercourse - Clinical Reports
 “Shedding Part 8” - A Deluge of Clinical Reports Pour In
 “Shedding” Part 9 - More and More Clinical Case Descriptions of Shedding Pour In

 P.P.S - Proud to report that my book is sometimes gaining Best Seller status on Amazon in several countries and is climbing up the U.S Amazon rankings… Link:

Summary: In order to transmit or "shed" the Covid mRNA encapsulated lipid nanoparticle and/or the transcribed spike protein product, dissemination to organs and body fluids must occur. Does it? Answer: Yes.


“Shedding” of Covid mRNA Vaccine Components and Products From The Vaccinated to the Unvaccinated - Part 1

Awareness of the Federal Regulators and Vaccine Manufacturers
 The data showing the toxicity and lethality of the vaccines started within weeks of the roll-out with hundreds of thousands of adverse events and hundreds of deaths reported to VAERS in January of 2021, far exceeding previous stopping points of any new medical product or vaccine.
 Although ignored (to this day), anyone paying unbiased attention could see a further mountain of evidence develop, including a skyrocketing number of newspaper and television reports of healthy athletes and young people arresting and dying while doing normal everyday activities or sports (countered by corporate/government controlled media with a plethora of fact checking articles using cherry picked data to inform the world that what they are seeing is not factually true).
 Then life insurance industry data emerged showing historically unprecedented rises in death claims being paid out amongst the healthiest sectors of society temporally associated with the proliferation of Covid mRNA vaccine mandates within schools, corporations, universities, health care institutions, federal contractors etc. Most telling of the deathly impact of mandates was the fact that the largest increases among the sudden, rapid rises in excess deaths occurred among employed white collar workers.
 The reality is that these data are still ignored by media and public health agencies across the world. Even more worrying are the more recent reports finding universal contamination of every studied vaccine vial with large magnitude, excess levels of DNA fragments and DNA plasmids. Then the discovery that the DNA plasmids used in the manufacturing process contained genetic sequences that both promote DNA integration into the human genome as well as promote the development of cancer .
 It truly is unimaginable that we now must consider the risks (and reality) of “shedding” of the vaccine products from the vaccinated to the unvaccinated. This now has implications for nearly every human being walking the earth, vaccinated or unvaccinated (including me).
 This series will explore the regulatory, scientific, epidemiological, and clinical data indicating that shedding is occurring. The health of who knows how many is now being threatened, with the extent of the risks likely both highly variable and difficult to predict, both in the short term and long term. That is unless we start to seriously study the phenomenon further. So, let’s review what is known.
 Within 3 months of the rollout of the global Covid mRNA vaccination campaign, I was consulted by two different unvaccinated women in their late 30’s and early 40’s respectively, who reported that they were suffering acute menstrual abnormalities in the days following close exposure to a recently vaccinated practitioner (one visited a massage therapist and another an acupuncturist). Both had a history of highly regular, uncomplicated menstrual cycles over decades.
 Since that time, at least twenty other unvaccinated and vaccinated people, both men and women, have reported to me compelling histories of typical post-mRNA vaccine adverse effects subsequent to close exposure to vaccinated family members, contacts, or friends.
 Further, my partner Scott Marsland at our Leading Edge Clinic , who also specializes in treating Long Covid/Long Vax syndromes, has a growing series of detailed case histories of similar “shedding” events occurring. I will revisit this in a later post in this series, but I will briefly say here that our clinical observations conclude that symptomatic shedding events do occur. However, we have little idea of exactly how common it is occurring among the general population.
 This is further complicated by the fact that even if it were occurring frequently, the vast majority of people suddenly developing typical vaccine side effects symptoms after exposure to a vaccinated person would never think to relate it to exposure to shed vaccine products. It is my belief that very few people in the general public are aware of the possibility it could occur. You know, because the regulators have assured the country that mRNA technology is “safe and effective.”
 However, my general sense is that it occurs largely in people who have increased physiologic sensitivity to environmental exposures, toxins, or pharmaceuticals and that it is generally transmitted by someone recently vaccinated or someone who is producing a lot of spike protein. Note that is my “general sense.” More studies are required to fully understand both the frequency of and physiologic impacts from such events.
 My ignorance as to the frequency of symptomatic shedding events is due to the fact that the concept of transmitting spike proteins (or lipid nanoparticles) from a Covid mRNA vaccinated person to another is one of the least studied and published-on aspect of the mRNA vaccine technology.
 What is so shocking about that lack of research (actually nothing is shocking anymore) is that shedding has major global implications. Apparently it is not just me who thinks this because, as an expert on several aspects of Covid, I have been lecturing across the U.S, Europe, and South America in conferences, Parliamentary hearings, or invited lectures. Questions about shedding appear everywhere (in the dozens of Q & A’s that I have participated in, it is nearly always the first question. It is also a very common topic in the chat of our FLCCC weekly webinar .
 Know that in tonight’s FLCCC webinar ( Wednesday 7p.m EST ), I will be presenting a 15-20 minute overview of this series along with my private practice partner Scott Marsland. We expect to be deluged with questions after.
 As a physician committed to education, I (finally) decided to respond to the void of information around shedding with this series of deeply researched posts. If you appreciate the effort, please consider supporting my commitment to continuing this Substack with a paid subscription (I have been debating whether to give it up due to too many competing demands of my time - help me make that decision :).
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 Anyway, I believe that by the end of this series on the science, epidemiology, and clinical observations of shedding, you will be convinced that it can and does occur.
 What Is The Definition Of Shedding In Regards To The Covid mRNA Vaccines?
 From our Federal government, in this FDA document , the term “shedding” is defined as:
 “ The release of viral or bacterial gene therapy products from the patient by any or all of the following routes: feces (feces); secretions (urine, saliva, nasopharyngeal fluids, etc.); or through the skin (pustules, lesions, sores).”
 They forgot to mention “exhaled breath.” More on that later. The “products” they refer to that can be transmitted from a Covid vaccinated person to another include not only the genetically programmed spike protein product, but also the lipid nanoparticle (LNP) containing the mRNA that is in the injections as well as naked mRNA that can be released from the LNP. Even more worrying is the recent shocking discovery that every single Moderna and Pfizer vaccine vial is contaminated with high levels of DNA plasmids potentially capable of integrating into the human genome. Contemplating that last one is disturbing, the implications of which we will not know for some time.
 Why Would The Modified mRNA Vaccine Technology Lead To The Possibility of Shedding?
 First off, let’s be clear that the Covid mRNA and DNA vaccines are gene therapy medicinal products (GMTPs or GTP’s) as stated in the FDA’s 2015 document on Gene Product Shedding Studies .
 “Gene therapy products are all products that mediate their effects by transcription and/or translation of transferred genetic material and/or by integrating into the host genome and that are administered as nucleic acids, viruses, or genetically engineered microorganisms.
 Also note that in this European Medicines Agency (EMA) document , the mRNA vaccines also meet their definition of gene therapy medicinal products (GMTP’s).
 Ok, now that we know what a gene therapy product is and that the Covid mRNA injection is actually a form of gene therapy (marketed to the public as a “vaccine”), what does that have to do with “shedding?” Again from the FDA document regarding the evaluation of the safety of gene therapy products, they emphasize the importance of studying shedding:
 Shedding is distinct from biodistribution because the latter describes how a product is spread within the patient’s body from the site of administration while the former describes how it is excreted or released from the patient’s body. Shedding raises the possibility of transmission of virus or bacteria based gene therapy products (VBGT) from treated to untreated individuals (e.g., close contacts and health care professionals).
 This guidance represents FDA’s current thinking on how and when shedding data should be collected for VBGT and oncolytic products during preclinical and clinical development and how shedding data can be used to assess the potential for transmission to untreated individuals.
 So, with these findings in mind, it may be no wonder why the FDA insists on shedding studies:

 Further on in the document, the FDA emphasizes the importance of doing human shedding studies and not just relying on animal studies:
 To inform the design of human shedding studies, shedding data may be collected in animals following administration of the VBGT or oncolytic product. These data can help estimate the likelihood and potential shedding profile in humans, particularly when there is concern about transmission to untreated individuals. However, such data cannot substitute for human shedding studies for several reasons.
 But again, no studies testing whether excretion of mRNA-containing LNPs, modified spike-encoding mRNA, or spike produced by vaccinated people have been done. Well, I shouldn’t say none, because in this paper the author cites a Pfizer document obtained by FOIA which apparently revealed that shedding was studied in the urine and feces of intra-muscular injected rats. Unfortunately, t hat document is no longer at the website referenced.
 To summarize from the above, the FDA’s position is that:
 the mRNA vaccines are gene therapy products

 Gene therapy products require shedding studies in both animals and humans

 Gene therapy product shedding raises the possibility of transmission from treated to untreated individuals

 Note that much of the rest of this series of posts on shedding is guided by a masterful comprehensive review of the topic of gene therapy product shedding by independent researcher (by definition) Helene Banoun in Infectious Diseases Research . Hers is one of the only papers I could find that attempted to meticulously explore what is known about shedding of the mRNA gene therapy vaccines.
 As already stated, an important point Banoun makes is:
 There was no regulation of mRNA clinical trials prior to RNA vaccines, yet there is strict regulation of gene therapy products. It is difficult to justify that mRNA vaccines are not considered in the same way as gene therapies regarding this regulation; indeed the only difference is that they are ( historically ) supposed to protect against a disease and not cure it. Gene therapies are intended for a small number of people in poor health, whereas vaccines are used on a large scale on healthy people: it would therefore be wise to apply stricter rules to them.
 She further points out another omission of the regulatory process:
 Any experiment involving the deliberate transfer of a nucleic acid to a human must be preceded by Institutional Biosafety Committee approval (document on the regulatory standards is here ), but approval was not given because of the emergency clearance given to mRNA vaccines.
 Therefore, according to both the American and European agencies, mRNA vaccines are gene therapy products and should have been subjected to excretion studies of all secreted fluids (urine, exhaled droplets, saliva, sputum, nasopharyngeal fluids, semen, breast milk, feces, and sweat). Again, these studies were not done for mRNA vaccines nor for the DNA adenovirus vaccine (J&J).
 So, where are the clinical human shedding studies? Well, I just learned of one that is about to be published (next ten days?) where the research team exposed a population of unvaccinated women to vaccinated individuals and their assessment outcome was the development of menstrual abnormalities. I know the results but want to respect the research teams right to present their original work. They have promised to share their manuscript with me and Paul Marik as soon as the peer-review and acceptance process is complete. I have no idea what journal they submitted to but I can be highly confident it is not the New England Journal of Medicine.
 The entire reason why I did a “deep dive” into shedding science is because shedding was not studied when it absolutely should have been and I believe with near certainty that it occurs. Note my use of “near certain” is only to seem objective but it really is too late for that - both my partner Scott and I have diagnosed and successfully treated a number of shedding “victims.”
 The lack of shedding studies prior to the mRNA rollout was, in my opinion, an insanely reckless and irresponsible omission (or willfully criminal, take your pick). As an evolving expert in the evaluation and treatment of Covid mRNA vaccine injury syndromes, I and others have identified the spike protein as the main component responsible for not only the pathogenicity of Covid but also of the vaccines, with this review paper proposing a new field named “spikeopathy” (study of the disease processes triggered by the spike protein).
 If vaccine transcribed spike protein can be transmitted in sufficient quantity from vaccinated folks to unvaccinated ones, it stands to reason that adverse effects of the vaccine can develop in some unvaccinated people who came into contact (or close proximity) with vaccinated people. How did they get away with not studying this possibility?
 An easy answer is they were doing science at “warp speed.” The more uncomfortable answer is that the “vaccines”, although meeting the definition of a gene therapy product, were actually not even legally considered a medical product at all and thus did not require a diverse range of safety studies (like on genotoxicity, reproductive risks, excretion potential etc). What? Why? How?
 The reality is that the Covid vaccines, as a result of successive federal legislative actions which evolved over decades, was legally categorized as a “countermeasure” under a “public health emergency.” Such “countermeasures” require no specific regulatory approval process prior to dissemination. All a countermeasure needs is the recommendation of the Secretary of Health and Human Services that “it may be effective.”
 This is the conclusion derived from the legal investigatory work of various independent and legal experts and researchers like Catherine Watts , Todd Callender, and Sasha Latypova. If interested in learning more, I would watch this lecture by Sasha Latypova (scroll down the page to find her lecture). As they have uncovered, “countermeasures” (even gene therapy ones) do not legally require studies of excretion potential, bio-distribution, pharmacokinetics, genotoxicity, insertional mutagenesis etc.
 They don’t even require FDA regulated clinical trials of efficacy or safety.
 So why did Pfizer and Moderna even do the efficacy trials? Latypova maintains that they did this not only to satisfy the public’s confidence to increase vaccine uptake, but also to “fool” the public into thinking these vaccines were medical products subject to standard (albeit accelerated) pharmaceutical product regulatory processes.
 This obscured the reality that they were instead classified as military “countermeasures” against a perceived (if not actual) bioweapon. To wit, the COO of Operation Warp Speed was a General from the Department of Defense (DOD) and the vaccine manufacturers were under contract with the DOD to produce the countermeasure, sometimes referred to as a “demonstration (demo)” and/or a “prototype” in numerous legal documents they uncovered.
 Anyway, as a result of this lack of a legal requirement to fully study these products in a public health emergency, the list and types of studies that should have been conducted (but were not) is long. Researchers and clinicians have been screaming about this since they were rolled out. These cries were met with a deafening silence by governmental health agencies across the world.
 I know, it is a lot to take in.
 But the latest “word on the street” is that the finance and insurance industries may finally be waking up to this fraud and its devastating impacts on U.S disability and death rates. Knowledge of these society-wide impacts largely results from the work of two different research teams led by former Blackrock portfolio manager Ed Dowd and insurance industry consultant Josh Stirling ).
 This article describes the reasons why Pfizer and Moderna stock are crashing of late. Put more succinctly, from what I hear it is due to the hedge fund guys shorting their stock. I believe Pfizer is in even deeper trouble now that this “forensic” paper just got published finding that they hid vaccine trial deaths which obscured a 3.7 fold increased risk of cardiac death in the vaccinated arm of their trial.

 Links to all the other (already active) posts in this series is after the subscribe button below.

 P.S. I just want to say thanks to all my subscribers, especially the paid ones! Your financial support is greatly appreciated as it allows me to devote what is often large amount of time I spend researching and writing my posts, so again, thanks. - Pierre
 Subscribe now
 “Shedding” Part 1 - Shedding of Covid mRNA Vaccine Components and Products From The Vaccinated to the Unvaccinated - Part 1
 “ Shedding” Part 2 - The Bio-Distribution and Excretion Potential of Covid mRNA Vaccine Products
 “ Shedding” Part 3 - Can You Absorb Lipid Nanoparticles From Being Exposed To a Vaccinated Person?
 “ Shedding” Part 4 - Evidence of Placental and Breast Milk Transmission of Covid mRNA Vaccine Components
 "Shedding" Part 5 - Evidence of Shedding Causing Illness In Others
 “Shedding Part 6 - Clinical Case Notes Describing Shedding Phenomena Among Leading Edge Clinic Patients
 “Shedding” Part 7 - Shedding Via Sexual Intercourse - Clinical Reports
 “Shedding” Part 8 - A Deluge of Clinic Reports Pour In
 “Shedding” Part 9 - More and More Clinical Case Descriptions of Shedding Pour In

 P.P.S - Proud to report that my book is gaining Best Seller status on Amazon in several countries and is climbing up the U.S Amazon rankings… Link:

Summary: It's happening. The manufacturers and regulators knew it was a risk, yet, like numerous aspects of the Covid vaccine mRNA technology, did not test for excretion potential of spike proteins or LNP's.


COVID OUT CRITIQUE

COVID-OUT.
 Randomized Trial of Metformin, Ivermectin, and Fluvoxamine for Covid-19
 COVID-OUT remote RCT, showing no significant differences compared to a combined metformin/placebo "control" group. Results for other treatments are listed separately - metformin , fluvoxamine .
 Authors include metformin patients in the control group, allowing details of adjustments to affect results. Using standard treatment vs. placebo analysis shows 61% lower hospitalization, or 75% lower for patients with onset ≤5 days (not statistically significant with only 7 and 5 events). These results are not reported in the paper or the supplementary appendix, readers need to request the data. Authors note that "hospitalization is perhaps the most accurate and well-documented end point".
 There are many major issues as detailed below. We provide more detailed analysis of this study due to widespread incorrect press. Submit Updates or Corrections
 SeverityIssueCRITICAL1. Ivermectin vs. placebo analysis - 61% lower hospitalization CRITICAL2. Severity mismatch for ivermectin treatment but not for any other medication or control CRITICAL3. ER results unreliable, not related to symptoms CRITICAL4. Mismatch with reported death and symptoms CRITICAL5. Ivermectin vs. placebo symptoms consistent with efficacy CRITICAL6. Multiple outcomes missing, including time to recovery CRITICAL7. Hypoxemia results unreliable but prioritized CRITICAL8. Adverse events not reported, partial data shows no increase CRITICAL9. Control group includes metformin, adjustment protocol violation CRITICAL10. Viral load results missing CRITICAL11. Metformin/fluvoxamine conclusions opposite of Together Trial, but matching earlier studies on each team CRITICAL12. Author claims results from 596 researchers should be censored for false information CRITICAL13. Administration on an empty stomach CRITICAL14. Results delayed 6 months (including life-saving metformin results) SERIOUS15. Fewer comorbidities for serious outcomes SERIOUS16. Control arm results very different between treatments SERIOUS17. COVID-19 specific symptoms hidden in appendix SERIOUS18. Authors claim placebo is not better than the treatments SERIOUS19. Incorrect claim that no treatment reduced severity SERIOUS20. False conclusion SERIOUS21. Trial outcomes modified SERIOUS22. Very high percentage of missing data SERIOUS23. Medication delivery varied significantly SERIOUS24. Treatment 3 days for ivermectin, 14 days for metformin and fluvoxamine SERIOUS25. SAP dated after trial SERIOUS26. Test requirement and delivery prohibits early treatment SERIOUS27. Conclusion modified by journal SERIOUS28. Symptom results contradictory SERIOUS29. Adherence very low SERIOUS30. Inconsistent blinding statements SERIOUS31. Author indicates a best guess can be used for onset MAJOR32. Ivermectin from source chosen has shown lower efficacy MAJOR33. Adherence subgroups analysed but not reported UNKNOWN34. Maximum symptom duration not clear UNKNOWN35. No discontinuation due to hospitalization for ivermectin COMMENT36. Authors indicate up to 5 day delay in real-world usage
 Author responses 14. Results sent to the US government twitter.com (BC) . Note most people live outside the US, and there was no action.No response for all other items
 Ivermectin vs. placebo analysis - 61% lower hospitalization. Authors include metformin patients in the control group, allowing details of adjustments to affect results. Using standard treatment (ivermectin only) vs. placebo analysis shows more favorable results for ivermectin, with 61% lower hospitalization, or 75% lower for patients with onset ≤5 days (not statistically significant with only 7 and 5 events). Authors note that "hospitalization is perhaps the most accurate and well-documented end point".
 Severity mismatch for ivermectin treatment but not for any other medication or control. The table shows the percentage of patients reporting severe dyspnea for each active treatment and respective control. We expect that patients reporting ER visits would be more likely to experience severe dyspnea. This is true for all cases except for ivermectin treatment, suggesting unlucky randomization for ivermectin treatment, or a potential data error. The percentages are with respect to the total number of patients reporting symptom data in each case.
 Ivermectin activeIvermectin controlMetformin activeMetformin controlFluvoxamine activeFluvoxamine control ER 0.0%9.1%13.3%10.0%10.0%14.3% Non-ER 6.1%6.9%8.0%7.8%6.4%8.4%
 ER results unreliable, not related to symptoms. Authors detail why the main hypoxemia results are unreliable, however the ER results appear to be similarly uninformative. ER visits do not appear to be related to symptoms. The mean total COVID-19 symptom score for patients reporting an ER visit is 55 compared to 56 for patients reporting no ER visit (or hospitalization/death). Visualization of the ER patient symptoms raises the question of why most of them went to the ER. Of the 26 patients reporting an ER visit and symptom data, only one ever reported severe dyspnea, 5 more reported at most moderate dyspnea, 11 more reported at most mild dyspnea, and 9 reported no dyspnea at any time. ER patients were less likely to report severe or moderate dyspnea. The decision to go to the ER appears to be more of a personal preference rather than based on symptoms. Patients that signed up for the trial may be especially concerned about PASC for example, and seek help based on potential future problems rather than current symptoms.
 Maximum dyspnea severityER patientsNon-ER/hosp./death patients Severe3.8%6.5%Moderate19.2%22.2%
 Mismatch with reported death and symptoms. There was only one death for a patient that was treated very late (7 days). The patient was not hospitalized. The death is reported within 14 days, however the patient reported symptom data for all 14 days, showing substantial recovery several days prior, with only 2 of 14 symptoms remaining and reported as mild. Data suggests that the death was not due to COVID-19.
 Ivermectin vs. placebo symptoms consistent with efficacy. Authors include metformin patients in the control group, allowing details of adjustments to affect results. Using standard treatment vs. placebo analysis gives the mean COVID-19 symptom scores below, matching expectation for an effective treatment with the low-risk fast recovering population (note that administration on an empty stomach is expected to delay the time when therapeutic effects may be reached).

 Multiple outcomes missing, including time to recovery. Multiple outcomes are missing, for example time to recovery (where ACTIV-6 showed superiority of ivermectin): "Time to meaningful recovery (symptoms or severity improved by one category and sustained for at least 36 hours)" (protocol page 91). Notably, the definition is less biased than the ACTIV-6 definition, including improvement by one category, making allowance for mild fatigue and cough, and requiring 36 hours sustained rather than 3 days. More notably, the result is not reported.
 Hypoxemia results unreliable but prioritized. Authors detail why the hypoxemia results are unreliable vimeo.com (E) @28:30, however they are still prioritized in the presentation, and included in the abstract without mentioning that these results are unreliable.
 Adverse events not reported, partial data shows no increase. Adverse events are not reported (other than to note none were serious). Partial information is contained in Table S2 and Figure S5. Notably, there is no significant increase for ivermectin for any of the expected side effects, in contrast to other trials, e.g. Lim . These results are unexpected if patients received and took authentic ivermectin at the dosage indicated.
 Control group includes metformin, adjustment protocol violation. The "control" group includes patients receiving metformin, which is known to be beneficial for COVID-19 c19early.org (C) . Authors present adjusted results however they do not appear to fully account for metformin efficacy. For example, the adjusted result for ivermectin ER/hosp./death is close to the unadjusted result, while a greater difference would be expected based on the metformin efficacy reported (which is not expected to be doubled in the metformin + ivermectin arm). The trial has 5 treatments arms, but is presented as if there was 3, which adds complexity, makes the results subject to potential interactions between treatments, and introduces the potential for investigator bias in adjustments. Notably, the protocol specifies primary and secondary adjustments (page 74), and the paper reports only one set of adjustments, which matches neither the primary or secondary adjustments in the protocol.
 Viral load results missing. One of the primary objectives of the trial was "To understand if the active treatment arms are superior to placebo in improving viral load, serologic markers associated with Covid-19, and gut microbiome in non-hospitalized adults with SARS-CoV-2 infection." In the July 8 presentation authors report having analyzed viral load data vimeo.com (E) @19:20. No viral load results have been reported.
 Metformin/fluvoxamine conclusions opposite of Together Trial, but matching earlier studies on each team. The Together trial and COVID-OUT both tested metformin and fluvoxamine. Notably, they came to opposite conclusions. In Together, authors found efficacy for fluvoxamine, but the metformin results were so negative that the trial was terminated early. In COVID-OUT it was the opposite, authors (although not the journal editor) found efficacy for metformin, while the fluvoxamine results were so negative that the trial was terminated early twitter.com (Y) . Note that the Together authors include researchers that found fluvoxamine effective in earlier studies, while the COVID-OUT authors include researchers that found metformin effective in earlier studies.
 Author claims results from 596 researchers should be censored for false information. 60 studies by 596 scientists report statistically significant positive results for ivermectin treatment of COVID-19 c19ivm.org (F) . One author claimed that a report of positive results is "disinformation" and distributed a request to report and censor the author twitter.com (AA) , twitter.com (AB) , twitter.com (Z) . While discussion is warranted for all studies, a call for censorship of results is extreme and raises questions. Author provides no basis for the results of the 596 scientists being wrong and warranting of censorship, and there is no indication that author has even read most of the studies. Author cherry-picked two of 99 studies, (COVID-OUT and ACTIV-6 Bramante , Naggie , both very high COI studies with an extensive list of issues and very delayed treatment) and claimed that "no benefit of ivermectin was observed" twitter.com (AC) . In addition to ignoring the 60 studies reporting statistically significant positive results, ACTIV-6 c19ivm.org (G) reported a posterior probability that ivermectin is effective of 99%, 98%, and 97% for mean time unwell, clinical progression @14 days, and clinical progression @7 days (even though none of the pre-specified primary outcomes were reported, and noting that these preprint results were changed without explanation), and COVID-OUT showed 61% lower hospitalization with ivermectin vs. placebo (not including metformin), although this was not reported.
 Administration on an empty stomach. Authors instructed patients to take ivermectin on an empty stomach, but other treatments with food. Guzzo show that the plasma concentration of ivermectin is much higher when administered with food (geometric mean AUC 2.6 times higher). "Ivermectin or matching placebo should be taken by mouth on an empty stomach with water. 1 hour before or 2 hours after a meal. All other agents should be taken by mouth at the end of a balanced snack or small meal."
 Results delayed 6 months (including life-saving metformin results). Results were delayed for 6 months with no explanation, with followup ending Feb 14, 2022. Results were not presented until July 8 rethinkingclinicaltrials.org (B) , and they were still not available to the public due to a news embargo for over a month. Embargo and delay of clinical trial results during a pandemic is not consistent with a goal of minimizing mortality and morbidity. Notably authors report very positive results for metformin (although journal editors changed the conclusion as below).
 Fewer comorbidities for serious outcomes. Patients experiencing serious outcomes are expected to be more likely to have comorbidities, however the opposite is seen.
 OutcomeComorbidity prevalence Non-ER/hosp./death53%ER45%Hospitalization12.5%Death0%
 Control arm results very different between treatments. Control arm results are very different between treatments, for example considering hospitalization/death, this was 1.0% for ivermectin treatment vs. 2.7% for metformin control, however it was 1.3% for the ivermectin control. The metformin arm started earlier, however the difference in outcomes is very large given that most patients are in the shared period.
 COVID-19 specific symptoms hidden in appendix. Authors present results for all symptoms in Figure 2, and for COVID-19 symptoms in the appendix Figure S4. Notably, the COVID-19 specific results are better for ivermectin and especially for fluvoxamine.
 Authors claim placebo is not better than the treatments. Authors state: Neither overall symptoms nor Covid-19–specific symptoms were reduced faster with placebo than with any of the trial drugs. This may be true, Figure S4 shows symptoms were reduced faster with all treatments (with ivermectin and fluvoxamine showing greater improvement than metformin), but the reverse claim is very unusual — placebo is not expected to be better. Note that the graphs and data refer to the control groups including other treatments, while the statement refers to placebo only.
 Incorrect claim that no treatment reduced severity. Authors claim that "None of the trial drugs resulted in a lower severity of symptoms than identically matched placebo." The intended meaning — compared to the "control" groups used, since that is the data reported — is incorrect, multiple results show lower severity in the treatment groups in terms of the symptom scores and severity resulting in hospitalization. Individual results may not reach statistical significance, however ER/hosp./death does in the larger metformin group.
 False conclusion. Authors claim "None of the three medications that were evaluated prevented the occurrence of hypoxemia, an emergency department visit, hospitalization, or death associated with Covid-19." Taking the literal wording, this is false, there were no deaths with fluvoxamine. Taking the likely meaning (no treatment reduced incidence of these events), this is false, reduced incidence is seen in several results (mostly without statistical significance).
 Trial outcomes modified. Trial outcomes were changed on January 20, 2022 clinicaltrials.gov (H) , and again on March 2, 2022 clinicaltrials.gov (I) .
 Very high percentage of missing data. There is a very high percentage of missing data. 25% of patients have zero symptom data reported for all 14 days in the data file. This does not match the paper which reports 20% of patients did not contribute symptom data (Figure 2).
 Medication delivery varied significantly. Medication delivery varied significantly over the trial. In this presentation vimeo.com (F) , author indicates that delivery was initially local, later via FedEx, was much slower in August, there were delays due to team bandwidth issues, and they only realized they could use FedEx same day delivery in September.
 Treatment 3 days for ivermectin, 14 days for metformin and fluvoxamine. Treatment was 14 days for metformin and fluvoxamine, but only 3 days for ivermectin.
 SAP dated after trial. The SAP is dated February 14, 2022, which authors note is one day before unblinding. However, the protocol notes that the statisticians are unblinded: "There is one unblinded statistician with two unblinded supporting statisticians on the study team", and "All analyses will be carried out by the un-blinded statisticians". The protocol also notes that the SAP will be developed by unblinded statisticians in one case, and blinded in a second case: "detailed statistical analysis plan will be developed by the unblinded statisticians", and "statistical analysis plan will be developed by the blinded statistician."
 Test requirement and delivery prohibits early treatment. The requirement for a positive test and delivery of medication introduces substantial delay and largely excludes the possibility of early treatment. The protocol requires verifiable results using a local laboratory standard which excludes most home antigen tests (supplementary data page 5). Note that the trial results do not generalize to real-world usage, where clinicians recommend treatment immediately on symptoms.
 Conclusion modified by journal. Author statements indicate that the conclusion was modified by the journal twitter.com (BD) , twitter.com (BE) .
 Symptom results contradictory. Authors consider only metformin results to be positive (the journal editor considers none to be positive), however the symptom results in Figure S4 show the opposite: ivermectin and fluvoxamine show faster improvement (without statistical significance), while no difference is seen for metformin.
 Adherence very low. Adherence was very low, with 77% overall reporting 70+% adherence, and 85% for ivermectin reporting 70+% adherence. An author has claimed 85% took all doses but that is contradicted by the 20% reported "Total Interruption or Discontinuation" in Table S2. Numbers for 100% adherence are not provided.
 Inconsistent blinding statements. Protocol page 12 states that "The research team statisticians will remain blinded", while the supplementary data page 40 states that "There is one unblinded statistician with two unblinded supporting statisticians on the study team".
 Author indicates a best guess can be used for onset. One author suggests that investigators can use a "best guess" if a patient gives a range for time of onset, which would allow a biased investigator to present an incorrect lower average time from onset twitter.com (BF) .
 Ivermectin from source chosen has shown lower efficacy. Authors chose to source ivermectin from Edenbridge, which ranked 7 out of 11 brands in In Vitro tests for antiparasitic efficacy Williams , requiring 5 days compared to 2 days for the best performing brand, and 3 days for 4 other brands.
 Adherence subgroups analysed but not reported. Authors indicate they performed subgroup analysis by adherence vimeo.com (E) @18:30, however these results have not been reported.
 Maximum symptom duration not clear. The procol excludes patients with >7 days of symptoms, i.e. patients 7 days from onset are included. The paper claims "less than 7 days" in one instance and "within 7 days" in another. The presentation reports "<7 days" vimeo.com (E) .
 No discontinuation due to hospitalization for ivermectin. Table S2 shows 9 placebo patients discontinued treatment due to hospitalization, compared to zero for ivermectin. While ivermectin patients only received 3 days treatment, they received placebo tablets for the remaining days. If this number is only counting discontinuation during the first three days, the result highlights that treatment was stopped before any patients were hospitalized. The protocol notes "Study drug will be stopped at the time of hospitalization for any reason".
 Authors indicate up to 5 day delay in real-world usage. Authors note up to 11 days treatment delay with a remote clinical trial compared to up to 5 day for "real-world use" vimeo.com (E) @43:00, where the 5 days derives from testing and medical system delays. However, logical real-world use, as used in many locations, is to have the treatment on hand to take immediately.

Summary: Note this critique was compiled by the c19early.com research group at ivmmeta.com and does not represent my original work.