Author: Amy Kelly

The post Report 60: 449 Patients Suffer Bell’s Palsy Following Pfizer mRNA COVID Vaccination in Initial Three Months of Rollout. A One-Year-Old Endured Bell’s Palsy After Unauthorized Injection. appeared first on DailyClout.

March 6, 2023

Report 59: The Flawed Trial of Pfizer’s COVID-19 mRNA “Vaccine.” 90% of Original Placebo Group Received at Least One mRNA Injection by March 2021.

The clinical trial of Pfizer’s mRNA “vaccine” did not prove the mRNA injection is safe and effective, despite Pfizer’s claims to the contrary. In fact, Pfizer stopped collecting useful data long before the planned end date of the clinical trial. Based on an inaccurate diagnostic test confirming COVID-19 in a tiny fraction of the study population, Pfizer researchers unblinded the control group and injected them with Pfizer’s mRNA “vaccine.” Because of these flaws in Pfizer’s clinical trial, no valid conclusions can be drawn about safety and effectiveness of Pfizer’s mRNA injection.

Pfizer researchers originally designed the clinical trial using the gold standard for drug testing: a double-blind, randomized, controlled trial. In this type of trial, neither patients nor researchers know who receives the drug (or intervention) being tested and who receives a placebo (double-blind). Researchers randomly choose trial participants to receive either the drug or placebo (randomized). Finally, researchers compare results of those who received the drug being tested (the experimental group) to those who received the placebo (the control group).

The Phase 3 randomized, controlled trial is the accepted standard method for assessing whether there is likely a beneficial effect due to an intervention (efficacy of the intervention). Randomized controlled trials “are the most stringent way of determining whether a cause-effect relation exists between the intervention and the outcome” (Kendall 2003, https://emj.bmj.com/content/20/2/164).

Pfizer initiated a Phase 3 trial on July 27, 2020, which enrolled more than 40,000 adults (age 16 and older). About half of the participants received two doses of the Pfizer mRNA injection, and the other half received two doses of a saline placebo. According to the trial protocol, Pfizer expected participants in both groups to continue for up to 26 months (p. 15, Clinical Protocol, https://cdn.pfizer.com/pfizercom/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf), regardless of when various predetermined endpoints were reached.

Clinical trials typically involve both safety and efficacy endpoints. The safety of an intervention refers to the absence or low incidence rates of harmful side effects (adverse events). Efficacy endpoints refer to measurable outcomes, such as the rate of disease incidence (efficacy in the research world is generally equivalent to effectiveness in the real world). For a vaccine trial, researchers hypothesize that the disease rate in the experimental group will be significantly lower than the rate in the control group, based on a predefined expected difference.

As an endpoint, vaccine efficacy measures the reduction in disease rates (unvaccinated rate minus vaccinated rate) relative to the rate in the unvaccinated group. The Pfizer trial was designed to observe enough cases to provide a sufficient chance of detecting a minimal vaccine efficacy rate. Researchers can sometimes stop a trial early if the safety endpoint is clearly not being achieved and is thereby subjecting trial participants to high risks, or if the relative efficacy of the intervention is much greater than expected and can be established sooner than anticipated (that is, with fewer subjects). If researchers stop a vaccine trial early for reasons of efficacy, they may not have gathered sufficient data to establish the safety of the vaccine across various safety endpoints.

Pfizer designed its clinical trial to continue until 164 cases of COVID-19 were confirmed in trial participants after their second dose of Pfizer’s mRNA injection. These 164 cases would “be sufficient to provide 90% power to conclude true VE [vaccine efficacy] >30% with high probability” (p. 38, Clinical Protocol, https://cdn.pfizer.com/pfizercom/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf). The US Food and Drug Administration (FDA) accepted this endpoint when it approved Pfizer’s original protocol.

Pfizer declared Phase 3 of the trial a success on November 18, 2020, after 170 confirmed cases of COVID-19 and just about four months after the trial began. In a press release, Pfizer announced, “Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints” (emphasis added). After just 170 cases of COVID-19 in 41,135 participants who had received their second doses by November 13, 2020, Pfizer called the efficacy test a success based on a COVID-19 incidence rate of only 0.4% (170/41,135).

To make matters worse, Pfizer researchers diagnosed these COVID-19 cases using the faulty polymerase chain reaction (PCR) test (p. 55, Clinical Protocol, https://cdn.pfizer.com/pfizercom/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf). Researchers knew at the time that this test was inaccurate and had high rates of both false negative and false positive results. Yet the FDA approved PCR use in this clinical trial. Because most of these questionable COVID-19 cases were in placebo recipients, Pfizer declared the mRNA injection effective in preventing COVID-19, and the FDA approved the Pfizer injection for emergency use (EUA) on December 11, 2020.

At the same time, Pfizer and the FDA knew that some clinical trial participants had reported serious side effects from the mRNA injection. On November 24, 2020, Pfizer informed the FDA of the trial results in an interim report. Those results included 285 serious adverse events such as heart, liver, and neurological disease; cancers; and deaths. At that point, all trial participants were still blinded, and Pfizer could have continued the gold standard conditions for drug testing. Perhaps Pfizer and the FDA preferred to end the trial before more reports of serious adverse events could be recorded?

Meeting a milestone does not necessarily mean the end of a clinical trial. Yet, having reached the efficacy endpoint, in December 2020 Pfizer unblinded the placebo group and offered the mRNA injection to original placebo recipients (p. 4, Interim Protocol, https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M5_5351_c4591001-interim-mth6-protocol.pdf). By March 2021, nearly 90% of the original placebo group had received at least one dose of the Pfizer mRNA injection (p. 3, Safety Tables, https://phmpt.org/wp-content/uploads/2023/01/125742_S38_M5_c4591001-508-safety-tables.pdf). Thus, Pfizer effectively lost the ability to assess safety of the mRNA injection in comparison to a true control group.

Without a control group, data on adverse events are very difficult to interpret correctly, especially if one identifies only the original placebo and experimental (“vaccine”) groups without considering what happens to the placebo group after they receive the mRNA injection. If someone originally receives a placebo, later receives the mRNA injection, and then has a serious side effect, how is this event counted—as occurring in the placebo group or in the experimental group? If the event is counted among the placebo recipients, then potential harms caused by the mRNA injection are masked, making it difficult to get a true picture of the cause-effect relation.

Those reporting the data must pay close attention to the date a placebo recipient received the mRNA injection (dose 3) and the date they experienced side effects. For example, Fig. 1 shows cardiac events in the original placebo (light blue) and original “vax” (light red) groups. When these groups are adjusted (dark blue and dark red) to account for cardiac events in the unblinded placebo recipients after they received the mRNA injection (dose 3), cardiac events in the original placebo group (light blue) are shifted to the adjusted “vax” group (dark red). Thus, the adjustment increases cardiac events in the “vax” group; conversely, cardiac events in the placebo group decrease when the onset date of the adverse event is determined to be after the placebo recipient was unblinded and given the mRNA injection (dose 3).

Pfizer graded these cardiac events as least serious (toxicity grade 1) to most serious (toxicity grade 4). In all grades, the effect of unblinding the placebo group was the same (Fig. 1). In all but grade 3, those who received the mRNA injection had more cardiac events than those who received the placebo (for grade 3, events in both groups were equal).

Pfizer sent a second interim report on these and other serious medical events to the FDA on April 1, 2021 (p. 77, Table 16.2.7.4.1, Interim Adverse Events, https://pdata0916.s3.us-east-2.amazonaws.com/pdocs/070122/125742_S1_M5_5351_c4591001-interim-mth6-adverse-events.zip). When Pfizer presented these data, did they distinguish between the original placebo group and the unblinded, mRNA-injected placebo group? When FDA personnel reviewed this report, did they consider that most of the original placebo group had already received at least one dose of the Pfizer mRNA injection?

Why did the FDA authorize emergency use of Pfizer’s mRNA injection based on COVID-19 diagnosis in such a small fraction (0.4%) of the total study population? Why did the FDA approve the inaccurate PCR test for use in diagnosing COVID-19? Why did the FDA allow Pfizer to unblind the control group and abandon the gold standard in its clinical trial even as more and more mRNA recipients were seriously injured every day?

To Pfizer and the FDA, the clinical trial was a success; a “historically unprecedented achievement” according to Pfizer’s press release. But when Pfizer unblinded the placebo recipients and ruined the control group, the clinical trial of Pfizer’s mRNA injection did, in fact, fail. The ability to gather conclusive evidence of the long-term effects of Pfizer’s mRNA injection was destroyed, and no valid conclusions can be drawn about safety and effectiveness from Pfizer’s flawed clinical trial. When will Pfizer and the FDA admit this failure and stop promoting the mRNA “vaccine” as safe and effective?

Fig. 1 Cardiac adverse events (AEs) adjusted for placebo group unblinding (dose 3)

Report Summary

Most important finding: The clinical trial of Pfizer’s mRNA “vaccine” failed, despite Pfizer’s claims that the mRNA injection has been proven to be safe and effective.

Key detail leading to finding: Pfizer researchers deliberately stopped collecting data on the control group soon after the trial began.

Events of concern: Pfizer stopped the trial

long before the planned end date
when only a small fraction of participants had contracted COVID-19
after COVID-19 diagnoses made based on inaccurate PCR tests
while other participants were still reporting serious side effects

Further investigation: Why did the FDA authorize emergency use of Pfizer’s mRNA injection based on COVID-19 infection in a small fraction (0.4%) of the total study population? Why did the FDA approve the flawed PCR test for use in diagnosing COVID-19? Why did the FDA allow Pfizer to unblind the control group and abandon the gold standard in its clinical trial even as more and more mRNA recipients were seriously injured every day? When Pfizer presented subsequent data, did they distinguish between the original placebo group and the unblinded, mRNA-injected placebo group? When FDA personnel reviewed subsequent data, did they consider that most of the original placebo group had already received at least one dose of the Pfizer mRNA injection?

Scale of situation: The FDA approved Pfizer’s mRNA injection based on a flawed clinical trial.

Explanation of key scientific term: A double-blind randomized controlled trial is an experiment in which neither patients nor researchers know who receives the drug (or intervention) being tested and who receives a placebo (double blind); the trial participants are randomly chosen to receive either the drug or placebo (randomized); and the results of those who received the drug being tested (the experimental group) are compared to those who received the placebo (the control group).

(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9702955/)

The post Report 59: The Flawed Trial of Pfizer’s COVID-19 mRNA “Vaccine.” 90% of Original Placebo Group Received at Least One mRNA Injection by March 2021. appeared first on DailyClout.

March 3, 2023

Report 58: Part 2 – “Autopsies Reveal Medical Atrocities of Genetic Therapies Being Used Against a Respiratory Virus”

This report is a follow-up to “Report 56: Autopsies Reveal Medical Atrocities of Genetic Therapies Being Used Against a Respiratory Virus” and offers critical additional analysis.

Histopathological reevaluation of serious adverse events and deaths following COVID-19 vaccination

Professor Arne Burkhardt

Pathologist

Reutlingen, Germany

Professor Dr. Arne Burkhardt gave an update on his series of autopsy and biopsy cases associated with Spike associated gene therapy entitled “Histopathological reevaluation of serious adverse events and deaths following COVID-19 vaccination” at the January 2023 Pandemic Strategies: Lessons and Strategies conference in Stockholm Sweden, presented by the Swedish physician group Läkaruppropet. (The Doctors’ Call) https://lakaruppropet.se/ [Note: A rough draft was prepared using voice recognition then was edited for clarity with an effort to retain Professor Dr. Burkhardt’s original meaning. The text was then added to the presentation graphics. Text in italics has been added by the current author.]

Arne Burkhardt, Professor and M.D. of Pathology studied Medicine at the Universities of Kiel, Munich and Heidelberg. He trained in Pathology at the Universities of Heidelberg and Hamburg (1970 -1979) and became Professor of Pathology at the Universities of Hamburg (1979) and Tübingen (1991). He holds a position as an Extraordinarius Emeritus for General and Special Pathology at the University of Bern, Switzerland, and has been practicing as a pathologist in his own laboratory since 2008. Dr. Burkhardt has held guest professorships in numerous universities in the United States (Harvard, Brookhaven), Japan (Nihon), South Korea, and Europe. He has authored more than 150 original publications in international and German medical journals and contributed to textbooks in German, English, and Japanese.

Summary

The Burkhardt Group (TBG) now consists of a 10-member international research team of pathologists, coroners, biologists, chemists and physicists.

TBG now has 100 autopsy and 20 biopsy cases in various stages of analysis, 51 of which are the subject of this report.

There were 26 men and 25 women; ages ranged from 21 to 94.

Death occurred from seven days to six months after the last injection of Spike-mediated gene therapy. The larger series had one case in which death occurred eight months after the last gene therapy injection.

The deceased received Spike-inducing drugs from four manufacturers: Janssen/Johnson and Johnson, Pfizer/BioNTech, Moderna and AstraZeneca.

Initial autopsy reports listed cause of death as or “natural” or uncertain in 49/51 cases.

Evaluation consisted of Histology, Special Stains, Immunochemistry, and Advanced physicochemical methods.

Forensic autopsy disclosed that the cause of death at a highly likely or likely level of probability (to a reasonable degree of medical probability) was from Spike-inducing gene therapy products in 80% of cases.

Findings:

I. General Lesions affecting more than one organ were characterized by:

Presence of Spike protein and absence of nucleocapsid protein (SARS-CoV-2 only).
Both arterial and venous systems had inflammation of the inner lining of the blood vessel wall.
Larger vessels had evidence of inflammation in the elastic fibers of the aorta and larger vessels.
Crystals consistent with cholesterol were identified in remote tissues and were thought to have been released from atheromata that were unroofed after the inner arterial lining were disrupted by Spike-caused erosion of the endothelium releasing debris and cholesterol emboli.
Abnormal proteinaceous material consistent with amyloid was identified in multiple tissues.
Unusual and aggressive cancer was identified and labelled “Turbo Cancer.”
Atypical “clot” formation was identified.
“True” foreign bodies from contaminated vaccines were identified.

II. Specific Organ and Tissue Lesions involving the vascular system were characterized by:

Small Vessels:

Heart, lung and brain had evidence of inflammation of the inner wall of blood vessels (endotheliitis).
Evidence of bleeding (hemorrhage).
Unusual blood clot formation comprised of amyloid, spike protein, and fibrin.
Presence of small blood clots and clot forming blood cells.
Obliteration of blood vessels.

Large Vessels:

Disrupted blood vessel wall of the aorta with associated lymphocytic vasculitis and perivasculitis.
Damage to the inner lining of blood vessels with “unroofing” of cholesterol filled plaque.
Disruption of the inner lining of blood vessels with dissection into the muscular middle layer of major arteries and subsequent dissection and aneurysm formation.
Full thickness disruption of the aorta with exsanguination.
Thrombotic casts.

III. Main Pathologic Findings (other organs) were characterized by:

Myocarditis – lymphocytic infiltration with/without destruction of muscle fibers / scar formation
Alveolitis – diffuse alveolar damage (DAD) / lymphocytic interstitial pneumonia / endogen-allergic?
Lymphocytic nodules outside lymphatic organs / association with autoimmune diseases / Lymphocyte – Amok

Dr. Burkhardt: “I have to tell you how it all started…

Soon after the first vaccinations were done in Germany, I was approached by relatives whose loved ones had died suddenly after the vaccination. They were autopsied, and the pathologist said, ‘Well, it’s all natural causes.’ The loved ones didn’t believe it. So, they went to other pathologists. They declined to look at these slides. And I was approached if I could give a second opinion.

And I said, ‘Well, of course I’ve done this in 40 years of pathology practice, and I will do it.’ After the first five cases, I realized that this was not an easy task and that it had to change from a second opinion to a scientific project. First of all, I was alone, then joined by Professor Dr. Lang of the University of Hannover. He’s also an experienced pathologist.

We started to look many times at these specimens that were sent to us, and which had come from the autopsies done by other pathologists. Now we are all in all 10 pathologists, coroners, biologists, chemists, and physicists that have joined to elucidate these cases.

I have to remind you that this is an ongoing examination. In the tables that will follow, I have different collectives because I cannot update every time I give a lecture.

In August 22 we had:

51 deceased and four living persons that we examined. (As of January 2023, we have 100 autopsies and 20 biopsies.)
Of the 51 deceased, we had 26 men and 25 women.
Age range: 21 to 94.
Death occurred seven days to six months after the recent injection.

The vaccines are the ones that are usually in Germany. The task was to see if the vaccination had anything to do with the death occurrence.

Among 51 cases:

22 cases were autopsies by coroners and usually without histology.
20 cases were autopsies by pathologists.
One case by a pathologist and a coroner.
In all but two cases the cause of death was reported as “Uncertain” and mostly as “Natural.” Whatever natural death is.
It was stated the death could be possibly related to vaccination in only in one case.

After looking at all these specimens, histological slides in the microscope, we came to the conclusion that in 80% the vaccination had some influence on the death occurrence.

Death, of course, is a complicated occurrence, especially in an older person. But it may be influenced by vaccination, and there is usually a timely correlation. There’s one other study at Heidelberg University. They said in 30% that death after vaccination is correlated to the vaccination. (Schwab, et al.)

Most of the patients that we examined had a sudden death. They were found at home, on the street, or in the car. So, we don’t have changes caused by treatment like artificial respiration and so on. And of these, 15 of 19, were in the, in the category of what we call now sudden adult death syndrome (SADS). And you may notice this is a new term that has not existed before the vaccination.

What did we do? First of all, we had to realize that there is a difference between the true Corona infection and the vaccination to the body. The Corona infection has protein and other viral antigens like nucleocapsid, while the vaccination only has a spike protein.

So, we have a common denominator. There is an overlap between the true infection and the vaccination; but, in the vaccination, we have other components that might be of relevance to pathological changes like the lipid nanoparticles, mRNA, cholesterol, and, in some cases, contamination, for example, by metals. The later has not been very closely examined until now.

What is the difference between the entry and the primary target of the COVID-19 infection? The true infection goes to the epithelium: eyes, nose, pharynx, airways, and lung. This epithelium is immunocompetent. While, when we inject the vaccine, it goes into the interstitial tissue, into the muscle cells, the endothelium, and usually into the vessels. And these are not immunocompetent.

Now, what are the methods that we used? We used common histology, special stains, immunohistochemistry, and, in some cases, advanced physical chemical methods. From the beginning on, we were aware that this is a special challenge to us, because we don’t have a toxin that is coming from the outside, either by ingestion or by injection.

For example, systemic or histologic demonstration of toxins would not be of any significance; but we had to demonstrate a toxin that the body itself produced, and this was a Spike protein. And that’s why we very soon we developed a method to show the Spike protein in the tissues. (below)

And we differentiated this from the true infection by demonstrating the nucleocapsid antigen.

General Findings:

This is the first part of my presentation — general lesions expect affecting more than one organ.

Now, the first thing that we examined was the expression of Spike protein in the tissue. Then, we found that the endothelium is mostly affected, and there’s a disturbance of vessels generally, especially the larger vessels.

Then we have displaced unidentified vacuolar and crystalline particles, proteinaceous deposits, functional amyloidosis. We have unusual cancer manifestations, and we have clot formations in the blood and, in some cases, true foreign bodies. So, I will show you examples of these.

First of all, you’ve seen this already in the morning. This shows that we could confirm that the Spike protein is produced in the deltoid muscles where the vaccine is injected, but we could show it (Spike protein) in almost all organs, more or less explicitly.

And here (Below) you see a case where we show the testis. You can see that, in this 28-year-old man who had a healthy son and who died 140 days after injection, the Spike protein is strongly expressed in the testis.

Normal (https://histologyguide.com/) on the left. Compare the circled region in a normal subject with the corresponding section in the 28-year-old man. Look at the lack of cells, not the color, as the stains are different.

And you can see there are almost no spermatocytes (above right) in here, but there is strong expression of Spike protein in the spermatogonia.

This is an old man. And you can see here, also, a strong expression of Spike in the spermatogonia. There’s not one single spermatozoa in this.

So, if I may make a personal comment, this is not a scientific comment. If I were a woman in fertile age, I would not plan a motherhood from a person, from a man, who has been vaccinated. I think these pictures are very disturbing for me.

Lymphocyte Amok involving the testis.

In the testis, you can see this phenomenon which we called Lymphocyte Amok. We can see a lymphocytic infiltration and inflammation in the testes (above).

In the prostate gland, you can see a strong expression of Spike protein in this man.

This is very disturbing, but its meaning we don’t know yet. This is inflammation in the prostate.

This is not a prostatitis. It’s a lymphocytic infiltration in the prostate.

But I come now to the main changes, the main damage that is done by the Spike protein which is induced by the vaccination.

You can see here a Spike protein demonstration in a small capillary. You can see this is fat tissue. These are vascular structures, and you can see the Spike protein clearly and very distinctly marks capillary.

You can see here, on the left side, the spike protein in a small arteriole. The right inset box shows tissue with NO nucleocapsid protein thus no evidence of Covid-19 Spike. Only Spike from drug therapy is present.

Strong and distinct expression of Spike in the vascular endothelium of a small arteriole (below).

Inner part of these vessels has strong production of Spike protein that elicits a strong immunological reaction with destruction of endothelium. (Autoimmunity). Destruction of endothelium may be a major factor of the adverse effects of this vaccination.

Swelling of the endothelium associated with impaired perfusion (circulation) in a lower leg eight months following vaccination. Endothelium clearly expresses Spike. Occluded vessel on the right.

Aorta showing expression of Spike protein involving the endothelium (inner cell lining) and myofibroblastic (damaged heart muscle is replaced by fibrous tissue made by these cells) cells.

Foreign Body Reactions

Giant cell formation with needle-like cholesterol crystals. (Giant cells are formed from fusion of other white cells such as macrophages in areas of chronic inflammation involving a variety of agents including foreign material such as surgical implants, bacterial, viral, parasitic or fungal infections. (Amy K. McNally, James M. Anderson, Macrophage fusion and multinucleated giant cells of inflammation, in Cell Fusion in Health and Disease, Springer 2011, pp 97 – 111 Dittmar and Zänker (eds.))

Birefringent (https://www.youtube.com/watch?v=WdrYRJfiUv0) microscopy shows small cholesterol crystals.

Heart muscle with rod-like structures in vaculoes made of cholesterol crystals.

Tablet-shaped larger objects with small, granular ones thought to be cholesterol crystals.

Left: Rod-like crystals in a cholesterol preparation. Right: Rod-like cholesterol crystals in heart muscle.

Archive photograph: Where does the cholesterol come from? Not from the injection, because the amount would not be sufficient. We now believe that the cholesterol comes from the wall of the aorta and atherosclerotic vessels. When the Spike attacks the endothelium, the cholesterol is released.

Schematic of arterial wall showing an atheromatous plaque, two red stars, containing spindle-like cholesterol needles on the right side, a thick muscular layer occupying about 80% of the full thickness of the vessel, and the external surface of the artery, the vasa vasorum. The vessels on the outside of the artery are also induced to form Spike proteins.

Atheromatous plaques could be set free into the body’s circulation, right side showing cholesterol and debris being released into circulation.

Vaccinated person with an atheroma laid open by the destruction of endothelium releasing the contents into the artery.

Same Case:

Cholesterol has come out of the atheromatous plaque of the aorta and lodged in a splenic vessel.

Strange clots have been associated with LNP/mRNA treatment.

Lady with damaged capillary endothelium with severe disturbance to the circulation. Sometimes she is unable to walk. Pictured here, on the sole of the foot, is red discoloration signifying inflammation in blood vessels called vasculitis.

Blood was taken from this lady, and this clot formed in the serum after centrifugation and cooling in the refrigerator.

Clot stained and magnified. Proteinaceous practically acellular substance.

Examination of this clot was performed by specialized physical chemists, and they compared the contents of the plasma phase to the clot itself by mass spectroscopy. (Note: Proteomics is a branch of biotechnology concerned with applying the techniques of molecular biology, biochemistry, and genetics to analyzing the structure, function, and interactions of the proteins produced by the genes of a particular cell, tissue, or organism, with organizing the information in databases, and with applications of the data.)

137 proteins were present in the clot and not in the serum. In Red are substances related to the endothelium, a sign of continuous damage.

There are some hints that amyloid, a waxy translucent substance consisting primarily of protein that is deposited in some animal organs and tissues under abnormal conditions, could be formed of or by Spike proteins.

We very early found these deposits especially in vessel walls. You can see they are acellular (red stain) and compressed the vessel walls. Very early we had the suspicion this could be amyloid. (https://www.karger.com/Article/FullText/506696)

This could be proven by the special stain of Congo Red. (https://www.pathologyoutlines.com/topic/stainscongored.html)

This is spleen and was found in the biopsy specimen of this lady that I showed you before (Case 39). So, she has some amyloid and, certainly, this has some meaning for the function of the vascular tissue. Also, we have these deposits in the brain.

Specific Organ and Tissue Lesions

We come to the specific on organ lesions. We have the small vessels showing destruction of the endothelium.

Here you can see the normal on the left side and the destructive capillary endothelium in heart muscle on the right side.

You can see that we can show Spike protein in these lesions.

We can find a CD61+ thrombocyte apposition in these lesions. The CD (Cluster of Differentiation) designation refers to a convention of nomenclature for molecules of the cell surface of certain white cells. [https://www.hcdm.org/index.php/component/molecule/?Itemid=132] These white cell surface molecules are important to the function of the immune system. [https://www.immunopaedia.org.za/immunology/basics/cd-nomenclature/] Combined with CD41, the CD61 cell plays a role in platelet aggregation and clotting. [Principles of Immunophenotyping Faramarz Naeim, in Hematopathology, 2008, https://www.sciencedirect.com/science/article/pii/B9780123706072000028.]

This is the amyloid deposition in a small vessel in the heart muscle.

Occlusion (blockage or closing) of this vessel.

This is in the brain with inflammation of the small vessels.

Here is Spike protein demonstration.

One very important finding, in our view, is the destruction and disruption of larger vessel walls.

We found media necrosis and breakup in these larger vessels.

Where do we find the media necrosis? We found it in idiopathic arteriosclerosis as shown here, and infection-toxic syphilis, Lathyrism and, apparently, Spike-induced.

This is an historic specimen from before World War I showing syphilitic destruction of the media (the middle, muscle layer of the artery).

You can see what a normal aorta looks like this. It has a very regular, organized situation.

You can see here what we found in our deceased persons. You can see that the aorta is split.

The media (yellow) is necrotic, and there are inflammatory infiltrates, which in idiopathic form is not present. We can see that the media is largely destructed.

There are inflammatory infiltrates and destruction of the elastic lamella (layer of tissue) (yellow). You can see that the elastic lamellae are discontinuing. There are inflammatory infiltrates, which in the idiopathic form is not present.

We can see media (yellow) largely destroyed.

The inflammatory infiltrates

with destruction of the elastic lamella. You can see that the elastic lamellae are discontinuous.

We can show here that the Spike protein expression in these hyperplastic myofibrils and also in the inflammatory infiltrate.

This is one of the autopsies that we did in a 56-year-old man.

He had this, media[l] necrosis of the aorta. You can see here that the wall of the aorta is split (Red) into two parts, and in the middle there’s black blood. (Yellow)

And this is a histological preparation. You can see very clear that there is medial necrosis,

and you can see here that there’s a dense inflammatory infiltrate

and a mass of histiocytes and macrophages.

First of all, we thought, we may be looking at a phantom; but, in Japan, they saw the same thing – aorta dissection, complicated by pericarditis and inflammation.

So, we did not only see this in the aorta, but also in the renal artery,

in the splenic artery,

the carotid artery.

Here you can see vacuolar degeneration of the media.

Also seen in the vertebral artery.

In the brain, there are residuals of bleeding. (Congo Red stain)

Blue stain represents Iron (Fe), so there has been bleeding in the small arteries in the brain.

You can see that the elastic lamellae are disrupted, and there are small, what we call aneurysms,

which might be ruptured at any time.

This occurred not only in the brain but also in the thyroid gland arteries. We saw these residuals of the destruction of the elastic lamella and iron deposition.

Here you can see the iron in the vessel wall.

And now I come to the very delicate point because this might be the reason for some of the cases of a sudden death syndrome, because we see this in the coronary artery. At the bottom, you see a normal artery without arteriosclerosis. And you can see in the upper part, you can see there’s a cushion-like expansion and occlusion in the upper part. We saw this in many of the cases where the coronary artery was examined.

You can see here the medial necrosis with vacuolar degeneration (red arrow).

This is not arteriosclerosis. This is medial necrosis…

with some infiltration (yellow arrow) and vacuolar degeneration.

Here we demonstrate Spike protein in the inflammatory and myofibroblastic (https://www.ahajournals.org/doi/10.1161/CIRCRESAHA.120.316958) cells.

There are many T lymphocytes which, of course, cause immunological auto-aggression (autoimmunity).

This is a case of a 22-year-old man who has a scar in the coronary artery. This is not an arteriosclerotic plaque.

I come to the meaning of these findings.

I think that the Sudden Adult Death Syndrome, means a death without conventionally detectable cause. Pathologists’ term this as ‘arrhythmogenic heart failure,’ which I don’t really know what they mean by that; but we have a focal medial necrosis of the coronary artery with swelling and luminal construction, with and without thrombosis.

We have Spike protein expression, T lymphocyte, macrophage and myofibroblastic reaction. We have lymphocytic perivascular inflammation, and this may be the underlying cause of what we call an acute coronary artery.

There’s no time that true necrosis of the muscle is manifest. So, there’s no pathologic findings of myonecrosis (dead heart muscle). We have no drugs outside the lymphatic organs showing an association of autoimmune disease.

We are increasingly seeing younger persons with skin lesions. This is a 20-year-old man with vasculitis and atypical lichen of the skin. You can see here the vasculitis.

We have another case, a very impressive case of a 30-year-old woman two weeks after the second injection. She had zero general side effects but had massive skin lesions, rash, (inaudible), and bullae. She corresponded with me. She told me, ‘…my beautiful skin full of stains, my sexual life because I do not undress anymore.’

I left out some details. ‘I love the sea. It was taken from me because I cannot wear a bikini. Before I have felt fine. Now I get panic attacks without reasons.’

And these are the skin lesions that she never had before.

We see what we call, what is typical of an autoimmune disease, destruction of the basal cells with a band-like lymphocytic infiltration.

But in the lower part, you can see a small vessel, and this is atypical. It’s a vasculitis.

You can see the vacuolated basal cells are disrupted. And you can see again Spike (red arrow) protein can be demonstrated in the cell.

This is a vasculitis (yellow circle) and also in the small vessel are Spike protein.

The last picture I will show you: the brain has Congo Red (stain) deposits which are very much like what we find in Alzheimer’s disease and…

Alzheimer’s disease is increasing.

There is an association of COVID-19, but as we see also with the vaccination.

Now, it’s unfortunately this was meant to be funny some years ago, but it has become a grim reality now. (Translation: I refer you to a Pathologist.)

I get about 20 to 35 telephone calls, because my name is now well-known in Germany and also in some adjourning country state, call me and they ask for help and they ask if I can do an examination and evaluation of their deceased relatives. All of themselves or the relatives with severe side effects.

I think I can close here. I could show you more cases. I have a collection, as I said, of 100 cases now, and it’s very hard to select what I want to show you. But I think I have been able to show you that there are very disturbing, very alarming findings that we have in the autopsy and also in the biopsy cases.

I think this is a reason to stop this vaccination at once.“

lorrie.mcneill@fda.hhs.gov

The post Report 58: Part 2 – “Autopsies Reveal Medical Atrocities of Genetic Therapies Being Used Against a Respiratory Virus” appeared first on DailyClout.

March 1, 2023

Losing Control of the Controlled Clinical Trial in These Times of Emergency Use Authorization (EUA) Vaccines

Do you remember your high school science teacher explaining what a controlled experiment is? It is when just one thing is changed in the group receiving the experimental intervention (compared to the “control” group receiving standard or no treatment), then one waits to see if there is a difference in the outcome between the two groups. In controlled clinical trials, the “standard” treatment is often a marketed product with an already well-known safety profile, and the “no treatment” is placebo. https://www.fda.gov/patients/clinical-trials-what-patients-need-know/glossary-terms

Merriam-Webster defines a “controlled experiment” as “an experiment in which all the variable factors in an experimental group and a comparison control group are kept the same except for one variable factor in the experimental group that is changed or altered.” https://www.merriam-webster.com/dictionary/controlled experiment

What does the Food and Drug Administration (FDA) say about this basic tenet of science? In a 2014 draft guidance, they acknowledge that “the simultaneous use of more than one investigational product may confound the results of the clinical investigations” and voice concern for subjects “exposed to more than one investigational product for which the safety profile may not be well understood.” https://www.fda.gov/regulatory-information/search-fda-guidance-documents/informed-consent

In study protocol documents, such as those found on https://clinicaltrials.gov, one might see such language prohibiting administration of two investigational products during a single time period in either the eligibility criteria or concomitant medications sections. Just a few examples:

Exclusion Criteria: Patients who have received any other investigational agent ≤ 28 days prior to registration are not eligible. https://clinicaltrials.gov/ProvidedDocs/43/NCT02808143/Prot_SAP_000.pdf
Exclusion Criteria for enrollment: Prior/Concomitant therapy: Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccine during the period beginning 30 days before the dose of study vaccine, or planned use during the study period. https://clinicaltrials.gov/ProvidedDocs/98/NCT04657198/Prot_000.pdf
Concomitant Medications: Restricted Treatments: Investigational agents
Note: prohibited within 4 weeks prior to https://clinicaltrials.gov/ProvidedDocs/94/NCT04173494/Prot_000.pdf

Early on in the initial COVID-19 vaccine rollout, a very reasonable question was posed to the FDA regarding receipt of an unplanned, additional investigational product (such as an EUA vaccine) during a controlled clinical trial. The FDA responded with the following guidance:

Q27. Certain clinical trial protocols have an exclusion criterion for receipt of another “investigational medical product.” If a participant receives a vaccine or other medical product for the prevention or treatment of COVID-19 authorized under an Emergency Use Authorization (EUA), would FDA consider this receipt of an investigational medical product?

When a medical product is being used under an EUA, it is an authorized (though not an approved or cleared) medical product for use in clinical care that has met the statutory criteria under section 564 of the FD&C Act. The product is not being studied under an IND or IDE when used pursuant to an EUA, and FDA therefore does not consider receipt under an EUA as receipt of an investigational product.82 In contrast, when the same product is used in a clinical investigation under an IND or IDE, the product’s safety and/or effectiveness is being studied for investigational uses, and FDA would consider receipt in this situation to be receipt of an investigational product.

As always in the design of a clinical investigation, there may be valid scientific reasons to have an exclusion (and even a discontinuation) criterion for a medical product—a monoclonal antibody or vaccine, for example—whether that product was used under an EUA or not. These scientific reasons may include risks to an individual if they enroll or continue to participate in a clinical trial after receiving (or having received) the excluded product, or the potential impact of the use of the excluded product on trial objectives, such as confounding the determination of effectiveness of the product under investigation. [https://www.fda.gov/media/136238/download]

To me, this recommendation did not jibe with the tenets of modern drug development. Concerned, I wrote to the FDA that it was not “acceptable for an experimental medical product to be randomly introduced into a proper clinical trial if in the setting of an ’emergency.’” Receipt of an EUA COVID-19 vaccine by a clinical trial subject already taking the trial’s investigational agent would result in exposure “to more than one investigational product,” regardless of regulatory pathway. https://www.pandata.org/a-second-letter-to-dr-peter-marks-food-and-drug-administration/

For your reference, the FDA’s response back to included below.¹

The FDA guidance above (“Q27”) is “intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).”

Someday, when all “declarations” are over, will we return to the controlled clinical trial as I once understood it?

References:

McNeill, Lorrie

May 27, 2021, 5:18 AM

to me

Dear Dr. Taccetta –

Thank you again for your March 22, 2021 correspondence regarding the Emergency Use Authorization for COVID-19 vaccines. The following information addresses the topics conveyed in your letter to Dr. Peter Marks.

Please refer to FDA’s January 2017 Guidance for Industry and Other Stakeholders titled, Emergency Use Authorization of Medical Products and Related Authorities (https://www.fda.gov/media/97321/download). Section III of this guidance document states:

“The EUA authority under section 564 allows FDA to facilitate availability and unapproved uses of MCMs needed to prepare for and respond to CBRN emergencies. The EUA authority is separate and distinct from use of a medical product under an investigational application (i.e., Investigational New Drug Application (IND) or Investigational Device Exemption (IDE)), section 561 expanded access authorities, and section 564A emergency use authorities discussed in section IV of this guidance.”

For your convenience, we have underlined the relevant sentence of the paragraph that pertains to your statement, “As all COVID-19 vaccines are products under EUA, thus “investigational vaccines,” by allowing patients in any non-designated trial to randomly receive these vaccines, we are essentially altering the general investigational plan of said trial by adding an additional investigational agent(s).” In summary, each vaccine that FDA makes available by EUA authorizes use of an unlicensed product based on criteria set out by statute and when used according to the conditions of the EUA, the IND regulations are not applicable.

We have restated your topics below and addressed them accordingly:

Subject Participation in More Than One Clinical Investigation

As stated above, each vaccine that FDA makes available by EUA authorizes use of an unlicensed product based on criteria set out by statute and when used according to the conditions of the EUA, the IND regulations are not applicable. In addition, please refer to FDA’s January 2021 Guidance for Industry, Investigators, and Institutional Review Boards titled Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency (https://www.fda.gov/media/136238/download). Specifically, Question and Answer #27 states:

Question– Certain clinical trial protocols have an exclusion criterion for receipt of another “investigational medical product.” If a participant receives a vaccine or other medical product for the prevention or treatment of COVID-19 authorized under an Emergency Use Authorization (EUA), would FDA consider this receipt of an investigational medical product?

Answer– When a medical product is being used under an EUA, it is an authorized (though not an approved or cleared) medical product for use in clinical care that has met the statutory criteria under section 564 of the FD&C Act. The product is not being studied under an IND or IDE when used pursuant to an EUA, and FDA therefore does not consider receipt under an EUA as receipt of an investigational product. In contrast, when the same product is used in a clinical investigation under an IND or IDE, the product’s safety and/or effectiveness is being studied for investigational uses, and FDA would consider receipt in this situation to be receipt of an investigational product. As always in the design of a clinical investigation, there may be valid scientific reasons to have an exclusion (and even a discontinuation) criterion for a medical product—a monoclonal antibody or vaccine, for example—whether that product was used under an EUA or not. These scientific reasons may include risks to an individual if they enroll or continue to participate in a clinical trial after receiving (or having received) the excluded product, or the potential impact of the use of the excluded product on trial objectives, such as confounding the determination of effectiveness of the product under investigation.

Muddying of Safety Signals

Under FDA regulations at 21 CFR 312.32, an IND sponsor must report to FDA any serious adverse event (SAE) that is both unexpected and for which there is a reasonable possibility that the drug caused the serious adverse event, i.e., there is evidence to suggest a causal relationship between the drug and the adverse event.

For an individual who has received an FDA-authorized COVID-19 vaccine (i.e., not as a participant in a COVID-19 vaccine clinical trial) and is participating in a clinical trial that is investigating another medical product, the sponsor of the trial or the participant may report a suspected vaccine adverse event to the Vaccine Adverse Event Reporting System (VAERS).

In addition, regarding the COVID-19 clinical trials, the general safety evaluation of COVID-19 vaccines, including the size of the safety database to support vaccine licensure, have not been different than for other preventive vaccines for infectious diseases. Furthermore, a comprehensive surveillance system is in place to monitor the safety of COVID-19 vaccines post authorization. The details of the safety surveillance system are available on the FDA website at https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/covid-19-vaccine-safety-surveillance.

For each of the COVID-19 vaccines that have received Emergency Use Authorization, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) includes information on adverse reactions that were reported during clinical trials.

In the design of any clinical investigation, consideration should be given to potential confounding of the evaluation of safety of the investigational product that may be introduced by receipt of another medical product, including COVID-19 vaccines or other vaccines – whether under an EUA or not.

Please note that the circumstances of each clinical trial are different, and sponsors are encouraged to discuss any questions with FDA.

No Communication of Risk

Please refer to page 24 of FDA’s January 2017 Guidance for Industry and Other Stakeholders titled, Emergency Use Authorization of Medical Products and Related Authorities.

“Although informed consent as generally required under FDA regulations is not required for administration or use of an EUA product, section 564 does provide EUA conditions to ensure that recipients are informed about the MCM they receive under an EUA.”

FDA must ensure that recipients of the product are informed, to the extent practicable given the applicable circumstances, that FDA has authorized the emergency use of the product, of the known and potential benefits and risks, and of the extent to which such benefits and risks are unknown, that they have the option to accept or refuse the product, and of any available alternatives to the product. Typically, this information is communicated in a “fact sheet.” Each

COVID-19 vaccine authorized by FDA for Emergency Use has a Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and a Fact Sheet for Recipients and Caregivers and these are available on the FDA website at:

Absence of Cohesive and Collaborative Safety Reporting

Please refer to our response in the section titled “Muddying of Safety Signals.”

In addition, as a condition of the EUA, each EUA holder (Pfizer Inc. Moderna TX and Janssen Biotech) is required to report the following to the Vaccine Adverse Event Reporting System (VAERS) for their vaccine:

•Serious adverse events (irrespective of attribution to vaccination),

•Cases of Multisystem Inflammatory Syndrome in children and adults; and

•Cases of COVID-19 that result in hospitalization or death that are reported to the EUA holder

Furthermore, it is mandatory for healthcare providers administering COVID-19 vaccines (vaccination providers) to report the following to VAERS:

•Vaccine administration errors whether or not associated with an adverse event,

•Serious adverse events* (irrespective of attribution to vaccination),

•Cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and

•Cases of COVID-19 that result in hospitalization or death.

As you are likely aware, anyone can submit a report to VAERS.

Questions about Liability

Please refer to page 41, section VII, Liability Protection of FDA’s January 2017 Guidance for Industry and Other Stakeholders titled, Emergency Use Authorization of Medical Products and Related Authorities for information pertaining to your question.

In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) for each COVID-19 vaccine that has been made available by EUA includes the following information:

The Countermeasures Injury Compensation Program

The Countermeasures Injury Compensation Program (CICP) is a federal program that has been created to help pay for related costs of medical care and other specific expenses to compensate people injured after use of certain medical countermeasures. Medical countermeasures are specific vaccines, medications, devices, or other items used to prevent, diagnose, or treat the public during a public health emergency or a security threat. For more information about CICP regarding the COVID-19 Vaccine used to prevent COVID-19, visit www.hrsa.gov/cicp, email cicp@hrsa.gov, or call: 1-855-266-2427.

Please be assured that each vaccine authorized for emergency use by FDA has met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.

We hope that you have had the opportunity to receive one of the three COVID-19 vaccines.

Best regards –

Lorrie

Lorrie H. McNeill
Director

Office of Communication, Outreach and Development

Center for Biologics Evaluation and Research

U.S. Food and Drug Administration