Yet Another Validation of DNA Contaminants in COVID-19 mRNA Vaccines

TrialSite recently covered the unfolding “plasmidgate” controversy involving DNA contamination found in same of COVID-19 mRNA vaccine product. To date, this media reported on four such studies featuring what some experts are declaring are unacceptable amounts of DNA contamination in the mRNA vaccines, with an emphasis on the Pfizer-BioNTech product.

A new study has been uploaded to OSF Preprints, and one of the authors is a regular TrialSite contributor, David Wiseman, Ph.D., but also includes none other than Kevin McKernan of Medicinal Genomics in Beverly, Massachusetts, the investigator leading the first study verifying that DNA contaminants in the mRNA vaccine vials exceeded the European Medicines Agency 330ng/mg requirement and the Food and Drug Administration (FDA) 10g/dose requirements.

The new study is titled “DNA fragments detected in monovalent and bivalent Pfizer/BioNTech and Moderna modRNA COVID-19 vaccines from Ontario, Canada: Exploratory dose response relationship with serious adverse events.” While this study is not yet peer reviewed, meaning as a matter of scientific practice the findings should not be cited as evidence, the combination of seriousness, relevance and timeliness of findings merit high level introductory overview in the TrialSite.

Representing the study as corresponding author is Dr. David J. Speicher, Ph.D., DTM, a molecular virologist and clinical epidemiologist whose Ph.D. thesis in 2012, on the detection and characterization of HHV-8 led to the first HHV-8 quantitative PCR assay in Australia. He currently teaches and does research at University of Guelph.

Other authors involved with this study include Jessica Rose, Ph.D. and Maria Gutschi, a research pharmacist and drug assessor in Canada.

The study team acknowledges in their study paper the recent studies covered by TrialSite pointing to significant levels of plasmid DNA in both mRNA COVID-19 vaccine products (Pfizer-BioNTech and Moderna). But the authors acknowledge that the previous study findings were based on output based on a limited number of lots, as well as questions linked to variance and quality of the underlying samples used in those studies.

The Study

In vitro transcription employed to generate nucleoside RNA (modRNA) for SARS-CoV-2 vaccines to date relies on an RNA polymerase transcribing from a DNA template, meaning DNA is required in the mRNA production process.

In this context, as an example, the manufacture of the modRNA used in the original Pfizer randomized clinical trial was based on such PCR-generated DNA template.

In fact, by generating clones into a bacterial plasmid vector for amplification in Escherichia coli before linearization, part of the second process making up this study, the team can expand the size and complexity of possible residual DNA, while bringing sequences not present in the template mentioned above.

Articulating that Moderna’s vaccine, both clinical trials and post authorization mRNA product, is based on a comparable plasmid-based set of processes, the present authors used quantitative polymerase chain reaction (qPCR) and Qubit® fluorometry as part of a process to test the additional 27 vials of mRNA COVID-19 vaccine product obtained in Canada.

With the samples drawn from 12 unique lots including:

5 lots of Moderna child/adult monovalent
1 lot of Moderna adult bivalent BA.4/5
1 lot of Moderna child/adult bivalent BA.1
1 lot of Moderna XBB.1.5 monovalent
3 lots of Pfizer adult monovalent
1 lot of Pfizer adult bivalent BA.4/5

To better understand safety profile, the authors queried the U.S. Vaccine Adverse Event Reporting System (VAERS) database for the number and categorization of adverse events (AEs) reported for each of the lots tested. Using Oxford Nanopore sequencing, this helped the team investigate the content of one of the previously studied Pfizer COVID-19 vaccine vials as part of the quest in this study to determine the size distribution of DNA fragments.

Speicher and team also used the sample to verify if the “residual DNA is packaged in the lipid nanoparticles (LNPs) and thus resistant to DNaseI or if the DNA resides outside of the LNP and is DNaseI labile.”

Findings

Based on the dose response model established, Speicher and team conducted an exploratory analysis, finding at least early evidence of a dose response relationship of the amount of DNA per dose and the frequency of serious adverse events (SAEs). Could it be that COVID-19 mRNA vaccine safety as reflected in the number of safety incidences could be predicted based on this model?

The study authors report that the Pfizer and Moderna products differed based on size distribution analysis---mean and maximum DNA fragment lengths of 214 base pairs (bp) and 3.5 kb, respectively.

Disturbingly, the study authors write, “The plasmid DNA is likely inside the LNPs and is protected from nucleases.”

Takeaway

Of course, this study output needs to be vetted via peer review, but the authors demonstrate the presence of billions to hundreds of billions of DNA molecules per dose in the studied Pfizer and Moderna mRNA 19 vaccines.

The study team was able to verify using fluorometry that “all vaccines exceed the guidelines for residual DNA set by FDA and WHO of 10 ng/dose by 188 – 509-fold.”

During this study, Speicher et al. point to the need for methodological clarity and consistency when interpreting quantitative guidelines based on observations for instance, that the qPCR residual DNA content in all vaccines were below established guidelines.

They point out, “The preliminary evidence of a dose-response effect of residual DNA measured with qPCR and SAEs warrant confirmation and further investigation.”

Perhaps most importantly is the overall mounting unease about the COVID-19 mRNA vaccines. This concern is expressed by the present authors:

“Our findings extend existing concerns about vaccine safety and call into question the relevance of guidelines conceived before the introduction of efficient transfection.”

https://www.trialsitenews.com/a/yet-another-validation-of-dna-contaminants-in-covid-19-mrna-vaccines-deae0432

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Ivermectin/Hydroxychloroquine Lawsuits Continue On

Physicians in Iowa are suing the state’s licensing boards to overturn restrictions associated with repurposed drugs used for COVID-19, including Hydroxychloroquine and Ivermectin. The physician has filed a civil lawsuit seeking a court order to force pharmacies to fill prescriptions for these drugs.

This news was reported by the Des Moines Register and other sources. Why is Iowa doctor David Hartsuch pursuing a lawsuit against the Iowa Board of Medicine and Iowa Board of Pharmacy? He is accusing them of dissuading members against use of hydroxychloroquine and ivermectin as a regimen for COVID-19.

Citing one study published in the Journal of the American Medical Association, the plaintiff points out that despite the fact that the FDA doesn’t authorize the drugs for COVID-19, approximately 1 in 20 U.S. adults are identified as using hydroxychloroquine or ivermectin for COVID-19 treatment.

Briefly authorized as an emergency medicine during COVID-19, Hydroxychloroquine’s status was revoked when ensuing research suggested the potential for harm. Although conflict ensued thereafter over the research, with some studies showing efficacy and others not. Ivermectin was never authorized in the United States although at least a dozen nations, mostly in low-and middle-income countries, authorized ivermectin on an emergency basis against COVID-19.

While some prominent larger studies (TOGETHER, COVID-OUT, ACTIV-6) showed no efficacy, many others have shown promise. For example, a website tracks ongoing studies which now total 99 studies covering 137,255 patients across 28 countries. The takeaway: the drug can statistically lower risk for mortality, ventilation, ICU and other targeted outcomes. But critics in institutions such as the NIH suggest these studies are not trustworthy, with poor design, questionable data, and the like.

Regardless, by 2021, weekly ivermectin prescriptions, according to one study, skyrocketed from 3,000 per week to nearly 90,000 per week!

The FDA joined in on an information war against the drug, labeling it only as an animal drug, when of course hundreds of millions of doses are administered to humans per year.

Iowa Clash

Dr. Hartsuch’s conflict with the Iowa licensing boards emerged in March 2020. While during summer and late 2020 growing ivermectin use across America was generally accommodated, as Biden entered the White House, the conditions changed.

This market demand triggered a massive industry, government and academic medical system response. TrialSite examined how the federal government went after doctors indirectly in December 2021. In “Feds coming after Doctors & Pharmacies that Market Ivermectin as Safe & Effective for COVID-19” for example, the FDA wrote letters to group such as the Federation of State Medical Boards (FSMB) warning state groups to monitor members for espousing misinformation involving ivermectin.

This campaign spooked doctors and pharmacists around the nation. By the fall of 2021, it was becoming harder for doctors such as Hartsuch to prescribe the off-label drug to his patients. Pharmacies were increasingly on alert.

So, a patient of Dr. Hartsuch for example, could not get ivermectin prescriptions filled, which led to investigations by the Board of Medicine into the doctor’s ivermectin prescribing trends.

But the Iowa physician points out in his complaint that warning letters received by the Iowa Board of Medicine were violative of core free speech rights, during his professional brand reputation.

Now seeking the court to expunge the warning letter from his record, he demands an injunction requiring pharmacies to fill prescriptions for the off-label drugs.

The Iowa physician’s point of view: doctors’ rights to consider and prescribe repurposed off-label drugs is a basic physician right, as long as they follow their professional standards (e.g., consent, etc.).

In other states such as Nebraska, the attorney general doesn’t enforce disciplinary measures should physicians prescribe drugs like ivermectin or hydroxychloroquine for COVID-19.

Before COVID-19 physicians routinely would prescribe off label drugs typically with little to no problems.

https://www.trialsitenews.com/a/ivermectinhydroxychloroquine-lawsuits-continue-on-81c1b8ee

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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The Decline and Near Fall of the COVID Vaccine Makers

The uptake of the latest version of the COVID vaccines, which underwent almost no testing but were rubber-stamped by regulators anyway, has been far lower than expectations. The CDC is not publishing real-time data but what we know so far suggests that it is in the realm of 2 percent.

This is incredibly low. The most pessimistic prediction I had heard was 5 percent. This is a deep failure by any standard. That is precisely why the numbers are not being advertised. The average person has stopped buying what they are selling.

Initially, the excuse was that drug stores faced logistical problems. Then it was widely suggested that they were too expensive. For a few weeks, such diversions dominated the messaging. But in the end, the reality is here: people just don’t want them.

Now we see why the shot pushers were so intent on mandates wherever and however they could. The makers always claimed that the shots were safe and effective but that bypasses a more fundamental question: were they necessary?

The demographics of risk of COVID have been published and unchanged since February 2020, fully a year before the shots became generally available. By that time, millions were already exposed and gained immunity without the shots.

From the beginning, the claims for what they called a vaccine were wildly exaggerated and obviously so. Vast numbers of people had figured this out by the time they were rolled out.

The Biden administration was advised early on that ending the pandemic required 70 percent uptake, which is consistent with the pharmaceutical target for herd immunity. But that goal presumes an absence of natural immunity, which the crowd in charge at the time pretended did not exist or that there was not enough evidence to rely upon it.

When that number failed to stop the spread, the Biden White House kept expanding the goal, from 70 percent to 85 percent to 90 percent to everyone. Finally, they said that the whole reason COVID still existed was due to the unvaccinated, which most every expert knew was false but the needs of industry at that point overrode all science.

The main competitor to the two mRNA shots of Pfizer and Moderna was Johnson & Johnson, which was a more traditional vaccine and required only one shot. But that was withdrawn briefly for safety concerns by the Food and Drug Administration (FDA) in 2021, which wrecked its market share, leaving only two giants to scoop up the fiduciary rewards of public panic.

Keep in mind that these vaccines were developed by tax dollars. The companies enjoyed patent protection. Briefly, the Biden administration toyed with the idea of giving away the formulas so that anyone could make them but that idea faded quickly following panicked industry protests. Then they relied on mandates, which is a form of conscription. Further, they enjoyed indemnification against harms. Finally, they are publicly listed companies so could reap the whirlwind of profits, and they did.

After three years, where does the stock price of Pfizer and Moderna stand? Moderna has lost 74 percent of value in two years, while Pfizer has lost 46 percent. No question that the time to have sold these stocks was two years ago. The layoffs have already started and their valuation will likely crawl back to what it was two years ago.

There is a temptation to cheer when big shots bite the dust, and I share that sense. And yet, nothing about a fallen stock price undoes the tremendously terrible history of these shots: the expense, the coercion, the harms, and the wealth transfer associated with them.

All of which is to say: they will likely get away with the whole thing.

I often think back to what we knew about coronaviruses from the first days. Such viruses are mostly unstable, prone to constant mutation. They are not candidates for viable vaccines. At best, pharmaceuticals can chase down the last variant and provide some therapeutic benefit. They are completely unlike polio, measles, rubella, or smallpox, which are stable viruses against which there have been sterilizing vaccines for a very long time.

Again, this is not wisdom we recently discovered. It was widely known, and has been for many decades. You could find it in any medical textbook. You could even learn about it in 9th grade biology class a generation or two ago.

For some strange reason, by the time 2020 came around, enough people had forgotten or never learned that bad actors were able to manipulate the public into believing that a magic shot could make a respiratory virus go away. There was never any chance that we could vaccinate our way out of this one. Never.

As for safety and efficacy of the shot, I can only quote Tracy Høeg: “There was thus no informed consent and, as stated, safety and efficacy almost entirely unknown when the vaccine was administered to the public.”
Meanwhile, the FDA had a strong team focused on vaccines, which resigned when they saw what was coming with the first booster and how the manufacturers were essentially buying their way into the approval process. Those who remain, it is widely acknowledged, are entirely in the pay of the industry.

Will they get away with all of this? Certainly the public and the financial markets are now in a punishing mode. It’s about time. As for larger accountability, it’s unclear. We had investigations going and some focus on Capitol Hill but all that might be shelved now in light of the huge attention being paid to war in the Middle East. War tends to do this: put everything else on the back burner.

No question that we urgently need reforms, particularly with the problem of regulatory capture and indemnification against harms. The 1986 act (National Childhood Vaccine Injury Act [NCVIA]) that protects vaccine makers against harms needs an urgent repeal. That will bring an element of reality back to these markets.

And measures need to be taken to restore integrity and science at the FDA. That’s just the beginning.

At the start of this entire mess, thinking and writing not as an expert but as a literate human being, I pretty much assumed that the vaccine would be a great distraction from the need for good protocols for dealing with the sick. It turned out to be far worse than a distraction. Many people have been injured and many have died. The entire fiasco has massively raised public doubt about all vaccines, pharmaceuticals, medical services, and public health generally.

What this means is that even without serious efforts at reform, we could see de facto refusal of the public to go along anymore. Public health in this country and around the world squandered decades of goodwill and built up reputational capital on an unworkable project that was never necessary for the vast majority. Now we are stuck with the consequences.

Given all this, a lowered stock valuation for the main two vaccine distributors is small consolation.

https://www.theepochtimes.com/opinion/the-decline-and-near-fall-of-the-covid-vaccine-makers-5513280?ea_src=au-frontpage&ea_med=opinion-6

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COVID-19 Vaccines and Reports of Deep Vein Thrombosis (DVT)

Reports of deep vein thrombosis (DVT), the formation of blood clots, as an adverse effect associated with COVID-19 vaccines, are increasing. TrialSite has reported before on the blood clot crisis linked to COVID-19 and its vaccines. A compilation of such hematological case reports has been contributed by Aaron Hertzberg. We will summarize some of them here.

Deep vein thrombosis (DVT) is a medical condition where blood clots form in a deep vein; usually in the lower leg, thigh, or pelvis. However, sometimes they can form in the arm.

Case reports of the adverse events following the COVID-19 vaccine administration are appearing after the massive vaccination campaigns to control the pandemic. Studies have been conducted to investigate the link between these vaccines and blood clot formation. Here we present a summary of case reports of DVT, post-COVID-19 vaccination.

Case 1
The first paper mentioned here entitled “Deep vein thrombosis (DVT) occurring shortly after the second dose of mRNA SARS-CoV-2 vaccine” was published in the Internal and Emergency Medicine journal in 2021.

This case involved a 66-year-old female who received two doses of the Pfizer vaccine. Before vaccination, the woman had been completely healthy and did not smoke or have any allergies. She just had a history of left leg neuropathy (damage to peripheral nerves in the leg) after a trauma. A day after receiving her second dose, she had a persistent fever with chills, fatigue, muscle pain, and discomfort. To control these symptoms, she was administered acetaminophen, a drug used for bringing down fever and easing pain. The fever had not resolved by the next day and the patient had also developed acute pain in her right calf in the absence of any trauma. On the third day post vaccine administration, she could not walk and was admitted for investigations. She had mild swelling in her right calf. A diagnosis of DVT was confirmed through a color-doppler ultrasound scan, a non-invasive method to test for deep vein thrombosis. To treat this condition, she was given 10 mg of apixaban, an anticoagulant, for a week. The dose was later reduced to 5 mg and the symptoms resolved rapidly.

Case 2
The second case study was published in the American Journal of Case Reports in 2021. It is titled “A 59-Year-Old Woman with Extensive Deep Vein Thrombosis and Pulmonary Thromboembolism 7 Days Following a First Dose of the Pfizer-BioNTech BNT162b2 mRNA COVID-19 Vaccine”.

It involved a 59-year-old female who reported to a hospital in Oman after suddenly experiencing pain in her left leg. She had a medical history of type 2 diabetes mellitus (T2DM), a condition in which there is a decrease in the insulin secretion to metabolize glucose in the body, osteoarthritis, a degenerative joint disease, and COVID-19 pneumonia. She had been diagnosed with COVID pneumonia in September 2020 for which she had been hospitalized for a week, but the condition had not been complicated. Seven months later, she received the Pfizer BioNTech vaccine, and seven days after that, she developed leg pain with swelling and tenderness. Acute DVT was diagnosed by performing duplex ultrasonography, a test to visualize how blood travels through arteries and veins. The patient experienced tachycardia for which computed pulmonary tomography angiography (CTPA) was performed to look for blood clots within the arteries of the lungs. The test confirmed the presence of blood clots in her pulmonary arteries. For treatment, she was given enoxaparin, an injectable anticoagulant. This was later switched to rivaroxaban – an oral anticoagulant – due to a positive heparin-induced thrombocytopenia test (HIT).

Case 3
The third case report entitled “An unusual presentation of acute deep vein thrombosis after the Moderna COVID-19 vaccine-a case report” was published in 2021 in the Annals of Translational Medicine journal.

It involved a 27-year-old female who had been completely healthy before receiving the second dose of mRNA-1273 (Moderna) COVID-19 vaccine. She had an unremarkable medical history. On the third day after receiving the dose, she reported to the hospital with swelling, redness, and pain with bruising in her upper right arm. (The first dose of this vaccine had been well-tolerated by her with mild soreness at the injection site which had lasted for a few days.) An acute thrombosis in her subclavian and axillary veins was diagnosed using venous duplex ultrasound. For treatment, she was given a heparin infusion to clear the blood clots. After that, she was given rivaroxaban for three months. Her symptoms significantly improved two weeks after being discharged.

Case 4
The fourth case titled “Deep Vein Thrombosis and Pulmonary Thrombosis After BNT162b2 mRNA SARS-CoV2 Vaccination” was published in Circulation Journal in 2022.

This case involved a 14-year-old male who presented at the clinic with pain in his left lower leg 24 hours after receiving the second dose of the Moderna vaccine. He had no family history of juvenile thrombosis or medical history of thrombosis. A contrast-enhanced computed tomography scan revealed multi-organ thrombosis. The patient was administered heparin initially and then shifted to an oral anticoagulant.

The bottom line

While COVID-19 vaccines have been promoted as safe and effective by the World Health Organization (WHO) and public health organizations like the Centers for Disease Control and Prevention (CDC), several adverse events have been associated with them. These include musculoskeletal events, neurological and cardiovascular events as reported in this article.

While some of these adverse events are manageable, several vaccine-injured individuals are yet to recover completely from the effects of these vaccines. This highlights the need for in-depth investigations into the safety profile of these vaccines, as well as the possible link between adverse effects and the vaccines.

https://www.trialsitenews.com/a/covid-19-vaccines-and-reports-of-deep-vein-thrombosis-dvt-a874d074

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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DNA contamination with residual bacterial plasmids and truncated mRNA from the manufacturing process

The more I hear about mRNA vaccines, the more pleased I am that I had only the British AstraZeneca shot, which was a more conventional product. I deliberately chose it because I thought it would be safer. Sadly, it was never approved for use in the USA. I guess I should mention that I had zero after effects from my two injections: Not even a sore arm

We highlight the inherent safety issues associated with a lax regulatory framework for approval of the COVID-19 mRNA vaccines. In this article, we consider how lax regulation is related to DNA and RNA contamination issues.

Summary of Key Facts

Concerns have been raised about DNA contamination in the mRNA COVID-19 vaccines. The specific concern is the presence of higher-than-expected residual DNA plasmids used in the original mRNA production. Independent investigations suggest that the Pfizer mRNA vaccine may have high levels of DNA contamination, potentially exceeding regulatory limits.

There are theoretical risks associated with plasmid DNA expression and migration to the gut, which could affect human health and the microbiome. Concerns have also been raised about the quality control and manufacturing oversight of mRNA vaccines.

The European Medicines Agency (EMA), Europe's drug regulatory authority, noted the presence of truncated and modified RNA as impurities in the mRNA COVID-19 vaccines, raising the need for oversight.

Related to the manufacturing process, a Danish study compared the rate of adverse events to the batch size (number of doses in a batch) and found a correlation.

The Advisory Committee on Immunization Practices met last week to recommend the updated COVID-19 vaccine. However, the manufacturers presented little data from testing in humans. Moderna was the only manufacturer to present safety and antibody response data from experience with 101 individuals. Pfizer presented antibody response data from 20 mice and is currently collecting data from 400 individuals in clinical testing. No data on manufacturing oversight was presented during the meeting.

As part of the safety evaluation of drug approval, the CMC (chemistry, manufacturing, and controls) process becomes critical in identifying and eliminating impurities. It sets strict standards and product specifications to maintain the purity of each batch. Compliance with these standards is essential for obtaining approval from global health authorities.

Imagine you're a coffee drinker, and you decide to buy a bag of premium, freshly ground coffee beans from your favorite store. You expect that each bag contains pure, high-quality coffee grounds to brew that perfect cup of coffee. However, when you open the bag, you discover that it isn't just coffee grounds; it also contains a mixture of sand and other foreign particles. This unexpected impurity completely ruins your experience.

Just as you rely on the purity of your coffee grounds for a great cup of coffee, the pharmaceutical industry, including vaccine production, has regulations in place to ensure good manufacturing practices. Patients and consumers expect that these guidelines mean that drug or vaccine formulations are free from unwanted substances, ensuring their safety and effectiveness.

Controlling impurities in traditional chemical products is a well-established practice, but for biological products such as mRNA-based vaccines, managing impurities presents unique challenges.

mRNA Products Contain 'Gene Factories'

Double-stranded DNA (dsDNA) is used to make the mRNA contained in the COVID-19 vaccines. Tiny dsDNA plasmids are small engineered gene factories (Figure 1). These factories produce the mRNA strands contained in the LNPs. A plasmid appears like a tiny micro-bracelet with different segments representing different pieces of genes.

Regulatory agencies like EMA—Europe's drug regulatory authority—set limits for the number of plasmids in the final lots distributed for injection. New questions have been raised about how much contamination there is, and whether the FDA is monitoring this. It is also unclear whether the plasmids can merge with human genes within the cell or travel to the gut.

The EMA standard for DNA contamination of vials is 0.33 percent (330 pg/mg), or roughly one DNA molecule for every 3,000 mRNA molecules. Although the Moderna mRNA-1273 vaccine meets this standard, the actual volume may be higher due to poor quality control. The DNA must be removed from the final product before distribution, but some residual amount is expected to remain.

Unanswered questions include: How much DNA is in the vials? Is it over the limit? Is the FDA tracking this? And what are the implications, if any, with regard to persistence in the recipient?

There are at least two independent groups of investigators who have conducted lab tests and confirmed the mRNA vaccine of Pfizer has been contaminated by DNA.

One team of scientists, led by microbiologist Kevin McKernan, published a preprint paper showing that the Pfizer/BioNTech BNT162b2 vaccine has DNA “orders of magnitude higher than the EMA’s limit.” His paper has not yet been peer-reviewed. The batches examined, provided by an anonymous source, were unopened, expired vials that were not delivered on dry ice. If these data hold, the actual amount of plasmids was 18 to 70 times higher than the EMA limit. (Table 3, page 12.)
Obviously, future investigations should attempt to establish contamination levels using unexpired doses with an intact cold chain.

Professor Phillip Buckhaults, who holds a doctorate in biochemistry and molecular biology and is considered an expert in cancer genomics research at the University of South Carolina, performed an independent analysis for the presence of DNA in Pfizer batches.

Professor Buckhaults in testimony stated the following:
"The Pfizer vaccine is contaminated with plasmid DNA. It's not just mRNA. It's got bits of DNA in it. This DNA is the DNA vector that was used as the template for the in vitro transcription reaction when they made the mRNA. I know this is true because I sequenced it in my own lab."

We will continue to follow this line of research.

Theoretical Risk of Plasmid DNA Contamination

While having some DNA in a sample is unavoidable and deemed acceptable, some have raised questions about the possibility for genomic integration of the DNA. Our cells use DNA in the nucleus to make protein, so if the plasmid DNA gets into the nucleus, there is a theoretical risk that it can get transcribed and make a protein.

About 5 to 10 percent of our human genome contains ancient retroviral DNA. However, this DNA is mutated to a point that is no longer harmful. Any further research on this topic will therefore need to establish not just the presence of DNA plasmid integration, but also its biological activity.
Professor Buckhaults further commented in his testimony:

"I am kind of alarmed about the possible consequences of this—both in terms of human health and biology—but you should be alarmed about the regulatory process that allowed it to get there."

Concerns About DNA Migration to the Gut

Related to the DNA contamination is the concern about residual expression vectors, or plasmids, in the vials. To make a billion doses of mRNA vaccine, more than a kilogram of DNA is required. Plasmids help produce the DNA by splicing in the desired sequence into a bacterial plasmid (Figure 1).

Then workhorse bacteria, often E. coli, help spin out the DNA for production. These bacteria have an extra burden: They must replicate not only their own genome but also the plasmid DNA inserted within their genome. This takes slightly more time, so the bacteria without the additional DNA will eventually outcompete those with the DNA.

To solve this problem, scientists also splice in an antibiotic resistance gene. The entire pool of bacteria is then treated with an antibiotic to kill the faster-replicating bacteria without the conferred antibiotic resistance. This selective elimination allows the plasmid-carrying antibiotic-resistant bacteria to continue growing. In other words, this antibiotic resistance gene confers an advantage that drives selection pressure to favor the bacteria producing the desired DNA.

However, some scientists are concerned that exceeding EMA standards for DNA plasmid contamination could affect an already growing antibiotic resistance problem. This would be a potential concern only if plasmids containing the antibiotic resistance gene migrate to the gut, integrate with bacterial targets in the gut flora, and disrupt the microbiome of the gut accordingly. Diseases, including obesity, diabetes, cardiovascular disorders, cancer, hypertension, and irritable bowel syndrome have been loosely linked with disturbances of the gut microbiome.

Truncated mRNA Contamination

Nucleic acid contamination with truncated, or shortened, mRNA fragments is something that EMA has been following since February 2021. On page 35 of the EMA assessment report (pdf) on the BNT162b2 mRNA vaccine reviewed in Part 1, the EMA states, "Truncated and modified RNA are present as impurities." The agency noted that the impurities were found at different levels during production. For instance, levels may be higher in smaller test batches than in larger commercial batches.

In fact, Danish scientists, Max Schmeling, Vibeke Manniche, and Peter Riis Hansen linked adverse events with vaccination records and found that smaller batches of the BNT162b2 mRNA vaccine may have a higher rate of adverse events (AEs). While this finding is intriguing, the authors call for more research to see if this is a consistent pattern. We reviewed the raw data provided by the authors and agree that a clustering of AEs seems to be found with batches having fewer than 100,000 doses.

It has already been demonstrated in vitro in a laboratory experiment that mRNA can be reverse-transcribed to DNA within six hours. A remaining question is whether this can happen in a live organism. Thus far, there is no evidence that a reverse-transcribed DNA product can merge with a human cell’s genome. Claims about integration are solely speculative and based upon an evolutionary precedent for such a process.

The EMA asked for additional testing but allowed distribution to go forward. The scientists believed these fragments were unlikely to be intact mRNA fragments. An intact mRNA fragment needs to have a cap and a tail. The cap and tail are needed to tell the cell when to start and stop producing the spike protein.

Nevertheless, the EMA requested additional reports. The agency was concerned that an autoimmune reaction could be triggered if fragments' potentially encoded proteins resemble human proteins. In other words, if the fragments "mimic" human proteins, antibodies could be developed against our own bodies.

"Any homology between translated proteins (other than the intended spike protein) and human proteins that may, due to molecular mimicry, potentially cause an autoimmune process should be evaluated. Due date: July 2021. Interim reports: March 2021, and on a monthly basis," the EMA stated.

It is clear that the mass production of mRNA at an industrial scale carries potential risks. This issue has been raised recently by other researchers pointing out the role of manufacturing quality control. For instance, The Epoch Times has previously investigated the link between quality issues and clotting risk (Part 1, Part 2, and Part 4).

This issue of contamination by DNA and mRNA fragments should also be explored further to understand whether certain lots were affected more than others. We also need to know whether DNA contamination is linked to adverse events. The EMA should strictly follow its monitoring standards.

The issue of having any DNA contamination is biologically unavoidable given that the mRNA is transcribed from DNA vectors. The potential issue here is the unusually high level of DNA contamination involved in the mRNA vaccines.

However, pivoting these RNA therapeutics to a vaccine platform in the context of a lagging regulatory framework has left us with many unanswered questions. Public health officials, nevertheless, were adamant that this new product should be deployed in a one-size-fits-all manner ignoring differential COVID-19 risk profiles across a broad population. This, in turn, we believe, set the stage for policy overreach resulting in unethical and harmful mandates.

https://www.theepochtimes.com/health/covid-19-mrna-vaccine-contaminated-by-mystery-dnas-and-truncated-mrnas-health-implications-5201359?ea_src=au-frontpage&ea_med=health-0

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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Rome-Based IRCCS Team Find Distinct Markers Linked to mRNA COVID-19 Vax-Induced Myocarditis

A large team of Italian specialist physician-investigators represented by corresponding author Paolo Palma, affiliated with Rome Italy’s prestigious Instituto di Ricovero e Cura a Carattere Scientifico (IRCCS), the Research Unit of Clinical Immunology and Vaccinology at Bambino Gesu Children’s Hospital, and colleagues conducted a prospective observational study including 15 pediatric patients referred to the hospital’s emergency department for cardiac events (namely suspected acute myocarditis/pericarditis) after receiving a COVID-19 mRNA vaccine.

In this study, all patients were hospitalized and had samples taken on admission or within 48 hours for baseline evaluation, as well as within six months for follow-up evaluation. The study team performed cardiological evaluation with electrocardiogram (ECG) as well as echocardiogram. In this study, the physician-scientists examined the inflammatory features of the Rome children’s hospital pediatric patients developing myocarditis post the mRNA COVID-19 jab. The team combined clinical and routine laboratory data along with high-dimensional proteomic analysis.

Patients meeting the clinical case definition of the CDC (probable myocarditis, confirmed myocarditis, or acute pericarditis) were deemed “c-AEFI patients,” and compared to children with MIS-c and cardiac involvement, SARS-CoV-2 infected children and healthy controls. The Rome-based team was able to confirm a “distinct inflammatory and androgenic profile in patients developing c-AEFI following mRNA vaccination which persists months after the acute event, whereas excluding a pathogenic role of autoantibodies.”

Dr. Palma heads up the pediatric department at the tertiary care academic children’s hospital in Rome that is under extraterritorial jurisdiction of the Holy See—the jurisdiction of the Pope in his role as the bishop of Rome and sovereign of Vatican City.

The study team reports that the subjects represent the clinical and demographic characteristics in line with previously published case series, including class of vaccine product, dose linked to the injury, and the gender ratio.

All the patients in this study developed symptoms following the second or third dose except those who already experienced SARS-CoV-2 infection, who developed symptoms after the first dose. Could this point observed indicate that previous exposure to spike protein may play a role in the pathogenesis of this condition? The study authors believe so.

Study Methods

During this study, the study team investigated the inflammatory features of pediatric patients developing myocarditis following mRNA COVID-19 vaccination, by combining clinical and routine laboratory data along with high-dimensional proteomic analysis.

During the study period the team enrolled 17 patients who met the criteria for the study—CDC work case definitions for myocarditis. These patients all went into observation due to chest pain after COVID-19 mRNA vaccine (BNT162b2 mRNA-Pfizer-BioNTech and the mRNA-1273-Moderna), from August 2021 to February 2022.

The study authors report the exclusion of two patients due to not meeting the study inclusion criteria. The study team used CDC work case definitions to categorize case definitions, fitting as probable myocarditis, confirmed myocarditis or cute pericarditis. All are referred to as c-AEFI.

The Rome-based team was able to use other cohorts for comparison participant data from the CACTUS study—these children were affected by SARS-CoV-2 infection; or had MIS-C with cardiac involvement all before any treatment, as well as healthy children collected in the pre-pandemic period.

Addressing the possibility of confounding factors of age, the team age matched patients, using for comparison of proteomic analysis 21 children with acute COVID-19 infection, 14 children with MISC-C and 31 healthy children. Also, the study team compared androgen levels in children with myopericarditis.

So, what did the Italian researchers find under Dr. Palma and colleagues? TrialSite breakdowns down the outcomes.

Why conduct this study?

Because the risk of acute myocarditis linked to the mRNA vaccines developed in response to COVID-19 attracts lots of attention, and is hotly debated, particularly in the pediatric population. This is a cohort where the risk-benefit of the vaccine must be carefully evaluated. Moreover, the pathogenesis of COVID-19 mRNA vaccine-linked myocarditis remains poorly understood. Several mechanisms are possible.

What are the possible mechanisms involved with COVID-19 mRNA vaccine-induced myocarditis?

The authors suspect one or more of the following:

Immune reactivity

Cross-reacting antibodies to SARS-CoV-2 spike glycoproteins with myocardial contractile proteins

Hormonal differences

So, what were the team’s finding?
Cardiac adverse Events Following COVID-19 Immunization (c-AEFI) have been reported, are a real-world phenomenon, although rare, and were distinctly identified in this study.

Such events not to mention the severe cardiac involvement reported in Multisystem inflammatory syndrome in children (MIS-C) appear more frequent in young adult males. The team here investigates the inflammatory profiles of patients experiencing c-AEFI in comparison with age, pubertal age and gender matched MIS-C with cardiac involvement. Interestingly the study team reports when comparing MIS-C patients to vaccine injured myocarditis patients (c-AEFI), the former possess higher levels of proteins related to systemic inflammation than compared to the latter c-AEFI. But higher levels in proteins related to myocardial injury were found in c-AEFI.

In addition, higher levels of hormones such as DHEAS, DHEA, and cortisone were found in c-AEFI which continued months later during ongoing follow-up. No anti-heart muscle and anti-endothelial cell antibodies have been detected. Overall current comparative data showed a distinct inflammatory and androgens profile in c-AEFI patients which results in being well restricted on heart and to persist months after the acute event.

https://www.trialsitenews.com/a/rome-based-irccs-team-find-distinct-markers-linked-to-mrna-covid-19-vax-induced-myocarditis-1871528d

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COVID-19 Vaccines and Reports of Deep Vein Thrombosis (DVT)

Reports of deep vein thrombosis (DVT), the formation of blood clots, as an adverse effect associated with COVID-19 vaccines, are increasing. TrialSite has reported before on the blood clot crisis linked to COVID-19 and its vaccines. A compilation of such hematological case reports has been contributed by Aaron Hertzberg. We will summarize some of them here.

Deep vein thrombosis (DVT) is a medical condition where blood clots form in a deep vein; usually in the lower leg, thigh, or pelvis. However, sometimes they can form in the arm.

Case reports of the adverse events following the COVID-19 vaccine administration are appearing after the massive vaccination campaigns to control the pandemic. Studies have been conducted to investigate the link between these vaccines and blood clot formation. Here we present a summary of case reports of DVT, post-COVID-19 vaccination.

Case 1
The first paper mentioned here entitled “Deep vein thrombosis (DVT) occurring shortly after the second dose of mRNA SARS-CoV-2 vaccine” was published in the Internal and Emergency Medicine journal in 2021.

This case involved a 66-year-old female who received two doses of the Pfizer vaccine. Before vaccination, the woman had been completely healthy and did not smoke or have any allergies. She just had a history of left leg neuropathy (damage to peripheral nerves in the leg) after a trauma. A day after receiving her second dose, she had a persistent fever with chills, fatigue, muscle pain, and discomfort. To control these symptoms, she was administered acetaminophen, a drug used for bringing down fever and easing pain. The fever had not resolved by the next day and the patient had also developed acute pain in her right calf in the absence of any trauma. On the third day post vaccine administration, she could not walk and was admitted for investigations. She had mild swelling in her right calf. A diagnosis of DVT was confirmed through a color-doppler ultrasound scan, a non-invasive method to test for deep vein thrombosis. To treat this condition, she was given 10 mg of apixaban, an anticoagulant, for a week. The dose was later reduced to 5 mg and the symptoms resolved rapidly.

Case 2
The second case study was published in the American Journal of Case Reports in 2021. It is titled “A 59-Year-Old Woman with Extensive Deep Vein Thrombosis and Pulmonary Thromboembolism 7 Days Following a First Dose of the Pfizer-BioNTech BNT162b2 mRNA COVID-19 Vaccine”.

It involved a 59-year-old female who reported to a hospital in Oman after suddenly experiencing pain in her left leg. She had a medical history of type 2 diabetes mellitus (T2DM), a condition in which there is a decrease in the insulin secretion to metabolize glucose in the body, osteoarthritis, a degenerative joint disease, and COVID-19 pneumonia. She had been diagnosed with COVID pneumonia in September 2020 for which she had been hospitalized for a week, but the condition had not been complicated. Seven months later, she received the Pfizer BioNTech vaccine, and seven days after that, she developed leg pain with swelling and tenderness. Acute DVT was diagnosed by performing duplex ultrasonography, a test to visualize how blood travels through arteries and veins. The patient experienced tachycardia for which computed pulmonary tomography angiography (CTPA) was performed to look for blood clots within the arteries of the lungs. The test confirmed the presence of blood clots in her pulmonary arteries. For treatment, she was given enoxaparin, an injectable anticoagulant. This was later switched to rivaroxaban – an oral anticoagulant – due to a positive heparin-induced thrombocytopenia test (HIT).

Case 3
The third case report entitled “An unusual presentation of acute deep vein thrombosis after the Moderna COVID-19 vaccine-a case report” was published in 2021 in the Annals of Translational Medicine journal.

It involved a 27-year-old female who had been completely healthy before receiving the second dose of mRNA-1273 (Moderna) COVID-19 vaccine. She had an unremarkable medical history. On the third day after receiving the dose, she reported to the hospital with swelling, redness, and pain with bruising in her upper right arm. (The first dose of this vaccine had been well-tolerated by her with mild soreness at the injection site which had lasted for a few days.) An acute thrombosis in her subclavian and axillary veins was diagnosed using venous duplex ultrasound. For treatment, she was given a heparin infusion to clear the blood clots. After that, she was given rivaroxaban for three months. Her symptoms significantly improved two weeks after being discharged.

Case 4
The fourth case titled “Deep Vein Thrombosis and Pulmonary Thrombosis After BNT162b2 mRNA SARS-CoV2 Vaccination” was published in Circulation Journal in 2022.

This case involved a 14-year-old male who presented at the clinic with pain in his left lower leg 24 hours after receiving the second dose of the Moderna vaccine. He had no family history of juvenile thrombosis or medical history of thrombosis. A contrast-enhanced computed tomography scan revealed multi-organ thrombosis. The patient was administered heparin initially and then shifted to an oral anticoagulant.

https://www.trialsitenews.com/a/covid-19-vaccines-and-reports-of-deep-vein-thrombosis-dvt-a874d074

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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FDA Finds Safety Signal for COVID-19 Vaccination Among Toddlers

A safety signal is a sign that a health condition may be caused by vaccination, but further research is required to verify a link.

A safety signal of seizures for young children following COVID-19 vaccination has been detected by the U.S. Food and Drug Administration (FDA).

Seizures/convulsions "met the statistical threshold for a signal" in children aged 2 to 4 following receipt of a Pfizer COVID-19 vaccine and children aged 2 to 5 following receipt of a Moderna COVID-19 vaccine, researchers with the FDA and three large healthcare companies said in a new preprint study.
A safety signal is a sign that a health condition may be caused by vaccination, but further research is required to verify a link.

The data came from three health claims databases run by Optum, Carelon Research, and CVS Health, supplemented with vaccination information from state and local systems. The health claims databases are part of the FDA's Biologics Effectiveness and Safety System, a drug safety monitoring system.

Researchers looked at 15 health conditions following vaccination entered in the commercial databases and compared rates among children aged 6 months old to 17 years old to background rates from 2019, 2020, or both.

Overall, 72 cases of seizures/convulsions were recorded within seven days of a shot among toddlers and other young children. Most happened within three days of a shot.

When stratifying the data by dose, the researchers found signals for dose one and dose two for Pfizer's shot in two of the three databases in children aged 2 to 4. They also found a signal following dose two of Moderna's shot in children aged two to five.

The signal for seizures/convulsions for the young children "has not been previously reported for this age group in active surveillance studies of mRNA COVID-19 vaccines," the researchers said, referring to the Pfizer and Moderna shots.

There are reports of seizures and convulsions after COVID-19 vaccination among children in the Vaccine Adverse Events Reporting System, the researchers noted. Though anybody can lodge reports with the system, most are made by health care professionals.

Another five convulsions were reported after Pfizer vaccination in Pfizer's clinical trial.

The research did not cover the bivalent COVID-19 vaccines, which were introduced for some populations in 2022 and completely replaced the old vaccines in April, or the newest versions of the vaccines that were rolled out in September.

It's not clear when the signal was first detected. The FDA and Patricia Lloyd, an FDA statistician who is the study's corresponding author, did not respond to requests for comment. Pfizer and Moderna did not return inquiries.

Caution Warranted: Researchers

The researchers said the signal "should be interpreted with caution and further investigated in a more robust epidemiological study."

That's partly because the signal disappeared when changing background rate years. The signal was detected when comparing rates with background rates from 2020. But when using background rates from 2022, which were about 2.3 times higher, a signal was not detected.

The higher number of cases in 2022 may stem from an increased incidence of respiratory infections such as influenza, the researchers posited.

The case count may have also included seizures "unrelated to vaccination," the researchers said.

Similar to previously analyzed data from the same system, the researchers also detected a signal for heart inflammation and a related condition, or myocarditis and pericarditis, for children aged 12 to 17. Because that signal has been known since 2021, researchers did not attempt to further explore it.
No other signals were detected.

Strengths of the study include the population covered by the databases being large and geographically diverse. Limitations include a lack of control of confounding factors.

Stroke Risk in Elderly

The FDA and the U.S. Centers for Disease Control and Prevention in January announced they detected a signal for ischemic stroke for people aged 65 or older following receipt of Pfizer's bivalent vaccine. Ischemic stroke is a type of stroke caused by blood clotting.

In another preprint paper published on Oct. 15, FDA researchers said they analyzed Medicare data to estimate the risk of stroke after bivalent vaccination.

They included Medicare beneficiaries aged 65 or older who received a bivalent shot or an influenza vaccine and suffered stroke, except for stroke cases deemed to have been caused by something other than a COVID-19 shot.

The primary analysis did not identify an increased risk of stroke, but stratifying the population by age showed an increased risk after Pfizer vaccination for people aged 85 or older of non-hemorrhagic stroke and for non-hemorrhagic stroke/transient ischemic attack. An increased risk was also found for Moderna recipients aged 65 to 74 for non-hemorrhagic stroke/transient ischemic attack.

No increased risk was found for hemorrhagic stroke.

For people who received a Pfizer jab with an influenza shot, an elevated risk of non-hemorrhagic stroke was detected. For people who received a Moderna jab with an influenza shot, an elevated risk of transient ischemic attack was detected.

A separate analysis of only influenza vaccination detected an increased risk of non-hemorrhagic stroke following receipt of a high-dose/adjuvanted influenza shot, and signals for different ages upon stratification.

"Our study did identify an elevated risk of stroke when the COVID-19 bivalent vaccines were administered with a concomitant high-dose/adjuvanted influenza vaccine. However, the observed effects were not consistent," the researchers, with the FDA and Acumen, said.

A similar finding was detected in a study of data from the Centers for Disease Control and Prevention's Vaccine Safety Datalink system.

The researchers said that the study's findings suggest the elevated risk of stroke in the group that received influenza and COVID-19 vaccines together "was likely driven by influenza vaccination alone rather than concomitant administration."

https://www.theepochtimes.com/health/fda-finds-safety-signal-for-covid-19-vaccination-among-toddlers-5511516?ea_src=au-frontpage&ea_med=top-news-health-0-large-0

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Collapsing Demand for Pfizer products leads to price RISES

On Thursday, Oct. 12, the Director of the Centers for Disease Control and Prevention (CDC) perhaps, inadvertently shared the current state of COVID-19 vaccine demand, which appears fairly abysmal. Mandy Cohen mentioned at a mobile clinic situated in an elderly community center in California late last week in California that to date, since the vaccine was recommended Sept. 12 by her agency, 7 million doses of the monovalent COVID-19 booster targeting XBB.1.5 have been administered. This represents 2.1% of the total population. For comparison purposes, ultimately about 56.4 million people across the USA opted for the bivalent booster made available last September, representing about 17% of the nation’s population. Pfizer recently predicted the rate of vaccination with the new monovalent vaccine would hit 24%. Director Cohen’s reference to the total number vaccinated was first picked up by the San Jose Mercury News, then later other media such as Reuters and CNN.

Various news agencies attempted to spin the weak turnout for the inoculation noted by some of the right-leaning media such as The Blaze, Glen Beck’s media outlet. For example, CNN positioned the vaccinated figure in a positive light given the “rocky rollout.” COVID-19 has surged somewhat, and based on CDC data, by Sept. 30, approximately 11% of all COVID-19 tests making their way to the national public health agency evidenced a positive for the virus. In this latest surge, 1.6% of all emergency department visits are associated with COVID-19.

Not surprisingly, the weak demand impacts the COVID-19 vaccine manufacturers’ revenue and profit forecasts. With a deceptively innocuous title, Pfizer issued somewhat of a bombshell report on Friday, October 13, titled “Pfizer Amends U.S. Government Paxlovid Supply Agreement and Updates Full-Year 2023 Guidance.”

Among other things, Albert Bourla disclosed in a video the updated Pfizer—U.S. government arrangement. By January 2024, Paxlovid will be available via commercial payers, not just the U.S. government via the emergency use authorization. In what clearly hints at mounting pressure on the Pfizer chief, he noted the parties agreed to a Paxlovid stockpile for the U.S. government until 2028, “at no cost to the taxpayer.” This stockpile will include 1 million courses.

The dropping demand for COVID-19-related products impacts the company’s full 2023 guidance. Some key notable points:

Paxlovid revenues are estimated to decline by approximately $7 billion ($4.2 billion of this part of the non-cash revenue revealed for the return of the approximately 7.9 million treatment courses of EUA labeled U.S. government inventor)

COVID-19 vaccine Comirnaty revenues decline by $2 billion
A $5.5 billion non-cash charge in 2023 in Q3 due to inventory write-offs caused by lower-than-expected demand for the company’s COVID-19 products.

While Pfizer’s other pharmaceutical products appear to likely meet full-year expectations (6% to 8% growth), the company is cutting $3.5 billion, including $1 billion this year and $2.5 billion in 2024. The company holds its analyst and investor call today at 8 AM EDT.

How will Pfizer attempt to overcome this COVID crisis? Much like the large pharmaceutical companies did during the last couple of decades, by raising vaccine prices. In fact, TrialSite reported in March 2021, at the height of the pandemic that Pfizer informed investors the company would find ways to monetize the pandemic products---meaning extract as much money out of them as possible.

At the time Frank D’Amelio, Pfizer’s Chief Financial Officer called pricing at $19.50 “pandemic pricing.” He shared candidly with investors, “[There’s] significant opportunity for those margins to improve once we get beyond the pandemic environment that we’re in.”

That’s happening now as the company’s Comirnaty list price skyrocketed to $120 to $130 per dose covered last month by AP. While mainstream media avoids coverage of the price surge in any material way, that’s likely due to the reality that pharmaceutical advertising represents a sizable portion of overall ad revenue for media companies.

But some media have become more critical, such as the Washington Post. In a piece authored by Jenna Portnoy, a chief operating officer at a Maryland-based hospital shared that the price of the jab has risen to $150 in some cases. Jenna Vallejo told the reporter, “That’s ridiculous.” Meanwhile, the company is pricing what the market will bear, and even though technically under federal law the jabs should still be covered by public or private payers, the company and its fulfillment chain will likely try to squeeze as much out of consumers as possible.

What did Pfizer’s disclosure do to the stock price? At 3:30 PM on Thursday, Oct. 12, the company’s stock price equaled $33.10. While Pfizer is a huge company with blockbuster and innovative niche medicine, the company’s stock is in trouble. And as the reality of how the company behaved during the pandemic comes to light, likely investors may see more troubles with this stock.

To put it all in perspective, the company’s stock was priced at 59.48, an all-time high on December 13, 2021, at the height of the pandemic. But aside from the temporary surge, Pfizer equity has been on a cascading slide downward since then. It’s the artificial nature of the pandemic surge in revenues that likely helped spook investors, along with other disturbing behavior such as how the company abused its position in contracting during the crisis. As of today, Oct. 16, 2023, Pfizer’s price is $32.11.

TrialSite reported that Pfizer recently sought out unorthodox financing, inking a deal with Blackstone, a private equity group investing in drug development.

Meanwhile, TrialSite has predicted that Moderna faces real trouble when the market rejects their Spikevax COVID-19 vaccine—the only revenue-generating product.

Presently priced at $98.30 per share, Moderna’s slide throughout 2023 is apparent upon instant gaze of their chart. By Sept. 6, 2021, again right in the middle of the pandemic, Moderna’s stock hit an all-time high of $449.38. It’s been all downhill since then, currently priced at 98.30.

https://www.trialsitenews.com/a/collapsing-demand-for-pfizer-covid-19-vaccines-paxlovid-pfizer-cuts-3.5-billion-f05401bf

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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Australian Medical Society Investigating Excess Deaths—Suspects the Population Faces a doctor-caused Crisis

The Australian Medical Professionals Society (AMPS) recently launched an inquiry into Australia’s excess mortality: Unveiling an overlooked crisis. Throughout the medical system, the political system and the media, the fact that there are too many Australian people dying is being ignored. And the group of providers seeks to change that. The group has commissioned studies and expressed concern that mass COVID-19 countermeasures have led to excess mortality.

Recently, the society was in touch with TrialSite, sharing updates on imminent activity and events involving the controversial, but important topic.

This Wednesday, October 18, in Parliament House, Canberra, the AMPS holds an inquiry, addressing the alarming rise in excess mortality in Australia since 2021. This timing is of deep concern given the mass vaccination scheme occurred right at this time.

This inquiry aims to uncover the most pressing question: What is causing Australians to die at unprecedented rates? Why has the death rate rocketed? In response to the Senate's extraordinary decision on 23 March 2023, against investigating this sudden excess mortality, a committed group of Australians, in collaboration with international colleagues, has undertaken the investigation that, unfortunately, Australian political and medical authorities thus far have refused to pursue.

Delving deeper into the regulatory failures hindering the proper analysis of preclinical data concerning experimental COVID-19 vaccines, the Australian Medical Society reports serious shortcomings, potential data discrepancies, and alarming signals of harm being overlooked.

It is hoped that this investigation will in fact shed light on the inadequacies within the Therapeutic Goods Administration's (TGA) pharmacovigilance systems. The TGA regulates drugs and vaccines in Australia.

The analysis conducted by AMPS indicates that Australia is facing an iatrogenic crisis – one that has resulted from policies based on insufficient evidence. A bombshell of an allegation, AMPS alleges that the COVID-19 mass countermeasure response is likely linked to the death signals.

Conclusions from AMPS are documented in a book due for release titled, Too Many Dead – An Inquiry into Australia’s Excess Mortality. In collaboration with peers around the world, the group calls for an immediate suspension of the vaccination rollout, pending a full and transparent investigation.

Invitations have been issued to hundreds of politicians especially ministers; and to health authorities, medical colleges and associations Australia-wide including all members of ATAGI, the TGA, and academics in the health fields.

As a society committed to the well-being of all Australians, AMPS shares its commitment to ensuring accountability, transparency and justice, even when the facts may be unpalatable.

https://www.trialsitenews.com/a/australian-medical-society-investigating-excess-deathssuspects-the-population-faces-an-iatrogenic-crisis-ff734f27

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Yale Medicine Refers to the ‘Tripledemic’ That Never Was

Major academic medical institutions such as Yale Medicine go on record that the United States already experienced a “Tripledemic.” That’s the implication of a headliner accompanying the recent piece by Kathy Katella writing for Yale Medicine, implying that the presence of influenza, respiratory syncytial virus (RSV), and COVID-19 over the past few years led to such an event.

Well, another fact check is in order: one covering one of the most elite of medical institutions. Yes, there was a COVID-19 pandemic, but never a “tripledemic.” But it’s true that all three viral infections can raise the risk of morbidity and mortality in vulnerable individuals, typically the elderly and individuals with comorbidities but also in some cases children.

Katella, a senior clinical writer for Yale Medicine, follows her hyperbolic headline with a report that this year, for the first time vaccines are available that help to “prevent these diseases, including an updated COVID vaccine, as well as vaccines and a monoclonal antibody injection for those most vulnerable to RSV.”

The Yale article borders on misinformation right at the onset with the title: “Can RSV and COVID Vaccines Prevent Another Tripledemic?”

First, it should be noted that there was never a tripledemic over the past “several” years as Katella states. So why refer to “another tripledemic” unless the author purposely seeks attention for this headline? Disingenuous, we expect a lot more from a prestigious place like Yale.

Does the piece fall under the category of misinformation or disinformation? Very possibly. Importantly, the distinction is that the former is false or inaccurate information—getting the facts wrong, while the latter represents false information which is deliberately intended to mislead—intentionally misstating the facts. Based on these definitions including a clearly inaccurate headline likely means the whole piece falls in the latter category, unfortunately.

The writer turns to be honest when addressing actually how helpful would the three vaccines be for individuals this winter, especially vulnerable persons to these viruses, stating it “is still difficult to say.”

But how to know how these vaccines can help? We cannot know for sure, more honestly, thus academia’s penchant for models. The Yale writer refers to the positive prospects of the use of “predictive models” citing a quote from infectious disease specialist Shana Gleeson, M.D.. Honesty again prevails, as the Yale doc states, “But we can’t say for sure how it’s all going to play out.”

Have any formal clinical trials testing approved COVID-19, influenza and RSV vaccines ever been undertaken and completed? Not at all, but you won’t get that information from Yale. What about the fact that Moderna is currently testing its mRNA vaccine with influenza vaccine for safety? Not a peep. But at TrialSite, you can learn more about these unfolding activities. See TrialSite in “Is it Safe to Receive both Moderna mRNA COVID-19 Vaccine Influenza Vaccine—Clinical Trial Designed to Find Out.” Why Yale doesn’t take the time for basic research 101 we cannot say, other than it’s following some top-down approach to research and health communications.

Meanwhile, the influenza jab vaccine effectiveness was an abysmal 16% effective in the 2021-22 season. This is NOT to discourage those in high-risk cohorts from getting that vaccine. But for a healthy young person, we should ensure to understand a rational risk-benefit analysis and understand with such low effectiveness many of the vaccinated will still pass on the virus. So like COVID-19, the only reason to get vaccinated at this point is if one falls at risk for more severe flu, or for that matter, if one’s preference is to bolster their protective probabilities, even if it’s more psychological than scientific, for some.

The public health tools definitely help, but they are not the panacea promoted by the government, academic medicine and industry. And there are externalities involved, especially for the COVID-19 mRNA products. During emergency times the math of acceptance was more liberal, than today.

COVID-19 vaccines in the age of Omicron involve many breakthrough infections, meaning vaccinated persons can and do carry and spread the disease. With the COVID-19 vaccines, TrialSite started reporting on this scientific understanding by spring of 2021.

Yet Dr. Gleeson assumes all three of these vaccines are essentially sterilizing, in that they will stop viral transmission in all three viruses. She exhibits this bias upon addressing factors as to their effectiveness and impact. Dr. Gleeson states that one potential factor is how many people get the new shots. She implies the more people that get the shots, the more people will avoid infection, and consequently not spread the disease to others.

But given we don’t know the true effectiveness rates yet, and that these are not necessarily sterilizing vaccines, how can she be certain the volume of shots will make a difference at all? The truth is that she cannot. True, she can look back at epidemiological data and find some correlations, but this does not mean causation.

Other factors according to Gleeson such as masking, and the assumption that fewer people will take their masks off in the forthcoming season, along with crowding and get-togethers in enclosed places (think Holiday Season) all spell potential trouble for the “tripledemic.”

More here:

https://www.trialsitenews.com/a/yale-medicine-refers-to-the-tripledemic-that-never-was-6b0fbe6a

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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UK: Vaccine injury scheme ramps up staff as claims over Covid jabs keep growing

Increasing demand for Covid vaccine injury payments has seen the number of staff processing claims increase 20-fold, figures show.

The Vaccine Damage Payment Scheme (VDPS) has scaled up operations and boosted its administrative staff from four to 80 to handle the claims.

A project is also under way to digitalise the application process to make it simpler and quicker for claimants.

But MPs, campaigners and families have called for the process to be reformed, arguing that the payment cap of £120,000 is too low, too slow and bureaucratic, and the eligibility criteria is too strict.

If a person is left severely disabled as a result of receiving certain vaccines they could be entitled to the one-off payment from the Government.

Families can also apply for the payment if a loved one died as a result of a vaccination.

It is not treated as compensation, meaning claimants can still seek damages in court.

“Inadequate funds to families’

A group of patients and families are now taking legal action against AstraZeneca after they suffered injury or bereavement as a result of complications from the Covid vaccine.

The Hausfeld Claimant group, which includes 13 bereaved families and 28 survivors, says the VDPS offers “inadequate funds to families”.

Sarah Moore, leading the litigation, said: “No amount of compensation will bring back loved ones or restore those injured to health but it can make life a little bit easier for the mothers, fathers, children, parents and partners who are now reshaping their lives.”

Figures released under a Freedom of Information (FOI) request in March show more than 4,000 claims related to a Covid-19 vaccine have been submitted since Nov 1 2021.

The payment scheme was taken over by the NHS Business Services Authority in November 2021, after previously being handled by the Department for Work and Pensions.

Of the 4,017 claims made, 334 relate to a claimant who has died.

Some 48 claims have been approved so far, Maria Caulfield, a health minister, told MPs in February.

A separate FOI document published in February revealed 3,842 claims had been received, meaning the number submitted has increased by almost 200 in one month alone. Of those, 814 claims were unsuccessful and a further 37 did not meet the eligibility criteria.

Under the VDPS, severe disablement means a patient must be at least 60 per cent disabled to qualify, based on the Social Security (General Benefit) Regulations 1982.

‘Balance of probabilities’

A patient’s medical records along with “all scientific evidence” will be considered in the application by an independent medical assessor.

They will decide if the person is due a payment based on whether “on the balance of probabilities” the vaccine caused the disability, and if the level of disability is 60 per cent.

Many claimants have been diagnosed with vaccine-induced thrombocytopenia and thrombosis, a rare condition linked to the Covid-19 jab.

The number of people who experienced life-changing adverse reactions to coronavirus vaccines is tiny compared to the millions who received the jab.

Data from the Medicines and Healthcare products Regulatory Agency, up to Nov 23 2022, show 445 cases of major thromboembolic events (blood clots) with concurrent thrombocytopenia (low platelet counts) in the UK following an AstraZeneca jab. The overall case fatality rate was 18 per cent with 81 deaths.

The Government says it can take “at least six months” to process a VDPS claim, but a claim about a Covid-19 vaccine “will take longer”.

Jeremy Wright, Conservative MP for Kenilworth and Southam, raised the issue in the Commons this week and called on the Prime Minister to revamp the scheme.

He told The Telegraph: “It's good news if they're improving the resources to handle claims. There are a lot of claims and it's taking a very long time to process them.”

He added there were still “structural problems” with the scheme, including the low cap and 60 per cent disablement cut off.

Rishi Sunak said on Wednesday: “We are taking steps to reform vaccine damage payments schemes by modernising the operations and providing more timely outcomes, but of course I'd be happy to talk to the honourable gentleman further about it.”

The Telegraph has spoken to families who have waited more than a year for the payment.

Sheila Ward, whose husband Stephen, 57, died after having the Covid vaccine, said the compensation scheme was “not fit for purpose”.

Her husband, who was retired, had the Oxford AZ jab in March 2021. Mr Ward had no pre-existing conditions but after a few days developed a headache and had to stay in bed.

“We just thought he had been doing too much,” said Mrs Ward, 55, who lives in Newcastle.

When she went upstairs to check on him she found him unable to speak. He was taken to hospital where he was treated for a stroke. The doctors found bleeds and clots on his brain.

Compensation took a year

Later Mrs Ward was told by doctors that her husband had suffered seizures. He died before he could receive an operation.

A coroner’s certificate listed the vaccine as one of the causes of death but obtaining compensation took a year.

“The whole process was very slow and they never gave me updates unless I chased them,” said Mrs Ward, whose claim was finalised in June 2022.

“Personally, I don't think the compensation families receive is enough. I'm in a fortunate position that my husband had a pension, so my income has been subsidised that way.

“For anyone who has been left with a lifelong disability or young children, it simply wouldn’t be enough to replace somebody's income.”

Mrs Ward said the Government should consider raising the cap but also make the process faster. “It is not fit for purpose,” she said. “I’ve heard of cases where it takes 20 months for a decision. That is far too long”.

Vikki Spit, 40, lost her partner Zion of 21 years in May 2021 after he suffered a blood clot linked to the AZ vaccine. It took more than a year for Ms Spit, who campaigns for Vaccine Injured Bereaved UK, to receive the VDPS.

“The [60 per cent disabled] criteria is a really big [issue], because there are so many people just left with nothing after being severely injured, and have life-changing disabilities, and they’re just told ‘well you’re not interested enough’,” she said.

https://www.telegraph.co.uk/news/2023/03/24/vaccine-damage-payment-scheme-boosts-staff-numbers-four-80-covid/

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Immune Tolerance and the COVID-19 Vaccines

Turbo-cancers, which are very aggressive cancers characterized by 1) rapid progression and 2) diagnosis at a late stage, have been increasing significantly in the last couple of years. One of the major factors that may be contributing to this increase is the COVID-19 vaccine, especially those vaccines operating on the mRNA platform. In particular, one of the major mechanisms associated with the modus operandi of these mRNA vaccines is the class-switch from IgG3 to IgG4, and the subsequent reversal in the phenomenon known as Immune Tolerance.

Immune Tolerance can be defined as 1) “the process by which immune cells are made unresponsive to self-antigens to prevent damage to healthy tissues. It prevents an immune response to antigens produced by the body itself or recognized from a prior encounter.”, or 2) “the state of an active, highly regulated unresponsiveness of the immune system to self-antigens or against a particular antigen that can induce an immune response in the body.”, or 3) “prevention of an immune response against a particular antigen. For instance, the immune system is generally tolerant of self-antigens, so it does not usually attack the body's own cells, tissues, and organs. However, when tolerance is reduced substantially, disorders like autoimmune disease or food allergy may occur.” Immune tolerance is analogous to a military operation defending one’s homeland against invasion from without and within, where it is desired to do maximum damage to the invaders and minimum damage to the homeland and its residents (also see the following references for more comprehensive analyses of Immune Tolerance (link#1; link#2; link#3; link#4; link#5; link#6).

Immune Tolerance is important for analyzing biological mechanisms, and for examining the onset and progression of many diseases. A more comprehensive view of Immune Tolerance would be useful for understanding its mechanisms and impacts. This Op-ed provides an overview of Immune Tolerance, based on the contents of the premier biomedical literature (Medline). The main output of this study is a hierarchical taxonomy of the Immune Tolerance biomedical literature, where the taxonomy is generated using a text-clustering approach. This Op-ed will show how the immune system uses Immune Tolerance to destroy foreign invaders or endogenous dysfunctional processes like rapid cancer cell multiplication without destroying the host in the process, or, conversely, how the immune system allows mild foreign invaders, such as allergens, to co-exist within the host with minimal damage to the host. It will also show how factors that adversely impact the immune system can distort the function of Immune Tolerance, and allow foreign invaders or endogenous dysfunctional processes to exert massive damage on the host.

METHODOLOGY

A query was developed to retrieve articles from Pubmed that focused on Immune Tolerance, and was entered into the Pubmed search engine on 25 September 2023. It retrieved 23,049 articles (with Abstracts only) for the period 1 January 1993-31 December 2023. The records retrieved were imported into the CLUTO text-clustering software, 64 leaf clusters were selected, and a hierarchical taxonomy was generated by the algorithm. Each leaf cluster was analyzed by visual inspection, and aggregate categories consisting of related leaf clusters were constructed.

The Immune Tolerance phenomena related to COVID-19 vaccine effects were identified from the records retrieved by the Pubmed query (as well as records related to the records retrieved by the query). and discussed.

The Pubmed query used is: "Immune Tolerance" [Majr] OR "immune tolerance" [tiab] OR “immune system tolerance" [tiab] OR “immunological tolerance" [tiab], where Majr is major MeSH theme and tiab is title and abstract.....

Some of the more egregious contributors to immune system dysfunction and, in some sense, promoters of unwanted Immune Tolerance to both micro-organisms and cancer cells are the present bioweapon injections masquerading as COVID-19 vaccines. The immune system consequences of these injections are highlighted here because of the large number of people who received them. Our studies have shown that the fundamental modus operandi of these injections is destruction of the immune system, where the level of immune system destruction increases with each injection. This immune system destruction can potentially lead to i) increased numbers of, and more aggressive, cancers, ii) reactivation of dormant viruses, and iii) increases in autoimmune diseases. The Immune Tolerance that accompanies this immune system destruction plays a strong role in each of the three adverse effects mentioned above.

Specific mechanisms of both the SARS-CoV-2 virus and the COVID-19 (mainly) mRNA vaccines that could induce unwanted Immune Tolerance were presented in the text, but only those arising from the COVID-19 vaccines will be presented here. They include: Class switching to increased IgG4; Incorporation of pseudouridine into mRNA; Multiple mRNA injections; Degradation and suppression of the immune system potentially leading to cancer (Suppression of Toll-Like Receptors, Impact on Tumor Suppressor Protein p53 and Genomic Transposable Element LINE-1, Spike Protein Interference with DNA Repair Mechanisms, Vaccines contaminated with Plasmid DNA containing SARS-CoV-2 spike protein, Simian virus 40 (SV40) in DNA discovered in Pfizer mRNA vaccine vials, Enhanced expression of PD-L1, Induction of pseudo-autoimmunity (more focused on autoimmunity rather than cancer)). Additionally, excerpts from critical papers show some of the synergies among these mechanisms acting in concert.

https://www.trialsitenews.com/a/immune-tolerance-and-the-covid-19-vaccines-27e6426a

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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15 October, 2023

New York State Supreme Court Issues Final Blow to Vaccine Mandate for Healthcare Workers

The pandemic is over. The Biden administration was forced to end the COVID-19 public health emergency declaration in May. Most people threw out their masks, embraced large indoor gatherings once again, and stores finally ditched those obnoxious and ineffective Plexiglass dividers. But even in this post-pandemic era, there are still legal battles playing out across the country over vaccine mandates.

In January, New York's Supreme Court struck down the state's vaccine mandate for healthcare workers but, of course, the Empire State didn't want to let go without a fight.

Last week, however, the Supreme Court Appellate Division, Fourth Department, dismissed the state's appeal.

"The mandate is over and declared unconstitutional," Sujata Gibson, attorney for the plaintiffs, said on X.

"This was an important victory. While it does not make healthcare workers whole, it does protect us from future overreach by the executive branch," she noted, according to Children's Health Defense.

The state Supreme Court on Jan. 13 declared New York’s COVID-19 vaccine mandate for healthcare workers “null, void, and of no effect,” and ruled that the New York State Department of Health (NYSDOH) lacked the authority to impose the mandate.

The ruling pertained to a lawsuit filed on Oct. 20, 2022, against the NYSDOH, Gov. Kathleen C. Hochul and health commissioner Mary T. Bassett, by Medical Professionals for Informed Consent — a group of medical practitioners impacted by the mandate — and additional plaintiffs, including two doctors, a nurse, a radiologic technologist and a medical laboratory specialist. Children’s Health Defense (CHD) funded the lawsuit.

On Jan. 24, the state appealed the Supreme Court’s ruling that overturned the mandate. However, before the appeals court ruled, Jonathan Hitsous, attorney for the New York State Attorney General’s office, announced unexpectedly during a May hearing that the state planned to rescind the mandate.

Hitsous argued that the repeal would render the original lawsuit “moot” — meaning the rights and interests of the parties involved would no longer be at stake — and he requested that the lower court’s Jan. 13 decision striking down the mandate be vacated.

CHD and Gibson opposed the move in a joint statement, arguing that vacating the lower court’s decision would “leave open the very real possibility that this constitutional violation could happen again and ruin many more lives.”

“The law does not allow an agency to voluntarily stop an illegal activity and then claim they shouldn’t be held legally accountable,” Gibson told CHD.TV at the time.

Since then, New York formally repealed the mandate through the administrative process. In its ruling issued last week, the court held that the repeal “moots” the state’s appeal, but it declined to vacate the lower court’s decision or to take any position on it.

The vaccine mandate for healthcare workers went into effect in September 2021, which led to about 34,000 medical professionals to quit or be terminated.

Margaret Florini, a spokesperson for Medical Professionals for Informed Consent, told The Defender, "This is just the beginning."

"I think we will see many new lawsuits come about because of this historic win," Florini said. "There is still plenty of work to be done. We lost so much, not just money but relationships, marriages, friends, and homes. We cannot forget what was done to us and we must continue to shed light on it and make impactful changes that will truly prevent this from happening again."

https://townhall.com//tipsheet/leahbarkoukis/2023/10/13/new-york-state-supreme-court-vax-mandate-n2629822

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Beware the COVID Cranks

Dr. Anthony Fauci is back in the news as the media hype a resurgence of COVID-19 cases. Asked earlier last month by CNN’s Michael Smerconish if people should begin wearing masks again, he said, "I hope they would abide by the recommendation and take into account the risks to themselves and to their families. We are not talking about forcing anybody to do anything." Fauci, of course, backed a national mask mandate in 2020.

But that’s the least of the COVID contradictions from Fauci and others. Put aside the obfuscations of the origin of the virus (smearing proponents of the Wuhan “lab-leak” as conspiracy theorists.) Our public health bureaucracy has made so many misleading and confusing pronouncements, and FGI has uncovered such inconvenient facts through FOIA requests, that the public should take any new dictates with a truckload of salt.

Prior to COVID, the only randomized control trial (RCT) of cloth mask efficacy was performed in the context of SARS virus. Considered to be the “gold standard” for drawing scientific conclusions, the RCT study found that cloth mask “filtration was extremely poor (almost 0%).” So, when COVID hit, the information with the highest integrity indicated cloth masks were virtually useless as a filter for airborne SARS virus. Perhaps Fauci was thinking of this study when he initially said there was no need for masks.

By October 2020, Fauci was a mask-believer, and working on a paper for the Journal of the American Medical Association (JAMA) that praised mask efficacy when The Federalist published an article that cited the findings of a CDC study completed the month before. Masks and face coverings, the CDC concluded, were ineffective in preventing the spread of COVID-19.

The records obtained by FGI showed that Fauci was aware of both the article and the CDC study while working on his JAMA paper, as a co-author sent them to him the day the article was published. Fauci’s response: “Not good for our paper.”

In another email she stated, “I would not tell people that the cloth masks we are all wearing provide PERSONAL PROTECTION against acquisition of the virus-they may to some degree, but I have never seen convincing data on this.”

Shortly thereafter, Fauci’s JAMA paper was published without reference to the inconvenient studies, instead relying on an already discredited mask study. When another scientist pointed out the blunder, Fauci told his assistant to make a note of it but not to take any action to correct it.

It wasn’t just Fauci. Early in the pandemic, the CDC and the Infectious Diseases Society of America (IDSA) created the COVID-19 Real-Time Learning Network website purporting to share “accurate, timely information about COVID-19.” In November 2021, Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, penned an official letter with several colleagues to the medical editor of the website, pointing out that both the site and the CDC’s guidance on masks currently contained incorrect, harmful advice for the American public.

Osterholm warned that the flawed information would “not only damage the credibility of science and endanger public trust by misrepresenting the evidence, but also provide false expectations in terms of respiratory protection to the public.” Officials should “reconsider [their] statements about the efficacy of masks and face coverings for preventing transmission of SARS-CoV-2.” Osterholm identified a pattern of cherry-picking studies based on their alignment with the administration’s policy agenda, saying, “Studies that do not support its perspective are similarly downplayed.”

Osterholm was ignored and CDC doubled down on claims that “any mask is better than no mask.”

Unfortunately, the dysfunction doesn’t end with masks. In November 2022, Vice President Kamala Harris tweeted, “One shot, once a year—that’s all most people will need to stay protected from COVID year-long.” The next day, HHS Secretary Becerra tweeted, “An updated COVID vaccine can help protect you from the worst outcomes of COVID. If it’s been over 2 months since your last dose, make a plan to get one now.” Becerra repeated his two-month recommendation the following day in another tweet.

Upon seeing the tweets, FGI made a FOIA request for documentation of the scientific reasoning supporting Becerra’s prescription for COVID-19 vaccine booster shots every two months. By law, the government is given 20 business days to respond to a FOIA, yet it took eight months and a lawsuit for the HHS to confirm that there was no medical evidence for six shots per year nor were there any documents or communications explaining the origin of the Secretary’s public health pronouncement.

We can hope COVID-19 as a public health issue and the government dysfunction that came with it will continue to fade into memory. Our public health bureaucracy didn’t exactly cover itself in glory while it was trying to cover our faces – and its posterior.

https://townhall.com/columnists/petemcginnis/2023/10/10/beware-the-covid-cranks-n2629584

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Italian Study Claims Neanderthal Genes Are Linked to Long Covid

The cause of Long Covid has been the source of ongoing speculation. Studies have pointed to a dysfunction in the immune system and another points Covid-19 latching onto the ACE2 (angiotensin-converting enzyme 2) receptor, which acts as the doorway through which the virus infects cells. The depletion of ACE2 is central to the neuromuscular complications experienced by a significant percentage of Covid-19 patients. There may be at least 6 million people worldwide suffering from Long Covid and the prolonged disease also has advocacy groups. Now, a recent study out of Italy indicates the reason some people are infected with Long Covid is because of ancient genes.

Neanderthal Genes

A recent study from Milan, Italy and carried out in the Northern Italian city of Bergamo, suggests genes inherited from Neanderthals, extinct cousins of modern humans, could help explain why some people developed life-threatening forms of Long Covid while others didn’t. The Northern Italian city was hit very hard by the Covid pandemic, and Bergarmo suffered one of the highest death rates of the pandemic. The high number of infections provided scientists with data for the study, though the research doesn’t address why so many people died there compared with other parts of Italy or Europe.

The researchers were led by Giuseppe Remuzi. They found genes passed down from Neanderthals may confer higher risk from Covid-19. Remuzi is with the Mario Negri Institute for Pharmacological Research in Milan. This research was done on behalf of WHO’s ORIGIN study group.

The study was a genome wide associate study (GWAS). The researchers studied a sample of nearly 10,000 people in the Bergamo area, identified several genes associated with the development of severe respiratory illness. Three of those genes belonged to a group of variations in DNA, or haplotype, inherited from Neanderthals. The study found that people who carry the Neanderthal haplotype were twice as likely to develop severe pneumonia from a Covid infection than those who didn’t, and three times as likely to be hospitalized in intensive care units and put on ventilators.

What is not known is whether the haplotype is more common in the Bergamo region than in other Italian or European regions. Epidemiologists still don’t know why parts of northern Italy suffered such high death tolls, especially early in the pandemic. Scientists have suggested factors could have included age, air pollution and that the virus hit the region early in the pandemic and spread undetected.

Study Shows Risk for Some

“This study shows there is a particular section of the human genome that is significantly associated with the risk of getting Covid-19 and of developing a severe form of it,” says Remuzzi. “That section is more important than any others to explain why some fall seriously ill.” Remuzzi added in Bergamo 33% of those who developed life-threatening forms of Covid had the Neanderthal haplotype.

About 2% of the genomes of people of European or Asian ancestry is inherited from Neanderthals, and they have been linked to modern humans’ susceptibility to a variety of diseases. The study adds to a growing body of research which indicates that a cluster of Neanderthal genes increases the likelihood of developing severe forms of Covid-19. Bergamo was an early epicenter of the pandemic. As pointed out, a notable feature of Bergamo is that its population is relatively homogeneous. Perhaps this study provides the answer as to why Covid was so prevalent in the Northern Italian city.

https://www.trialsitenews.com/a/italian-study-claims-neanderthal-genes-are-linked-to-long-covid-3dc2770d

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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