Thursday, May 16, 2024

National University Singapore Scientists Develop mRNA-based Mucosal Nasal Vaccine

Scientist, academic researcher and entrepreneur Ayça Altay Benetti, Ph.D., of National University of Singapore (NUS) along with Kevin P. White and Giorgia Pastorin—both professors also at NUS and colleagues present design and characterization attributes of a novel formulation for delivery of COVID-19 mRNA vaccine targeting the nasal mucosal pathway. They are exploring alternative substances to use as a vehicle to not only efficiently deliver mRNA payloads to the nasal mucosa, but also with the ability to promote uptake by target cells such as epithelial and immune cells.

Identifying chitosan, a natural polysaccharide derived from chitin for this purpose—given its biocompatibility, biodegradability and mucoadhesive characteristics, the Singapore-based team reports on formulations achieving a mRNA encapsulation efficiency of ~80.2% with chitosan-lipid nanoparticles, as measured by the RiboGreen assay.

Reporting on transfection levels in select human cells as part of the evaluation of SARS-CoV-2 Spike (S) receptor-binding domain (RBD) expression via ELISA for the group’s vaccine formulations, the most promising vaccine formulation was also responsive to lyophilization (freeze drying or cryodesiccation)with minimal degradation of loaded mRNA, demonstrating a pathway towards a more accessible and stable vaccine.

Studying the highly experimental vaccine in in vivo mice studies, the team evaluated the systemic and local immune responses. The authors report that a nasal bronchoalveolar lavage fluid (BALF) wash evidenced sufficient levels of antibody concentrations less any problematic systemic antibody response. The academic center scientists in Singapore suggest they have developed a potential candidate for clinical development and commercialization.

Why Researchers Look into Nasal Mucosal Vaccines against COVID-19?

Nasal mucosal vaccines targeting COVID-19 are desirable for several reasons.

First, they can potentially enhance immune response at the SARS-CoV-2 pathogen entry point. COVID-19 primarily enters the body via the respiratory tract. Nasal vaccines can induce strong mucosal immune response in nasal passages and upper respiratory tract, and this happens to be the initial site of the infection.

The premise here is that such localized immunity can potentially prevent the virus from establishing an infection, thereby providing an effective first line of defense. Furthermore, this class of vaccine can potentially reduce aid reduction in transmission, meaning that when nasal mucosal vaccines generate immunity directly in the respiratory mucosa, nasal vaccines possibly can reduce viral shedding and transmission. Put another way, if SARS-CoV-2 is neutralized in the nasal passages, it is less likely to be spread to others through respiratory droplets.

Also, this vaccine method could be administered without needles, meaning it’s easier to administer. This results in a more user-friendly form of vaccine, reducing any discomfort and anxiety associated with injections. But there is more. A nasal mucosal vaccine may stimulate broader immune response, including the production of IgA antibodies, which play a key role in mucosal immunity. This can complement the systemic immunity (IgG antibodies generated by traditional intramuscular vaccines, potentially offering more comprehensive protection.

Other potential benefits of a nasal type of vaccine targeting COVID-19 include the potential for rapid deployment, improved acceptance (given its non-invasive delivery) and cross-protection against variants. On this latter point, preliminary research suggests that mucosal immunity might offer better cross-protection against various variants of the virus. Why? Well, since the nasal passages are the primary entry point for respiratory viruses, a robust mucosal immune response could help in neutralizing diverse viral strains before they cause systemic infection.

The Singapore-based team points out in their paper published in MDPI’s Vaccines, that a chitosan-based formulation represents a good possibility for an mRNA nasal vaccine. With a mucoadhesive nature and ability to transiently open tight junctions between epithelial cells, chitosan facilitates the transport of macromolecules across the nasal mucosa. In their paper, the authors note, “One of the few natural polymers with a positive charge at a slightly acidic pH, chitosan is expected to prolong the local delivery of actives at the mucosa through electrostatic interactions with negatively charged mucin.”

Based on some evidence, the authors suggest this could enable the efficient delivery of mRNA to target cells within the nasal epithelium, ultimately offering opportunity to develop COVID-19 vaccines through the intranasal route.

The authors point to the promise of using the unique mucoadhesive properties of chitosan, potentially in combination with the delivery capabilities of LNPs or liposomal vehicles. This could lead to new avenues for the development of mRNA-based nasal therapeutics. And establish in the future ways to treat COVID-19 via local immunization, along with other benefits including improved bioavailability, reduced systemic degradation, and enhanced uptake by target cells within the nasal mucosa.

But can mucosal formulations overcome some of the current limitations or challenges associated with the current COVID-19 vaccines?

Threats to cargo (mRNA) stability mainly include RNAse enzymes, which easily degrade mRNA (which is hydrolyzed at pH > 6). Even through the existing COVID-19 vaccines use LNPs to encapsulate the nucleic acid therapeutic, regardless instability still occurs in the LNP system when cationic lipids lower the pKa of ribose 2′ hydroxyl group in mRNA, which can increase RNA hydrolysis.

Need for ultra cold chain

mRNA vaccines need to be stored at far lower temperatures. If compromised by external factors resulting from storage conditions, these dosage forms will cause the premature release and degradation of the mRNA by RNase

So, to improve mRNA formulation stability requires one of two directions: either modify the mRNA itself (the cargo) or improve the drug delivery system. The study team assumes that the current methodology is safe and effective, not concerned with a growing, yet not frequently cited literature expressing concern around stability and there are safety issues linked to the instructions to produce the spike protein, although the majority medical research establishment has yet to acknowledge or accept such concerns.

The Study Background

In this study, the team evaluated the stability and efficacy of liposomal formulations, in the presence or absence of chitosan or PEG lipids loaded with linear or circular mRNA. By comparing circular RNA (cRNA) to traditional linear poly-adenylated RNA, the team studied whether the cRNA could display greater stability due to its resistance to exonucleases.

Importantly, what they refer to as optimized formulations in the investigation depend on “self-assembling systems” involving lipids complexed with mRNA, an adjustable process allowing differing ratios of cationic lipid to cholesterol or the ratios of lipid to cholesterol to PEG lipid to chitosan.


Achieving an mRNA encapsulation efficiency of ~80.2% using chitosan-lipid nanoparticles, the team employed use of RiboGreen assay for measuring results.

Using ELISA to evaluate the team’s vaccine formulations and corresponding spike protein receptor-binding domain (RBD) expression, the team reports transfection levels “in human embryonic kidney cells (HEK 293), lung carcinoma cells (A549), and dendritic cells (DC 2.4) equal to 9.9 ± 0.1 ng/mL (174.7 ± 1.1 fold change from untreated cells (UT)), 7.0 ± 0.2 ng/mL (128.1 ± 4.9 fold change from UT), and 0.9 ± 0.0 ng/mL (18.0 ± 0.1 fold change from UT), respectively.”

With their top investigational vaccine prospect amenable to lyophilization with minimal degradation of loaded mRNA, the Singapore-based team expresses enthusiasm for the prospect of a more accessible and stable vaccine.

Summarizing at least initial in vivo studies in mice with a nasal bronchoalveolar lavage fluid (BALF) wash highlighting an optimized formulation, which led to local antibody concentrations less any systemic antibody response.

They suggest, “If further improved and developed, it could potentially contribute to the management of COVID-19 through nasopharyngeal immunization strategies.”


Ear nose and throat illness was slightly elevated among Covid vaccine users

Do COVID-19 vaccines lead to otolaryngology-based adverse events, and ultimately injuries? A medical specialty which is focused on the ears, nose, and throat as well as otolaryngology-head and neck surgeries, these specialists are trained in both medicine and surgery. An otolaryngologist is often called an ear, nose, and throat doctor, or an ENT for short, and recently, specialists from the Tri-State Area published a report on “Otolaryngologic side Effects After COVID-19 Vaccination.” Led by Christina Fang, M.D., Department of Otorhinolaryngology – Head and Neck Surgery, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York, the team designed a r1etrospective analysis of national registry the team investigated the frequency of otolaryngologic adverse events (AEs) after COVID-19 vaccination as compared to other vaccines in a national database.

Tapping into the Food and Drug Administration's (FDA) Vaccine Adverse Event Reporting System (VAERS) database from December 2020 to May 2021, for all COVID-19 vaccination AEs, the team represented by Dr. Fang and colleagues categorized complaints as otolaryngologic and sub stratified into different anatomic components. The study authors determine reporting odds ratios (ROR) and proportional reporting ratios (PRR) were determined for AEs of clinical significance.

While the investigators identified numerous otolaryngologic symptoms, few were found to be clinically significant. Fang and team report facial paralysis, Bell's palsy, and anaphylaxis did not meet signal thresholds to be determined significant. However, signal ratios were detected for a range of issues including dysgeusia, ageusia Tinnitus and Vertigo.

The recent outcomes were reported in the journal The Laryngoscope.


The authors reported 1,280,950 AEs from vaccination potentially linked to Moderna, Pfizer-BioNTech, and Janssen. 4.9% of the total or 62,660 fell in the otolaryngologic category.

32.6% of the incidents were associated with oropharynx/larynx, 18.3% with the nasal cavity/sinuses, 17.1% with the ears/vestibular system, 10.0% with the oral cavity, and 21.9% miscellaneous.

According to Fang and colleagues, “Signal ratios reached significance levels for dysgeusia (n = 2124, PRR: 17.33, ROR: 16.36), ageusia (n = 1376, PRR: 2.81, ROR: 2.81), anosmia (n = 983, PRR: 4.01, ROR: 4.01), rhinorrhea (n = 2203, PRR: 2.99, ROR: 3.00), throat tightness (n = 3666, PRR: 4.99, ROR: 5.00), throat irritation (n = 3313, PRR: 4.51, ROR: 4.52), dysphagia (n = 2538, PRR: 2.07, ROR: 2.07), tinnitus (n = 4377, PRR: 3.97, ROR: 3.98), and vertigo (n = 2887, PRR: 3.93, ROR: 3.93).”

However, no significant signal ratios were identified for facial paralysis, Bell's palsy, anaphylaxis, sinusitis, hearing disability, and ear pain.




Wednesday, May 15, 2024

Thousands of Children Prescribed Ivermectin or Hydroxychloroquine for COVID: Study

Doctors prescribed ivermectin or hydroxychloroquine more than 4,400 times to children with COVID-19 during periods of time when the drugs were not recommended against the illness by authorities, according to a new study.

Doctors issued 813 prescriptions of hydroxychloroquine to minors with COVID-19 after the Pediatric Infectious Diseases Society on Sept. 12, 2020, advised against using hydroxychloroquine outside of a clinical trial, researchers found. The recommendation came after the U.S. Food and Drug Administration (FDA) revoked emergency use authorization for hydroxychloroquine against COVID-19.

Another 3,602 prescriptions of ivermectin for children with COVID-19 were issued after Feb. 5, 2021, when the Infectious Diseases Society of America released guidelines advising not to use ivermectin outside of a trial. The FDA later in 2021 urged people not to take ivermectin against COVID-19, although it has since been forced to rescind those warnings.
Dr. Julianne Burns, a clinical assistant professor of pediatric infectious diseases at Stanford Medicine Children’s Health, and other researchers examined records from Komodo Healthcare Map, a health care claims database that Komodo Health says covers 330 million patients. They looked for children who had acute COVID-19 from March 7, 2020, to Dec. 31, 2022.

After excluding some children, including those who did not have continuous insurance coverage for at least one year prior to diagnosis, the researchers found approximately 4,480 prescriptions of “nonrecommended medications.”

All but a few dozen of the prescriptions were for ivermectin or hydroxychloroquine.

Both drugs are approved by the FDA, but not against COVID-19. Some agencies, groups, and doctors say the drugs should not be used against the illness, pointing in part to clinical trials that have found little or no evidence that they’re effective. Other organizations and doctors, though, say the drugs work against COVID-19, citing their own experience and other trials that found the drugs were beneficial. Off-label prescriptions are common in the United States.

Dr. Burns and the other researchers who conducted the new study, which was published by the American Academy of Pediatrics’ journal, said their findings showed “children were prescribed ineffective and potentially harmful medications for acute COVID-19 despite national clinical guidelines.”

The only data on effectiveness or lack thereof they cited was the FDA’s authorization revocation for hydroxychloroquine and the guidance from the Pediatric Infectious Diseases Society and Infectious Diseases Society of America. As for their safety description, they pointed to a federal advisory that found a 24-fold increase in ivermectin prescriptions and a five-fold increase during the same time of ivermectin-related calls to poison control centers.

Dr. Robert Apter, who was not involved in the study, highlighted how the study referred to potential issues but cited no evidence of actual issues from usage of the drugs against COVID-19.

“The fact that there was a report of increased calls to poison control centers about ivermectin doesn’t mean a thing. When something gets in the news and people are curious about it, they may call the poison control center,” Dr. Apter told The Epoch Times.

He said that the drugs “have a long history of safe use in children.”

Dr. Apter has prescribed treatments for thousands of COVID-19 patients and was one of the doctors who sued the FDA over its anti-ivermectin statements. He said he’s prescribed ivermectin or hydroxychloroquine for several teenagers who became so sick that their families became concerned. Those children improved quickly and there were no side effects, according to the doctor.

Dr. Burns did not respond to a request for comment.

The researchers said limitations to their study stemmed from their reliance on health care records, which can’t account for COVID-19 infections that were not reported to a health care provider and might contain mislabeled codes. Funding came from the Stanford Maternal and Child Health Research Institute. No conflicts of interest were listed.

A previous study, examining claims data from Dec. 1, 2020, through March 31, 2021, identified 128 prescriptions of ivermectin for children for non-parasitic infections, with researchers assuming the prescriptions were for COVID-19. That paper drew from IQVIA’s health claims database. The researchers also examined data from patients with Medicare Advantage insurance and found some ivermectin prescriptions, though none for children.


UPenn Led Researchers Find Political Bias in Who Reports COVID-19 Vaccine Adverse Events

True, the COVID-19 pandemic became ultra-politicized but was this something that manifested in the reporting of injuries linked to the COVID-19 vaccines? Researchers affiliated with University of Pennsylvania (UPenn) and Washington University School of Medicine in St. Louis sought to investigate.

Designing a cross-sectional study involving 620,456 adverse event reports, David A. Asch, M.D., MBA, Senior Vice President for Strategic Initiatives, and the John Morgan Professor at the Perelman School of Medicine and at The Wharton School, and colleagues at UPenn uncovered aw10% increase in state Republican voting was associated with a 5% increase in the odds that a COVID-19 vaccine adverse events would be reported, a 25% increase in the odds that a severe adverse event would be reported, and a 21% increase in the odds that any reported adverse event would be severe.

Interesting Data Points

With 620,456 adverse events (435,797 from women [70.2%]; mean [SD] age, 51.8 [17.7] years) linked to COVID-19 vaccination, the UPenn-based team found a 10% increase in state-level Republican voting associated with increased odds of adverse event reports (odds ratio [OR], 1.05; 95% CI, 1.05-1.05; P < .001). Looking at severe adverse event reports (OR, 1.25; 95% CI, 1.24-1.26; P < .001), plus the proportion of such adverse events reported as severe (OR, 1.21; 95% CI, 1.20-1.22; P < .001) such positive associations between political inclination and reports of COVID-19 vaccination adverse events are revealed in the table above against no associations between political inclination and reports of influenza AEs.

The authors also report the same pattern across all age strata in stratified analyses and in analyses less the District of Columbia, all sustained in the previously cited sensitivity analysis.


Does the association between observation and belief run both ways? Does the saying “seeing is believing” recognize that humanity’s individual experiences inform our sense of truth? Does “believing is seeing” recognize that human preconceptions control what we experience in the first place? Asch and his colleagues write, “In finding that Republican-inclined states show higher COVID-19 adverse event reporting than Democrat-inclined states, this study suggests that Republicans are more likely to perceive or report those adverse events and that Democrats are less likely to.”


While vaccine reporting and political voting happen at an individual level, they are measured at the level of states, and the authors ponder the likelihood of their assumptions as not high.

Yet what’s interesting is that clearly, highly intelligent authors don’t educate the reader on the true limitations of a study such as this one. For example, such cross-sectional studies are unable to establish causality. While this class of study can certainly provide a snapshot of a population as a specific point in time, establishing cause-and-effect relationships between variables is very difficult.

Moreover, such studies are generally fixed in time, meaning they cannot capture changes in variables over time—in this latter case, longitudinal data is superior. What about any bias in sample selection? And then there is the reality that such studies can provide prevalence data but lack the ability to determine incidence. And there is the potential for confounding variables, and other limitations.

Despite these limitations, cross-sectional studies can help generate hypotheses, estimating prevalence, identifying associations between variables, and providing a snapshot of a population's characteristics at a specific point in time.


Australia: Three years on from Covid lockdown protests Judge Liz Gaynor of the County Court slams police for responding with 'unjustified violence'

In a shock decision, a judge has ruled that Victoria Police used 'unlawful' and 'unjustified violence' on anti-lockdown protesters during the Covid-19 pandemic.

Judge Liz Gaynor of the County Court ruled the police were the 'aggressors' at a protest in Melbourne on May 29, 2021 which left a man with a dislocated arm.

Victoria had some of the world's strictest lockdown conditions at the time, including that people could only move within a 5kilometre area of their home for shopping or exercise, and the banning of public and private gatherings.

The May 29 gathering at Flagstaff Gardens saw police officers vastly outnumbering the 150 protesters who turned up, more than a dozen of whom were arrested for offences such as assault and breaching the chief health officer's directions.

Jason Reeves, Nicholas Patterson and Adam Roob were each thrown to the ground and arrested at the protest after being asked to leave, the Herald Sun reported.

Judge Gaynor said the men's arrests were unlawful and that they had done nothing to warrant the violent response captured on the police's body-worn cameras.

Mr Reeves was punched in the face by police and thrown to the ground, which the judge said was an 'immediate and violent' response.

Mr Patterson and Mr Roob said they tried to defend Mr Reeves and in doing so were pepper sprayed and thrown to the ground, with Mr Paterson's arm dislocated in the scuffle.

Mr Roob and Mr Patterson were in court for charges such as common law assault and assaulting an emergency worker on duty.

But the judge ruled that the police evidence was inadmissible because 'by their unlawful violence police instigated the response by the accused which underlies the charges they now face'.

Judge Gaynor said the police had several options to deal with the pair, such as issuing infringement notices or telling them they breaching restrictions and were to be placed under arrest.

'However, the police chose not to respond that way. I am satisfied that in arresting Mr Reeves, police used unnecessary and unwarranted force and violence.'

She said video of the group in the 30 minutes before the arrest did not indicate they would be violent and that she was 'satisfied that (police) were the aggressors in the situation and that they employed unjustified violence on Mr Reeves'.

The judge said the police did not speak to him and tell him he was under arrest or why he was arrested, but instead 'confronted, pushed, and attacked him before bringing him to the ground'.

She also found that Mr Paterson and Mr Roob 'were met with physical intervention'.




Tuesday, May 14, 2024

Technofascist Acts Against Health Freedom

I am not quite sure what to make of the article below by Maryam Henein. She seems to be an "alternative" person rather than a person with a science background but there is no doubt that censorship of Covid matters has been extreme. I am the most mainstream scientist you would meet. I even talk about such things as "an experiment-wise error-rate approach to significance testing". Yet Google have censored even me on occasions. So the advocacy of free speech by Maryam Henein is welcome.

How many of us in this Post-Truth world have been silenced? It hurts a bit more when your profession is to be a messenger, report, and alert.

I have been banned for life from PayPal, Amazon, Venmo, and Vimeo. I was scrubbed off Kiva and GoFundMe. My COVID-19 Vaccine Detox Guide to help injured people was removed from SmashWords and my entire profile.

Google buried my company,, and our Facebook ads were temporarily shut down while our data was wiped out. Chase debanked me. Media Matters and NBC Peacock smeared me in a horrendous series like Shadowland, where they assured me they’d feature my story but only discovered my person. You can watch my reaction to the series here.

In truth, I can write a whole series about technofascist acts in the health and wellness space.

In 2018, Care2, a site that “connects people with causes,” closed down its “Healthy Living and Causes” sections. They claimed this was to ‘sharpen its focus on advocacy work and nonprofit partners.” They could have archived the stories but deleted THOUSANDS of informative articles about alternative health instead. Poof. Gone. Vaporized.

While putting together my presentation for Anarchapulco Reborn X 2024, titled Health Censorship In An Age of Technofascism & How To Navigate for Truth, it occurred to me that they knew the Rona Regime was coming, and they scrubbed the articles because they did NOT want those locked down at home to educate themselves.

“I know it’s super frustrating to see content that you’ve written disappear,” one of their old editors wrote. Super frustrating? I’d never had my content deleted. Now five years later, i am a seasoned censored pro.

As Mercola wrote:

“It’s a frightening future. Big Tech has joined the movement, bringing in a global concentration of wealth to eliminate competition and critical voices—voices that bring awareness . . . .as our rights, freedoms, and competition erode into a fascist sunset, all disguised as a means to protect you from ‘misinformation.’”

Chet Bowers, who first used the word ‘technofascist’ asks:

“Will enough of the public recognize the dangers that lie ahead, and will they be able to articulate the importance of what is being lost, including how what is being lost undermines the diversity of common cultural experiences that are more ecologically sustainable?

The most critical question is whether there will be resistance to how everyday lives are being increasingly monitored, motivated to pursue the increasingly narrow economic agenda of the emerging techno-fascist culture and stripped of historical values and identity?”

In “1984,” the torture is too much. Winston, the main character, betrays his lover, Julia, in exchange for his own life. She does the same.

“Power is in tearing human minds to pieces and putting them together again in new shapes of your own choosing,” Orwell writes.

In 2019, I asked If we would stand up for rights for health, freedom, and sovereignty. Or sit back and play with our phones while we lose our rights and are forcefully stuck with needles?

Unfortunately, we know the answer by now. Maybe next time, it will be different???

“Anytime you are truly free, there is a cost to pay,” Dr. Cornel West told Joe Rogan.

I agree, but the alternative is ghastly. I don’t believe we have to be slaves to Big Brother. Speak out and share. Tend to your gut and your brain with micronutrients and access the cleanest food. De-Google your life and use other search engines like QWANT.

As Orwell says, “Until they become conscious, they will never rebel, and until after they have rebelled, they cannot become conscious.”


The Tide Turns: Research on COVID Vaccine Harms, Once a Taboo Subject, Now Appearing in Some Medical Journals

By Joe Wang

When COVID-19 took the world by storm in early 2020, I mostly relied on reading Nature Medicine, The Lancet, and a few other medical journals to learn the latest on this new disease.

In March 2020, I read an article published in Nature Medicine titled “The proximal origin of SARS-CoV-2” with great interest. Written by California-based Scripps Institute’s Kristian Andersen and four other well-known professors, it said SARS-CoV-2 binds to human cells much better than any computer programs predicted, and concluded that “SARS-CoV-2 is not the product of purposeful manipulation.”
Having been a scientist with the world’s largest vaccine company for more than 10 years, I took issue with this claim.

In a May 2022 commentary titled “Pandemic Lessons Learned: Scientific Debate Silenced, With Deadly Consequences” I wrote: “If SARS-CoV-2 infects people better than your computer predicts, then the only conclusion you can draw is that your computer sucks. How did these world-renowned scientists get the basic logic so wrong? And how did the prestigious publication Nature Medicine not catch that? Did anyone even read the paper before publishing it, not to mention peer review it?”

The Andersen article’s conclusion, as it turned out, was a complete flip-flop on Andersen’s Jan. 31, 2020, email to Dr. Anthony Fauci, then the director of the National Institute of Allergy and Infectious Diseases (NIAID), in which he wrote that “some of the features (potentially) look engineered,” referring to the coronavirus.

The Fauci emails were made public in June 2021 via Freedom of Information Act requests.

Nevertheless, the Nature Medicine paper became the authority on the origin of COVID. It essentially excluded the Chinese Communist Party (CCP) and Dr. Fauci from any responsibility for the emergence of the virus. Any attempts to investigate or explore other possibilities were labelled conspiracy theories.

Andersen, and the article itself, were the subject of a U.S. Congressional Hearing by the Select Subcommittee on the Coronavirus Pandemic in June 2023. The debate on how COVID originated is still ongoing today.

The Lancet and the Daszak Statement

Andersen and Nature Medicine weren’t the only ones trying to please the CCP and Fauci.

On Feb. 18, 2020, The Lancet, another top medical journal, published a political statement with no science in it. It was organized by Peter Daszak from EcoHealth Alliance, which was the middleman for channeling Fauci’s National Institutes of Health (NIH) funds to the Wuhan Institute of Virology, according to a U.S. Congress report released on May 1 of this year.

The Daszak et al. statement dismissed as a conspiracy theory any suggestion that COVID was not of natural origin.

“We stand together to strongly condemn conspiracy theories suggesting that COVID-19 does not have a natural origin,” they wrote. “Conspiracy theories do nothing but create fear, rumours, and prejudice that jeopardize our global collaboration in the fight against this virus.”

The Tune Is Set

The Daszak statement, along with the Andersen article, set the tune for the officially accepted narrative. The narrative then expanded from “a natural origin of the virus” to “a COVID vaccine will flatten the curve and save the world.” Scientists, doctors, and journal editors who dared to challenge the narrative were cancelled and/or labelled conspiracy theorists and anti-vaxxers.

It has been four years and six months since the world first encountered SARS-CoV-2. Despite the claims by famous scientists like Fauci and Andersen, and despite the countless efforts by top virologists and public health professionals, evidence that the virus originated naturally has not been found.

More and more people now believe that the virus was leaked or escaped from a laboratory at the Wuhan Institute of Virology, which has been doing gain-of-function research on coronaviruses, and published such research in Nature Medicine in 2015, with NIH funding acknowledged.

The lab origin is no longer a conspiracy theory. The U.S. Energy Department and the FBI both now believe that the virus was more likely leaked from a lab than having developed naturally.

Encouraging Developments

Since the pandemic, The Epoch Times and NTD have been publishing documentary films on COVID origin and vaccine injuries. The first such documentary, Joshua Philipp’s “Tracking Down the Origin of the Wuhan Coronavirus,” was viewed over 100 million times on different platforms combined. However, such reports are rarely seen in other legacy media.
It has also been a taboo subject for scientific research and publication, but that may be starting to change.

Recently, I wrote a commentary about a new paper by five Japanese scientists that was published on Cureus, a peer-reviewed medical journal owned by the Springer Nature Group, the same company that owns Nature and Nature Medicine.
The scientists analyzed data collected from the entire 123 million Japanese population and concluded that the majority of the 115,799 excess deaths in 2022 was not due to COVID infection but rather vaccination, in particular the third COVID shot.

I was pleasantly surprised that a once-taboo subject was now published in a peer-reviewed medical journal, especially a member journal of the Springer Nature Group.

In another positive development, this month the International Journal of Biological Macromolecules (IJBM) published a paper titled “Review: N1-methyl-pseudouridine: Friend or foe of cancer?” linking a key ingredient in the COVID-19 mRNA vaccine with cancer development.

IJBM is owned by the Dutch academic publishing company Elsevier, which also owns renowned publications like The Lancet, Cell, and ScienceDirect.

May the Force Be With the Editors-in-Chief

In the spring of 2022, when more scientists started to challenge the accepted narratives and seek the truth, I co-wrote the commentary “May the Force Be With Them: Scientists Fight Back.”

At that time, these brave scientists needed all the help they could get. For example, when a journal published a well-researched, well-written, and fact-based scientific paper on the safety concerns of the mRNA vaccines, the editor-in-chief of that journal was ousted.

The journal was Food and Chemical Toxicology, another Elsevier publication, and the editor-in-chief was Dr. José Luis Domingo.

Two years later, I’m optimistic that the IJBM editors-in-chief won’t face the same treatment as Dr. Domingo.

Why? I believe the tide has turned.

A recent New York Times article on COVID vaccine injuries is also an encouraging sign. It cites the Food and Drug Administration’s former acting commissioner Dr. Janet Woodcock as saying the injuries are “serious” and “life-changing,” and “should be taken seriously.”

“I’m disappointed in myself,” she added. “I did a lot of things I feel very good about, but this is one of the few things I feel I just didn’t bring it home.”

Among the reported injured is the editor-in-chief of the journal Vaccine, Dr. Gregory Poland. He has been suffering from tinnitus since his first shot. The Centers for Disease Control didn’t take his report on his personal experience seriously. He told the NY Times that he did not “get any sense of movement (from the CDC).”

“If they have done studies (on vaccine injury), those studies should be published,” Dr. Poland added.

The journal Vaccine is also an Elsevier publication, and as the editor-in-chief, Dr. Poland is well positioned to offer his encouragement on vaccine injury studies.

Yes, I believe the tide has turned.

However, as of today, the Daszak statement is still on The Lancet website and the Andersen paper is still on Nature Medicine.

I wonder when the Lancet and Nature Medicine will have the courage to retract them? And when will these two eminent journals start publishing research on COVID vaccine injuries?




Monday, May 13, 2024

COVID-19 Medical Freedom Warriors Seek to Use the Courts to Take on Vaccines

The undoubted bad behavior of governments during the pandemic has undermined their authority and tends to hand authority to the courts, which may not always be very friendly to personal liberty

While numerous bills were introduced in state legislatures prior to the pandemic challenging state vaccine requirements, politicization of vaccines has intensified since the COVID-19 pandemic. As politicians and in some cases, state health officials make moves to cater to angry, at times conservative or medical freedom-focused populations reacting to what many felt were overreaching COVID-19 pandemic programs, the health crisis led to a notable surge in vaccine-related litigation across America. To some extent, the vaccine policy area has moved from lawmaking and legislators into the courts, but TrialSite notes legislation continues to play a key role in vaccination policy. However, could litigation increasingly constrain what public health-minded legislatures can do to protect the public with vaccination schemes statewide?

SCOTUS shoots down some federal mandates

Since COVID-19 TrialSite reports on a growing presence of the courts as a source of power and vaccine policy---for example, profound issues related to vaccine science and public health powers may now be settled more by judges than by legislatures or public health experts via administrative actions.

An area with precedent, over a century of settled law confirms the constitutionality of state vaccine mandates—however, these increasingly may fall into question as dissenting justices of the US Supreme Court could lean toward undoing such legal tenets.

The highest court in America heard cases pertaining to federal and employer powers to compel vaccination, and in some cases shot down presidential edict during the pandemic on grounds of constitutionality, or lack thereof. More on that below.

CICP backlogged

A major thrust involving a confluence of forces, from traditional anti-vaxxers to newbies in the health freedom movement, to groups with claims such as the COVID-19 vaccine injured, targets the lower courts. In these forums, could some conservative-minded appellate judges possibly make moves to grind down liability protections for vaccine manufacturers? Meanwhile, political pressure against vaccine liability protection may grow, given the huge backlogs linked to the U.S Countermeasure Injury Compensation Program (CICP), established to compensate persons injured by COVID-19 countermeasures (vaccines).

How many are injured from COVID-19 vaccines?

TrialSite has reported on the appalling state of those programs, an utter failure leaving possibly tens of thousands of people with nowhere to turn. Some medical freedom movement figures claim the figure of COVID-19 vaccine injured to be in the many millions. TrialSite has estimated the number to be between a quarter-of-a-million to about two million people nationwide grappling with some set of challenges impacting quality of life. To put these figures in context, about 230 million people in the U.S. were deemed fully vaccinated during the pandemic.

With no end in sight, litigation could represent profound challenges for what government health agencies refer to as vaccine confidence or the lack thereof. Even public health itself during the pandemic, due in part to politicization from all sides, but also a range of behavior from over-reach to incompetence on the part of the government, has led to even questions about the legitimacy of public health agencies such as the Centers for Disease Control and Prevention (CDCP itself).

Does Jacobson v. Massachusetts stand the test of time?
Could the result of all of this be seismic changes in law around the country?

For example, states’ traditional rights to mandate vaccination could be under fire given the backlash against vaccination since COVID-19. For example, with the intense array of rules, mandates and the like emerging during the pandemic, now numerous lawsuits play out, reaching the highest levels including the Supreme Court.

In fact, on that topic, several cases have made their way to the high court, and the justices, conservatively leaning, have demonstrated a proclivity for revisiting past policies promulgated at the state level. Laws under the gun include Jacobson v. Massachusetts (1906) and Zucht v. King (1922)—both cases affirming a state’s ability to use its police powers to compel vaccination.

While Jacobson didn't touch on religion exemption cases working their way up, the highest courts are looking at these issues. Known as the COVID-19 Bar, the milieu of lawyers involved with challenging what’s known as the COVID regime, they suggest that Jacobson was decided in an era when the Supreme Court was upholding forced sterilization laws, and the eugenics movement sought to perfect the human race with unbridled and faith in science as an example of a different point of view.

Is Gorsuch a Justice to watch?

Justice Neil Gorsuch, a conservative-minded judge nominated by former President Donald Trump has expressed particularly more radical views when considering the mainstream medical and health policy establishment’s paradigm.

For example, Gorsuch has voiced agreement with expanding religious exemptions to immunization requirements, plus went on the record about COVID-19 public health actions stating they were, “the greatest intrusions on civil liberties in the peacetime history of this country.”

Moreover, in another case, Gorsuch suggested that public health actions need a material check on powers, lacking any imminent disease threat.

However, if such a ruling were ever to become reality the public health establishment would argue that this would undermine the ability of states’ public health agencies to strive for and maintain herd immunity against vaccine-preventable diseases, not to mention stopping outbreaks.

Importantly, in Zucht v. King (1922), the Supreme Court ruled that public schools can constitutionally exclude unvaccinated students, even when there isn't an outbreak of a particular illness. The 9–0 decision was made on November 13, 1922, after the case was argued on October 20, 1922.

But what if Gorsuch and others became a majority on this matter? Could they eventually overturn Zucht? That would dramatically change the face of public health in the United States. Will Gorsuch find the opportunity, based on mounting litigation working its way up the lower courts and above thanks to conflicting decisions—to apply his thinking which could literally eliminate modern public health powers?

What’s the status of religious exemption cases?

In Mississippi last year, a judge at the federal court level ordered the state to allow religious exemptions to immunization requirements. The result? What essentially is the upending of a 44-year-old state law established at the Supreme Court level, ruling that a lack of those exemptions does not violate religious freedom? How? By placing such religious freedom beliefs of a minority over more far-reaching public health interests.

In the above case, it was reported in the Mississippi Free Press on September 29, 2023, that the state’s attorney general would not oppose the ultimate decision favoring the anti-vaccine—or some might say pro-freedom litigants.

While such decisions may lead to less vaccination with traditional childhood scheduled immunizations, meaning diseases such as the measles could rise, public health agencies are also concerned about more systematic efforts of religious-focused anti-vaccine groups use of the topic as a front to systematically attack tried and true vaccination programs more broadly.

Ongoing litigations threaten federal powers

To many persons in what is broadly referred to as the medical freedom movement, President Joe Biden’s proclamations in August 2021 were an affront on freedom. A milieu of actions, from mandates to policies to bolster COVID-19 immunization rates, Biden’s administration took this approach despite the fact that the federal government traditionally wields little power involving healthcare laws. Rather, these laws fall under the state and local jurisdiction.

Biden’s actions generated resistance across a range of interests, including TrialSite. While this media is not “anti-vaxx” or even part of a “medical freedom movement,” we simply reported on the contradictions in the series of mandates and requirements Biden announced. One challenge was that by that point in time, the unfolding science was evident, that the COVID-19 vaccines did not stop viral transmission. Since they were not sterilizing vaccines and the durability of the vaccines was mediocre to say the least (e.g. waning in protection as quickly as in 90 days) the impetus to compel vaccination seemed a real stretch. After all these “vaccines” behaved more like temporary therapeutics.

Biden tapped into and exploited a collection of laws, powers and policies, from the Center for Medicare and Medicaid Service (CMS) contingencies for accepting federal health-related money to the Occupational Safety and Health Act involving government contractors to military personnel. The White House’s moves were challenged, with the Supreme Court ultimately diverging on the Biden mandates. While the Medicare requirement was kept, the Supreme Court shot down the other Biden mandates.

But even the CMS ruling, that contractors or organizations funded with CMS monies needed to mandate the COVID-19 vaccine, was ultimately terminated by the Biden administration itself. Was this move by Biden further evidence of a strengthening of the medical freedom movement?

Other upending of the public health system?

Attorneys favoring universal vaccination and robust public health authority express concern about recent court decisions. In one case, a New York judge rejected standard government vaccination policy because the COVID-19 vaccine failed to stop all viral transmission. Public health advocates fret that such decisions inhibit the exercise of public health authority on what they would argue were based on faulty premises. While not all vaccines fully stop transmission, they tend to certainly slow the spread, along with contributing to substantially lower morbidity and mortality rates. With courts intervening, inhibiting the public health authority to achieve its aims not only threatens the public health but also the balance of powers in the United States.

Supreme Court ruling tosses out “de minimus” standard
Has the medical freedom movement’s backlash to COVID-19 impacted what’s been an accepted authority on behalf of an employer to mandate vaccination on the job? Absolutely! See SCOTUS’ Groff v. DeJoy in 2022. In this case, the court clarified the undue hardship legal standard by addressing various lower court tests developed over the last 50 years that evaluated undue hardship in terms of whether an accommodation imposed “more than de minimis costs” or “substantial costs or expenditures” to the employer.

Based on this decision, employers must now prove “substantial increased costs” rather than the de minimis cost standard. We see a mounting number of cases driven by the Equal Employment Opportunity Commission (EEOC) involving numerous cases targeting employers due to the denial of religious exemptions to the COVID-19 vaccines. Will employers face more aggressive EEOC enforcements involving refusal to grant mandate exemptions? Some experts believe so.

What about the PREP ACT?

Importantly, manufacturers who marketed countermeasures during the pandemic (and after) benefit from broad liability waivers granted to vaccine makers such as Pfizer and Moderna, thanks to the Public Readiness and Emergency Preparedness Act (PREP Act). The presumption here is that any and all vendors involved with the development and administration of COVID-19 countermeasures benefit from universal liability protection by the government, again thanks to this legislation. But the emergence of some lawsuits has spooked government, industry, and other attorneys representing the countermeasure value chain. For example, in a handful of cases, the courts of appeal ruled that the PREP Act was not meant to preempt state tort claims, given that the emergency act fails to offer adequate judicial alternatives for injured plaintiffs.

Courts suggest ways around PREP Act

For example, ruling that the PREP Act wasn’t meant to fully supersede state law claims, the Third, Fifth, Seventh, and Ninth federal circuit courts have suggested that the PREP Act cannot completely preempt state law claims, thus allowing these claims at the state level to proceed. So, for example, negligence/willful negligence, or wrongful death, or perhaps some form of fraud could trigger state-based actions, meaning a federal action might be avoided in association with the case. TrialSite is currently tracking this topic. In one major case, M.T. v. Walmart Stores, Inc. invoking the PREP Act led to the ruling that this Act fails to afford an acceptable judicial alternative for injured parties.

In another major test, however, the Court of Appeals of Kansas found that the PREP Act does in fact preempt vaccine-related tort claims. As mentioned above, TrialSite has reported on emerging judicial conflict at the level of the federal appeals court, meaning the high likelihood of litigation over the PREP act.

Could Pfizer, Moderna, or even health systems that administered the mRNA COVID-19 vaccines confront hostile courts in the future? Any litigation that makes it through the seemingly impenetrable wall of PREP Act could open up discovery and a process not conducive to pharmaceutical industry innovation, especially if product liability claims breached such a legislatively constructed fortress.

Do we have the right to refuse?

With a marked rise in vaccine litigation post the COVID-19 pandemic and a fledgling medical freedom movement—which generally refers to a range of beliefs and activities advocating for individuals to have autonomy and choice regarding their own medical decisions, a host of issues, such as the right to refuse certain medical treatments or interventions; or for that matter, the right to choose alternative or complementary therapies, will increasingly confront courts at all levels.

Medical Freedom Movement’s future

Over a century of case law and precedent, involving an incrementally evolving, empowered public health reality could be under assault, or at least under fire, from a growing cadre of interests interested in the right to make informed decisions about one's own health care without undue interference or coercion. Ironically at least some stakeholders within the medical freedom movement take a staunchly anti-abortion stance, which has been embraced as part of the women’s freedom movement over the past decades. Will the medical freedom movement, often intersecting with debates around vaccine mandates, medical privacy, informed consent, and governmental or institutional policies that affect individual health choices, accelerate post-COVID-19, or on the other hand, slow down as the populace tires of anything and everything COVID-19?

Personal autonomy versus public health

Proponents argue that individuals should have the freedom to make decisions about their own bodies and health care without interference from external authorities, while critics may raise concerns about public health implications and the potential for misinformation to influence decision-making. This latter point of view raises serious concern about some of the court decisions made during the COVID-19 pandemic period. They view such decisions as a step backward from modernity. The medical freedom movement reflects broader discussions about personal autonomy, individual rights, and the balance between personal choice and public health considerations in the realm of medicine and healthcare, and no doubt the courts will continue to be where the parties clash.




Sunday, May 12, 2024

Why Major Ivermectin Clinical Trials Need to be Questioned--Investigated

There were four large randomized, ivermectin trials I have exhaustively analyzed, likely more than any human--TOGETHER from McMaster University in Canada, COVID-OUT in University of Minnesota, ACTIV-6 sponsored by NIH and run by Duke and PRINCIPLE run by Oxford.

Note that my findings are in the context of a clear information war that unfolded during the COVID-19 pandemic against ivermectin. In fact, the Food and Drug Administration (FDA) recently lost a lawsuit, as front-line doctors challenged the agency’s unethical, illicit behavior during the pandemic.

In the aggregate, tens of billions of dollars of potential profits were within reach of pharmaceutical companies during the pandemic. A system with biases and importantly, pecuniary interests heavily influence paradigms and strategies for combating pandemics. During the unprecedented federal takeover of medicine during the pandemic, government actors clearly favored branded and expensive drugs over economically accessible generic combinations, as the latter would not drive exorbitant profits. This is the context for which a handful of key ivermectin studies were designed and executed.

After an exhaustive review of these studies, what follows are key points of concern, discrepancies and other issues that I have found, and thus raise substantial doubt about the outcomes announced. While my findings are not published nor peer-reviewed, I invite anyone interested to review and verify for themselves. My findings reveal a disturbing set of patterns that suggest that these clinical trials were designed with failure in mind. But importantly, review and come to your own conclusions.

1. All these clinical trials as if synchronized gave patients within 23% of the same dose. The dose was 42% of the average recommended cumulative dose of the front-line physicians who were arguably the top front-line physicians prescribing the drug off-label during the pandemic. Known as the Front Line COVID-19 Critical Care (FLCCC) Alliance, these physicians aligned with providers from Australia and Eastern Europe to Bangladesh and India; from Nigeria and Latin America to Zimbabwe and Peru, forming a community-centric, bottom-up, patient-centric approach to rapid, early treatment often in combination with doxycycline and zinc during the worst pandemic in a century.

The world’s top ivermectin experts, at least during the pandemic, ironically first learned about ivermectin’s use around the world via TrialSite News The FLCCC is of course, not an acknowledged evidentiary reference body, nonetheless the group kept the spirit of the local community physician, seeking what’s right for the patient alive and well during the unprecedented pandemic, with its federally-driven, top-down, truly unorthodox approach to medicine.

The FLCCC physicians were so influential that the ACTIV-6 investigators consulted with them via online communication, but the latter failed to heed their advice. An investigator from one of these studies claimed on Twitter (now X) that the FLCCC said that their dosing was perfectly reasonable. This is not a factual statement, as proven by the FLCCC website and Dr. Pierre Kory’s Twitter page.

The point here is to emphasize the influence of the FLCCC and its ivermectin-based protocols, irrespective of whether its’ recommendations were included by federal authorities or medical bodies during the pandemic—which they were not.

2. All the trials gave ivermectin on an empty stomach when the blood level is 157% higher when the typical dose that they used, 30 mg, is given with a fatty meal. This regimen markedly differed from what the physician experts in the field recommended at the time.

3. TOGETHER, ACTIV-6 and PRINCIPLE all limited the dose by weight for no medical reason. Overweight patients who were at higher risk, had their dose limited the most, which made no sense.

4.All the trials gave ivermectin late, at an average of 4.9 days of symptoms. Paxlovid is usually given in one to two days. What we found is that there was a regular and systematic pattern of not only underdosing the drug but having the drug taken when it was frankly, too late.

5. The NIH-sponsored ACTIV-6 ivermectin trial gave 37% of the FLCCC recommended cumulative dose on an empty stomach and got it to patients at an extremely late six days on average. 75% of the patients would not have been candidates for Paxlovid, meaning the trial looked at from this lens was all but designed to fail. 75% of the patients would not have been candidates for Paxlovid, meaning the study wasn’t enrolled with the right participants.

6. Ivermectin would be declared effective if it showed at least a 95% chance of benefit in the entire 1591 patients or in any of the analyses every 300 patients. Yet as will be shown, when the data demonstrated a positive impact, nothing was done.

7. Despite the undertreatment and late treatment, ivermectin evidenced a 98% chance of benefit, so the investigators changed the primary endpoint from 14 days to 28 days, which is unethical. It showed a 91% chance of benefit, which was not statistically significant. The investigators said that ivermectin could not be recommended. Any normal person would have been happy to take a cheap, safe drug if it had a 91% chance to help them.

8. The investigators never reported any of the interim analyses because that would have revealed significant benefit at 900 patients. Ivermectin was effective for the first 900 patients who had over 90% Delta. It is highly likely that ivermectin would also have shown benefit at 600 patients. The actual data from the trial is needed to prove this. It could be obtained by a subpoena from the House Select Subcommittee on the COVID-19 pandemic or in discovery in targeted litigation.

9.Ivermectin should have been declared effective in the initial ACTIV-6 trial, later called ACTIV-6 400. As suggested above, at certain points the data suggested efficacy.

10. Early intervention with combinations such as ivermectin with doxycycline and zinc could have helped alleviate some of the suffering during the pandemic. I am a retired physician, and it is my opinion that had ivermectin been declared effective as it should have been by December 2021, hundreds of millions to billions of people around the world could have received and benefited from the drug. In the U.S., about 200 million people fell ill to COVID-19 since Dec 2021, and in my opinion, the information war launched against ivermectin by the U.S. FDA and to some extent, NIH caused tremendous unnecessary harm to Americans and others worldwide.

TrialSite chronicled extensively public health initiatives involving the combination of ivermectin, doxycycline and zinc in the Indian state of Uttar Pradesh for example, where the battle against Delta was so successful that even the World Health Organization issued a press release to celebrate the turning around of the COVID-19 [Delta] surge during the spring to summer of 2021.

Read “Uttar Pradesh going the last mile to stop COVID-19” by the WHO---they report on the entire public health initiative, only omitting the medicines used in the local home medical kit---which of course included ivermectin. See the link.

Let's do a proper comparison. In my opinion, a large, randomized trial of ivermectin at an appropriate dose versus Paxlovid or molnupiravir in patients with COVID-19 for five days or less would settle the issue once and for all. A recent study revealed Paxlovid isn’t even effective against placebo in healthy people, and molnupiravir is avoided by most doctors now.


AstraZeneca Covid vaccine withdrawn over side effects but ‘fear more deadly’

I have doubts about whether ANY of the Covid vaccines was of net benefit but if we accept that AstraZeneca was of net benefit, the observations below are reasonable

A leading infectious diseases physician says overblown fears about the AstraZeneca Covid-19 vaccine probably caused more deaths than the vaccine’s rare ­adverse side effects.

The response comes as the vaccine was withdrawn globally after the manufacturer admitted it can cause rare blood clots.

The Anglo-Swedish pharmaceutical producer withdrew the vaccine globally on Tuesday.

It comes after Australia’s Therapeutic Goods Authority discontinued use of the AstraZeneca vaccine in April last year.

On April 30 this year, AstraZeneca conceded the vaccine, sold under the name Vaxzevria, can cause fatal blood clots.

The admission came through court documents in a British class action lawsuit that sought £100m ($190m) for almost 50 victims of AstraZeneca vaccine side effects.

The application to withdraw the vaccine was made on March 5 and came into effect on May 7.

“I can see why it’s recalled because it does have probably a death rate of about 1 in 100,000 people from this clotting disorder,” the ANU’s Professor Peter Collignon said.

“But having said that, there are deaths associated with every drug and every vaccine we have – even aspirin, if you take it regularly, about 1 in 100,000 people per year die from that.

“One of the things that this side effect induced back in 2021, in my view, was the fear and the publicity about the adverse effect caused more deaths than the actual vaccine did. If you were an 80-year-old and got Covid, you had a 1 in 10 chance of dying. Yet, if you had this vaccine, you had a 1 in 100,000 chance of dying from the effect of a complication. Yet, there were a lot of people, because we had zero Covid at the time, who said, ‘oh no, I’ll wait because the Pfizer vaccine’s better’.”

The TGA provisionally approved the AstraZeneca vaccine for use for people aged 18 and over as a primary course from February 15, 2021 and as a booster from February 8, 2022. In the same period, Pfizer and Moderna vaccines were recommended over the AstraZeneca vaccine.

In June 2021, the Australian Technical Advisory Group on Immunisation recommended that Australians over the age of 60 avoid taking Vaxzevria.