Thursday, April 04, 2024

Will NIH & Industry Consider Universal Coronavirus Vax Developed by Scientists in Georgia/Wisconsin & Tokyo?

Georgia Institute of Technology Scientists, in collaboration with investigators from University of Wisconsin—Madison as well as University of Tokyo continued pursuing the optimal coronavirus vaccine since the Covid-19 pandemic started. The mRNA vaccines developed through the federal government's "Operation Warp Speed" program were a massive innovation; however, annually updating those boosters for specific SARS-CoV-2 variants is inefficient for scientists and patients, although the spin given to the public by the leadership at the time at the National Institutes of Health and the companies was the opposite.

Now, the collaborators have developed a new vaccine that offers broad protection against not only SARS-CoV-2 variants, but also other bat sarbecoviruses. The groundbreaking trivalent vaccine has shown complete protection with no trace of virus in the lungs, marking a significant step toward a universal vaccine for coronaviruses. Findings were recently presented in “Broad protection against clade 1 sarbecoviruses after a single immunization with cocktail spike-protein-nanoparticle vaccine,” published in the February edition of Nature Communications.

For context, SARS-CoV-2 is just one member of the Sarbecovirus (SARS Betacoronavirus) subfamily (others include SARS-CoV-1, which caused the 2002 SARS outbreak, as well as other viruses circulating in bats that could cause future pandemics).

According to Ravi Kane, professor in the School of Chemical and Biomolecular Engineering, “We had been working on strategies to make a broadly protective vaccine for a while.” Professor Kane continued, “This vaccine may protect not just against the current strain circulating that year, but also future variants.”

Research goes back in time

Kane and his research group have been working on the technologies to develop more widely protective vaccines for viruses since he joined Georgia Tech in 2015. Although the team didn’t specifically foresee Covid-19 arising when it did, pandemics have regularly occurred throughout human history. While the team pivoted their vaccine research to address coronaviruses, they were surprised by how rapidly each new variant arose, making their broader vaccine even more necessary.

Once they realized the challenge inherent in how fast SARS-CoV-2 mutates, they had two options for how to build a vaccine: design one to be widely preventative against the virus, or use the influenza vaccine, which updates annually for the anticipated prevalent variant, as a model.

Considering Durability, Breadth

Making a broad vaccine is more appealing because it enables patients to get one shot and be protected for years. To create their general vaccine, Kane’s team capitalized on the key to the original mRNA vaccines — the spike protein, which binds the virus to healthy cells. Their vaccine uses three prominent spike proteins, or a trivalent vaccine, to elicit a broad enough antibody response to make the vaccine effective against SARS-CoV-2 variants as well as other sarbecoviruses that have been identified as having pandemic potential.

“If you know which variant is circulating, you can immunize with the spike protein of that variant,” Ph.D. student and co-author Kathryn Loeffler said. “But a broad vaccine is more difficult to develop because you’re protecting against many different antigens versus just one.”

It Starts with Preclinical Animal Research

Collaborators in the Kawaoka group at the University of Wisconsin tested their vaccine in hamsters, which they had previously identified as an appropriate animal model to evaluate vaccines and immunotherapies against SARS-CoV-2. The vaccine was able to neutralize all SARS-CoV-2 omicron variants tested, as well as non-SARS-CoV-2 coronaviruses circulating in bats. Even better, the vaccine provided complete protection with no detectable virus in the lungs.

Kane hopes that the vaccine strategy his team identified can be applied to other viruses — other coronavirus subfamilies as well as other viruses such as influenza viruses. They also expect that some of the specific antigens they describe in this paper can be moved toward preclinical trials. Someday, a trivalent vaccine could comprise a routine part of people’s medical treatment.


Australia: COVID-19 Vaccine Side Effects Under Scrutiny: Ralph Babet initiates Senate Inquiry Targeting Excess Mortality

Babet is the lone libertarian senator so it is good to see him having an effect

Australians concerned about excess deaths in recent years are now able to have their voice heard by the parliament as a new Senate inquiry has gone online.

Following the establishment of a Senate inquiry into excess mortality in the week ending March 31, the Australian parliament has opened a new page for the inquiry on its website, allowing concerned individuals and organisations to make submissions.

According to Australian Bureau of Statistics data, excess mortality rose from minus 3.1 percent in 2020 to 1.6 percent in 2021 and 11.7 percent in 2022 before dropping to 6.1 percent in 2023.

Notably, there were almost 20,000 cases of excess deaths in 2022 alone.

The inquiry was established after the parliament narrowly passed a motion moved by United Australia Party Senator Ralph Babet with a 31-30 vote on Feb. 26.

Mr. Babet had the support of the Opposition, One Nation Party, and some independent senators, while the Labor and the Greens opposed the motion.

In a social media post, Mr. Babet said this was an opportunity for Australians to have a say on the issue.

“Many submissions are expected to be received from both individuals and professional organisations, with the opportunity for public hearings to follow later this year,” he wrote.

“This is your opportunity to have your say. If you have a personal story, knowledge, or expertise in this space, please prepare a submission for the committee.”

Australians can make submissions online via the parliament website, or they can send letters and emails to the Senate Community Affairs References Committee, which is responsible for investigating the matter.

Mr. Babet also said the committee was expected to finalise a report by the end of August. “May this committee process give a voice to the family members of the deceased and deliver the answers that our nation so desperately needs,” he wrote.

In an interview with 2GB Radio, Mr. Babet said the inquiry would look into the side effects of COVID-19 vaccines to determine whether they were connected to excess deaths.
“There would have to be at least a part of this, which is due to the vaccine,” he said.

“I want an answer at the end of this to say hey, that vaccines were a part of this, or the vaccines were not a part of the sport, or we don’t know, let’s investigate more.”

At the same time, the senator mentioned the challenges he faced during the process of establishing the inquiry, alleging that many politicians did not want to investigate the issue.

“For the last two or three years, none of the other senators … most of them have not wanted to take a look,” he said.

“They want to sweep things under the carpet. That’s what they’ve wanted to do.

“It’s not okay. It’s not how you do things. This is Australia. This is not a communist dictatorship.”

Meanwhile, Labor Senator Tim Ayres criticised the idea of having the parliament investigate excess deaths, saying it was opportunistic behaviour.

“Some people in the political system, of course, where they see fear, see opportunity. Where they see a capacity to divide people, to isolate them, and to frighten them, that is an opportunity,” he said.

While independent Senator David Pocock did not believe in COVID-19 vaccine “conspiracies,” he said there was a need to investigate the issue of excess mortality.

“I don’t accept the conspiracy theories that have been featured so heavily in Discord around COVID-19 vaccines,” he said.

“However, I do acknowledge there is data showing excess mortality rates that have increased in recent years.”




Wednesday, April 03, 2024

Doctors Force FDA To Remove False Statements About Ivermectin

The U.S. Food and Drug Administration (FDA) has agreed to remove social media posts and webpages that urged people to stop taking ivermectin to treat COVID-19, according to a settlement dated March 21

The FDA has already removed a page that said:

“Should I take ivermectin to prevent or treat COVID-19? No.”

Within 21 days, the FDA will remove another page titled, “why you should not use ivermectin to treat or prevent COVID-19,” according to the settlement announcement, which was filed with federal court in southern Texas.

“The FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals,” the page currently states. It also says that data do not show ivermectin is effective against COVID-19, despite how some studies it cites show ivermectin is effective against the illness.

The FDA in the settlement is also agreeing to delete multiple social media posts that came out strongly against ivermectin, including one that stated:

“You are not a horse. You are not a cow. Seriously, y’all. Stop it.”

In exchange, doctors who sued the agency are dismissing their claims, the filing states.

“FDA loses its war on ivermectin and agrees to remove all social media posts and consumer directives regarding ivermectin and COVID, including its most popular tweet in FDA history,” Dr. Mary Talley Bowden, one of the doctors, said in a statement. “This landmark case sets an important precedent in limiting FDA overreach into the doctor-patient relationship.”

“We are extremely pleased with the outcome of the settlement as it is a victory for every doctor and patient in the United States,” added Dr. Paul Marik, chief scientific officer of the FLCCC Alliance and another plaintiff.

“The FDA interfered in the practice of medicine with their irresponsible language and posts about ivermectin. We will never know how many lives were affected because patients were denied access to a lifesaving treatment because their doctor was ‘just following the FDA.’”

An FDA spokesperson told The Epoch Times in an email that the agency:

“has chosen to resolve this lawsuit rather than continuing to litigate over statements that are between two and nearly four years old.”

“FDA has not admitted any violation of law or any wrongdoing, disagrees with the plaintiffs’ allegation that the agency exceeded its authority in issuing the statements challenged in the lawsuit, and stands by its authority to communicate with the public regarding the products it regulates,” the spokesperson said.

“FDA has not changed its position that currently available clinical trial data do not demonstrate that ivermectin is effective against COVID-19. The agency has not authorized or approved ivermectin for use in preventing or treating COVID-19.”

Ivermectin was approved by the FDA in 1996 to treat several conditions, including onchocerciasis, a tropical disease caused by a parasitic worm.

In the United States, it’s common for doctors to prescribe medicine off-label, or for a different purpose than the one for which the medicine is approved.

After some doctors began prescribing ivermectin for COVID-19, the FDA ramped up its campaign, including the Aug. 21, 2021, post on Twitter, now known as X.

Dr. Bowden and two other doctors sued the FDA, arguing the agency’s actions went beyond its authority, as conferred on it by Congress.

U.S. District Judge Jeffrey Brown dismissed the case in 2022, ruling that the FDA did not act outside the authority. But an appeals court in 2023 ruled in favor of the doctors, finding that the agency “has identified no authority allowing it to recommend consumers ‘stop’ taking medicine.”
Between the time of the ruling and the settlement, the FDA refused to change any of its statements on ivermectin, and asked for a fresh dismissal of the suit.

The Case

Drs. Robert Apter, Bowden, and Marik brought the case in 2022. They said they suffered repercussions after prescribing ivermectin to patients with COVID-19, and that the FDA was to blame.

Dr. Apter, for instance, said that pharmacists refused to fill the prescriptions, citing the FDA.

“This refusal delays his patients in obtaining their prescribed treatment—when early intervention is paramount—while they look for a pharmacy to fill their prescription, if they can find one at all,” the suit states.

He also said that insurance companies were refusing to pay for ivermectin to treat COVID-19.

The suit said the FDA illegally interfered with the relationships between the doctors and patients. The doctors said with regard to ivermectin, the FDA overstepped the authority conferred on it in the Federal Food, Drug, and Cosmetic Act.

Government lawyers argued that the FDA was acting within the confines of the law, and succeeded in getting the dismissal.

Judge Brown, appointed under President Donald Trump, said the FDA’s powers were only limited with regard to medical devices.

“As there is no statute limiting the FDA’s actions here, it cannot have acted outside of any statutory limitations,” he wrote in his ruling. “Further, it cannot be said that the FDA had no colorable basis of authority. The FDA is charged by Congress with protecting public health and ensuring that regulated medical products are safe and effective, among other things.”

A three-judge panel of the U.S. Court of Appeals for the Fifth Circuit disagreed, finding that the law did not authorize the FDA to give medical advice.

“FDA can inform, but it has identified no authority allowing it to recommend consumers ‘stop’ taking medicine,” U.S. Circuit Judge Don Willett, appointed under President Trump, wrote for the court.

The appeals court remanded the case back to the district court.


Another Outlandish Overreach by the CDC

Easter weekend was lovely in every way.

And yet I could not stop thinking about the strange manner in which the Centers for Disease Control and Prevention (CDC) has had such an outsized role in the ruination of American rights and liberties. This agency is supposed to be tracking infectious disease and finding ways out. This mandate became the leverage to allow them to impose nationwide mask mandates, a rental moratorium, a shutdown of the cruise industry, and otherwise send the whole country into fits of hysterics for two years and more.

So it occurred to make an inquiry into how the CDC handles questions of election processes. This is rather important in a democracy. This is how we select our leaders and the central way in which we can claim that the people have some influence over the regime that rules us. It is because of elections that we can claim to be better than ancient despotisms or medieval feudalism. We rule ourselves through the vote. That’s the whole idea.

As it turns out, the CDC had quite a large role in guiding election processes. Not that you can find the evidence on their website now. Nope, it’s all been scrubbed. However, if you look at the Wayback Machine, you can find an interesting little point. The CDC strongly recommended mail-in, absentee, and early voting as a means of disease control.

The theory was that people gathering in a polling place would be a super-spreader event. What science did they cite to demonstrate this? None at all. So far as I know, and I’ve looked far and wide, there is not a single study anywhere that purports to show some relationship between disease spread and in-person voting. The CDC just made that up... for whatever reason.

The day was March 12, 2020. This was the same day that President Trump went on national television in the evening to announce that there would be no more travel from the United States to Europe, the UK, and, later, Australia and New Zealand. He further said that all Americans living abroad needed to come home right away or be stuck.

That was a pretty shocking announcement. Nothing like this had ever happened in American history, not even this broadly in wartime. It seemed to come out of nowhere, our rights to travel suddenly deleted.

It seems that President Trump was following the advice of his scientific advisors who later turned out to be snake oil salesmen. Indeed, he seemed extremely uncomfortable making this announcement, almost like he knew that it was weird and probably unwarranted. Strange night.

As it turns out, earlier that day, the CDC decided that the whole country really ought to be voting by mail. They went into the website and edited the page that very day and produced the following checklist.

You can see for yourself at the Archive link. So far, the CDC has not proven itself powerful enough to scrub also its bread crumbs from the archive source, not yet in any case. The time might come. If they succeed, their role in creating the biggest voting scandal in a hundred years might never have been known by future generations.

There is simply no way that the CDC could not have known about the uncertainties and vagaries created by absentee ballots. They are banned by half the countries in the world for that reason. Those that do allow them govern them very strictly. You have to request a ballot. They are sent to your home. You have to provide extensive identity verification. You have to have a darn good excuse. It’s only for hardship cases and never the norm.

It was the CDC that decided to throw all that in the trash. Who even cares about the whole history of democracy, because, after all, there is a virus floating around! It’s amazing that this happened. But just as amazing is the idea of throwing out property rights, which they also did. But there it is.

To be sure, they could not actually force this result. But they sure could grant some scientific heft behind the idea. It also helped that only 10 days later, the U.S. Congress voted $2 trillion in payments to the states, a portion of which was to implement CDC recommendations. Most states were happy to do so, again, with full knowledge that this strategy would yield results that were sketchy at best.

As it turns out, of course, it was the mail-in ballots that might have made the difference in the election, or seemed to in any case. Everything got so much mixed up that it’s hard to say. And it’s not like people did not have warning signs of trouble. The primary season of that spring and summer yielded a slew of controversies about what was and was not true. There were more than enough controversies swirling about by the time of the general election.

The crucial point here is that the CDC massively overstepped the bounds of its mandate by intervening in the processes by which Americans select its leaders, strongly pushing a method that was a known source of fraud. Nor has the CDC ever been held to account for this, not to my knowledge in any case.

They were sued over the rent moratorium and the evil nationwide mask mandate. They lost both cases. But there has been no litigation against the CDC for disrupting the whole system by which we regulate elections. One might suppose that if an executive agency were to do something like this, they would have needed some permission from somebody. Surely such a gigantic change would and should require more than a low-level employee with logins to change a website text.

Speaking of which, who actually did this and why? Aren’t these interesting questions? Why is no one asking them? Where are the investigations? Where is the outrage?




Tuesday, April 02, 2024

Study Finds New Drugs Effective Against COVID-19 and Other Viruses

Studying the ways viruses impact cellular pathways during infection may help in developing treatments for infectious diseases such as COVID-19.

A new study, conducted by researchers at the University of Alberta and published in the npj Viruses journal found that certain cancer treatment drugs can promote cells to secrete antiviral interferons. These drugs target the SARS-CoV-2 virus, which causes COVID-19, and are also effective against multiple pathogenic RNA viruses.

Interferons are natural proteins that bolster the body’s immune system in combating infections and diseases like cancer. They earned their name because they interfere with viruses, stopping them from spreading.

Both COVID-19 and some cancers activate the Wnt/beta-catenin pathway—a chain reaction inside the cell. Drugs that block this pathway, originally made to treat cancer, might also help fight COVID-19.

When the Wnt/beta-catenin pathway gets activated, it slows down the production of interferons. This pathway also negatively impacts the immune system.

In a study, scientists tested two drugs, KYA1797K and E7449, that block the Wnt/beta-catenin pathway. They found that these drugs reduced the amount of virus in the lungs of mice. The drug E7449 was especially good at preventing weight loss and lung damage in the infected mice.

Tom Hobman, a professor of cell biology at the University of Alberta’s Faculty of Medicine and Dentistry and one of the study authors, explained in a press release that after using these drugs, cells produced interferons in response to viral infections at levels four to six times higher than before. Additionally, experiments also revealed that the virus was inactivated to less than one-ten-thousandth of its original levels.

He pointed out that interferons prevent infected cells from producing more viruses primarily in two ways, “It shuts down the infected cell, often resulting in cell death, and it also acts on the surrounding cells to prevent them from being infected.”

The researchers also tested viruses other than COVID-19 and found that the drugs exhibit broad-spectrum activity against a variety of RNA viruses. These include coronaviruses, responsible for seasonal respiratory infections, as well as mosquito-borne viruses like Zika and Mayaro.

Ongoing Drug Trials for COVID-19

In addition to drugs targeting the Wnt/β-catenin pathway, other drugs are also being explored for the potential to alleviate the COVID-19 virus.

A clinical trial published in February, which involved 1,821 mild to moderate COVID-19 patients, indicated that a drug called ensitrelvir significantly shortened the duration of symptoms in patients with COVID-19.

A phase II to III clinical trial of the anti-COVID-19 drug Simnotrelvir, involving 1,208 patients with mild to moderate COVID-19 infection, was published in the New England Journal of Medicine. The results showed that patients who received Simnotrelvir treatment within 72 hours of COVID-19 symptom onset had their “time to sustained resolution of symptoms” shortened by 35.8 hours. In a subgroup with risk factors for severe COVID-19, Simnotrelvir reduced the time by 60 hours.


Immunologists Call Out mRNA Vaccines—The Good, Bad & Ugly: Time to Go Back to Science

More data and analysis from various peer-reviewed journals raises serious concerns about the externalities associated with the mass countermeasures developed by the United States government in response to COVID-19. While the mRNA COVID-19 vaccines have been positioned as modern marvels of medicine—safety, effective and representative of the future of medicine, mounting literature not widely touted by American media implicates a different point of view.

Microbiologist and immunologist Botond Z. Igyártó, Ph.D., from Jefferson University in Philadelphia and immunology researcher Zhen Qin in the most recent edition of the peer-reviewed journal Frontiers in Immunology suggest the latest, accumulation of data points to the need for concern covering both safety and efficacy of the mRNA vaccines developed by Moderna in partnership with the National Institutes of Health and Pfizer in partnership with Germany’s BioNTech.

TrialSite has published article after article over the past couple years hinting at considerable challenges with mRNA platforms. The literature in the peer-reviewed journals amasses leading to questions for investors in the platform developers.

The authors herein call out for a security that represents an absolute must for the scientific community. With an unprecedented mass vaccination scheme via the use of an investigational product “that minimally protects from getting infected and spreading the virus during a pandemic,” the need for critical reflection becomes of paramount concern.

Was the strategy sound? Was her immunity a realistic expectation? Did the strategy as proposed by Geert Vanden Bossche lead to an actual acceleration of mutations? Should governments have focused on more vulnerable populations during the pandemic? Why was a novel mRNA platform opted for in the emergency over more known methods? Why focus on a single virus protein with a high mutation rate as TrialSite called out early on? Were the vaccine’s benefits (supposedly faster production, ease of updating for new variants, etc.) beneficial? Why did research leadership at the NIH for example ignore basic immunology knowledge during the pandemic?

Igyártó and Qin in this latest peer-reviewed output identify safety considerations, seeking to better understand the mechanisms of observed adverse events related to the mRNA jabs. Can such identified risk factors be mitigated by altering the mRNA platforms?

Describing the standard and non-standard components of the mRNA-LNP COVID-19 vaccines, Igyártó and Qin then address what the pair of authors describe as “concerning” assumptions made in regard to this technology.

While formally, the public has been told that mRNA vaccines do not allow for reverse transcription into DNA, meaning that there is no risk of insertion into the human genome, the authors raise some questions for consideration.

In particular instances, RNA can in fact be reverse transcribed into DNA. The authors note, “With the Pfizer mRNA-LNP vaccine, it has been shown experimentally that the vaccine mRNA can be reverse-transcribed into DNA in an immortalized human hepatocyte cell line.”

Also, the pair of authors note other possibilities for this concerning action, plus localization of the spike protein. A series of studies suggest the possibility of transcribed possibilities.

The authors point out:

“While to our knowledge similar studies have not been performed with COVID-19 mRNA vaccines that code for full-length pre-fusion fixed form of SARS-CoV-2 spike protein, comparable transport of spike protein/mRNA to the nucleus could be expected. Because the mRNA can enter the nucleus, where it might be reverse-transcribed into DNA, this increases its potential to integrate into the genome.

Furthermore, the mRNA-LNP diffuses throughout the body and can accumulate in both the testes and ovaries and is reported to alter the menstrual cycle in women. Therefore, it could potentially be reaching the stem cells of the reproductive organs. These findings highlight the need to take these data and concerns seriously and conduct specific experiments to address them.”

On the topic of the mRNA vaccine product degrading in vivo in hours or a matter of a few days, the authors challenge this misinformation to argue that the vaccines do not disrupt normal cell biology.

While it’s likely that this assumption (rapid product degradation) likely arose given that unmodified mRNAs have overall short in vivo half-life, real-world since points to a very different situation.

For example, “…human lymph node biopsies taken at different time points post-exposure to the mRNA-LNP revealed detectable levels of vaccine mRNA and spike proteins up to eight weeks.” And of course, TrialSite has reported on peer-reviewed data featuring the distribution and circulation of spike protein derived from the mRNA vaccines in humans for periods over a year.

Also, the effects of modified ribonucleotides (incorporated into the vaccine products to lower innate reactogenicity) just recently became more apparent.

Igyártó and Qin point out, “Incorporation of N1-methylpseudouridine into mRNA resulted in +1 ribosomal frameshifting in vitro and cellular immunity in mice and humans to +1 frameshifted products from BNT162b2 vaccine mRNA translation occurred after vaccination.”

A key message from the authors on the overall topics: it’s dangerous to “assume and extrapolate in science” then apply existing paradigms to novel, untested platforms and technologies.

And just how safe and effective are the COVID-19 mRNA countermeasures?

Reviewing many of the same recent peer-reviewed journal entries, case reports and publicly available adverse event database as TrialSite, the current authors argue that this fact “cast doubts on the safety and effectiveness of these products.”

For example, on the topic of safety the authors point to a range of formidable entries calling out one concern to another. As TrialSite has editorialized many of the studies cited by Igyártó and Qin on the topic of COVID-19 mRNA vaccine safety suggest concern.

Similar outcomes can be found when probing efficacy. As the authors point out, “The effectiveness of these therapeutics in preventing infections and limiting the spreading of the virus has been highly eroded from the early reports, and nowadays, their efficacy is mainly limited to potentially decreasing the disease severity and death in susceptible people.” Pointing out that the efficacy that has been reported likens to the immune suppressive characteristics of these mRNA products, the authors urge for a “rigorous pre-clinical studies to limit potential unexpected consequences for novel platforms.”

Final Thoughts

Pointing out that “several fundamental questions persist surrounding the pandemic measures and the adoption of this new vaccine platform,” the scientists cogently argue “rather than advocating for retraction and censorship” rather there should be a movement in science to foster for open dialogue, considering all perspectives.

And for those that despite the findings above would still justify all that was done during the pandemic as the efforts saved lives, Igyártó and Qin point out that “the robustness of supporting data raises important inquiries.”

True trust is necessary to not undermine science and foster vaccine hesitancy, argue the authors of this important peer-reviewed paper. Seek to rebuild trust? Then, the authors argue it’s “crucial to return to the fundamental principles of scientific inquiry




Monday, April 01, 2024

COVID-19 Vaccines Performance Decline--Only 38% of At Risk Immunocompromised Kept out of Hospital

TrialSite continues to monitor the observational study output of the Centers for Disease Control and Prevention (CDC) funded VISION Network, a research collaboration involving multiple hospitals/sites with integrated electronic health records (EHR) across America. This is part of an ongoing real-world data effort to evaluate how well vaccines protect against seasonal viruses such as influenza or COVID-19.

In this latest study, the substantial VISION team utilizes a test-negative design to estimate COVID-19 vaccine effectiveness (VE). And the outcomes are not great, in fact, some could argue this latest vaccine bombed.

Why? Any commercial vaccine designed to keep people, especially at-risk cohorts out of the hospital, should perform at least at 50% vaccine effectiveness. At 38% between days 7-59 and 34% in the 60-119 days after the receipt of the updated dose, the only reason CDC can justify recommending the product includes A) because they are not considering full safety risks for this cohort and B) the logic that 38% protected is better than no one and for this latter point there is some rationale. Only 14% of immunocompromised opted to get the vaccine suggesting a near collapse in market demand for COVID-19 vaccines given the risks associated with this demographic.

The data reported herein results from the CDC’s latest Morbidity and Mortality Report (MMWR) titled “Interim Effectiveness of Updated 2023-2024 (Monovalent XBB.1.5) COVID-19 Vaccines Against COVID-19–Associated Hospitalization Among Adults Aged ≥18 Years with Immunocompromising Conditions — VISION Network, September 2023–February 2024.


By September 2021, the CDC’s Advisory Committee on Immunization Practices recommended updating 2023–2024 (monovalent XBB.1.5) COVID-19 vaccination for all persons aged ≥6 months to prevent COVID-19, including severe disease. The agency did not consider a risk-based approach like in most other nations at this point given the following:

Omicron has become much milder (e.g., case fatality rate at the level of influenza for most)

Large segments of the U.S. population have pre-existing immunity at some level

Growing recognition that some safety signals present (e.g., risk of myocarditis/pericarditis in young males, etc.).

Available treatments such as Paxlovid—while not accepted yet by the National Institutes of Health or the CDC,

accumulation of data that vitamin D supplementation very important to avoid more severe symptomatic COVID-19

The CDC suggests additional boosters for immunocompromised conditions should be considered, in this case representing a risk-based approach to public health.

In this latest observational study, the study team assesses how well the COVID-19 vaccines perform at helping immunocompromised persons infected with COVID-19 avoid hospitalization based on the data linked to hospitalization during the period September 2023-February 2024.


Few persons (18%) in this high-risk study population had received the updated COVID-19 vaccine. All persons aged ≥6 months should receive updated 2023–2024 COVID-19 vaccination; persons with immunocompromising conditions may get additional updated COVID-19 vaccine doses ≥2 months after the last recommended COVID-19 vaccine.

Out of 14,586 patients with immunocompromising conditions who were hospitalized with COVID–19–like illness, the study team included 1,392 case patients and 13,194 control patients.

The most common immunocompromising conditions among both case patients and control patients were solid organ malignancy (36% and 43%, respectively) and other intrinsic immune conditions or immunodeficiency (38% and 35%, respectively).

A total of 195 (14%) case patients had received an updated COVID-19 vaccine dose compared with 2,401 (18%) control patients. VE against COVID–19–associated hospitalization was 38% in the first

More Specifics

The CDC-funded VISION team reports only nine persons who received >1 updated COVID-19 vaccine dose were included!

The team estimated Odds ratios (ORs) using multivariable logistic regression comparing persons who received an updated COVID-19 vaccine dose with those who did not, irrespective of the number of previous original or bivalent COVID-19 vaccine doses received (if any), among case- and control patients.

They adjusted their regression models for age, sex, race and ethnicity, calendar time, and geographic region. While they calculated VE as (1 − adjusted OR) × 100%. Analyses were conducted using R software (version 4.3.2; R Foundation). This activity was reviewed by CDC, deemed not research, and was conducted consistent with applicable federal law and CDC policy.†† VISION activities were reviewed and approved by the Westat and site institutional review boards.

How does CDC rationalize this VE?

According to the VISION team, “Effectiveness estimates in this report were slightly lower than those in a recently published analysis from VISION and another CDC VE network showing COVID-19 VE against COVID-19-associated hospitalizations in adults without immunocompromising conditions was approximately 50%, but this report includes the analysis of an additional month of data compared with the previous report.”

The group still implies recommended vaccination because “persons with moderate or severe immunocompromising conditions are at higher risk for severe COVID-19 and might have decreased response to vaccination.” (2).


The VISION team discloses two primary limitations to this study. These include the following:

The use of selected discharge diagnoses as surrogates for presumed immunocompromised status and the absence of medication and other relevant data might have led to misclassification of immunocompromise status, which might have biased estimated VE in either direction

Immunocompromising conditions are heterogeneous and likely to create differential risk for severe COVID-19, as well as differential response to vaccination

CDC suggested implications

Although the VE of 38% to keep immunocompromised individuals out of the hospital evidences a waning performance (in fact under 50% and regulators used to question the overall value of the vaccine), the CDC team argues that “receipt of an updated COVID-19 vaccine dose provided increased protection against COVID-19–associated hospitalization among adults with immunocompromising conditions compared with no receipt of an updated dose.”

And the CDC takes the increasingly unpopular and isolated decision to continue to recommend that all Americans age ≥6 should get the 2023-2024 COVID-19 vaccine, regardless of fundamentally changing risk-benefit calculus.

That only 14% of the immunocompromised population opted to get this latest vaccine is most certainly telling of the market’s proclivity to go out and opt for this vaccine. At TrialSite, we have reported on a growing number of peer-reviewed studies evidencing instability in the current mRNA platforms. Is it a good idea to vaccinate children 6 months and above en masse given the risk-benefit calculus factors discussed above? Even the New York Times recently reported on the fact that the U.S. was now an outlier in recommending systematic COVID-19 vaccination of young children, especially when we factor in risks for myocarditis/pericarditis in young healthy males.

We suggest this latest vaccine effectiveness performance portends an ominous future for this class of vaccine.

TrialSite Critical View

The protection of mRNA vaccines is so transient TrialSite suggests a new metric for their assessment, at least when it comes to protection against infection. Peak efficacy in the first few weeks’ post immunisation is clearly completely irrelevant. What about calculating average 6- or 12-month efficacy?

This would be akin to measuring area under survival curve. Hence depending on the shape of the curve a vaccine that had 90% efficacy at two weeks and 10% efficacy at six months, may have an overall 6-month efficacy of say 20% if the curve falls steeply at the start or 60% if it falls steeply at the end.

We know from the Israeli data in July 2021 that Pfizer had fallen to just 12% efficacy at 6 months so its true overall 6-month efficacy must have been less than 50% even although they continued to quote >90% efficacy in the media.

Also say a vaccine drops from 90% efficacy at two weeks to 0% efficacy at 4 months – how then to describe its overall efficacy over 6 months – intuitively it should be 0% not the average as over the last two months no one is protected, so everyone will now get infected if exposed, even if they got some protection over the first 4 months – i.e. their infection was just delayed.

This requires sophisticated biostatistician input. After all, COVID-19 infections are not linear over time, but highly clustered into outbreaks. If an outbreak occurs at the 5-month post vaccine point in the previous example, then true vaccine efficacy is 0% or may even go negative at least when measuring protection against infection.




Sunday, March 31, 2024

Study Shows 1 in 5 Australians Experiencing Long COVID After Positive Test

Around one in five Australians who tested positive for COVID-19 displayed symptoms consistent with long COVID, according to a study by the Australian National University (ANU).

This comes after Queensland’s Chief Health Officer John Gerrard called for the term “long COVID” to be scrapped following a study that found the long-term effects of the virus were no different from the seasonal flu, and that long-term COVID symptoms were not “unique and exceptional” to other viral infections.

Long COVID is described by the World Health Organisation as the continuation or development of new symptoms three months after the initial SARS-CoV-2 infection, with these symptoms lasting for at least two months without any alternative explanation.

The ANU study drew on nearly 71,000 participants in Western Australia (WA) who tested positive for COVID-19 from July 16, 2022, to Aug. 3, 2022.

Of the 70,876 adult participants who consented to the research, 11,697 (16.5 percent) provided complete responses provided by the researchers.

Among the respondents, 2,130 respondents (18.2 percent) satisfied the researchers’ criteria for long COVID—reporting new or ongoing symptoms or health problems 90 days after a positive SARS-CoV-2 test result.

The study found the following:

Long COVID risk was greater for women, people aged 50–69 years or with pre-existing health conditions, and those with two or fewer COVID-19 vaccine doses.

Common long COVID symptoms included fatigue and concentration difficulties.

In a highly vaccinated population not broadly exposed to earlier SARS-CoV-2 variants, 18 percent of people infected with the Omicron variant reported symptoms consistent with long COVID 90 days after infection.

18 percent of these people had not fully resumed previous work or study by 3 months, and 38 percent required care from general practitioners for their symptoms 2 to 3 months after infection.

Higher Risk of Developing Long COVID from Omicron Variant
Lead researcher Mulu Woldegiorgis said the results show the risk of developing long COVID from the Omicron variant is higher than originally thought.

“It is more than double the prevalence reported in a review of Australian data from earlier in the pandemic, and higher than similar studies done in the UK and Canada,” Ms. Woldegiorgis said.

“Our finding is, however, lower than that of a recent Queensland study, which found that 21 percent of people reported ongoing symptoms twelve weeks after PCR-confirmed infections with the SARS-CoV-2 Omicron variant,” the researchers wrote.

“Despite reports that the risk of long COVID may be lower following Omicron infections than with earlier SARS-CoV-2 variants, we found that the burden of long COVID may be substantial 90 days after Omicron infections.”

Ms. Woldegiorgis added: “The risk of long COVID was greater for women and people aged 50 to 69, as well as those with pre-existing health conditions and people who’d had fewer vaccine doses.”

Additionally, the study found that 90 percent of the study participants with long COVID reported experiencing multiple symptoms, such as tiredness and fatigue (70 percent), followed by difficulty thinking or concentrating (“brain fog”), sleep problems, and coughing.

A third of women with long COVID also reported changes in their menstrual cycle.

“More than a third of individuals with persistent long COVID—38 percent—had sought medical care in the month prior to the survey,” she said.

“This most frequently involved a visit to a GP, hospitalisations or trips to the emergency department were thankfully less common.”

The study also found that 64 percent of participants with long COVID were able to fully return to work or study within a month of their infection, but 18 percent reported still not being well enough to do so three months after their infection.

The authors noted a number of limitations to the study, including the unclear diagnosis of long COVID, not comparing participants to non-positive participants, and not including asymptomatic or undetected infections.

Link Between Vaccination and Long COVID

While the above study did not look at the link between vaccination and the development of long COVID, a study by Germany’s Martin Luther University Halle-Wittenberg has shown that unvaccinated people infected with the Omicron variant had the lowest risk of long COVID.

The study found that while previous infections reduce the risk of long COVID by 86 percent, vaccination status prior to COVID infection is irrelevant to a person’s risk of developing long COVID.

“Vaccination offered no meaningful protection against developing PCC [post-COVID condition] in case of an infection. In contrast, there was … strong evidence that a previous infection reduced the risk of PCC,” the authors wrote.

However, the authors of the German study acknowledged that none of the participants were given an actual diagnosis of long COVID or tested for comorbidities.

At the same time, a long COVID clinic in England reported a 79 percent drop in referrals that followed the rollout of the second dose of COVID-19 vaccinations, despite having four times as many cases of COVID-19 over the same period.

Meanwhile, a study published by the Lancet found higher rates of lung, brain, and kidney injuries among those with long COVID in the UK, compared with those who did not contract COVID-19.


Neurologic Devastation Hits Young Canadian Mother Left to Survive in New Post-Vaccine Reality

By Peter A. McCullough, MD, MPH

Good doctors learn from every patient they see and hear about. I was very impressed with the vignette disclosed by Kayla Pollock. She courageously appeared with myself and Greg Boulden, the highly acclaimed journalist, producer and managing editor of America Emboldened.

Kayla’s story is similar to the case described by Rabbani et al at the University of Oklahoma. They called what they found “longitudinally-extensive” transverse myelitis, in a 60-year old man who had received a Moderna mRNA vaccine ten days earlier. Transverse myelitis is a form of spinal cord inflammation caused by COVID-19 vaccines that is analogous to a spinal cord transection that would occur with severe trauma.

You have to listen to this report from Kayla, who is a young mother who was already managing Type 1 diabetes. Boulden and myself were shocked with the gaslighting and terrible care she received in the Canadian health system in metro Toronto. Kayla’s story is one of tragedy and perseverance. You can tell that I was trying to view her case on the bright side with suggestions to give her the best chance of recovery (Base Spike Detoxification, high-dose corticosteroids, IVIG, plasma exchange, rituximab, hyperbaric oxygen, advanced physiotherapy).

The interview turned dark when Kayla told us that the Canadian government, instead of doing everything they could to help her recover, offered MAID. Canada updated its law on medical assistance in dying (MAID) in 2021 to allow people with “grievous and irremediable” mental illness to seek death at the hands of a physician. This was astounding given Kayla is a young mother in her thirties and has a 9 year old son to raise.

I followed up and can confirm The Wellness Company will be supplying Kayla with The Ultimate Spike Detox trio of products that is featured in McCullough Protocol Base Spike Detoxification.