Sunday, December 31, 2023

Consent of the Governed, Where Art Thou?

When authority-loving do-gooders run wild

Dr. Robert Malone

I am often asked some form of the question “What caused you to come out of the closet and start criticizing the vaccines?” On a related note, when interviewed by a reporter from the infamous Atlantic August 2021 hit piece, Stan Gromkowski (a former Vical colleague of mine) prophetically opined, “He’s [expletive] up his chances for a Nobel Prize.”

The answer to this persistent question is nicely summarized in the first essay which I wrote in objection to what was being done, titled “COVID Vaccine Deployment under EUA: It’s time we stop and look at what’s going down,” published in Trial Site News on May 30, 2021 (three months before the defamatory Atlantic attack). I guess that article struck a nerve, because it currently has over 19,000 likes; pretty good for an article on a specialty paid site targeting the clinical research industry.

The essay was prompted by a midnight Saturday evening Zoom call with a Canadian physician who was pleading for me to help intervene with the Canadian authorities overseeing the “vaccine” campaign. This specific physician later had his office raided and office computers damaged by the Canadian government for prescribing early treatment and writing vaccine exemptions, and has now being required to submit to the Canadian government re-education and contrition program for his sins if he wishes to retain the ability to practice medicine, just as has been required of Jordan Peterson. But that was all in the future.

Talking until midnight Saturday, he had described what was being done in Canada to force toxic COVID “vaccines” on an unwitting population including children, imploring me to somehow intervene with Health Canada to stop the madness. I told him I did not have the necessary connections, and there was nothing much I could do to help.

Waking early the following Sunday, I realized there was something I actually could do to advance his cause. I could dip into my extensive training in bioethics and write about the fundamental breaches of established biomedical ethics that were going on in Canada, and would soon migrate to the United States, Australia, New Zealand, the United Kingdom, and across the western “democracies.”

The following is the core of my argument back then (May 2021), which I assert has withstood the test of time much better than the notorious Atlantic hit piece published three months later.

* * *

I believe that adult citizens must be allowed free will, the freedom to choose. This is particularly true in the case of clinical research. These mRNA and recombinant adenovirus vaccine products remain experimental at this time. Furthermore, we are supposed to be doing rigorous, fact-based science and medicine. If rigorous and transparent evaluation of vaccine reactogenicity and treatment-emergent post-vaccination adverse events is not done, we (the public health, clinical research and vaccine developer communities) play right into the hands of anti-vaxxer memes and validate many of their arguments.

The suppression of information, discussion, and outright censorship concerning these current COVID vaccines which are based on gene therapy technologies cast a bad light on the entire vaccine enterprise. It is my opinion that the adult public can handle information and open discussion. Furthermore, we must fully disclose any and all risks associated with these experimental research products.

In this context, the adult public are basically research subjects that are not being required to sign informed consent due to EUA waiver. But that does not mean that they do not deserve the full disclosure of risks that one would normally require in an informed consent document for a clinical trial. And now some national authorities are calling on the deployment of EUA vaccines to adolescents and the young, which by definition are not able to directly provide informed consent to participate in clinical research—written or otherwise.

The key point here is that what is being done by suppressing open disclosure and debate concerning the profile of adverse events associated with these vaccines violates fundamental bioethical principles for clinical research. This goes back to the Geneva convention and the Helsinki declaration.

There must be informed consent for experimentation on human subjects. The human subjects—you, me, and the citizens of these countries—must be informed of risks.As a community, we have already had a discussion and made our decision—we cannot compel prisoners, military recruits, or any other population of humans to participate in a clinical research study. For example, see the Belmont report, which provided the rationale for US federal law Code of Federal Regulations 45 CFR 46 (subpart A), referred to as “The Federal Policy for the Protection of Human Subjects” (also known as the “Common Rule”).

Quoting from the Belmont Report:

“Informed Consent. — Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied.

While the importance of informed consent is unquestioned, controversy prevails over the nature and possibility of an informed consent. Nonetheless, there is widespread agreement that the consent process can be analyzed as containing three elements: information, comprehension and voluntariness.”

Information, comprehension, and voluntariness. To my eyes, it appears that in many regions public health leadership has stepped over the line and is now violating the bedrock principles which form the foundation upon which the ethics of clinical research are built. I believe that this must stop. We must have transparent public disclosure of risks—in a broad sense—associated with these experimental vaccines. It is either that, or the entire modern bioethical structure which supports human subjects research will have to be re-thought.

* * *

This was not a major intellectual leap. It was a simple restatement of the training in clinical research bioethics which I had received and which had been repeatedly reinforced over the prior decade. No big deal, except that few if any were willing to make such a statement at that time. Long before the infamous Dark Horse or Rogan podcasts.

The failure to disclose the risks of the gene therapy-based COVID vaccines by the U.S. and other “Western” governments became widespread, chronic, and well-documented. Fast forwarding to the present, on Dec. 22, 2023 investigative journalist Greg Piper of the alternative “Just the News” published yet another chapter in the abundant library of documented government withholding of key information concerning COVID genetic “vaccine” harms.

* * *

Misinformation for thee, not me? FDA had similar concerns as COVID vaccine skeptics, docs suggest

FOIA production shows the agency wasn’t impressed by Pfizer’s plan to mitigate “endotoxins,” complained about insufficient cleaning in manufacturing, and had no basis to claim post-vax heart inflammation was rare.

If an outsider raises questions about contamination of COVID-19 vaccines or how closely the Food and Drug Administration monitors for severe adverse events, the agency considers it a boon to misinformation that lowers vaccine uptake and hence kills people.
If the FDA itself raises these issues, that’s a different story ....

The FDA documents, some heavily redacted under the FOIA exemption for trade secrets, show less daylight than may be thought between the agency and critics of federal COVID policy such as Florida Surgeon General Joseph Ladapo.

* * *

Mr. Piper went on to summarize a range of recent Freedom of Information Act (FOIA) and court-ordered document disclosures which clearly demonstrate a systematic and intentional failure by the U.S. government to properly inform the public of the risks associated with accepting gene therapy-based COVID “vaccine” products.

• The CDC had no scientific research to back its public claim in January that people can safely get their COVID, flu, and monkeypox vaccines “at the same time.”

• “Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, didn’t just tell Florida Surgeon General Joe Ladapo last week his concerns about DNA contamination were ‘quite implausible’ but also shamed him for feeding what he considered misinformation that will cause preventable deaths. Yet an Aug. 6, 2021 email to Pfizer from CBER Senior Regulatory Review Officer Mike Smith about ‘endotoxins’—potential contaminants introduced in pharmaceutical manufacturing—shows the feds had similar concerns as they considered full approval for Pfizer’s Comirnaty.”

• “A month before then-acting FDA Commissioner Janet Woodcock told the media that post-vaccination heart inflammation ‘appears to be very low,’ a CBER ‘surveillance’ scientist made clear that the leader was not relying on the agency’s own data. Joyce Obidi reviewed how well CBER’s Sentinel Program, created under a 2007 law to monitor drug safety through electronic healthcare data, could ‘evaluate the serious risk for myocarditis and pericarditis’ following Pfizer COVID vaccination in recipients 16 and older, the first population authorized for emergency use.

‘Post-authorization safety data identified serious risks for myocarditis and pericarditis after COMIRNATY, with increased risk in males under 30 years of age,’ Obidi wrote in the May 18, 2021, memo, which is also buried in the agency’s 246-document public folder on materials related to Comirnaty’s approval.”

• Obidi also stated that “Available data sources in the CBER Sentinel Program are NOT sufficient to identify the outcomes of myocarditis and pericarditis” and not “sufficiently powered to assess the magnitude of risk” for ages 12-30. She wrote. The program would need a minimum of 3-6 months follow-up data to check for “long-term sequelae,” and it cannot study subclinical myocarditis “because of the absence of a definition of subclinical myocarditis and unknown background incidence of troponin abnormalities,” according to Obidi. Sentinel’s data sources at full approval of Comirnaty did not have “sufficient power to assess the magnitude of risk in patients 12-30 years of age” and hence cannot assess the “serious risks of myocarditis and pericarditis, and subclinical myocarditis” associated with the vaccine.

• “In another May 18, 2021, memo reviewing Pfizer’s proposed pharmacovigilance plan for its vaccine, Analytic Epidemiology Branch Medical Officer Deborah Thompson evaluated the company’s claim that ‘vaccine-associated enhanced disease’ is just a ‘theoretical risk.’ She cited Vaccine Adverse Events Reporting System reports of deaths in ‘fully vaccinated’ patients at that early stage of vaccination. ‘Severe manifestations and death from COVID-19 raise the possibility’ of VAED because it has ‘overlapping clinical manifestations with natural SARS-CoV-2 infection, making it difficult to differentiate VAED from severe’ infection in VAERS reports.”

• Despite assurances otherwise from Peter Marks in his letter to the Florida Surgeon General, major manufacturing process good practices were breached. “In a Form 483 to Pfizer following inspections that uncovered possible or actual product adulteration, FDA investigators made 13 observations about procedures at Pfizer’s Andover, Massachusetts, manufacturing facility. They include “insufficient data to support product quality prior to the release” of vaccine batch FA8057. The observation says “a deviation [redacted] was initiated due to the multiple control limit excursions during [redacted]” and the “affected batch was manufactured with a process that deviated from the validated process parameters” and was “not put on stability until July 22, 2021.” It was released on a redacted date.

An observation on “inadequate quality oversight” implies that Pfizer was late in adding a notation to a batch record that “[redacted] exceeded the allowable [redacted].” The company’s quality assurance does not review “electronic data/reports” from a redacted manufacturing process “during batch record review or prior to batch release.” [Note: No clinical trial I have ever been involved in has been associated with an FDA 483 warning letter. This is no small matter.]

• Just the News asked the FDA prior to publication of this report on Dec. 22 for its characterization of the FOIA-disclosed and related documents in light of Marks’ comments to Ladapo about feeding misinformation. A spokesperson responded two days later, saying the agency was working to provide an answer. As of Dec. 27, the FDA still has not provided a response.

At this point, the burden of publicly available documentation clearly demonstrates multiple examples of intentional breaches of informed consent by both the U.S. government and the pharmaceutical industry manufacturers of these products. It is difficult to dispute that the U.S. government and the pharmaceutical industry sponsors are colluding in a public-private partnership to suppress information concerning risks of these products. Likewise, there has been an agreement between the UK and U.S. governments to suppress disclosure of information concerning risks and adverse events associated with these products.

In a normal, historic regulatory and bioethical environment, this breach of international bioethical norms concerning informed consent would rise to the level of a clear-cut crime against humanity. But in the “through the looking glass” world of COVID post-late 2019, established legal, moral, and ethical norms concerning patient and citizen rights to proper informed consent have all been turned upside down. All of these clear-cut breaches ostensibly being actively “justified” by mockingbird media, the massive censorship-industrial complex, and government officials as being in service of the public interest and the greater good.

The western Five Eyes alliance participants, deferring to the leadership of the U.S. government, are all acting in coordination and cooperation to disregard and hide the implications and consequences of their illegal and unethical actions. This is being justified based on the following oft-repeated catechism, each element of which is demonstrably false or opposed to established Western bioethical consensus:

1. COVID-19, the disease caused by infection with SARS-CoV-2, is highly pathogenic with a case fatality rate of 3.4. [The actual case fatality rate was approximately 0.02 percent when this disease was first “modeled” in 2020 and is much lower now.]

2. The gene therapy-based COVID-19 “vaccines” are safe and effective, are effective as prophylactics, are effective in preventing infection and spread of COVID-19 disease, and if taken by a sufficient fraction of the population [a moving goalpost] can be used to achieve herd immunity. [All of these previous claims are now clearly demonstrated unsupported falsehoods.]

3. The gene therapy-based COVID-19 “vaccines” are effective at preventing severe disease and death from SARS-CoV-2, and have saved 14 million lives. [This 14 million lives saved claim turns out to be based on flawed mathematics, and all cause mortality data analysis indicates something more like 17 million lives lost globally due to the products.]

4. Fully disclosing actual risks, morbidity and mortality data concerning the COVID-19 genetic vaccines will result in “increased vaccine hesitancy” and avoidable harm due to reduced “vaccine” (booster) uptake. [At this point in the outbreak, multiple data sources indicate that acceptance of boosters is associated with “negative effectiveness,” meaning that after a 2-3 month lag period (shorter in some studies) you are more likely to suffer death or severe COVID-19 disease—and other diseases—if you accept injection with these products than if you do not.]

This fourth point is a clear-cut example of flawed logic. Flawed both in terms of the data on morbidity, mortality, and immune imprinting, as well as flawed bioethical reasoning.

Think this through with me. The essence of the statement is essentially the governments’ assertions that “if the public knew about the risks that we know about, then they would choose not to accept those risks based on their assessment of the effectiveness of the product and the clinical risks of infection with the virus. Therefore there would be much more avoidable disease, disability, and death from COVID-19 than would be saved from vaccine products not administered.”

And on the basis of this ill-logic, governments and Pharma are withholding adverse event data, and thereby are unilaterally making medical decisions for sovereign individuals and their children. This is what we have come to. The ultimate embodiment of the nanny state, with corporatist allies. The State knows best, and will withhold medical information from the public which would cause members of that public to question its wisdom and decision-making.

Basically, the State is asserting that it has the right to sentence you to increased risk of death and disease by purchasing (using tax dollars), mandating (vaccines for children program), distributing, enticing, and marketing an injectable product while censoring or defaming (using modern psychological warfare technologies) any and all who disagree or even have the temerity to question the decisions and rights of the State to do so.




Friday, December 29, 2023


It is clear that my Fridays have usually become too busy for me to do much blogging. Today, for instance, I spent most of my morning in hospital undergoing a cancer treatment. So henceforth I will not usually post on Fridays. And Saturday is the true Sabbath so I never post then. I usually post on Sunday but this Sunday is New Year's Eve so I might pass then too

Thursday, December 28, 2023

NY Times Reports on a “Possible” Myocarditis Death Due to the Covid Vaccine

Throughout the pandemic, TrialSite News investigated, corroborated and reported on the reported side effects of the Covid vaccine. To support a group that had little to none, the media’s leadership sought out partnerships to be supportive, such as patient advocacy group React19, as well as enabling a censor-free Covid injury support group while also focusing on the incidence of Covid vaccine-related myocarditis in young men.

One example was an Israeli doctor who reported the ailment directly to Pfizer, yet he was ignored. It was only after the doctor had his findings published in The New England Journal of Medicine when the pharmaceutical company finally took notice and realized they might have a problem.

Additionally, TrialSite covered Wisconsin Senator Ron Johnson and his concerns on those injured by the vaccine and the hearings Johnson conducted on the vaccine injured as well as physicians who opposed the vaccines and vaccine mandates. Also there have been articles on parents who’ve lost children due to post vaccine heart ailments a celebrity pro-vaccine doctor in Mexico who mysteriously died after getting the shot as well a professional basketball player who claimed, before his death, the Covid vaccine was responsible for his decline. The point is these stories were published and available for reference. But, it seems, one major news outlet has just discovered the story.

The New York Times

In a story published on December 13, The New York Times reported on the death of a 24-year-old man “caught the attention of the movement of vaccine opponents”. The article tells the story of George Watts, Jr. of Elmira, NY, who died a month after his second shot of the Covid vaccine. The medical examiner in nearby Binghamton, NY discovered Watts’ heart muscle, the myocardium, was losing some of its strength and sagging. After examination under a microscope, parts of the heart were inflamed. These symptoms are indications of myocarditis. The article went on to say myocarditis is a slight risk of the mRNA vaccines, but doctors conclude the benefits of the serums outweigh the risks.

Additionally, according to the Times, “There were 224 verified cases of myocarditis among vaccinated children and young adults in the United States from late 2020 to mid-2022, out of the nearly seven million vaccine doses that were administered, according to one study.” And, according to the article, deaths from myocarditis due to the Covid vaccine worldwide are “extremely rare” among the millions of people who’ve been vaccinate. However, the Times does point out the Centers for Disease Control (CDC) changed its guidelines increasing the amount of time males, 12-39 years old should wait between their first and second vaccine dose. The agency increased the time between shots from 3 to 4 weeks to 8 weeks.

NY Times Makes the Story Political

The Times claims after the death of George Watts Jr., anti-vaxxers picked up his story and made it political because the medical examiner blamed the death on the Covid vaccine. According to the article, “Noticing that George Jr.’s story could yield some political influence, a collection of anti-vaccine influencers sought out the Watts family, introducing them to large platforms and even larger goals.” This was especially after George’s father posted the pain of his loss on Facebook. The social media platform then limited how much George Sr. could post. Not an uncommon dynamic, blatant censorship TrialSite reported on frequently.

Other groups came into the picture including Children’s Health Defense, the group founded by Robert F. Kennedy, Jr. (now an independent presidential candidate growing in popularity) Doctors also came out in support of the vaccine saying the medical examiner may have jumped to a conclusion blaming the death on the Covid jab.

What the article seems to ignore and what has been bought into light is the relationship between Big Pharma and government regulatory agencies like the CDC and the National Institutes of Health (NIH). In other countries such as Germany, some groups suspect Covid vaccination deaths have been under counted.

The Times article also ignores groups like the aforementioned React-19, a science-based support group for people who’ve suffered from long term effects of the Covid vaccine.

However, a report is being prepared by the CDC on the death of George Watts, Jr. If the agency agrees with the medical examiner’s report that the cause of death was Covid vaccine myocarditis, it would be a first for the CDC. But, given the relationship between the current White House which bet the house on these vaccines, Big Pharma and the government agency the outcome of the report may not satisfy anyone. Broader state-agency-industry entanglements become larger, more complex and influential.

But a larger question, however, centers on the reality that legitimate reports of myocarditis and vaccine injury have been available since the beginning of the mass countermeasure response to the pandemic. Where has The New York Times been with their reporting? Can they even be considered a legitimate news organization after Covid?


Study looks at association between vitamin C consumption and duration, severity of the common cold

In a study recently published in BMC Public Health, researchers conducted a meta-analysis looking at trials linking vitamin C supplementation and common cold severity and duration.

The use of antibiotics to treat a common cold is common, but futile, as almost all colds are caused by viruses. Yet, results from surveys carried out in the USA found that about half of all common cold patients received antibiotics. Overuse of antibiotics contributes to antibiotic resistance, a significant concern. Given this, alternative treatment options for the common cold have substantial public health relevance. Vitamin C, which has various effects on the immune system, is one such alternative.

The common cold has been associated with temporarily lowered levels of vitamin C levels in the urine, plasma, and leucocytes of infected people.

Despite compelling evidence from randomized control trials and meta-analyses that vitamin C supplementation can reduce the duration and severity of colds, disproportionately influential publications (some of which were subsequently retracted) led to a persistent belief that it is not beneficial.

For the current study, researchers compared the effect of vitamin C on mild symptom duration versus severe symptom duration across trials that reported both effects. The two outcomes of focus were (1) common cold severity in terms of symptoms, duration of severe symptoms, and days spent indoors or absent from work and (2) how long the cold lasted overall.

Trials were included in the analysis if they were placebo-controlled, and a minimum of 1g of vitamin C per day was orally administered over the study period to people who were healthy at baseline.

These criteria allowed researchers to examine how regular supplementation would affect the colds that occurred during the study. The minimum dose was determined by previous findings that indicated a dose-response relationship in that range.

The researchers identified fifteen comparisons from 10 trials which reported both mild and severe symptoms. All trials were randomized and double-blind.

Results indicated that vitamin C supplementation reduced days absent from school (for students) and confined at home by 15%. The groups receiving the supplement also showed decreased common cold severity by 13%.

Across all 15 comparisons, the pooled effect of 1g or more of vitamin C was 15%, indicating a significant reduction in severity.

In terms of the duration of severe symptoms, the analysis found a reduction of 26% as compared to no significant effect of vitamin C supplementation on mild symptoms. There were some indications that effects could be stronger for males compared to females.

The findings strengthen existing evidence of the efficacy of vitamin C in reducing the symptoms of the common cold, particularly in people with severe symptoms. Further research on the therapeutic effects of vitamin C on the common cold should measure outcomes of differing levels of severity, the authors conclude.




Tuesday, December 26, 2023

Boxing day

Like most people I am still in holiday mode so no new postings today

Monday, December 25, 2023



Sunday, December 24, 2023

COVID-19 Vaccines Can Potentially Worsen Cancer: Review

COVID-19 vaccines can trigger genetic changes in cancer patients that could aid in the further development of the disease in such individuals, according to a recent peer-reviewed analysis.

The review, published in the Cureus medical journal on Dec. 17, looked at the relationship between COVID-19 vaccines and cancer. A review of multiple studies led the authors to conclude that certain COVID-19 vaccines may create an environment that predisposes some cancer patients, including survivors, to “cancer progression, recurrence, and/or metastasis.”

The conclusion was based on two factors. First is the “multi-hit hypothesis” of cancer, which suggests that cancer is the consequence of several genetic mutations.

The second is the “growing evidence and safety reports” in the Vaccine Adverse Effects Report System (VAERS), which suggested that some cancer patients who took COVID-19 vaccines saw their conditions worsen.

“In light of the above and because some of these concerns also apply to cancer patients infected with SARS-CoV-2, we encourage the scientific and medical community to urgently evaluate the impact of both COVID-19 and COVID-19 vaccination on cancer biology and tumor registries, adjusting public health recommendations accordingly,” the review said.

The review focused on mRNA vaccines, Pfizer/BioNTech and Moderna, and adenovirus-vectorized vaccines, Johnson & Johnson and Oxford/AstraZeneca, as these products were most widely used in global COVID-19 vaccination campaigns.

mRNA vaccines have the potential to trigger a set of biological mechanisms that could lead to the progression of cancer, it said.

These effects are attributed to factors like the “pro-inflammatory action” of lipid nanoparticles (LNPs) and tumor-causing effects of the vaccines’ antigens, namely the spike protein.

LNPs are nanoparticle drug delivery systems that can be used to deliver DNA and mRNA into a body. The spike protein, found on the surface of the COVID-19 virus, facilitates the entry of the virus into healthy cells.

The authors who wrote the review are Raquel Valdes Angues from the Oregon Health and Science University School of Medicine in Portland and Yolanda Perea Bustos from the education department in the Government of Catalonia, Barcelona, Spain. They declared “no financial support” from organizations that might have an interest in their work and no other relationships or activities that could have influenced the review.

The analysis outlined several genetic effects that COVID-19 vaccines could have on cancer cells and thereby potentially negatively impact the lives of patients suffering from the illness.


The review noted that COVID-19 vaccination has been associated with lymphopenia—a condition in which there is an abnormally low count of lymphocytes, a type of white blood cell that helps the immune system fight against foreign bacteria and viruses.

Clinical trials of the Pfizer and AstraZeneca vaccine described a “decrease in plasma lymphocytes 6-8 days post-vaccination in 45 percent-46 percent of participants.”

“Lymphopenia has long been associated with increased cancer incidence and risk of malignancy,” said the review. “Lymphocyte alterations are frequent in patients with cancer and strongly impact prognosis and survival.”

Given that lymphopenia contributes to creating an environment favorable to the progression of cancer, “extreme caution” must be observed when recommending COVID-19 to cancer patients—“especially those undergoing anticancer treatment.”

Spike Proteins

The spike protein present in COVID-19 coronaviruses has two key functional subunits—S1 and S2. S1 helps the virus in infecting human cells and has been found to affect the mechanism of cell growth.

Meanwhile, the spike protein has been shown to influence a mechanism that regulates several key cellular behaviors, specifically inflammatory responses and cellular growth. When activated in cancer cells, this specific mechanism promotes chemoresistance and proliferation. In a tumor microenvironment, it stimulates immune suppression.

As COVID-19 vaccines introduce spike proteins into the body, “it is hence imperative to monitor the mid-and long-term consequences” of such vaccination, the review stated.

Compromising Immunity

Researchers suggested that mRNA vaccines are “designed to deactivate” an individual’s innate immunity.

The innate immune system of mammals is stimulated through the activation of a class of proteins called Toll-like receptors (TLRs). TLRs are known to trigger several signaling pathways for the production of various cytokines that play an important role in many diseases, including cancer.

The signaling pathways involve IFN regulatory factors (IRFs) critical in several aspects of immune response. The review cited research showing that Pfizer COVID-19 vaccines “significantly decreased” the production of type I IFN and type II IFN.

TLRs are not only expressed in immune cells but also in tumor cells, in which they can either promote or inhibit malignancy. Type I IFN has also been found to be important in controlling the growth of tumors and in the response to anti-tumor therapies.

The review notes that the “exceedingly complicated” role of TLR and type I IFN responses in tumor biology “prompt caution” when using synthetic mRNAs for therapeutic applications.

The lipid nanoparticles (LNP) used in the mRNA vaccines have been found to be “highly inflammatory” in mice, the review said, citing a report.

Injection of LNPs led to “rapid and robust activation of diverse inflammatory pathways” as well as the production of various inflammatory cytokines and chemokines in the mice. Cytokines and chemokines regulate responses to injuries and infections.

In the context of cancer, inflammation is conducive to the development of the disease and promotes all stages of tumorigenesis—the initial formation of a tumor in an individual.

“Around 15 percent-20 percent of all cancer cases are preceded by infection, chronic inflammation, or autoimmunity at the same tissue or organ site,” the review stated. “In such cases, cancer-promoting inflammation is induced and exists long before tumor formation.”

Such extrinsic inflammation—referring to inflammation caused by outside sources—can result in immunosuppression, where the immune system becomes temporarily dysfunctional. This immunosuppression can provide the environment for the development of tumors.

“Given that LNPs often accumulate in tumors, due to enhanced permeability and retention effect (EPR), protecting cancer cells from transformation-related stress stimuli, including inflammation …. is of paramount importance,” the authors wrote.

Genomic Integration

The review highlighted a study discussing the possibility that certain parts of the COVID-19 virus might undergo “genomic integration within infected cells.”

The study found copies of the virus in human cells and speculated that the same phenomenon could occur once human cells are exposed to COVID-19 mRNA vaccines.

Another study found that a “retrotransposon” called long interspersed nuclear element-1 (LINE-1) was affected following cellular exposure to the Pfizer COVID-19 mRNA vaccine. Retrotransposons are genetic elements that replicate and integrate the DNA into new sites in a genome.

The review speculated that the mRNA vaccine’s impact on LINE-1 might “enhance the risk of mutations in tumor suppressor genes and lead to sustained DNA damage in cells and tissues targeted by the vaccine.”

The researchers insisted that there is a “pressing need for clarity on the potential COVID-19- and COVID-19 vaccine-induced activation of LINE-1 and its repercussions in cancerous and/or precancerous cells with intrinsic high levels of LINE-1 expression.”

Tumor Suppression

An October 2020 study showed that the S2 subunit of the COVID-19 virus “strongly interacts” with tumor suppressor proteins p53 and BRCA1/2, said the review.

Proteins like p53 and BRCA1/2 act as a “major barrier” to tumor progression. The possibility that the virus’ spike protein can interact with tumor suppressor protein is critical since both mRNA and adenovirus-vectorized vaccine contain the “genetic material that instructs the host cells to express spike.”

Studies on the Pfizer vaccine have shown that it accumulates in various organs within 48 hours of vaccination. In addition, lipid nanoparticles “preferentially accumulate” in the tumor tissue rather than the healthy tissue.

Given these findings, the review suggested a detailed look into the potential interactions between S2 and tumor suppressor proteins p53 and BRCA1/2 in both COVID-19 patients and those who have received COVID-19 vaccination.

Such an analysis is necessary to determine if the interactions provide a “selective advantage” for cancer or precancerous cells, the researchers wrote.

Mutations to TP53, the gene that provides instructions for making p53, can lead to cancers of the breast, bone, soft tissue, and brain. Less frequent cancers include stomach cancer, leukemia, and colorectal cancer. Impaired BRCA1 activity is associated with cancers of the breast, ovaries, uterus, and prostate.

‘Dubious’ Vaccination Benefits

The researchers noted that they have shown COVID-19 spike protein-based vaccines to “have the potential to interact with tumor suppressor proteins, promote inflammation, activate oncogenic pathways, and disrupt the fine-tuning of the immune response.”

“These dysregulated mechanisms and signaling pathways underlie most types of cancer.” A more “balanced risk/benefit evaluation is urgently needed” regarding COVID-19 vaccination and people with or at high risk of cancer.

For people with poor immune responses, “the benefits of vaccination are dubious, and the cumulative risks of successive boosters are unknown.”

An area of concern is that the co-administration of anticancer treatments and COVID-19 vaccines could pave the way for “toxic effects.” The review cited an article that found that when cancer patients were given Pfizer’s COVID-19 vaccine, there was a “constant and variable increase of all COVID-19 vaccination side effects.”

“There is thus a concern that the simultaneous use of immunotherapy and COVID-19 vaccines boosts the body’s immune response, resulting in enhanced immune-related adverse events,” the researchers wrote.

The review stated that between Jan. 7, 2018, and July 2, 2022, there were approximately 13,000 cancer deaths per week in the United States, with peaks occurring in January 2021 and January 2022. While public health agencies have admitted a rise in cancer deaths, they have mostly attributed the excess deaths to the COVID-19 infection.

Even though cancer mortality peaks in 2021 and 2022 correlate with COVID-19 winter surges, “they also follow two major COVID-19 vaccination and booster campaigns,” the researchers pointed out.

“As noted earlier, both SARS-CoV-2 and SARS-CoV-2 spike protein-based vaccines promote the production of spike within human cells, which, in light of the above, might facilitate malignant transformation.”

The authors noted that even though many institutions and experts promote COVID-19 vaccines as safe and effective in patients with cancer, “these claims are unsupported.”

“Our suggestion is that individuals with cancer or a history of cancer should receive the genetic COVID-19 vaccines only if the benefits clearly outweigh any risks and after careful evaluation case by case,” said the review.

“Most importantly, there is the possibility that cancer risk is dose-dependent.” As such, only individuals who have taken multiple COVID-19 immunizations may be at higher risk of cancer malignancy.

“The success of the novel mRNA-based vaccines against COVID-19 has created a widespread interest in mRNA technology as a solution to some of the deadliest infectious diseases (i.e., malaria, tuberculosis, and HIV/AIDS) for which an effective and easily deployable vaccine is urgently needed,” the authors wrote.

However, “current safety concerns should be promptly addressed before mRNA-based nanomedicines further transform the way diseases are managed and prevented in the future.”




Saturday, December 23, 2023

Another Friday hiatus

Health problems

Thursday, December 21, 2023

Is this the smoking gun for the Covid lab leak? Blueprint for creating a 'SARS-CoV' virus with an altered spike protein in Wuhan was published in 2018, bombshell new records show

A newly-uncovered trove of documents detailing plans to create a Covid-like virus in China months before the pandemic make the 'lab leak almost certain', experts say.

The records - obtained now by FOIA requests - lay out a plan to 'engineer spike proteins' to infect human cells that would then be 'inserted into SARS-Covid backbones' at the infamous Wuhan virology lab from December 2018.

Just a year later, in late 2019, the Covid-19 virus emerged with a uniquely adept ability to infect humans, going on to cause a global pandemic.

The proposal was made by the now-notorious EcoHealth Alliance, a New York nonprofit that channels US government grants abroad to fund these types of experiments.

Ultimately, the application was denied by the US Department of Defense, but critics say the plans laid out in the proposal serve as a 'blueprint' for how to create Covid, and inadvertently start a pandemic.

The documents also show how EcoHealth deliberately tried to mislead the Pentagon on how risky the experiments were to secure funding.

Sen Rand Paul - who has been a vocal supporter of the lab leak theory - added the documents further support of the 'deception' used by players tied to the Wuhan lab.

Matt Ridley, a biologist and science writer who has written extensively about the potential lab leak in the past, said: 'This latest [document] leak makes the case for a lab leak almost certain.

'A reckless experiment, known at the time to be reckless, probably caused the death of millions of people. 'Scientists and the media conspired to conceal the evidence. Let that sink in.'

The documents were obtained by nonprofit public health research group US Right to Know, which has previously been accused of fueling anti-vaccine sentiments.

The grant proposal was entitled Project DEFUSE: Defusing the Threat of Bat-borne Coronaviruses.

It proposed engineering high-risk coronaviruses of the same species as the original SARS to preempt a human spillover and develop vaccine technology and strategies.

The team sought to synthesize spike proteins with furin cleavage sites that had been designed to bind to human receptors more easily.

The furin has been one of the focal points of debate about Covid-19's origin, with some experts claiming it could only have been acquired through lab experiments.

The grant then proposed attaching the furin to coronavirus strains and infecting mice to see how ill it would make them.

The plan was then to use drugs and vaccines to treat the disease.

Dr Richard Ebright, a chemical biologist at Rutgers University in New Jersey, told 'These revelations are important because the experiments in the grant proposal likely - indeed highly likely - led to the creation and release of SARS-CoV-2.'

The grant proposal has raised concerns and some say it serves as further support of the Covid lab leak theory - that the virus was borne out of gain-of-function research bankrolled by the US taxpayer through Dr Anthony Fauci's former department, a theory the FBI and other government agencies now subscribe to.

The principal investigator on the project is listed as Peter Daszak, president of EcoHealth, a now-notorious health agency that uses US government money to sponsor there's types of experiments abroad.

Other team members listed on the proposal include researchers from Duke-NUS Medical School, University of North Carolina, the USGS National Wildlife Health Center, Palo Alto Research Center and the Wuhan Institute of Virology, the lab where Covid is believed to have originated from.

The proposal listed Professor Shi Zhengli - been dubbed the 'bat lady' for her extensive work on bat coronaviruses at the WIV - as the lead on the project in Wuhan.

Additionally, Dr Ralph Baric was listed as a subcontractor on the project. Dr Baric is a known expert in making recombinant coronaviruses.

The documents show the experiments were proposed to take place at the WIV, which has fewer safety precautions for working with pandemic-potential specimens than the US, which was advertised to the DoD as cost-saving.

The American scientists concealed the lack of safety precautions from DARP in order to avoid national security concerns about conducting high-level biosafety research in China.

In initial proposals for DEFUSE, the lab work was to be done in a biosafety-level 2 lab, which researchers said would appeal to DARPA grant-makers as 'highly cost effective' despite the fewer safety precautions taken in lower-level labs

Dr Baric acknowledged in an edited version of the proposal US researchers would 'freak out' if they knew novel coronavirus engineering and testing was being done in a BSL-2 lab.

Similar experiments in the US are conducted in BSL-3 labs.

A later version of the proposal changed BSL-2 to BSL-3.

Biosafety levels range from one to four, with four being the strictest and experimenting on the most dangerous pathogens.

Dr Baric wrote: 'In the US, these recombinant SARS-CoV are studied under BSL3, not BSL2, especially important for those that are able to bind and replicate in primary human cells.'

BSL-2 labs feature ventilated safety cabinets and researchers must wear surgical masks and lab coats. Experts say pathogen with the possibility of being transmitted through the air should be, at a minimum, performed in a BSL-3 lab, which has researchers in more protective respirators.

Dr Ebright told 'The new documents reveal that EcoHealth Alliance planned to use US Department of Defense funds to perform high-risk virus experiments at WIV at a biosafety level that was inadequate for research with a potential pandemic pathogen.'

He added: 'The new documents also reveal that EcoHealth Alliance deliberately concealed these plans - both the plan to perform high-risk experiments at WIV and the plan to perform them using inadequate biosafety protections - from the US Department of Defense in order to improve the chances of receiving funding.'

Dr Ebright tweeted: 'At this point, there is sufficient evidence to conclude, beyond reasonable doubt, that SARS-CoV-2 entered humans through a lab accident.'

While people who believed and promoted the lab-leak origin were initially accused of being xenophobic and pushing a conspiracy theory, the FBI and several other governmental agencies ascribe to this theory.

The formal DEFUSE grant proposal states the engineering of the coronavirus spike protein would be carried out by Dr Baric in North Carolina.

However, in an earlier comment on the proposal, Daszak said WIV will actually be doing most of the work but this fact was left out of the proposal to make DARPA more 'comfortable' with the details.

Dazsak said in an email: 'If we win this contract, I do not propose that all of this work will necessarily be conducted by Ralph, but I do want to stress the US side of this proposal so that DARPA are comfortable with our team.

'Once we get the funds, we can then allocate who does what exact work, and I believe that a lot of these assays can be done in Wuhan as well.'

In another comment, however, Daszak reiterates his desire to stress the US-focus of the project.

He wrote: 'I am planning to use my resume and Ralph's [Baric]. Linfa/Zhengli, I realize your resumes are also very impressive, but I’m trying to downplay the non-US focus of this proposal so that DARPA doesn’t see this as a negative.'

In a statement Tuesday, EHA called the documents ' incomplete' and said the 'allegations are false based on misunderstanding of edits and comments on the document, and based on misleading out-of-context quotations and a lack of understanding the process by which federal grants are awarded.'

Justin Goodman, president of The White Coat Waste Project, a watchdog group fighting to stop sending American tax dollars overseas to fund dangerous virus research, told the documents prove US tax dollars have 'footed the bill for the shady EcoHealth Alliance and their comrades at the reckless Wuhan lab to supercharge coronaviruses in dangerous gain-of-function experiments.'


High Incidence of Long COVID in Africa, but NOT Among Black Ethnic Groups

Although the continent of Africa was spared much of the fatality rates experienced by other continents, a recent comprehensive review of previous studies and analysis tracking a total of 29,213 people, about 50% of the COVID-19 cases in Africa involves residual long COVID cases. A substantially higher number than in America, for example, which is about 10%, but some studies show higher. With improved ability to track long COVID, this review of the evidence suggests long COVID represents a far bigger problem than previously understood.

Does long COVID emerge as a far bigger problem in the African continent than elsewhere? While estimates of long COVID varied from 2% in Ghana to 86% in Egypt, the most recent study Prevalence and risk factors for long COVID and post-COVID-19 condition in Africa: a systematic review - The Lancet Global Health published in The Lancet Global Health reports the incidence of COVID-19 is in fact, underestimated. With 12 million documented cases and likely, many more un-documented cases, the German and Africa-based study team looks into the evidence on prevalence, associated risk factors for long COVID, and systemic or sociocultural determinants of reporting long COVID.

The Study

Conducting a systematic review incorporating data from PubMed, the Living Overview of Evidence platform, and grey literature sources for publications from Dec 1, 2019, to Nov 23, 2022, the authors included articles published in English, French, Spanish, or Portuguese that reported on any study type in Africa with participants of any age who had symptoms for 4 weeks or more after an acute SARS-CoV-2 infection.

The authors excluded secondary research, comments, and correspondence. The study protocol called for two reviewers to both screen and extract data. Extracting summary estimates, such as sociodemographic factors, medical history, prevalence of persistent symptoms, and symptoms and associated factors, the authors performed a descriptive analysis registering the whole investigation on the results which were analyzed descriptively. The study was registered on the Open Science Framework platform.


Out of 294 articles, (including 24 peer-reviewed manuscripts) the fully vetted patient count equaled 9712 patients from eight African countries.

Out of the entire set of studies, one investigation focused exclusively on children, and one other study included children as part of their study population.

The authors report a low risk of bias associated with the selected studies. The findings suggest an extremely low prevalence of long COVID in the West African nation of Ghana (2%) to extremely high incidence in the northern African nation of Egypt (86%).

What are some indicators of a higher frequency of Long COVID?

Female sex
Non-Black ethnicity
Low level of education
Severity of COVID-19 infection
Underlying Co-morbidity

Interestingly, HIV and tuberculosis were not pegged as factors.

Importantly, other studies have also demonstrated the lack of COVID-19 incidence in sub-Saharan Africa, a fascinating ongoing observation further validated in this study. No one can be certain why, but explanations range from the younger average age in sub-Saharan Africa to different microbiome dynamics to mass exposure to ivermectin at least in some countries (part of anti-parasitic regimen program).

To broaden African observations in this study, the factors influencing reporting included absence of awareness, inadequate clinical data and diagnostics, and little access to health-care service.

Regardless, this study advances the collective knowledge somewhat as to long COVID and the African continent.




Wednesday, December 20, 2023

Uncovering COVID-19 Origins: Why Congress Must Breach Biden’s Stonewall

Next month, the House Select Subcommittee on the Coronavirus Pandemic will interview Dr. Anthony Fauci, the former director of the National Institute of Allergy and Infectious Diseases. After two days of behind-closed-doors interviews, the subcommittee will schedule a public hearing to take his sworn testimony.

Fauci’s testimony will doubtless cover a wide variety of topics, ranging from masking to vaccine mandates. But rest assured that congressional investigators will zero in on Fauci’s knowledge of, and response to, crucial information concerning the origins of the pandemic in China.

To secure a fully transparent accounting, House and Senate investigators are also pressing the administration to release key details about what Fauci and his colleagues knew about the origin of the pandemic, and when they knew it. But Biden administration officials continue to stall the release of relevant information, offering transparently lame excuses, to block congressional access and public disclosure of unredacted documents.

Team Biden’s persistent lack of transparency on COVID-19 has been nothing short of scandalous. Here is the latest proof:

Exhibit A: Blocking Document Disclosure. In October 2017, well before the outbreak of the COVID-19 pandemic, Dr. Ping Chen, an NIAID official, visited the Wuhan Institute of Virology and prepared a trip report for top NIAID officials.

Sens. Rand Paul, R-Ky., and Ron Johnson, R-Wis., learned of the trip four years later and, in August 2021, wrote Health and Human Services Secretary Xavier Becerra and acting National Institutes of Health Director Lawrence Tabak asking them to release unredacted records of Chen’s visit to Wuhan. In response, the Department of Health and Human Services instead provided a heavily redacted copy of Chen’s report, plus redacted emails.

In a subsequent briefing for Senate staff, Dr. Melanie Egorin, HHS assistant secretary for legislation, said the redactions were for “security” reasons. But that excuse was clearly incorrect because, as the senators noted, HHS had already conceded that national security was not at issue and the documents themselves were unclassified.

As Johnson remarked, “Given HHS’s extensive redactions of unclassified documents, I can only assume that the true nature of HHS’s ‘security’ interest is to protect itself from additional embarrassment over its handling of the COVID-19 pandemic.”

Johnson has since renewed his request to interview Chen and asked for a complete and unredacted copy of her report and related documents. Thus far, no response.

Exhibit B: Flaunting Federal Records Rules. On June 11, 2021, Johnson, Paul, and three other Senate colleagues sent Becerra a letter requesting documents relating to NIH officials’ response to the pandemic’s origins.

The senators had learned that Dr. David Morens, senior scientific adviser to Fauci, had emailed Dr. Peter Daszak, president of EcoHealth Alliance, on Jan. 9, 2020, asking Daszak for any “inside info” on the novel coronavirus. Daszak replied that NIAID had been funding coronavirus research for “the past five years” and taxpayer monies had been funneled to the Wuhan Institute of Virology.

For several years, Daszak’s controversial firm had indeed gotten substantial NIAID funding; and the Wuhan Institute of Virology, which had been a center of China’s coronavirus research, had been a subcontractor of the EcoHealth Alliance.

According to Johnson’s account, upon receipt of the June 2021 letter, Morens told Daszak and a small group of his colleagues that he had retained “very few” documents on these “matters.” Morens cautioned the group to correspond with him outside of official channels at his Gmail address, adding, “I have tried to make sure I have retained no documents that might lead other members of ASTMH to be approached for similar document production.” (ASTMH stands for the “American Society of Tropical Medicine and Hygiene,” Morens’ little group).

Among those receiving this Gmail warning were three prominent virologists, Dr. Kristian Andersen, Dr. Robert Garry and Dr. Edward Holmes, who had published a prominent 2020 article in Nature Medicine arguing that a COVID-19 lab origin was “improbable.” That article was a sharp and rapid reversal of their original assessment of an “unnatural” origin of the coronavirus.

When Johnson learned in August 2023 that Morens was apparently using his personal Gmail in communications concerning COVID-19 origins, he wrote Christi Grimm, HHS inspector general, asking her to investigate the apparent attempt to use to evade requests for public information under the Freedom of Information Act.

Johnson also told Grimm that an unnamed whistleblower claimed that NIH officials may have destroyed sensitive federal records related to the Wuhan Institute of Virology, a serious criminal offense with severe penalties.

For their part, NIH officials claimed they conducted an internal investigation of that allegation, and determined to their own satisfaction that the charge was without merit. Satisfied that there was nothing more to it, the National Archives and Records Administration, the agency charged with the preservation of official records, also dropped its inquiry into the matter.

Remarkably, Grimm rejected Johnson’s request for a Senate staff briefing on the controversy, claiming that it is standard practice to “neither confirm nor deny” the existence of ongoing investigations.

Johnson nonetheless renewed his request that Grimm investigate Morens’ use of Gmail to conduct agency business, the alleged NIH destruction of official agency records, and any effort by Morens or and others to evade the Freedom of Information Act. But she denied the request once again.

In a Nov. 15, 2023, letter to Becerra, recounting the foregoing facts, Johnson tried again:

I request you immediately provide complete responses to my June 2021 and March 2023 letters on the origins of Covid-19—including responsive records contained in Dr. Morens’ Gmail account—produce all text messages or communications contained in Dr. Morens’ HHS-issued cell phones(s) dated from June 1, 2019 – present, and provide a detailed explanation for how HHS will hold Dr. Morens accountable for his apparent mishandling of federal records and potential violations of federal record keeping laws. I also request that HHS make Dr. Morens available for an interview with my Subcommittee staff. Please provide this information and interview by no later than December 6, 2023.

Thus far, no response.

Closing In. Johnson and his colleagues do not have subpoena power. As he told this writer, “I am attempting to convince Chairman Blumenthal to issue subpoenas to the non-responsive agencies. If that proves unsuccessful, you can rest assured that, if I become Chairman of the Permanent Subcommittee on Investigations, subpoenas will be issued and enforced.”

House Republicans do, however, have subpoena power. When Fauci testifies early next year before the House Select Subcommittee on the Coronavirus Pandemic, congressional investigators should probe his recollections concerning Chen’s report and Morens’ intriguing communications.

During his November 2022 deposition in the federal case of Missouri vs Biden, Fauci said he could not recall 174 times in response to questions related to the COVID-19 pandemic. House investigators will thus have an excellent opportunity to refresh his memory on what he learned about the origins of the deadly disease, when he learned it, and how he responded.


The Omicron Family Gets Bigger: Characteristics of New Dominant Subvariant HV.1

According to the Centers for Disease Control and Prevention (CDC), the second half of the November 2023 data demonstrates that the HV.1 subvariant of the SARS-CoV-2 virus comprises 31.7% of all cases in the U.S. This makes it the new dominant subvariant circulating since mid-August. TrialSite previously discussed characteristics of the Eris (EG.5) subvariant which was dominant during the 2023 summer period. The Omicron family in general is highly transmissible, and HV.1 is no exception which makes it a concern for public health. In this article, we will discuss the characteristics of HV.1.

Since the advent of the COVID-19 pandemic, virologists have been on the lookout for new variants of SARS-CoV-2 that might cause concern because of their transmissibility and severity. In this lookout, Omicron was one of the difficult opponents since it spreads so fast. Luckily, the symptoms of Omicron variants tended to be mild including runny nose, sore throat and other cold-like symptoms.

Omicron emerged in November 2021 and took over the Delta variant which was previously dominant. The initial version of the Omicron variant is called BA.1. This was followed by other subvariants – BQ.1, BQ.1.1 and XBB. All of these mutations make it more difficult for our immune systems to recognize and fight the virus. However, this does not mean that these mutations will always cause a more severe disease.

Characteristics of HV.1

HV.1 is a lineage of the Omicron variant of SARS-CoV-2. It evolved from EG.5 (and previously XBB.1.5) and its characteristics are very similar to other Omicron strains. This means that it spreads fast but does not cause severe illness.

Infectious disease professor at Vanderbilt University Medical Center, William Schaffner, M.D. stated that while HV.1 may be more transmissible, it does not appear to cause more severe disease or hospitalizations. “I don’t think people should be very concerned about this,” he said. On the other hand, Schaffner also warns about the possible increase of cases in winter, as was the case for the past three years.

The symptoms of the HV.1 are not different from classical COVID-19 symptoms, including fever, cough, fatigue and sore throat. No new or alarming symptoms have been observed with the emergence of HV.1. The severity of these symptoms can vary depending on an individual's immunity and vaccination status. Additionally, while these symptoms are mostly mild, they can be dangerous for immunocompromised individuals.

Unlike its family members, HV.1 still does not have a catchy nickname, so all the sources still use the scientific Pango name. Healthcare professionals continue to investigate this new variant, and fortunately, most diagnostic tests currently in use can still reliably diagnose the various strains of the SARS-CoV-2 virus.

Will vaccines work for these new variants?

Mutations that cause HV.1 allow it to infect people with previous immunity to the SARS-CoV-2 virus more easily. Therefore, it is an important concern if the vaccines and other preventive and therapeutic measures can keep up with these new subvariants.

Moderna announced in August 2023 that its updated COVID-19 vaccine will target the expected circulating variants of COVID-19. The president of Moderna, Stephen Hoge, M.D., specifically claimed that the new results from the clinical trial data of the updated COVID-19 vaccine illustrated a robust immune response against the XBB strains including the EG.5 subvariant.

Pfizer also created a version of its shots to target the XBB strain, and Reuters mentioned that it showed effectiveness against EG.5 in a mice study.

Although they did not specifically state HV.1, since it is from the same family as XBB, one can assume that updated vaccines are expected to be effective against this new dominant subvariant.

Matthew J. Binnicker, Ph.D., who studies viral infections and is a Director of Clinical Virology at Mayo Clinic, emphasized that along with the updated vaccines, antiviral treatments such as Paxlovid can still work for the HV.1.

A new omicron sub-variant to look out for JN.1 has some concerning attributes. According to the Centers for Disease Control and Prevention (CDC) this variant is the second most predominant one in the United States.

What to expect from future variants

According to a Euronews Next article, Dr. Maria Van Kerkhove, an infectious disease epidemiologist and COVID-19 Technical Lead at the World Health Organization (WHO), emphasized that people have moved on from COVID-19 but the virus is still circulating. She stated that it continues to cause deaths and we need to keep up with it.

To understand and anticipate the future variants of SARS-CoV-2, researchers used molecular dynamics simulations. Investigating the molecular dynamics of mutations helps scientists understand how the virus creates advantages for itself to evolve.

A Think Global Health article envisioned that it is almost impossible to predict the behavior of a new variant before it comes up. But the worst-case scenario is the possibility of a “deltacron” variant which is a combination of the Delta variant’s severity and the Omicron variant’s transmissibility. This might be the scenario in which a greater death rate occurs but luckily, it seems unlikely to evolve. For now, the dominant variant HV.1 does not seem harmful in terms of creating a deadly disease but is still contagious enough to not be ignored.

TrialSite will continue to investigate newly appeared variants and their characteristics.




Tuesday, December 19, 2023

FDA Inspects Moderna Main COVID-19 Vax Manufacturing Facility—Finds Numerous Quality Breaches—Issues 483 Warning Letter, Yet Not Disclosed Publicly

A recent Reuters-sponsored Freedom of Information Act (FOIA) request turned up information about Moderna production problems. Specifically, the Food and Drug Administration (FDA) in an inspection discovered serious quality control lapses at the mRNA biotech company’s main production site, including issues associated with the manufacturing of the COVID-19 vaccine known as mRNA-1273 or Spikevax. Interestingly, the inspection occurred back in September, yet to date, the FDA still has not shared the warning letter publicly. See the database. Could this finding in any way tie into DNA fragments found in samples?

Apparently, the FDA inspection was conducted between Sept. 11-21 at the Norwood, Massachusetts production site, used to manufacture both the Spikevax COVID-19 vaccine plus the investigational mRNA cancer regimen currently under development, part of a partnership with Merck, reports Patrick Wingrove.

But Moderna shared that this particular FDA inspection was routine, ensuring that any observations were not implications for product quality or safety concerns.

They said all products released by the company were tested and met product specifications and international regulatory requirements.

What did the FDA find in the inspection?

According to the Reuters entry, the FDA inspectors cited five distinct observations including the company’s failure to verify cleaning tests concerning production equipment used to make the COVID-19 vaccine.

Additionally, the regulatory agency, according to Reuters found that Moderna lacked the appropriate quality control (policies, procedures, processes and systems) at the Norwood site to offer assurance that expired materials would not be used to make vaccines, nor that airborne contaminants did not make it into any products.

According to the report by Patrick Wingrove, the FDA report found 2,000 expired items in the company’s warehouse, plus cold storage not contained in a separate or defined location from other materials.

Another indicator of slipping quality were materials put to use beyond the appropriate expiration date.

No disclosure as to risk to the public

Not known at this point is whether the batches under scrutiny made their way to the public. The agency declined to comment to Reuters. Why did Reuters have to issue a FOIA? Why hasn’t the FDA shared the 483 letters with the public as typically done?

Moderna in a statement said: "Upon receipt of the FDA’s findings, Moderna immediately and comprehensively updated the specific procedures identified and is confident that the actions taken will be satisfactory to regulators."

No Evidence of Harm, But No Evidence of Not Harm Either
Reuters reported no evidence that the quality lapses leading to the FDA observations (writer up in Form 483 letter) led to any consumer harm associated with the COVID-19 mRNA vaccines. On the other hand, they didn’t provide evidence that they have not caused problems.

Favoring a Moderna interpretation is the fact that at least thus far, there have been no FDA-issued recalls of Moderna vaccines.

Expert Commentary

Wingrove spoke with Steven Lynn, a former head of the FDA's Office of Manufacturing and Product Quality who is now a regulatory compliance consultant. He reported that the use of the drug substance in question represented a serious matter but again, it hasn’t been disclosed by the regulatory if any of the output made its way to the market.

“At face value, it appears multiple controls designed to prevent contamination were deficient,” said Lynn.

Japanese Problems

The Reuters piece reminded the reader of problems with Moderna’s quality in Japan in 2021. In that Asian nation, regulators suspended the use of 1.63 million doses of the mRNA vaccine after contaminates were found in some vials produced by a Spanish contract manufacturer called Rovi.

TrialSite has reported on anomalies with Moderna involving its communications around their key vaccine. See TrialSite’s “Moderna--Questions Regarding the Company’s Next Generation mRNA Vaccine.” This media has also questioned the true value, at least in the short to intermediate run, of the company’s pipeline. Other potential issues may present soon, concerning the dependence on one commercial product (the vaccine). The government primed the pump of demand during the pandemic. But COVID-19 national emergency status is over.

In financial disclosures as recently as 2020, the company acknowledged it had no commercial manufacturing experience, and in many ways, like Pfizer, was building the airplane while flying.

Not surprisingly, Moderna went on the record: the COVID-19 vaccines are safe and effective. Yet given the enormous cash infusion into the company thanks to the COVID-19 mandates and government support why have the quality conditions become lax enough for several observations? This finding and the lack of transparency could be indicative of more challenges ahead.


New Study Confirms CDC and Other ‘Experts’ Hurt Children for Nothing

There have clearly been many, MANY aspects of our COVID response that were and remain inexcusable.

Vaccine passports and mandates, the nonsensical curfews and capacity limits, general mask mandates, and of course, closing beaches, should never been forgotten.

But few, if any of our pointless, ineffective COVID-era restrictions were as indefensible as child masking. And thanks to the awe-inspiring incompetence of the CDC and Dr. Anthony Fauci, the United States was a global outlier; obsessively dedicated to forcing toddlers as young as 2-years-old to wear masks.

Schools, youth programs, camps, on airplanes... anywhere children gathered, they were forcibly masked. Horrifying videos emerged of teachers or flight attendants putting masks on crying children.

Calls to mask children in schools have disturbingly continued into late 2023 in certain parts of the country.

But new research has confirmed what was obvious to anyone who studied the data and evidence over the past few years: it was all for nothing.

Child Masking Is Ineffective, New Study Finds

“Trust the science,” “Follow the data,” “Listen to the experts.”

Starting in 2020, those phrases became a relentless mantra of an oppressive government/pharma/media playbook. Instead of examining the actual evidence, data, and pre-COVID consensus, politicians, administrators, and huge swaths of the public put their faith and trust in a few unreliable, self-interested individuals. And with disastrous results.

Following the actual evidence would, in theory, have meant using evidence-based methods as espoused by experts in that field, such as Carl Heneghan from Oxford University. Primarily, that means using a hierarchy of studies, based on quality, to create systematic reviews of well-conducted research.

Instead, we were fed the CDC’s reporting of non-statistically significant results based on phone surveys, and we watched as those results were included in pro-masking reviews designed to promote an ineffective policy.

But a new systematic review from Tracy Beth Høeg and a number of other researchers has just been released on mask mandates for children. And unlike the pro-mask propaganda, it actually attempts to use high-quality evidence to come to its conclusion.

“Background Mask mandates for children during the Covid-19 pandemic varied in different locations. A risk-benefit analysis of this intervention has not yet been performed. In this study, we performed a systematic review to assess research on the effectiveness of mask wearing in children.”
They even used independent reviewers to ensure that there was no bias involved in the study selection criteria.

“Methods We performed database searches up to February 2023. The studies were screened by title and abstract, and included studies were further screened as full-text references. A risk-of-bias analysis was performed by two independent reviewers and adjudicated by a third reviewer.”

That meant that out of 597 studies screened, just 22 were included after meeting the criteria. And in a sign of how the CDC abdicated their responsibility, none were randomized controlled trials (RCT). Sure enough, when filtering out information at a risk of serious bias or confounding, there was no association between forcing kids to wear masks and infection or transmission.

“Results There were no randomised controlled trials in children assessing the benefits of mask wearing to reduce SARS-CoV-2 infection or transmission. The six observational studies reporting an association between child masking and lower infection rate or antibody seropositivity had critical (n=5) or serious (n=1) risk of bias; all six were potentially confounded by important differences between masked and unmasked groups and two were shown to have non-significant results when reanalysed. Sixteen other observational studies found no association between mask wearing and infection or transmission.”

As every intellectually honest scientist, researcher, or expert would admit, their inescapable conclusion is that the “current body of scientific data does not support masking children for protection against COVID-19.”

“Conclusions Real-world effectiveness of child mask mandates against SARS-CoV-2 transmission or infection has not been demonstrated with high-quality evidence. The current body of scientific data does not support masking children for protection against Covid-19.”

Who would have guessed?

Low-Quality Research Used to Create Low-Efficacy Policy

The details of the studies involved in this systematic review are even more damning.

Of the six observational studies that supposedly showed a benefit to masking kids, all were fatally flawed in important ways. Specifically, there were significant confounding differences between unmasked and masked children that undermine any of the reported results.

Differences included the “number of instructional school days, differences in school size, systematic baseline differences in case rates in all phases of the pandemic, testing policies, contact-tracing policy differences and teacher vaccination rates.” With differences that substantial, it’s impossible to determine whether or not the claimed reduction in infection or transmission is due to masks or one or many of those other factors.

This is why randomized controlled trials are so important. And why the CDC should have conducted them during the pandemic years. Yet at the same time, considering the results of masking RCT’s conducted on adults, it’s pretty obvious why they didn’t. Because they knew it would show that masks didn’t work.

The researchers also touched on the fact that some of the studies promoted by the CDC saw their effects vanish upon re-analysis. Specifically, one of the “observational CDC funded study” in the United States claimed to show an association between county-wide mask mandates and pediatric case counts.

Yet when subjected to “expanded reanalysis,” that association disappeared.

That initial result though is how you use low-quality studies to launder low-quality information. The CDC funds a study with what it expects are pre-determined results, the media reports the results of that study—despite being misleading, expert researchers reassess using conventional methods, and the supposed benefit disappears.

But the correction receives none of the attention of the original, because it shows a result the CDC deems unacceptable.

Even observational reporting has shown masks don’t matter at a population level for younger aged individuals. Virginia faced massive criticism for ending school mask mandates early in 2022, only to see cases collapse after a massive surge with mask mandates in place.

Similarly, cases in Philadelphia schools dropped two weeks after the mask mandate was lifted in 2022, and rose substantially for two weeks after the mask mandate in January 2023 came into effect.

As often discussed, in a sane world, this systematic review would permanently shut the door on further discussions of forced child masking. Higher quality research has confirmed that there is no evidence masks are effective and eliminating bias and confounders unsurprisingly shows the same result with children.

But sanity is dead. Therefore the current CDC director defiantly refuses to admit that masking toddlers was a mistake.

She doesn’t have to. Høeg and the other researchers who conducted this review said it for her.




Monday, December 18, 2023

Chinese Scientists Make Inhalable Dry Powder COVID-19 Vaccine

Scientists from China have made an aerosol-based inhalable vaccine against COVID-19, which they claim provides “effective protection” against infection based on animal trials.

The study, published in the Nature journal on Dec. 13, involved researchers testing “an inhalable, single-dose, dry powder aerosol SARS-CoV-2 vaccine” that they developed. The vaccine uses nanoparticles and contains SARS-CoV-2 antigens, or substances that trigger the immune system to generate antibodies against it. Researchers designed the vaccine to target multiple COVID-19 lineages. The particles were one to four micrometers in size, optimized to be deposited in the deep lung region.

The vaccine was found to induce “strong production of IgG and IgA,” two types of antibodies. It also triggered a response from local T cells, a type of white blood cell that helps fight germs. Collectively, this conferred “effective protection” against COVID-19 among mice, hamsters, and nonhuman primates.

The study noted that while several intranasal immunization products are developing, many are largely limited to the nasal passage. In contrast, aerosol-inhaled vaccines, like the one developed by the researchers, “can penetrate deeper and wider (to major and small airways).” This can confer the vaccine's benefits even to the lower respiratory tract.

The vaccine also showed promise for “readily responding” to future co-circulation of multiple COVID-19 strains and preventing the transmission of the Omicron variant, the dominant variant under circulation in the United States.

The study noted that the current crop of COVID-19 vaccines was delivered via intramuscular injections to alleviate the infection. However, “vaccines delivered intramuscularly do not provide a first line of protection at the respiratory tract owing to deficiencies of secretory IgA and IgG.”

Several intranasal vaccines are being developed or approved to overcome this. But such vaccines “are in liquid form, necessitating cold chain transportation and storage, and generally require two or three inhaled immunizations or the use of a heterologous booster vaccination.”

These limitations “motivated” the researchers to develop “a dry powder vaccine suitable for single-dose inhalation.”

“The inhalable vaccination addresses a known public health issue, in that there is more enthusiasm for this type of administration than for traditional injection, and a single-dose regimen is favorable for substantially increasing the proportion of total completed vaccination recipients,” the study said.

“Furthermore, the dry powder form of the vaccine can provide savings in storage and transportation costs, potentially supporting increased immunization coverage to remote areas,” it stated.

Moreover, the dry powder vaccine uses a microcapsule that is based on a material already approved by the U.S. Food and Drug Administration (FDA), thus boosting the prospects of the vaccine’s “clinical translation.”

“We envision that our inhaled vaccine could serve as a promising multivalent platform for fighting COVID-19 and other respiratory infectious diseases.”

The study received funding from the National Natural Science Foundation of China, Beijing Natural Science Foundation, the CAS Project for Young Scientists in Basic Research, the National Key Research and Development Program of China, the Strategic Priority Research Program of the Chinese Academy of Sciences, CAMS Innovation Fund for Medical Science, and the Major Science and Technology Special Projects of Yunnan Province.

Some “competing interests” were reported. Authors Hengliang Wang and Li Zhu have patent applications related to cholera toxin B subunit (CTB) nanoparticles submitted by the Beijing Institute of Biotechnology. The dry powder vaccine uses CTB with SARS-CoV-2 antigens.

Author Guanghui Ma is an inventor in a patent application related to porous microcapsules submitted by the Institute of Processing and Engineering.

‘Scandal of Epic Proportions’

A Dec. 13 article in Nature, which commented on the study, calls the dry powder vaccine a “unique approach” to dealing with COVID-19. However, it notes that the vaccine’s “safety and immune potency remain to be tested by clinical trials in humans.”

The researchers “have shown that the dry-powder shot remains stable at room temperature for at least one month, but it will be essential to determine how long this stability lasts at room temperature and above, and how degradation of the vaccine affects immune potency.”

“The question remains whether this 1−4-µm (micrometer) dry powder vaccine will be safe and drive an immune response when inhaled by people,” it said while raising concerns about potential “undesired inflammation.”

Regarding the dry powder vaccine’s effectiveness against emerging COVID-19 variants, the article noted that the study demonstrated the feasibility of including the spike antigens of multiple COVID-19 variant viruses into the vaccine. However, the vaccine’s protective efficacy “was not assessed,” it stated.

In addition, “frequently updating the spike antigen in vaccines might not be a viable solution to the emergence of new strains because SARS-CoV-2 evolves rapidly and thereby evades targeting by antibodies.”

The article has stoked controversy due to a statement that “intramuscularly injected vaccines cannot induce immunity in the mucosal tissues of the airways, which is the site of SARS-CoV-2 entry.”

“There's a scandal of epic proportions brewing here. A new study in Nature now asserts that mRNA ‘vaccines’ were, by their very nature, never able to stop the spread. Impossible in theory and practice. Yet that was the excuse used to force everyone to get injected with this stuff,” legal author Hans Mahncke said in a Dec. 14 X post.

“I reported this years ago. The mechanism by which the spike proteins work does not innoculate the epithelial lining from infection. Thus, it can still be spread by sneezing and coughing. Nature is a little late to the party,” podcast host Kyle Becker said in a Dec. 15 post on X.

“Intramuscular vaccines cannot induce mucosal immunity in airways (the site of SARS2 entry). This is why they did not stop the spread of Covid. Nor do much to prevent Longcovid. So let’s put that fable to rest & focus on blocking infection already,” author Dana Parish said in an X post.


Australian Scholar Picks Apart Study Justifying Risk-Benefit of mRNA COVID Vax--Points to Mistakes & Errors

Recently, a University of Sydney professor issued a refutation to an American Journal of Epidemiology (AJE) article declaring the COVID-19 vaccines being worth the risk in the omicron era. Why is this topic relevant? Because as the science unfolds it becomes clearer that the risks associated with the Omicron version of SARS-CoV-2 become less severe (although still quite transmissible) while more safety information becomes available about the COVID-19 vaccines. Not to mention the significant benefits of preexisting and hybrid immunity against Omicron. Will someone lose their job over this one as the author Down Under implies?

Recently Raphael Lataster, Ph.D. wrote “Revisiting a Risk Benefit Analysis of mRNA COVID-19 Vaccines during the Omicron Era” declaring in his blog as well that “Someone may well lose their job over this one.”

The Challenged Piece

Published by Oxford University Press, the AJE is one of the top epidemiology-focused journals. A Johns Hopkins study (Kitano et al.) pointed out that COVID-19 vaccines are still worth the risk in the Omicron era, across all groups. Source.

Ironically, or perhaps not so, Professor Lataster reports that much of the study’s funding came from industry—grants from Merck and Johnson & Johnson. Of course, this doesn’t mean bias on its face but it most certainly should be noted.

Professor Lataster, a supporter of TrialSite, pointed to our attention that the AJE published a follow-up article by Lataster, who informs the world he has zero funding industry. In his rebuttal the Australian academic points to numerous issues and errors with the study.

What’s wrong with Kitano et al.?

As Lataster delineates in this study and corresponding blog:

The study employs peculiar timeframes, such as “Less than 5 months (days 14–149) after the primary 2 doses versus no doses.” No explanation is given. Recall a recent series of journal articles on counting window issues, likely leading to exaggerated efficacy and safety estimates in clinical trials and observational studies, that I was involved with.

"I note that there can be no valid reason why adverse effects caused by the vaccine, in the several months between the 1st injection and 14 days after the 2nd injection, should be ignored”, pointing to an anaphylaxis death occurring very soon after vaccination.

“The authors themselves made reference in their article to a Japanese study, Suzuki et al., which concerns deaths “within seven days after COVID-19 vaccination”, including myocarditis deaths, and found that several of these deaths did “show a causal relationship to vaccination”. Not only are the authors inexplicably omitting relevant data from their analysis, but they knowingly do also so.”

It’s not just when the counting windows begin that is the problem, but their length as well. “The authors only consider vaccine effectiveness and safety up to around 5 months after the last injection. This is problematic with regards to effectiveness as the vaccine is known to rapidly decline in effectiveness around that time and can even become negatively effective. This is also problematic with regards to safety as the vaccine’s long-term safety profile is still, by definition, unknown. We do know that the vaccines can cause myocarditis, however, a potentially long-term and deadly issue. While the authors effectively assume no myocarditis deaths due to a lack of data, there are recent studies that do provide some data on myocarditis deaths caused by the mRNA vaccines, meriting a reanalysis.”

Even with the data as limited and selected as it is, “the stated net benefits of the vaccines are minute”, as “the smallest gain was found to be 18.7 QALY “per 100,000 vaccinees in the 4–5 months after vaccination” (5–11-year-old males with no comorbidities, third dose vs. no third dose, Pfizer vaccine), or less than 2 hours per person”. “And even these are subject to the uncertainties and estimations admitted to by Kitano et al, to say nothing of the aforementioned criticisms, all of which may well reduce these QALY gains to effectively zero, or even negative figures.” Read that again. By having very limited data, and by being very selective with that data (just ignoring highly relevant data, because why not…), their stated net benefits are almost nothing. The actual net benefit could be zero, or even less than zero. Worth potentially risking your life for?

Lataster comments, “While attempting to argue that COVID-19 vaccination is still worthwhile, the authors inadvertently demonstrate that in the omicron era, COVID-19 is now extremely benign and that the potential benefits to the vaccines are minimal at best, at least in the young and healthy.”

TrialSite emphasizes the importance of critical review of journal material during the COVID-19 period, and frankly all the time. Industry bias, ever so subtle, is real and must be identified, called out, and countered.

While it's up to the reader to determine the merits of (Kitano et al.) and the Lataster refutation, it’s unfortunate that more media channels don’t encourage this kind of unbiased, objective presentation for critical review.