The Totally Civil Covid Thread. (Closing 31/05)

Healthcare Worker Study Cohort Study: mRNA Boosters Not Adequately Controlling Omicron COVID-19 Surges

Healthcare Worker Study Cohort Study: mRNA Boosters Not Adequately Controlling Omicron COVID-19 Surges

Swedish researchers affiliated with the preeminent academic medical center Karolinska Institutet studied breakthrough infections in triple vaccinated…

www.trialsitenews.com

Swedish researchers affiliated with the preeminent academic medical center Karolinska Institutet studied breakthrough infections in triple vaccinated healthcare workers (HCW) both with and without non-Omicron COVID-19 infection during a four-week stretch between January to February 2022. This was a time when Omicron first presented in Sweden, specifically, a time when BA.1, BA.1.1. and BA.2 predominated in Stockholm, Sweden’s capital and largest city. The study supported a comparison of breakthrough infections across the three Omicron sublineages. Analyzing serum antibody levels, protection against infection, and viral RNA trajectories, the study outputs evidence of a high cumulative incidence in breakthrough infections across the Omicron sublineages. What was indicative of infectivity? Viral RNA trajectories measured at week five after the initial COVID-19 vaccine booster dose. The study authors point out that greater post-booster serum antibody titers indicated a protective role against infection, thus reducing the effect of viral load, independent of mucosal spike-specific IgA titers. Based on the results of this real-world study, the authors question the association of detection of vaccine-induced serum antibody levels and Omicron risk protection. The study herein demonstrates a high viral load in triple-vaccinated healthcare workers, indicating substantial rates of breakthrough infections with the current mRNA COVID-19 vaccines associated with Pfizer-BioNTech and Moderna. The study authors report that based on this observational data, albeit with limitations, booster doses are not controlling the surge in cases.

Overview

With the surge of infection caused by Omicron (B.1.1.529) even in populations with high vaccine uptake, the implementation of mRNA booster doses (third shot) appears to have reduced more severe COVID-19, yet was far less effective at stopping viral transmission during this period. The study team sought to better quantify the dynamic—after all, vaccine-induced serological responses correlate well to risk of infection with the ancestral virus and pre-Omicron variants of concern---so they applied to the Omicron infection.

The Swedish team organized this study because little data has been collected as to the characteristics from serum antibody titer correlation to protection, viral abundance and clearance of Omicron infection in vaccinated persons.

Drilling into the data associated with 368 triple vaccinated healthcare workers, the study team presented 4-week twice-weekly SARS-CoV-2 qPCR screening output meaning spike-specific IgG levels, neutralization titers and mucosal spike-specific IgA levels from study start and samples at two weeks.

The authors report 81 (cumulative incidence 22%) BA.1, BA.1.1, and BA.2 infections were detected. Evident protection against infection were high serum antibody titers (p < 0.0) which linked to reduced viral load (p < 0.01) as well as time to clearance (p < 0.05).

While pre-Omicron COVID-19 infection was independently associated to increase protection against Omicron, the Swedish study authors report this was “largely mediated by mucosal spike specific IgA responses (nested models lr test p = 0.02 and 0.008).

With only 10% of infected study subjects remaining asymptomatic through the course of their infection, the study team report that “high levels of vaccine-induced spike-specific WT antibodies are linked to increased protection against infection and to reduced viral load if infected, and suggest that the additional protection offered by pre-omicron SARS-CoV-2 infection largely is mediated by mucosal spike-specific IgA.”

With acknowledged limitations and a sharing of the data, the study team identified possible immune correlates of protection from infection while attempting to shine a light on the kinetics of COVID-19 Omicron shedding in the vaccinated, critical data necessary to better understand just how to “guide infection control measures and vaccination policy.”

The net result of this study isn’t great from the standpoint of the mRNA vaccines serving as neutralizing vaccine products. On the contrary, the data from this study involving Swedish healthcare workers evidence a “high incidence of Omicron infection in a recently triple vaccinated healthcare worker cohort.”

Known of course as “breakthrough infections,” they are associated with high viral load, which the study authors suggest is “likely” contributing to the global surges in SARS-CoV-2 infections. The results aren’t promising given the “very high cumulative incidence” of infections despite the recent booster push in Sweden.

One possible takeaway: The study authors question the very relation associated with detection of vaccine induced serum antibody levels and Omicron risk prediction. How might this study result impact the COVID-19 vaccination policy in the United States and elsewhere?

Two Ph.D. students helped lead this study with the oversight of seasoned physician-scientists from both Karolinska Institutet, Uppsala University and Linköping University.

The trial site location

The healthcare workers were associated with Danderyd Hospital, one of Sweden’s largest emergency hospitals offering university affiliated healthcare distributed across twelve operational areas. Annually, the hospital receives approximately 90,000 emergency patients, 429,000 outpatient visits and 50,000 inpatient visits, and performs 6,300 deliveries. In collaboration with the Karolinska Institutet (KIDS), education and research are conducted around the most common public diseases. Annually, roughly 2,000 students from 100 different institutions of higher learning are welcomed in about 30 different educational programs. The hospital was founded in 1922, as Stockholm County's central hospital in Mörby and was renamed in 1964 to Danderyd Hospital. Danderyd’s Sjukhus AB is a wholly owned company within Region Stockholm and has around 4,500 employees.

Lead Research/Investigator

Ulrika Marking, Ph.D. student Karolinska Institutet Danderyd Hospital

Sebastian Havervall, Ph.D. student, Karolinska Institutet Danderyd Hospital

Charlotte Thålin, Karolinska Institutet Danderyd Hospital

Mikael Åberg, Uppsala University, Department of Medical Sciences, Clinical Chemistry & SciLifeLab

Jonas Klingström, Karolinska Institutet, Center for Infectious Medicine, Department of Medicine Huddinge; Linköping University, Division of Molecular Medicine and Virology, Department of Biomedical and Clinical Sciences

Correlates of protection and viral load trajectories in omicron breakthrough infections in triple vaccinated healthcare workers - Nature Communications

Correlation between vaccine induced serological response and protection against SARS-CoV-2 omicron infection is not well understood. Authors investigate…

www.nature.com

Norway-based Study—COVID-19 Vaccines Associated with All-Cause Mortality in 2022!

Norway-based Study—COVID-19 Vaccines Associated with All-Cause Mortality in 2022!

Two professors from Western Norway University of Applied Science, Olav Andreas Kvitastein and Jarle Aarstad, recently uploaded a paper in a preprint server…

www.trialsitenews.com

Two professors from Western Norway University of Applied Science, Olav Andreas Kvitastein and Jarle Aarstad, recently uploaded a paper in a preprint server titled “Is there a Link between the 2021 COVID-19 Vaccination Uptake in Europe and 2022 Excess All-Cause Mortality?” While the piece still needs peer review, it undoubtedly will cause a stir. Why? Well, for starters, the growing reports of excess mortality continue to spook populations across the developed world. An excess rate that corresponds with the largest mass vaccination program in history. Now, a study that still needs peer review intensifies concerns.

So, what did the two Norway-based academics find?

Analyzing weighted data of 31 European countries by population size, their analysis reveals that all-cause mortality during the first nine months of 2022 grew markedly with 2021 vaccination uptake.

For example, Norwegian scholars point out that “a one percentage point increase in the 2021 vaccination uptake was associated with a monthly mortality increase in 2022 by 0.105 percent (95% CI, 0.075-0.134).”

How about controlling for alternative explanations? Unfortunately, according to the Norwegian professors, “The association remained robust,” thus leading to a discussion as to causality as well as “potential ecological fallacy.”

The authors point out that the data indicates that in 2021 “all-cause mortality was lower the higher the vaccination uptake,” however, this association, argues the researchers, “became non-significant when controlling for alternative explanations.”

TrialSite suggests this is not a matter that can be swept under the proverbial carpet—it must be rigorously investigated. Of course, this output should not be used as evidence as it needs to go through vetting, but the findings, given the alarming data points across many nations, raise a serious need for more investigation.

About the academic center

Western Norway University of Applied Science is a Norwegian public institution of higher education, established in January 2017, through the merging of formerly independent colleges across five campuses: Bergen, Førde, Haugesund, Sogndal and Stord.

Is there a Link between the 2021 COVID-19 Vaccination Uptake in Europe and 2022 Excess All-Cause Mortality?

We primarily study a possible link between 2021 COVID-19 vaccination uptake in Europe and monthly 2022 excess all-cause mortality, i.e., mortality higher than…

www.preprints.org

Right Wing Dutch Shine Light on German COVID-Vax Safety Report: German Health Minister Knew COVID-19 Vax Dangers

Right Wing Dutch Shine Light on German COVID-Vax Safety Report: German Health Minister Knew COVID-19 Vax Dangers

More mainstream media in Europe reports the German Health Minister&rsquo;s &ldquo;coming out&rdquo; to discuss his concerns about the COVID-19 vaccines. As…

www.trialsitenews.com

More mainstream media in Europe reports the German Health Minister’s “coming out” to discuss his concerns about the COVID-19 vaccines. As already reported by TrialSite, the German official Karl Lauterbach reports that 1 in 500 persons that receive a COVID-19 vaccine experiences a significant side effect. But matters worse when looking at 1 in every 3,500 vaccinated persons suffer from a fatal or life-threatening side effect, the German minister declared on television earlier this month.

Admitting that he has been aware of these risks, the Dutch press highlighted that far-right politicians such as Thierry Henri Philippe Baudet who have been warning the European population about the risks associated with the COVID-19 vaccines since near the start of the mass vaccination campaign.

Much like in America, Dutch media FDL reports that anyone that raised a question about the COVID-19 vaccines was immediately classified as right-wing conspiracy nuts, loons and other assorted name-calling.

However, the right-wing populist party “Forum for Democracy," (FVD) considered “Eurosceptic” which is often brand associated with racism and xenophobia, claims they have been open and leery about the COVID-19 vaccines since the start.

The Dutch right-wingers are now capitalizing on the German minister’s admission based on a report from the esteemed Paul Ehrlich Institute which recently conducted research into COVID-19 vaccine side effects. The large-scale study revealed according to right-wing press that no less than 1 in 500 vaccinated people experienced significant side effects and complaints associated with the investigational mRNA vaccines.

But what were these complaints and do they supersede the benefits as measured by saved lives, especially for the elderly cohorts? For the side effects the populist Dutch political party reports fever, severe pain but also permanent complaints such as ringing ears, facial paralysis and substantial uterine bleeding and menstrual disorders all manifested as common side effects.

The more life-threatening events (1 in 3,500 which if true is a significant safety signal) suggest 1 in 3,500 persons suffer from life-threatening or even fatal side effects from myocarditis and pericarditis to heart and cerebral infarctions and fertility issues.

German embarrassment?

The right-wing Dutch are pointing at the Germans, declaring that they are embarrassed by the recent study result. After all, Minister Lauterbach was pro-mass vaccination program from the start. The Dutch press reports Lauterbach was responsible for the vaccination of 65 million Germans with what they refer to as “experimental mRNA vaccines.” Yet now he acknowledged he [Lauterbach] was always aware of the risks!

Playing down the results of the recent study by the populist Dutch media, they claim that Lauterbach refers to the most favorable number in what they cite as a “damning report” that “only” 1 in 10,000 people would suffer from “serious side effects.” Yet that is only the data associated with the recent Omicron booster reports, FVD.

The political party explains:

"If we look at all vaccinations together, the picture that was already mentioned above is 1 in 500 vaccinated people experience significant side effects.”

The right-wing parties are not acknowledging any good that the COVID-19 vaccines have done. What’s unfolding is an incredibly polarizing situation where either one stands with the COVID-19 vaccines or against them. TrialSite suggests the actual truth is far more complex, that these vaccines have both helped save lives and that they were rushed, and that the full safety profile wasn’t known—hence the mounting injuries. The former doesn’t excuse the latter, but news media and political parties unfortunately are now taking sides and not looking at the actual situation from an objective lens. On the one side is big money media, backed by Pharma advertising and government propaganda, on the other side rag tag right-leaning crews that at times take the narrative to the extremity of reason.

Some more radical or fringe groups are even declaring because the U.S. Department of Defense was intimately involved with the American COVID-19 emergency countermeasure response that this means automatically based on a review of contractual artifacts that the “countermeasures” were designed from the ground up to hurt, or even kill people. This media declares this a ludicrous proposition, a way of thinking that likely results from either extreme emotional-driven response (people have a reason to be angry) or worse, we have been informed (but we cannot verify) provocateurs possibly associated with Russia or China.

A recent report

One of the most recent COVID-19 vaccine safety reports from the Paul Ehrlich Institute can be viewed here.

The elite German agency reports they found 444 suspected cases of side effects or vaccination complications in temporal connection with the booster doses recently approved including Pfizer-BioNTech (Comirnaty) original and Omicron mRNA; BA.1, Comirnaty Original/Omicron BA.4-5 or Moderna’s Spikevax bivalent/Omicron BA.1 product.

During this period, they carried out 1,907,923 vaccinations with the above bivalent vaccines. The reporting rate for suspected cases of side effects or vaccination complications after the bivalent vaccinations was 0.23 per 1,000 vaccinations and for suspected serious side effects 0.03 per 1,000 vaccinations.

A total of 333,492 suspected cases of side effects and 50,833 suspected cases of serious side effects were reported to the German health agency after primary immunization plus booster vaccinations. The reported rate for all individual reports was 1.78 per 1,000 doses of vaccines, and for serious individual reports 0.27 per 1,000 doses of vaccine.

Importantly, Paul Ehrlich Institute reports that no new safety signals were detected after the administration of the new bivalent mRNA vaccines.

Duitse minister erkent ernstige risico’s coronavaccins

De Duitse minister van Volksgezondheid geeft toe dat hij vanaf het begin op de hoogte was van de ernstige risico’s van de mRNA-vaccins.

fvd.nl

Quote from RobertBryant

My wife has to administer Remdesivir infusion today to an Omicron patient

Cost to the taxpayer...~2000 $

Sorry to hear that your wave now is mafia slave and has to intentionally destroy the live of a patient. May be she should change the hospital...

Remdesivir just is poison as the vaxx too. Even simple calciferol is better and of course high dose (8x) Ivermectin

Real World Israeli Study Suggests Moderna CEO Lied to Senate

Real World Israeli Study Suggests Moderna CEO Lied to Senate

Although during his recent Senate testimony, Moderna Chief Executive Officer St&eacute;phane Bancel declared under oath that young adults face more risk for…

www.trialsitenews.com

Although during his recent Senate testimony, Moderna Chief Executive Officer Stéphane Bancel declared under oath that young adults face more risk for incidence of myocarditis and pericarditis from SARS-CoV-2 infection than from the mRNA COVID-19 vaccines, studies in the real world show the opposite. For example, last year, prominent Israeli medical researchers affiliated with University of Jerusalem and Tel Aviv University studied the incidence of post-acute COVID-19 myocarditis and pericarditis using data from one of Israel’s largest managed healthcare organizations known as Clalit Health Services. The retrospective cohort study of 196,992 adults tracked the patients from March 2020 through January 2021, early on during the pandemic. The investigators were aware that these cardiovascular-related conditions could be the result of potential COVID-19 infection arising from adaptive immune responses. The results of these study point to a reality that COVID-19 infection in Israel didn’t lead to a greater incidence of myocarditis and pericarditis like the Moderna CEO declared.

The study

Tracking inpatient myocarditis and pericarditis diagnoses by the tenth day after the patients’ PCR test showed positive infection, they did censor followed ups on February 28, 2021, for a minimum observation of 18 days. The study protocol included a control cohort involving 590,976 adults with at least one negative PCR and no positive PCR matched with age and sex.

While the mass COVID-19 vaccination program commenced in Israel on December 20, 2020, the study team match the control cohort from December 15, 2020.

What did they find?

Out of the COVID-19 patient cohort, 9 of the study participants developed myocarditis (0.0046%), while 11 patients were diagnosed with pericarditis (0.0056%). What about the control cohort? 27 of the study participants has myocarditis (0.0046%), and 52 were diagnosed with pericarditis (0.0088%). The Israeli study authors, represented by corresponding author Jacob George, Hebrew University of Jerusalem, Heart Center, Kaplan Medical Center in Rehovot, and colleagues report age (adjusted hazard ratio [aHR] 0.96, 95% confidence interval [CI]; 0.93 to 1.00) and male sex (aHR 4.42; 95% CI, 1.64 to 11.96) were associated with myocarditis. Additionally, when looking at male sex (aHR 1.93; 95% CI 1.09 to 3.41) as well as peripheral vascular disease (aHR 4.20; 95% CI 1.50 to 11.72) associated with pericarditis.

The authors declared, “Post-COVID-19 infection was not associated with either myocarditis (aHR 1.08; 95% CI 0.45 to 2.56) or pericarditis (aHR 0.53; 95% CI 0.25 to 1.13). We did not observe an increased incidence of either pericarditis or myocarditis in adult patients recovering from COVID-19 infection.”

Lead Research/Investigator

Ortal Tuvali Hebrew University of Jerusalem, Heart Center, Kaplan Medical Center

Sagi Tshori Hebrew University of Jerusalem, Research Authority

Estela Derazne Tel Aviv University, Sackler Faculty of Medicine

Rebecca Regina Hannuna Hebrew University of Jerusalem, Research Authority

Arnon Afek Tel Aviv University, Sackler Faculty of Medicine; The Chaim Sheba Medical Center, General Management

Dan Haberman Hebrew University of Jerusalem, Heart Center, Kaplan Medical Center

Gal Sella Hebrew University of Jerusalem, Heart Center, Kaplan Medical Center

Jacob George Hebrew University of Jerusalem, Heart Center, Kaplan Medical Center

Call to Action: Congress should hold accountable executives from life science firms to the unfolding science, not to what is politically expedient. This study was published in the peer-reviewed Journal of Clinical Medicine.

The Incidence of Myocarditis and Pericarditis in Post COVID-19 Unvaccinated Patients-A Large Population-Based Study - PubMed

Myocarditis and pericarditis are potential post-acute cardiac sequelae of COVID-19 infection, arising from adaptive immune responses. We aimed to study the…

pubmed.ncbi.nlm.nih.gov

Quote from Wyttenbach

Sorry to hear that your wave now is mafia slave and has to intentionally destroy the live of a patient. May be she should change the hospital...

Remdesivir just is poison as the vaxx too. Even simple calciferol is better and of course high dose (8x) Ivermectin

Anti Virals across the board aren't very effective. The major problem is they interact with other medications. I suggest substituting peppermint and honey. Remdesivir is a dead end, no pun intended

Quote from Fm1

Remdesivir is a dead

the patient is recovering at home from 4 vaccinations,,,,Omicron and the Balm of Gilead..

another 100mg of Blessing today...courtesy of the US/Oz taxpayer,,

Hallelujah

Gilead donates Covid-19 drug remdesivir to Australia’s medical stockpile after US buys up supply

US bought more than 500,000 doses, representing all of Gilead’s production for July and 90% of August and September

www.theguardian.com

The TGA (Therapeutic Goods Administration) is 98% funded by BigPharma.

There is no conflict of interest with being a rubberstamp for BigPharma,

Senator Rennick is not well known in Australia

There are still some Americans with an independent mind:: https://www.thedesertreview.co…ed-a3ec-b73c57143d06.html

Court upholds the blocking of the Biden "kill" (vaxx to death) the employees mandate...

This has Collins and Fauci fingerprints all over it

The researchers catalog what they call the "U.S. health disadvantage" – the fact that living in America is worse for your health and makes you more likely to die younger than if you lived in another rich country like the U.K., Switzerland or Japan

Live free and die'? The sad state of U.S. life expectancy

https://www.npr.org/sections/health-shots/2023/03/25/1164819944/live-free-and-die-the-sad-state-of-u-s-life-expectancy

Just before Christmas, federal health officials confirmed life expectancy in America had dropped for a nearly unprecedented second year in a row – down to 76 years. While countries all over the world saw life expectancy rebound during the second year of the pandemic after the arrival of vaccines, the U.S. did not.

Then, last week, more bad news: Maternal mortality in the U.S. reached a high in 2021. Also, a paper in the Journal of the American Medical Association found rising mortality rates among U.S. children and adolescents.

Poland force majeure...2 milion refugees..

let Ursula pay Pfizer herself

Quote from Fm1

"U.S. health disadvantage"

Health and BigPharma profits have a negative correlation

Quote from Fm1

Just before Christmas, federal health officials confirmed life expectancy in America had dropped for a nearly unprecedented second year in a row – down to 76 years.

This is good news for the social security (less money for pensions needed..) and the rich that can afford good food and correct medical treatment.

If you give big pharma the license to kill and suck out the state this will end with a live expectancy around 40 years as it was about 200 years ago...

Death by vaxx (RNA immune therapy)

Death by Burger, Donuts, Marsh mellows, Coke, Fanta, Pizza,....

Death by Remdesivir, Statins, Molnupavir,

Death by preventing Covid treatment

Death by to many other vaccines > 30 needed in New York

Death by not allowing regular (yearly) parasite treatments with Praziqantel, Nitazoxanide, Albendazole, Mebendazole, Iveremctin.

Death from legal drugs like opioides

Death by neighbor guns

Death form air pollution

Quote from RobertBryant

There is no conflict of interest with being a rubberstamp for BigPhatma,

Another COVID study pointing to vitamin D as the key. And another study that omits telling you that!!!

SARS-COV-2 Virus Changes Human Genomic Structure—Any Risk with mRNA Vaccines to do the Same?

SARS-COV-2 Virus Changes Human Genomic Structure—Any Risk with mRNA Vaccines to do the Same?

Houston, Texas-based scientists at the University of Texas Health Science Center and MD Anderson Cancer Center&nbsp;report a disturbing finding that…

www.trialsitenews.com

Houston, Texas-based scientists at the University of Texas Health Science Center and MD Anderson Cancer Center report a disturbing finding that SARS-CoV-2, the virus behind COVID-19, can actually change the infected host’s genome structure which just might explain the immunity-related conditions not to mention the risks of long COVID report the study authors. The implications of this study cannot be underestimated. Unlike any other coronavirus, SARS-CoV-2’s unique mechanism can disrupt and change a human’s genome structure, possibly the cause behind so many different debilitating conditions associated with COVID-19. This topic remains highly relevant: almost 1 in 5 Americans infected with SARS-CoV-2 continue to suffer from one or another long COVID symptoms, up to several months after the initial infection. Can the recent findings in Houston help pave the way for research that can lead to longer-term relief? A more provocative question: would the COVID-19 mRNA vaccines also trigger a similar mechanism, potentially changing the human genome structure? Should this question be followed up with study?

Background

While some viruses are known to breach and transform chromatin, the structure where human genetic cells are stored, it wasn’t known if this process was associated with the SARS-CoV-2 pathogen, until now. With results recently published in the journal Nature Microbiology, senior author Wenbo Li and colleagues from University of Texas Health Science Center.

The Study

In this study, researchers used leading-edge methods and comprehensively characterized the chromatin architecture in human cells after a COVID-19 infection.

The Houston-based scientists characterized the 3D genome and epigenome of human cells after SARS-CoV-2 infection, finding widespread host chromatin restructuring that features widespread compartment A weakening, A–B mixing, reduced intra-TAD contacts and decreased H3K27ac euchromatin modification levels.

Interestingly, the researchers did not find such changes following common-cold-virus HCoV-OC43 infection. Noteworthy, the cohesion complex was markedly depleted from intra-TAD regions, indicating that SARS-CoV-2 disrupts cohesin loop extrusion. These altered 3D genome/epigenome structures correlated with transcriptional suppression of interferon response genes by the virus, while increased H3K4me3 was found in the promoters of pro-inflammatory genes highly induced during severe COVID-19.

The recent findings were reported in UTHealth Houston News by Jeannette Sanchez.

The Findings

SARS-CoV-2 acutely can rewire host chromatin which can lead to a myriad of adverse and diverse outcomes observed with COVID-19. The results suggest the importance of studying the long-term epigenomic impacts of this viral infection.

Principal Investigator Point of View

The study’s senior author, Wenbo Li, PhD, went on the record:

“This particular finding is quite unique and has not been seen in other coronaviruses before.” Li continued “What we found here is a unique mechanism of SARS-CoV-2 that is associated with its severe impacts on human health.”

Drilling into the findings Dr. Li continued:

“We found that many well-formed chromatin architectures of a normal cell become de-organized after infection. For example, there is one type of chromatin architecture termed A/B compartments that can be analogous to the yin and yang portions of our chromatin. After SARS-CoV-2 infection, we found that the yin and yang portions of the chromatin lose their normal shapes and start to mix together. Such mixing may be a reason for some key genes to change in infected cells, including a crucial inflammation gene interleukin-6 that can cause cytokine storm in severe COVID-19 patients.”

COVID-19 also alters the chemical modifications on chromatin. Study author Xiaoyi Yuan declared “The changes of chemical modifications of chromatin were known to exert long-term effects on gene expression and phenotypes. Therefore, our finding may provide an unrealized new perspective to understand the viral impacts on host chromatin that can be associated with long COVID .”

Next Research Steps

Senior author LI hopes that future research centers on better understanding how SARS-CoV-2 mechanisms uniquely alter human chromatin, thus triggering the various symptoms associated with the infectious disease. Li mentions that the next round of study will need to be in both cell and animal models plus the use of samples from COVID-19 patients. Why will finding the mechanism of action help? Perhaps there are therapeutic strategies to safeguard human chromatin?

UTHealth Houston

Established in 1972 by the University of Texas System Board of Regents, the University of Texas Health Science Center at Houston (UTHealth) is Houston’s Health University and Texas’ resource for health care, education, innovation, scientific discovery and excellence in patient care. Considered the nexus of academic health centers in the UT System as well as the entire U.S. Gulf Coast region, UTHealth houses the schools of biomedical informatics, biomedical sciences, dentistry, medicine, nursing and public health. UTHealth includes The University of Texas Harris County Psychiatric Center, as well as the following clinical practices: UT Physicians, UT Dentists and UT Health Services. The university's primary teaching hospitals are Memorial Hermann-Texas Medical Center, Children's Memorial Hermann Hospital and Harris Health Lyndon B. Johnson Hospital.

The Research team at UTHealth Houston

Lead Research/Investigator

Wenbo Li, PhD, Corresponding Author, Associate Professor, Department of Biochemistry and Molecular Biology, McGovern Medical School, UTHealth Houston

Xiaoyi Yuan, PhD; Ruoyu Wang, MS; Joo-Hyung Lee, PhD; Jieun Kim, PhD; Feng Xiong, PhD; Lana Al Hasani, BS; Yuqiang Shi, PhD; Erin N. Simpson, BS; Xiaoyu Zhu, PhD; Yi-Ting Chen, BS; Pooja Shivshankar, PhD; Joanna Krakowiak, PhD; and Yanyu Wang, PhD. David M. Gilbert, PhD, is with the San Diego Biomedical Research Institute

Study: SARS-CoV-2, the virus causing COVID-19, can alter genome structure of our cells

People infected with SARS-CoV-2, the virus that causes COVID-19, may experience genome structure changes that not only may explain our immunological ...

www.uth.edu

Nuclear receptor activation shapes spatial genome organization essential for gene expression control: lessons learned from the vitamin D receptor

Nuclear receptor activation shapes spatial genome organization essential for gene expression control: lessons learned from the vitamin D receptor

Spatial genome organization is tightly controlled by several regulatory mechanisms and is essential for gene expression control. Nuclear receptors are…

www.ncbi.nlm.nih.gov

Add ginseng and or Ginkgo biloba to your supplements to protect your p450 enzymes

Both are cyp2 inducers

How Bill Gates Hijacked a Failing Pharma System and Smashed It: A Tale of Incompetence, Deceit, Greed, and an Unmitigated Thirst for Power

How Bill Gates Hijacked a Failing Pharma System and Smashed It: A Tale of Incompetence, Deceit, Greed, and an Unmitigated Thirst for Power

Oh, what a tangled web we weave,When first we practice to deceive! &mdash; Marmion (1808) by Sir Walter Scott

www.trialsitenews.com

Oh, what a tangled web we weave,

When first we practice to deceive!

— Marmion (1808) by Sir Walter Scott

It began with strategic incompetence. Prior to the early 1980s, there was no such thing as Big Pharma. Pharmaceutical companies were all big in those days because that’s what it took to develop a safe, effective, fit-for-purpose medicinal product. In the same way, there is no Big Aerospace, Big Automotive, or Big Electronics sector in those industries; small fry can't make it. A company supplying highly complex products to consumer markets must be big to get done all the research and design, manufacturing, and product distribution work.

So, where did the boutique pharmaceutical trend that gave rise to Big Pharma come from?

In the early 1980s, pharmaceutical companies that had hitherto been highly vertically integrated began casting off their physical assets, including:

Manufacturing facilities, making the people working in them redundant

Distribution warehouses, making the people working in them redundant

Quality control laboratories, making the people working in them redundant

Clinical trials units, making the people working in them redundant

Products that patients were dependent on (out-of-patent products that weren't making them cash any more)

Today, what are referred to as Big Pharma companies merely patent molecular compounds, hand them over to third-party contractors, and market the life out of the paltry few that are approved for sale. Those same Big Pharma companies have also outsourced drug development, to small companies that are no bigger than your local supermarket in terms of employee numbers—all in the name of reducing the risk of failure.

The small companies developing medicinal products (known as drugs in the US) will have never brought any kind of drug to market. How’s that for broken?

I explained the background to this strategic incompetence in one of my books, What Patients Need to Know About: Pharmaceutical Supply Chains. For this article, all you need to know is the outcome—pharmaceutical companies selling medicinal products are now dried-up prunes, compared to the fulsome plums they used to be.

Enter Lady Deceit

The number of new medicinal products coming to market every year has been in constant decline for many years. Jack Scannell et al. shone light on this in the paper Diagnosing the decline in pharmaceutical R&D efficiency, dubbing the trend Eroom's Law (Moore’s Law spelt backwards). They stated:

The past 60 years have seen huge advances in many of the scientific, technological, and managerial factors that should tend to raise the efficiency of commercial drug research and development (RD). Yet the number of new drugs approved per billion US dollars spent on RD has halved roughly every 9 years since 1950, falling around 80-fold in inflation-adjusted terms.

Even more tellingly, the US Government Accountability Office produced a report, dated November 2006, that confirmed this sorry state of affairs. Out of every 250 development candidates entering the development pipeline, just one gets approved for sale. Failure percentages for products in the industry were recorded as being in the high nineties. The report analysis also revealed the timelines in drug development:

Preclinical studies = 3 years | Clinical studies = 7 years | Regulatory evaluation = 1½ years

Total time to develop and gain approval = 11½ years (not the nine months of the Covid era!)

These shocking statistics have been hidden in the shadows, as patent protection allows pharmaceutical companies to charge eye-watering prices, enabled by massive sales and marketing budgets, keeping the customers rolling in.

The ugly truth is that this is an industry in deep trouble, trying desperately to keep its investors supplied with blockbuster returns while staying tight-lipped on the worrying secrets within. I can confidently say that today, I’m revealing the truth.

Why so confident?

The reason I can say this so confidently is that I authored a book on the pharmaceutical industry, entitled Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics, which was published by specialist firm Wiley in 2011. It describes the above issues in detail.

The preface read:

I was staying at a budget hotel on the outskirts of London when I checked my Blackberry for email. It was probably around 3.00 a.m., so my sight was less than perfect. Squinting allowed me to make out the opening: “My name is Jonathan Rose, the Wiley editor for pharmaceutical science books.” Jonathan went on to say: “With interest, I note that you are leading the coming workshop ‘Supply Chain Management in Pharma/Biotech.’ Given the importance of managing supply chain procedures and costs during drug production and manufacture, I believe that a book explaining the concepts, methods, and applications of supply chain management to the pharmaceutical industry would make a timely and well-received text. Such a book would be an important reference and resource for professionals involved in drug development and manufacturing, quality assurance and control, chemical and biological engineering, and regulatory personnel.”

That is what I hope to have achieved with this book. I have attempted, of course, to contribute the maximum possible from my own personal databanks; along with this is supplementary commentary from what I can best describe as “expert witnesses.” The contributors have been hand-picked by me to reinforce, support, and move forward the sentiments in the book. Their powerful contributions are of varying length and depth.

I hope that you enjoy what we present here. The style is meant to entertain as well as to inform; and by informing, the hope is that the overall theme of the book strikes home—the pharmaceutical industry must change in radical ways if supply chains of the future are to meet stakeholder expectations.

I’ve included this short extract above to lend credibility to my comments and analysis here, so please excuse if it sounds immodest. It is, however, essential that as you read this article, you believe me, rather than lending unearned credence to the various actors involved.

Now for the greed and thirst for power

There was a tremendous amount of molecular patenting going on in the industry prior to 2009, delivering massive returns for investors of a more avaricious persuasion. There was no questioning of the goose’s ability to continue delivering its golden eggs. Numerous more cautious investors steered well clear of the peaks and troughs of this industry.

From 2009 onwards, the story takes on a far more complex form, as greed and thirst for power meld into each other, with governments beginning to play a leading role—none more so than the UK Government, under the sales pitch of a strategy for life sciences.

The first step was the creation of a British Office for Life Sciences. Wikipedia states:

The Office for Life Sciences was created in 2009 following an announcement by UK Prime Minister Gordon Brown on the establishment of a new cross-government unit to drive forward innovation within the healthcare system, and to support national policy making on the UK's attractiveness as a market for medicines and medical devices and technologies. The OLS was supported through its inception by Lord Drayson as Minister of State for Science and Innovation.

The OLS' first policy paper was entitled UK Life Sciences Strategy and was posted on the government website on 5 December 2011. The summary of key actions reads as follows:

We will take action to make the UK a world-leading place for life sciences investment:

Early in 2012 the MHRA will bring forward for consultation proposals for a new ‘Early Access Scheme’ to increase the speed and efficiency of routes to market approval for innovative, breakthrough therapies.

Through the MHRA, we will work with industry and other international regulators to develop actions which will create a more enabling regulatory environment for the adoption of innovative manufacturing technology. We will do this by the second quarter of 2012.

We will invest £310m to support the discovery, development and commercialisation of research. This covers £130m for Stratified Medicine and £180m for a Biomedical Catalyst Fund.

Through the NIHR, we will re-launch an enhanced web-based UK Clinical Trials Gateway in March 2012. This site will provide patients and the public with authoritative and accessible information about clinical trials in the UK.

We will support patients to have access to novel treatments, and be part of the development of wider patient benefits by consulting on an amendment to the NHS Constitution so that, whilst protecting the right of an individual to opt out, there is a default assumption that:

data collected as part of NHS care can be used for approved research, with appropriate protection for patient confidentiality; and

patients are content to be approached about research studies for which they may be eligible, to enable them to decide whether they want a discussion about consenting to be involved.

The Cambridge, Oxford and London BRCs will work with the BRU in Leicester, to develop a national NIHR Bioresource. This will make the UK the ‘go-to’ place for experimental medicine.

As announced in the Autumn Statement 2011, we will introduce the EU VAT cost-sharing exemption in the Finance Bill 2012.

We will hold a series of investment and policy events to promote the UK’s world-leading position in healthcare and life sciences in advance of the London 2012 Olympics.

We will introduce, via Cogent, Higher-Level Apprenticeships (HLAs) covering post-A-level education. Our ambition is to deliver 420 Apprenticeships over the next five years.

We will appoint two independent Life Sciences Champions: The first of these champions will act as chair of an independent Life Sciences Advisory Board. The second will act as a collaboration champion to foster partnership across the UK clusters and within government.

Note one of the comments that I have emphasised above: “This will make the UK the ‘go-to’ place for experimental medicine.”

An update is published soon afterwards

Hot on the heels of the initial strategy paper, an update was issued: the Life Sciences Strategy Update of August 2012.

It contained a letter from David Willetts, the then Science Minister, to stakeholders about progress in implementing the ‘Strategy for UK Life Sciences’.

Some key extracts from the letter:

The establishment of the Cell Therapy Catapult (previously known as the Technology Innovation Centre) is close to completion. To be based at Guy's and St Thomas' NHS Foundation Trust, London, and operational by this autumn, this centre aims to grow a UK-based cell therapy industry with access to finance, clinical and technical expertise to allow rapid exploitation of cell therapies.

Through the Medicines and Healthcare products Regulatory Agency (MHRA), progress has also been made in reducing the burden of regulation on research-active businesses, universities, and NHS trusts, ensuring that patients have access to promising, cost-effective new treatments.

We will continue to drive delivery, focusing on areas which you tell us are important and where we think we can do more. Our two Government-appointed life sciences Champions, Chris Brinsmead and Sir John Bell, are busy helping us do so.

These comments signalled a shift towards cell and gene therapies, regulatory ‘flexibility’, and advances in genetics.

Another strategy update after a mere twelve months

The Strategy for UK Life Sciences: One Year On morphed the Government's original British life sciences vision of just a couple of years previously into three rather different key principles:

Building a life sciences ecosystem

We committed to build on our existing strengths and partnerships between universities, the wider research base, businesses, and the NHS to establish a cohesive system of integration.

Attracting, developing, and rewarding the best talent

We acknowledged the need to nurture highly skilled researchers, clinicians, and technicians, assisting them to work collaboratively across traditional boundaries to create value throughout the ecosystem.

Overcoming barriers and creating incentives for the promotion of health care innovation

We agreed to create the right environment to translate discovery into real benefits for patients and nurture innovation through the translational funding gap, whilst at the same time reducing regulatory bureaucracy to provide a route for early adoption and diffusion in the NHS.

Prime Minister David Cameron’s foreword included this passage:

Genetic science has the potential to transform healthcare systems around the world and support the emergence of British companies creating new jobs and revenues for the UK. My ambition is nothing less than for the UK to become the world leader in this emerging industrial sector, and this strategy document sets out the direction for how we will meet this global ambition. In the coming years, we will start to harness the power of genomic data in the UK to improve patient care, develop innovative new drugs and bioinformatics technologies, and create world-class genomic platforms for innovation that will drive global investment to the UK.

The world of life sciences is in a period of relentless disruption. Advances in technology are enabling new approaches to drug discovery, accelerating clinical development, and restructuring pharma supply chains. Innovative treatments such as mRNA vaccines and cell therapies are reshaping healthcare as we know it. But the thirst for investment in life sciences is endless and pharma is not immune to the impact of global economic turbulence.

By now, there were two official British ‘champions’ of life sciences strategy: Professor Sir John Bell and Chris Brinsmead.

My entry into implementation of the Office for Life Sciences strategy

In early 2013, I was contacted by the Technical Director of the UK's HealthTech and Medicines Knowledge Transfer Network (as it was then), now branded as Health KTN. He explained that no British life sciences company had been successful in bid submissions to the first two rounds of the UK's Advanced Manufacturing Supply Chain Initiative (AMSCI). He went on to say that the Office for Life Sciences was not happy with this. The feedback the OLS had received was that the bids were heavy on science but showed little understanding of the manufacturing supply chain. That was not a surprise to me!

Given my background, he asked whether I would be open to a four-day consultancy project to find a UK-based life sciences company that could fit the bill as a candidate to submit a bid for Round 3. The brief was to attend the launch meeting for Round 3 and 4, then to use my extensive network in biopharmaceutical supply chain strategy and management to identify a target company and sign them up.

I’ve never been one to turn down a challenge.

The launch meeting was held at the QEII Centre, the largest dedicated conference and exhibition space in central London.

The government description of this £120 million funding competition for manufacturing supply chain companies stated:

AMSCI is a funding competition designed to improve the global competitiveness of UK advanced manufacturing supply chains. £120 million is available for rounds 3 and 4, and the competition is open to all organisations that are part of a manufacturing supply chain. This funding is available to support research and development, skills training and capital investment. It will help UK supply chains achieve world-class standards and encourage major new suppliers to locate in the UK.

Michael Fallon said:

I cannot stress enough the importance of developing strong supply chains if we want major manufacturers to invest in this country. In the new rounds of AMSCI we will welcome applications from foreign investors who wish to establish or strengthen their manufacturing presence in the UK.

On the day at the QEII Centre, we sat at tables of eight people around the room. Michael Fallon, one of a breed of politicians we no longer see (my opinion only), gave an excellent opening address. As the day progressed, people around the table began to chat, as they do. At our table, a gentleman representing a low-carbon vehicle developer began to talk about the biotech industry.

Curious as ever, I asked him how he knew about this line of work.

“I’m the Chairman of Oxford Biomedica,” he revealed.

Well, you could have knocked me down with a feather duster.

More surprises were in store: the day ended with me being invited to visit the site to meet Oxford Biomedica’s Director of Manufacturing.

Next, it was a day at Oxford Biomedica’s facility in Cowley. It wasn’t difficult to find the site on the outskirts of Oxford. I had previously worked as a senior director at the site for two previous owners of the facility, British Biotech and OSI Pharmaceuticals. It overlooked the BMW manufacturing plant in Cowley, where we could watch the Minis rolling out, in various colours and shades, by the hundreds and thousands (not in work time, of course).

Oxford Biomedica (OXB) had purchased a biologics manufacturing facility on the site, known as Harrow House. OXB was then, and still is, a Contract Development and Manufacturing Organisation (CDMO), meaning that it provides scale-up solutions and commercial supply of viral vectors to pharmaceutical and biotech companies in the fast-growing field of cell and gene therapy.

The day went well, as the Manufacturing Director was not apprehensive of new ways of working. The next non-surprise was that the Head of Supply Chain had been a master production scheduler in my team at Bayer. I left with a commitment from OXB to draft a consultancy agreement for signature. Within a week, I was signed up.

As I always do, I began the assignment with a current state assessment. This involves mapping the inbound supply chain, the internal manufacturing flows, and the outbound journey to the next stage. The various items to be procured are identified, their suppliers listed, and data such as lead times and shipping conditions (mainly cold chain) are collected and documented.

Inside the plant, data on the stages in the process flow, batch sizes, production cycle times, waiting times, and a significant amount of other data were captured, and likewise for outbound flows. Now we had detailed the current state supply chain, it was time to work out the future state, or what was ‘to be’.

For this bid to be classed successfully as ‘an advanced manufacturing supply chain initiative’, it had to be something of exceptional merit, given that no other British life sciences company had achieved a successful bid to date. I was confident, however, because the company had good, skilled staff and the Director of Manufacturing was fully on board.

Knowing this was a gigantic challenge, I reached into my LinkedIn network (which, sadly, no longer exists) for a suitable ally. The right man whom I netted this way turned out to be a Royal Academy of Engineering Professor at nearby Cranfield University—a former medic who, in another of these odd twists, had turned to design Jaguar cars. This was the perfect candidate for an academic partnership on the project. He is still a very good friend today.

He put me in touch with a fellow Welsh person, who happened to be Head of Innovation at a hospital network in the English West Midlands: another perfect partner to provide the NHS perspective. She, likewise, is still a very good friend of mine.

Together, we were ready to work with OXB to deliver an end-user-focused model for developing gene therapy products—and the Office for Life Sciences (part of the Department for Business, Innovation and Skills (BIS) at the time) was delighted with the prospect.

How did it turn out? Cutting to the chase, the bid was successful and OXB received the funding sought:

Oxford, UK—11 September 2013: Oxford BioMedica plc (“Oxford BioMedica” or “the Company”) (LSE: OXB), the leading gene-based biopharmaceutical company, announces that it has been selected as a winner of a funding award under the UK Government’s Advanced Manufacturing Supply Chain Initiative (AMSCI), in recognition of the Company’s potential to become a world-leader in Advanced Therapy Medicinal Product (ATMP) manufacture and supply chain expertise.

Oxford Biomedica led the successful bid with four other UK-based participants: the Heart of England NHS Foundation, Cranfield University, Cell Therapy Catapult Ltd and Biotec Services International Ltd (together, the “consortium”). Subject to due diligence and final confirmation by Birmingham City Council, the consortium has been awarded a £2.4 million grant, of which Oxford Biomedica will receive £1.8 million, and a £5.3 million loan to Oxford Biomedica which is repayable by March 2017.

What followed was a get-together of the winning team with representatives from the Office for Life Sciences—some very clever, young civil servants—and the fund administrators. Much patting of backs ensued.

My exit from the OLS strategy implementation

Not long after the project, I was asked to attend a meeting at the Business, Innovation and Skills Department's headquarters, chaired by a senior civil servant. The great and the good were there, representing Big Pharma, biotech, the OLS and other stakeholders in life sciences. Needless to say, my comments did not follow party lines, and that was the last such meeting I was to attend.

From then on, I became a disinterested keen observer of what was going on in cell and gene therapy and the broader life sciences landscape. I began to write articles that were widely published in industry journals, pointing out the gigantic logistics and supply chain management challenges presented by gene therapies—especially those known as autologous therapies, where the patient is both the source and destination of the product. As an example, I wrote Advanced Therapies: Patient-Centric Heaven or Supply Chain Hell?

My role as a dispassionate observer persisted until the SARS–CoV–2 enigma struck. How could a biologically-derived gene therapy product be developed and manufactured in nine months?

That conundrum got me digging and digging until the stark reality of what has gone on was laid bare.

The first bit of digging

Oxford Biomedica press releases revealed that the company had developed and manufactured the adenovirus drug substance for the AstraZeneca SARS–CoV–2 injections, as below, recounted chronologically:

8 April 2020

Oxford Biomedica joins Consortium to rapidly develop a COVID-19 vaccine candidate

13 May 2020

Oxford Biomedica receives MHRA approval for the first two manufacturing suites in Oxbox

20 July 2020

Oxford Biomedica notes interim results from AstraZeneca on AZD1222 showing strong antibody and T-cell responses and acceptable safety profile

1 September 2020

Oxford Biomedica Signs Supply Agreement with AstraZeneca to Expand Manufacturing Support of COVID-19 Vaccine Candidate, AZD1222

6 October 2020

Oxford Biomedica receives MHRA approval for fourth manufacturing suite in Oxbox

23 November 2020

Oxford Biomedica notes AstraZeneca’s AZD1222 met primary efficacy endpoint in preventing COVID-19

30 December 2020

Oxford Biomedica notes AstraZeneca’s COVID-19 vaccine has been authorised for emergency supply in the UK

18 January 2021

Prime Minister Boris Johnson formally opens Oxford Biomedica’s manufacturing facility Oxbox

1 July 2022

Oxford Biomedica signs new three year agreement with AstraZeneca

This public-domain chronology tells us that the AstraZeneca SARS–CoV–2 injections were developed, manufactured, and supplied at breakneck speed, and not by AstraZeneca or Oxford University. Remember, AstraZeneca has no capability to develop these products—and Oxford University certainly doesn’t.

It is the breakneck speed that is the real concern. How could the British regulator, the MHRA, award a Manufacturing and Import Licence (MIA)—which would have been required to undertake the development and manufacture—in the space of a few months, while only ever carrying out virtual inspections? That is just plain impossible, unless all the regulatory aspects had been totally ignored.

Further digging reveals dark forces operating

I found an article entitled Tough choices to reduce Ebola transmission, published in Nature on 13 November 2014. It speaks to the work that the Bill and Melinda Gates Foundation had been carrying out in Africa since the early 2000s, in the name of global health. If you scan through it, it could easily be applied to the Covid débâcle we have just been through.

Look at the team that created the article, with their job titles at the time:

Christopher J. M. Whitty, chief scientific adviser at the UK Department for International Development.

Jeremy Farrar, director of the Wellcome Trust in London, UK.

Neil Ferguson, professor of mathematical biology at Imperial College London, UK.

W. John Edmunds, professor of infectious-disease modeling at the London School of Hygiene & Tropical Medicine, UK.

Peter Piot, director of the London School of Hygiene & Tropical Medicine, UK.

Melissa Leach, director of the Institute for Development Studies in Brighton, UK.

Sally C. Davies, chief medical officer and chief scientific adviser at the UK Department of Health.

You may recognise Whitty, Farrar, Ferguson, and Davies as familiar names in the fearmongering campaign.

Prior to that article, Trevor Mundel, former global head of development with Novartis, joined the Bill and Melinda Gates Foundation as President, Global Health, in 2011. Mundel was recorded speaking at the Johns Hopkins University March 2014, under the title Global Health Needs Innovation. A more recent Gates Foundation interview with Mundel bore the title Developing COVID-19 therapeutics: An investment that needs to happen.

In it, he says:

Yes, there are comparable examples going back to the Second World War. Pharmas worked with governments to accelerate the identification and development of antibiotics based on Alexander Fleming’s initial discoveries from the late 1920s. This collaboration played a critical role in saving the lives of wounded soldiers.

That is twisting the truth, as he has missed out the fact that it took from 1928 to 1943 (fifteen years) to bring penicillin to the world. Was his omission to mention this salient detail an innocent mistake?

Then, Ian Hudson, CEO of MHRA, joined the Gates Foundation in 2019, as Senior Advisor, Integrated Development. His biography there states:

Dr. Ian Hudson has a leading role on the team in areas that include optimizing clinical studies and strengthening regulatory systems in Africa and other low-resource regions, particularly for malaria, polio, and COVID-19 drugs.

Ian was a practicing pediatrician before joining SmithKline Beecham in 1989 to work in research and development. In 2001, he joined the UK government’s Medicines & Healthcare products Regulatory Service (MHRA), where he served as director of licensing and then CEO. Ian was the UK delegate to the scientific committee of the European Medicines Agency’s Management Board, CHMP, later becoming its vice chair. He was also an honorary senior lecturer in clinical pharmacology at the University of London and served as chair of the International Coalition of Medicines Regulatory Authorities.

Hudson mysteriously set up a self-appointed organization in 2016 (was he moonlighting?), which has the presumption to describe itself as the International Coalition of Medicines Regulatory Authorities (ICMRA).

The history of this outfit goes back to 2012:

In May 2012, before the 65th World Health Assembly in Geneva, more than 30 medicines regulatory authorities participated in a seminar promoted by Brazil aimed at stimulating a debate among health officials and the diplomatic community on how to improve cooperation among medicines regulatory authorities. The discussion highlighted the importance of better promoting and coordinating international cooperation among medicines regulatory authorities in order to strengthen dialogue, facilitate the wider exchange of reliable and comparable information, encourage greater leveraging of the resources/work products of other authorities, and promote better informed risk-based allocation of authorities’ resources. These efforts would strengthen the quality, safety and efficacy of medicinal products globally.

The irony is that the regulatory authorities (FDA, EMA, MHRA, Japan's PMDA, Brazil's ANVISA, Australia's TGA) were already fully harmonised. I was left with the distinct impression that ICMRA was nothing but the Trojan horse for the Gates Foundation to infiltrate and contaminate countries' regulatory bodies worldwide—with great success!

The current Chair of ICMRA is Ms Emer Cooke, also Executive Director of the European Medicines Agency. Make of that what you will.

UK Vaccine Task Force steps in to fight SARS–CoV–2

Britain's Vaccine Taskforce was set up at the behest of Sir Patrick Vallance, chaired by Kate Bingham. The government press release stated:

Kate is temporarily stepping back from her full-time role as Managing Partner at SV Health Investors, a leading international life sciences venture capital firm to take on this role as Chair of the Taskforce.

Bingham reported directly to the Prime Minister.

The former CEO of Glaxo (now known as GSK) then took over the role, issuing an end-of-year report entitled UK Vaccine Taskforce 2020 Achievements and Future Strategy. The Vaccine Taskforce's objectives and the membership of its steering group are an instructive read.

The Government then transmogrified the objective by press release to: Bold new life sciences vision sets path for UK to build on pandemic response and deliver life-changing innovations to patients.

Now, the Task Force is being absorbed into the UK Health Security Agency (UKHSA), headed up by Dame Jenny Harries, former Deputy Chief Medical Officer for England and a regular member of the Government’s daily news briefings on the rising SARS–CoV–2 infections that were supposedly set to kill millions. Those briefings preached lockdowns, masks and all the other measures that we know were diametrically opposite to what should have been done.

Then we have the Head of the Wellcome Trust, Sir Jeremy Farrar (whose role during Covid was equivalent to Dr Anthony Fauci's in the US). He is shortly to take up his post as Chief Scientist of the World Health Organisation. His book, Spike, proclaims:

My preference would be to streamline the architecture of global health with the WHO in the middle of the web, convening, advising, guiding and providing an emergency response [...] Crumbs from the table will not cut it in the era of pandemics.

Finally, we have Ian McCubbin, the new Chair of the official British body charged with bringing truckloads of of mRNA products to the world—the flippantly-named Cell and Gene Therapy Catapult:

The Cell and Gene Therapy Catapult (CGT Catapult), an independent technology and innovation organisation, announces today the appointment of Ian McCubbin OBE, CBE, to its Board of Non-Executive Directors as Chairman, effective 1st February 2022. With over 30 years of experience in the pharmaceutical industry and as a pharmacist by training, Ian has worked for industry leading companies including GlaxoSmithKline (GSK).

A cursory perusal of the clinical trials database that the Catapult maintains reveals how little progress is being made. The incestuous, opaque nature of this swirl of key players, companies, government departments, interests and objectives—coupled with an unhealthy partnership with self-admitted “enabling” regulatory bodies such as the MHRA—might lead the man on the street to suspect fraud on the public and the public purse.

Oh, what a tangled web of blind leading the blind

What you have just read is undeniably a tangled web. The actors in the web come in all shapes and sizes—high-net-worth individuals, NGOs, pharmaceutical companies, their suppliers, universities, research funding bodies, regulatory authorities, government agencies, and of course, government itself.

There is one thing they all have in common, however. That is, they lack expertise in how to develop, manufacture and distribute any kind of medicinal products—especially gene therapies, where they have been trying to solve the supply chain challenges for over a decade, with no meaningful success.

How Bill Gates hijacked a failing pharma system and smashed it: A tale of incompetence, deceit, greed, and an unmitigated thirst for power was first published by UK Column, Wednesday, 1st March 2023.

Literature Review: Halt Use of COVID-19 Vaccines Until Their Bio-Distribution & Bio-Persistence Attributes are Quantifiably Understood

Literature Review: Halt Use of COVID-19 Vaccines Until Their Bio-Distribution & Bio-Persistence Attributes are Quantifiably Understood

Recently, a prominent group of mostly independent physicians and scientists including some TrialSite contributors address what they lambast as…

www.trialsitenews.com

Recently, a prominent group of mostly independent physicians and scientists including some TrialSite contributors address what they lambast as “indiscriminate COVID-19 vaccination” extended to the vast majority of developed world populations, including healthy young people and others with “minimal danger of suffering serious complications due to COVID-19.” Challenging the status quo and medical establishment’s foundational position that the COVID-19 vaccines are indeed “safe and effective” with rare adverse side effects, study authors of this yet to be peer reviewed literature review output posit that “solid immune-histopathological evidence demonstrates that COVID-19 genetic vaccines can display an off-target distribution in tissues that are terminally differentiated, triggering autoimmune reactions.” The authors include the prominent cardiologist-epidemiologist Dr. Peter McCullough, one of the world’s most prominent COVID-19 vaccine critics, as well as corresponding author Italy-based structural biologist Panagis Polykretis. They reveal that this “off-target distribution” of the SARS-CoV-2 spike protein can include organs such as the heart and brain, “which may incur in situ production of spike protein eliciting a strong auto immunological inflammatory response.” The authors herein point out that all human cells involved with the synthesis of non-self-antigens ultimately are targeted by the immune system. But unlike how much present information about biomedical science, the human body isn’t some “strictly compartmentalized system” which means according to the authors’ argument, vaccine researchers today lack sufficient and accurate pharmacokinetic and pharmacodynamic data associated with the COVID-19 vaccines. What’s needed moving forward? Bio-distribution studies targeting the COVID-19 “genetic” vaccines plus a “rational harm-benefit assessment by age cohort are necessary.

Pointing out that a plethora of studies feature autoimmune reactions post the COVID-19 jab, the authors argue that histopathological data furthers “indisputable evidence” demonstrating that the COVID-19 vaccines present an off-target distribution, which can lead to synthesis of the spike protein and ensuing autoimmune inflammatory reactions. This dynamic can unfold even in tissues terminally differentiated.

The authors, generally critics of the COVID-19 vaccination program worldwide, remind their fellow scientists that “the mechanisms of the antigen processing and presentation and the consequences for cells synthesizing viral proteins are largely known and have been characterized for decades.”

Yet despite this, governments prompted by regulators, national public health agencies and apex research institutes rolled out mass COVID-19 vaccination programs less any truly accurate bio-distribution and bio-persistence evaluations. The study group includes TrialSite contributor Dr. David Wiseman. He pointed out that “the scientific community accepted that [mass vaccine rollout less the bio-distribution and bio-persistence data] without concern.”

Sufficient evidence?

Pfizer’s own documents point to some potential problems, write the authors. For example, on page 20 of the American pharmaceutical company’s non-clinical overview submitted to the FDA in 2021, it states, “No RNA or protein metabolism or excretion studies will be conducted” (“BNT162b2 Module 2.4. Nonclinical Overview).

Also during the June 15, 2022 FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC), advisor and expert Dr. Jay Portnoy’s concerns about the number of cells generating spike protein as well as the amount and persistence of spike protein production after mRNA vaccine administration were immediately dismissed by Pfizer executive Dr. William Gruber as “academic.”

Additionally, Moderna certainly didn’t fare much better on this topic of spike protein bio-distribution and bio-persistence, at least optically, with an answer one of their representatives gave to Dr. Pablo Sanchez on June 23, 2022, part of the Advisory Committee on Immunization Practices (ACIP) associated with the Centers for Disease Control and Prevention (CDC):

“The spike protein availability, I believe, is on the order of days, but like less than a week. But I will confirm that with our tox folks as well.”

Peter McCullough, M.D., MPH

What’s a key premise of the study authors?

The prospective risks associated with COVID-19 vaccines that the authors classify controversially as “genetic vaccines” point to the current COVID-19 vaccines authorized in the United States.

COVID-19 Vaccine

Description

Pfizer-BioNTech, BNT162b2/Comirnaty

mRNA -based vaccine targeting SARS-CoV-2

Moderna, mRNA-1273/Spikevax

mRNA -based vaccine targeting SARS-CoV-2

Novavax (Nuvaxovid and Covovax)

Protein subunit vaccine targeting SARS-CoV-2

Janssen/J&J (Jcovden)

Viral vector vaccine targeting SARS-CoV-2

Because the actions associated with these vaccines, particularly the mRNA products induce human cells to become targets for autoimmune attack the actual risks must be further studied. Scientists need to better understand the exact distribution and kinetics associated with both LNPs and mRNA itself, in addition to what the authors argue is the associated production and pharmacokinetics of the spike protein.

It is “a matter of serious concern” involving any current or future vaccines inducing human cells to synthesize non-self-antigens, warns the authors, given “the human body is not a strictly compartmentalized system.” They point out that “for terminally differentiated tissues,” cell loss can lead to “irreversible damage with a potentially fatal prognosis.”

Call to Action: The study authors call for the immediate halting of the COVID-19 vaccination program until and only when “accurate pharmacokinetic, pharmacodynamic and genotoxicity studies” are conducted and completed. Conversely, the authors point to a parallel track where the COVID-19 vaccines should be used only in instances where the risk-benefit calculus is compelling (e.g., where the “benefits greatly outweigh the risks”).

The authors list no limitations to their work uploaded to Preprints.org.

What’s the impact of this report?

It’s a literature review that has yet to be peer-reviewed. However, the study authors raise important points that need more public dialogue urgently.

Any critics?

Interestingly, one commenter suggests that the authors were “inaccurate” as to their analysis of how autoimmunity occurs in response to cellular activity. The commenter points out that “cells do not express the spike protein fully on the membrane triggering an autoimmune response.” They continue, “Typically, HLA class I, present on all nucleated cells” displaying peptides derived from the proteins made inside the cell. “Autoimmunity arises because of B and T cells that have occurred in the peripheral tissue that have not gone through the self/non-self-selection process in the bone marrow and hence cannot distinguish between self and non-self-peptides presented on cells and then proceed to target cells that are not infected. Another mechanism that can cause problems is molecular mimicry where peptides are similar to proteins found on native cells and antibodies that are created attack those native cells, as in Guillain Barre Syndrome.” Some other assumptions in this report were challenged.

Lead Research/Investigators

Researcher/Author

Background

Panagis Polykretis, Ph.D.

Allineare Sanità e Salute” Foundation; Independent Medical Scientific Commission—both in Milan, Italy.

Alberto Donzelli, M.D.

Allineare Sanità e Salute” Foundation; Independent Medical Scientific Commission—both in Milan, Italy.

Janci C. Lindsay, Ph.D.

Toxicology & Molecular Biology, Toxicology Support Services, LLC., Sealy, Texas

David Wiseman, Ph.D.

Synechion, Inc, Dallas, Texas

Anthony M. Kyriakopoulos, BSc (Hons) Dip.LSHTM MSc Ph.D. FIBMS

Infectious Disease, Nasco AD Biotechnology Laboratory, Piraeus, Greece

Michael Mörz, M.D.

Independent researcher, Dresden, Germany

Paolo Bellavite, MD

Independent medical researcher, Verona, Italy

Masanori Fukushima, M.D., Ph.D.

Foundation of Learning Health Society Institute, 450-0003 Nagoya, Japan

Stephanie Seneff, Ph.D.

Computer Science and Artificial Intelligence Laboratory, MIT, Cambridge, MA

Peter A. McCullough, M.D., MPH

Cardiology, Truth for Health Foundation, Tucson, AZ; well known cardiologist and prominent critic of the government’s COVID-19 response strategy.

References

Autoimmune Inflammatory Reactions Triggered by the COVID-19 Genetic Vaccines in Terminally Differentiated Tissues

Autoimmune Inflammatory Reactions Triggered by the COVID-19 Genetic Vaccines in Terminally Differentiated Tissues

As a result of the spread of SARS-CoV-2, a global pandemic was declared. Indiscriminate COVID-19 vaccination has been extended to include age groups and…

www.preprints.org

Autoimmune Inflammatory Reactions Triggered by the COVID-19 m-RNA Vaccines in Terminally Differentiated Tissues

Solid immuno-histopathological evidence demonstrates that the COVID-19 genetic vaccines can display an off-target distribution in tissues that are terminally differentiated, triggering autoimmune reactions. These include the heart and brain, which may incur in situ production of spike protein eliciting a strong autoimmunological inflammatory response. Due to the fact that every human cell which synthesizes non-self antigens becomes inevitably the target of the immune system, and since the human body is not a strictly compartmentalized system, accurate pharmacokinetic and pharmacodynamic studies are needed in order to determine precisely which tissues can be harmed.

Uncritical supporters of Big Pharma don't realize, that m-RNA vaccines are based on solely different concept than all previous types. They don't lure immune cells to particles of adjuvans simulating pathogens OUTSIDE of healthy cells of tissue - they attract and train them to healthy cells INSIDE of normal tissue. The consequences are easily foreseeable: the immune cells will start to attack healthy tissue and myocarditis (and another autoimmune diseases) will ensue. This is just a consequence of fact, that producers of vaccines started to produce them inside of human bodies rather than with animal cells cultures for the sake of expenses cuts.

Ecological Data Point to COVID-19 Vaccines as a Determinant of Increased All-Cause Mortality

Countries Must Urgently Merge Vaccine Administration and Death Databases

Ecological Data Point to COVID-19 Vaccines as a Determinant of Increased All-Cause Mortality

Countries Must Urgently Merge Vaccine Administration and Death Databases

petermcculloughmd.substack.com

By Peter A. McCullough, MD, MPH

The biggest global news story in 2021, 2022, and now in 2023 is that people around the world are dying in ever great numbers as the pandemic winds down. This is just the opposite of what was expected since COVID-19 mortality was largely in the elderly and those with many medical problems, the viral illness should have had a “culling” effect leaving 2022 and now 2023 to have decreased mortality.

Multiple sources of data suggest the swell in mortality occurring is not just among the elderly. Edward Dowd’s book "Cause Unknown": The Epidemic of Sudden Deaths in 2021 & 2022 numerous sources of insurance data are cited suggesting death claims among working age persons are skyrocketing.

Aarstad et al have published an ecological analysis demonstrating that deaths tracked with increased COVID-19 vaccination rates. But as the authors point out, these observations are not conclusive that the vaccines independently are responsible for the alarming trend