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

Quote from Fm1

Did you write that conclusion?

Trial suggests metformin effective at reducing odds of serious outcomes for COVID-19 patients seeking early treatment

I noticed that. But the conclusions were correct: unless you are a member of FLCC you don't view figures with 95% CI including 1.0 as definite enough to be proper conclusions.

They could have said: the results for metformin show a strong positive effect which is close to being statistically significant (CI=0.2 - 1.11). This motivates further studies of metformin.

THH

Expert Review of Anti-Infective Therapy

Vitamin D attenuates COVID-19 complications via modulation of proinflammatory cytokines, antiviral proteins, and autophagy

Vitamin D attenuates COVID-19 complications via modulation of proinflammatory cytokines, antiviral proteins, and autophagy

Introduction: Global emergence of coronavirus disease-19 (COVID-19) has clearly shown variable severity, mortality, and frequency between and within…

www.ncbi.nlm.nih.gov

Expert opinion: Interaction of vitamin D and vitamin D receptor (VDR) triggers the cellular events to modulate the immune system by regulation of many genes. Vitamin D operates as a double-edged sword against COVID-19. First, in macrophages, it promotes the production of antimicrobial and antiviral proteins like β-defensin 2 and cathelicidin, and these proteins inhibit the replication of viral particles and promote the clearance of virus from the cells by autophagy. Second, it suppresses cytokine storm and inflammatory processes in COVID-19.

Quote from Mark U

one sees that the FDA's analysis of the same data from Pfizer and Moderna has them cheating

Usually in USA this is done at a round table of a well known golf club near Washington or Florida... After two cases of best Bordeaux the FDA (CDC) will sign any crap. Do not ask with what the cases are filled afterwards ...

USA is a banana state with a 100% corrupt inner circle that ends at the president. Same for Russia,Germany,China,....

Why do people "left,right" elect their own butchers? Divide et impera!

Israel:: Vaxxxination has no effect on death from/with Omicron.. https://datadashboard.health.gov.il/COVID-19/general

The ration is about 2:1 ... 3:1 vaxx:unvaxx for death. (is about the vaxx ratio..)

But interesting is that at the beginning very high numbers of boostered died, what undermines that the Pfizer crap induces Covid and death.

The Media’s Culpable Refusal to Consider the Role of the Vaccines in Driving Excess Deaths

The Media’s Culpable Refusal to Consider the Role of the Vaccines in Driving Excess Deaths

The high number of U.K. excess deaths since April has finally made it into the mainstream media, courtesy of the

dailysceptic.org

Humour

What's happened to his nose?

Oh, syphilis not monkeypox

Great take from JP

Unknown Cause of Death? Our Latest Propaganda

A gargle a day keeps Covid away!

Antiviral effect of cetylpyridinium chloride in mouthwash on SARS-CoV-2

Antiviral effect of cetylpyridinium chloride in mouthwash on SARS-CoV-2 - Scientific Reports

www.nature.com

Abstract

Cetylpyridinium chloride (CPC), a quaternary ammonium compound, which is present in mouthwash, is effective against bacteria, fungi, and enveloped viruses. This study was conducted to explore the antiviral effect of CPC on SARS-CoV-2. There are few reports on the effect of CPC against wild-type SARS-CoV-2 at low concentrations such as 0.001%–0.005% (10–50 µg/mL). Interestingly, we found that low concentrations of CPC suppressed the infectivity of human isolated SARS-CoV-2 strains (Wuhan, Alpha, Beta, and Gamma) even in saliva. Furthermore, we demonstrated that CPC shows anti-SARS-CoV-2 effects without disrupting the virus envelope, using sucrose density analysis and electron microscopic examination. In conclusion, this study provided experimental evidence that CPC may inhibit SARS-CoV-2 infection even at lower concentrations.

Don't bogart that joint my friend, pass it over to me!

Cannabinoids Block Cellular Entry of SARS-CoV-2 and the Emerging Variants

https://pubs.acs.org/doi/10.1021/acs.jnatprod.1c00946

Abstract

As a complement to vaccines, small-molecule therapeutic agents are needed to treat or prevent infections by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and its variants, which cause COVID-19. Affinity selection–mass spectrometry was used for the discovery of botanical ligands to the SARS-CoV-2 spike protein. Cannabinoid acids from hemp (Cannabis sativa) were found to be allosteric as well as orthosteric ligands with micromolar affinity for the spike protein. In follow-up virus neutralization assays, cannabigerolic acid and cannabidiolic acid prevented infection of human epithelial cells by a pseudovirus expressing the SARS-CoV-2 spike protein and prevented entry of live SARS-CoV-2 into cells. Importantly, cannabigerolic acid and cannabidiolic acid were equally effective against the SARS-CoV-2 alpha variant B.1.1.7 and the beta variant B.1.351. Orally bioavailable and with a long history of safe human use, these cannabinoids, isolated or in hemp extracts, have the potential to prevent as well as treat infection by SARS-CoV-2

Pfizer-BioNTech: Authorize Our mRNA Product for Humans 12+ for BA.5 Based on Animal Data First

Pfizer-BioNTech: Authorize Our mRNA Product for Humans 12+ for BA.5 Based on Animal Data First

Pfizer (PFE) and BioNTech (SE) Submitted their Application to U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of Omicron…

www.trialsitenews.com

Pfizer (PFE) and BioNTech (SE) Submitted their Application to U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine even through clinical trials data hasn’t been received as part of the regulatory submission. The companies are requesting the EUA for a 30-µg booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older. Both Pfizer and BioNTech report in their press release that they have scaled production and stand ready to deliver doses of Omicron BA.4/BA.5-adapted bivalent vaccines for September and will begin shipping immediately, pending authorization. The companies benefit from a rolling submission for Omicron BA.4/BA.5-adapted bivalent vaccine to be completed with the European Medicines Agency in the coming days. There’s one notable consideration: the data for this rapid-fire authorization of the BA.5 subvariant is based on laboratory animals in preclinical study. Should this product be authorized on an emergency basis before complete human trials? Is the emergency still so dire that traditional good clinical practices continue to be set aside for accelerated pathways? Or is this accelerated pathway meant for emergencies still the way to go?

The application follows guidance from the FDA to include clinical data from the companies’ bivalent Omicron BA.1-adapted vaccine and pre-clinical and manufacturing data from the companies’ bivalent Omicron BA.4/BA.5-adapted vaccine to address the continued evolution of SARS-CoV-2. Pending authorization, the Omicron BA.4/BA.5-adapted bivalent vaccine will be available to ship immediately.

A conditional marketing authorization application has also been initiated with the European Medicines Agency (EMA) for the Omicron BA.4/BA.5-adapted bivalent vaccine and is expected to be completed in the coming days.

The Investigational product

TrialSite notes any product shipped and consumed under EUA is deemed an investigational product. The bivalent vaccine contains mRNA encoding the original SARS-CoV-2 spike protein, which is present in the original Pfizer-BioNTech COVID-19 Vaccine, together with mRNA encoding the spike protein of the Omicron BA.4/BA.5 variant. Pre-clinical data showed a booster dose of Pfizer and BioNTech's Omicron BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against Omicron BA.1, BA.2 and BA.4/BA.5 variants, as well as the original wild-type strain.

A human-based clinical study investigating the safety, tolerability, and immunogenicity of the Omicron BA.4/BA.5-adapted bivalent vaccine in individuals 12 years of age and older is expected to start this month.

TrialSite’s founder and CEO Daniel O’Connor shared,

“American consumers should at least come to understand that the sponsor and regulator are gearing up to authorize and deliver this product before a full clinical trial is conducted and completed on humans. Meaning that the data obtained from laboratory experiments with animals, known as preclinical data, is sufficient for the pharmaceutical companies and what has been the world’s top food and drug regulatory body. If they accept this EUA, I’m not sure we can say that about the FDA anymore.”

“But on the other hand, some highly respected minds in our network argue this approach beats what the UK has done. Goes this argument, the BA.5 sequences has been vetted via massive exposure to BA.5 in circulation. A tested BNT162b2 platform coupled with BA.1/Wu bivalent data plus BA.5/Wu animal model data makes for a not-so-unreasonable decision. But are we on a competitive race to ever lower standards?”

What’s going on here?

As mentioned by TrialSite’s founder above, Pfizer-BioNTech and the FDA have agreed to ship a human vaccine product before the clinical trial data has been generated—in fact, before the clinical trial has even been started!

TrialSite communicated in “Public Health Leadership Becomes More Reckless: Choices Prolong the Pandemic & Pad Pfizer’s Pockets” about Pfizer's Phase 2 clinical trial that was just posted on July 25th and updated on August 10th.

This media shared that the data derived from human research didn’t include a candidate with BA.5 at all. They include two bivalent candidates. The first is Wuhan/BA.1 and the second is Wuhan/BA.2. This media suggested it's possibly a mistake to include Wuhan variant (bivalent) since it may reinforce immune imprinting (aka: Original Antigenic Sin). It's an even bigger mistake to then also not use the currently dominant BA.5 which differs markedly from other Omicron subvariants. Two of the amino acid mutations that its codes for are highly correlated with antibody immune evasion. Of course, at the time, this media assumed they would get that data from human trials before the authorization.

But in Pfizer’s press release the company along with BioNTech announced they requested the EUA for the 30-µg booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older.

But how could they introduce an Omicron BA.4/BA.5 adopted bivalent COVID-19 vaccine for persons aged 12 and up when they haven't tested this product in humans? Remember by June 28th the FDA vaccine advisers recommended that these booster products include BA.4 and BA.5 subvariants. These are far more transmissible pathogens more easily evading earlier immunity from both vaccines and natural immunity from previous infection. Outbreaks consequently rage worldwide.

This point was covered in mainstream media today such as USA Today. Moreover, the FDA previously issued a memorandum on the Fall booster update. See the link.

The FDA stated that they would rely on BA.1 clinical data: "Should we receive requests to authorize modified COVID-19 vaccines, in evaluating such requests we expect that it will be appropriate to consider that available clinical immunogenicity data from clinical studies of vaccines containing Omicron BA.1 components, among other data potentially applicable to the safety and effectiveness of modified vaccines."

TrialSite and its network of contributors actually made the assumption that the agency would use human data as it became available and prior to EUA submission. Perhaps the manufacturers thought that too, and that's why they estimated that their delivery date would be pushed to late October or November if they had to pivot from BA.1 to BA.5. However, now they are planning on delivering in Sept. Was the human trial data showing neutralizing antibody titers forfeited in order to step up the timeline?

Will Humans Receive a Vaccine Tested on Animals Only?

It turns out Pfizer has declared they will commence a clinical trial in humans later in August, yet the company has taken steps to boost production capacity to meet anticipated demand come September just in time to beat the cool fall and cold month-driven anticipated surges in infections once the Gold Standard agency authorizes this product. But a clinical trial for a major vaccine update takes far more than a month. Politics is supposed to be completely separate from the regulatory and scientific process, but this media questions that assumption based on the behavior during this pandemic—from both parties. It appears President Biden is concerned about more than fall SARS-CoV-2, BA.5-based infection surges. He’s also thinking about the mid-term election in early November. Perhaps he wants to overcome or control the virus prior to that milestone? If we have learned anything over the past couple of years, this pathogen is most certainly not easily controlled.

This reminds this media of the Phase 3 AstraZeneca trial that was oddly timed to be the shortest of all Phase 3 vaccine studies—possibly the one study that would help former President Trump meet his target for a vaccine before the 2020 elections. This media cannot prove this claim, but the timing of Trump’s announcements and the unprecedented compression of the Phase 3 AstraZeneca timeline caught TrialSite’s attention.

But the whole affair becomes more questionable when considering that the FDA informed Pfizer it could submit clinical data for its bivalent BA.1 vaccine in parallel to preclinical and production data associated with a BA.4 and BA.5 BNT162b2 version. What does this mean? Simply that data from laboratory animals is good enough for the FDA to authorize the product on the American people—starting at the tender age of 12 years old and up! That’s right—because recent tests on laboratory animals triggered robust neutralizing antibody responses against Omicron BA1, BA.2 and BA.4 and BA.5 variants as well as the original SARS-CoV-2 virus are ready. On one matter, TrialSite concurred with Pfizer: that the monovalent version elicited a more robust response than the bivalent less the risks. But the FDA opted for the latter after the June 28 Vaccine and Related Biological Products Advisory Committee (VRBPAC). TrialSite recommends that no product is authorized for emergency use until full human clinical trial data are completed and fully analyzed. COVID-19 is far better understood now, and enough safety vaccine surprises have emerged to stick to the standard good clinical practices.

Another Point of View

TrialSite contributor Paul Elkins shared, “In my opinion this is a better approach than what the United Kingdom undertook. Taking an obviously less efficacious vaccine update (BA.1/Wu) for expediency. At least Pfizer's path will result in a more efficacious vaccine booster. I also believe that the BA.5 sequence has already been well tested in humans through massive exposure to the circulating BA.5 subvariant. The platform has been tested, BA.1/Wu bivalent data is available so relying on that and the animal model data for BA.5/Wu isn't all together unreasonable. I'm just surprised that we waited this long to update the vaccines (which is long overdue), but now we can't wait another 1-2 months for human data.”

Of course, this assumes the human data can be collected in such a condensed period of time—remember they haven’t even commenced yet.

So, what does Pfizer’s CEO have to say about this?

Albert Bourla, the company’s Chairman and Chief Executive Officer, went on the record, “The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech COVID-19 Vaccine, has allowed us to develop, test and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed.” Bourla continued, “Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorized, to help protect individuals and families as we prepare for potential fall and winter surges."

Meanwhile, BioNTech’s CEO and Co-Founder said Prof. Ugur Sahin, MD declared, “Given the ongoing evolution of SARS-CoV-2 and its variants, it's of great importance that vaccines can be rapidly adapted to the major circulating Omicron lineages.”

He shared, “In less than three months after the FDA provided its guidance for adapted vaccines in the U.S., we are ready to ship the first doses of our Omicron BA.4/BA.5-adapted bivalent vaccine, pending regulatory authorization, to provide people in the U.S. with the possibility to get a booster adapted to the currently most dominant strain of the virus.”

The company’s previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial of a 30-µg booster dose of their Omicron BA.1-adapted bivalent vaccine candidate, which combines the existing vaccine and a vaccine targeting the Omicron BA.1 variant spike protein. The Omicron BA.1-adapted bivalent vaccine elicited a superior immune response against the Omicron BA.1 variant compared to the companies’ current COVID-19 vaccine. The Omicron BA.1-adapted bivalent vaccine was well-tolerated with a favorable safety profile.

Following guidance from the EMA and International Coalition of Medicines Regulatory Authorities (ICMRA), Pfizer and BioNTech submitted an application for the Omicron BA.1-adapted bivalent COVID-19 vaccine in July.

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 (Comirnaty®) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

Is this an approved product or EUA?

One other somewhat complicated matter emerges from Pfizer’s recent announcement. While Comirnaty is now approved in the United States, it hasn’t been in circulation. Rather, the EUA-based product BNT162b2 is what Americans have received since December 2020. TrialSite suggests this complex, bifurcated approval was accomplished to justify pending COVID-19 mandates.

The recent announcement is for EUA use. This means that despite this complex regulatory classification the product will be yet again accelerated to market by September (again without complete human clinical trials data). Thus, the product will fall under the EUA category rendering it investigational.

What’s the U.S. indication & Authorized use?

Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.

Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide:

Primary Series

A 3-dose primary series to individuals 6 months through 4 years of age

a 2-dose primary series to individuals 5 years through 11 years of age

a 2-dose primary series to individuals 12 years of age and older

a third primary series dose to individuals 5 years of age and older with certain kinds of immunocompromise

Booster Series

a single booster dose to individuals 5 through 11 years of age who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine

a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)

a first booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series

a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine

a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine

What is COMIRNATY® INDICATION?

COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine approved for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

What’s the purpose of the EUA?

Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in individuals 6 months of age and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

How can both BNT162b2 (EUA vaccine) and Comirnaty (approved vaccine) be classified differently yet at least theoretically be the same?

The answer is INTERCHANGEABILITY. Pfizer and BioNTech note that the FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine FDA authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older can be used interchangeably by a vaccination provider when prepared according to their respective instructions for use.

The formulation of the Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 6 months through 4 years of age, 5 through 11 years of age, and 12 years of age and older are different and should therefore not be used interchangeably.

Some contributors to TrialSite have raised serious concerns about labeling and dose batches. See the link.

Conclusion

The major impetus to get this vaccine out before it’s tested-on humans is the countermeasure response to the ongoing emergency. The government anticipates a surge in cases come the fall and wants a vaccine in place by September so that by the time October rolls around the surge of antibodies are triggered in as many people as possible. In this emergency, the countermeasure purportedly is accelerated to save lives.

Another possible consideration is politics. This entire pandemic has been politicized beyond the pale so it’s not beyond possibility that pressures from high-up push for a vaccine well before the mid-term election. After all, the stakes are big. If the pandemic continues to rage more than likely voters will opt for change, which means throwing Democrats out.

The regulators appear to be becoming more lax in this pandemic by the quarter, supporting what this media generally considers a questionable move to announce their intention to work with a major pharmaceutical company to allow an investigational product used on humans from age 12 on up without what some experts may claim is sufficient human clinical trials data.

UK excess deaths still up at 18% https://www.ons.gov.uk/peoplep…onal/weekending22july2022

You have to read the text below to get the correct number of deaths...

The number of deaths registered in the UK in the week ending 22 July 2022 (Week 29) was 12,439, which was 17.3% above the five-year average (1,839 excess deaths); of these deaths, 864 involved COVID-19, which was 168 more than in Week 28.

Why do they restart cheating ??? Or just sloppy work?

My town currently is a waste water Covid hot spot with 25% : https://www.covid19.admin.ch/de/epidemiologic/waste-water

This was a Swiss invention for area monitoring. Worst places are Engelberg (tourists) and young urban small towns like Uster.

Quite interesting to see where hot spots develop.

Covid-19 Omicron (the real vaccine) is a harmless cold as Quatar data shows too ::

COVID-19 Disease Severity With Omicron Sublineages and Vaccination Status

This retrospective study compares the severity of SARS-CoV-2 infection among persons infected with BA.1 and BA.2 sublineages by vaccination status.

jamanetwork.com

No difference between BA.1/BNA.2 could be found and 3 deaths in 21'000. So mortality of known cases was 0.015.. Far below any flu.

Nothing is said about the unvaxx... I guess none died...But Gillead payed...

To hold the public’s trust again, Walensky should ask Congress to cut the CDC down to size, restoring its focus on preventing communicable diseases. Many of the agency’s other efforts can be sent to other government agencies, many within the National Institutes of Health, for primary responsibility. Without such a drastic move, no apology, however sincere, will save the agency.

The CDC is broken and apologies can’t fix it

The CDC is broken and apologies can’t fix it

In truth, the CDC did a great deal of damage to public faith in science and enormous damage to public trust in government writ large.

thehill.com

Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, is getting credit for a mea culpa for saying what seems obvious: “For 75 years, the CDC and public health have been preparing for COVID-19, and in our big moment, our performance did not reliably meet expectations,”

This is a classic act of contrition theater, in which Walensky avoids taking any responsibility for the agency’s failure to understand the threat the nation faced or the CDC’s unfounded “guidance” regarding how to slow the spread of COVID, measures that the agency now acknowledges are flawed

It is not a small issue that CDC personnel undermined respected scientists outside of government who quarreled with mask mandates, social distancing, shutting schools, closing businesses, and promoting universal vaccination with serums whose known risks to some were downplayed. All this while dismissing Americans who doubted that the CDC had a monopoly on “the science.”

Front Line COVID-19 Critical Care Alliance (FLCCC) Statement on the Resignation of Anthony Fauci, MD

Front Line COVID-19 Critical Care Alliance (FLCCC) Statement on the Resignation of Anthony Fauci, MD

WASHINGTON, D.C. – The Front Line COVID-19 Critical Care Alliance (FLCCC), a group of highly published, world-renowned critical care physicians…

www.trialsitenews.com

WASHINGTON, D.C. – The Front Line COVID-19 Critical Care Alliance (FLCCC), a group of highly published, world-renowned critical care physicians and scholars is pleased to learn that Anthony Fauci will be leaving government service at the end of the year. Unfortunately, the damage he has done to medical research, science and public health over his long career will be felt for years to come.

Dr. Fauci’s career is a clear demonstration of what many fear most from our government: ego-driven technocrats pushing a failing, evidence-free political agenda on the country with no transparency or accountability. Dr. Fauci’s promotion of expensive, untested new COVID-19 medications to the exclusion of safe, extensively studied generic treatments has caused an untold amount of illness, suffering and death.

“Virtually all of our governments’ failed pandemic policies can be traced back to Dr. Fauci’s, from lockdowns to indiscriminate vaccinations to vaccine mandates,” said Pierre Kory, M.D., M.P.A., president and chief medical officer of the FLCCC. “He ignored natural immunity and blindly pushed mass vaccinations, even after it was clear that they weren’t effective in preventing the spread of COVID-19. Cheap repurposed medicines like fluvoxamine proved effective at reducing COVID-19 hospitalizations and deaths as far back as 2020, yet he ignored them all.”

“I am saddened to think of the countless lives that could have been saved if Dr. Fauci has actually been the leader we all needed and let science instead of profit guide our policies,” said Paul Marik, M.D., co-founder and chief scientific officer of the FLCCC. “Early in the pandemic my colleagues and I saw positive results using widely available repurposed drugs to treat COVID patients. We told the world, including Dr. Fauci, what we knew, but he refused to listen, and countless people suffered while so many senselessly died.”

About the Front Line COVID-19 Critical Care Alliance

The FLCCC Alliance was organized in March 2020 by a group of highly published, world-renowned critical care physicians and scholars with the academic support of allied physicians from around the world. FLCCC’s goal is to research and develop lifesaving protocols for the prevention and treatment of COVID-19 in all stages of illness including the I-RECOVER protocols for “Long COVID” and Post Vaccine Syndrome. For more information: http://www.flccc.net

Quote from Fm1

“I am saddened to think of the countless lives that could have been saved if Dr. Fauci has actually been the leader we all needed and let science instead of profit guide our policies,”

As said: He admires Dr.Mengele...

FLCCC long vaxx protocol :: https://covid19criticalcare.co…r-post-vaccine-treatment/

What you don't like to see. Vaxx insury meeting : https://odysee.com/$/embed/FLCCC-I-RECOVER-Post-Vaccine-Syndrome-Protocol-promo/c71ad2b16b4a899403e678db39658fde7e53eab6?r=BkjnKWKUaBMwqzvheB3m2ueJ4ceNRm1g

Pavloxid:: https://www.canadiancovidcarea…med-Decision-20220727.pdf

Another study looking at PAXLOVID™, the EPIC-SR study, is ongoing. Both unvaccinated adults who are

at standard risk (i.e., low risk of hospitalization or death) as well as vaccinated adults who had one or more

risk factors for progressing to severe illness are being enrolled. Results from this ongoing study are

unavailable, but a press release reported that there was no appreciable difference between

nirmatrelvir/ritonavir and placebo: with 662 subjects enrolled for interim analysis, 2/333 (0.6%) receiving

nirmatrelvir/ritonavir and 8/329 (2.4%) receiving placebo were hospitalized

think long COVID

Associations Between 25-Hydroxyvitamin D and Total and γ' Fibrinogen and Plasma Clot Properties and Gene Interactions in a Group of Healthy Black South African Women

Associations Between 25-Hydroxyvitamin D and Total and γ' Fibrinogen and Plasma Clot Properties and Gene Interactions in a Group of Healthy Black South African Women

The role of 25-hydroxyvitamin D [25(OH)D] in reducing the risk of cardiovascular disease (CVD) has been recognized, but the mechanisms involved are unclear.…

www.ncbi.nlm.nih.gov

Abstract

The role of 25-hydroxyvitamin D [25(OH)D] in reducing the risk of cardiovascular disease (CVD) has been recognized, but the mechanisms involved are unclear. Researchers have discovered a link between vitamin D and fibrinogen. Until now, data on the relationship between vitamin D and the γ' splice variant of fibrinogen and fibrin clot characteristics remain unexplored. In this study, 25(OH)D, total and γ' fibrinogen, as well as turbidimetrically determined plasma clot properties, were quantified, and fibrinogen and FXIII SNPs were genotyped in 660 Black, apparently healthy South African women. Alarmingly, 16 and 45% of the women presented with deficient and insufficient 25(OH)D, respectively. Total fibrinogen and maximum absorbance (as a measure of clot density) correlated inversely, whereas γ' fibrinogen correlated positively with 25(OH)D. γ' fibrinogen increased whereas maximum absorbance decreased over the deficient, insufficient, and sufficient 25(OH)D categories before and after adjustment for confounders. 25(OH)D modulated the association of the SNPs regarding fibrinogen concentration and clot structure/properties, but did not stand after correction for false discovery rate. Because only weak relationships were detected, the clinical significance of the findings are questionable and remain to be determined. However, we recommend vitamin D fortification and supplementation to reduce the high prevalence of this micronutrient deficiency and possibly to improve fibrinogen and plasma clot structure if the relationships are indeed clinically significant. There is a need for large cohort studies to demonstrate the relationship between vitamin D and cardiovascular and inflammatory risk factors as well as to uncover the molecular mechanisms responsible.

People with long-Covid have blood-clotting imbalance, Irish research team discovers

People with long-Covid have blood-clotting imbalance, Irish research team discovers

People with long-Covid can have their immune systems “tipped out of balance” long after the initial infection, shedding light on why they continue to feel…

www.independent.ie

People with long-Covid can have their immune systems “tipped out of balance” long after the initial infection, shedding light on why they continue to feel unwell, according to new Irish research

The team from the Royal College of Surgeons of Ireland (RCSI) found a blood-clotting imbalance persists in people with long-Covid.

The team of researchers, led by Prof James O’Donnell and Dr Helen Fogarty, analysed blood from 50 patients with long-Covid syndrome up to 12 weeks after infection with the virus.

They compared the samples to ‘controls’: blood from healthy people who did not have long-Covid syndrome.

Thrombin generation and fibrin clot structure after vitamin D supplementation

Thrombin generation and fibrin clot structure after vitamin D supplementation

Objective Vitamin D deficiency is associated with increased risks of arterial and venous cardiovascular events. Hypothetically, supplementation with vitamin D…

ec.bioscientifica.com

Thrombin generation and fibrin clot structure after vitamin D supplementation

in Endocrine Connections

Abstract

Objective

Vitamin D deficiency is associated with increased risks of arterial and venous cardiovascular events. Hypothetically, supplementation with vitamin D may lead to a less prothrombotic phenotype, as measured by global coagulation assays and fibrin clot structure.

Methods

In this prospective cohort study, we enrolled adult outpatients attending the Primary Care Division of the Geneva University Hospitals with a severe vitamin D deficiency (25-hydroxyvitamin-D3 (25-OHD) <25 nmol/L), excluding obese patients or with a recent acute medical event. We evaluated changes in coagulation times, thrombin generation assay, clot formation and clot lysis time, 25-OHD and parathormone before and 1–3 months after cholecalciferol oral supplementation with one-time 300,000 IU then 800 IU daily. Paired t-tests with a two-sided alpha of 0.05 compared absolute mean differences.

Results

The 48 participants had a mean age of 43.8 ± 13.8 years. After supplementation, 25-OHD levels increased from 17.9 ± 4.6 nmol/L to 62.5 ± 20.7 nmol/L 6.4 ± 3.0 weeks after inclusion. Endogenous thrombin potential and thrombin generation peak values both decreased significantly (−95.4 nM × min (95%CI −127.9 to −62.8), P < 0.001; −15.1 nM (−23.3 to −6.8), P < 0.001). The maximum absorbance by turbidimetry decreased significantly (P = 0.001) after supplementation. There was no change in clot lysis time, coagulation times or plasminogen activator inhibitor-1 and homocysteine levels.

Conclusions

In severe vitamin D deficiency, a high-dose cholecalciferol supplementation was associated with a reduction in thrombin generation and an average decreased number of fibrin protofibrils per fibers and fibrin fiber size measured by turbidimetry. This suggests that severe vitamin D deficiency may be associated with a potentially reversible prothrombotic profile.

Keywords: vitamin D; parathyroid hormone; cardiovascular; hormone action

Associations of Cholecalciferol Supplementation with Thrombin Generation and Fibrin Clot Structure in Severe Vitamin D Deficiency: A Prospective Cohort Study

Associations of Cholecalciferol Supplementation with Thrombin Generation and Fibrin Clot Structure in Severe Vitamin D Deficiency: A Prospective Cohort Study

Introduction: Vitamin D deficiency has been associated with increased risks of both arterial and venous cardiovascular events. The underlying possible…

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Abstract

Introduction: Vitamin D deficiency has been associated with increased risks of both arterial and venous cardiovascular events. The underlying possible mechanisms remain incompletely understood, and whether vitamin D supplementation influences hemostasis has not been thoroughly assessed. We hypothesized that supplementation with vitamin D in deficient patients would lead to a less prothrombotic hemostatic profile, as measured by global coagulation assays and fibrin clot structure.

Methods: We enrolled adult patients attending the outpatient clinic of the Primary Care division of the University Hospitals of Geneva with a vitamin D deficiency (25-hydroxyvitamin-D3 (25-OHD)<25nmol/L) from 9.2016 to 5.2017, in whom a standard supplementation (oral cholecalciferol 300,000IU once, followed by 800IU per day) was prescribed. Exclusion criteria included ongoing cholecalciferol supplementation or anticoagulant treatment, renal insufficiency (GFR<30ml/min), BMI>30kg/m2, cancer, and a recent hospitalization or infection. Blood was taken before supplementation and after 1-3 months. We evaluated standard coagulation times, thrombin generation assay, fibrin polymerization and clot lysis times (in triplicates). Paired t-tests with a two-sided alpha of 0.05 compared absolute mean differences of these measurements, and in secondary analyses relative differences of their geometric means.

Results: Among 48 mostly white and healthy adults (56% women), mean age and BMI were 43.8 years and 24.2kg/m2. Prevalences of hypertension, smoking, diabetes and past cardiovascular disease were 23%, 29%, 13% and 2%, respectively. At a mean of 6.4 weeks after supplementation with cholecalciferol , 25-OHD levels increased in all participants, from an average of 17.9±4.6 (SD) nmol/L to 61.2±20.7 nmol/L. There were no change in aPTT, TP% and fibrinogen levels. Thrombin generation ETP decreased from 1384±218 to 1289±197 nM*min (absolute decrease of 95 nM*min, relative decrease of geometric means of 6.8%, p<0.0001). Thrombin peak values decreased (p<0.001), and time to peak and lag time increased (p<0.03). The maximum polymerization (absorbance) decreased from 0.43 to 0.40 OD (absolute decrease of 0.04, relative decrease of geometric means of 8.5%, p=0.001). Clot lysis time remained unchanged after supplementation.

Conclusions: Among non-obese patients with a severe vitamin D deficiency, a high-dose supplementation with cholecalciferol is associated with a reduction in thrombin generation and maximum fibrin polymerization. These findings suggest that vitamin D deficiency may be responsible for a potentially reversible prothrombotic profile.

Association of vitamin D status with COVID-19 disease severity in pediatric patients: A retrospective observational study

https://onlinelibrary.wiley.com/doi/10.1002/hsr2.569

Abstract

Background and Aims

Vitamin D deficiency is associated with increased vulnerability to respiratory infections. This study aimed to determine the potential relationships between coronavirus disease 2019 (COVID-19) severity, serum vitamin D concentrations, and some inflammatory markers among pediatric COVID-19 patients in Iran.

Methods

A retrospective study was conducted among hospitalized pediatric COVID-19 cases in Abuzar Hospital (Ahvaz, Iran) for 6 months. The COVID-19 diagnosis was based on the real-time reverse transcription-polymerase chain reaction technique. Demographic and clinical data of patients were recorded. Patients with serum vitamin D levels lower than 20 ng/ml were assigned as Group 1 and those with serum vitamin D concentrations equal to or more than 20 ng/ml were considered as Group 2.

Results

A total of 144 patients were enrolled. Their mean age was 80  ±  49 months (range: 1–16 years). Patients in Group 1 had significantly lower levels of serum vitamin D, calcium, and lymphocytes, as well as higher fibrinogen, d-dimer, and C-reactive protein (CRP) levels compared with those in Group 2 (p < 0.001). In addition, they had a significantly higher dry cough, fever, chest radiographic findings, respiratory rate, and longer hospital length of stay than patients in Group 2. Serum concentrations of vitamin D were positively correlated with levels of serum calcium, lymphocytes, and neutrophils but negatively correlated with CRP, fibrinogen, and d-dimer values. Furthermore, patients with moderate or severe courses of COVID-19 had significantly higher inflammatory markers (CRP, d-dimer, and fibrinogen), as well as lower levels of serum calcium, vitamin D, lymphocytes, and neutrophils than those with mild COVID-19 (p < 0.001). In the multivariate analysis, fibrinogen level on admission was detected as the independent predictor of severe COVD-19 (odds ratio = 1.06, 95% confidence interval: 1.03–1.09; p < 0.001).

Conclusion

This study indicated associations between the severity of COVID-19, serum vitamin D concentrations, and some inflammatory markers in pediatric COVID-19 patients.

Does Natural Immunity Theory Mean Go Back to Pre-Vaccine Era When 2.5m Children Died Annually?

Does Natural Immunity Theory Mean Go Back to Pre-Vaccine Era When 2.5m Children Died Annually?

Answer: As usual, it&rsquo;s never a good idea to compare apples to oranges:

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Answer:

As usual, it’s never a good idea to compare apples to oranges:

First, as far as SARS-CoV-2 is concerned, we’re dealing with a PANDEMIC, and that will remain so for as long as we don’t reach herd immunity, which is well known to be (far!) beyond reach when using non-sterilizing vaccines in the middle of a pandemic.

For measles, polio, and other childhood diseases, herd immunity has largely been established. This reduces the occurrence of these viral diseases to (local) ‘outbreaks’ whenever there is a gap in that herd immunity, especially in countries/regions where the virus remains endemic and can spread asymptomatically on a background of herd immunity (e.g., in several third-world countries). Secondarily, in contrast to SARS-CoV-2, polio and measles are acute-self-limiting infections with strict host selectivity for humans. These limitations to viral spread (i.e., background of herd immunity and human-to-human transmission only!) makes it possible to terminate or prevent an outbreak (but never a pandemic!) using vaccines. However, this is only possible provided one uses LIVE ATTENUATED vaccines, as the latter induce full-fledged natural immunity (i.e., INNATE! and adaptive). The better the environmental hygiene (avoidance of overcrowding, sufficient ventilation, decent basic sanitation, access to potable water etc.), the lower the vaccine coverage rate required to tame an outbreak.

Any mass vaccination program that fails to generate population-level sterilizing immunity (i.e., herd immunity) will inevitably fail to stop the spread of acute, self-limiting viral infections in an immunologically naïve population. This particularly applies when non-replicating vaccines (e.g., all C-19 vaccines) are used in an attempt to control acute, self-limiting viral infections that can also spread and replicate through other animal species (e.g., SARS-CoV-2).

If one ignores this well-established principle, vaccines will inevitably foster natural selection and propagation of more infectious, and ultimately more virulent, SARS-CoV-2 variants. The emergence of the latter has already been documented in vitro (e.g., Omicron BA.4 and BA.5 lineages), and it is just a matter of time before these (sub)variants will also manifest enhanced virulence in vivo.

Children have an amazing innate immune capacity to generate sterilizing immunity. From a public health viewpoint (herd immunity!), it is therefore critical that we leave the children alone. But protecting our children from C-19 vaccination is also critical from an individual health viewpoint as vaccination with these non-replicating vaccines will prevent adequate education of their immune system. This is because spike (S)-specific, non-neutralizing antibodies (Abs) that are continuously recalled by the circulating Omicron (sub)variants will steadily outcompete their innate Abs and thereby prevent the child’s innate Abs to instruct the immune system on how to discriminate ‘self’ from ‘self-like’. Furthermore, vaccination of older children is highly likely to cause Ab-dependent enhancement of C-19 disease, as non-neutralizing, infection-enhancing Abs may enable the virus to break through the innate immune system when the latter is not yet sufficiently trained[1]. That is going to become particularly problematic once the virus completely subverts vaccine-induced adaptive immunity, and consequently, leaves the child at the mercy of its (untrained) innate immune system!

Of course, one may prefer to ignore the science or decide to take the risk, but even then, the question remains as to why we have not been vaccinating our children against seasonal influenza in the past (preferably using non-replicating vaccines!), and why no single childhood vaccine is using non-replicating virus to immunize young children against glycosylated viruses (e.g., measles, mumps, rubella, varicella, rotavirus)? Despite all ‘modern’ technologies, vaccinology has remained an empirical business. However, vaccinologists sometimes hit the nail right on the head: we now understand that these replication-competent childhood vaccines train the innate immune response in children whereas non-replicating vaccines don’t. That is why live attenuated vaccines can – under certain conditions- be useful to prevent or abrogate outbreaks and why they haven’t been replaced yet by more modern/sophisticated vaccine technologies!

[1] The updated Omicron vaccines cannot be expected to prime new neutralizing Abs instead of recalling infection-enhancing Abs: https://www.voiceforscienceand…pact-on-the-c-19-pandemic

Has “Long Covid” been exaggerated?

Has "Long Covid" been exaggerated?

New evidence suggests that the extent of the “Long Covid” phenomenon may have been dramatically exaggerated. The risks of Long Covid was a central argument in…

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The risks of Long Covid was a central argument in favour of draconian restrictions during the pandemic and, according to official figures, the condition remains extremely widespread. The Center for Disease Control and Prevention in the United States states that nearly one in five American adults who have had Covid-19 are experiencing Long Covid. Meanwhile, self-reported survey data from the UK indicates that there are 1.8 million people — 2.8% of the whole population — currently living with the condition.

But new data is complicating this picture, and indicating that many of the self-reported Long Covid cases may be incorrectly recorde

A paper published on 14th August by the Institute of Child Health at Great Ormond Street, currently undergoing peer review, found that teenagers whose parents have had Long Covid symptoms are more likely to report suffering Long Covid symptoms themselves. Notably, this association was present in teenagers regardless of whether they tested positive or negative for Covid-19 at the outset of the trial period.