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Scientists Develop Game-Changing Needle-Free COVID-19 Intranasal Vaccine
By Griffith University
September 1, 20244

A new mucosal COVID-19 vaccine poised to revolutionize the delivery process is especially beneficial for those with a fear of needles.

A next-generation COVID-19 mucosal vaccine is set to be a game-changer not only when delivering the vaccine itself, but also for people who are needle-phobic.

New Griffith University research, published in Nature Communications, has been testing the efficacy of delivering a COVID-19 vaccine via the nasal passages.

Professor Suresh Mahalingam from Griffith’s Institute for Biomedicine and Glycomics has been working on this research for the past four years.


Benefits of Live-Attenuated Vaccines

“This is a live attenuated intranasal vaccine, called CDO-7N-1, designed to be administered intranasally, thereby inducing potential mucosal immunity as well as systemic immunity with just a single dose,” Professor Mahalingam said.

“The vaccine induces strong memory responses in the nasal mucosa offering long-term protection for up to a year or more. It’s been designed to be administered as a single dose, ideally as a booster vaccine, as a safe alternative to needles with no adverse reactions in the short or long term.”


COVID-19-Intranasal-Vaccine.jpg

COVID-19 intranasal vaccine. Credit: Griffith University


Live-attenuated vaccines offer several significant advantages over other vaccine approaches.

They induce potent and long-lived humoral and cellular immunity, often with just a single dose.

Live-attenuated vaccines comprise the entire virus thereby providing broad immunity, in contrast to a single antigen which is used in many other vaccine platforms.

Lead author Dr Xiang Liu said the vaccine provides cross-protection against all variants of concern, and has neutralising capacity against SARS-CoV-1.

“The vaccine offers potent protection against transmission, prevents reinfection and the spread of the virus, while also reducing the generation of new variants,” Dr Liu said.

“Unlike the mRNA vaccine which targets only the spike protein, CDO-7N-1 induces immunity to all major SARS-CoV-2 proteins and is highly effective against all major variants to date.

“Importantly, the vaccine remains stable at 4°C for seven months, making it ideal for low- and middle-income countries.”


Licensing and Future Prospects


The vaccine has been licensed to Indian Immunologicals Ltd, a major vaccine manufacturer.

Dr. K. Anand Kumar, co-author of the publication and Managing Director of Indian Immunologicals Ltd. Said: “We are a leading ‘One Health’ company that has developed and launched several vaccines for human and animal use in India and are currently exporting to 62 countries.”

“We have completed all the necessary studies of this novel COVID-19 vaccine which offers tremendous advantages over other vaccines. We now look forward to taking the vaccine candidate to clinical trials.”

Professor Lee Smith, Acting Director of the Institute for Biomedicine and Glycomics, said he was delighted with the research findings.

“These results towards developing a next-generation COVID-19 vaccine are truly exciting,” Professor Smith said. “Our researchers are dedicated to providing innovative and, crucially, more accessible solutions to combat this high-impact disease.”

Reference: “A single-dose intranasal live-attenuated codon deoptimized vaccine provides broad protection against SARS-CoV-2 and its variants” by Xiang Liu, Wern Hann Ng, Eva Zusinaite, Joseph Freitas, Adam Taylor, Venugopal Yerragunta, Shukra Madhaha Aavula, Sambaiah Gorriparthi, Santhakumar Ponsekaran, Rama Lakshmi Bonda, Priyanka Mani, Sridevi V. Nimmagadda, Sainan Wang, Laura Sandra Lello, Ali Zaid, Ujjwal Dua, Sharon A. Taft-Benz, Elizabeth Anderson, Victoria K. Baxter, Sanjay Sarkar, Zheng L. Ling, Thomas M. Ashhurst, Samuel M. S. Cheng, Priyabrata Pattnaik, Anand Kumar Kanakasapapathy, Ralph S. Baric, Felicity J. Burt, Malik Peiris, Mark T. Heise, Nicholas J. C. King, Andres Merits, Rajendra Lingala and Suresh Mahalingam, 26 August 2024, Nature Communications.
DOI: 10.1038/s41467-024-51535-y
 

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This is why I strongly believe the immune escape pandemic will eventually transition into a hyperacute phase…
By Geert Vanden Bossche
August 21, 2024

Some folks seem to wonder whether a hyperacute phase (as I predict) will follow the current, more 'chronic' course of the C-19 pandemic or if the increase in mortality will instead be driven by a gradual rise in excess deaths directly or indirectly caused by the insane C-19 vaccination program.

While I am not a prophet, I want to emphasize that the current 'chronic' phase is ‘practically’ unsustainable for the virus. Suppressing the acute course of a virus that naturally causes an acute, self-limiting infection severely hampers its ability to proliferate and spread effectively.

This unsustainable situation can only conclude in one of two ways: Either the virus's spread is halted entirely (hooray!), or a randomly emerging mutant is naturally selected that allows the virus to spread more efficiently, even if it requires the virus to systemically disseminate within the body rather than transmit from one host entry portal to another.

Given the current, prolific emergence of new variants—and their combinations—in a myriad of highly C-19 vaccinated countries, I find it inconceivable that such a 'virulent' phenotype will not emerge and undergo natural selection in the very near future. Due to the high immune pressure on the virus's chances of survival, this will inevitably lead to a hyperacute phase causing a huge wave of severe disease enhancement. Only after this can balance be restored, and we will again deal with an acute, self-limiting course of this viral infection on the backdrop of herd immunity. That a hyperacute phase must precede the end of this immune escape pandemic is bad news, which is why I continue to warn that society in highly C-19 vaccinated countries will be caught off guard (which would not be the case if the 'chronic' course continued).
 

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The asymptomatic circle is closing!
By Geert Vanden Bossche
August 21, 2024

At the beginning of the C-19 pandemic (i.e., before the rollout of the mass vaccination program), the rapid asymptomatic spread of the SARS-CoV-2 wild-type (Wuhan-Hu-1) strain was accompanied by a rapidly growing wave of acute C-19 disease and hospitalizations, primarily affecting the vulnerable parts of the population.

At this stage of the immune escape pandemic, we're witnessing the prolonged asymptomatic spread of highly infectious variants among C-19 vaccinated individuals, accompanied by an extended wave of chronic disease and hospitalizations.

Only those with a superficial understanding of science perceive this phase as the post-pandemic endemic stage. True endemicity occurs when the virus seasonally resurfaces due to a collective decline in natural immunity (herd immunity), combined with increased infectious pressure (e.g., due to prolonged viral survival in colder temperatures and more indoor activities). However, to achieve herd immunity, chronic asymptomatic transmission would need to first transition into a hyperacute phase of high viral virulence. This transition would be necessary to eliminate individuals who cannot contribute to herd immunity due to vaccine-induced immune dysfunction.
 

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More about immune refocusing
By Geert Vanden Bossche
August 29, 2024

Nature's clever way of restoring disturbed ecosystems often puts the simplistic conclusions of short-sighted scientists to shame.

I recently bumped into the following publication: ‘Repeated Omicron exposures redirect SARS-CoV-2–specific memory B cell evolution toward the latest variants’

(x.com).

This is what I call steric immune refocusing! It seems that scientists are finally providing more evidence about this fascinating phenomenon. What’s new to me is their interesting discovery that the redirected antibodies (Abs) don’t result from de novo synthesis, but from redirecting previously primed memory B cells away from the original strain and toward newly emerging variants. This makes a lot of sense to me, as I hypothesized that immune refocusing is driven by previously primed T helper (Th) cells (see my book at The Inescapable Immune Escape Pandemic). So, it’s not surprising that these Th cells drive somatic hypermutation of memory B cells—previously primed by ancestral strain-based mRNA vaccines—to shift their specificity from the ancestral strain to newly emerging variants.

Although repeated vaccine breakthrough infections with Omicron descendants redirect SARS-CoV-2-(SC-2) specific memory B cell evolution toward the latest variants, the authors don’t seem to recognize that what they describe as ‘resilience to viral adaptation’ actually refers to the generation of new Abs that target more conserved spike-associated epitopes but have suboptimal neutralizing/infection-inhibiting capacity! As a result, these Abs promote viral immune escape and contribute to the (co-)emergence of more infectious (sub)variants.

It’s unbelievable that scientists go to great lengths to unravel complex immunological mechanisms but have no clue about the impact these mechanisms have on the virus’s evolutionary dynamics when they operate at the level of entire (highly C-19 vaccinated) populations. Their conclusion that their findings support the continued use of updated SC-2 vaccines is therefore short-sighted and only underscores their ignorance of the effects of collective immune pressure on the virus’s evolution.
 

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To Whom It May Concern
By Geert Vanden Bossche
August 29, 2024

To Whom It May Concern,

Anyone familiar with biology will recognize that biological systems and phenomena are often very complex. The more one studies biology in detail, the more one becomes aware of its intrinsic complexity. Molecular biologists will certainly agree with this. The level of sophistication increases even more as biological systems become more vulnerable, especially when interactions with other biological systems create dynamics that are vital for their maintenance. This is why the level of biological complexity within entire ecosystems culminates at a point that is difficult for humans to fully comprehend.

But what is the biological significance of this complexity? The complexity of biological phenomena often resembles a real spiderweb, where, much like a busy traffic intersection, many paths cross and change direction. By alternating steps in one direction with steps in another, often even opposite direction, it becomes possible to continuously adjust, modulate, and refine biological processes and reactions. This not only leads to a high degree of sophistication, and therefore vulnerability, in vital biological phenomena but also to a high degree of versatility and diversity. It is precisely this variation that is crucial for ensuring that complex, and hence more fragile, biological systems can thrive, even in the face of environmental threats. This is especially true when these threats come from biological agents that have evolved to sustain themselves with a much lower degree of biological complexity and vulnerability. It is precisely the spectrum of variations generated by the complexity of biological processes themselves and the myriads of mutual interactions with other systems that creates a wide range of possibilities for these vulnerable systems to adapt purposefully to threatening environmental factors. This adaptation occurs through the natural selection of the random’ variant(s)’ whose phenotypic complexity confers a competitive fitness advantage in hostile circumstances.

If the responsiveness of autonomously living biological organisms consisted only of a simple black-and-white reaction, then the confrontation with an unfavorable environmental factor would either result in a large-scale extinction of the species or in its widespread survival, ultimately leading to other factors that could also threaten the species' survival (e.g., depletion of food resources or other detrimental consequences of overpopulation). However, when the adaptability of an entire ecosystem—such as an animal population interacting with a pathogenic germ—is undermined by an unnatural, ill-adapted large-scale intervention, the population's capacity to effectively control the pathogen is at risk of gradually declining. It is not difficult to understand that this is particularly true when the 'hostile' environmental threat comes from a viable biological agent that, due to its primitive reproduction strategy, is much less vulnerable because it only needs to survive and reproduce within the safe environment of a host cell, such as a virus. In this way, the roles are reversed, and the more evolved and vulnerable organism gradually loses its ability to adapt, giving the more primitive adversary a strategic advantage.

For those who have followed my insights and predictions regarding the endpoint of the ongoing immune escape pandemic, this precisely explains how mass vaccination against SARS-CoV-2 during the pandemic has actually benefited the virus's adaptation, rather than that of the Covid 19 (C19)-vaccinated population. The systematic breakthrough infections in C19-vaccinated individuals have led to a collective reduction in the immune system’s adaptability (i.e., adaptive immunity) of highly C-19 vaccinated populations, thereby improving the survival chances of the less vulnerable virus. The adaptive capacity of highly C-19 vaccinated populations has eventually been limited to protection against virulence through polyreactive non-neutralizing antibodies (PNNAbs), a protection that we know does not evolve further and cannot prevent the virus from spreading (and thus adapting). Because the evolutionary dynamics of the virus, fueled by nonpharmaceutical infection-prevention measures and mass vaccination, have caused the antigenic stimulus that maintained the concentration of these antibodies to disappear, it seems more than plausible that this human-induced viral dynamics will ultimately pull the emergency brake to prevent the extinction of highly C-19 vaccinated populations. Indeed, if the collective immunological adaptability is restricted to the extent that it prevents the development of herd immunity, then only a higher degree of adaptability of the virus can offer a solution. The evidence of the virus's increasing adaptability has become clearly visible for quite some time, especially since the emergence of Omicron. At the current stage of this immune escape pandemic, the virus's adaptability is only further stimulated by the increasingly reduced capacity of highly C-19 vaccinated populations to control viral spread and replication.

There is no doubt that under the significant but 'misplaced' immune pressure exerted by highly C-19 vaccinated populations, the virus’s unchecked adaptability can only escalate. This escalation could ultimately give the unvaccinated part of these populations the opportunity to establish herd immunity through epigenetic reprogramming (‘adaptation’) of their innate immune cells, thereby breaking the cycle of ongoing immune escape by the virus.

It is also logical that when the robust adaptability of vulnerable biological entities is disrupted, it may take some time before their stability is collectively undermined and the system collapses under hostile pressure. Nevertheless, it’s clear that when small cracks in a dam’s wall begin to expand into larger fissures, the system’s stability deteriorates very rapidly, and thus the metastable system can suddenly collapse, much like a thunderbolt striking out of a clear sky. Such entities will therefore likely be caught off guard...

Together with those who criticize the timeline I predicted for the termination of the C-19 immune escape pandemic, I am amazed by the remarkable resilience of the complex biological system involved. This can only mean that the ability of our mammalian immune system to collectively adapt to far less biologically complex pathogens is truly spectacular and shows a resilience of unprecedented magnitude. Such remarkable resilience can only be destroyed by large-scale, unnatural and thoughtless immune interventions, but not in a way that nature has not provided a contingency plan to ensure the survival of our species.
 

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Simple measures lessen hospital-acquired COVID-19 infections, shows study
by Burnet Institute
September 2, 2024

Hospitals are places where people who are sick expect to receive treatment to feel better. Instead, for many, it has been where they contracted COVID-19, leading to further medical complications.

In a new study published in the Journal of Hospital Infections, Burnet researchers found simple infection control measures could save lives and reduce costs for hospitals.

These measures include testing patients for COVID-19 on admission, requiring staff to wear N95 masks in clinical areas and using Rapid Antigen Tests (RAT) or Polymerase Chain Reaction (PCR) tests to prevent transmissions.

One of the paper's lead authors, Burnet Associate Professor Nick Scott, said on average, 15–25% of patients who tested positive for COVID-19 in hospital had contracted the virus after being admitted.

"The data also showed mortality was 6 percentage points higher for people who caught COVID-19 in hospital, compared to controls who did not," he said.

The mathematical modeling in the study used data from outbreaks in Victorian hospitals and is one of the first studies to consider the economics of reducing COVID-19 infections in hospitals.

It found that although surgical masks had lower upfront costs, N95 masks offered greater protection and ultimately provided cost-saving benefits for hospitals.

Burnet mathematical modeler and lead author on the study, Fenella McAndrew, emphasized the hidden costs associated with choosing surgical masks over N95 masks in hospital settings.

"It may seem like surgical masks are the cheaper option, but when you consider extended hospital stays for patients and sick days taken by staff, it ends up being more expensive," she said.

"People shouldn't die or have medical complications from a COVID-19 infection they caught in hospital, and hospital workers shouldn't have to take sick leave due to a COVID-19 infection they caught at work."

The study assessed the cost-effectiveness of scaling up masks and testing interventions during COVID-19 outbreaks, finding that even targeting high-prevalence periods could reduce deaths and save costs.

"COVID-19 isn't going away, so there will continue to be outbreaks," Associate Professor Scott said. "My hope is this study will provide evidence to support strategies to manage COVID-19 outbreaks in hospitals in the future."

More information: F. McAndrew et al, Admission screening testing of patients and staff N95 respirators are cost-effective in reducing COVID-19 hospital-acquired infections, Journal of Hospital Infection (2024). DOI: 10.1016/j.jhin.2024.06.015
Provided by Burnet Institute
 

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Thailand medical authorities report more than a 100 percent increase in weekly COVID-19 hospitalizations. New XEC variant suspected as culprit
James Josh Fact checked by: TMN Team
Sep 02, 2024


Thailand medical authorities reported a total of 569 new weekly COVID-19 hospitalizations for the week 25th to 31st of August, representing an average of about 81 new COVID-19 hospitalizations per day.


Of this new weekly COVID-19 hospitalizations, 91 needed supplemental oxygen and are in ICU.


This new data on COVID-19 hospitalizations represents more than a 100 percent increase compared to the previous week where only 258 new hospitalizations were reported for the period 18th to 24th of August 2024.


There was only one COVID-19 death reported for the week 25th to 31st of August.

The total number of COVID-19 patients treated in hospital since 1 January 2024 totals 37,922.

The total number of COVID-19 deaths since 1 January 2024 is 200.



Possibility of New SARS-CoV-2 XEC variant behind the new surge.
We cannot confirm nor validate if the new XEC variant is behind the new surge.

This new SARS-CoV-2 XEC variant is supposed to be more transmissible than even the KP.3.1.1 variant.

This XEC variant a recombinant of KS.1.1 (FLiRT) and KP.3.3 (FLuQE). First detected in Berlin in late June 2024, this XEC variant has shown an unprecedented growth rate, making it a likely contender against the currently dominant DeFLuQE variants, such as KP.3.1.1 and its descendants.


covSPECTRUM

This XEC variant todate has spread rapidly across Europe, North America, and Asia, with hundreds of samples reported from 15 countries across three continents.& lt;br />

At present in the United States, it now represents 0.25% of all samples collected.

So far, we cannot find any data if the XEC variant has already debuted in Thailand as genomic sequencing is extremely minimal. Some doctors and Thailand Medical experts however speculate that this new variant has already made its way to Thailand and is possibly behind the week’s increase and they anticipate that cases will start to rise once again gradually.

The unique characteristics of XEC, including the spike T22N mutation in combination with FLuQE mutations, may give it a significant advantage in transmissibility. It also contains the spike F59S mutation.

Current data indicate that XEC is growing at a rate of 3.8% per day, translating to a weekly growth of 27%, the fastest of any known variant. While it remains in the early stages of spread, experts anticipate that XEC could become more prevalent by October or later, particularly in countries like Germany, Denmark, and the Netherlands, where its presence has already been noted.
 

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There Are No Licensed COVID Vaccines for Kids Under 12 — But CDC Wants Babies to Get 3 Pfizer Shots by Age 9 Months
According to the latest CDC guidance, 9-month-old babies must receive multiple doses of an unlicensed mRNA COVID-19 vaccine to be considered “up to date” with their COVID-19 vaccination.

by Ray L. Flores II, Esq., Suzanne Burdick, Ph.D.
September 3, 2024

Nine-month-old babies must receive multiple doses of an unlicensed mRNA COVID-19 vaccine to be considered “up to date” with their COVID-19 vaccination, according to the Centers for Disease Control and Prevention (CDC).

The CDC’s updated guidance, issued Aug. 30, states that children — as young as 6 months old — should get either two doses of the 2024-2025 Moderna vaccine or three doses of the 2024-2025 Pfizer-BioNTech vaccine.

If getting the new Pfizer shot, the baby is supposed to receive the first dose at 6 months, the second dose three weeks later and the third dose at least eight weeks after the second dose — meaning, that by 9 months old, babies are supposed to have received three Pfizer shots.

If getting the latest Moderna shot, the CDC recommends babies get the first dose at age 6 months and the second dose a month later.

The latest Pfizer and Moderna COVID-19 shots for children under 12 are unlicensed in the U.S. The U.S. Food and Drug Administration (FDA) has granted only emergency use authorization (EUA) for the vaccines.

Children’s Health Defense (CHD) CEO Mary Holland told The Defender, “The earlier COVID shots have been proven unsafe and ineffective. Now we’re asked to believe that newer versions are miraculously safe and effective?”

“This is an insult to people’s intelligence,” she said, “I pray that parents will have the good sense to say no to these dangerous and unnecessary shots for babies.”

As of July 28, 37,814 deaths following COVID-19 vaccination had been reported to VAERS, the Vaccine Adverse Event Reporting System, run by the FDA and CDC.

Of those, 187 reports were for children and teens under 18. Nearly 13,000 reports listed the age as “unknown.”

VAERS analyst and expert Albert Benavides recently told The Defender he believes VAERS is “throttling” and underreporting deaths of all ages following COVID-19 vaccination.

Meanwhile, the CDC continues to tell the public that COVID-19 vaccines are “safe and effective.”


CDC ‘absolutely misleading’ public on safety of EUA vaccines


Holland said the CDC is “absolutely misleading” the public by asserting that COVID-19 EUA vaccines are safe and effective because EUA vaccines are not held to the same safety or efficacy standards as licensed vaccines.

“By law,” she explained, “EUA products ‘may be effective,’ and they have not undergone the safety testing required to permit licensing.”

“This is one more horrific example of the CDC putting profits before people and acting as an unethical arm of Big Pharma’s marketing operation,” Holland added.

CHD Chief Scientific Officer Brian Hooker agreed. “It is criminal that these untested vaccines are being recommended to infants and children, especially given the fraudulent tactics to market them to an unsuspecting public,” Hooker told The Defender.


There’s no licensed COVID vaccine for kids under 12


There are still no licensed COVID-19 vaccines available for children under 12, Hooker said — so all COVID-19 vaccines given to young kids are EUA products.

The FDA’s website on EUA for medical products states that EUA vaccines only have to meet the standard of “may be effective” as long as if, “based on the totality of the scientific evidence, it is reasonable to believe that the product may be effective for the specified use.”

“The ‘may be effective’ standard for EUAs provides for a lower level of evidence than the ‘effectiveness’ standard that FDA uses for product approvals,” the website states.

Before a vaccine can be fully licensed, the vaccine maker typically is required to conduct numerous clinical trials to demonstrate that the product is safe. However, the safety requirements for EUA are more flexible.

According to the FDA:

“The amount and type(s) of safety information that FDA recommends be submitted as part of a request for an EUA will differ depending upon a number of factors, including whether the product is approved for another indication and, in the case of an unapproved product, the product’s stage of development.”

Despite this, the first statement on the CDC’s “6 Things to Know about COVID-19 Vaccination for Children” says, “COVID-19 vaccination for children is safe.”


Risks outweigh benefits for kids

Hooker said the CDC’s actions are especially problematic as, historically, the meaning of “safe” has been interpreted by regulatory authorities as meaning that the benefits of a drug outweigh its risks.

“With the risk to children of dying from a COVID-19 infection being statistically zero, it is unclear if there is any benefit,” he said.

Meanwhile, the CDC still claims that “while adverse reactions are rare, the benefits of COVID-19 vaccination outweigh the known risks of COVID-19 and possible severe complications.”


Pfizer fact sheet more forthcoming about risks


For licensed vaccines, the CDC typically provides an official vaccine information statement (VIS) that describes the vaccine’s risks and potential benefits.

According to the CDC website, “Federal law requires that healthcare staff provide a VIS to a patient, parent, or legal representative before each dose of certain vaccines.”

However, for EUA COVID-19 vaccines, the CDC directs people to “fact sheets” — produced by the vaccine manufacturer, not the CDC, and authorized by the FDA — which detail the product’s risks and benefits.

There is no federal law requiring healthcare providers to share these fact sheets with patients, or parents of minors, before a COVID-19 vaccination.

“Pfizer’s own ‘fact sheet’ for its latest COVID-19 vaccine appears to give a more accurate picture [of the vaccine’s risks] than the CDC’s own websites,” Hooker said. “Shouldn’t the CDC be more a watchdog than Pfizer?”

For example, Pfizer’s fact sheet states, “A product authorized for emergency use has not undergone the same type of review by FDA as an FDA-approved product.”

The Pfizer fact sheet also acknowledges that its vaccine “may not protect everyone” and that reported side effects associated with the Pfizer vaccines include myocarditis and pericarditis.

Hooker pointed out that research has shown that vaccine-induced myocarditis, inflammation of the heart, and pericarditis, inflammation of the tissue surrounding the heart can be fatal.

He urged parents to “read between the lines” when assessing the CDC’s COVID-19 vaccination recommendation for babies and children.

“Most of all,” he added, “use common sense to decide if the CDC’s and the FDA’s logic is sound.”
 

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COVID-19 government disaster loans saved businesses, but saddled survivors with debt
Mae Anderson
Tue, Sep 3, 2024, 12:41 PM EDT

NEW YORK (AP) — In 2020 and 2021, COVID-19 Economic Injury Disaster Loans were a lifeline for small businesses.

But now some small businesses are having trouble paying them off. And a Small Business Credit Survey report from the 12 Federal Reserve banks shows that small businesses that haven't paid off COVID-19 Economic Injury Disaster Loans are in worse shape than other small businesses.

Dwayne Thomas, owner of events lighting company Greenlight Creative in Portland, Oregon, got a roughly $500,000 EIDL loan in 2020, when all events shut down, crippling his businesses.

EIDL loans were designed to help small businesses stay afloat during the COVID-19 pandemic. Most of these loans have a 30-year term with a 3.5% interest rate. With lower interest rates than typical loans, the loans were provided for working capital and other normal operating expenses.

Thomas says his business would not have survived without the loan. But, at 64, his plan to sell his business in a few years and retire has been scuttled, since the 30-year loan has left his business saddled with debt, even though otherwise it's a healthy business that turns a profit.

“We’re as successful as we’ve ever been," Thomas said. “It’s just that we have this huge thing hanging over us at all times. It is not going away on its own.”

The SBA awarded about 4 million loans worth $380 billion through the program. More than $300 billion was outstanding as of late 2023. Unlike some other pandemic aid, these loans are not forgivable and must be repaid.

The survey by the Federal Reserve Banks found firms with outstanding EIDL loans had higher debt levels, were more likely to report challenges making payments on debt and were less likely to be profitable as of fall 2023, when the survey was conducted.

Firms with outstanding EIDL debt are also more likely to be denied when applying for additional credit. Half said they were denied for having too much debt.

Still, the survey stopped short of saying the disaster loans were a negative for companies. Some companies said they would have gone out of business altogether if it weren't from the loans. And it's impossible to measure whether the companies that haven't paid off these loans weren't in worse shape from the start.

Colby Janisch, a brewer at 902 Brewing Company in Jersey City, New Jersey, received a loan from the EIDL program of about $400,000. But unlike a loan for an asset that you can pay off, the loan just went to rent and other overhead costs. And Janisch said the outstanding debt stops them from taking on other loans for assets that could help the business.

“It's hindered us because we don’t want to take out any loans to invest in the company now because we have such outstanding (debt),” he said. “So it’s definitely like a weighing on us, of like what we do going forward.”
 

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Late start of COVID treatment may still benefit immunocompromised patients

by Georgia State University
September 3, 2024

study-late-start-of-co.jpg

C57BL/6 CD4+/CD8+ T cell mouse depletion model. (a) Study schematic. Blood, turbinates, and lungs were harvested and processed for flow cytometry; n numbers as specified. (b) Body weight curves of mice, normalized to the initial weight before the first depletion injection (study day -5). Graphs show each replicate (aligned). Horizontal dashed line denotes the predefined 20% weight-loss endpoint criteria, and vertical dashed lines indicate time of depletion injections. (c–e) Flow cytometric analysis of blood (c), turbinates (d), and lungs (e). A representative plot is shown for each analysis and condition. Right panels show CD4 and CD8 frequencies (in %). Data represent mean ± SD, P values based on one-way ANOVA with Dunnett post-hoc test. Credit: Journal of Virology (2024). DOI: 10.1128/jvi.00905-24



Starting antiviral treatment as late as 14 days after infection with SARS-CoV-2 may still be beneficial in hosts with compromised immune systems, who are at greatest risk of developing severe COVID-19, according to researchers in the Center for Translational Antiviral Research at Georgia State University's Institute for Biomedical Sciences.

While it's best to begin treatment earlier, in immunocompromised hosts, drugs like paxlovid and molnupiravir appear to inhibit replication of the virus even if they are initiated up to 14 days after infection.

The study, published in the Journal of Virology, offers new information about late-onset treatment introduced 14 days after infection with SARS-CoV-2, the virus that causes COVID-19. The findings demonstrate that antiviral therapeutics could have valuable clinical use in late-onset management of persistent SARS-CoV-2 infection in immunocompromised patients, in addition to reducing the risk of progression to severe disease.

The researchers sought to offer specific SARS-CoV-2 treatment plans to the immunocompromised and tested late-onset therapeutic options with standard-of-care paxlovid and molnupiravir and experimental therapeutic 4'-Fluorouridine (4'-FlU) in a T-cell depleted immunocompromised mouse model of SARS-CoV-2.

The Centers for Disease Control and Prevention (CDC) recommends that individuals with impaired immune functions use antivirals and immunomodulatory drugs at doses and durations similar to the general patient population, but this new study indicates benefits of late treatments to mitigate persistent viral replication, the authors explained.

"Paxlovid, molnupiravir and pre-clinical candidate 4'-FlU significantly lowered virus loads in turbinates (bony structures in the nose that regulate airflow and warm and humidify air that is inhaled) when treatment was initiated 14 days after the infection for seven days," said Dr. Carolin M. Lieber, first author of the paper and a postdoctoral fellow in the Center for Translational Antiviral Research at Georgia State.

"We demonstrated that late-onset antiviral treatment can provide major therapeutic benefit to an immunocompromised host infected with SARS-CoV-2," said Dr. Richard K. Plemper, senior author of the study, Regents' Professor and Director of the Center for Translational Antiviral Research at Georgia State. "This study highlights that appropriately powered clinical trials are urgently needed to best serve the specific needs of a patient population at high risk to develop severe COVID-19."

In the study, immunocompromised mice experienced low-level viral replication for 35 days after the infection with SARS-CoV-2. When started on antivirals 14 days after infection, however, the duration of virus replication was significantly shortened, which could have implications for clinical usage of antiviral drugs in immunocompromised patients.

Additional authors of the study include Hae-Ji Kang, Vu Ngo and Andrew Gewirtz of the Institute for Biomedical Sciences at Georgia State; Elizabeth Sobolik and Alexander Greninger of the University of Washington Medical Center; Zachary Sticher, Alexander Kolykhalov and Michael Natchus from the Emory Institute for Drug Development; and Mehul Suthar from the Emory University School of Medicine.

More information: Carolin M. Lieber et al, Efficacy of late-onset antiviral treatment in immunocompromised hosts with persistent SARS-CoV-2 infection, Journal of Virology (2024). DOI: 10.1128/jvi.00905-24
Journal information: Journal of Virology
Provided by Georgia State University
 

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Newly discovered antibody protects against all COVID-19 variants
by University of Texas at Austin
September 3, 2024

Researchers have discovered an antibody able to neutralize all known variants of SARS-CoV-2, the virus that causes COVID-19, as well as distantly related SARS-like coronaviruses that infect other animals.

As part of a new study on hybrid immunity to the virus, the large, multi-institution research team led by The University of Texas at Austin discovered and isolated a broadly neutralizing plasma antibody, called SC27, from a single patient. Using technology developed over several years of research into antibody response, the team led by UT engineers and scientists obtained the exact molecular sequence of the antibody, opening the possibility of manufacturing it on a larger scale for future treatments.

"The discovery of SC27, and other antibodies like it in the future, will help us better protect the population against current and future COVID variants," said Jason Lavinder, a research assistant professor in the Cockrell School of Engineering's McKetta Department of Chemical Engineering and one of the leaders of the new research, which was recently published in Cell Reports Medicine.

During the more than four years since the discovery of COVID-19, the virus that causes it has rapidly evolved. Each new variant has displayed different characteristics, many of which made them more resistant to vaccines and other treatments.

Protective antibodies bind to a part of the virus called the spike protein that acts as an anchor point for the virus to attach to and infect the cells in the body. By blocking the spike protein, the antibodies prevent this interaction and, therefore, also prevent infection.

SC27 recognized the different characteristics of the spike proteins in the many COVID variants. Fellow UT researchers, who were the first to decode the structure of the original spike protein and paved the way for vaccines and other treatments, verified SC27's capabilities.

The technology used to isolate the antibody, termed Ig-Seq, gives researchers a closer look at the antibody response to infection and vaccination using a combination of single-cell DNA sequencing and proteomics.

"One goal of this research, and vaccinology in general, is to work toward a universal vaccine that can generate antibodies and create an immune response with broad protection to a rapidly mutating virus," said Will Voss, a recent Ph.D. graduate in cell and molecular biology in UT's College of Natural Sciences, who co-led the study.

In addition to the discovery of this antibody, the research found that hybrid immunity—a combination of both infection and vaccination—offers increased antibody-based protection against future exposure compared with infection or vaccination alone.

The work comes amid another summer COVID spike. This trend shows that while the worst of the pandemic may have passed, there's still a need for innovative solutions to help people avoid and treat the virus.

The researchers have filed a patent application for SC27.

More information: William N. Voss et al, Hybrid immunity to SARS-CoV-2 arises from serological recall of IgG antibodies distinctly imprinted by infection or vaccination, Cell Reports Medicine (2024). DOI: 10.1016/j.xcrm.2024.101668
Journal information: Cell Reports Medicine
Provided by University of Texas at Austin
 

Heliobas Disciple

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‘A ton of Covid out there’: US summer wave not taken seriously enough – experts
Epidemiologists push newly approved booster vaccines as current virus strain threatens at-risk groups

Eric Berger
Wed 4 Sep 2024 08.00 EDT

Infectious disease experts say many people are not taking the latest Covid-19 wave in the US seriously enough and are not getting vaccinated or using antiviral drugs when sick, despite a summer wave that was larger and came earlier than anticipated.

Epidemiologists are saying that while symptoms of this wave are more mild than earlier strains, the virus remains a threat – particularly for older adults and people with underlying health conditions.

In response, public health officials are urging people to get a booster now – unless they recently had Covid, in which case they should wait three to four months – and to take a rapid test when sick. And if they have Covid, they should ask their doctors about antiviral treatments.

“There is a ton of Covid out there,” said Jennifer Nuzzo, an epidemiologist and director of the Pandemic Center at the Brown University School of Public Health. “If you’re experiencing any kind of symptoms, test yourself because you might benefit from getting medicine. At the very least, you can learn that you’re infected and stay home so you don’t give it to other people.”

Notably, the Covid viral activity in wastewater in August in the United States was almost twice as high as the same time last year and about the same as the peak of summer 2023, according to Centers for Disease Control and Prevention data. Still, hospitalizations and deaths are a fraction of what they were in 2022.

“Every time someone gets sick, there is always a risk involved, but the fact that we haven’t seen a massive upswing in hospitalizations or deaths is what ultimately we look at because this virus isn’t going away,” Nuzzo said.

Justin Lessler, an epidemiology professor at the University of North Carolina, attributes the unexpectedly high wave to new variants that have “run away from our immune system a little faster than we expected” and to people being less cautious about the virus than in previous years.

When someone develops symptoms of Covid – such as fever, cough or sore throat – they should take a test, even if they are not worried about it, Lessler said.

“It’s more about courtesy now than direct public health impact,” Lessler said. That means considering “people who may be at high risk or more worried about the disease than others”.

The Biden administration recently announced that it would again make free Covid-19 tests available at the end of September. US households can order four Covid tests at Covidtests.gov.

Testing when you develop symptoms is also important because antiviral drugs like Paxlovid are most effective when taken early in the course of an illness. Despite the drugs’ benefits, studies have shown that they are underutilized.

“I think doctors, just like members of the public, have come to think of Covid as just one of those things, as opposed to something which can be responded to quickly and proactively with antivirals where appropriate,” said Bill Hanage, an epidemiologist at the Harvard TH Chan School of Public Health.

Though the virus is not as dangerous as it was during the height of the pandemic, Covid can still cause severe symptoms.

Last month, the Food and Drug Administration approved new Pfizer-BioNTech and Moderna vaccines. The epidemiologists recommend that people get the booster now rather than wait until closer to winter.

Hanage is concerned that “people will be not taking advantage of the available protection and that we will end up seeing more serious illness, more hospitalizations and more deaths than we need to”.

Nuzzo said she would not argue with younger people who decide that they are OK with potentially getting Covid, but she wants to make sure older adults who are at high risk get the vaccine.

“There is a clear benefit,” Nuzzo said.

As to what the Covid numbers could look like in the fall and winter, epidemiologists do not have definitive answers.

“I think there is a little chance it will be on the smaller side because the summer wave was so big, but that being said, we have not had a winter without a wave yet,” Lessler said. “I don’t see any reason that should change.”
 

Heliobas Disciple

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(fair use applies)


For people without insurance, updated Covid-19 shots are no longer free of charge at pharmacies
Jacqueline Howard, CNN
Thu, September 5, 2024, 12:47 PM EDT

The rollout of updated Covid-19 vaccines has begun in the United States, but for the first time, the shots will no longer be free of charge for people without insurance at their local pharmacy.

Earlier in the pandemic, vaccines were purchased by the federal government and free for everyone. Last year, as the shots transitioned to the commercial market, the US Centers for Disease Control and Prevention’s Bridge Access Program provided free Covid-19 vaccines to adults without insurance and those whose insurance didn’t cover all vaccine costs. The program ended last month due to lack of federal funding.

“This means that purely uninsured people do not have access to get free Covid shots and so if they went to their pharmacy to try to get one, they’d come with a cost,” said Lori Freeman, chief executive officer for the National Association of County and City Health Officials. About 26 million people in the United States are uninsured.

“We know that cost, at this moment in time with the economy, is even more of a burden than ever,” Freeman said.

Most people with private insurance, Medicare or Medicaid will still be able to get vaccinated at no out-of-pocket cost, but for adults without insurance or those whose insurance does not cover the vaccine, getting the updated shot at a pharmacy could cost $201.99.

The change may catch some people by surprise.

CVS Pharmacy has posted information on its website about how much the updated Covid-19 vaccines may cost without insurance, said CVS spokesperson Amy Thibault. On a Q&A page on its site, it urged people to check whether their insurance plan covers the vaccines and if CVS is in-network.

During the last several months, Walgreens has been educating its pharmacy team members on the discontinuation of the Bridge Access Program, Walgreens corporate spokesperson Samantha Stansberry said in an email Tuesday.

“Our pharmacists are aware of the changes and can assist any patients who have questions,” Stansberry said. “Walgreens remains committed to driving equitable and convenient access to life-saving vaccines. We will continue to work with patients eligible for the COVID-19 vaccine to determine the best and most cost-efficient way to receive one.”

In some states, there might still be free shots available to some people. The CDC announced last month that it is distributing $62 million to state and local health departments to provide free Covid-19 vaccines to adults who wouldn’t otherwise be able to afford them.

States can order Covid-19 vaccines now, a CDC spokesperson said in an email Thursday. The program will provide vaccines through the 2024-2025 fall and winter respiratory season.

“We expect the supply in states to continue to increase,” the spokesperson said. “These funds will enhance immunization programs through support to state and local health departments, which will work with vaccine providers in their states to make them available.”

Once a health department receives the vaccines, some may decide to host public vaccination clinics or events, Freeman said.

Even with the end of the Bridge Access Program, Freeman said that many state and local health departments still would like to be involved in making updated Covid-19 vaccinations accessible to the public.

“We want the local health department to be a primary provider with the state and to have that continuous public health program,” Freeman said. “There has to be a way to both leverage the need to get vaccines safely in the hands of public, but also recognize the permanent role of the health department as a provider.”

Covid-19 levels in the US are very high and rising, according to wastewater surveillance data from the CDC. Levels have been rising since May and are already as high as they were in December of last year. Hospitalization rates related to Covid-19 also remain elevated, particularly among adults 65 and older and children under 2 years, according to the CDC.

Last season, an estimated 22.5% of adults and 14.4% of children were fully vaccinated against Covid-19 with updated shots.

People still should make a commitment to get vaccinated against Covid-19 with the updated shots this fall, said Dr. Georges Benjamin, executive director of the American Public Health Association.

“If you’re insured, you ought to check with your insurance company to find out what the parameters are around getting vaccinated. Your vaccination should be free under the Affordable Care Act,” Benjamin said.

“If you are uninsured or underinsured, then you should check with your state or local health department and see what provisions they’re making for uninsured and underinsured people. Some of the state and local health departments, understanding this is a problem, are working with their governor’s office or mayor’s office to find funding to provide access to vaccine. In most cases, if the vaccine is available and if they have vaccine, they’ll be able to provide it for you at either no cost or reduced cost,” he said. “And there are some pharmacy assistance programs that should be available for Pfizer and Moderna.”
 

Heliobas Disciple

TB Fanatic
(fair use applies)


French study finds that COVID-19 vaccination increases risk of heavy menstrual bleeding

Nikhil Prasad Fact checked by:Thailand Medical News Team
Sep 06, 2024

A recent nationwide case-control study in France has shed light on the potential link between COVID-19 mRNA vaccination and the risk of heavy menstrual bleeding in women. Conducted by researchers from various French institutions, including EPIPHARE Scientific Interest Group in Epidemiology of Health Products, the French National Agency for the Safety of Medicines and Health Products (ANSM), and the French National Health Insurance (CNAM), the study provides valuable insights into a health concern that has been inconsistently reported in previous research. This Medical News report explores the study findings, methodology, and its implications for public health.


Study Background and Purpose

The European Medicines Agency (EMA) had earlier considered abnormal menstrual bleeding as a potential side effect of COVID-19 mRNA vaccines, such as Comirnaty (Pfizer/BioNTech) and Spikevax (Moderna). Many women reported experiencing heavier-than-usual menstrual bleeding after receiving these vaccines. However, the link between the vaccines and menstrual irregularities, specifically heavy menstrual bleeding requiring hospital care, remained uncertain.

The French researchers aimed to address this gap in knowledge by assessing the risk of hospital care for heavy menstrual bleeding after COVID-19 vaccination, considering the number of doses and time since vaccination.


Methods and Study Design
This nationwide case-control study used data from the French National Health Data System, which includes information on healthcare use, socio-demographic characteristics, COVID-19 vaccinations, and hospital care. The study examined 4,610 women aged 15 to 50 years who were hospitalized for heavy menstrual bleeding between May 2021 and August 2022. These women, referred to as "cases," were compared to a control group of 89,375 women who had not been hospitalized for menstrual irregularities. The researchers matched the cases and controls based on factors such as age, place of residence, social deprivation index, and contraceptive use.

The study's primary focus was on determining the association between COVID-19 vaccination and heavy menstrual bleeding requiring hospital care. The researchers analyzed the risk based on the timing of the last vaccine dose and the type of vaccine received. Both primary vaccination (first and second doses) and booster doses were included in the analysis.


Key Findings: Increased Risk Within Three Months After Vaccination
The study found that women who had received a primary dose of the COVID-19 vaccine within the last 1 to 3 months were at a 20% higher risk of being hospitalized for heavy menstrual bleeding compared to unvaccinated women. The risk was especially pronounced among women living in socio-economically deprived areas and those who were not using hormonal contraception.

Interestingly, no increased risk was observed within the f irst month after vaccination or beyond three months. Additionally, booster doses did not appear to elevate the risk of heavy menstrual bleeding.

In practical terms, the study estimated that approximately 103 cases of heavy menstrual bleeding requiring hospital care in France could be attributed to COVID-19 vaccination during the study period. Given that over 13 million women in France were vaccinated between May 2021 and August 2022, the overall risk remains relatively low. However, for the women affected, the experience was significant enough to require hospital care.


Implications for Public Health and Vaccine Safety
These findings provide important context for ongoing discussions about COVID-19 vaccine safety, particularly in relation to women's health. While the study confirms a modest increase in the risk of heavy menstrual bleeding after primary vaccination, it also underscores that the overall incidence remains low. Moreover, the increased risk appears to be short-lived, confined to the three-month period following vaccination.

From a public health perspective, this study reinforces the importance of monitoring vaccine side effects, especially those that may disproportionately affect specific populations, such as women in socio-economically disadvantaged areas. Health professionals should be aware of these findings to provide appropriate care and reassurance to women who experience abnormal menstrual bleeding after vaccination.


Understanding the Biological Mechanism
The biological mechanism behind the association between COVID-19 vaccination and menstrual disturbances remains unclear. Researchers have proposed several hypotheses, including the involvement of the hypothalamic-pituitary-ovarian axis and immune-mediated changes that could affect menstrual bleeding. Some experts suggest that immune changes triggered by the vaccine may lead to temporary disruptions in menstrual cycles, similar to the way other vaccines can cause menstrual irregularities.

While this study focused on mRNA vaccines, similar menstrual side effects have been reported with other vaccines, such as the human papillomavirus (HPV) vaccine and hepatitis B vaccine. Understanding the underlying mechanisms may help researchers develop strategies to mitigate these side effects in future vaccination campaigns.


Study Limitations and Strengths

As with any study, there are limitations to consider. One of the primary limitations of this research is its reliance on hospital data. While the study captured the most severe cases of heavy menstrual bleeding that required hospital care, it may have missed less severe cases that were managed in outpatient settings. This limitation could result in an underestimation of the true incidence of post-vaccination menstrual disturbances. Additionally, the study was limited to women aged 15 to 50 years, so its findings may not apply to other age groups, such as post-menopausal women.

Despite these limitations, the study has several strengths. The use of nationwide data and a large sample size enhances the reliability of the findings. Furthermore, the researchers adjusted for numerous potential confounding factors, including socio-demographic characteristics, healthcare use, and comorbidities, which helps to isolate the effect of COVID-19 vaccination on heavy menstrual bleeding.


Conclusion: A Modest but Manageable Risk

In conclusion, this study provides valuable evidence of an increased risk of heavy menstrual bleeding within three months of primary COVID-19 vaccination with mRNA vaccines. However, the risk is modest and appears to be temporary, with no increased risk observed beyond three months. For women who experience heavy menstrual bleeding after vaccination, the findings suggest that the condition is likely to resolve over time. Importantly, the study highlights the need for continued monitoring of vaccine side effects, particularly those that affect women's reproductive health.

The study findings were published in the peer-reviewed journal Vaccine.

 

Heliobas Disciple

TB Fanatic
This isn't true. Well, some think it's true;). But it was debunked up thread and we agreed to disagree.

Here's an article that may state it better than my attempt up thread.

(fair use applies)


No, NZ police can’t forcibly vaccinate under pandemic plan
David Williams
August 16, 2024

WHAT WAS CLAIMED
New Zealand’s Pandemic Plan gives police power to restrain citizens for forced vaccination.

OUR VERDICT
False. NZ's Bill of Rights Act prevents any forced medical procedure.


AAP FACTCHECK – New Zealand police have been given the power to restrain citizens for forced vaccinations under a new pandemic plan, viral social media posts claim.

This is false. Legal experts say there’s no law in NZ that gives police or anyone else the power to enforce any medical procedure, including vaccinations, and that doing so would contravene the country’s Bill of Rights Act.

Multiple Facebook posts make the claim, including one that shares a screenshot of an X post that reads: “New Zealand has legalized the use of physical force to vaccinate”.

It continues: “They can tie you down on a bed and inject a barbaric cocktail into you. And you have no recourse when it harms you, because the manufacturers have immunity and the government aren’t breaking the law.”

Like other posts, it shares a link to an article headlined “New Zealand Police given power to restrain citizens for forced vaccinations under new ‘Pandemic Plan'”.

It’s published by The People’s Voice, a site that has been checked multiple times by AAP FactCheck.

The article refers to “special powers” included in the NZ government’s Pandemic Plan, which was updated in July 2024 and sets out the country’s strategy for preparing for and responding to future pandemics.

The section concerning “special powers” (p125) outlines the scope of the powers that are granted within section 70 of the NZ Health Act 1956.

They include the power to require people to be isolated, quarantined or disinfected, “until they have undergone such preventive treatment as the medical officer of health prescribes”.

This section of the plan also refers to section 71A of the act, which it says gives police the power to “do anything reasonably necessary (including the use of force) to help a medical officer of health” exercise their powers under sections 70 or 71 of the act.

This is the part of the plan that has fuelled reaction online.

But neither the Pandemic Plan’s section on special powers, nor sections 70 and 71 in the Health Act, mention forced vaccinations.

However, section 11 of the NZ Bill of Rights Act states that “everyone has the right to refuse to undergo any medical treatment”.

Forcing someone to take any treatment, including vaccines, would contravene this right.

Professor of law at the University of Canterbury, John Hopkins, said there were no powers for the police to restrain people for vaccination or to force people to undergo medical procedures of any kind in NZ.

“Such powers are contrary to the New Zealand Bill of Rights Act (s11) and while [the act] can be overridden by a specific statute this would be very unlikely to occur,” Prof Hopkins told AAP FactCheck.

“Such powers certainly couldn’t exist in a pandemic plan which is not a legal document. It’s a strategy document to guide planning and response.”

Prof Hopkins said it was important to distinguish between the ability to force someone to undertake medical treatment, and the consequences that might occur if they refuse to undertake that treatment.

The former is not permitted under NZ law. But the latter can be, if the consequences are proportionate, such as prolonged isolation.

Associate Professor of law at the University of Auckland, Hanna Wilberg, told AAP FactCheck that “during the Covid pandemic, [NZ] required certain professions to be vaccinated, but the element of compulsion was that they might not be able to work in that profession if they did not comply.

“There was never any suggestion of physically forced vaccinations.”

Prof Wilberg said that if forced vaccinations were ever planned this would have to be provided by law, not just a pandemic plan.

She said if that was ever the case, NZ courts would “almost certainly” find forced vaccinations to be an “unjustified limit on the right to refuse medical treatment”.

“On that basis, if it was in secondary legislation they would find it unlawful. If it was in an Act of Parliament they would try to read it some other way so as not to authorise forced vaccinations, and otherwise would declare the Act to be inconsistent with the Bill of Rights.”
 

Heliobas Disciple

TB Fanatic
(fair use applies)


Do At-Home COVID-19 Tests Still Work?
Jamie Ducharme
Fri, September 6, 2024, 10:44 AM EDT

These days, many people use at-home COVID-19 tests when they feel ill, rather than going out to get tested by a professional. (That’s when they bother to test at all.) But for all their convenience, the antigen tests commonly used at home have never been as accurate as PCR tests done in a lab—and the continued mutation of the virus raises additional concerns about their performance.

Rapid COVID-19 tests have never been perfect. How are they holding up as new variants emerge?

The U.S. Food and Drug Administration (FDA) continues to monitor the efficacy of the diagnostics it regulates—and as of August 2023, the FDA said none of the antigen tests on the market were expected to have reduced performance against Omicron or its subvariants. (All of the variants that have emerged since late 2021, including recent ones like KP.3.1.1, are relatives of the original Omicron strain.)

The FDA has also collaborated with a U.S. National Institutes of Health task force set up to monitor how variants affect tests. In 2022, well into Omicron's dominant era, that team concluded that DIY diagnostics continued to work well. Task force member Richard Creager wrote in an email to TIME that the tests still seem able to catch the Omicron spinoffs that are circulating now. “The rapid tests are having no issue detecting the variants,” he wrote, noting that the protein that antigen tests look for has remained fairly stable as the virus changes.

Even if tests have remained constant, our immune systems haven’t. Early in the pandemic, an infected person's “viral load”—the amount of virus in their system—tended to peak around the time their symptoms began. So if someone self-tested on the first or second day they felt sick, they likely had enough virus in their body for a rapid test to detect it.

Now that most everyone has prior immunity from multiple vaccines or infections, the timeline seems to be extended. Viral load now tends to peak around day four or five of symptoms, according to a study published in early 2024. That’s likely because the immune system is primed for action by its previous encounters with the virus, so it responds faster, even before lots of virus has built up in the body. A quicker immune response may mean a faster onset of symptoms.

“If your body has seen the virus before, you’re going to react to it and have an immune response more quickly,” explains study co-author Dr. Nira Pollock, co-director of the Infectious Diseases Diagnostic Laboratory at Boston Children’s Hospital. “That immune response can show up as symptoms.”

From an immune perspective, that’s a good thing. But it can complicate testing, because it means someone may not test positive for COVID-19 until they’ve already been feeling sick for days. In their recent study, Pollock and her co-authors estimated that a COVID-19 antigen test is somewhere between 30% and 60% accurate at detecting an infection on someone’s first day of symptoms, but up to 93% accurate on day four.

Based on such findings, Pollock and other researchers cautioned in a recent review article that people who are symptomatic shouldn’t assume they’re COVID-free based on a single negative antigen test result. Although it's a hard sell for people who no longer take precautions, the ideal scenario is for someone to stay isolated—or at least wear a mask when around other people—and test again around day four of symptoms.

“The instructions for these tests are to do serial testing,” Pollock says. “If you’re symptomatic, you should test early. But if you’re negative, you need to repeat it, because the amount of virus in your nose may not be high enough yet to detect.”

One other factor to consider: tests don’t last forever. Many people stockpiled tests when they were previously available for free through government programs and insurance, and those kits may have since expired. (You’ll soon be able to order four more free tests through the government.) The FDA’s website provides up-to-date guidance on determining how long your kits last.

Expired tests can still work, says Dr. Zishan Siddiqui, an assistant professor at the Johns Hopkins University School of Medicine. He co-authored a 2023 study on Abbott’s popular BinaxNOW tests, which found no major accuracy differences between unexpired tests and those that were five months past expiration. (Siddiqui’s other research suggests unexpired BinaxNOW tests accurately detect COVID-19 cases more than 80% of the time.)

But, although Siddiqui says he isn't too worried about using expired tests, it’s good to remember that their performance can suffer if they’re long past their recommended use dates. If the control line on your test strip doesn’t show up or looks distorted, that’s a good indication that it’s too old to use, he says. Even in Siddiqui's study, which found that expired tests still work, the lines on the old tests showed up more faintly than on fresh tests, making them harder to read.

Whether your tests are old or brand new, it’s good to use some healthy skepticism when interpreting their results. “I trust these tests,” even as the virus evolves, Siddiqui says—but a single result doesn’t always tell the whole story. If you have COVID-like symptoms but test negative, it’s best to be cautious and retest in a few days.
 

Tristan

TB Fanatic
Dr. Campbell discusses recent peer-reviewed studies, freely available, that claim the growth of nano-particle structures.

Woo/Not Woo?

He is concerned that the video will be censored, but hasn't been to this point. He also takes the opportunity to chide governmental agencies regarding their lack of transparency and unwillingness to actually study any issues.

I've been following the idea that there could be these structures for quite some time, and had filed it away under 'woo' or 'probable woo'. Not so sure now.

mRNA nanostructures​

View: https://www.youtube.com/watch?v=eEgjuB-0bw8

rt: 15:11

There is a link to the complete study in pdf form in the description. It is a large file, too large to cut-n-paste here.

(If this isn't the appropriate place to post this, let me know and I'll move it.)
 
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jward

passin' thru
You should post this to the pox thread.
You're always welcome to repost anything I've posted to any location you think would benefit if you wish, or to ask me to add it somewhere.


This isn't true. Well, some think it's true;). But it was debunked up thread and we agreed to disagree.

Here's an article that may state it better than my attempt up thread.
Thanks for clearing that up- I'll leave my wrong post though, for clarity, and coz it looks cheesy when folks go back and change their posts- and because the time has elapsed for me to change it LOL.
 

Heliobas Disciple

TB Fanatic
Thanks for clearing that up- I'll leave my wrong post though, for clarity, and coz it looks cheesy when folks go back and change their posts- and because the time has elapsed for me to change it LOL.

Fine with me if you leave it. We had a nice back and forth about whether it was true when it was posted a few weeks ago and never resolved it. Well, each of us thought it was resolved as for what we believed, but we never did agree! We decided to agree to disagree. So now we revisited ;)

HD
 

Heliobas Disciple

TB Fanatic
Dr. Campbell discusses recent peer-reviewed studies, freely available, that claim the growth of nano-particle structures.

Woo/Not Woo?

He is concerned that the video will be censored, but hasn't been to this point. He also takes the opportunity to chide governmental agencies regarding their lack of transparency and unwillingness to actually study any issues.

I've been following the idea that there could be these structures for quite some time, and had filed it away under 'woo' or 'probable woo'. Not so sure now.

mRNA nanostructures​

View: https://www.youtube.com/watch?v=eEgjuB-0bw8

rt: 15:11

There is a link to the complete study in pdf form in the description. It is a large file, too large to cut-n-paste here.

(If this isn't the appropriate place to post this, let me know and I'll move it.)

So, of course, it's been deleted. I would've liked to watch this. Dr. McMillan also posted something today about mrna nanostructures, I wonder if it was the same study? I'll post that one below. I will look for Dr. Campbell's video on Rumble or Bitchute and if I find it, I will edit this post with a link to his video there.

ETA:


This is a link I found on bitchute. It's not on his page, it's someone who mirrored it, so there's no link to the study, but watching it now and looking at his pictures, it looks like it's the same study that Dr. McMillan is discussing in the video below and the link is in that post. I'll also post a link to a pdf of the study:

15 min 11 sec


also mirrored here, in case one of them gets taken down



Adding Rumble links, these too are mirrors of the video, not posted on John Campbell's page. Hopefully one of all of these (bitchute and rumble) will remain and not be taken down;






HD
 
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Heliobas Disciple

TB Fanatic
View: https://www.youtube.com/watch?v=o4IU71zHnCQ
Vaccine Nanobots: The Conspiracy That Could Be True
Vejon Health
Streamed live 15 hours ago
34 min 58 sec

In this incredible video, we dive deep into the controversial topic of vaccine nanobots. Are they a ground-breaking scientific advancement or just a conspiracy theory?

~~~~~~~~~~~~~~~~

Here's the article he wrote about it on his substack page:


(fair use applies)

Is the Vaccine Nanobot Theory Real?
A Deep Dive Into Strange Science of Abnormal findings in the Vaccine Vials!

Dr Philip McMillan
Sep 07, 2024

What I'm about to share with you is so strange that I almost didn't talk about it. Even though it’s based on a peer-reviewed, published paper, I initially planned to ignore it. But something equally bizarre happened regarding Health Canada that pushed me to take a closer look.

Now, if you've followed my work, you know that I'm not afraid of diving into controversies or conspiracy theories. I analyse the science thoroughly to see if it holds up. And what’s disturbing is that many of the things I've questioned have turned out to be true. So, when I stumbled upon this paper, I had to ask myself: Could this wild idea about vaccine nanobots actually be real?

The study I’m talking about was published in the International Journal of Vaccine Theory, Practice, and Research in July 2024. The researchers conducted a longitudinal study on mRNA vaccines, primarily from Pfizer and Moderna. Their findings were alarming: they observed the self-assembly of artificial constructs, like worm-like entities and strange geometric shapes, in the vials. They concluded that there may be some form of nanotechnology involved.

Lee, Young Mi, and Daniel Broudy. "Real-Time Self-Assembly of Stereomicroscopically Visible Artificial Constructions in Incubated Specimens of mRNA Products Mainly from Pfizer and Moderna: A Comprehensive Longitudinal Study." International Journal of Vaccine Theory, Practice, and Research 3.2 (2024): 1180-1244.

I know how this sounds. Mainstream science would dismiss this immediately. But just because it wasn't published in The Lancet doesn't mean it should be ignored. The journal’s authors, including experts from South Korea and Japan, spent up to two years analysing these samples. The research is extensive, and it raises valid questions that should be explored, not dismissed outright.

What’s even stranger is a recent move by Health Canada. They ordered the destruction of all existing COVID vaccines in September, right before the new versions are released. Why destroy them now, especially in the middle of a summer wave of infections? It makes me wonder if there’s a connection between this destruction and concerns over contaminants in the vaccines.


Ottawa News - Sept 4, 2024, Elizabeth Payne
Read article here >

This is where I have to pause and reflect. Could these findings, though controversial, be connected to larger issues like the embalmers’ clots I’ve been studying? I’ll be discussing my thoughts on this in an upcoming webinar. If you're curious, I encourage you to register—it could be eye-opening.

In conclusion, I’m not saying that vaccine nanobots are real. But these findings and the actions of Health Canada should make us all ask harder questions. Sometimes where there’s smoke, there’s fire. And it’s our responsibility to investigate that smoke.
 
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Heliobas Disciple

TB Fanatic
(fair use applies)


COVID-19 surges in France as 24,693 new cases reported for the week August 26th to September 1st 2024

Sebastian Lavoie Fact checked by:Thailand Medical News Team
Sep 07, 2024

During the epidemiological week 35 of 2024 (August 26 to September 1), France experienced an increased incidence of acute respiratory infections (ARIs), including COVID-19, flu, and other respiratory viruses. The estimated ARI rate in general medicine consultations was 91 cases per 100,000 inhabitants, unchanged from the previous week. Specifically, COVID-19-related ARIs accounted for 37 cases per 100,000 inhabitants, totaling an estimated 24,693 new cases.


Regional COVID-19 Trends
The ARI surveillance, conducted by the Sentinelles and EMR networks, reported stable rates across all age groups compared to the previous week.

Virological tests for COVID-19 (RT-PCR or antigen tests) confirmed the spread of respiratory viruses, with a notable presence of COVID-19 among other viral infections. The analysis includes data from both face-to-face clinical consultations and teleconsultations, providing a comprehensive view of the epidemiological situation.

The geographic distribution of ARIs across metropolitan France shows variability, but the overall activity remains moderate. The highest rates of COVID-19 and other respiratory infectiosn have been observed in Corsica, Britanny and Auvergne-Rhone-Alpes.

Out of declared ARI cases by general practitioners, majority were thoroughly documented, with a median patient age of 41 years. Additionally, 18% of the patients exhibited risk factors for complications, while 2% required hospitalization.

Local COVID-19 News reports have also indicated that outpatient visits to hospitals and clinics have risen in the last two weeks coupled with sales of rapid COVID-19 test kits from drug stores and pharmacies.


SARS-CoV-2 KP.3 Variants and Sub-lineages Predominantly at Play.

Data from the Cov-Spectrum platform shows that it is mainly the various KP.3 variants and sub-lineages that are predominantly circulating in France at the moment.



Broader Respiratory Virus Landscape

France faces the circulation of multiple respiratory viruses, including SARS-CoV-2, influenza, respiratory syncytial virus (RSV), rhinovirus, and metapneumovirus. Medical practitioners continue to collect patient samples for virological analysis when respiratory infections peak. This surveillance is carried out by general practitioners and pediatricians in collaboration with public health institutions like Santé Publique France and the National Reference Center for Respiratory Virus Infections.


Conclusion

As week 35 closes, the stability of COVID-19 and other ARI rates in France provides a sense of control over respiratory virus activity, although continued vigilance is necessary.
 

Heliobas Disciple

TB Fanatic
(fair use applies)


Study warns that new COVID-19 subvariants LB.1, KP.2.3, KP.3, and KP.3.1.1. with Del S31 mutation challenge vaccines
Nikhil Prasad Fact checked by:Thailand Medical News Team
Sep 08, 2024

As the global pandemic continues to evolve, scientists have been closely monitoring new variants of the SARS-CoV-2 virus. Recently, a study conducted by researchers from American institutions including The Ohio State University, University of Texas Health Science Center at Houston, and others, has brought to light important findings about the new COVID-19 subvariants derived from the JN.1 strain. This Medical News report explains the critical aspects of these subvariants in a way that is easy to understand for anyone, without requiring a medical background.


Rising Concerns: New Subvariants Emerge
COVID-19 cases surged globally in 2024, driven by subvariants of the JN.1 strain of SARS-CoV-2. The study focused on several specific subvariants: LB.1, KP.2.3, KP.3, and KP.3.1.1. These variants were found to be particularly concerning due to their ability to evade neutralizing antibodies, the proteins in our immune system designed to protect us from the virus.

The study sheds light on how these subvariants have developed unique features, making them harder for the immune system to recognize and fight off. These variants carry a mutation, referred to as Del S31, located in the spike protein’s N-terminal domain (NTD). This mutation is primarily responsible for the variants' ability to escape the immune system.


The Role of the Spike Protein
The spike protein of the SARS-CoV-2 virus is crucial because it allows the virus to enter human cells. The study focused on how mutations in the spike protein have allowed the virus to become more stable and evade immune responses more effectively.

One of the main findings of the study was that the Del S31 mutation changes the way the spike protein behaves. The mutation causes a shift in how the spike protein interacts with cells and antibodies. Specifically, the change stabilizes the spike protein, making it harder for neutralizing antibodies (nAbs) to recognize and bind to the virus.


Impact on Vaccine Efficacy

The study tested the ability of neutralizing antibodies from healthcare workers who had received the bivalent mRNA vaccine to block the virus. Unfortunately, the new subvariants showed a marked reduction in antibody neutralization. This reduction was observed in people vaccinated with both the earlier versions of the COVID-19 vaccines and those who received the newer, updated vaccines designed for the Omicron variants.

One critical discovery was that the Del S31 mutation dramatically reduced the effectiveness of antibodies produced by the vaccine. The subvariants with the Del S31 mutation showed up to a 9.3-fold decrease in neutralizing antibody levels, meaning that people vaccinated with the bivalent vaccine might not be as well protected against these newer subvariants.


Resistance to Monoclonal Antibodies
Monoclonal antibodies, lab-made proteins that mimic the immune system's ability to fight off harmful pathogens, have been an essential tool in treating COVID-19. However, the study found that all newly emerged JN.1 subvariants, including LB.1, KP.2.3, and KP.3.1.1, were resistant to S309, one of the broadest neutralizing monoclonal antibodies.

This resistance poses a significant challenge to current treatment options, making it more difficult to combat severe cases of COVID-19 caused by these variants.


Infectivity of the New Subvariants
The study also looked at how infectious these new subvariants were compared to earlier versions of the virus. In laboratory tests using human cells, subvariants like KP.3 and KP.3.1.1 showed increased infectivity, meaning they could spread more easily. Interestingly, the DelS31 mutation played a role in this increased infectivity, particularly in lung cells, which are the primary targets of the virus.

However, despite their increased infectivity, the subvariants were less effective at fusing with human cells compared to earlier variants. This fusion process is an essential step in how the virus spreads from one cell to another within the body.


Spike Protein Stability
Another critical finding was that the DelcS31 mutation made the spike protein more stable at higher temperatures, which could potentially allow the virus to survive longer in different environments. The researchers found that viruses with the DelcS31 mutation, such as KP.3.1.1, were more resistant to being inactivated by heat. This stability might give the virus an evolutionary advantage, allowing it to spread more effectively in warmer climates or survive on surfaces longer.


The Importance of Developing New Vaccines
The study highlights the need to update COVID-19 vaccines to include antigens containing the Del S31 mutation. As these subvariants continue to evolve, it becomes increasingly important for vaccines to keep pace with the changes in the virus. Without these updates, the effectiveness of current vaccines may continue to decline, leaving populations vulnerable to new waves of infection.

Researchers also emphasized that monitoring the virus’s evolution remains critical for controlling the pandemic. Understanding how mutations like Del S31 affect viral behavior will guide the development of better vaccines and treatments in the future.


Conclusion
In summary, this study provides important insights into the ongoing evolution of the SARS-CoV-2 virus. The JN.1-derived subvariants LB.1, KP.2.3, KP.3, and KP.3.1.1 have shown significant immune evasion, particularly due to the Del S31 mutation. These variants are resistant to neutralizing antibodies from both vaccines and monoclonal antibodies, and they display increased stability and infectivity.

The study highlights the urgent need for updated vaccines and new treatments to address these rapidly evolving variants. As the pandemic continues, ongoing research and surveillance will be essential to staying ahead of the virus and protecting public health.

The study findings were published on a preprint server and is currently being peer reviewed.

 

Tristan

TB Fanatic
So, of course, it's been deleted. I would've liked to watch this. Dr. McMillan also posted something today about mrna nanostructures, I wonder if it was the same study? I'll post that one below. I will look for Dr. Campbell's video on Rumble or Bitchute and if I find it, I will edit this post with a link to his video there.

ETA:


This is a link I found on bitchute. It's not on his page, it's someone who mirrored it, so there's no link to the study, but watching it now and looking at his pictures, it looks like it's the same study that Dr. McMillan is discussing in the video below and the link is in that post. I'll also post a link to a pdf of the study:

15 min 11 sec


also mirrored here, in case one of them gets taken down



HD

Thank you.

For any such 'uncomfortable' subjects, perhaps it's best for folks to consider downloading the vid while available.


eta: interestingly, Dr. Campbell's video, as well as another regarding a German Pathologist's findings, are gone from my viewing history.


No doubt that they are erasing history.
 
Last edited:

Heliobas Disciple

TB Fanatic
Thank you.

For any such 'uncomfortable' subjects, perhaps it's best for folks to consider downloading the vid while available.


eta: interestingly, Dr. Campbell's video, as well as another regarding a German Pathologist's findings, are gone from my viewing history.


No doubt that they are erasing history.

It's amazing the censorship that still goes on 3-4 years later...

I added some Rumble video links to my post. And I agree that if a video shows up that looks like it's not going to stay up very long, best to download it if you want to be able to rewatch it. Interestingly, Dr. McMillan's video on the same subject it still up, that's probably because he doesn't have the huge audience and reach that Dr. Campbell has. Right now he has 47,000+ views. I saw a video last night that said that within a few hours Dr. Campbell had over 300,000. That will bring it to the attention of the censors much faster...

HD
 

Tristan

TB Fanatic
It's amazing the censorship that still goes on 3-4 years later...

I think they're clutching even tighter to the web of deception that they spun; as the holes appear, they are ever more desperate to patch it over.

Metaphorically speaking.

Because if the entire world knew in detail, with perfect clarity, what is assumed by some to have happened...

Perhaps they fear they may not be able to enjoy their 'retirement'.
 

Heliobas Disciple

TB Fanatic
Here's the article about Canada's order to destroy the old vaxx vials.


(fair use applies)


Health Canada orders provinces to destroy old COVID-19 vaccines amid wait for new batch
Luca Caruso-Moro
Wednesday, September 4, 2024 2:16PM EDT Updated Thursday, September 5, 2024 9:59AM EDT

Health Canada has directed provinces to withdraw and destroy remaining supplies of last year's COVID-19 vaccines while it works to authorize updated shots, which is expected to happen in October, according to Ontario’s health ministry.

“Vaccines will be available once Ontario receives supply from Health Canada following their regulatory authorization of the new, updated vaccine formulation," read a statement from Ontario spokesperson Hannah Jensen.

A notice posted on the federal government’s immunization guide says vaccines aimed at Omicron variant XBB.1.5 is no longer available in Canada. Updated shots, made to target the now-dominant JN.1 or KP.2 strains are expected to get the green light “in the coming weeks.”

Meanwhile, COVID-19 is spreading quickly and widely across Canada, wastewater sampling and test positivity rates suggest.

Alberta's health ministry has confirmed old-strain COVID-19 vaccines are no longer available. Quebec’s public health director told CTV News current stockpiles are to be returned to Ottawa. Saskatchewan has disposed of their Moderna Spikevax XBB.1.5 and Pfizer Comirnaty XBB.1.5 vaccines in anticipation of new doses.

"It is estimated Ontario, and other provinces, will receive supply from Health Canada in October," Jensen added.

CTV News has sought further comment from Health Canada on what it will do to remedy what appears to be a widespread gap in access to vaccines. The agency told CTV News Calgary that the swap should be timed so that there is uninterrupted access to shots.

In a statement, a spokesperson told CTVNews.ca that public health is working on a vaccine transition plan with provinces and territories, adding that it’s in talks with those governments “to ensure common understanding of the transition.”

The agency also says it maintains a federal reserve of XBB vaccines to respond to “any unexpected health need.”


COVID-19 spreading fast

While regional and federal governments have largely scaled down their surveillance on the spread of COVID-19, national wastewater sampling suggests the virus remains active throughout the country.

“The viral activity level of COVID-19 is high,” reads Canada’s Wastewater monitoring dashboard. Regional sampling reveals a high level of viral activity in B.C., Saskatchewan, Manitoba, Ontario, Nova Scotia, and Newfoundland and Labrador.

The spread in Yukon, Alberta and Quebec is described as “moderate.” There is no data available for the Northwest Territories nor Nunavut.

The COVID-19 test positivity rate was 18 per cent for the week of Aug. 24 – it’s highest since early December 2023 when Canada had begun its descent from a wintertime wave of infections.
 

CnMO

Veteran Member
So, of course, it's been deleted. I would've liked to watch this. Dr. McMillan also posted something today about mrna nanostructures, I wonder if it was the same study? I'll post that one below. I will look for Dr. Campbell's video on Rumble or Bitchute and if I find it, I will edit this post with a link to his video there.

ETA:


This is a link I found on bitchute. It's not on his page, it's someone who mirrored it, so there's no link to the study, but watching it now and looking at his pictures, it looks like it's the same study that Dr. McMillan is discussing in the video below and the link is in that post. I'll also post a link to a pdf of the study:

15 min 11 sec


also mirrored here, in case one of them gets taken down



Adding Rumble links, these too are mirrors of the video, not posted on John Campbell's page. Hopefully one of all of these (bitchute and rumble) will remain and not be taken down;






HD
On Rumble @ DrJaneRuby- Broke the story from the 2 doctors / Dr. Lee in Korea, Dr Brody is in Japan, about their 2 year incubation of mrna CV 19 shots. She had Dr Lee on for 3 hours, 3 part video. She spoke about this the whole month of August.
Their first report is on a sub stack (because it's not getting taking off) that you can download , 62 pages and read see the pictures. Also they published in a medical journal.
More reports are coming from the 2 doctors. IF you have not see Dr. Ruby interviews with Dr. Lee of Korea, YOU MUST SEE. shocking..... also test done on sperm and skin
People may feel fine, but the nanostructures are growing .
 

CnMO

Veteran Member
A shocker from the Dr Ruby interview with Dr. Lee. Was in 1 nanoparticle 1 Terabyte (sp) can be download into it.
Doc. Lee and Brody have a Large international team put together, that they are working with, people in special fields as, chemical, metals , computer chips, emf/5g, all kinds of doctors, etc....
 

Heliobas Disciple

TB Fanatic
(fair use applies)


EXCLUSIVE: New Data Prompts Sen. Ron Johnson to Seek Answers on COVID-19 Vaccine Deaths
Fred Lucas
September 05, 2024

Sen. Ron Johnson, R-Wis., is asking two federal health agencies to review new data from the government of the Czech Republic on mortality rates from COVID-19 vaccines.

Johnson—who has conducted oversight into the government’s handling of the pandemic—wrote Wednesday to Food and Drug Administration Commissioner Dr. Robert M. Califf as well as Dr. Mandy K. Cohen, director of the Centers for Disease Control and Prevention.

“The Czech data evidences the Moderna COVID-19 vaccine (Spikevax) increased all-cause-mortality (ACM), as measured over a 12-month period from the time of vaccination for every age, compared to the Pfizer-BioNTech vaccine (Comirnaty),” Johnson writes in the letter to Califf and Cohen, a copy of which was obtained by The Daily Signal.

Johnson is the ranking member and former chairman of the Senate Homeland Security and Governmental Affairs subcommittee on investigations. He previously conducted Senate oversight of the government’s response to the COVID-19 pandemic.

In the letter, Johnson cites Steve Kirsch, a Silicon Valley philanthropist who founded the COVID-19 Early Treatment Fund. Kirsch translated and reviewed official Czech Republic government data on COVID-19 vaccines administered there. Kirsch obtained the information through a public records request.

Johnson’s letter also references analysis by diagnostic pathologist Dr. Clare Craig regarding the Czech data. Craig concurred with Kirsch’s findings.

“I urge you to review the official Czech government data on COVID-19 vaccines administered in the Czech Republic, and Mr. Kirsch’s and Dr. Craig’s analysis on the ACM [all-cause-mortality] of the Moderna and Pfizer COVID-19 vaccines,” Johnson writes.

He specifically asks the FDA and CDC to review the “one-year and two-year mortality rates from second shot mortality rate for the Pfizer-BioNTech and Moderna vaccine for those injected in 2021, by 5-year age categories.”

Johnson also asks the two agencies to review the “one-year mortality rate ratio for both Moderna and Pfizer, for those who died in high COVID-19 versus low COVID-19 months.”

“Please explain if your agency is certain that the Moderna and Pfizer vaccines are equally safe,” Johnson writes the two public health officials, “and if so, on what data or studies do you base your opinion?”

Finally, the Wisconsin Republican asks: “Has your agency determined if there is any COVID-19 mortality or any other effectiveness difference between the Moderna and Pfizer vaccines?”

FDA press officer Cherie Duvall-Jones, responding to an inquiry from The Daily Signal, said only: “When the FDA receives a letter from a member of Congress, the agency reviews and responds to the member directly.”

A CDC spokesperson told The Daily Signal, “CDC has received the request from Sen. Johnson and is working to respond.”

The Daily Signal sought comment Thursday morning from the media relations offices of Moderna and Pfizer about Johnson’s letter and the Czech data. Neither responded by publication time Thursday afternoon.

letter page1.JPG
letter page2.JPG
 

Heliobas Disciple

TB Fanatic
(fair use applies)


Early signs California's COVID surge is peaking: 'It's not gone away. It's just lower'
Rong-Gong Lin II - Los Angeles Times
Mon, September 9, 2024, 6:00 AM EDT

Unlike recent temperatures, California's COVID summer may no longer be heating up — though officials caution the virus continues to circulate at levels plenty high enough to pack a potent infectious punch.

Any discernible slowdown would still be welcome news for the virus-weary state, however. And although it'll take a few more weeks of measurement to confirm the trajectory, health officials hope the release of updated vaccines will help further dent the wave.

"It's not gone away. It's just lower. It's just gone from 'very high' to 'high,'" said Dr. Peter Chin-Hong, a UC San Francisco infectious diseases expert.

California has endured "high" levels of coronavirus in its wastewater since early June, and "very high" levels since July. But for the week ending Aug. 31, the most recent data available, California's coronavirus sewage levels fell back to "high," according to the U.S. Centers for Disease Control and Prevention.

California is also now one of 16 states in which COVID is estimated to be "declining" or "likely declining," the agency said.

COVID levels in wastewater are considered "high" or "very high" in 44 states and the District of Columbia, and "moderate" in four. There were no estimates for the two remaining states, according to the CDC.

Other states where COVID is estimated to be "declining" or "likely declining," the CDC said, include Texas, Florida, New York and Illinois. COVID is thought to be "growing" or "likely growing" in seven states, including Michigan and Washington. COVID's trajectory was "stable or uncertain" in 24 states and the District of Columbia, and there were no estimates for three states.

But not all metrics are moving in the rosy direction, and doctors have cautioned transmission could once again rebound on account of travel and gatherings over Labor Day weekend. It'll take another week or more to get a better sense of how the holiday may influence COVID trends.

In California, more than 13% of coronavirus tests for which there is an officially recorded result came back positive over the week ending Sept. 2 — higher than the peaks seen both last winter and summer. A month ago, the figure was 12%, according to the California Department of Public Health.

In Los Angeles County, coronavirus levels in wastewater were at 75% of last winter's peak for the 10-day period ending Aug. 24. That's down from the reading of 86% for the 10-day period that ended Aug. 17.

Official coronavirus case counts have declined, though reporting may have been interrupted by the Labor Day holiday.

For the week ending Sept. 1, there were an average of 381 coronavirus cases reported daily in L.A. County, down from 410 the prior week. Those counts include only those infections confirmed at medical institutions and don't reflect the results of at-home tests. Fewer people are testing at all when they're sick.

"We're seeing, I would say, somewhat of a cresting of cases," said Dr. Elizabeth Hudson, regional chief of infectious diseases for Kaiser Permanente Southern California.

There are certainly new COVID patients coming into doctor's offices and clinics, but the overall numbers as of Friday no longer appear to be accelerating as they were a month ago, Hudson said.

The percentage of emergency room visits related to the coronavirus across L.A. County has hovered at a relatively high level for the past six weeks, at between 3.7% and 4.3%. Last summer peaked at 5.1%.

Coronavirus-related hospitalizations in L.A. County remain relatively high for this summer but are not increasing. For the week ending Aug. 31, there were an average of 447 coronavirus-positive people in hospitals in L.A. County per day, down from the prior week's seasonal high of 499. Last summer's peak was 620.

In the San Francisco Bay Area, coronavirus levels in sewage have also declined. Coronavirus levels are now considered "medium" in the sewersheds of San José and Palo Alto, and "low" in Sunnyvale, according to the Santa Clara County Public Health Department.

And at UC San Francisco's hospitals, there were about 10 coronavirus-positive patients as of Friday, down from the seasonal peak of roughly 30.

COVID deaths have ticked upward, an expected development reflecting the summer transmission increase. L.A. County averaged about 2.7 COVID deaths a day over the week ending Aug. 13, the most recent for which data are available — up from the average of between 1 and 2 that had held steady since early July.

Deaths have also been on the rise nationally. For the week ending Aug. 10, 971 COVID deaths were reported. That's more than double the weekly tally from the start of summer, but only two-thirds as many as the 2023 midyear peak.

In a statement, the L.A. County Department of Public Health said it "will continue to monitor COVID-19 data in the coming weeks to better understand if we have truly passed this summer’s peak."

Even with COVID potentially on the downswing for now, doctors are urging people to get their COVID and flu vaccinations for the fall, when both viruses typically begin to pick up steam. Australia was recently hit with a significant wave of flu during its winter, and U.S. doctors look to the country's experience as a potential sign of things to come.

"They saw an early start to their flu season with a very large number of cases. ... We expect to see a pretty robust flu season," Hudson said. "Getting your flu vaccine now ensures your protection for the entire flu season."

The CDC recommends that everyone age 6 months or older get this season's updated COVID and flu vaccinations. The best months to get them are in September and October, according to the CDC, and people can get both shots during the same visit.

There are also ways to get vaccinated for flu without getting a shot. One option, called FluMist, is available as a nasal spray for nonpregnant people ages 2 to 49. There is another needle-free flu vaccine option, called Afluria.

As for when exactly is the ideal time to get vaccinated, doctors offered varying advice.

Hudson suggested getting both vaccines now — as she already has.

"It's so easy for all of us ... to put things off," she said. "This is the time to really do it. Do it before we start to get busy with all the stuff that comes with the holidays, with the kids going back to school."

The shots have been widely available at stores like CVS, Walgreens, Rite Aid, Ralphs, Vons, Albertsons, Pavilions and Safeway. As of Monday, updated COVID vaccines will be available at Kaiser's California locations for people age 5 years and older. For babies and younger children, vaccinations will probably be available in mid-September.

Sutter Health expects to begin offering COVID vaccinations in mid- or late September.

"By taking one of these vaccines, that's a really good way for us to potentially nip this current wave in the bud," Hudson said.

Chin-Hong suggested it's important that older and immunocompromised people get their vaccinations done now if they haven't been vaccinated against COVID in a year or more. But for younger people who aren't immunocompromised, he suggested a sweet spot for timing COVID and flu vaccinations is October, which would be closer to the expected peaks of the autumn-and-winter COVID-and-flu season.

Older people who last got vaccinated in the spring can probably wait until October for another dose, Chin-Hong said.

The COVID vaccination will boost protection against severe illness and hospitalization for at least a year, Chin-Hong said. But one reason to consider waiting until October is that the best protection against infection is within roughly six to eight weeks after getting the shot. That window can be wider if the vaccine is a close match to circulating subvariants, Chin-Hong said.

He said he plans to get his COVID and flu vaccinations in mid-October.

If you're trying to time your COVID vaccination for maximum protection against infection ahead of a big event, like a vacation, about two weeks ahead of time is a safe bet. Chin-Hong said immunity revs up just a few days after the shot, but the biggest benefit is reached starting about a week or two afterward.

It's also especially important that pregnant moms-to-be get vaccinated against COVID.

"For them ... if they want to protect the baby, they should really get it at least two weeks before they deliver," Chin-Hong said. "The antibodies have to cross the placenta," and that takes time.

Masking in indoor public settings also remains a prudent idea for those seeking to avoid getting infected, Hudson said.

Reducing the risk of a COVID infection also cuts down on the risk of long COVID, and the significant health problems it can cause. Sérgio Mendes, the legendary Grammy-winning Brazilian musician, died Thursday at the age of 83 in Los Angeles, and his family said his health "had been challenged by the effects of long term COVID."

Generally speaking, long COVID can contribute to a wide variety of ailments, including difficulty breathing and shortness of breath — as well as difficulty maintaining blood pressure. For some people, long COVID can begin a series of health problems that persist for months, or even years.

The CDC also recommends vaccination against the respiratory syncytial virus, or RSV, for everyone age 75 and up, as well as for adults age 60 to 74 at increased risk of severe RSV. The RSV vaccine is not annual, meaning people who got one last year don’t need to get another one at this time, the CDC said. It can also be administered during the same visit as flu and COVID shots.

An RSV vaccine is also available for expectant mothers at weeks 32 to 36 of pregnancy to pass protection on to their fetuses. An RSV antibody is available for babies and some young children, too.
 

Heliobas Disciple

TB Fanatic
(fair use applies)


Teen brains 'aged' during Covid lockdowns, new research suggests
Patrick Martin and Jane Weaver - NBC News
Mon, September 9, 2024, 7:20 PM EDT

Covid lockdowns, such as school closures, canceled sports activities and stay-at-home orders, prematurely aged teen brains by as much as four years, researchers from the University of Washington found.

The new study, published Monday in the Proceedings of the National Academy of Sciences, is more evidence of how disruptions to daily routines may have contributed to behavioral problems, an increase in eating disorders, anxiety and depression in adolescent girls and boys.

Scientists at the university's Institute for Learning & Brain Sciences (I-LABS) began the study using MRIs in 2018 to see how the brain structure of 160 teens from the Seattle area developed over time. The participants, a nearly equal number of boys and girls, ranged in age from 9 to 19 at the start of the study.

Lead researcher Patricia Kuhl, co-director of I-LABS, said that after Covid lockdowns began in 2020, they couldn’t do brain scan follow-ups until 2021. So they shifted the focus of the study to learn how the lockdowns had affected adolescent brain structure.

By measuring the thickness of the cerebral cortex — the outer layer of tissue in the brain which controls higher level functions of the brain like reasoning and decision-making — they discovered the brains of teen boys had prematurely aged 1.4 years. The brain scans of the girls showed accelerated aging of 4.2 years, according to the study.

The cerebral cortex naturally thins as we age. Chronic stress can also cause similar changes in the brain. But in the three-year period between the first scan and the follow-up, there was much more thinning than the researchers expected.

“As we age, the thinning of the cortex is associated with less fast-processing time, with less flexible thinking, with all of the things that we associate with aging,” Kuhl said. “All of the teens in general showed this accelerated aging.”

For teenage girls the aging was more pronounced. The thinning was found to be widespread throughout the female brain, occurring in 30 regions across both hemispheres and all lobes, the scans showed. In the male brain, the thinning was limited to only two regions, both in the occipital lobe, which affects distance and depth perception, face recognition and memory.

The greater influence on girls could be due to differences in the importance of social interaction for girls versus boys, Kuhl said. Boys tend to gather for sports and physical activity. Adolescent girls may rely on personal relationships for emotional support and self-identity.

“When girls and women are stressed, there is a natural response to get together and talk about it, and we release oxytocin and other neurotransmitters that make us feel better, said Dr. Ellen Rome, head of adolescent medicine at Cleveland Clinic Children’s Hospital. Rome was not involved in the new research.

What does the premature brain aging mean in the day-to-day lives of young people who navigated pandemic restrictions, often alone in their rooms, taking classes over Zoom or missing social connections?


Are there long-term risks for ‘pandemic brains’?

The research doesn’t prove the lockdowns caused the brain changes — mental health disorders were rising among children even before Covid. It does suggest, however, that the thinning of the cortex can be connected to increased anxiety, depression and other behavioral disorders, Kuhl said.

Another brain scan study in 2022 from Stanford University showed similar changes in cortical thickness in teen brains during Covid restrictions. The Stanford researchers compared the stress and disruptions of the pandemic to childhood trauma such as violence, neglect and family dysfunction.

The pandemic was a traumatic time for everyone, Kuhl said. For young people — at a time in their lives when they’re already experiencing intense changes in their emotional and behavioral development — the isolation was even more damaging for their emotional health.

“The pandemic was dramatic and unexpected, of course, but dramatic and catastrophic in a way, not only for physical health, but mental health,” she said.

Since 2021, several reports on youth mental health from the Centers for Disease Control and Prevention revealed unprecedented levels of hopelessness and suicidal thoughts among teenage girls and boys. In early August, a CDC survey released found a small improvement in teen mental health, although 53% of young women in high school say they are still feeling persistent sadness.

In brain development there are periods of time when certain types of learning are most effective, said Dr. Jonathan Posner, professor of psychiatry at Duke University School of Medicine. For example, it’s much easier to learn language as a young child than as an adult.

“The teenage years are hugely important for social development,” said Posner, who was not part of the new study. “If you don’t have those social interactions, there’s just not the opportunity to have that social learning.”

The cortex can’t regrow and continues to shrink throughout life. It’s not yet clear whether the young people’s prematurely aging “pandemic brains” could be at higher risk for disorders like ADHD and depression and, possibly, even diseases like Alzheimer and Parkinson, Kuhl said.

Seattle mom Karin Zaugg Black, 54, saw how the pandemic affected her two children during more than a year of remote school classes. Her daughter Delia, 14, was in seventh grade; Sam, 10, in fourth.

Delia especially felt the loss of social interaction.

“When she reflects back on that time, she was definitely like, 'Yeah, it was really hard. I felt like I had no friends, and that was really difficult,'” Black said about her daughter’s time during the pandemic.

“Their social skills are behind. You know, sort of they lost that ability to navigate in the social world with their peers,” she said.

The good news is Delia, now a senior in high school, has regained a lot of the social interaction muscle she lost during the pandemic.

Experts say the loss doesn’t have to be permanent if young people’s social interactions and connections have recovered since the pandemic.

“Fortunately, kids are really resilient, and we can get them back out there and help them catch up,” said Posner. “But we also don’t want to deceive ourselves that this was nothing. It had a significant impact on growth and development.”
 

Heliobas Disciple

TB Fanatic
A more technical presentaion of the above study:

(fair use applies)


COVID-19 lockdowns prematurely aged teenage brains, study finds

by University of Washington
September 9, 2024


covid-19-lockdowns-pre.jpg

New research from the University of Washington's Institute for Learning & Brain Sciences, or I-LABS, found the COVID-19 pandemic lockdowns resulted in unusually accelerated brain maturation in adolescents. This maturation was more pronounced in females, as seen on the left. Credit: University of Washington I-LABS

During the COVID-19 pandemic, governments around the world implemented restrictive measures—such as stay-at-home orders and school closures—to mitigate the spread of the respiratory illness. It's been well-documented that this disruption of daily routines and social activities had a negative impact on the mental health of adolescents.

Adolescence, the period of transition between childhood and adulthood, is marked by dramatic changes in emotional, behavioral and social development. It's also a time when a sense of self-identity, self-confidence and self-control are developed. The pandemic reduced social interaction for teenagers and led to documented reports of anxiety, depression and stress, especially for girls.

New research from the University of Washington, published online Sept. 9 in the Proceedings of the National Academy of Sciences, found the pandemic also resulted in unusually accelerated brain maturation in adolescents. This maturation was more pronounced in girls. When measured in terms of the number of years of accelerated brain development, the mean acceleration was 4.2 years in females and 1.4 years in males.

"We think of the COVID-19 pandemic as a health crisis," said Patricia Kuhl, senior author and co-director of the UW Institute for Learning & Brain Sciences (I-LABS), "but we know that it produced other profound changes in our lives, especially for teenagers."

Brain maturation is measured by the thickness of the cerebral cortex, the outer layer of tissue in the brain. The cerebral cortex naturally thins with age, even in teens. Chronic stress and adversity are known to accelerate cortical thinning, which is associated with an increased risk for the development of neuropsychiatric and behavioral disorders. Many of these disorders, such as anxiety and depression, often emerge during adolescence—with females at a higher risk.

The UW research began in 2018 as a longitudinal study of 160 teens aged between 9 and 17 years, with the original objective of evaluating changes in brain structure during typical adolescence.

The cohort was slated to return in 2020, but the pandemic delayed the repeat tests until 2021. By then, the original intent to study typical teen development was no longer viable.

"Once the pandemic was underway, we started to think about which brain measures would allow us to estimate what the pandemic lockdown had done to the brain," said Neva Corrigan, lead author and research scientist at I-LABS. "What did it mean for our teens to be at home rather than in their social groups—not at school, not playing sports, not hanging out?"

Using the original 2018 data, researchers created a model of expected cortical thinning during the teen years. They then re-examined the brains of the adolescents, over 80% of whom returned for the second set of measurements. The teens' brains showed a general effect of accelerated thinning across adolescence, but this was much more pronounced in females. The cortical thinning effects in females were seen all over the brain, in all lobes and both hemispheres. In males, the effects were only seen in the visual cortex.

The greater impact on female brains as opposed to male brains could be due to differences in the importance of social interaction for girls versus boys, Kuhl said. She added that female teenagers often rely more heavily on relationships with other girls, prioritizing the ability to gather, talk to each other and share feelings. Boys tend to gather for physical activity.

"Teenagers really are walking a tightrope, trying to get their lives together," Kuhl said.

"They're under tremendous pressure. Then a global pandemic strikes and their normal channels of stress release are gone. Those release outlets aren't there anymore, but the social criticisms and pressures remain because of social media. What the pandemic really seems to have done is to isolate girls. All teenagers got isolated, but girls suffered more. It affected their brains much more dramatically."

The cerebral cortex is unlikely to get thicker again, Kuhl said, but the potential for recovery might take the form of slower thinning over time, after the return of normal social interactions and outlets. Further research will be needed to see if this is the case.

"It is possible that there might be some recovery," Kuhl said. "On the other hand, it's also possible to imagine that brain maturation will remain accelerated in these teens."

In older populations, measures of cognitive brain function, such as processing speed and the ability to complete typical tasks, correlate with how much the cerebral cortex has thinned. That kind of data is not yet available for teenagers, Kuhl said, but it could be where future research is headed.

"The pandemic provided a test case for the fragility of teenagers' brains," Kuhl said. "Our research introduces a new set of questions about what it means to speed up the aging process in the brain. All the best research raises profound new questions, and I think that's what we've done here."

Ariel Rokem, a UW research associate professor of psychology and data science fellow at the eScience Institute, is a co-author.

More information: Kuhl, Patricia K., COVID-19 lockdown effects on adolescent brain structure suggest accelerated maturation that is more pronounced in females than in males, Proceedings of the National Academy of Sciences (2024). DOI: 10.1073/pnas.2403200121. doi.org/10.1073/pnas.2403200121
Journal information: Proceedings of the National Academy of Sciences
Provided by University of Washington
 
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