CORONA Main Coronavirus thread

naegling62

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Did you have a severe case of COVID-19? Research suggests that Neanderthal genes could be to blame
Charles R. Davis - Business Insider
Sun, September 17, 2023, 11:04 AM EDT

  • Neanderthal genes could be to blame for severe cases of COVID-19, The Wall Street Journal reported.
  • Scientists in Italy found people with Neanderthal gene variants were more likely to be hospitalized.
  • The research suggests the variants are a "major genetic risk factor for severe COVID-19."

Researchers in Italy say their study of people infected with COVID-19 shows that those with certain genetic variations attributable to Neanderthal ancestry were far more likely to experience severe symptoms requiring hospitalization, The Wall Street Journal reported Sunday.

Writing in the journal iScience, the researchers, associated with the nonprofit Mario Negri Institute for Pharmacological Research, reported that they examined the DNA of nearly 1,200 volunteers in the Bergamo province, which was especially hard hit in the early days of the pandemic. What they found is that "Neanderthal haplotype," a set of genetic variants associated with the human ancestor, is "the major genetic risk factor for severe COVID-19."

In particular, they found that people with the Neanderthal haplotype were twice as likely to develop severe pneumonia, the Journal reported, and three times as likely to end up on a ventilator in an intensive-care unit.

The link between health and Neanderthal DNA has been suggested by other studies. A study published in June by the journal Molecular Biology and Evolution indicated a link between Neanderthal DNA and a genetic disorder known as Dupuytren's disease. And in March, a study published in Nature also found a connection between Neanderthal ancestry and an increased risk of an extreme immune response, or cytokine storm, from contracting COVID-19.
From my own anecdotal experience I just didn't see that. Blacks and Hispanics in Alabama got hit hard with deaths. I haven't seen the end tally and really don't trust the numbers but I think the vitamin D deficiency was the biggest indicator not genetics.

Speaking of genetics though, race did have an effect on vitamin D. From what I've read sub-Saharan blacks can't produce adequate D above New Orleans.
 

Heliobas Disciple

TB Fanatic
If you have the time, watch this one. Dr. McMillan does a really good job making complex subjects easy to understand. He explains Ig4 increase after vaxx - which has been discussed on this thread when those studies came out.


View: https://www.youtube.com/watch?v=fpAKi2poiWw

Are mild Covid Infections in the Vaccinated Necessarily good?
Vejon Health
Streamed live on Sep 17, 2023
19 min 18 sec

The concern is regarding recurrent mild breakthrough COVID-19 infections across highly vaccinated regions. Could they indicate longer term risks?

Kiszel, Petra, et al. "Class switch towards spike protein-specific IgG4 antibodies after SARS-CoV-2 mRNA vaccination depends on prior infection history." Scientific Reports 13.1 (2023): 13166.


Nagata, Keiko, et al. "Epstein–Barr virus lytic reactivation induces IgG4 production by host B lymphocytes in Graves' disease patients and controls: a subset of Graves' disease is an IgG4-related disease-like condition." Viral immunology 31.8 (2018): 540-547.

 

Heliobas Disciple

TB Fanatic
View: https://www.youtube.com/watch?v=6C4s7zheskc

10 Mice Tested for FDA Booster Authorization for 2023/2024
Drbeen Medical Lectures
Streamed live on Sep 14, 2023
38 min 59 sec

Let's review the approach FDA took to authorize/approve the monovalent boosters for 2023 fall season. It is interesting to see the vaccine efficacy duration and the data used to get the authorization.

URL list from Thursday, Sep. 14 2023

Vaccines and Related Biological Products Advisory Committee June 15, 2023 Meeting Announcement - 06/15/2023 | FDA

Vaccines and Related Biological Products Advisory Committee June 15, 2023 Meeting Briefing Document- FDA

Vaccines and Related Biological Products Advisory Committee June 15, 2023 Meeting Presentation- CDC: COVID19 vaccine effectiveness updates

Vaccines and Related Biological Products Advisory Committee June 15, 2023 Meeting Presentation- Pfizer: 2023-2024 COVID19 Vaccine Formula- Clinical and Preclinical Supportive Data

Vaccines and Related Biological Products Advisory Committee June 15, 2023 Meeting Presentation- Novavax: Data in Support of 2023-2024 Vaccine Update

FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants | FDA
 

Heliobas Disciple

TB Fanatic
(fair use applies)


Wastewater shows COVID levels dipping as hospitalizations tick up
Clara Duhon - The Hill
Tue, September 19, 2023, 7:42 PM EDT

New data collected from wastewater samples indicates that detected COVID-19 levels are decreasing nationwide, while cases and hospitalizations continue to tick up.

The levels of COVID detected in wastewater samples dropped by about 5 percent nationwide in the last week, according to data from Biobot Analytics, a platform that tracks COVID through wastewater. Data from wastewater can provide early warnings of the spread of COVID cases across regions.

Though wastewater collection sites in the West, Midwest and Northeast show a steady uptick in levels of COVID detected, wastewater samples in the South show enough of a decrease to tip the overall national detected levels in a downward trajectory for the last week.

However, wastewater data from the Centers for Disease Control and Prevention shows virus levels increasing at more sites reporting data within the last week, though the CDC indicates that data collected since the beginning of the month may be subject to reporting delays.

In addition, positive cases and COVID-related hospitalizations and deaths are still continuing to rise through the end of summer and into the beginning of fall, according to data from the CDC.
 

Heliobas Disciple

TB Fanatic
(fair use applies)


Despite recent uptick, Covid leveling off in some areas of the country, wastewater testing shows
Erika Edwards - NBC News
Tue, September 19, 2023, 5:07 PM EDT

Wastewater data suggest that the recent uptick in Covid cases may have peaked, at least in some areas.

Biobot Analytics, a company that tracks wastewater samples at 257 sites nationwide, said that the current average Covid levels across the United States are approximately 5% lower than they were last week.

"All fingers crossed," Cristin Young, a Biobot epidemiologist said, "this wave is plateauing and may be declining."

While data from the Centers for Disease Control and Prevention show a rise in Covid-related hospitalizations and deaths, wastewater may indicate what's to come.

After a mid- to late-summer rise, the CDC's Covid wastewater surveillance now shows declines in mid-Atlantic states, such as Virginia and Maryland.

The findings are backed up from surveillance in North Carolina, said Jessica Schlueter, an associate professor in the department of bioinformatics and genomics at the University of North Carolina Charlotte. Her lab is responsible for testing 12 sites across the state.

The increase in Covid wastewater samples during the last six months "seems to be peaking and starting to taper off," she said. That means a fall in cases could follow.

Wastewater collection sites in the Midwest and the Northeast, however, show a steady uptick in Covid spread.

Increases that coincide with the start of the school year have become par for the course based on the past three years of Covid activity, but are not expected to last long, said Amy Kirby, who heads the CDC's wastewater monitoring program.

"We have seen enough data over the years to know that around the time when school starts, we will start seeing some increases," she said, "which plateau and then come back down" before another winter surge.

Another monitoring system called WastewaterSCAN, which tracks 183 sites in 36 states, is slightly more conservative in its analysis of the latest Covid wastewater data.

"What we're seeing right now is a kind of 'flattening out,'" said Marlene Wolfe, an assistant professor of environmental health at Emory University and program director for WastewaterSCAN. "We haven't really seen a true downturn happen yet."

Like the CDC data, she said, the WastewaterSCAN findings indicate a current rise in Covid spread in the Midwest. That area of the country is "in this surge right now," she said.

Wastewater surveillance of viruses is the only meaningful indication of viral activity, experts said, because public health officials no longer track Covid cases.

"We have essentially given up on other types of surveillance," said Bill Hanage, an associate director at the Center for Communicable Disease Dynamics at Harvard University, as well as a scientific adviser to Biobot.

"People are testing at home," he said. "The only way we really have of keeping hold of what pandemic activity is going on is through stuff like wastewater."

Hanage likened wastewater predictions to weather reports. "That's about as close as we can to forecasting," he said.

People infected with Covid shed the virus in sewage pipes about a week before they ever feel sick and get tested for the virus. Every time a person flushes a toilet, it gives wastewater analysts an indication of how viruses like Covid are spreading long before a need for nasal swab tests.

“As long as you’re using a toilet that’s connected to the sewer system, we can get information about the health of communities without asking people to change their behavior at all. That’s why it’s so powerful,” Kirby said.

While the latest Covid wastewater data are encouraging, she said people should protect themselves against another potential uptick in viral activity in the months to come.

"Hopefully with updated vaccinations, we will not see a big winter surge as we have in the past," Kirby said. "But it's really too early to tell."
 

Heliobas Disciple

TB Fanatic
(fair use applies)


Study Finds Most Sudden Unexplained Deaths With Negative COVID-19 Swab Test Were Due To High SARS-CoV-2 Viral Loads In Lungs
Nikhil Prasad Fact checked by:Thailand Medical News Team
Sep 20, 2023

In a world gripped by the COVID-19 pandemic, the pursuit of answers is relentless. As we navigate through uncharted waters, new revelations emerge, challenging our understanding of the virus and its impact on human lives.

A recent study conducted by the Forensic Medicine Department at the Pomeranian Medical University in Szczecin, Poland, has shed light on a startling phenomenon: a significant number of sudden unexplained deaths, even in individuals with negative COVID-19 swab tests, can be attributed to high SARS-CoV-2 viral loads in the lungs. This groundbreaking research has profound implications for our comprehension of COVID-19 and its consequences, particularly among children.


The Pandemic's Unseen Toll

The COVID-19 pandemic, caused by the SARS-CoV-2 virus, has left a profound mark on humanity. It has taken countless lives and brought healthcare systems to their knees. Amid this global crisis, forensic autopsies have taken on new significance, as they offer valuable insights into the mysterious ways in which the virus operates and claims lives.

Numerous studies, cases reports and past COVID-19 News reports have showed the increasing trends of unexplained sudden deaths in otherwise healthy individuals and even in infants and young children and many tested negative for COVID-19 prior to their deaths!

The study findings present a summary of an autopsy-based study conducted on 23 individuals who experienced sudden and unexplained deaths. It is crucial to highlight that some of these cases involved children whose initial cause of death was attributed to Sudden Infant Death Syndrome (SIDS). These autopsies, carried out meticulously at the Department of Forensic Medicine and Forensic Genetics, Pomeranian Medical University in Szczecin, were enriched with molecular diagnostics of the SARS-CoV-2 virus and detailed histopathological analysis of lung tissue.


The Dual Nature of COVID-19

Initially, COVID-19 was perceived as primarily attacking the respiratory system. However, only through autopsies combined with clinical data did we discover that this virus is far more insidious, causing multi-organ dysfunction. Forensic autopsies, distinct from clinical dissections, involve analyzing the internal organs without access to the deceased's clinical history. This research aims to unravel the factors contributing to COVID-19-related deaths in the absence of such information.


The Surprising Persistence of SARS-CoV-2

One of the most perplexing aspects of SARS-CoV-2 is its persistence even after death. While previous studies have identified the presence of the virus's genetic material in deceased individuals for up to several days, the exact duration of its viability in the human body remains uncertain. Detecting the virus's genome post-mortem raises questions about its infectiousness and the source of infection for pathologists.

Research on other viruses, such as the influenza virus and the Ebola virus, has shown that their genomes can remain detectable in corpses for extended periods. The SARS-CoV-2 virus, being an RNA virus like the influenza virus, shares this trait. Factors like temperature and humidity play a role in the virus's viability post-mortem. Consequently, it is plausible that the transmission of the virus from the deceased is possible even after death, despite stringent safety measures during autopsies.


The Risk of Cadaver Transmission

The risk of infection transmission, both to autopsy staff and bereaved families, is a significant concern. This risk is particularly pronounced in cases involving the SARS-CoV-2 virus due to its unique genome structure, which dictates its infectivity. Thus, the argument for molecular testing (RT-PCR) of every body entering the Department of Forensic Medicine, especially during a pandemic, gains legitimacy.


Children and COVID-19: An Evolving Understanding

One of the most startling findings of this study is the reevaluation of sudden child deaths, often attributed to SIDS. SIDS remains a mysterious entity with an unclear etiology. Some theories suggest an association with the immaturity of a child's respiratory system. However, the presence of the SARS-CoV-2 virus in child deaths classified as SIDS raises new questions about potential viral contributions to these tragedies.


The Findings: COVID-19 as a Common Denominator


This study presents compelling evidence that the SARS-CoV-2 virus played a central role in all the examined cases, even those involving infants. The molecular test results and histopathological analyses consistently pointed to COVID-19 as the cause of death. In the case of infants, there is a suspicion that chronic viral infections might intersect with SIDS, as evidenced by distinct lung patterns observed in these cases. Elderly individuals who underwent autopsies also displayed chronic inflammatory processes and lung tissue fibrosis, underscoring the multi-faceted nature of COVID-19's impact.


The Role of Autopsies in a Global Crisis

The COVID-19 pandemic has placed an unprecedented burden on global healthcare systems and the medico-forensic community. This has prompted some health authorities to issue guidelines for waiving autopsies for COVID-19-suspected cases. However, autopsies remain invaluable in understanding the pathophysiology of the disease, the mechanisms of death, and the complications arising from COVID-19, particularly clotting disorders.


False Negative Results in Swab Tests

The standard diagnostic method for COVID-19 is the RT-PCR test, typically performed using a nasopharyngeal swab. However, this study has revealed the potential for false-negative results, even in individuals with high viral loads in the lungs. The concentration of viral RNA in the upper respiratory tract peaks shortly before or after symptom onset, and it fluctuates throughout the day. This variation can result in false negatives, especially in the later stages of infection. These findings question the efficacy of nasopharyngeal swabs as the sole diagnostic tool and emphasize the importance of considering other diagnostic methods, such as bronchoalveolar lavage and sputum samples, which may yield more accurate results.


Mutations and the Mystery of "Gene Dropping Out"

The SARS-CoV-2 virus's genetic plasticity and high mutation rate pose additional challenges in diagnosing and understanding the virus's behavior. This study observed instances of "gene dropping out" in eight of the twenty-three cases, highlighting the need for ongoing research into the virus's ever-evolving genetic landscape.


Children as Silent Carriers

Children, with their milder COVID-19 symptoms, may be silent carriers of the virus. This study found that children often exhibited lower viral loads than adults but could still transmit the infection. The possibility of false-negative test results in children further complicates efforts to control the virus's spread.


Conclusion

The research conducted by the Forensic Medicine Department at the Pomeranian Medical University in Szczecin, Poland, has illuminated a previously unexplored aspect of the COVID-19 pandemic. It has shown that high SARS-CoV-2 viral loads in the lungs can be a crucial factor in sudden unexplained deaths, even in individuals with negative nasopharyngeal swab tests. This discovery challenges our understanding of COVID-19, particularly in children, and emphasizes the importance of postmortem molecular diagnostics to comprehensively assess the cause of death and the potential for virus transmission.

As the world continues to grapple with the COVID-19 pandemic, rigorous adherence to safety protocols and standard procedures remains paramount. This study underscores the need for postmortem molecular diagnostics to provide a more comprehensive understanding of COVID-19-related deaths and to minimize the risk of virus transmission. It also calls for continued research into the virus's behavior, mutations, and its impact on different age groups. In

The study findings were published in the peer reviewed journal: Diagnostics.

 

Heliobas Disciple

TB Fanatic
(fair use applies)


How many more times will I have to tell you that this ‘immune escape’ pandemic will not have a happy ending?
By Geert Vanden Bossche
September 19, 2023

The exotic and highly infectious nature of the currently circulating variants raises questions. New emerging variants are now succeeding each other at a rapid pace (e.g., FL.1.5.1, BA.2.86, EG.5). While they share a phylogenetic relationship, they have become so antigenically distinct from their predecessors that they should no longer be considered mere variants but rather different serotypes.

Mutations, as identified by mutation-spotters and confirmed by molecular epidemiologists, are no longer converging to a well-defined spike (S)-associated domain. It appears that mutations enhancing the virus's intrinsic infectivity are currently thriving and competing with each other. This suggests that the viral evolutionary dynamics are no longer driven by ‘herd’ immune selection pressure on viral infectivity.

In the absence of immune selection pressure on viral infectivity and with highly infectious variants in circulation, variants which incorporated spontaneous mutations conferring an even higher level of intrinsic viral infectivity are now more likely to emerge. This is because the higher the viral infectivity, the more the virus replicates and the more likely it is for variants with even higher infectivity to gain a competitive advantage over existing lineages or less infectious offspring. If not constrained by selective immune pressure, variants with steadily increasing infectivity can lead to higher rates of asymptomatic transmission among COVID-19 vaccinees and compete for dominance.

Because public health authorities do not fully comprehend the dynamics of the population-level immune adaptation at play, they do not consider the current evolution very threatening for several reasons:
  • Antibodies in vaccine recipients are mistakenly believed to have the capability to effectively neutralize the newly emerging variants in vivo, even those that are highly infectious, albeit with somewhat reduced effectiveness (All That Glitters Is Not Gold).
  • Although hospitalization and morbidity rates are now gradually increasing, most hospitalizations are primarily associated with SARS-CoV-2 but are not directly attributed to it.
  • Cases of mild to moderate COVID-19 disease, whether in the vaccinated or unvaccinated, have become increasingly rare.
  • While viral transmission rates are increasing, they remain lower than during the initial circulation of Omicron and its early variants.
Few appear to acknowledge that the spread of more infectious Omicron-derived lineages is resulting in reduced attachment of S variant-nonspecific, non-neutralizing antibodies to a highly conserved antigenic site within the N-terminal domain of S protein (therefore also called ‘polyreactive’, non-neutralizing antibodies; PNNAbs). This site is exposed on the surface of S proteins found on progeny virions that adhere to migrating dendritic cells (DCs) surveying the upper respiratory tract. This diminished binding can result in flawed inhibition of viral trans infection in distal organs and may lead to the cell-to-cell trans fusion of virus-infected host cells (How Has the COVID-19 Mass Vaccination Campaign Made the Natural Selection and Rapid Propagation of a HIGHLY Virulent Variant Highly Likely?).

Trans fusion of SARS-CoV-2-infected cells is indicative of high viral pathogenicity, which can clinically manifest as severe or systemic COVID-19 disease. When the segment of the population exerting suboptimal PNNAb-mediated immune pressure on viral trans infectivity surpasses a specific threshold, the entire population represented by that segment will collectively exert immune selection pressure on this trait. This will inevitably lead to the natural selection and spread of a new variant that combines high viral infectivity with high viral trans infectivity (i.e., enhanced virulence) when infecting a population experiencing such immune selection pressure (i.e., highly COVID-19 vaccinated populations).

So, whereas Omicron resisted the infection-inhibiting activity of neutralizing Abs (NAbs) and redirected population-level immune selection pressure on the infectivity of SARS-CoV-2 to population-level immune selection pressure on trans infectivity of Omicron descendants, a novel (O-glycosylated) variant, which I've termed "Hi-Vi-Cron" as an acronym for "Highly Virulent Omicron descendants," might possess the capability to withstand the trans infection- inhibiting effects of PNNAbs while leveraging these antibodies to amplify viral infectivity (Geert Vanden Bossche Predictions on evolution Covid 19 pandemic [UPDATE May 2022] | Voice for Science and Solidarity). This increased viral infectivity, in conjunction with heightened virulence, is likely to lead to hyperacute systemic COVID-19 disease, instead of facilitating the adaptation of the host immune response through immune refocusing (as explained in my recently published book: “The Unescapable Immune Escape Pandemic”; drgeert.com).

Understanding the immunological consequences of mass vaccination during a pandemic of a virus causing acute self-limiting infection (e.g., SARS-CoV-2) is essential. The advent of Omicron signaled the irrevocable loss of the opportunity for the population to develop herd immunity and instead turned mass vaccination into an unprecedented and life-threatening "gain-of-function" experiment with the global population as guinea pigs. Just as Omicron came like a thief in the night, so too will Hi-Vi-Cron surprise society.

Predicting complex biological dynamics requires a rigorous scientific analysis of the fundamental causes of these dynamics and their alignment with forthcoming data and observations, rather than extrapolation from ad hoc data or previous observations. Regarding the ongoing immune escape pandemic, the dominant biological patterns are governed by the evolving dynamics of the virus, molded and remolded by the population-level immune response imprinted by mass vaccination. As these viral evolutionary dynamics were initiated in the wrong direction (the immune response should ideally adjust to the virus, not the other way around!), Nature is now compelled to eliminate all incorrect immune adaptations from the population. This scenario will, however, leave many vaccinated individuals (i.e., those who were vaccinated in ways that made them exclusively reliant on this mistaken immune imprinting) entirely unprotected. I cannot imagine how this would not lead to significantly increased mortality rates before protective herd immunity can be achieved. However, this may only transpire once the rate of excess deaths in vaccinees due to immune suppression or immune-related pathology indirectly resulting from mass vaccination has further increased. (What's driving turbo cancers and autoimmune flare-ups? | Voice for Science and Solidarity).

The scenario depicted above represents the only means through which nature can transform the ongoing herd immune selection pressure (on viral virulence) exerted by highly COVID-19 vaccinated populations into a state of optimal, sterilizing herd immunity (primarily conferred by the unvaccinated).

The rise in hospitalization and mortality rates could rapidly strain healthcare and funeral service systems in highly COVID-19 vaccinated countries. I therefore urge all healthy unvaccinated individuals to be prepared to assist in such scenarios, whenever and wherever they may arise.
 

Zoner

Veteran Member
(fair use applies)


How many more times will I have to tell you that this ‘immune escape’ pandemic will not have a happy ending?
By Geert Vanden Bossche
September 19, 2023

The exotic and highly infectious nature of the currently circulating variants raises questions. New emerging variants are now succeeding each other at a rapid pace (e.g., FL.1.5.1, BA.2.86, EG.5). While they share a phylogenetic relationship, they have become so antigenically distinct from their predecessors that they should no longer be considered mere variants but rather different serotypes.

Mutations, as identified by mutation-spotters and confirmed by molecular epidemiologists, are no longer converging to a well-defined spike (S)-associated domain. It appears that mutations enhancing the virus's intrinsic infectivity are currently thriving and competing with each other. This suggests that the viral evolutionary dynamics are no longer driven by ‘herd’ immune selection pressure on viral infectivity.

In the absence of immune selection pressure on viral infectivity and with highly infectious variants in circulation, variants which incorporated spontaneous mutations conferring an even higher level of intrinsic viral infectivity are now more likely to emerge. This is because the higher the viral infectivity, the more the virus replicates and the more likely it is for variants with even higher infectivity to gain a competitive advantage over existing lineages or less infectious offspring. If not constrained by selective immune pressure, variants with steadily increasing infectivity can lead to higher rates of asymptomatic transmission among COVID-19 vaccinees and compete for dominance.

Because public health authorities do not fully comprehend the dynamics of the population-level immune adaptation at play, they do not consider the current evolution very threatening for several reasons:
  • Antibodies in vaccine recipients are mistakenly believed to have the capability to effectively neutralize the newly emerging variants in vivo, even those that are highly infectious, albeit with somewhat reduced effectiveness (All That Glitters Is Not Gold).
  • Although hospitalization and morbidity rates are now gradually increasing, most hospitalizations are primarily associated with SARS-CoV-2 but are not directly attributed to it.
  • Cases of mild to moderate COVID-19 disease, whether in the vaccinated or unvaccinated, have become increasingly rare.
  • While viral transmission rates are increasing, they remain lower than during the initial circulation of Omicron and its early variants.
Few appear to acknowledge that the spread of more infectious Omicron-derived lineages is resulting in reduced attachment of S variant-nonspecific, non-neutralizing antibodies to a highly conserved antigenic site within the N-terminal domain of S protein (therefore also called ‘polyreactive’, non-neutralizing antibodies; PNNAbs). This site is exposed on the surface of S proteins found on progeny virions that adhere to migrating dendritic cells (DCs) surveying the upper respiratory tract. This diminished binding can result in flawed inhibition of viral trans infection in distal organs and may lead to the cell-to-cell trans fusion of virus-infected host cells (How Has the COVID-19 Mass Vaccination Campaign Made the Natural Selection and Rapid Propagation of a HIGHLY Virulent Variant Highly Likely?).

Trans fusion of SARS-CoV-2-infected cells is indicative of high viral pathogenicity, which can clinically manifest as severe or systemic COVID-19 disease. When the segment of the population exerting suboptimal PNNAb-mediated immune pressure on viral trans infectivity surpasses a specific threshold, the entire population represented by that segment will collectively exert immune selection pressure on this trait. This will inevitably lead to the natural selection and spread of a new variant that combines high viral infectivity with high viral trans infectivity (i.e., enhanced virulence) when infecting a population experiencing such immune selection pressure (i.e., highly COVID-19 vaccinated populations).

So, whereas Omicron resisted the infection-inhibiting activity of neutralizing Abs (NAbs) and redirected population-level immune selection pressure on the infectivity of SARS-CoV-2 to population-level immune selection pressure on trans infectivity of Omicron descendants, a novel (O-glycosylated) variant, which I've termed "Hi-Vi-Cron" as an acronym for "Highly Virulent Omicron descendants," might possess the capability to withstand the trans infection- inhibiting effects of PNNAbs while leveraging these antibodies to amplify viral infectivity (Geert Vanden Bossche Predictions on evolution Covid 19 pandemic [UPDATE May 2022] | Voice for Science and Solidarity). This increased viral infectivity, in conjunction with heightened virulence, is likely to lead to hyperacute systemic COVID-19 disease, instead of facilitating the adaptation of the host immune response through immune refocusing (as explained in my recently published book: “The Unescapable Immune Escape Pandemic”; drgeert.com).

Understanding the immunological consequences of mass vaccination during a pandemic of a virus causing acute self-limiting infection (e.g., SARS-CoV-2) is essential. The advent of Omicron signaled the irrevocable loss of the opportunity for the population to develop herd immunity and instead turned mass vaccination into an unprecedented and life-threatening "gain-of-function" experiment with the global population as guinea pigs. Just as Omicron came like a thief in the night, so too will Hi-Vi-Cron surprise society.

Predicting complex biological dynamics requires a rigorous scientific analysis of the fundamental causes of these dynamics and their alignment with forthcoming data and observations, rather than extrapolation from ad hoc data or previous observations. Regarding the ongoing immune escape pandemic, the dominant biological patterns are governed by the evolving dynamics of the virus, molded and remolded by the population-level immune response imprinted by mass vaccination. As these viral evolutionary dynamics were initiated in the wrong direction (the immune response should ideally adjust to the virus, not the other way around!), Nature is now compelled to eliminate all incorrect immune adaptations from the population. This scenario will, however, leave many vaccinated individuals (i.e., those who were vaccinated in ways that made them exclusively reliant on this mistaken immune imprinting) entirely unprotected. I cannot imagine how this would not lead to significantly increased mortality rates before protective herd immunity can be achieved. However, this may only transpire once the rate of excess deaths in vaccinees due to immune suppression or immune-related pathology indirectly resulting from mass vaccination has further increased. (What's driving turbo cancers and autoimmune flare-ups? | Voice for Science and Solidarity).

The scenario depicted above represents the only means through which nature can transform the ongoing herd immune selection pressure (on viral virulence) exerted by highly COVID-19 vaccinated populations into a state of optimal, sterilizing herd immunity (primarily conferred by the unvaccinated).

The rise in hospitalization and mortality rates could rapidly strain healthcare and funeral service systems in highly COVID-19 vaccinated countries. I therefore urge all healthy unvaccinated individuals to be prepared to assist in such scenarios, whenever and wherever they may arise.
Thanks for the post. He is guessing this fall.
 

Heliobas Disciple

TB Fanatic
(fair use applies)


‘Definite Causal Link’ Between COVID Vaccine Rollouts and Peaks in All-Cause Mortality, New Study Finds
Researchers estimated the COVID-19 vaccines led to approximately 17 million deaths worldwide, with the most deaths occuring among the elderly.

By Brenda Baletti, Ph.D.
09/20/23

A new study of 17 countries found a “definite causal link” between peaks in all-cause mortality and the rapid rollouts of the COVID-19 vaccines and boosters.

Researchers with Canada-based Correlation Research in the Public Interest found more than half of the countries analyzed had no detectable rise in all-cause mortality after the World Health Organization declared a global pandemic on March 11, 2020 — until after the rollout of the COVID-19 vaccines and boosters.

They also found that all 17 countries, which make up 10.3% of the global population, had an unprecedented rise in all-cause mortality that corresponded directly to vaccine and booster rollouts.

Through a statistical analysis of mortality data, the authors calculated the fatal toxicity risk-per-injection increased significantly with age, but averaged 1 death per 800 injections across all ages and countries.

By that calculation, with 13.5 billion injections given up to Sept. 2, 2023, the researchers estimated there were 17 million COVID-19 vaccination deaths (± 500,000) globally following the vaccine roll-out.

“This would correspond to a mass iatrogenic event that killed 0.213 (± 0.006) % of the world population and did not measurably prevent any deaths,” the authors wrote.

This number, they noted, is 1,000 times higher than previously reported in data from clinical trials, adverse event monitoring and cause-of-death statistics gleaned from death certificates.

In other words, “The COVID-19 vaccines did not save lives and appear to be lethal toxic agents,” they wrote.
The shots were the most toxic for the most elderly across all 17 countries analyzed.

The authors concluded governments should “immediately end the baseless public health policy of prioritizing elderly residents for injection with COVID-19 vaccines, until valid risk-benefit analyses are made.”

The 180-page paper, by Denis Rancourt, Ph.D. former physics professor and lead scientist for 23 years at the University of Ottawa, Marine Baudin, Ph.D., Joseph Hickey, Ph.D. and Jérémie Mercier, Ph.D. was published Sept. 17.


Using all-cause mortality to identify deaths caused by vaccines

All-cause mortality (ACM) — a measure of the total number of deaths from all causes in a given time frame for a given population — is the most reliable data used by epidemiologists for detecting and characterizing events causing death and for evaluating the population-level impact of deaths from any cause, the authors wrote.

Unlike other measures, ACM data are not susceptible to reporting bias or to biases that may exist in subjective assessments of the cause of death. Any event, from a natural disaster like an earthquake to a wave of seasonal or pandemic illness appears in ACM data.

Using methodologies developed in their previous research on COVID-19 and vaccination in India, Australia, Israel, the U.S. and Canada, the authors used changes in all-cause mortality rates to identify deaths associated with mass vaccination.

Rancourt told The Defender that after identifying the “stunning” correlation between vaccines, boosters and rising ACM in those five countries, the authors looked for other countries that had similar data so they could repeat the analysis to determine if the same synchronicity occurred.

They tracked and statistically analyzed the temporal relationship between spikes in national all-cause mortality rates, stratified by age where data were available, and the COVID-19 pandemic period and the vaccine and booster rollouts.

In other words, they analyzed whether “excess mortality” appeared following the announcement of the COVID-19 pandemic and following the introduction of initial vaccines or booster shots relative to previous all-cause mortality rates.

Excess mortality is a term used in epidemiology and public health that refers to the number of deaths from all causes during a crisis above and beyond what we would have expected to see under ‘normal’ conditions, according to Our World in Data.

Controlling for confounding factors such as seasonality, the authors calculated the vaccine-dose fatality rate (vDFR) — the ratio of vaccine-attributable deaths to the number of vaccines given. They found it ranged from 0.02 to 5%, depending on country, age and number of shots given and that the overall, all-ages vDFR for all 17 countries averaged 0.126 ± 0.004%.

“These findings appear to confirm arguments made by biologists including Mike Yeadon and Sucharit Bhakdi that the dangers for adverse autoimmune reactions would be predicted to increase with each subsequent exposure to the transfection,” said Childrens’ Health Defense Staff Scientist J. Jay Couey.

Factors such as seasonal illnesses can complicate analysis of all-cause mortality rates, because deaths from things like respiratory illnesses tend to peak in winter.

To eliminate seasonality as a possible confounding factor, the Correlation researchers, examined all available data for countries that rolled out the vaccines but where there was no seasonal fluctuation (equatorial countries) or the vaccines/boosters were rolled out during the summer and so the effects of the rollouts could be seen most clearly.

Those countries, all located in the equatorial region or the Southern Hemisphere where the rollouts were in the summer, included Argentina, Australia, Bolivia, Brazil, Chile, Colombia, Ecuador, Malaysia, New Zealand, Paraguay, Peru, Philippines, Singapore, South Africa, Suriname, Thailand and Uruguay.

The authors are working on extending this analysis to all countries across the world where data is available, Rancourt told The Defender.


Vaccination associated with high all-cause mortality regime in all countries

In nine of 17 countries analyzed, there was “no detectable excess mortality in the year or so between when a pandemic is announced on 11 March 2020 and the starting time of the first vaccine rollout in each country,” the paper reported.
In Australia, Malaysia, New Zealand, Paragua, Philippines, Singapore, Suriname, Thailand and Uruguay, excess mortality appeared only after the vaccine rollout.

In the other eight countries — Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Peru and South Africa — excess mortality can be seen prior to the vaccine rollout.

However, the researchers said, “In all 17 countries, vaccination is associated with a regime of high mortality, and there is no association in time between COVID-19 vaccination and proportionate reduction in ACM.”

Also, all 17 countries showed a strong correlation with higher rates of ACM in early 2021, following the initial vaccine rollout and in early 2022, when the boosters were rolled out.

The authors underscore the finding that where age-stratified data were available, there were “remarkable temporal associations” between rapid first dose and booster rollouts and immediate peaks in all-cause mortality, and the transition to what Rancourt called “a new regime in mortality, where the mortality just stayed high for a long time.”

The paper includes reporting, graphs and data analysis by a number of different methods showing the temporal relationships between the pandemic announcement, vaccines and spikes in all-cause mortality for each individual country.




Transitions between regimes of mortality — ACM by time (blue), vaccine administration by time (orange) and the average ACM by time (red). The March 11, 2020 pandemic declaration date is shown by a vertical grey line in each panel. The data sources are specified in Appendix A of the study. Credit: Rancourt, Baudin, Hickey and Mercier.


Causation, not just correlation

The authors argue the evidence collected supports a causal link between vaccines and high mortality rates.

First, they cite autopsy studies, adverse event monitoring and peer-reviewed publications, studies of vaccine-induced pathologies, analysis of adverse events in industry clinical trials and payouts from global vaccine injury compensation programs, which together they say demonstrate the COVID-19 vaccines caused many individual deaths.

Then they point to several population-level studies, including their own prior research, that demonstrated a likely causal link.

And they cite principles of immunology that explain the mechanisms from severe harm from the COVID-19 vaccines.
The authors also addressed and discounted several proposed alternative explanations for the spikes in ACM, including that those changes are due to seasonal variation, heat waves, earthquakes, conflict, COVID-19 countermeasures, underlying health conditions or the appearance of COVID-19 variants.

They argued that COVID-19 variant “waves” cannot explain the spikes, they wrote.

For that to occur, the new variants would have to cause simultaneous peaks and surges in mortality in 17 countries, “which is a statistically impossible occurrence if we accept the theories of spontaneous viral mutations and contact spreading of viral respiratory diseases; and all the resulting peaks of mortality would have the remarkable coincidence of occurring precisely when vaccine boosters were rolled out.”

The authors concluded that the strong correlation between vaccine rollouts and the new higher regimes of ACM shows causality, according to the “experiment, temporality and consistency” criteria laid out by Dr. John Ioannidis in a 2016 paper.

The same phenomenon, they write, is observed in different age and geographical settings (experiment), the rises in all-cause mortality are synchronous with the vaccine rollouts (temporality) and the phenomenon is qualitatively the same each time it occurs (consistency).


Prioritizing elderly people for vaccination was ‘reckless’

These “conclusive” findings contradict the common claims that the vaccines, despite their adverse effects, actually saved lives.

Instead, the authors write:

“We have found no evidence in our extensive research on ACM that COVID-19 vaccines had any beneficial effect. If vaccines prevented transmission, infection or serious illness, then there should be decreases in mortality following vaccine rollouts, not increases, as in every observed elderly age group subjected to rapid booster rollouts.”

To the contrary, the study confirmed the authors’ previous findings that vDFR grows exponentially with age. They found the risk of dying from the COVID-19 injection doubled with every 4-5 years of age, which is approximately half the doubling age of dying of all causes of mortality, including cancer, pneumonia and heart disease.

They found large and age-dependent values of vDFR in elderly people that included, for example, a rate of 0.55% (one death per 180 injections) for people 80 and over in Israel to 5% (one death per 20 injections) for people 90 and over in Chile and Peru.

That means, the authors said, that there is not and was never any age-stratified risk of fatality data to support the public health policies that prioritized elderly people for vaccination.

“Prioritizing elderly people for COVID-19 vaccination, in the absence of relevant data, was reckless.”
 

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View: https://www.youtube.com/watch?v=3t7qGKMaT7s

VAERS data made transparent
Dr. John Campbell
Sep 20, 2023
17 min 26 sec


VIDEO HAS ALREADY BEEN TAKEN DOWN. Must have struck a nerve. :shk:

Here it is on Rumble with a new title.



Rumble summary:
The OpenVAERS Project allows browsing and searching of the VAERS reports
Vaccine Adverse Event Reporting System (VAERS)
https://vaers.hhs.gov/docs/VAERSDataUseGuide_November2020.pdf
Home - OpenVAERS
COVID Vaccine Data - OpenVAERS
Guide to Interpreting VAERS Data
VAERS - Guide to Interpreting VAERS Data
"Underreporting" is one of the main limitations of passive surveillance systems,including VAERS.
VAERS receives reports for only a small fraction of actual adverse events.
Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS)
https://digital.ahrq.gov/sites/defa...ion/r18hs017045-lazarus-final-report-2011.pdf
Less than 0.3% of all adverse drug events, and 1-13% of serious events are reported to the Food and Drug Administration (FDA). Likewise, fewer than 1% of vaccine adverse events are reported. I would add essentially only shows temporal correlations Covid vaccines in comparison with traditional vaccines and other common drugs
FINAL Covid-19 Vaccine Pharmacovigilance Report
VigiBase Services
 

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Biden administration announces $600M to produce COVID tests and will reopen website to order them

By WILL WEISSERT
September 20, 2023, 3:00 PM

WASHINGTON (AP) — The Biden administration announced Wednesday that it is providing $600 million in funding to produce new at-home COVID-19 tests and is restarting a website allowing Americans to again order up to four free tests per household — aiming to prevent possible shortages during a rise in coronavirus cases that has typically come during colder months.

The Department of Health and Human Services says orders can be placed at COVIDTests.gov starting Sept. 25, and that no-cost tests will be delivered for free by the United States Postal Service.

Twelve manufacturers that employ hundreds of people in seven states from California to Maryland have been awarded funding and will produce 200 million over-the-counter tests to replenish federal stockpiles for government use, in addition to producing enough tests to meet demand for tests ordered online, the department said.

The new effort is meant to guard against supply chain issues that sparked some shortages of at-home COVID tests made overseas during past surges in coronavirus cases. But it also illustrates the political balance President Joe Biden is trying to strike as he seeks reelection next year between trumpeting his administration having led the country through the worst of the pandemic while also trying to trying to better prepare for the continued effects of a virus that persists.

Dawn O’Connell, assistant secretary for preparedness and response at HHS, said that though some portions of the public may be tired of the pandemic and its implications, at home-testing remains a key way to slow the spread of new cases.

“Whether or not people are done with it, we know the virus is there, we know that it’s circulating. We know, if past is prologue, it’ll circulate to a higher degree and spread, and cases will go up in the fall and winter seasons," O’Connell said. "Anticipating that that would be true again, or something similar, we want to make sure the American people have these tools.”

O’Connell said the website will remain functional to receive orders through the holidays and “we reserve the right to keep it open even longer if we're starting to see an increase in cases.”

“If there is a demand for these tests, we want to make sure that they're made available to the American people for free in this way,” O'Connell said. “But, at this point, our focus is getting through the holidays and making sure folks can take a test if they're going to see Grandma for Thanksgiving."

The tests are designed to detect COVID variants currently circulating, and are intended for use by the end of the year. But they will include instructions on how to verify extended expiration dates, the department said.

The initiative follows four previous rounds where federal officials and the U.S. Postal Service provided more than 755 million tests for free to homes nationwide.

It is also meant to complement ongoing federal efforts to provide free COVID tests to long-term care facilities, schools, low-income senior housing, uninsured individuals and underserved communities which are already distributing 4 million per week and have distributed 500 million tests to date, the department said.

O’Connell said manufacturers would be able to spread out the 200 million tests they will produce for federal use over 18 months. That means that, as demand for home tests rises via the website or at U.S. retailers when COVID cases increase around the country, producers can focus on meeting those orders — but that they will then have an additional outlet for the tests they produce during period when demand declines.

She also said that each winter since the pandemic began “as people move indoors into heated spaces” cases rise and added that also “there’s always an opportunity or chance for another variant to come” but “we’re not anticipating that.”

“That’s not why we’re doing this,” O'Connell said. "We’re doing this for the fall and winter season ahead and the potential for an increase in cases as a result.”

HHS Secretary Xavier Becerra said that the "Biden-Harris Administration, in partnership with domestic manufacturers, has made great strides in addressing vulnerabilities in the U.S. supply chain by reducing our reliance on overseas manufacturing.”

“These critical investments will strengthen our nation’s production levels of domestic at-home COVID-19 rapid tests and help mitigate the spread of the virus," Becerra said in a statement.
 

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US households will be able to order more free Covid-19 tests starting Monday
Jamie Gumbrecht, CNN
Wed, September 20, 2023, 10:26 PM EDT

The US government will relaunch a program to provide free Covid-19 home tests to Americans, US Department of Health and Human Services said Wednesday.

“We will once again begin our program to provide Americans with an opportunity to request tests,” HHS Secretary Xavier Becerra said during an event at a Washington CVS Pharmacy where he was vaccinated against Covid-19 and flu.

US households can order four free tests from Covidtests.gov starting September 25.

The US government has shipped more than 755 million free Covid-19 tests to people who requested them through Covidtests.gov. The program was suspended in May, after the end of the Covid-19 public health emergency, to preserve supply.

Becerra said HHS’s Administration for Strategic Preparedness and Response “has been resupplying our stockpile.”

The tests coming available soon are intended for use through the end of 2023 and will include instructions on how to verify extended expiration dates, HHS said in an announcement Wednesday. The expiration dates of many home Covid-19 tests have been extended well beyond what’s printed on the package.

HHS and ASPR also announced $600 million for 12 US Covid-19 test manufacturers to strengthen manufacturing capacity and purchase about 200 million over-the-counter Covid-19 tests for use by the federal government. The funding will go to manufacturers in New Jersey, California, Texas, Washington, Maryland, Pennsylvania and Delaware.

“The Biden-Harris Administration, in partnership with domestic manufacturers, has made great strides in addressing vulnerabilities in the U.S. supply chain by reducing our reliance on overseas manufacturing,” Becerra said in a statement. “These critical investments will strengthen our nation’s production levels of domestic at-home COVID-19 rapid tests and help mitigate the spread of the virus.”

Covid-19 hospitalizations have been on the rise in the United States since July, with weekly admissions now more than triple what they were two months ago. More than 20,500 people in the US were admitted to the hospital with Covid-19 during the week ending September 9, according to data from the US Centers for Disease Control and Prevention — about 8% higher than the week before.
 

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Australia to hold independent inquiry into handling of COVID pandemic
Renju Jose
Wed, September 20, 2023, 11:47 PM EDT

SYDNEY (Reuters) - Australia's centre-left Labor government on Thursday said it would hold an independent inquiry into the handling of the COVID-19 pandemic to better prepare for future health crises.

Australia closed its international borders and locked down cities among other pandemic restrictions that helped keep infections and deaths far below levels in other comparable developed economies such as the United States and Britain.

It shifted to living with the virus in early 2022 after a majority of the population was vaccinated.

A three-member panel, which includes an epidemiologist, public service expert and economist, will conduct the inquiry, Prime Minister Anthony Albanese told a media conference.

"We need to examine what went right, what could be done better with a focus on the future," Albanese said. "Because the health experts and the science tells us that this pandemic may ... not likely to be the last one that occurs."

Albanese said the inquiry was of national interest, but the opposition coalition which was in power during the height of the pandemic said it did not want it to become a "witch-hunt".

The opposition also criticised Albanese's government for excluding from the inquiry state-level restrictions, such as the stop-start lockdowns by the Victoria government of Melbourne, which endured a total of 262 days in lock down, one of the longest in the world.

"If we don't learn the lessons of what happened during the course of COVID, good and bad, by every level of government, how do we expect to go into the next pandemic not understanding what had happened in the previous one," opposition leader Peter Dutton told reporters.
 

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DeSantis says he won’t support Covid vaccine funding if elected president
Steve Contorno and Kit Maher, CNN
Wed, September 20, 2023, 11:04 PM EDT

Ron DeSantis on Wednesday said if elected president, he would not pay for further coronavirus vaccines for Americans.

“Certainly, we’re not going to fund them,” the Florida Republican governor said during a wide-ranging interview with ABC News recorded Wednesday from Midland, Texas, where he announced his domestic energy policy.

The comment comes as DeSantis has ramped up his attacks in recent weeks on former President Donald Trump, the front-runner for the GOP presidential nomination, over his administration’s response to the Covid-19 pandemic. As a presidential candidate, DeSantis has regularly warned that mandates and restrictions would return, if the government is given the opportunity.

“The implication is they would not hesitate to do it again. Well, when I’m president, we’re not going to let that happen. We’re going to hold people accountable and we’re going to ensure that in the United States, you’re never infringed upon by some health bureaucrat trying to take away your freedom,” DeSantis said in Spencer, Iowa, in late August.

President Joe Biden last month said he “signed off” on a proposal to request more funding for Covid-19 response, including funding for the development of new vaccines. Although the end of the federal public health emergency in May means the US government is no longer covering the cost of Covid-19 vaccines for most Americans, the US Department of Health and Human Services announced last month that it’s awarded more than $1.4 billion toward the development of new vaccines and therapies as part of the $5 billion Project NextGen initiative.

As some limited, local mask mandates have returned, DeSantis held a roundtable last week on the new Covid-19 shots from Pfizer/BioNTech and Moderna, where his surgeon general recommended people under 65 against receiving them.

DeSantis in the ABC interview doubled down on recent guidance from his state discouraging anyone under 65 from getting them, contradicting federal health officials’ recommendations.

The governor said the US Centers for Disease Control and Prevention cannot be trusted – a response that elicited a prolonged on-air clarification about the scientific evidence supporting the efficacy of coronavirus vaccines from ABC anchor Linsey Davis.

“How good is CDC done with all due respect over the last few years,” DeSantis said. “How many people trust CDC at this point? And I was somebody five years ago, you would have said CDC said this, that would have carried a lot of weight for me. I was in the trenches during Covid. They were citing flimsy studies saying that masks will stop Covid. They were citing flimsy studies about the mRNA shots.”

DeSantis in the interview dismissed recent criticism from Republican donors who appear increasingly disenchanted by the Florida Republican after supporting his reelection, including hedge fund manager Ken Griffin, a prolific GOP donor and one-time DeSantis backer who remains on the sidelines.

“Here’s the thing: I’m a leader. I’m not a follower,” he said. “So, we lead and we do what we think is right. And people can support us or not support us financially, but you should not be led by trying to please very wealthy donors, and I’ve never operated that way. So, for example, it’s been in the press that he’s been upset with him in the tussle with Disney over the over the school curriculum. We were right on the school curriculum, we stood for parents’ rights in education. And I’m not gonna back down from that.”

Asked to contrast himself with Trump, DeSantis rattled off a list of differences, touching on their upbringings and early adult life while continuing to push pragmatic arguments about their capacity to serve.

“We’ve got a lot of differences,” he said. “He was born to great wealth. I’m a blue collar kid that had to work minimum wage jobs to get where I was. You know, he did, obviously a lot, young in business. You know, I volunteered to serve in Iraq and serve in the military. I could serve two terms. He would be a lame duck on day one. I ran 16 points better than him in Florida in my most recent race than he did in his most recent race. I’ve also delivered on these America first policies more than I think anybody in the country and would have a much better chance of actually delivering all this as president.”
 

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'Scientifically bizarre': Research, CDC data undermine COVID vax recommendations for kids, new moms
Pfizer-funded paper and researchers conflate two- and three-dose vax for young kids to bury muddled results on hospital visits. 'Trace' mRNA shows up in vaxxed breast milk, vax weakens immune response to other pathogens in 5-11 year-olds.

by Greg Piper
September 20, 2023 11:00pm

New research on how COVID-19 vaccines affect children and nursing mothers, and the government's own estimates of severe side effects in teenagers, is putting scrutiny on the CDC's recommendation that all ages stay "up to date" with newly authorized formulations.

Fully vaccinated versus unvaccinated children under age 5 were roughly as likely to require medical visits among those testing positive for SARS-CoV-2 in a large California study, challenging the Centers for Disease Control and Prevention's claim that the shots "protect children against severe disease and hospitalization."

A small Australian study found that 5-11 year-olds after vaccination had weaker immune responses to non-COVID infections. Trace amounts of mRNA were found in breast milk tested up to 45 hours after vaccination among lactating mothers in a small New York study.

Before recommending the new Omicron XBB.1.1-based mRNA vaccines this month, the CDC's own Advisory Committee on Immunization Practices reviewed trial data that showed a high rate of "severe" side effects among 12-17 year-olds who took the original monovalent vaccines.

Page 56 of the "Evidence to Recommendations Framework" shows 750 reactogenicity "events" categorized as "grade 3" or higher among 3,616 teens in applications for full vaccine approval by Pfizer (ages 12-15) and Moderna (12-17).

Possibly due to its higher dosage, Moderna's severe event rate was 25% compared to Pfizer's 11%.

The National Institutes of Health defines grade 3 as "incapacitating; unable to perform usual activities; requires absenteeism or bed rest."

By contrast, the CDC estimates every million vaccinations of 12-17 year-olds prevents zero to one COVID-related death, according to page 65 of the framework.

Former Brown University epidemiologist Andrew Bostom pointed out Wednesday that the CDC's own pediatric seroprevalence figures show all minors tested positive for COVID antibodies in the most recent eight-week survey in Brown's home of Rhode Island. He said the virus has become "the common covid cold" for kids.

The research comes as the summer wave of COVID infections and its attendant alarm about new variants appears to have peaked on average, calling into question the feds' call to get new jabs starting two months after the last.

NBC News reported Tuesday that wastewater-surveillance company Biobot Analytics found 5% lower COVID levels nationwide this week compared to last, while the Stanford-Emory research project WasteWaterSCAN found "flattening" more than "true downturn."

Among nearly 1,000 wastewater sites partnering with the CDC, 36% show decreases in COVID levels, 8% no change and 56% rising as of Sept. 11, and a tiny decline in test positivity overall as of Sept. 9. CDC data also show the negligible increase in COVID-related deaths this summer, near an all-time low, has already reversed.

The Journal of the American Medical Association published a "research letter" last week coauthored by three researchers affiliated with Pfizer, based on a Kaiser Permanente Southern California (KPSC) study funded by the pharmaceutical company.

Among nearly 177,000 emergency, urgent care and outpatient visits for acute respiratory infections from July 2022 through May 2023 for children 6 months through 4 years, researchers found 2,300 COVID infections in 24,000 tests performed. Only 6% of tested children were vaccinated, defined as two or three Pfizer doses.

The FDA let Pfizer add a third dose after it started the trial in young children because two weren't showing "non-inferiority," with the agency authorizing the three-dose schedule as their primary series, which is also what the CDC recommends.

While the study found those who received "at least 2" doses had a lower risk of these medical visits than unvaccinated children, the researchers played down the differences between two and three doses, which are only addressed in a chart and one sentence in the "discussion" section.

Three doses has an adjusted odds ratio just under 1, which means no effect, and a confidence interval whose upper boundary substantially crosses 1, meaning even less certainty. The adjusted OR for two doses was 0.5, a strong effect against medical visits, and an upper CI boundary below 1.

The apparently lower risk of "SARS-CoV-2 encounters" for two versus three doses "is likely due to more immune-evasive Omicron sublineages (eg, BQ.1-related and XBB-related strains) becoming dominant by the time young children received their third dose and longer median time since dose 3 compared with dose 2," they wrote.

Former Surgeon General Jerome Adams touted the study without apparently noticing the conflation of doses.

The researchers' combination of two and three doses while leaving out one-dose recipients entirely is "scientifically bizarre," given that Pfizer and the feds agree three doses is standard for young kids, former New York Times drug industry reporter Alex Berenson wrote. A vaccine that performs worse with more doses "lacks any biological plausibility."

The study's corresponding author, Sara Tartof in KPSC's Department of Research & Evaluation, did not respond to Just the News queries to explain the framing of the study. The paper's conflict-of-interest disclosure shows she received "grants from Pfizer paid directly to her institution during the conduct of the study."

The Australian study, published last month in Frontiers in Immunology, took blood samples from 29 children 5-11 years of age who were part of a "well-described cohort followed up since birth."

Researchers analyzed their "in vitro cytokine responses" to several pathogens before and 28 days after Pfizer vaccination, with eight of them also analyzed six months later.

Crucial immune responses to eight of the pathogens, including E. coli, influenza and hepatitis B, "decreased compared to pre-vaccination" at 28 days, while there were "sustained decreases in cytokine responses to viral, but not bacterial, stimulants" at six months, the researchers found.

The implication that a COVID vaccination can alter immune response to diseases, not all vaccine-preventable, is "particularly relevant in children" because of their "extensive exposure to microbes at daycare, school, and social occasions," often for the first time, and they receive many vaccines in the childhood schedule, they wrote.

The New York University medical school study, published Tuesday in The Lancet journal eBioMedicine, collected breast milk samples from "13 lactating, healthy, post-partum women before and after COVID-19 mRNA vaccination," a population "largely excluded from most vaccine clinical trials."

Ten of the 20 vaccine "exposures" had detectable mRNA, concentrated in the extracellular vesicles, though they "neither expressed SARS-COV-2 spike protein nor induced its expression" in the cell line used by the researchers. The mRNA retained 12-25% of its "original integrity."

"Although we believe breastfeeding after mRNA vaccination is safe" and the mRNA "appears to be translationally inactive," the researchers said healthcare providers should talk to mothers about the benefits and risks of breastfeeding in the first two days after vaccination. Further research is needed to determine how much mRNA is needed for newborns to "elicit an immune response."

The CDC did not answer queries for its defense of one-size-fits-all vaccination recommendations in light of the research and its own data.
 

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Biden HHS Hits Wuhan Lab With 10-Year Funding Ban Amid Mounting Evidence Of Leak

by Tyler Durden
Wednesday, Sep 20, 2023 - 08:40 PM

The Biden administration's Department of Health and Human Services announced on Wednesday that it has officially banned the Wuhan Institute of Virology from receiving US funding for a decade, based on mounting evidence that it was ground zero for the Covid-19 pandemic.

On Tuesday, Health and Human Services Secretary Xavier Becerra sent a letter to WIV Director Genera, Dr. Yanyi Wang, to inform her that the lab - which Dr. Anthony Fauci offshored risky gain-of-function research to, would no longer be funded by US grants until July 16, 2033, the NY Post reports.

The letter notes that attempts had been made to contact the lab via fax, email and mail about HHS’s decision to suspend funding in July, but no WIV officials had contested the designation or even responded to the agency.
In that earlier missive, the NIH said it found the Wuhan Institute of Virology had “conducted an experiment yielding a level of viral activity which was greater than permitted under the terms of the grant,” which was for the study of bat coronaviruses.
Other requests for the Chinese research institution’s lab findings had also been ignored after NIH made requests for them on Nov. 5, 2021, and Jan. 6, 2022. -NY Post

"WIV has not acknowledged the violations, has not cooperated with the Government to address the violations, has not accepted responsibility for the violations, and, therefore, presumably has taken no action to eliminate the risk to the Government in conducting business transactions with WIV presently or into the future," the letter reads.

On Wednesday, the House Select Subcommittee on the Coronavirus released a redacted copy of the letter, calling it an "obvious step in the right direction."

"This is especially timely as mounting evidence and intelligence continue to suggest that the COVID-19 pandemic originated from a laboratory failure in Wuhan," said Wenstrup, a Republican from Ohio. "Rewarding the likely source of a global pandemic with American resources will only lead to more future health risks."

"Further, the Select Subcommittee recently revealed that prominent public health authorities — including Dr. Anthony Fauci — knew about the risky laboratory conditions in Wuhan prior to the spread of COVID-19 worldwide," he added.

"Covering up for the failures of a Chinese lab, hiding critical evidence from the American people, and facilitating the public promotion of a false, alternative narrative is extremely concerning and deserves thorough investigation."

Recall that Fauci - who offshored banned gain-of-function research to make bat coronaviruses more transmissible to humans - was accused by Congressional investigators of having 'prompted' the fabrication of a paper by a cadre of scientists aimed at disproving the Covid-19 lab-leak theory.

As the Post further notes, US taxpayers paid more than $2.1 million in grant funding via the National Institutes of Health (NIH) and the US Agency for International Development (USAID) between 2014 and 2021. Over $1.4 million of this went to WIV via EcoHealth Alliance.
US intelligence agencies have issued conflicting reports about the origins of the COVID pandemic, with the FBI being the first to declare a lab leak the most likely explanation for the pandemic.
The Energy Department has also concluded that SARS-CoV-2 most likely leaked from a Chinese lab. The CIA has been unable to come to a determination about pandemic origins. -NY Post

Meanwhile, a senior CIA whistleblower recently told Congress that six analysts who originally concluded a lab-leak was the most likely origin of the pandemic were "given a significant monetary incentive to change their position."

Hey, remember when the Facebook fact checker who worked at the Wuhan lab decreed that a lab-leak was impossible? Good times.
 

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Booking a COVID-19 vaccine? Some are reporting canceled appointments or insurance issues
DEVI SHASTRI
Thu, September 21, 2023, 4:06 PM EDT

MILWAUKEE (AP) — Some people seeking the newest COVID-19 vaccine are running into high demand, insurance headaches and supply delays coast to coast.

Millions of the newly formulated vaccines have shipped out since the Centers for Disease Control and Prevention signed off on them last week for ages 6 months and up. Cases started rising again in late summer, and experts hope that the new shots will help protect people during the upcoming fall respiratory virus season.

But some people have had to cancel appointments because their insurance hasn’t updated the billing codes to cover the vaccines. Others signed up for an appointment, only to have it canceled due to supply issues. And in some places, there are no available nearby vaccines: A search in Juneau, Alaska, through the federal government’s website shows no available appointments within 100 miles.

Some pharmacies have a limited supply of the shots, Alaska Department of Health spokesperson Alex Huseman said, but order backlogs and slow shipments have prevented the vaccines from being widely available. Private health care providers hopefully can get them as early as next week, she said.

“This rollout has been a little bumpier than anticipated, but we do not believe there will be any significant delay in vaccine availability,” Huseman said.

This is the first time that the vaccines are reaching most Americans through the commercial market, bringing public and private health insurers back in the mix. Previously, the federal government bought and distributed COVID-19 vaccines for free since they became available.

CVS Pharmacy spokesperson Matt Blanchette said some insurers are still in the process of updating their billing systems to cover the vaccines. For others, the shots were covered by insurance without issue, but appointments were canceled by their pharmacy due to supply delays.

Walgreens and CVS confirmed that delivery delays to some stores across the country had led to canceled appointments.

“We are aware of isolated incidences at a small number of locations where appointments had to be rescheduled due to delays in supply,” a Walgreens spokesperson said, noting most stores “have supply to support existing patient appointments.”

Moderna and Pfizer representatives told The Associated Press that they have enough supply. Pfizer spokespeople said it is not experiencing any shortages and has “shipped and delivered several million doses of its 2023-2024 COVID-19 vaccine.” Moderna had six million available as of Thursday, vice president of communications Chris Ridley said.

Marwa Bakr, the owner of a small, private pharmacy on Milwaukee’s southwest side, said she put in a preorder for Pfizer and Moderna’s new vaccines a month ago. She got a call from Moderna this week telling her she should get the vaccines in the next two weeks, and Pfizer has said the shots could come by the end of next week.

She used to order the vaccines through the federal government, and said the return to the commercial process is “taking longer.”

“I receive a lot of phone calls every day from people asking when the vaccine will be available,” Bakr said.

Still, the supply issues aren’t deterring people from looking for the vaccine.

Karen Ramos of Temecula, California, made an appointment at her local CVS as soon as she heard that the vaccines were approved. The 57-year-old insurance underwriter has never had COVID-19 — at least, as far as she is aware. She wanted to keep it that way ahead of a scheduled Caribbean cruise on Oct. 1.

She had scheduled an appointment last Saturday, but the day before, she got a text from the pharmacy saying the new vaccine was not available and her appointment had been canceled. She set a new appointment for Tuesday, which also was canceled “due to unforeseen circumstances.”

Ramos started searching for appointments at any CVS between her home and office in San Diego. By expanding her search to Walgreens, she was able to snag an appointment in Temecula on Tuesday.

“It was frustrating, because I was excited to get it two weeks in advance (of the cruise), and then having to scramble to reschedule,” she said.
 

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Study details immune cells vital to success of vaccines against coronavirus
by NYU Langone Health
September 21, 2023


study-details-immune-c.jpg

Multimodal identification of SARS-CoV-2 mRNA vaccine-induced CD8+ T cells. Credit: Nature Immunology (2023). DOI: 10.1038/s41590-023-01608-9


A study has revealed new details about a key population of immune system cells critical to successful vaccination against the pandemic virus, SARS-CoV-2.

Led by researchers at NYU Grossman School of Medicine and New York Genome Center, the current study focused on T cells, which along with B cells, compose the human immune system's response to invading viruses and bacteria. A subset of T cells, labeled with the surface protein CD8, produce molecules that directly kill infected cells. B cells produce antibody proteins that neutralize and label infected cells for removal from the body.

Without risking infectious disease itself, vaccines expose patients to a piece of an invading microbe to generate responses that include B and T cell activation, such that the system is ready for the invader should it be encountered again. The mRNA vaccines deployed against COVID-19 were based on RNA, a genetic material used to encode the spike protein that the virus needs to attach to human cells. Once injected, mRNA instructions are read, the spike is built, and the immune response is triggered.

In the rush to develop vaccines against SARS-CoV-2, and with the rapid testing of thousands of patients required, clinical trials relied mostly on antibody levels, where efficient tests were available, to judge whether patients' immune responses to mRNA vaccine candidates were protective.

The resulting clinical protection, however, was evident as early as ten days after the first vaccine shot, well before neutralizing antibodies could possibly be generated. T cells were suspected to be at least as important to this protection, but standard methods for tracking them were too slow, and so careful analyses of CD8+ T cell responses were sidelined.

Published online September 21 in Nature Immunology, the new study describes a fast (high-throughput) method to track T cell responses, confirms them to be vital to early protection provided by mRNA vaccines against COVID-19, and reveals the T cell subsets most responsible for it.

"Our study identified markers for the CD8+ T cells that arise from mRNA vaccination and that track closely with successful vaccination, which had previously been difficult to quantify on the population level," says co-first study author Rabi Upadhyay, MD, assistant professor in the Department of Medicine at NYU Langone Health, and faculty in its Perlmutter Cancer Center.

"Although our study looks at mRNA vaccination against coronavirus, the antigen-specific CD8+ T cell subpopulations we uncover represent key features of immune responses more broadly, and may help us to study T cells in other disease settings."

For the current study, the research team analyzed gene expression over time in single T cells collected before and after immunization with the mRNA vaccine produced by BioNtech and Pfizer against SARS-CoV-2. The researchers found distinct subsets of CD8+ T cells that reliably multiplied (proliferated) 21 days after the original vaccination, specifically targeting and attacking key proteins (antigens) that make up the pandemic virus.

In looking at the genetic make-up of the most effective T cells, the researchers observed that cells lacking a surface protein called KLRG1, which stands for co-inhibitory receptor killer-cell lectin like receptor G1, were the most likely to multiply quickly after mRNA vaccination and specifically attack. When study authors checked for these profiles in hospitalized COVID-19 patients, those with the most "properly programmed" T cells—lacking KLRG1 but expressing other markers such as CD38 and HLA-DR—were the most likely to successfully recover from their infections.
Quicker answers on cancer

In the years since the pandemic began, mRNA vaccines, first used against the virus, are now in clinical trials wherein they direct the body's immune system to attack cancerous cells. By clarifying T cell markers (e.g., KLRG1, CD38, HLA-DR), and the timeline for when CD8+ T cells arise in the blood after vaccination, the new work may enable clinical teams to tell which patients are responding to the vaccines within days or weeks, say the authors.

That compares to the more than two months that oncologists must currently wait after mRNA vaccination to perform CT scans and assess whether their lung, breast, or prostate cancer patients responded to an mRNA vaccine. If they are validated in this setting and dramatically shorten such wait times, the new profiling methods promise to help patients pivot more quickly to other treatments if necessary, the researchers say.

Furthermore, the study authors refer to a recent study led by a different research team which found that T cells with very similar attributes—again involving KLRG1, CD38, and HLA-DR—were the most effective at attacking cancer cells after treatment with an immune system-triggering drug (immunotherapy), just as they were the most effective at attacking the SARS-CoV-2 virus in the current study.

"It is remarkable that T cell attributes found after treatment with an effective immunotherapy mirrored those that we found to track with patient recovery from COVID-19," says co-corresponding author Dan Littman, MD, Ph.D., the Helen L. and Martin S. Kimmel Professor of Molecular Immunology in the Department of Cell Biology at NYU Langone. "This pattern suggests that the close monitoring of antigen-specific CD8+ T cell subpopulations will be central to future efforts to design treatments and vaccines against either viruses or tumors."

Along with Upadhyay and Littman, study authors from NYU Langone were Marie Samanovic, Ramin Herati, Jordan Axelrad, and Mark Mulligan. Study authors from the New York Genome Center were co-first author Bingjie Zhang, Yuhan Hao, John Blair, and co-corresponding author Rahul Satija. Littman is also a member of Perlmutter Cancer Center and a Howard Hughes Medical Institute (HHMI) investigator.
 

psychgirl

TB Fanatic
(fair use applies)


Booking a COVID-19 vaccine? Some are reporting canceled appointments or insurance issues
DEVI SHASTRI
Thu, September 21, 2023, 4:06 PM EDT

MILWAUKEE (AP) — Some people seeking the newest COVID-19 vaccine are running into high demand, insurance headaches and supply delays coast to coast.

Millions of the newly formulated vaccines have shipped out since the Centers for Disease Control and Prevention signed off on them last week for ages 6 months and up. Cases started rising again in late summer, and experts hope that the new shots will help protect people during the upcoming fall respiratory virus season.

But some people have had to cancel appointments because their insurance hasn’t updated the billing codes to cover the vaccines. Others signed up for an appointment, only to have it canceled due to supply issues. And in some places, there are no available nearby vaccines: A search in Juneau, Alaska, through the federal government’s website shows no available appointments within 100 miles.

Some pharmacies have a limited supply of the shots, Alaska Department of Health spokesperson Alex Huseman said, but order backlogs and slow shipments have prevented the vaccines from being widely available. Private health care providers hopefully can get them as early as next week, she said.

“This rollout has been a little bumpier than anticipated, but we do not believe there will be any significant delay in vaccine availability,” Huseman said.

This is the first time that the vaccines are reaching most Americans through the commercial market, bringing public and private health insurers back in the mix. Previously, the federal government bought and distributed COVID-19 vaccines for free since they became available.

CVS Pharmacy spokesperson Matt Blanchette said some insurers are still in the process of updating their billing systems to cover the vaccines. For others, the shots were covered by insurance without issue, but appointments were canceled by their pharmacy due to supply delays.

Walgreens and CVS confirmed that delivery delays to some stores across the country had led to canceled appointments.

“We are aware of isolated incidences at a small number of locations where appointments had to be rescheduled due to delays in supply,” a Walgreens spokesperson said, noting most stores “have supply to support existing patient appointments.”

Moderna and Pfizer representatives told The Associated Press that they have enough supply. Pfizer spokespeople said it is not experiencing any shortages and has “shipped and delivered several million doses of its 2023-2024 COVID-19 vaccine.” Moderna had six million available as of Thursday, vice president of communications Chris Ridley said.

Marwa Bakr, the owner of a small, private pharmacy on Milwaukee’s southwest side, said she put in a preorder for Pfizer and Moderna’s new vaccines a month ago. She got a call from Moderna this week telling her she should get the vaccines in the next two weeks, and Pfizer has said the shots could come by the end of next week.

She used to order the vaccines through the federal government, and said the return to the commercial process is “taking longer.”

“I receive a lot of phone calls every day from people asking when the vaccine will be available,” Bakr said.

Still, the supply issues aren’t deterring people from looking for the vaccine.

Karen Ramos of Temecula, California, made an appointment at her local CVS as soon as she heard that the vaccines were approved. The 57-year-old insurance underwriter has never had COVID-19 — at least, as far as she is aware. She wanted to keep it that way ahead of a scheduled Caribbean cruise on Oct. 1.

She had scheduled an appointment last Saturday, but the day before, she got a text from the pharmacy saying the new vaccine was not available and her appointment had been canceled. She set a new appointment for Tuesday, which also was canceled “due to unforeseen circumstances.”

Ramos started searching for appointments at any CVS between her home and office in San Diego. By expanding her search to Walgreens, she was able to snag an appointment in Temecula on Tuesday.

“It was frustrating, because I was excited to get it two weeks in advance (of the cruise), and then having to scramble to reschedule,” she said.
I heard this going on at Walgreens Monday.
Line of people in there, the Pharm tech loudly saying to someone, “ma’am, insurance isnt paying for your flu vaccine. It’ll be 59$ and we don’t have the new Covid vaccine yet”….
 

Zoner

Veteran Member


WASHINGTON (AP) — The Biden administration announced Wednesday that it is providing $600 million in funding to produce new at-home COVID-19 tests and is restarting a website allowing Americans to again order up to four free tests per household — aiming to prevent possible shortages during a rise in coronavirus casesthat has typically come during colder months.


(I wonder what are on those swabs.)
 

Quiet Man

Nothing unreal exists
View: https://twitter.com/backtolife_2023/status/1703493448089686151


Wittgenstein
@backtolife_2023


India's Kerala state shut some schools and offices this week as officials raced to halt the spread of the deadly Nipah virus, after it killed two people in the fourth outbreak since 2018. Here's everything you need to know about the virus. Source: Reuters

View: https://www.youtube.com/watch?v=NC0MUMsWUcM
2:15 min
We don't know if this will be just another trial balloon, or if it will be a serious threat. We must be on the watch. The most useful part of the following Substack article on Nipah virus is:
We also know that the best protocol for the Nipah-based weaponized virus(es) uses both the SARS-CoV-2 and Ebola/Marburg courses of treatment in a combination of Fenbendazol, Ivermectin and Doxycycline.


Pictures removed...

UPDATE: BREAKING BOMBSHELL: What the Next "Pandemic" Will Look Like​


2ND SMARTEST GUY IN THE WORLD
SEP 22, 2023

Over the weekend this Substack covered the latest “outbreak” in India, and how the bioterror One World Government will attempt to deploy the Nipah virus as the followup to PSYOP-19:

BREAKING BOMBSHELL: What the Next "Pandemic" Will Look Like

“That, you know, I’d say— ah— will get attention this time.” — Bill Gates The democidal maniacs are ramping up their followup COVID-19 fear-mongering, but that will merely serve as their ingenious head fake. The next “pandemic” will be one that scant few are expecting, with the requisite brand new Modified mRNA DEATHVAX™ offerings.

Read full story

And now we are seeing the first instances of the seeding and normalization of lockdowns: Kenora is being trial ballooned to be the Wuhan of 2023.

https://substackcdn.com/image/fetch/f_auto,q_auto:good,fl_progressive:steep/https://substack-post-media.s3.amazonaws.com/public/images/9ead0a7d-52c6-4ebb-9f75-9e32ca9feb3d_550x309.jpeg
Health workers wearing protective gears shift a man with symptoms of Nipah virus to an isolation ward at a government hospital, in Kozhikode in Kerala on Saturday. (AFP)

In an Hindustan Times article entitled, Nipah virus: Health department tightens restrictions in Kerala, the authorities have begun to clamp down:
All 38 wards of Feroke Municipality and seven wards of Kozhikode Municipal Corporation have been declared as containment zones, the collector said.

How many “cases” of this Nipah bioweapon did it take for this latest round of tyranny you might ask?
The Kerala health department on Saturday tightened restrictions in Kozhikode district in the wake of the sixth case of Nipah virus being reported the previous day, officials familiar with the matter said. No fresh infections were reported on Saturday, as 11 more samples of ‘high-risk’ contacts sent for testing turned out to be “negative.”

As readers of this Substack are well aware, schools will be an important deployment vector for this latest global “outbreak:”
Kozhikode district collector A Geetha ordered the closure of all educational institutions in the district including schools, colleges, tuition centres and professional coaching centres till September 23 and advised that online classes be held for students until then. The development comes as various parts of the district have been declared as containment zones, making it difficult for students from these areas to reach schools and other institutions.

The Canadian Mockingbird MSM outlet CBC has also been activated to maximize the fear:
View: https://twitter.com/Gykiwi03/status/1703534195400937590

We know that a virus this deadly does not spread. What we do not know is the kind of gain of function that has been performed on this Nipah virus bioweapon to alter its natural infectivity and evolution over time; in other words, if you are in the viral deployment vicinity where they are deliberately infecting people, then you may be exposed to all kinds of potential damage.

We also know that the best protocol for the Nipah-based weaponized virus(es) uses both the SARS-CoV-2 and Ebola/Marburg courses of treatment in a combination of Fenbendazol, Ivermectin and Doxycycline.

The democidal “authorities” have already developed their Modified mRNA DEATHVAX™ for Nipah. If this latest power grab takes hold over large enough swaths of the global population, then they will be pushing these poisons out soon after their current COVID boosters prove to be the low uptake failure that their bivalent offerings were.

Do NOT comply.
 
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Heliobas Disciple

TB Fanatic
(fair use applies)


As Covid-19 hospitalizations climb, rates among seniors and children raise concern
Jamie Gumbrecht, Deidre McPhillips and Betsy Klein, CNN
Fri, September 22, 2023, 5:34 PM EDT

Covid-19 hospitalizations have been on the rise in the United States for months, with weekly admissions now more than triple what they were two months ago. Seniors have the highest rates of Covid hospitalizations by far, but hospitalizations among children — especially among those younger than 5 — are rising fast.

More than 20,500 people in the US were admitted to the hospital with Covid-19 during the week ending September 9, according to data from the US Centers for Disease Control and Prevention – about 8% higher than the week before.

“We haven’t really seen this for many months, but we’re starting to see people come into the hospital critically ill,” said CNN medical analyst Dr. Jonathan Reiner, a cardiologist and professor of medicine and surgery at George Washington University. “There needs to be a greater sense of urgency because deaths are rising, hospitalizations are rising.”

On Friday, a White House official acknowledged increased infections and hospital admissions nationally, but noted that levels remain lower than during past Covid surges. The Biden administration is also preparing to ramp up messaging on flu, RSV and Covid vaccines, including for higher-risk populations such as seniors and young children.

“We are tracking upticks in some parts of the country but believe we remain in the strongest position yet as we head into fall,” the White House official told CNN.


Who’s hospitalized now


Nationally, more than half of new Covid-19 hospital admissions were among people age 70 and older, and more than two-thirds are among people age 60 and older, according to the latest CDC data.

But a new analysis of federal data from the American Academy of Pediatrics showed hospital admissions among children are rising faster than average. Nearly 1,200 children were admitted to the hospital with Covid-19 during the week ending September 9, marking a five-fold increase over the past three months. Hospitalizations among adults increased about three-fold in that same time period.

Admissions among children remain below previous pandemic peaks. There were about 1,800 new pediatric admissions in a week at the height of last winter’s wave, and more than 6,500 weekly admissions during Omicron, the AAP analysis shows.

Children accounted for 6% of all Covid-19 hospital admissions during the week ending September 9, federal data shows. And children under 5 were the most at risk, with about half of all pediatric Covid-19 hospitalizations among those younger than 5, according to the AAP analysis.

“This increase in hospitalizations, especially for the youngest children, is very concerning,” said Dr. Sandy L. Chung, president of the AAP. “We know this is the age group with the lowest vaccination rates. Right now, we have updated COVID vaccines that can help children’s immune systems learn to detect and resist the virus, including the strain that is circulating now. The virus is still here, and I’d urge parents to talk with their pediatricians about how they can protect their family.”

Vaccination rates have consistently lagged for children. In May, when the public health emergency ended, less than 1% of children under 5 had received the bivalent booster and less than 10% of children ages 5 to 17 had received it, data from the CDC shows.

Covid-19 remains the main virus of concern as the US heads into respiratory virus season, representing nearly all virus-associated hospitalizations since the beginning of the year. But RSV levels have started to pick up in most regions of the US.

Dr. Susan Walley, chief of the Division of Hospital Medicine at Children’s National Hospital in Washington, D.C., said they’ve seen in increase in hospitalized patients testing positive for all respiratory viruses, including Covid-19, since early September.

“It’s not unusual, unfortunately, for there to be an increase in children hospitalized with respiratory symptoms at the start of the school year, and it demonstrates the importance of all children who are eligible to get the COVID-19 and influenza vaccine,” Walley said in a statement.


Where hospitalizations are highest

For now, Covid-19 hospitalizations remain concentrated in the South. Florida had a higher hospitalization rate than any other state — 11 per 100,000 people in one week — and about 11% of all Covid-19 hospital admissions in the first week of September were in Florida.

After Florida, Washington, DC, had the highest rate of hospital admissions, about 10 per 100,000 people in one week. Arkansas, Alabama, Louisiana and West Virginia also among states with the highest hospitalization rates.

CDC guidance around masking is based on hospitalization metrics, and more than half of Florida’s counties fall into a category where masking is recommended for all high-risk individuals. More than two dozen counties in Arkansas, Kentucky, Texas and Georgia also fall into this category. Overall, masking is recommended at least for high-risk individuals in about 1 in 8 counties.

Despite the recent increases, Covid-19 hospitalizations are still roughly half of what they were during last winter’s peak. Virus levels are even starting to recede in parts of the country – especially the South – and the pace of increase is starting to slow nationwide.

Shifts in testing practices have made case counts less reliable, but tracking virus levels in wastewater can help gauge transmission. Levels have been on the rise nationwide since late June, but have started to tick down in September. The decrease is most pronounced in the South, where viral concentrations dropped about 25% in the first two weeks of the month.

However, CDC forecasting models suggest that weekly hospitalization rates will continue to rise, most likely to double what they are now by the season’s peak in December.


White House ramps up Covid-19 messaging

The Biden administration said Friday it’s working on community, stakeholder and digital outreach, including to physicians and other health care providers. Earlier this week, the administration announced Covidtests.gov will reopen on Monday for households to request four free Covid-19 tests.

It’s also preparing to ramp up messaging on Covid-19, flu and RSV vaccines.

“We will be encouraging all Americans to get those boosters in addition to flu shots, as well as the RSV immunization for people over 60 and for infants,” the White House official said.

US Health and Human Services Sec. Xavier Becerra and CDC Director Dr. Mandy Cohen are both hitting airwaves to press the importance of vaccines. Speaking on CNN on Friday, Cohen emphasized there are safe, effective strategies available to reduce risk, including washing hands, staying home when sick, improving ventilation, wearing a mask and getting vaccinated.

Flu vaccines are already broadly available in pharmacies and doctor’s offices. For the first time, there are vaccines available against RSV for people age 60 and older, and the US Food and Drug Administration recently approved a maternal vaccine and an antibody product that can protect infants.

Updated Covid -19 vaccines by Pfizer and Moderna are starting to roll out across the country, and are recommended for everyone 6 months and older.

“It’s important to know your own risk,” Cohen said. “Are you around folks who are older or who have underlying conditions? Then we need to use more layers of protection.

“The fact is we have tools, we need to use them.”
 

Heliobas Disciple

TB Fanatic
(fair use applies)


How hospitals have been coping with COVID as number of admissions tick up

MARY KEKATOS - ABC News
Fri, September 22, 2023, 3:00 PM EDT

Weekly COVID hospitalizations have been ticking up over the past 11 weeks, rising to 20,538 for the week ending Sept. 9, the highest figures seen since March of this year.

Although the majority of U.S. counties are reporting low hospital admissions levels, a growing number are seeing moderate and even high levels, according to data from the Centers for Disease Control and Prevention.

Despite the uptick, doctors and hospital administrators across the country said the number of patients they've seen this summer has been lower than previous years and the lessons they've learned over the course of the pandemic has helped them cope with increasing hospitalization rates.

In Sacramento County, California, hospital admissions have reached medium levels with about 10.1 admissions per 100,000.

Michael Korpiel, president of the Sacramento market for Dignity Health, a nonprofit that operates hospitals in three states, said there have been fewer than 20 people testing positive for COVID at any time in the six hospitals.

"The last three years have been a great learning experience for our system and our hospital, but I think for the Sacramento region, we are better prepared today than we have been in the past," he told ABC News. "We have shored up all of our supply lines, so that we make sure that we have enough equipment and supplies in place if we begin to see a spike in the number of COVID patients."


69f884e498b0304581cb1f5bbd657735

PHOTO: A map shows the weekly COVID-19 hospital admissions per 100,000 for the week ending Sept. 9, 2023. (CDC)

Similarly, Dr. Rami Zebian, chief medical officer for the Medical University of South Carolina Health Pee Dee Division -- which encompasses three hospitals -- told ABC News there has not been a huge surge in patients over the summer, but lessons learned have helped the division be prepared.

One example he gave was increasing the number of devices for non-invasive ventilation and knowing when to use ventilation on a patient.

"We have that equipment that can be used for both," he said. "We learned that we don't have to put people on the ventilator early on in their disease. If we can delay that, until they really need it, we don't have to do it."

Hospital staff are also kept safe by having enough personal protective equipment when dealing with patients. They're also encouraged to get the annual flu shot and the updated COVID vaccine that targets circulating variants.

None of the hospitals or health systems that ABC News spoke to said they have universal masking in place, but there are discussions about what the threshold would be to reinstate a mandate or if they would follow county health department guidelines.

As the U.S. moves into the colder weather months -- the traditional respiratory virus season -- hospitals also need to prepare for a possible "tripledemic," a mix of COVID, flu and RSV that could overwhelm health systems.

Dr. David Hirschwerk, an infectious disease specialist and the medical director at Northshore University Hospital in New York, said his hospital is in "a constant state of readiness for COVID" as well other viruses.

Nassau County, where NU Hospital is based, is currently in the medium admission category with 10.4 hospital admissions per 100,000, CDC data shows. Hirschwerk said the hospital has not been overwhelmed so far and protocols are in place to prevent it from becoming overwhelmed later in the year.

"Each year as we get into this time of year and as we move deeper into the fall and winter will be impacted by increase in respiratory viruses not only with COVID but also with influenza and other respiratory viruses like RSV," he told ABC News. "With that we have the tools to do testing, we have the space in our hospital, and we always manage and try to keep our environment safe by testing patients when it's indicated by screening visitors."

"It would be great if we don't see all three viruses simultaneously. But we know that we're going to see all three at some point and we'll be prepared regardless of how much there is and what the timing of it is," Hirschwerk added.
 

Heliobas Disciple

TB Fanatic
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Cancers Appearing In Ways Never Before Seen After COVID Vaccinations: Dr. Harvey Risch
by Tyler Durden
Friday, Sep 22, 2023 - 10:20 PM

Authored by Efthymis Oraiopoulos and Jan Jekielek via The Epoch Times


There is evidence that cancers are occurring in excess after people receive COVID-19 vaccinations, according to Dr. Harvey Risch.

Dr. Risch is professor emeritus of epidemiology in the Department of Epidemiology and Public Health at the Yale School of Public Health and Yale School of Medicine. His research has focused extensively on the causes of cancer as well as prevention and early diagnosis.

In an interview for EpochTV’s "American Thought Leaders," Dr. Risch said patients must now wait months, not weeks, to get an appointment at an oncology clinic in New York.

here is difficulty in observing whether a vaccine can cause cancer, because cancer usually takes time to develop, Dr. Risch said. It can take anywhere from two years to 30 years, depending on the different types of cancer, from leukemia to colon cancer.

“What clinicians have been seeing,” said Dr. Risch, “is very strange things: For example, 25-year-olds with colon cancer, who don't have family histories of the disease—that's basically impossible along the known paradigm for how colon cancer works—and other long-latency cancers that they're seeing in very young people."

He said this is not how cancer normally develops.

"There has to be some initiating stimulus to why this happens," he said.


Fighting Cancer

Dr. Risch said that in his opinion, cancer is something a healthy human body can fight and disable, as the non-normal cancerous cells are gobbled up when detected in a body with a functional immune system. If the immune system is compromised, however, it cannot cope with the task of neutralizing cancerous cells, and cancerous cells are left to multiply and grow, leading to symptoms of cancer.

“That’s the mechanism I think is most likely here,” Dr. Risch said. “We know that the COVID vaccines have done various degrees of damage to the immune system in a fraction of people who have taken them.”

That damage could translate to getting COVID more often, getting other infectious diseases, or getting cancer.

Another example Dr. Risch gave was breast cancer, which normally, if there is a remanifestation after surgical removal, the remanifestation occurs after two decades. However, vaccinated women are now seen to remanifest breast cancers in much shorter periods of time.

“Those are the initial signals that we’ve been seeing, and because these cancers have been occurring to people who were too young to get them, basically, compared to the normal way it works, they’ve been designated as turbo cancers,” Dr. Risch said.

“Some of these cancers are so aggressive that between the time that they're first seen and when they come back for treatment after a few weeks, they've grown dramatically compared to what oncologists would have expected for the way cancer normally progresses,” he added.

“Be attuned to your body,” Dr. Risch recommended, for noticing any new signals the body might give.


Adverse Events After Vaccination

Dr. Risch also talked about the aspect of official medical agencies not recognizing someone as being vaccinated inside the first two weeks of vaccination. This happens, he said, because the medical agencies say that the effects of the vaccine need two weeks to start manifesting. Adverse effects occurring a few days after vaccinations were officially counted as health conditions manifesting in unvaccinated people, he said.

However, serious adverse events after receiving the vaccine have occurred within the first four days, Dr. Risch said. He said three-quarters of adverse effects are being recorded as happening to unvaccinated people.

The decision makers who were in charge during the pandemic "threw out the principles of public health six days into the pandemic and did the opposite of everything that we knew should be done for respiratory viruses," he said.

One example was the denial of effective early treatment and unnecessary vaccinations, which show a “colossal failure of public health through this period," he said.

Dr. Risch said that a lot of people are now less likely to be “propagandized” regarding COVID, and that news reports about a new variant that is going to take over the world in the next month are “propaganda to sell the next batch of vaccines coming out in a few weeks.”

“People are fed up with this and it’s going to be a lot more pushback,” he said.


Risks to Society


Dr. Risch said that while the individual risk of an adverse reaction to the vaccine is relatively low, once that risk manifests itself at a greater scale, when millions of people have received the vaccine, the result is that hundreds of thousands of people are left with injuries and serious adverse events that are often worse than the virus itself.

Dr. Risch’s opinion is that nobody should get vaccinated with an mRNA vaccine, as the new variants are mild and not life threatening. He has heard of a few hospitalizations that lasted for some days, but as most people had COVID in the past, they have some immunity to these new variants as well.

"There is no reason for people to be vaccinated now, to any degree," he said.

He said COVID has become an illness similar to the flu in its degree of severity, and that propaganda to scare people is being pushed by the government on behalf of pharmaceutical companies to sell more vaccines.

“We live in social contact with each other and therefore spread low-level infections. This is part of human life that we take for granted and we try to treat it the best we can," he said. "That’s how we should be managing this."
 

Heliobas Disciple

TB Fanatic
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Unmasking Long COVID: The Unexpected Common Cold Connection
By Brian Doctrow, Ph.D., NIH
September 22, 2023

A study suggests that “Long COVID” may be linked to immune imprinting, where past virus exposures influence responses to new infections. Individuals with PASC showed weakened responses to SARS-CoV-2 but stronger reactions to another coronavirus, OC43. This insight may guide future treatment and risk assessment.

Prior infection with a common cold coronavirus may predispose some people to develop Long COVID.
The findings identify a potential marker that could help identify people at high risk of developing Long COVID.

Many infections with SARS-CoV-2, the virus that causes COVID-19, resolve within days or weeks. But a significant number of people have symptoms that linger for weeks, months, or even years. This is called post-acute sequelae of COVID-19 (PASC)—commonly known as “Long COVID.” While several risk factors for PASC have been proposed, we still don’t understand what causes it or why some people get it and others don’t. To further complicate matters, PASC may have different causes in different people.


Immune Responses and Long COVID

Some individuals with PASC have changes in certain immune responses, suggesting an immune mechanism for PASC. PASC is particularly common among people with systemic autoimmune rheumatic diseases. These are chronic diseases, such as lupus, where the immune system mistakenly targets the body’s own tissues to cause inflammation. Up to 45% of those with these rheumatic diseases who are infected with SARS-CoV-2 develop PASC.


Research Findings and Antibody Responses

An NIH-funded research team—led by Drs. Zachary Wallace at Massachusetts General Hospital (MGH), Jeffrey Sparks at Brigham and Women’s Hospital, and Galit Alter at MGH, MIT, and Harvard—examined antibody responses in people with rheumatic diseases who’d had COVID-19. The team measured antibody responses to SARS-CoV-2 and various other pathogens and vaccines. They compared the responses of those who developed PASC with those who didn’t. Results were published on September 6, 2023, in Science Translational Medicine.

The team found that participants with PASC had much weaker antibody responses to SARS-CoV-2 than those without PASC. However, those with PASC had enhanced responses to another coronavirus called OC43, an endemic virus that causes common cold-like symptoms. Moreover, the stronger the response to OC43 in people with PASC, the weaker their response to SARS-CoV-2. This suggests that antibodies against OC43 may also be reacting to SARS-CoV-2. The researchers observed these patterns in two independent groups of more than 40 patients with rheumatic diseases (about a third of whom had PASC).


Immune Imprinting and Its Implications

The findings indicate that PASC may arise from a phenomenon known as immune imprinting. This refers to how a person’s history of previous infections can affect their immune response to new infections. In this case, when a person who was previously exposed to OC43 is infected with SARS-CoV-2, their immune system responds partly by using antibodies developed during OC43 infection that also recognize SARS-CoV-2. This “recall” response to OC43 leads to an inefficient overall response to SARS-CoV-2. Further research will be needed to determine if and how this weak immune response may lead to PASC.

“When it comes to viruses, first exposure can shape lifelong immunity,” Alter explains. “We know that, in the setting of influenza, previous exposure to a viral strain can influence a person’s immune response to subsequent strains. This concept may be at play for coronaviruses, too, and may influence risk of Long COVID, especially among individuals with rheumatic disease.”

It remains to be seen whether these findings will also apply to people without rheumatic diseases. But the results may help explain why PASC develops, in at least some cases. They also provide clues to help guide the development of novel treatments. Finally, they suggest a marker that could help identify people at high risk of developing PASC for enrollment in more targeted clinical trials.

Reference: “Humoral immunity to an endemic coronavirus is associated with postacute sequelae of COVID-19 in individuals with rheumatic diseases” by Jonathan D. Herman, Caroline Atyeo, Yonatan Zur, Claire E. Cook, Naomi J. Patel, Kathleen M. Vanni, Emily N. Kowalski, Grace Qian, Shruthi Srivatsan, Nancy A. Shadick, Deepak A. Rao, Benjamin Kellman, Colin J. Mann, Douglas Lauffenburger, Zachary S. Wallace, Jeffrey A. Sparks and Galit Alter, 6 September 2023, Science Translational Medicine.
DOI: 10.1126/scitranslmed.adf6598
 

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EXCLUSIVE: An interview with Buckhaults about DNA contamination in covid vaccines... and the FDA responds
Maryanne Demasi, PhD
Sep 22, 2023

Earlier this year, genomics expert Kevin McKernan first discovered DNA contamination in vials of Pfizer and Moderna’s bivalent booster shots. He published his findings in a pre-print, but the research received little attention from the mainstream media.

Observing from afar was Phillip Buckhaults, a cancer genomics expert, and professor at the University of South Carolina. Initially, he dismissed McKernan’s findings as “conspiracy” and decided to debunk the work by carrying out his own testing on the mRNA vials.

But what Buckhaults discovered shocked him --> McKernan was right! Buckhaults found billions of tiny DNA fragments in Pfizer’s mRNA vaccine, and recently testified about it before a South Carolina Senate hearing - I covered in a previous article.

I presented the findings of Buckhaults and McKernan to the US FDA.

I asked the FDA if it had begun an investigation into the issue of DNA contamination and whether it would review its guidance to industry about residual DNA in vaccines.

I also asked the FDA if it had instructed Pfizer and Moderna to conduct further testing to demonstrate the absence or presence of genome modification and whether it would issue new warnings to the public about the potential risks, now that DNA contamination in the vaccines had been established and replicated.

The FDA responded but did not answer specific questions, nor did it acknowledge the problem of contamination and potential safety issues. In a written statement it said:
The mRNA COVID-19 vaccines authorized or approved for use in the United States are not defined as a gene therapy.
The FDA is confident in the quality, safety, and effectiveness of these vaccines. The agency’s benefit-risk assessment and ongoing safety surveillance demonstrates that the benefits of their use outweigh their risks.

I spoke with Buckhaults about the unfolding events. Our conversation was edited for clarity and brevity.

BUCKHAULTS: I didn't have any preconceived notions about there should be something bad in the vaccine, I'm not anti-vaccine, I've actually been vaccinated. And I recommended it to everyone in my family and everybody I care about, but I have been mindful of the fact that there seems to be some reports of vaccine injury out there and I would like to know what the reason is.

DEMASI: Why did you investigate this?

BUCKHAULTS: I could see anxious discussions online getting out of control.

DEMASI: Like what?

BUCKHAULTS: I saw people talking about SV40 (full virus) sequences…

DEMASI: So that’s a virus in monkeys and humans that can cause cancer?

BUCKHAULTS: Yes, and it was going to frighten people into not getting the vaccine. I wanted to put a stop to it. My plan was to examine the vaccine to debunk the fear of SV40 being in the vaccine. One of my good friends and colleagues that I trust kept every “empty” vial of vaccine that they administered in his freezer. Each vial had a little bit of vaccine left over.

DEMASI: What did you do with the vials?

BUCKHAULTS: I checked them first by a PCR assay that uses primers against the vector, and lo and behold, it fired very hot. A very, very high signal. So, then I happen to have a lot of nanopore sequencing capability in my lab from my COVID work. And so, we just had one of my students take everything that was in a few vials and precipitate and put it on the nanopore sequencer and son of the gun, Kevin McKernan was right, this plasmid is present in the vaccine. I proved that there is NOT SV40 full virus, but there is plasmid DNA. And that plasmid does have a little piece of SV40 in it.

DEMASI: When you say a ‘hot signal’, explain what you mean?

BUCKHAULTS: Well, on a PCR assay, water comes up at barely at cycle 40 or not at all, but the signal on the vaccine was coming up a cycle 20. That's like, a million-fold over background and that's like a ginormous signal. I was seeing about 2 billion copies per dose. One lot was 1.6 billion copies per 300 microliter dose and the other one was 2.5 billion copies per 300 microliter dose. So, the signal coming off the machine was a really hot signal - the Ct value was 20 cycles above background. That’s a lot.

DEMASI: So, the “conspiracies” were true?

BUCKHAULTS: Well, there is DNA contaminating the vaccine, but I was also able to put a stop to some of the rumours on social media about the SV40 virus being in the vaccine and that its going to give everybody cancer because that's not true. There's just a piece of SV40 promoter in the vaccine. And that's what people were seizing on, people were saying there’s a monkey virus, we're all going to turn into monkeys or get cancers next week or something. And, and I did my due diligence to tamp down that kind of fear - which was my original purpose.

DEMASI: What did you do once you discovered DNA in the vials?

BUCKHAULTS: I needed to say, look, I found this amount of DNA, it's really true, and there are many copies. We precisely measured it many, many times by PCR and I've done sequencing now about four times and it's there - lots of the DNA is chopped up into little bitty pieces, maybe one to 200 base pairs long, and the entire plasmid is represented, you can rebuild the whole the whole sequence. By PCR, I guesstimate that there's probably somewhere between 5 and 20 nanograms of this plasmid per dose for 300 microliter dose, in the two lots that I've looked at - it was the only two lots that we had here in Colombia. So the observation first reported by Kevin McKernan is absolutely true.

DEMASI: I read somewhere the FDA allows about 10ng of residual DNA to be left in the vaccine and that’s thought to be safe….?

BUCKHAULTS: I am not a regulatory expert but it appears this is a magic line the FDA arrived at before lipid nanoparticles existed. It was back when they were just injecting proteins and or attenuated viruses that they made in CHO cells and a little bit of DNA comes along for the ride, but it's naked DNA. Right? And they've done studies where they inject gobs of naked DNA into mice and never see any problems. But this isn’t naked DNA. This is different and that's what gives me pause that may be the regulatory limit is just not relevant to mRNA vaccines that have lipid-nanoparticles or LNPs, transporting the genetic material to the inside of cells.

The LNPs facilitate getting the DNA inside the cell - just inside the cell membrane. But once it's in the cytoplasm, bits of DNA go to the nucleus just by random chance. And that would happen no matter what the delivery mechanism was. Once the LNPs fuse with the membrane of cells and dump their cargo into the cytoplasm, they’ve done their job.

DEMASI: In the batches you tested, you found that most particles were less than 200 base pairs….what does that mean?

BUCKHAULTS: It matters about the size of the particles. The FDA says 10 nanograms. Now 10 nanograms could be from one molecule that's absurdly ginormous. Or it could be a whole bunch of little bitty molecules. And the hazard for genome modification is not a function of the mass. It's a function of how many independent molecules you've got. So, it's actually way worse, having a whole bunch of these little pieces in terms of a risk of some insertional mutagenesis happening. That's way worse than even having one big piece leftover. Right? I don't think there was anything nefarious about this. It just seems kind of accidentally administratively dumb. That's my own personal opinion.

DEMASI: Perhaps they were in a rush to get the vaccine out there? Operation Warp Speed…

BUCKHAULTS: Yeah, the world was on fire, and we were scared to death. So, I don't fault anyone. Rushing? It’s easy to sit back here now, in the safe comfort that the fear has passed and now, we're all sitting in our offices, and nobody's scared about the world coming to an end, and then throw rocks at what was done three years ago by people trying to save us all. I think that's really unfair. I really think that mostly people were working in good faith to try to put fire out.

DEMASI: So, how do you know that once inside the cell, DNA can travel to the nucleus and get into the genome?

BUCKHAULTS: I know that the potential for a piece of DNA to randomly insert eventually comes up. We do this in the lab all the time. We take pieces of naked DNA, put them in lipofectamine which is a solution that delivers genetic material into cells, and by magic, some of the pieces integrate into the cellular DNA, and permanently modified the cells. I've been doing this since I was a graduate student, so I know that this happens. The only question is, what is the frequency of this happening across a vaccinated population? And is that frequency high enough that we should worry about it? Or is it low enough that the good that comes from the vaccine far outweighs the risk? We just don't know what the frequency of genome modification is.

DEMASI: What does it mean for vaccinated people that the vials are contaminated with DNA?

BUCKHAULTS: People will disagree on the magnitude of the risk. We do not yet know if it means anything or not. There's a chance that this DNA does nothing, but because I have a background in cancer genetics and cancer biology, somatic mutations are my expertise. And I think that there is a reasonable chance that if you inject pieces of DNA that are wrapped up in this transfection particle – the lipid nanoparticles - there is a reasonable chance that some of this is going to get into cells, and then integrate into the genome of cells. I think we should check and find out.

DEMASI: If it does get into the genome, what does it mean?

BUCKHAULTS: IF genome modification is happening, It's just a matter of time before one of these fragments hits a tumour suppressor gene and initiates the beginning of cancer in a single stem cell. Also, there have been reports of myocarditis. I'm wondering if it's possible that these little bits of DNA actually encode pieces of the spike protein…..There's a lot of open reading frames in these pieces of DNA that code for peptides that don't belong in humans and are neo-antigens. And my concern is that some of these pieces of DNA could transform long lived stem cells in, maybe the myocardium, or pericardium, or maybe the liver, or lymph nodes…and now that tissue makes a long-lived expression of some neo-antigen that could be causing a long-term autoimmunity type response like myocarditis. So, they are the two things that immediately come to mind - the small possibility of cancers in people in the next five years down the road, or the possibility of autoimmunity from the production of these peptides.

DEMASI: Got it. Just so I'm clear, there haven't actually been studies or evidence of integration into a person's DNA? Am I correct?

BUCKHAULTS: No there is no evidence of genome modification, because, as far as I know, no one has looked. This is entirely a theoretical concern that in my view absolutely should be looked at. As I mentioned, people have done all kinds of studies with naked DNA and showed that it's not a hazard. But that’s because the naked DNA gets chewed up before it can ever get into the cells. But if LNPs are delivering it to the inside of cells like they are in the mRNA vaccines, then random piece of DNA can (theoretically) integrate into the human genome upstream of some cancer promoting tyrosine kinase, or an oncogene, or even K-RAS, any of your favourite oncogenes where overexpression of the gene can create cancer. Little bits of DNA can act like a promoter if inserted where they do not belong, or if they disrupt a transcriptional repressor gene, that’s another way that you can accidentally turn the gene expression volume knob up to 11. Also, the SV40 promoter/enhancer is a sure-fire way of increasing gene expression, so the risks of cancer would be if the SV40 piece lands upstream of MYC, or K-RAS or EGF receptor or any of the famous cancer genes. But you don't really need that for this hazard to be there. If the SV40 wasn't there, there will still be ways that this could happen.

DEMASI: About 18 months ago, there was a study that suggested the mRNA from the vaccine could be reverse transcribed into the genome of human cells in a petri dish…..doesn’t that suggest integration into the genome can happen? what did you think about that study?

BUCKHAULTS: 18 months ago people were asking about the RNA being reverse transcribed and I dismissed it on theoretical grounds. But there were some papers that showed staining of what looked like spike expression in places that it shouldn't be in experimental animals and the best I could think of was, well, this must be some sort of an artefact because there's no way to get from RNA to genome modification. Well, we didn't know back then that there was something more than RNA in the vaccine. We did not know that there was DNA contamination.

[continued next post]
 

Heliobas Disciple

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[continued from post above]

DEMASI: So this discovery of the DNA in the vaccine might be able to explain some of those findings?

BUCKHAULTS: That's exactly right, I put two and two together when I saw Kevin's sequencing results, I thought, oh, no, maybe this is explaining those results that I unfairly dismissed. They were right. Maybe they just didn't know the mechanism.

DEMASI: The FDA has always maintained that there was no evidence that RNA could modify the genome…

BUCKHAULTS: You can see why. They’d be thinking it's an RNA vaccine, there's no way for the RNA to get transcribed and become DNA and get integrated into your cells. And that's a reasonable response based on theoretical grounds…. But I bet you most people making such assurances did not appreciate that there was DNA in the vaccine. When Kevin McKernan first posted his findings, I thought, oh, my stars, there's actually DNA in the vaccine and maybe that explains what those people saw when they thought was somehow magic reverse transcriptase, turning the RNA into DNA, and then that getting integrated into cells. There's no need for reverse transcriptase. If there's pieces of DNA in the vaccine, some of them are long enough to have the entire spike open reading frame. And there you go, your cells are now making spike protein continuously.

DEMASI: There was an autopsy study that detected spike protein in the heart and brain of a patient who died after vaccination. They confirmed the patient had never had covid infection (absence of nucleocapsid proteins). Does this suggest genome integration?

BUCKHAULTS: Yes, this is a reasonable speculation. Spike protein in heart or brain proves the vaccine travelled away from the muscle, but does not necessarily mean genome integration happened. It could be the mRNA is being expressed there for many days before fading away. It definitely supports the hypothesis that rare myocarditis (and maybe stroke) is from immune attack on antigen created by the vax. The only nuanced difference between this and the DNA mechanism is the amount of time this immune reaction would last. If it’s against mRNA generated spike, then it will fade away with time, and hopefully fade before a critical number of those target cells are killed by the immune system. If it’s against an antigen created by DNA integrating into the genome of the transfected cell, it will last for the lifetime of that cell and be passed down to all that cells progeny. Think chronic auto-immune attack against some tissue.

DEMASI: Do you even need genome integration to show harm? We know from biodistribution studies that the LNPs travel all over the body and make cells produce spike protein, so couldn’t someone who was vaxxed develop myocarditis and die because of the spike protein in the tissues – or am I making a leap?

BUCKHAULTS: No, genome integration is not the only possible mechanism for harm. It’s just the one that will leave a calling card that can last years, and so is amenable to testing people months to years after the vaccine. Your speculative leap is not crazy and is precisely what I and a few other "experts" think is a reasonable explanation for what's going on. The vax was “sold” under the premise that expression was both local and temporary. Even if its temporary (no DNA involved) the fact that it is not really local undermines part of the sales pitch, and may be a fundamental feature of the platform. The only tough part with this RNA-only mechanism is how to explain the large variation in adverse events. Most people experience no adverse effects, but a few have catastrophic injury or death. I know of no batch-to-batch variation that would change the propensity of the mRNA to land in heart, brain, or gonads vs stay put in the deltoid muscle. That could be patient to patient variation from some unknown factor. However, the DNA based mechanism could be related to a manufacturing process in which there is wide batch-to-batch variability in the amount of DNA that makes it through and thus explain batch-to-batch variation in frequency of adverse events. This is all speculative, but reasonable hypotheses to test.

DEMASI: How should Pfizer have dealt with the problem of DNA contamination?

BUCKHAULTS: It looks like maybe they chopped up the plasmid DNA with the enzyme DNAase but they didn't purify all the bits away. So, they actually may have increased the hazard for genome modification. Because instead of having one big piece, you got like a bazillion little pieces. They turned a shotgun slug into buckshot pellets - It would have been optimal if they had chopped it up, and then done some size exclusion chromatography column that would get all the little pieces out and have only the big RNA left. And then there would not have been any chance for genome modification. But as I said earlier, its’ easy to be critical in hindsight. When the world was on fire, I think everyone was doing the best they could.

DEMASI: Studies have shown that spike protein has been detected in the body for several months – its long lasting – is that because of gene modification?

BUCKHAULTS: This is something that Kevin McKernan was voicing concerns about, instead of there being short pieces of DNA disrupting genes, there could be longer pieces of DNA that are long enough to contain the instructions for building an entire protein.

DEMASI: Like all the instructions to make a full spike protein in the person’s genome?

BUCKHAULTS: Yes, so what if someone got transfected with a long piece of DNA that had instructions that encoded for all of the Spike protein? And the long piece of DNA got integrated into the genome of some long lived cell type in the myocardium? Well, now, you have that cell type making spike protein all the time. That was the one of the concerns about a mechanism for myocarditis.

DEMASI: So, you’re saying that the cells of the myocardium could be permanently transformed?

BUCKHAULTS: It’s possible that long bits of DNA that encode spike are modifying the genomes of the just a few cells that make up the myocardium and cause long term expression of Spike, because they're permanently transformed. And then the immune system starts attacking those cells…and that's what causes these heart attacks. Now, that is entirely a theoretical concern. But it’s not crazy and it’s reasonable to check. Now, because the two batches that I looked at, had such a small percentage of the total reads that were long enough to contain all of spike that I didn't think it was a reasonable thing to worry about. The greater hazard in my view, would be from the short pieces of DNA disrupting some gene or expressing a small novel antigenic open reading frame. If there are other batches of vaccine out there that are contaminated with big chunks of DNA plasmid that code for spike protein, then absolutely that could be a problem too.

I don’t want to scare people in the general public, but I think it would be best to encourage the regulators and Pfizer and Moderna to check this quietly and fix future batches of vaccine by removing all traces of DNA. The public should be informed when there are clear answers, but not repeatedly troubled during the process of obtaining these answers.

DEMASI: Is it plausible that these gene mutations will be passed on to the next generation?

BUCKHAULTS: The material does migrate to ovaries so this would be a good place to look.

DEMASI: In Australia, lawyers have filed a case in the Federal Court suing Pfizer and Moderna for failing to register the product as a gene therapy – they argue that it meets the Australian legal definition of a genetically modified organism or GMO. Would you say this vaccine is a “gene therapy”?

BUCKHAULTS: It is technically true, because it has pieces of DNA in it that may be modifying the genome, but to call it gene therapy, is unfair hyperbole. It's not the intent of the therapy. The intent is to deliver the messenger RNA to make spike, and then to stimulate immunity. It might be accidental gene therapy, if my concerns are true, but it's not intentional gene therapy. I wouldn't call it gene therapy but there's a possibility of accidental genome damage.

DEMASI: What do you want to see happen?

BUCKHAULTS: I'd like to get hundreds of colleagues across the world who have the right samples and skills in their lab to just check what they've got. If interest is sparked among scientific circles then maybe additional genome jocks will investigate. For example, there are studies going on right now that may incidentally generate the answers we seek. The National Cancer Institute (NCI) has this programme called the SMaHT program, (Somatic Mosaicism Across Human Tissues) and they're basically taking normal cells from normal people and doing single cell sequencing to see what is the rate of somatic mutations in normal cells across the lifespan. By chance, there's going to be a bunch of samples taken from vaccinated people. So, checking on this hypothesis of genome modification might be pretty easy by looking at existing samples and upcoming data.

DEMASI: How about publishing these findings in a journal?

BUCKHAULTS: We will do this when we accumulate enough data.

DEMASI: Did you notify the FDA?

BUCKHAULTS: Yes, informally.

DEMASI: And have you had a response from the FDA?

BUCKHAULTS: No, no. And given the kind of radioactive nature of the topic, I don't expect them to say anything. The best case scenario is they'll go quietly check for genome editing - maybe they are already doing this and I just do not know about it -and then if they find something, they'll fix the production process. But in the meantime, independent academics with samples and skills should check.
 

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View: https://www.youtube.com/watch?v=ngYWeKEvfxo
Vaccine mRNA contaminates breast milk
Dr. John Campbell
Sep 22, 2023
19 min 38 sec

Biodistribution of mRNA COVID-19 vaccines in human breast milk https://www.thelancet.com/journals/eb... Background Several vulnerable groups, such as pregnant and lactating women, have been excluded from the initial vaccine clinical trials. The possible passage of the vaccine mRNA to breast milk (BM), resulting in neonatal exposure, was not investigated. As a result, limited research has been conducted on the systemic distribution of vaccine mRNA during lactation, and whether it is excreted in human breast milk (BM). We evaluated if COVID-19 vaccine mRNA is detectable in breast milk after maternal vaccination, and determined its potential translational activity. Methods We collected breast milk samples from 13 lactating, healthy, post-partum women before and after COVID-19 mRNA vaccination. Vaccine mRNA in whole breast milk and BM extracellular vesicles (EVs) assayed using quantitative Droplet Digital PCR, and its integrity and translational activity were evaluated. Findings Of 13 lactating women receiving the vaccine (20 exposures), trace mRNA amounts were detected in 10 exposures, up to 45 hours post-vaccination. The mRNA was concentrated in the breast milk extracellular vesicles (EVs); This can be significant as the breast milk extracellular vesicles act as natural LNPs, protecting the mRNA from degradation. Milk-derived EVs are resistant to proteolysis by gastric and pancreatic secretions and can be readily absorbed by intestinal epithelial cells However, these EVs neither expressed SARS-COV-2 spike protein, nor induced its expression in the HT-29 cell line. However, positive control samples used in concentrations similar to those of BM EVs also failed to induce S protein expression. Vaccine mRNA integrity was reduced to 12–25% in BM. Interpretation Our findings demonstrate that the COVID-19 vaccine mRNA is not confined to the injection site, but spreads systemically and is packaged into BM EVs. We believe breastfeeding post-vaccination is safe, especially 48 h after vaccination. Further investigation is required to determine the minimum amount of mRNA needed to elicit an immune response in newborns Nevertheless, since the minimum mRNA vaccine dose to elicit an immune reaction in infants less than 6 months is unknown, a dialogue between a breastfeeding mother and her healthcare provider should address the benefit/risk considerations of breastfeeding in the first two days after maternal vaccination. Funding Department of Pediatrics, NYU-Grossman Long Island School of Medicine. More detail The mRNA COVID-19 vaccines comprise lipid nanoparticles (LNPs) that contain mRNA coding the SARS-CoV-2 S protein as the active component. Relatively little has been reported on the tissue localization of the LNPs after intramuscular administration of the vaccine. Following intramuscular administration, the vaccine LNPs were rapidly disseminated to several organs Potential translational activity were not evaluated.
 

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Dr. McMillan did this video to answer questions under the assumption that the vaxx could help reduce long covid and if so, would he recommend it. PLEASE SEE NEXT POST!



View: https://www.youtube.com/watch?v=9tYJHzPNIZg
Covid Boosters - Does not knowing risk equate to having no risk?
Vejon Health
Streamed live 12 hours ago
17 min 55 sec

Responding to a question about the benefit of Covid vaccines for reducing long covid.
Is the benefit question all that matters?

More long Covid information here: Long Covid Analysed | Dr Philip McMillan | Substack

Nayyerabadi, Maryam, et al. "Vaccination after developing long COVID: impact on clinical presentation, viral persistence and immune responses." International Journal of Infectious Diseases (2023).
 

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Vaccination Offers 'No Meaningful Protection' Against Long COVID: Study
The unvaccinated were found to have a slightly lower risk.

By Marina Zhang
9/22/2023

Findings in a new study challenge the mainstream narrative that COVID-19 vaccinations prevent long COVID. The study found that while previous infections reduce the risk of long COVID by 86 percent, vaccination status prior to COVID infection is irrelevant to a person's risk of developing long COVID.

“The notion had been that both previous infection as well as vaccination reduce the chances of subsequent long COVID should you become infected,” Dr. William Schaffner, professor of preventive medicine and health policy at Vanderbilt University Medical Center, told The Epoch Times.

These investigators have poured "cool water" on that concept, he continued.

Researchers from Martin Luther University Halle-Wittenberg, an over-500-year-old research university in Germany, found that people with the highest risk of long COVID or post-COVID condition, as the authors wrote, were unvaccinated people infected with the Wuhan variant, followed by unvaccinated and vaccinated participants infected with the alpha variant.

While not explicitly discussed in the study, the study’s diagram and supplementary tables showed that with the exception of infection with the Wuhan variant, unvaccinated people tend to have a slightly lower risk of long COVID than their vaccinated counterparts.

Furthermore, unvaccinated people infected with the omicron variant had the lowest risk of long COVID.
“Vaccination offered no meaningful protection against developing PCC [post-COVID condition] in case of an infection. In contrast, there was … strong evidence that a previous infection reduced the risk of PCC,” the authors wrote.


Based on Online Questionnaire

Nearly 49,000 people in the German population responded to the survey. Participants were recruited through postal mail. They were then asked to fill out an online questionnaire that included a list of symptoms.

Participants self-reported if they tested positive for COVID-19 and the symptoms they experienced afterward.

The study authors asked for symptoms present from the four- to 12-week post-infection window and for symptoms that persisted after the 12th week. Symptoms that did not persist beyond that were not deemed as long COVID.

Depending on the date of infection, the authors categorized the participant as being infected by the dominant variant at the time.

“We categorized infections before January 1, 2021 as caused by the Wildtype (Wuhan) variant, infections between January 1, 2021 and June 30, 2021 as caused by the Alpha variant, infections between July 1, 2021 and December 20, 2021 as caused by the Delta variant, and infections from December 21, 2021 as caused by the Omicron variant,” the authors wrote.

Of all the surveyed people, around 17,000 had at least one COVID-19 infection, with around 2,800 reporting long-COVID symptoms.

None of the participants in the study was physically examined nor did they present lab tests on their health.

Doctors are engaged in a debate over the study's findings and its methodology.

Many were concerned that the questionnaire was too subjective. Like many large population-based studies, the findings are provocative, "but they're often not definitive. You have to do other follow-up studies, many of which are much smaller but much more precise, and they eliminate a lot of the uncertainty," Dr. Schaffner said.

Dr. Cody Meissner, a professor of pediatrics at the Dartmouth Geisel School of Medicine, argued that the study's participant is "so heterogeneous" and that he is not sure what to conclude from the study.
As the study authors admit, none of the participants was given an actual diagnosis of long COVID nor tested for comorbidities. It is possible that any of the patients could have been suffering from another disease that may have been unrelated to COVID-19.


Long COVID Is Hard to Define

Another major problem plaguing long-COVID research is that everyone has a different definition of long COVID.

"There is a post-COVID symptomatology ... But I don't think we understand the biological basis; we can't define it very clearly. So to make a statement that it was more or less common after certain variants or vaccines is pretty difficult," Dr. Meissner said.

Retired associate professor of Brown University Dr. Andrew Bostom agreed that the long-COVID condition is poorly defined in the literature, so it is hard to conclude if the symptoms are long COVID or if it is something else entirely.

Apart from the loss of smell and taste, all other symptoms that characterize the long-COVID condition can manifest through psychosomatic triggers, Dr. Bostom said.

The study's findings "look interesting, particularly to people like me that have been disappointed in how such short shrift was given to natural immunity," Dr. Bostom, who has extensive experience working on pharmaceutical clinical trials, told The Epoch Times. But it's hard to conclude prior infection is protective against long COVID "if you're not really sure what the post-COVID condition is."


Study Findings Validate What Some Doctors See

Dr. Joseph Varon, chief of the Critical Care and COVID-19 Department at the United Memorial Medical Center, told The Epoch Times that he can look past the flaws in the methodology since the study findings validate what he sees in his clinic.

The study did not discuss if vaccinations put people at risk of long COVID. Its graph showed that the vaccinated cohort tended to have a slightly higher risk of long COVID than the unvaccinated, when they were infected by the same variant.

Dr. Varon interpreted this to suggest that vaccinations may put people at a greater risk of long COVID, which is what he has been seeing in his clinic.

"What I'm seeing is that the higher the number of boosters that you have, the more chances ... you're going to have long haul syndrome," he said, adding that the majority of his long-haul patients are those who took four or more doses of the vaccine rather than those who took up to three doses or were unvaccinated.

Dr. Varon also found that the study's findings on the most prevalent symptoms very accurately mirror what he sees in his clinic, with fatigue and cognitive impairment being the most common symptoms among his patients.

Psychiatrist Dr. Adonis Sfera at Patton State Hospital agreed that the study's symptoms are mostly representative of what he sees in his clinic, though the primary symptoms are fatigue and shortness of breath.

He also agreed with the notion that more vaccinations may put people at risk of long-haul symptoms since the vaccinations would induce the production of more spike proteins, which can cause organ damage and symptoms.

"The vaccines make our cells express the spike antigen. So the more vaccinated you are, the more likely you are to express the antigen," he said.


Hide Vaccine Injuries From Scrutiny?

Nurse practitioner Scott Marsland, who shares the Leading Edge Clinic, a long-COVID and vaccine-injury practice, with pulmonary critical care physician Dr. Pierre Kory, expressed concern that the study findings may hide vaccine injuries from scrutiny.

"[The paper] helps perpetuate the narrative that ... it doesn't make a difference whether or not [someone] got the vaccine; it's all about whether or not they got infected and which variant they got," Mr. Marsland said.

Long COVID and vaccine injury can share very similar symptoms, but detailed patient records would show that the symptoms appeared after different exposures.

Mr. Marsland was concerned that the study dismisses the cumulative effects the vaccines may have on patients, which contradicts what he sees in his clinic.

Some of his patients developed mild symptoms after their first or second shot, but they did not link it temporally to the vaccines until "they got the booster or a second booster" and their symptoms became severe, he said.
 

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Another good video from Dr. McMillan, along the lines of Geert's thinking....


View: https://www.youtube.com/watch?v=wnb1ft0l5Pc
Will there be a massive surge in Mortality from Covid?
Vejon Health
Sept 23, 2023
30 min 28 sec

Reviewing the characteristics of the 1918 flu pandemic which disproportionally affected young adults in the second wave. Is that possible in this current evolving Covid Epidemic of highly vaccinated regions?

Quote: "Of the unexplained characteristics of the 1918–19 influenza pandemic, the extreme mortality rate among young adults (W-shaped mortality curve) is the foremost. Lack of a coherent explanation of this and other epidemiologic and clinical manifestations of the pandemic contributes to uncertainty in preparing for future pandemics."

Shanks GD, Brundage JF. Pathogenic responses among young adults during the 1918 influenza pandemic. Emerg Infect Dis. 2012 Feb;18(2):201-7. doi: 10.3201/eid1802.102042. PMID: 22306191; PMCID: PMC3310443.


 

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Biden has gotten the updated COVID-19 vaccine and the annual flu shot, the White House says

AP News
September 23, 2023

WASHINGTON (AP) — President Joe Biden has gotten the updated COVID-19 vaccine and annual flu shot, the White House said Saturday.

The White House physician, Dr. Kevin O’Connor, said in a memo that Biden received both shots on Friday. O’Connor said Biden, 80, also was vaccinated several weeks ago against the respiratory illness known as RSV.

“As we enter the cold and flu season, the President encourages all Americans to follow his example and to check with their healthcare provider or pharmacist to assure that they are fully vaccinated,” O’Connor wrote.

The Centers for Disease Control and Prevention earlier this month endorsed the new COVID-19 shot for everyone 6 months and older. The severity of the COVID-19 pandemic has faded, but there are still thousands of hospitalizations and hundreds of deaths in the United States each week.

Experts worry that immunity from previous vaccinations and infections is fading in many people, and a new shot would save many lives.

First lady Jill Biden tested positive for COVID-19 earlier this month but experienced only mild symptoms.

The CDC recommends that people who have COVID-19 and are in isolation should wait to get vaccinated until there symptoms are gone and isolation guidelines have been met. Children and adults who have multisystem inflammatory syndrome should wait to get vaccinated until recovering from being sick and 90 days have passed since the diagnosis, according to the CDC.

Biden tested positive for COVID-19 in July 2022 and a second time slightly more than three days after he was cleared to exit coronavirus isolation. The second incident was a rare case of “rebound” infection following treatment with an anti-viral drug.
 

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Long Covid linked to multiple organ changes: Research
by AFP - Agence France Presse
Sep 23, 2023, 11:30 AM SGT

PARIS – A third of people hospitalised with Covid-19 have “abnormalities” in multiple organs months after getting infected, a British study said on Saturday, potentially shedding light on the elusive condition of long Covid.

Millions worldwide are estimated to suffer from long Covid, in which a range of symptoms such as shortness of breath, fatigue and brain fog last long after patients first contracted the virus.

Yet much about the condition, including exactly how Covid-19 causes such a wide range of symptoms, remains unknown.

The authors of the new study, which was published in The Lancet Respiratory Medicine journal, said it marks a “step forward” in helping long Covid sufferers.

The study is the first to look at magnetic resonance imaging or MRI scans of multiple organs – the brain, heart, liver, kidneys and lungs – after being hospitalised with Covid-19.

It compared the organ scans of 259 adults hospitalised with Covid-19 across Britain in 2020 to 2021 with a control group of 52 people who never contracted the virus.

Nearly a third of the Covid-19 patients had abnormalities in more than one organ an average of five months after leaving hospital, the study found.

Those hospitalised with Covid-19 were 14 times more likely to have lung abnormalities and were three times more likely to have abnormalities in their brain, it said. However, hearts and livers appeared to be more resilient, the researchers added.

Abnormalities in the brain included a higher rate of white brain lesions, which have been linked to mild cognitive decline.

Scarring and signs of inflammation were among the changes seen in lungs.

People with multiple organ abnormalities were four times more likely to report severe mental and physical impairment, making them “unable to perform their daily activities”, lead author Betty Raman from Oxford University told an online press conference.

The study was conducted during an earlier phase of the pandemic, before mass immunity from vaccination and prior infection blunted the overall severity of Covid-19.

It did not cover the less severe Omicron variants which remain dominant around the world.

The Covid-19 group was also slightly older and generally less healthy than the control group, though the researchers sought to adjust their findings to account for these differences.

But people are still being hospitalised due to the virus across the world, the researchers emphasised.

Study co-author Christopher Brightling of Leicester University said the study provides “concrete evidence there are changes in a number of organs” after people are hospitalised with Covid-19.

Rather than being a cause for alarm, he said the finding is a “step forwards in terms of actually being able to help people with long Covid”.

Dr Matthew Baldwin, a pulmonary disease specialist at Columbia University not involved in the study, said “these results suggest that long Covid is not explained by severe deficits concentrated in any one organ”.

“Rather, the interaction of two or more abnormalities in organs might have an additive or multiplicative effect in creating physiological deficits that result in long Covid symptoms,” he wrote in a Lancet comment article. AFP
 

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Amplifying RNA’s Potential: MIT Engineers Design More Powerful Vaccines
By Anne Trafton, Massachusetts Institute of Technology
September 23, 2023

By adding synergistic self-adjuvanting properties to COVID-19 RNA vaccines, MIT researchers have found a new approach that could lead to intranasal vaccines for Covid-19 and other respiratory diseases.

The new approach could lead to intranasal vaccines for COVID-19 and other respiratory diseases.

RNA vaccines against COVID-19 have proven effective at reducing the severity of disease. However, a team of scientists at MIT is working on making them even better. By tweaking the design of the vaccines, the researchers showed that they could generate COVID-19 RNA vaccines that produce a stronger immune response, at a lower dose, in mice.

Adjuvants are molecules commonly used to increase the immune response to vaccines, but they haven’t yet been used in RNA vaccines. In this study, the MIT researchers engineered both the nanoparticles used to deliver the COVID-19 antigen, and the antigen itself, to boost the immune response, without the need for a separate adjuvant.


Potential Benefits and New Approach

If further developed for use in humans, this type of RNA vaccine could help to reduce costs, reduce the dosage needed, and potentially lead to longer-lasting immunity. The researchers’ tests also showed that when delivered intranasally, the vaccine induced a strong immune response when compared to the response elicited by traditional, intramuscular vaccination.

“With intranasal vaccination, you might be able to kill Covid at the mucus membrane, before it gets into your body,” says Daniel Anderson, a professor in MIT’s Department of Chemical Engineering, a member of MIT’s Koch Institute for Integrative Cancer Research and Institute for Medical Engineering and Science (IMES), and the senior author of the study. “Intranasal vaccines may also be easier to administer to many people, since they don’t require an injection.”

The researchers believe that the effectiveness of other types of RNA vaccines that are now in development, including vaccines for cancer, could be improved by incorporating similar immune-stimulating properties.

Former MIT postdoc Bowen Li, who is now an assistant professor at the University of Toronto; graduate student Allen Jiang; and former MIT postdoc Idris Raji, who was a research fellow at Boston Children’s Hospital, are the lead authors of the new study, which was published on September 7 in the journal Nature Biomedical Engineering. The research team also includes Robert Langer, the David H. Koch Institute Professor at MIT and a member of the Koch Institute, and several other MIT researchers.


Boosting Immunity

RNA vaccines consist of a strand of RNA that encodes a viral or bacterial protein, also called an antigen. In the case of COVID-19 vaccines, this RNA codes for a segment of the virus’s spike protein. That RNA strand is packaged in a lipid nanoparticle carrier, which protects the RNA from being broken down in the body and helps it get into cells.

Once delivered into cells, the RNA is translated into proteins that the immune system can detect, generating antibodies and T cells that will recognize the protein if the person later becomes infected with the SARS-CoV-2 virus.

The original COVID-19 RNA vaccines developed by Moderna and Pfizer/BioNTech provoked strong immune responses, but the MIT team wanted to see if they could make them more effective by engineering them to have immune stimulatory properties.


Research Details and Immunity Enhancement

In this study, the researchers employed two different strategies to boost the immune response. For the first, they focused on a protein called C3d, which is part of an arm of the immune response known as the complement system. This set of proteins helps the body fight off infection, and C3d’s role is to bind to antigens and amplify the antibody response to those antigens. For many years, scientists have been evaluating the use of C3d as a molecular adjuvant for vaccines made from proteins, such as the DPT vaccine.

“With the promise of mRNA technologies being realized with the Covid vaccines, we thought that this would be a fantastic opportunity to see if C3d might also be able to play a role as an adjuvant in mRNA vaccine systems,” Jiang says.

To that end, the researchers engineered the mRNA to encode the C3d protein fused to the antigen, so that both components are produced as one protein by cells that receive the vaccine.

In the second phase of their strategy, the researchers modified the lipid nanoparticles used to deliver the RNA vaccine, so that in addition to helping with RNA delivery, the lipids also intrinsically stimulate a stronger immune response.

To identify lipids that would work best, the researchers created a library of 480 lipid nanoparticles with different types of chemistries. All of these are “ionizable” lipids, which become positively charged when they enter acidic environments. The original Covid RNA vaccines also included some ionizable lipids because they help the nanoparticles to self-assemble with RNA and they help target cells to take up the vaccine.

“We understood that nanoparticles themselves could be immunostimulatory, but we weren’t quite sure what the chemistry was that was needed to optimize that response. So instead of trying to make the perfect one, we made a library and evaluated them, and through that we identified some chemistries that seemed to improve their response,” Anderson says.


Toward Intranasal Vaccines

The researchers tested their new vaccine, which included both RNA-encoded C3d and a top-performing ionizable lipid identified from their library screen, in mice. They found that mice injected with this vaccine produced 10 times more antibodies than mice given unadjuvanted Covid RNA vaccines. The new vaccine also provoked a stronger response among T cells, which play important roles in combating the SARS-CoV-2 virus.

“For the first time, we’ve demonstrated a synergistic boost in immune responses by engineering both the RNA and its delivery vehicles,” Li says. “This prompted us to investigate the feasibility of administering this new RNA vaccine platform intranasally, considering the challenges presented by the mucociliary blanket barrier in the upper airways.”

When the researchers delivered the vaccine intranasally, they observed a similarly strong immune response in the mice. If developed for use in people, an intranasal vaccine could potentially offer enhanced protection against infection because it would generate an immune response within the mucosal tissues that line the nasal passages and lungs.

Because self-adjuvanting vaccines elicit a stronger response at a lower dose, this approach could also help to reduce the cost of vaccine doses, which might allow them to reach more people, especially in developing nations, the researchers say.

Anderson’s lab is now exploring whether this self-adjuvanting platform might also help boost the immune response of other types of RNA vaccines, including cancer vaccines. Working with healthcare companies, the researchers also plan to test the effectiveness and safety of these new vaccine formulations in larger animal models, in hopes of eventually testing them in patients.

Reference: “Enhancing the immunogenicity of lipid-nanoparticle mRNA vaccines by adjuvanting the ionizable lipid and the mRNA” by Bowen Li, Allen Yujie Jiang, Idris Raji, Caroline Atyeo, Theresa M. Raimondo, Akiva G. R. Gordon, Luke H. Rhym, Tahoura Samad, Corina MacIsaac, Jacob Witten, Haseeb Mughal, Taras M. Chicz, Yue Xu, Ryan P. McNamara, Sangeeta Bhatia, Galit Alter, Robert Langer and Daniel G. Anderson, 7 September 2023, Nature Biomedical Engineering.
DOI: 10.1038/s41551-023-01082-6

The research was funded by the National Institutes of Health and Translate Bio.
 
It is only when soon the statistics will show excess mortality due to both Covid-19 and Covid-19 vaccine-related immune-mediated diseases to abundantly occur in the vaccinated (i.e., the many vaccinated individuals who could not build natural immunity due to the timing of vaccination) that it will become undeniable that humanity will need to rely on the once-hated unvaccinated to serve as a foundation for building a new society.
IMG_7148.jpeg
 

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CDC Refuses To Release Updated Information On Post-COVID Vaccination Heart Inflammation

by Tyler Durden
Sunday, Sep 24, 2023 - 09:25 PM

Authored by Zachary Stieber via The Epoch Times


The U.S. Centers for Disease Control and Prevention (CDC) is refusing to release updated information on reported cases of myocarditis and pericarditis following COVID-19 vaccination.

COVID-19 vaccines can cause the inflammatory conditions, the CDC has confirmed previously.

The agency has regularly conveyed the number of post-vaccination myocarditis and pericarditis cases to the Vaccine Adverse Event Reporting System (VAERS), which it helps manage, as it has consulted with its advisers on updates to the vaccines.

But during a meeting on Sept. 12, the CDC did not mention VAERS data.

Asked for the information, a CDC spokesman pointed to a CDC study that covers data only through Oct. 23, 2022.

That study identified nine reports of myocarditis or pericarditis following vaccination with one of the bivalent COVID-19 vaccines, which were introduced in September 2022. Seven of the reports were verified by medical review.

Asked for more current data, the spokesman acknowledged the agency has it but is not making it public.

"When appropriate, the updated safety data will be published," the spokesman told The Epoch Times in an email.

He did not answer when asked why the meeting was not an appropriate time.

"The CDC has acknowledged that heart inflammation is a complication of mRNA COVID-19 shots and, yet, the only published data released by CDC officials about that complication is a seven week study that ended on Oct. 23, 2022. Where is more specific myocarditis/pericarditis data related to bivalent COVID shots for the past 10 months?" Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, told The Epoch Times via email.

The mRNA shots are made by Pfizer and Moderna. Novavax's updated shot, which uses different technology, has not yet been authorized by the U.S. Food and Drug Administration (FDA).

"I am tired of the CDC and FDA deciding what information the public needs and doesn’t need. This is precisely the information that parents need to have especially when there are still schools and activities mandating these shots. This is evil playing out right before our eyes," Kim Witczak, a drug safety advocate who runs the nonprofit Woodymatters, told The Epoch Times in an email.

She added, "The CDC’s response of 'when appropriate, the updated safety data will be published' is unacceptable and they wonder why there is vaccine hesitancy and lack of trust in public health officials."
Presentation

During the recent meeting, CDC officials and their partners presented data on the bivalent shots to their advisory panel, the Advisory Committee on Immunization Practices. The advisers were considering which groups should be recommended to get one of the new COVID-19 vaccines, which were cleared by regulators with scant clinical trial data.

Dr. Nicola Klein, a Kaiser Permanente doctor who works closely with the CDC, gave a presentation (pdf) on COVID-19 vaccine safety. She presented data from the Vaccine Safety Datalink, a monitoring system that covers a much smaller population than VAERS.

Dr. Klein said that two cases of myocarditis after bivalent vaccination were detected in the Vaccine Safety Datalink (VSD) through March 11. It's not clear why more current data were not presented. Dr. Klein did not respond to a request for comment. The cases did not trigger a safety signal among adults, Dr. Klein said.

The presented data were widely cited by doctors quoted in news outlets, including Dr. Andrew Pavia, who told a briefing that there did not appear to be a "detectable risk" of the bivalent shots causing myocarditis.

"What I was conveying is that in the era of the bivalent vaccine, the number of cases has fallen to where it no longer is giving a signal that is detectable," Dr. Pavia, chief of the University of Utah's Division of Pediatric Infectious Diseases, told The Epoch Times in an email. In response to how he could say that with the missing VAERS data, he said "the strongest data are from the controlled studies like the VSD where you have built in controls."

Through Sept. 8, 98 cases of myocarditis, pericarditis, or myopericarditis were reported to VAERS following bivalent vaccination, according to a search of the system by The Epoch Times.

While anybody can lodge a report with VAERS, research has shown most reports are entered by health care providers. People who submit false information can face prosecution.

Five reports were for people aged 6 to 17 years while another 13 were for people aged 18 to 29.

When presenting to the panel, CDC official Megan Wallace said, "There are limited data to inform the myocarditis risk following an updated mRNA dose." She did not mention the cases reported to VAERS but alleged the benefits of the vaccines outweigh the risks, even for young, healthy males. The Vaccine Safety Datalink, she acknowledged, did have a "relatively lower sample size" of recipients.

Panel members were taken by the data. Dr. Oliver Brooks said "Feel good about the fact that in the bivalent we saw no signal from myocarditis," he said after the presentation. "Very important." Dr. Brooks, chief medical officer at Watts Healthcare Corporation, did not respond to an inquiry.

Dr. Pablo Sanchez, the only member to recommend against a widespread recommendation, said the risk of myocarditis was a reason.

"I think we really need to level with our patients and say what is known and unknown, rather than make a complete recommendation," he said, "especially for some groups that there are limited data."

The labels for the new vaccines say they can cause myocarditis.

"Postmarketing data with authorized or approved mRNA COVID-19 vaccines demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following vaccination," the labels state. While some people have recovered, others have not. The labels also say, "Information is not yet available about potential long-term sequelae."
 

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Johns Hopkins Study: Early Treatment With Plasma May Reduce Long COVID Risk
By Johns Hopkins Medicine
September 24, 2023

Johns Hopkins-led research finds early treatment with plasma from recovered COVID-19 patients reduces “long COVID” risks, with inflammation-inducing interleukin-6 (IL6) playing a key role in symptom development.

Findings from a nationwide, multicenter study led by Johns Hopkins Medicine and the Johns Hopkins Bloomberg School of Public Health suggest that patients with COVID-19 have less chance of developing post-COVID conditions — commonly known as long COVID — if they receive early treatment with plasma from convalescent (recovered) COVID patients that contain antibodies against SARS-CoV-2, the virus that causes COVID-19.

The new research, first posted online on September 19 in mBio, a journal from the American Society for Microbiology, is a follow-up investigation to the 2021 clinical trial that showed convalescent plasma is an effective and safe option as an early outpatient treatment for COVID-19. The latest study looked at the long-term outcomes of a large portion of the participants from the 2021 clinical trial.

“Following our initial study, health care professionals kept SARS-CoV-2 antibody-rich blood plasma available in their blood banks as part of the treatment arsenal against COVID-19 in people who are immunocompromised; and now, our new findings show it also may lower the risk of post-COVID conditions,” says study co-lead author David Sullivan, M.D., professor of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health with a joint appointment in infectious diseases at the Johns Hopkins University School of Medicine.


Details of the Original Trial

The original outpatient early treatment clinical trial was conducted between June 2020 and October 2021. The researchers provided 1,181 randomized participants with one unit each of either polyclonal high-titer convalescent plasma (containing a concentrated mixture of antibodies specific to SARS-CoV-2) or placebo control plasma (with no SARS-CoV-2 antibodies). The participants were 18 and older, and had tested positive for SARS-CoV-2 within eight days prior to transfusion. A successful outcome was defined as not requiring hospitalization within 28 days after plasma transfusion.

The original clinical trial found that 17 participants out of 592 (2.9%) who received the convalescent plasma required hospitalization within 28 days of their transfusion, while 37 out of 589 (6.3%) who received placebo control plasma did. This translated to a relative risk reduction for hospitalization of 54%.


Exploring Post-COVID Conditions

As part of the clinical trial, 882 participants also were evaluated for their levels of 21 different cytokines and chemokines at screening, and at 14 days and 90 days after they received either convalescent plasma or placebo control plasma. Cytokines and chemokines are signaling proteins secreted by cells in response to infection, and as a result, activate specific immune system functions such as inflammation. In turn, excessive or unchecked inflammation is believed to be a key factor in the development of post-COVID conditions.

For the latest study, the researchers used the cytokine and chemokine measurements, along with reports by patients of any post-COVID conditions at the 90-day examination, to determine if there was any association between early convalescent plasma therapy and long COVID symptoms. Statistical analyses were conducted to validate the findings, after adjusting for other factors that could make someone more prone to post-COVID conditions, such as demographics (e.g., age and race), competing diseases (e.g., diabetes), and vaccine status.

At 90 days after receiving either convalescent or control plasma, 590 (66.9%) of the study participants showed no post-COVID conditions, while 292 (33.1%) did. Of the latter group, the most commonly reported symptoms were fatigue and anosmia (loss of smell).

Levels of cytokines and chemokines were elevated at screening for most of the study participants, and decreased more by day 90 in those who had received convalescent plasma,” says study senior author Aaron Tobian, M.D., Ph.D., director of the Transfusion Medicine Division and professor of pathology at the Johns Hopkins University School of Medicine.

Additionally, study participants who had higher-than-normal levels of one particular cytokine, interleukin-6 (IL6), at screening were more likely to be among those with post-COVID symptoms by day 90. IL6 is known to trigger an inflammatory response in humans.

“Our study is among the first to show that elevation of IL6 early after the onset of infection is associated with post-COVID conditions,” says study co-lead author Kelly Gebo, M.D., M.P.H., professor of medicine at the Johns Hopkins University School of Medicine. “While cytokine levels decreased throughout the study population from infection to day 90, they dropped more significantly in those who received convalescent plasma early in the course of their illness. So, it appears that when IL6 levels remain elevated during the COVID-19 recovery phase, it likely contributes to post-COVID conditions.”

Future studies, says Gebo, could examine the impact of anti-IL6 agents combined with other treatments against COVID-19 among outpatients.

Reference: “Early antibody treatment, inflammation, and risk of post-COVID conditions” by Kelly A. Gebo kgebo@jhmi.edu, Sonya L. Heath, Yuriko Fukuta, Xianming Zhu, Sheriza Baksh, Allison G. Abraham and Feben Habtehyimer, 19 September 2023, mBio.
DOI: 10.1128/mbio.00618-23

The study was principally funded by the U.S. Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (DOD JPEO-CBRND), in collaboration with the Defense Health Agency (DHA). Initial support was received from the Bloomberg Philanthropies and the state of Maryland, with additional support coming from National Institute of Allergy and Infectious Diseases grant 3R01AI152078-01S1 and the agency’s Division of Intramural Research, National Center for Advancing Translational Sciences grant U24TR001609, the Mental Wellness Foundation, the Moriah Fund, Octapharma Plasma, the HealthNetwork Foundation and the Shear Family Foundation.

The views expressed are those of the authors and should not be construed to represent the positions of the U.S. Army or the U.S. Department of Defense. The data and opinions presented do not reflect the view of the U.S. government.
 

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Biden has gotten the updated COVID-19 vaccine and the annual flu shot, the White House says
AP News
September 23, 2023

WASHINGTON (AP) — President Joe Biden has gotten the updated COVID-19 vaccine and annual flu shot, the White House said Saturday.

The White House physician, Dr. Kevin O’Connor, said in a memo that Biden received both shots on Friday. O’Connor said Biden, 80, also was vaccinated several weeks ago against the respiratory illness known as RSV.

“As we enter the cold and flu season, the President encourages all Americans to follow his example and to check with their healthcare provider or pharmacist to assure that they are fully vaccinated,” O’Connor wrote.

The Centers for Disease Control and Prevention earlier this month endorsed the new COVID-19 shot for everyone 6 months and older. The severity of the COVID-19 pandemic has faded, but there are still thousands of hospitalizations and hundreds of deaths in the United States each week.

Experts worry that immunity from previous vaccinations and infections is fading in many people, and a new shot would save many lives.

First lady Jill Biden tested positive for COVID-19 earlier this month but experienced only mild symptoms.

The CDC recommends that people who have COVID-19 and are in isolation should wait to get vaccinated until there symptoms are gone and isolation guidelines have been met. Children and adults who have multisystem inflammatory syndrome should wait to get vaccinated until recovering from being sick and 90 days have passed since the diagnosis, according to the CDC.

Biden tested positive for COVID-19 in July 2022 and a second time slightly more than three days after he was cleared to exit coronavirus isolation. The second incident was a rare case of “rebound” infection following treatment with an anti-viral drug.
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