Thursday, February 22, 2024

Immunosuppression Prevalence Doubled, Linked to Medication Use and COVID: Experts

Between 2013 and 2021, rates of immunosuppression in adults have doubled, according to estimates from a Journal of the American Medical Association (JAMA) research letter.

In 2021, an estimated 6.6 percent of U.S. adults were immunosuppressed. “This rate of immunosuppression was higher than the previous national estimate of 2.7 percent using the 2013 [National Health Interview Survey],” the authors wrote in their paper.

The researchers estimated immunosuppression prevalence by analyzing National Health Interview Survey (NHIS) results.

Specifically, the authors analyzed responses to five questions. Over 29,000 individuals were asked if they had a health condition or were taking medication or treatments that would weaken their immune system. They were also asked if they had cancer or malignancy, the type of cancer, and their age at the time of cancer diagnosis.

In 2013, over 34,000 people were interviewed, garnering a response from 75 percent of households. In 2021, only about half of the households contacted responded to the survey.
Why the Rise in Immunosuppression?

“Given the documented increase in immunosuppression, studies are needed to understand the causes for this increase,” the authors wrote. However, they mentioned that the rise in self-reported immunosuppression may be due to increased use of immunosuppressive medications.

The use of adalimumab, a drug used to treat autoimmune conditions, has increased 3.5-fold between 2014 and 2021.

Immunosuppression carries significant risks, “including an increased susceptibility to infections, potential organ rejection, side effects of immunosuppressant drugs, elevated cancer risk, and pregnancy-related concerns,” Mohammad Razzaque, professor of pathology at the Lake Erie College of Osteopathic Medicine, told The Epoch Times.

Immunosuppression occurs naturally with age, but it can also occur due to the individual being on various immunosuppressive therapies. People undergoing such therapies include organ transplant patients and those with autoimmune diseases or cancer.

Dr. William Schaffner, a professor of medicine and preventative medicine at the Vanderbilt University School of Medicine, reasoned that the rising prevalence could signify progress in science and health.

“There are more and more people being kept alive and are being treated with immunosuppressant agents in the United States, and that treatment is extending life, which means that the proportion of the population that is immunosuppressed is increasing,” Dr. Schaffner said.

Crude data from NHIS have also shown a rise in self-reported rates of cancer. According to 2015 U.S. Centers for Disease Control and Prevention (CDC) statistics, 8.7 percent of adults reported cancer. In 2021, it was estimated that 9.8 percent of adults had cancer.

NHIS' most recent survey in 2022 estimated that a slight decrease of 9.6 percent of adults had cancer.

The COVID-19 pandemic may have also made individuals more aware of their immune health and whether they are immunosuppressed, the research letter authors added.

COVID-19 and Immunosuppression

Studies have shown that the COVID-19 virus can disrupt the function and order of the immune system, leading to immune dysfunction and possible immunodeficiency.

One 2o23 study published in Nature Reviews Rheumatology found that people with a COVID-19 infection are at a greater risk of developing autoimmune diseases, which may be linked to potential immunodeficiencies.

The COVID-19 pandemic may have been particularly challenging to those already immunocompromised.

Immunocompromised people tend to have an increased disease severity if they become infected with COVID-19, and the vaccine appears to be less effective for them. Public health measures put in place during the pandemic may also have created obstacles for these people to access health care and therapies for their immunosuppression, said Mr. Razzaque.

Other researchers and physicians argue that the COVID-19 vaccines may also contribute to immunosuppression and deficiencies, though some research has opposite findings.

Research from Cleveland Clinic suggests that repeated boosting of COVID-19 vaccinations has been shown to put a person at risk of future COVID-19 infections. Another letter to the editor from Columbia University authors published in the New England Journal of Medicine showed that people with higher vaccine antibody levels after vaccination were more strongly associated with breakthrough infections.

Most recently, an Australian review suggested that repeat COVID-19 vaccine boosting in immunocompromised individuals may impair immune activation within this population, possibly making them more vulnerable to infections and cancers.

In a research paper, Mr. Razzaque pointed to increased influenza infections reported in people who receive repeat influenza vaccinations, speculating if frequent boosting may be linked to immunosuppression.

Dr. Schaffner said whether increased infections linked to repeat vaccinations are a sign of general immunosuppression is debatable.

“It’s a very debatable issue,” he said, adding that even if there is an increased risk of COVID-19 infection linked to repeat vaccination, there does not seem to be “serious evidence” indicating a “general suppression of the immune system.”

However, works by Nordic researchers Drs. Peter Aaby and Christine Stabell Benn suggest that non-live vaccines, including COVID-19 and influenza vaccines, tend to make the immune system “lazy” and less equipped to fight an infection. In contrast, live vaccines train the immune system to become better fighters.

Gastroenterologist and CEO of ProgenaBiome, Dr. Sabine Hazan, has said that the COVID-19 vaccine may cause immunosuppression by reducing good Bifidobacteria in the gut. She showed that after COVID-19 mRNA vaccination, Bifidobacteria levels dropped by half among her trial participants.

Bifidobacteria are essential for boosting intestinal immunity. Dr. Hazan’s earlier work showed that people with reduced Bifidobacteria in the gut were at risk of severe COVID-19 infections, and therapeutics that replenished the Bifidobacteria, such as vitamins C and D and ivermectin improved patient survival rates.

“The pandemic appears to have influenced what the public thinks about their immune system. There has been a big jump in perceived weakness in the immune system. More research is needed to determine if either SARS-CoV-2 infection or COVID-19 vaccine indeed has impaired human immunity according to these perceptions,” Dr. Peter McCullough, renowned cardiologist and internist, told The Epoch Times.


Nova Scotia Health Authority Rescinds COVID Vaccine Mandate for Health Care Workers

The Nova Scotia Health Authority has announced it will be rescinding its COVID-19 vaccine mandate for health care workers due to the pandemic entering its endemic phase and its “commitment to respecting the choices and autonomy of our staff members.”

“Based on the current available evidence, Nova Scotia Health and IWK Health are amending their respective policies,” reads a joint statement released on Feb. 21 by the two health authorities, which was originally obtained by The Canadian Independent.

“Effective February 26, 2024, it will no longer be a requirement for employees, preferred candidates and on-site medical staff to submit proof of primary series COVID-19 immunization.”

The health organizations said the change represented the “evolving landscape of COVID-19 in its endemic phase.” They added that vaccination against the disease remained “highly effective” at preventing disease, hospitalization, and death, and encouraged all eligible residents to receive their boosters.

The organizations said the change in policy means health care workers who did not submit proof of vaccination and were subsequently let go from work would have the chance to “return to active employment.” Nova Scotia and IWK Health will be reaching out to those employees on administrative leave to discuss options for them to return to work.

Many Canadian provinces got rid of their vaccine mandates for health care workers in 2022, with Saskatchewan lifting the requirement on Feb. 14, Manitoba lifting the requirement on March 1, Ontario lifting it on March 14, New Brunswick ending it on April 11, Newfoundland ending it June 1, and Alberta lifting it on July 18.

The province of Quebec backed down from making COVID-19 vaccines mandatory for health care workers back in November 2021, as a Superior Court judge ruled in favour of a group of unvaccinated health care workers.

British Columbia is the only province that still has a COVID-19 vaccine mandate in place for health care workers. In September 2023, a vote was held at the Union of B.C. Municipalities about the mandate, which saw municipal leaders vote against a motion rescinding the policy.

The company Purolator suspended its COVID-19 vaccine mandate on April 13, 2023, asking employees who had been placed on unpaid leave to return to work by May 1. Following nearly a year of arbitration, Arbitrator Nicholas Glass ruled in a Dec. 14 decision that Purolator must compensate employees who were terminated for not receiving a COVID-19 vaccine.

A recent survey conducted by the Public Health Agency of Canada found that one-third of doctors and over half of nurses were reluctant to take the COVID-19 vaccine because they feared potential side effects. The research found that despite many health workers being reluctant, 89 percent received the vaccines, with the most commonly reported reason being a fear of job loss.




Wednesday, February 21, 2024

COVID Booster Shots Carry ‘Increased Myocarditis Risk’ for Young Adults: Nordic Study

Booster vaccination against COVID-19 is linked to a higher risk of heart inflammation among adolescents, according to a recent study using data from several Nordic nations.

The peer-reviewed study, published in the European Heart Journal on Feb. 15, evaluated the risk of myocarditis among 12- to 39-year-olds after receiving COVID-19 mRNA booster vaccination. Myocarditis refers to an inflammation of the heart muscle myocardium. The study analyzed data from 8.9 million young adults from four nations: Denmark, Finland, Norway, and Sweden.

In total, 1,533 cases of myocarditis were identified with the study concluding that the “booster dose is associated with increased myocarditis risk in adolescents and young adults.”

Among males, a third dose of the Pfizer or Moderna vaccine was associated with an “increased incidence rate of myocarditis” within 28 days of inoculation compared to a longer period after the second dose.

The study noted that the association of myocarditis with COVID-19 mRNA vaccines has appeared “strongest in male adolescents and younger males and after the second dose.”

The study was authored by 12 experts from the Norwegian Institute of Public Health, Swedish Medical Products Agency, Statens Serum Institut, and the Finnish Institute for Health and Welfare.

Significant Spike in Cases

Cases of myocarditis among vaccinated individuals in the United States spiked within the first year of the COVID-19 vaccination campaign, according to a study published in late January that looked at data from the Vaccine Adverse Event Reporting System (VAERS).

“We found the number of myocarditis reports in VAERS after COVID-19 vaccination in 2021 was 223 times higher than the average of all vaccines combined for the past 30 years. This represented a [2,500 percent] increase in the absolute number of reports in the first year of the campaign when comparing historical values prior to 2021,” the U.S. study said.

Roughly 50 percent of myocarditis cases occurred among youths and 69 percent of affected individuals were males. Out of a total of 3,078 COVID-19 vaccine-induced myocarditis cases as of August 2023, 76 percent resulted in emergency care and hospitalization, and 3 percent died.

New studies are being published looking at reducing myocarditis risk when vaccinating adolescents against COVID-19, appearing to confirm the fact that such a risk exists for the shots.

A Feb. 14 study in the journal Vaccines found that extending the interval between the first and the second dose of COVID-19 mRNA vaccines leads to a 66 percent “lower risk of incident carditis among adolescents.”

Carditis is the general term for inflammation of the heart.

The study referred to adolescents as a “vulnerable population” while pointing out that “previous studies indicate an increased carditis risk among adolescents following the two-dose messenger RNA COVID-19 vaccine.”

COVID-19 and Myocarditis

There have been suggestions that COVID-19 infections cause more myocarditis cases than the vaccines.

For instance, a study published by the American College of Cardiology in 2022 said that “overall, the risk of myocarditis is greater after SARS-CoV-2 infection than after COVID-19 vaccination.”

Dr. Daniel Jernigan from the U.S. Centers for Disease Control and Prevention recently testified at a hearing of the House Committee on Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic. In his testimony, Dr. Jernigan claimed that the risk of getting myocarditis is “much lower among those vaccinated than among those that are unvaccinated.”

However, cardiologist Dr. Peter McCullough disputes the claim that COVID-19 infections cause myocarditis.

In a post on his website, he described this argument as “a twisted rationale for giving out COVID-19 vaccines, and in a perverted manner, creating more myocarditis in the population. If SARS-CoV-2 infection caused myocarditis or inflammation of heart muscle tissue, then it would be seen on autopsy in fatal cases of COVID-19.”

Dr. McCullough cited an October 2022 study involving an autopsy of the hearts of COVID-19 infected individuals. The analysis “concluded the virus does not infect the heart,” he said.

The cardiologist called claims of the COVID-19 virus infecting the heart and causing myocarditis “false claims made from automated hospital data and not adjudicated, autopsy proven cases.”

“The COVID-19 vaccines install mRNA in the heart and the Spike protein directly damages and incites inflammation into the heart muscle causing the pathophysiology we see every day in cardiology practice,” he wrote.

Researchers from a Jan. 24 study who looked into the initial phase 3 trials of Pfizer and Moderna COVID-19 mRNA vaccines found that their estimated harms “greatly outweigh the rewards.”

They called on world governments to impose a “global moratorium” on the COVID-19 vaccines “given the well-documented [serious adverse events] and unacceptable harm-to-reward ratio.”

The authors also recommended an “immediate removal” of COVID-19 vaccines from the childhood immunization schedule, pointing out that children were at very low risk of infection.


Did lockdowns cause more harm than good?

The question of whether lockdowns caused more problems than they solved will be picked over for years to come, even if the official Covid-19 inquiry shows little interest in peering into the matter. The latest contribution, a paper from Lund University in Sweden, provides further evidence that this really is something that a UK inquiry needs to investigate. The paper, published by the Institute for Economic Affairs, seeks correlations between the severity of lockdown restrictions in 25 European OECD members and outcomes in terms of excess deaths, economic growth and public deficits. It seems to provide a fairly clear answer: lockdowns were associated with higher overall levels of excess deaths, poorer economic performance and higher public debt.

It starts by using a marking system for the severity of lockdown, which gives every country a figure of between 0 and 100 – where 0 would be no Covid measures at all and 100 a cessation of all economic and social life. On the this measure the UK comes out at 50, France 48 and Italy 60. Sweden was given a lockdown rating of 39. Interestingly, although Sweden was perceived as an outlier throughout the pandemic, and indeed it did plough a very different furrow in the early weeks, Norway and Finland were given slightly lower overall lockdown scores for the duration of the pandemic, owing to the greater relaxation of measures during the rest of 2020.

Overall, the study establishes a fairly weak positive correlation between severity of lockdown and excess deaths. It establishes stronger negative correlations between severity of lockdown and economic growth, and between lockdown severity and the fiscal cost of the pandemic (as measured by the size of the budget deficit in 2020 and 2021 divided by GDP in 2019).

In other words, lockdowns impacted negatively on the economy and the public finances, as might be expected, but they also appear to be associated with slightly higher rates of excess deaths. The study uses excess deaths rather than Covid deaths because it is trying to assess the total effect of lockdowns: how many lives they saved against how many lives they cost through poverty, loneliness, a failure of people to seek timely healthcare because they had been told to stay at home etc.

There are, however, a number of caveats to be put against these findings. Firstly, as the authors admit, the system for giving countries a lockdown score is largely subjective. This part was not in fact the work of the authors – they used a scoring system developed for an earlier study. Secondly, the study doesn’t account for the fact that different countries had different levels of exposure to the virus – which was bound to spread differently in a country like Britain, which has a high density of population and many interconnections with the rest of the world, than in say Norway, with a much lower population density, smaller urban areas and fewer international flights. Indeed, the pattern of excess deaths in Sweden reflects the number of people who had travelled to the Alps for skiing holidays in early 2020 – the areas where more people went to the Alps suffered higher death rates.

Thirdly, it overlooks the fact that lockdowns were often a consequence of high death rates rather than the other way about – Britain, for example, had two further lockdowns in the autumn and winter of 2020-21 precisely because death rates were high and rising.

Scandinavian countries got by with fewer restrictions because death rates were lower – but that doesn’t necessarily mean that they would have ended up with more deaths had they made restrictions tougher. We will never know what would have happened had Britain, say, followed the Swedish approach. Fourthly, there are plenty of other variables which were not measured in this study. You could, for example, see what correlation existed between excess death rates and obesity rates, smoking rates or vaccination rates.

All this said, there is clearly a strong case to be made that severe lockdowns caused more misery – deaths included – than they averted. It is essential that this is properly debated before we plan for future pandemics.




Tuesday, February 20, 2024

Largest Covid vaccine study ever finds shots are linked to small increased risk of neurological, blood and heart disorders - but they are still extremely rare

Covid vaccines have been linked to small increases in heart, blood, and neurological disorders, according to the largest global study of its kind.

An international coalition of vaccine experts looked for 13 medical conditions among 99 million vaccine recipients across eight countries in order to identify higher rates of those conditions after receiving the shots.

They confirmed that the shots made by Pfizer, Moderna, and AstraZeneca are linked to significantly higher risk of five medical conditions - including a nerve-wasting condition that leaves people struggling to walk or think.

But the study also warned of several other disorders that they said warranted further investigation, including the links between a brain-swelling condition and Moderna's shot.

Still, the team says the absolute risk of developing any one of the condition remains small. For instance, 13 billion doses of vaccines have been administered and there have only been 2,000 cases of all conditions.

Dr Harlan Krumholz, director of the Yale New Haven Hospital Center for Outcomes Research and Evaluation and a lead investigator behind the study, said: ‘Both things can be true.

'They can save millions of lives, and there can be a small number of people who’ve been adversely affected.’

Covid vaccines are estimated to have averted more than 19 million deaths worldwide, including three million in the US alone.

Among their discoveries was a twofold increase in the risk of a neurological condition known as Guillain-Barre syndrome,an autoimmune disorder in which the immune system attacks the body's peripheral nervous system, leading to damage to the protective casing around nerve cells.

The report said that of the 23 million AstraZeneca shots administered worldwide, they would have expected 76 cases of GBS - but 190 events were observed, accounting for a 2.9-fold increased risk.

While it cannot be proven that the vaccine caused these events, there is some evidence the vaccine triggers the immune system to attack its own nerves.

Meanwhile, the study also confirmed a threefold higher risk for a type of heart inflammation called myocarditis, though researchers did not give the number of expected cases versus actual cases.

Myocarditis was seen most commonly in young men. It's believed to be related to immune response triggered my the mRNA vaccines by Pfizer and Moderna, which work by instructing cells to produce the same protein that sits atop the coronavirus.

This prompts the immune system to produce antibodies against the spike protein, providing protection against Covid. In rare cases, this immune response may lead to inflammation in the heart muscle.

Typically, the myocarditis instances have been relatively mild, leading to just 28 deaths.

Additionally, both the first and fourth doses of the Moderna vaccine had between 1.7 and 2.6 times greater number of instances of pericarditis, an inflammation affecting the protective sac encasing the heart.

They looked at more than 39 million Moderna vaccine doses administered.

Like the link between mycarditis and the vaccines, links to pericarditis are still under investigation. It is believed to be caused by the same mechanism, an overactive immune response that attacks the thin sac-like membrane.

There was a greater than 3.7 times risk of a condition called Acute Disseminated Encephalomyelitis (ADEM), which causes swelling in the brain and spinal cord that damages the protective covering of nerve fibers in the brain and spinal cord, after the first dose of the Moderna vaccine.

Seven instances of ADEM occurred following vaccination with the Pfizer-BioNTech vaccine, surpassing the anticipated count of two cases.

There were nearly 190 million shots considered in the study.

The study also found that after getting the first dose of the AstraZeneca vaccine, there were 1.9 and 3.9 times increased risks of transverse myelitis and ADEM, respectively.

Bell’s palsy, which causes temporary weakness or paralysis of the muscles on one side of the face, had an increased odds of 1.05 after a first dose of the Pfizer vaccine.

There was also a 1.3 to 1.4 times greater risk of having a seizure following the first and second doses of the Moderna vaccine, as well as the fourth dose of the Pfizer vaccine.

Landmark study finds sudden cardiac deaths in sport fell over time

UK cardiologists say the findings from the 'landmark' Swiss and US study should reassure people about the safety of the mRNA Covid vaccines and the risk of myocarditis.

The researchers added a major caveat to this finding: ‘Chances of having a neurological event following acute SARS-CoV-2 infection were up to 617-fold higher than following COVID vaccination, suggesting that the benefits of vaccination substantially outweigh the risks.’

After a first dose of the AstraZeneca vaccine, there was a 3.2-times-greater than expected risk of Cerebral Venous Sinus Thrombosis (CVST).

The risks after the first dose of the Pfizer vaccine and after the second dose were 1.49 and 1.25 times higher.

CVST is a rare but serious condition characterized by the formation of blood clots in the large channels that drain blood from the brain and deliver it back to the heart after the AstraZeneca vaccine.

In total, 21 events were expected, while 69 events were observed.

Also after the first dose of the AstraZeneca vaccine, there was a 1.07 times higher risk of thrombocytopenia, a condition characterized by a lower-than-normal number of platelets in the blood.

After a third dose of ChAdOx1, the risk notably rose to 1.95.

Their research was published in the journal Vaccine.


Oh, So Shutting Down Schools And Making Kids Dumber Wasn't Required to Stop COVID

When the COVID pandemic hit, we shut down the schools to protect the kids. Everyone got subjected to remote learning, which didn’t work. When schools tried to re-open, teachers’ unions rioted, claiming selfish parents were trying to kill them. Teachers once again overshot their mark for a profession that doesn’t work year-round and who constantly want raises for mediocre test scores, especially when the damage from remote learning was revealed.

Besides test scores being the lowest in decades, the mental health crisis caused by extended periods of isolation is going to be a generational issue. The number of suicides was one of the most tragic stories coming out of the pandemic. And now, we have this study out of Canada showing that we never needed to shut down schools in the first place (via CP24):

An “extensive,” two-year review of COVID-19 in schools and daycares has revealed that these settings were not a significant source of transmission of the virus when infection prevention and control measures were used, researchers at McMaster University have found.

The review was published Thursday in The Lancet Child and Adolescent Health and examined more than 34,000 references, including databases, websites, and studies, related to transmission in child-care settings and schools across the globe.

The results of the review appear to cast doubt on the necessity of the repeated interruptions to in-person learning during the pandemic.

In Ontario schools were closed for a minimum of 135 days to prevent the spread of COVID-19, with disruptions in three successive school years.

“We found that after that initial shutdown where everything was locked down, schools did not appear to have much impact on community level transmission when infection prevention control measures were in place,” Sarah Neil-Sztramko, an assistant professor at the university and the lead author of the review, said in a written statement.

When the masking rules flopped around, followed by the science fiction that followed once the Omicron wave hit that upended the narrative about getting the COVID vaccine, we should have expected this outcome regarding the educational fallout from keeping kids away from each other.

Meanwhile, teachers’ unions have tried to gaslight who was behind and supported the classroom shutdowns. If this pandemic had hit ten years before the Trump presidency—would we have all lost our minds? Even Dr. Anthony Fauci initially took a blasé attitude to the virus until the 2020 election season blossomed. Would we not have reacted with such insanity? Who knows, but what is a fact is that the chasm in American education created by the lockdowns might be one too great to bridge, especially with the burgeoning bureaucracy associated with this sector.


FDA Official Acknowledges VAERS Faced 'Avalanche' of Reports After COVID Vaccine Rollout

A top FDA official admitted Thursday during a Select Subcommittee on the Coronavirus Pandemic hearing that the government's vaccine safety reporting system was not prepared for the “avalanche” of submissions entered after the rollout of the COVID-19 vaccines.

“As of February 2024, VAERS [Vaccine Adverse Event Reporting System] reports for COVID-19 vaccines total significantly higher than all other vaccines combined since 1990 as reported,” said Chairman Brad Wenstrup of Ohio. “This is a surprising figure. Dr. Marks, was the government prepared for an avalanche of reports to VAERS?”

Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, acknowledged it wasn't.

“We tried to be prepared for that,” he said, "but the avalanche of reports was tremendous. And again, it required re-tasking people on the fly…we had to usually staff up and had many meetings working to increase our ability to go through these reports because as you already mentioned, what the public sees on the public VAERS page is just a small fraction of the information that we ultimately collect and sift through that is very important to determine whether an adverse event is truly related to the vaccine

“One of the things we often receive is that we do not make additional information available,” he added. “I would say to you that it's a challenge. What we have learned is that it is very challenging to make available, essentially, protected health information...”

VAERS is an early-warning system but does not "prove that a vaccine caused a problem," according to the CDC. The information submitted, however, can highlight patterns and important information the agency and FDA can then investigate. Reports can be submitted by anyone




Monday, February 19, 2024

Hearing on the Hill Puts Feds on the Spot--Enormous Mistakes, Overreach & No Readiness for the Masses of Injured

The Select Subcommittee on the Coronavirus Pandemic hearing titled “Assessing America’s Vaccine Safety Systems, Part 1” examined the effectiveness of vaccine safety reporting and injury compensation systems after the rollout of the COVID-19 vaccine. Biden Administration officials from the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and Health Resources and Services Administration (HRSA) all testified that America’s vaccine injury and compensation systems have serious deficiencies related to inadequate staffing, lackluster surveillance, and overlapping programs.

Select Subcommittee Members were adamant of a false narrative: that rather than the safe and effective mantra touted over and over by health agencies, industry and the medical establishment, the efficacy of the COVID-19 vaccine was in question. They in some cases pressed witnesses aggressively to explain potentially politically motivated decision-making during the pandemic. In other ways, the event seemed like a COVID-19 kabuki.

TrialSite was one of the few media to announce the event in advance, one that Brad Wenstrup (R-Ohio) Select Subcommittee on the Coronavirus Pandemic Chairman, D.P.M., helped to organize.

Importantly, the Republican-led subcommittee sought out representation of patient groups. For example, Brianne Dressen, founder of React19, the largest COVID-19 vaccine injury group in the U.S. was in attendance and allowed to submit questions.

This first hearing was deemed part one of a two-part series of hearings. The second hearing focuses on the importance of the doctor-patient relationship in order to obtain public trust in vaccines during a future public health crisis.


In a nutshell, the Committee on Oversight and Accountability reports that the Biden Administration made the reckless move of mandating the COVID-19 vaccine less any kind of working system in place to compensate individuals injured by the policy.

Highlighting just how badly inadequate the government was to deal with any sort of vaccine-related injury HRSA Director at the Division of Injury Compensation Programs CDR George Reed Grimes: “At the beginning of the COVID-19 pandemic, we had not had a direct appropriation with the CICP. We also had only four staff.”

The hearing was also political kabuki for Republicans. They conveniently focus only on the Biden part of the COVID-19 history, excluding the Trump administration’s role in a reckless, relentless race to produce a vaccine first—TrialSite covered how various steps in the standard drug/vaccine development process were bypassed such as IND-enabling preclinical studies and the unreasonably compressed timelines (remember the AstraZeneca study) as examples.

In the hearing, the parties rather started with how the FDA accelerated the COVID-19 vaccine approval process to seemingly meet arbitrary mandate timelines set by the Biden Administration. This precedent was established by the Trump administration.

Executive branch officials from the CDC and FDA did express an accord that the federal government can never guarantee a vaccine is 100% safe. And of course, vaccines are public health tools involving tradeoffs, involving risk-benefit analyses.

Chairman Wenstrup asked: “Is any pharmaceutical 100% safe?”

FDA Director at the Center for Biologics Evaluation and Research, Dr. Peter Marks produced the honest answer: “No pharmaceutical is 100% safe.”

CDC Director at the National Center for Emerging and Zoonotic Infectious Diseases, Dr. Daniel Jernigan: “No medical intervention is risk-free.”

CDR Grimes: “There’s a reason we have a compensation program, and we’re dedicated to diligently carrying that out. I can’t say it any better than my colleagues sitting next to me have.”

Importantly, TrialSite has reported consistently how the U.S. federal government under both the Trump and Biden presidencies completely dropped the ball when it came to planning for the inevitable injuries that would present after the cranking out of a vaccine in such record time.

Is it a surprise to anyone that vaccine injury reporting and compensation systems were not prepared to handle what was described at the hearing as an “avalanche” of injury claims caused by the COVID-19 vaccine?

The FDA’s Dr. Peter Marks:“We tried to be prepared for that, but the avalanche of reports was tremendous. It, again, required re-tasking people on the fly…We had to usually staff up and had many meetings working to increase our ability to go through these reports.”

Not surprisingly, at times the politicians in the room used the forum for grandstanding, not intelligently delving deeper into what kinds of shortcuts the Trump administration allowed or looked the other way during Operation Warp Speed.

The Committee on Oversight and Accountability derived the summary: “Shortcomings in vaccine injury reporting and vaccine compensation systems, as well as ineffective government messaging during the pandemic, deteriorated public trust in vaccine safety.”

Dr. Peter Marks: “We probably have not done a good enough job of communicating sometimes the actual numbers of deaths versus what’s in VAERS.”

Of course, not all reports in VAERS are related to the vaccines. However, the magnitude of problems associated with the system, given the “avalanche” of vaccine injury reports, necessitates its investigation plus call for reform.

Member Highlights

Brad Wenstrup organized this event and during the hearing, argued that advancing an accurate narrative about the COVID-19 vaccine through doctor-patient relationships during the pandemic would have decreased misinformation and disinformation.

Chairman Wenstrup: “I want everyone to understand, especially those serving on the government side that the public perception becomes reality. And because of that, words matter. Words matter that are coming out, you know. For those of us as Members of Congress or as physicians at home, we’re face to face with people. We are sitting face to face with somebody. We’re not just looking at data on a sheet and making decisions. It needs to be done, what you’re doing, but there’s a difference and that’s why I say words matter. Let me give you an example. When you say safe and effective, that’s relative in your mind. It’s relative in your mind, but it’s not to the person at home. They hear 100% safe and 100% effective. That’s what they hear. This is why words matter. Dr. Fauci, in his testimony, even said, you can never say that any treatment is 100% safe. Yet, in essence, that’s what people heard and are still hearing today. We’ve got to change that because the doctor on the ground or the Member of Congress on the ground is one one-on-one with somebody and explains that to them.

“Let me tell you, I’m grateful we live in a country that has these systems (vaccine injury reporting and compensation systems) in place because they’re there to protect the American people and to provide for better health in America. But there are ways we can do better.”

Committee on Oversight and Accountability Chairman James Comer (R-Ky.) pressed FDA Director Dr. Peter Marks to admit he ignored warnings from his colleagues about the dangers of accelerating the COVID-19 vaccine approval process. Chairman Comer further noted that the timing of the Biden Administration’s vaccine mandate and the FDA’s rushed approval of the vaccine appear to correlate. See the link.

Chairman Comer: “Why were you pressuring the doctors and then removing them from the approval process when they disagreed?”

Dr. Marks: “The approval process was one that needed to move as rapidly as possible.”

Chairman Comer: “Do you recall any conversations regarding the need to approve the vaccines in order for it to then be mandated?”

Dr. Marks: “There was an acknowledgment that an approval could allow vaccine mandates to occur.”

Chairman Comer: “So, Dr. Gruber wrote that you and Dr. Woodcock expressed your opinion that absent a license, states cannot require mandatory vaccination. Do you recall this conversation?”

Dr. Marks: “I don’t know what you’re what you’re referring to, but there’s probably, it’s just a statement of fact that once you have a license, vaccine and mandate could be placed.”

Chairman Comer: “Do you recall seeing safety signals regarding myocarditis in young men during this time?”

Dr. Marks: “There were yes. There were safety signals known and they were placed on the label.”

A notable admission given Marks was for accelerating the approval by August 20; the eventual approval came three days later on August 23 and coincidentally the Department of Defense’s vaccine mandate occurred according to the exchange on August 20, 2021. On the timing Comer declared, “And that is interesting.”

Rep. Rich McCormick (R-Ga.), M.D., argued that the federal government wrongly inserted itself in the doctor-patient relationship during the COVID-19 pandemic. In actuality the feds extended their reach much more than that, working to censor doctors indirectly via pressure on the National Association of Medical and Pharmacy boards as TrialSite chronicled.

Overall, this “overreach” created a lack of trust between Americans and their public health system.

Rep. McCormick: “When you insert yourself between a doctor and a patient, and some doctors contradict you and you censor them, even when you’re not a doctor treating patients, people are going to say, why does the government have authority to do that, to censor my doctor? And then secondly, when you start requiring people to do something instead of encouraging the natural resistance of a freedom-loving people that were founded on those principles, will be to resist what you’re requiring. So, it shouldn’t be any surprise to us when the people say, I’m not going to do what you’re telling me I have to do when my doctor may agree with me and not you. You’re the government. Why do they insert themselves in inappropriate ways?

“And really, when we talk about the evolution of science, when you have immunity and you’re still requiring a vaccination that can cause a hyper-immune response, which we’re all scientists, we can admit to, there’s risk versus benefit on every decision. When the government says we’re going to make a carte blanche requirement without taking science into account, it’s no wonder people are mistrustful of our recommendations.”

Rep. Debbie Lesko (R-Ariz.) demanded FDA Director Dr. Peter Marks explain why the publicly reported data on vaccine injuries differs significantly from the confirmed death and injury count available to FDA officials. See the link.

Rep. Lesko: “We spoke over the phone back on August 10th of 2021, and I was asking about VAERS because I had lots of constituents reaching out to me saying there were tons of adverse effects, there were thousands of deaths, etc., and they were very concerned. And I asked how many were confirmed. And at that time, you said four. There were four cases that you confirmed deaths that were caused by the vaccine. I suggested, at that time, that the CDC and FDA do a better job of telling the public not just how many cases were reported, but how many were actually confirmed. And just if I heard you right, just recently, you said, well, we don’t want to give out too much information because of privacy rights. But certainly, we could put out how many were confirmed deaths, couldn’t we?”

Dr. Marks: “I fully agree with you that we probably have not done a good enough job of communicating sometimes the actual numbers of deaths versus what’s in VAERS. In fact, we just nearly fell prey to it here at this hearing.”

Rep. Lesko: “It seems very logical to me that if you’re saying the public shouldn’t count on VAERS because anybody can report to that, which they can, why wouldn’t you as actively report to the public — well, we confirmed this really low number of cases that actually were caused by vaccines. I mean, it’s been years now. Why? Why haven’t you done it?”

Dr. Marks: “We did present that in various settings, including at, I believe, at the Advisory Committee on Immunization Practices. It was mentioned at our vaccine advisory committee. It perhaps did not go as broadly.”

Rep. Mariannette Miller-Meeks (R-Iowa), M.D., uncovered evidence that the COVID-19 vaccine was mandated for healthy Americans and U.S. service members without a sufficient system in place to compensate those harmed by the coercive policy.

Rep. Mariannette Miller-Meeks: “I understand that there’s a current backlog of claims in CICP, by about more than 10,000. Why is there a backlog of claims for the COVID-19 vaccines?”

CDR Grimes: “At the beginning of the COVID-19 pandemic, we had not had a direct appropriation with the CICP. We also had only four staff. When we received our first direct appropriation in fiscal year 2022, we were able to ramp up quickly and now we have over 35 staff who are assisting to adjudicate claims.”

What have we learned from the COVID-19 pandemic? As healthcare itself became politicized and used by warring factions over access to power and money, the people generally suffer as a result. In a democratic society usurped by pecuniary interests, one normalizing the power of money over all else, little will likely change.




Sunday, February 18, 2024

Dispute over COVID-19 Vaccination & Children

A prominent British Immunologist and Professor in Biomedical Sciences and Public Engagement at the University of Manchester recently declared in an Op-Ed piece in The Guardian that British health authorities are deviating from the rest of the wealthy developed nations by not placing more emphasis on universal COVID-19 vaccination for children and young adults. Sheena Cruickshank argues that the risk-based approach to COVID-19 vaccination recommended by the UK Joint Committee on Vaccination and Immunization (JCVI)---that the vaccines are generally only available for high-risk groups deviates from the norm of wealthy peer nations.

But is Cruickshank correct? Not really. The JCVI’s recommendations reflect more the norm among most developed nations. Even the New York Times would concur. Just read the recent “Covid Shots for Children.” David Leonhardt reports, “Much of the world has decided that most young children don’t need to receive Covid booster shots. The U.S. is an outlier.” Why is this the case? While the COVID jabs helped mitigate risk during the pandemic, now experts align for the most part that the benefits of these jabs for children in most cases “fail to outweigh the costs.”

Contrary to Professor Cruickshank’s stance, the U.S. is an outlier in this regard. And Britain’s JCVI actually follows most of the peer national COVID-19 vaccine policy, where healthy children are not included in the seasonal vaccination campaign.

Either Professor Cruickshank doesn’t understand very well COVID-19 vaccination policy among the rich nations, which we find hard to believe, or she is using her position and the media platform to promote a particularly biased agenda.

What prompts the British immunologists’ call for a new vaccine strategy? She is trying to force an argument, a case, to spark a movement to pressure the government to open up its “limited” vaccination recommendation by attempting to connect it to problems like long COVID. Allow children to get the vaccines, and first, parents will line up to volunteer their children to get the jab. And this will lower long COVID rates, although there is limited evidence that in the age of Omicron long COVID is materially reduced by vaccination.

“We know vaccination helps protect against long COVID, but we are still seeing new cases, so it’s uncertain how long protection persists from previous vaccinations.”

She cites no studies. And that’s likely because there are no studies anywhere that conclusively prove causation linking COVID-19 vaccination conclusively to reductions in long COVID.

Some observational studies suggest an association, but such investigations must be interpreted cautiously given their limitations. In one prominent recent population-based cohort study in Sweden published in The BMJ, Maria Bygdel and colleagues point out what they found to be “a strong association between COVID-19 vaccination before infection and reduced risk of receiving a diagnosis of PCC (Post-COVID condition).

But all sorts of limitations in this Swedish study means such examples should not be used by experts to prove conclusively that the vaccine reduces long COVID.

Bygdel and colleagues point to studies looking into the impact of vaccination on existing PCC, “showing both no effect as well as alleviation and aggravation of PCC symptoms.” This means the science remains uncertain, the situation unfolding and therefore the responsible position of any scientist or doctor should be to acknowledge that reality.

Another reason Cruickshank gives for the UK to open up its COVID-19 vaccination recommendations to more groups such as healthy children and young adults: the “government already negotiated the purchase of millions of doses of COVID vaccines, to be delivered in stages between 2021 and 2024.”

Meaning that under the pretext of emergency the government made prior bulk procurement decisions and now such product would just go to waste because a large segment of the population is excluded from the vaccine category group established by JCVI.

What the University of Manchester professor doesn’t touch on however, are the data involving cost-benefit analysis.

Rather she implies that the JCVI could have some agenda. After all they are using a ‘bespoke, non-standard method of cost-effectiveness assessment” guiding priorities less any details.

Professor Cruickshank fails to make the case for opening up the COVID-19 vaccine category to include healthy children and young people.

She doesn’t’ produce any conclusive evidence of any kind, nor does she point to any morbidity or mortality numbers pressing the current JCVI position on the matter. In fact, she acknowledges the data involving COVID morbidity and mortality is better this year than last. Of course, this is the case, we are out of the pandemic, the emergency has been called off, and the Omicron variant is substantially milder in effect for the substantial majority of the population.

The professor ignores any safety issues, a considerable factor in the young healthy population given the higher incidence of myocarditis and pericarditis. While she points to the U.S. as an example the JCVI should consider, she considers what the U.S. Food and Drug Administration (FDA) package insert states about children and the Pfizer Comirnaty COVID-19 vaccine for example.

Under Section 8.4 of this formal regulatory artifact:

“The safety and effectiveness of COMIRNATY in individuals younger than 12 years of age have not been established. Evidence from clinical studies in individuals 6 months through 4 years of age strongly suggests that a single dose of COMIRNATY would be ineffective in individuals younger than 6 months of age.”

She also ignores whether someone has been infected or not. Natural immunity also can wear off given the mutating pathogen, but it’s a major contributing factor undoubtedly the JCVI and most other developed countries have factored into their analysis.

Professor Cruickshank cites a couple examples of developed nations making the vaccine universally available for healthy children and young adults--the U.S. and France. But as the New York Times now acknowledges, it’s the U.S that is an outlier, not the other way around, as Professor Cruickshank opines.

Finally, Cruickshank evades the topic of the market’s general rejection of the COVID-19 vaccines in the USA, despite continuous promotional energies across both public health authorities and industry. Less than one fifth of the eligible population stepped forward to get the latest monovalent booster (BA.4/BA.5), and the percentage of children that ultimately received a booster jab targeting Omicron BA.4/BA.5 was far less.


Long COVID can destroy your ability to exercise or do simple tasks — now we may know why

Extreme fatigue and difficulty exercising are common symptoms of long COVID — now scientists may finally have discovered why.

While most people who test positive for the coronavirus are over their symptoms within a week or two, more research is showing that some people continue to report symptoms — and even develop new ones — three months after their initial positive test, lasting for months or even years.

A new study, published in the journal Nature Communications, suggests that some of these symptoms may persist or worsen as those with long COVID-19 experience biological changes in their bodies after working out — most notably involving their muscles.

“We’re seeing clear changes in the muscles in these patients,” Michèle van Vugt, professor of internal medicine at Amsterdam UMC, said in a statement.

The study found that long COVID patients had extreme fatigue, changes in muscle composition and widespread muscle damage.

Researchers from Amsterdam UMC and Vrije Universiteit Amsterdam (VU) analyzed data from 25 long-COVID patients with post-exertional malaise (PEM) — meaning their symptoms worsened after the minor physical exertion, causing them to crash from extreme fatigue — and 21 healthy control participants after cycling for 15 minutes.

As patients experience PEM, even daily tasks like carrying groceries and brushing their teeth can be exhausting.

After analyzing blood and muscle tissue samples, the researchers discovered that those with long COVID had various abnormalities in their muscle tissue.

“At the cellular level, we saw that the mitochondria of the muscle, also known as the energy factories of the cell, function less well and that they produce less energy,” Rob Wüst, assistant professor at the Department of Human Movement Sciences at VU University, explained in a statement.

“So, the cause of the fatigue is really biological. The brain needs energy to think. Muscles need energy to move.”

This biological decrease in energy is specific to those with PEM and not seen in other chronic illnesses.

“Normally we know from all the other chronic diseases that exercise is good for you, that exercise is medicine,” Wüst told National Geographic. “However, these patients do get worse.”

Long COVID patients were also found to have a higher proportion of fast-twitch muscle fibers, which may also explain some of the fatigue.

These muscle fibers deplete energy faster, meaning they exhaust quicker.

“We know that it is difficult to change fiber types in people and that it doesn’t happen with inactivity,” Wüst told National Geographic. “Something else is changing the fiber types.”

The cause of this change is still unclear.

Along with changes to energy production and muscle composition, the research team also found those with long COVID had muscle damage — muscle scarring, inflammation and blood clots before and after working out.

Studies have shown that those with PEM struggle to recover from exercise, but this latest research showed that this may be caused by repeated overexertion — even from daily tasks — that prohibit the body from fully recovering.

The experts noted that this breakthrough will help guide more appropriate treatments for those with long-term COVID, though not everyone would necessarily benefit in the same ways.

“Keep in mind that every patient has a different limit,” Brent Appelman, a researcher at Amsterdam UMC, said in a statement.