FDA minimizes side effects of Updated COVID-19 Vaccines

Updated COVID-19 vaccines may cause heart inflammation and severe allergic shock, according to a new study from the U.S. Food and Drug Administration (FDA).

Researchers with the FDA, the U.S. National Institutes of Health, and companies like CVS looked at health care databases to try to figure out if there were signs the Moderna and Pfizer bivalent COVID-19 vaccines might be linked to any health issues.

They found several safety signals. One signal was for myocarditis, a form of heart inflammation, and a related condition called pericarditis following Pfizer vaccination in adults aged 18 to 35. Another was for anaphylaxis, or severe allergic shock, following Moderna and Pfizer vaccination in people aged 18 to 64.

The signals were detected in a database from Carelon Research.

The incidence rate for anaphylaxis was 74.5 cases per 100,000 person-years following Pfizer vaccination and 109.4 cases per 100,000 person-years following Moderna vaccination.

Researchers arrived at an incidence rate of 131.4 cases of myocarditis/pericarditis per 100,000 person-years after a Pfizer shot.

No stratification was done by gender, despite myocarditis, according to many studies, disproportionately affecting males.

Person-years is a measure used in some studies. In this study, all time during post-vaccination periods of time known as risk intervals were included. The risk intervals were different depending on the health outcome. For anaphylaxis, the risk interval was 0 to 1 day; for myocarditis/pericarditis, it was 0 to 7 days or 0 to 21 days.

Additional issues were also identified in the four databases that were analyzed, but none rose to the level of a safety signal, a set criteria that is an indication of a vaccine causing an issue.

The study analyzed data from people aged 6 months and older from August 2022 to July 2023. The bivalent shots were replaced soon after by updated vaccines because their effects, which already started low, were shown to wane in observational studies.

Researchers only included people who were continuously enrolled in an insurance plan and did not suffer health issues during a “clean interval,” or if the health outcome in question did not occur during a certain interval.

“References for the clean interval could not be located in the literature and are based on clinician input,” the authors said in a footnote.

Patricia Lloyd, an FDA researcher, and her co-authors said the study “supports the safety of these vaccines” and “supports the conclusion that the benefits of vaccination outweigh the risks.”

Asked for evidence to support those conclusions, Ms. Lloyd referred a request for comment to the FDA.

“With over a billion doses of the mRNA vaccines administered, available scientific evidence supports the conclusion that the vaccines are safe and effective. The FDA stands behind its findings of quality, safety, and efficacy for the mRNA vaccines. Additionally, it is simply a fact that millions of lives have been saved because of the COVID-19 mRNA vaccines, which most Americans undergoing vaccination have received,” an FDA spokesperson claimed.

The agency provided a single citation from the Commonwealth Fund, a foundation that used modeling to estimate that through November 2022, the vaccines prevented millions of deaths.
The study was published ahead of peer review on the medRxiv server.

Dr. Peter McCullough, a cardiologist and president of the McCullough Foundation, told The Epoch Times in an email that results from the paper show “cardiovascular and neurological safety events are numerous and unacceptable on a population basis.”

Dr. McCullough, who was not involved with the paper, noted that the study did not analyze COVID-19 vaccine effectiveness.

“The FDA’s conclusion on risk benefit is not valid and reflects agency bias in attempting to promote the unsafe, ineffective products,” he said. “Our regulatory agencies should not be promoting or advertising the products they are charged with regulating.”

The FDA clears vaccines. The agency in 2022 authorized and approved the bivalent vaccines despite there being no clinical trial data available.

Limitations of the new paper included the lack of medical record review. Many authors reported their employment for health care companies as conflicts of interest.

A previous study analyzing the health claims databases detected signals for seizures/convulsions among children aged 2 to 4 after Pfizer vaccination and children aged 2 to 5 following Moderna vaccination. That study analyzed the version of the vaccines that preceded the bivalent shots.

In another new study, co-authored by Dr. McCullough, researchers reported finding a spike in reports of myocarditis in the federally-run Vaccine Adverse Event Reporting System in 2021.

“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,” the researchers said.

Applying causality principles, the researchers said that COVID-19 vaccination was “strongly associated with a serious adverse safety signal of myocarditis, particularly in children and young adults resulting in hospitalization and death.”

Federal officials have said that the COVID-19 vaccines cause myocarditis, pericarditis, and anaphylaxis, but that the vaccines also provide protection against infection and severe illness, tilting the risk-benefit balance in their favor. They have increasingly cited, in lieu of clinical trials, observational studies from the FDA and U.S. Centers for Disease Control and Prevention (CDC), some of which lack peer review.

Current U.S. recommendations are for essentially all Americans aged 6 months and older to get one of the newest COVID-19 vaccines, introduced in 2023. That contrasts with a number of other countries, such as the United Kingdom, which have stopped offering or no longer recommend COVID-19 vaccination for wide swaths of their populations.

https://www.theepochtimes.com/health/fda-finds-safety-signals-for-updated-covid-19-vaccines-5576152

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Australia: Daniel was forced to have a Covid jab to keep his job. Then he fell gravely ill. Now he has secured a HUGE legal victory

A public servant who was forced to get a Covid vaccination to keep his job, but then fell gravely ill, has won a major legal battle and will be paid compensation.

Daniel Shepherd, 44, received two Covid-19 vaccinations when he was a youth worker at Baptist Care South Australia in 2021 and suffered adverse reactions to the jab.

The father of one started a new job with the Department for Child Protection (DCP) on October 19 that year, but was told on January 28, 2022, that he had to get a booster shot to keep his job as a child and youth worker.

Mr Sheperd was given a Pfizer mRNA jab on February 24, 2022, but a day later he had serious chest pains.

The pain kept getting worse until March 11, when he thought he was having a heart attack and was rushed to Adelaide's Ashford Hospital. There he was diagnosed with post-vaccine pericarditis - an inflammation of the membrane around the heart.

The illness meant Mr Shepherd was only able to work for a few months in a part-time administrative capacity.

DCP acknowledged the pericarditis was caused by the Pfizer mRNA booster shot, but it denied workers compensation liability, saying it was a legal government directive and so was excluded under the SA Emergency Management Act.

But Judge Mark Calligeros, the SA Employment Tribunal's deputy president, rejected the DCP's arguments.

'It is not surprising that some people who receive a dose of Covid-19 vaccine will sustain injury as a result,' he wrote in his judgment.

'It would be astonishing if parliament intended that an employee of the state, injured adhering to an EM (Emergency Management) Act direction, was to be precluded from receiving workers compensation.

'I am not satisfied that parliament intended to deny compensation to employees of the state injured by heeding a vaccination mandate designed to protect the health and welfare of citizens.'

Judge Calligeros added that Mr Shepherd was required to be vaccinated to continue working in healthcare.

This was 'because (the state) sought to protect and reduce the risk of infection to the public and general and those members of the public receiving healthcare services in particular.

'It would be ironic and unjust if Mr Shepherd was denied financial and medical support by complying with the state's desire to preserve public health.'

In a landmark ruling, the judge ordered that Mr Shepherd should get weekly income support payments and the payment of medical expenses.

The ruling came despite SA Health still enforcing a mandatory Covid vaccination policy for some employees, even though similar policies have been dropped in other states.

https://www.dailymail.co.uk/news/article-13023211/Covid-jab-legal-victory-Daniel-Shepherd.html

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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Before Pandemic Preparations, We Need Better Evidence Of Risk

Written by Meryl Nass MD

The world is currently reorienting its health and social priorities to counter a perceived threat of increased pandemic risk.

Spearheaded by the World Health Organization (WHO), the World Bank, and the Group of 20 governments (G20), this agenda is based on claims of rapidly increasing infectious disease outbreaks (epidemics), driven largely by an escalating risk of major “spillover” of pathogens from animals (zoonosis).

To be globally prepared for such pandemic risk, many quarters have pushed for comprehensive and urgent action, to avert an “existential threat” to humanity.

It is prudent to prepare for public health emergencies and pandemic risk. It is also sensible to assure that these preparations are reflective of the best available evidence concerning pandemic risk, and that any policy response is proportional to that threat.

One hallmark of evidence-based policy is that policy decisions should be substantiated by rigorously established objective evidence and not based merely on ideology or common belief.

This enables appropriate allocation of resources among competing health and economic priorities. Global health resources are already scarce and stretched; there is little doubt that decisions about pandemic preparedness will have significant implications for global and local economies, health systems, and well-being.

So, What Is The Evidence On Pandemic Threat?

The G20 declarations from 2022 (Indonesia) and 2023 (New Delhi) are based on the findings of its High Level Independent Panel (HLIP), laid out in a 2022 report informed by the World Bank and the WHO, and analysis commissioned from a private data company, Metabiota, and the consulting firm McKinsey & Company.

The report summarizes the evidence in two annexes (Figure 1 below), noting in its Overview that:

“Even as we fight this pandemic [Covid-19], we must face the reality of a world at risk of more frequent pandemics.”

while on page 20:

“The last two decades have seen major global outbreaks of infectious diseases every four to five years, including SARS, H1N1, MERS and Covid-19. (See Annex D.)”

“There has been an acceleration of zoonotic spillovers over the last three decades. (See Annex E.)”

By “zoonotic spillovers,” the report refers to the passage of pathogens from animal hosts to the human population. This is the generally accepted origin of HIV/AIDS, the 2003 SARS outbreak, and seasonal influenza.

Zoonosis is assumed to be the major source of future pandemics, barring laboratory releases of pathogens modified by humans. The basis of the G20 HLIP report’s sense of urgency is these annexes (D and E) and their underlying data.

In other words, it is this evidence base that supports both the urgency of establishing robust global pandemic policies, and the level of investment that these policies should involve.

So, What Is The Quality Of The Evidence?

Despite the importance the HLIP report gives to the data in Annex D, there is actually little data to assess. The Annex presents a table of outbreaks and the years they occurred, with no attribution or source provided.

While Metabiota and McKinsey are quoted elsewhere as primary sources, the relevant McKinsey report does not include this data, and the data could not be found when conducting searches of publicly-available Metabiota material.

To better understand the implications from the data in Annex D, we created a corresponding “best-fit” table of pathogen outbreaks and year (Figure 1), with official mortality data for the entire outbreak per pathogen (some extend beyond 1 year – see sources in Table 1).

In order to address an apparent oversight in the Annex D table, we also included the 2018 and 2018-2020 Ebola outbreaks in the Democratic Republic of Congo in our analysis, since there were no large outbreaks of Ebola reported in 2017.

This is likely what “Ebola 2017” was intended to denote in the Annex D table. In our analysis (Figure 1) we exclude Covid-19 since its associated mortality remains unclear and its origin (laboratory-modified or natural) is contested, as discussed later.

When comparisons are made between the HLIP outbreaks table and our table of the last two decades, one mortality event dominates – the 2009 Swine Flu outbreak that resulted in an estimated 163,000 deaths. The next highest, the West African Ebola outbreak, resulted in 11,325 deaths.

Although these absolute numbers are worrisome, in terms of pandemic risk it is necessary to note that the Ebola virus requires direct contact for spread and is confined to Central and West Africa, where outbreaks arise every few years and are dealt with locally.

Furthermore, in relative terms, consider that malaria kills over 600,000 children every year, tuberculosis kills 1.3 million people, while seasonal influenza kills between 290,000 and 650,000.

So, putting Annex D in context, the West African Ebola outbreak, the largest in history, thus resulted in the equivalent of 4 days of global tuberculosis mortality, while the Swine flu outbreak of 2009 killed less than influenza normally does.

The third largest outbreak listed by the G20 HLIP was the cholera outbreak in 2010, which was confined to Haiti, and thought to have originated from poor sanitation in a United Nations compound.

Cholera once caused major outbreaks (peaking between 1852-1859) and was the subject of the first international agreements on pandemics. Improved water and sewage sanitation has reduced greatly to a point where the Haiti outbreak was unusual, and there has been a consistent overall downward trend since 1859.

In terms of threat, no other outbreak listed by the HLIP over the 2000-2020 period killed over 1,000 people. The HLIP considers this table to show major global outbreaks every 4-5 years, whereas it actually shows mostly small, localized outbreaks of illness dwarfed by the everyday infectious and non-infectious diseases that all countries deal with.

There were just 25,629 non-Swine flu and non-Covid-19 deaths over two decades from the outbreaks considered by the HLIP to be severe (it is noted that other outbreaks occurred through this period that the HLIP did not consider sufficiently significant).

Covid-19 has of course intervened – the first outbreak since 1969 to result in greater mortality than seasonal influenza does each year.

This mortality has occurred predominantly in the sick elderly, at a median age above 75 years in higher-mortality high-income countries, and in people with significant comorbidities, a contrast to the predominantly childhood deaths from malaria and young to middle-aged adults who die from tuberculosis.

Excess mortality rose over baseline but separating out Covid-19 mortality from mortality resulting from the ‘lockdown’ measures, reducing disease screening and management in high-income countries and promoting poverty-related diseases in low-income countries, makes actual burden estimates difficult.

However, if we accept Covid-19 (for sake of argument) as a natural event, then it should obviously be included when determining risk.

There are meaningful debates about the accuracy of how deaths were recorded and attributed to Covid-19, yet assuming the WHO is correct in its estimates, then the WHO records 7,010,568 deaths attributed to (or associated with) the SARS-CoV-2 virus over 4 years, with most in the first 2 years (Figure 2).

Allowing for population increase, this is still higher than the 1.0 to 1.1 million deaths attributed to the influenza outbreaks in 1957-58 and 1968-69, and the largest since the Spanish flu that inflicted a mortality several-fold higher over a century earlier.

With an average mortality of 1.7 million per year over 4 years, Covid-19 is not greatly different from tuberculosis (1.3 million), but concentrated in a considerably older age group.

Tuberculosis, however, continues before and will continue after Covid-19, whereas Figure 2 indicates a rapidly waning Covid-19 outbreak.

As the first event in 100 years of this magnitude, though little different from major endemic tuberculosis, and against a background that does not demonstrate an overall increase in mortality from outbreak events, it appears to be an outlier rather than evidence of a trend.

The second piece of evidence used by the HLIP to substantiate its claim that we are living in a “pandemic age” is research conducted by Metabiota Inc., an independent company whose epidemiology team has since been absorbed by Ginkgo Bioworks.

The Metabiota data forms Annex E of the HLIP report (see Figure 3), which shows outbreak frequency of zoonotic non-influenza pathogens over 60 years to 2020, and influenza ‘spillover’ events for 25 years.

Although Metabiota is cited as the source, the data itself is not further referenced. That said, an identical non-influenza data set appears in an online presentation by Metabiota to the Center for Global Development (CGD) on August 25th, 2021 (Figure 4).

This dataset also appears in a more recent academic article in the British Medical Journal in 2023, co-authored by Metabiota personnel (Meadows et al., 2023). The authors analyzed the Metabiota database of 3,150 outbreaks, including all outbreaks recorded by WHO since 1963 as well as “historically-significant” prior outbreaks (Figure 5).

The data used in Meadows et al. (2023) is available in the article’s supplementary information, and former Metabiota staff confirmed to REPPARE that the dataset used in that article, as in the earlier analyses, is now commercially available through Concentric by Ginkgo Bioworks.

The data points are summarized in the HLIP Annex E via two corresponding claims. Firstly, that there is an “exponential” increase in non-influenza outbreak frequency. Secondly, that influenza ‘spillover’ (transfer from animals) has increased from “almost none” in 1995 to around 10 events in 2020. Both claims require examination.

Yet, as Meadows and co-authors confirm in their later paper, this increase in reporting frequency does not take into account the development of new surveillance and diagnostic technologies, which have enabled better (or in some cases any) detection.

PCR testing was only invented in 1983 and has steadily become more accessible in laboratories over the last 30 years. Antigen and point-of-care serology tests were only widely available in the past couple of decades, and genetic sequencing only very recently.

Since 1960, we also have had significant improvements in road transport, clinic access, and digital information sharing. As a result, this limitation in the Meadows study raises a key issue.

Namely, that advancements in detection technology may account for the large increase in reported outbreaks, since most small and localized outbreaks will have been missed 60 years ago.

As just one example, HIV/AIDS was missed for at least 20 years before identification in the 1980s.

What the above suggests is that there are certainly known spillover effects and that these do occur with some frequency and deadly effect.

What is less reliable is the claim that there is an increased frequency of zoonosis and/or that the increase in reporting cannot be fully or partly explained by advancements in detection technologies.

https://principia-scientific.com/before-pandemics-we-need-better-evidence-of-risk/

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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COVID Vaccine Trials Show Counting Window Issues

"Counting windows" refers to how long you wait for an effect to emerge. For example: If you took two years to die from the effects of a vaccination but your counting window is only one year you may fail to pick up that death as caused by vaccination

Written by Raphael Lataster, PhD

The Journal of Evaluation in Clinical Practice’s hugely important unofficial series of articles on exaggerated COVID-19 vaccine effectiveness and safety claims, involving BMJ editor Peter Doshi and myself, has now concluded. The initial Fung, Jones, and Doshi paper outlines statistical biases, such as the case counting window bias, that likely lead to the COVID vaccines’ effectiveness being exaggerated in observational studies.

The subsequent paper by Lataster (that’s me) then explained the situation is worse, as the case counting window bias is often accompanied by a definitional bias, and noted that this could exaggerate vaccine safety as well.

Doshi and Fung then returned with a further paper indicating that numerous cases in the vaccinated were overlooked in the clinical trials, likely leading to exaggerated effectiveness estimates.

The fourth and final article in this ‘series’, again by myself, notes that this also appears to apply to safety estimates in the clinical trials, whilst also confirming my earlier concerns about safety estimates in observational studies, and noting that the myocarditis issue alone could mean that the jabs are not worth the risk in the young and healthy.

Safety estimates appeared to be exaggerated in a recent observational study championing the use of the jabs in the omicron era, which OTN readers will already know all about.

I again state that Doshi’s team may have understated things. While they expect that effectiveness was exaggerated in the clinical trials, I note that “numerous issues with the clinical trials and FDA briefing documents had gone unmentioned.

For example, there are a significant number of trial participants lost to follow-up, and Pfizer also acknowledged ‘3410 total cases of suspected but unconfirmed COVID-19 in the overall study population’ in the FDA briefing document on their vaccine trial, split almost evenly between the treatment and placebo groups, which would have drastically brought down treatment efficacy estimates.”

Counting windows for adverse effects in the clinical trials were incredibly short, going against long-established norms, especially with the treatment and placebo groups quickly merged, and reliant on unsolicited reporting, as well as the opinions of researchers paid by BioNTech and Pfizer (like cardiovascular deaths being written off as unrelated to the jab when we now know the jab does cause cardiovascular deaths).

I note the concerning “large number of trial participants lost to follow-up” and that “deceased trial participants will not be contacting the researchers to describe their issues”. Wrap your head around that one. You’re in the vaccinated group. You die, thanks to the jab. As a result, you don’t report this to Pfizer. Your death is not included in the data, as with the potentially many other jab-caused deaths. With relatively few adverse reports the jab is declared safe. It’s a bit like how we can’t refer to many of the adverse event reports as they’re perpetually unverified.

Couldn’t avoid again referring to the Fraiman et al. and Benn et al. articles indicating that, with the data as unreliable as it is, the trials indicated an excess of deaths and “serious adverse events of special interest” in the vaccinated groups, relative to the unvaccinated groups.

I note that increasing research on myocarditis alone appears to indicate that the risks of the jabs outweigh the benefits in the young and healthy, the topic of my BMJ rapid response.

I reveal that Pfizer acknowledges myocarditis risks and limitations of their study. And that Pfizer is currently running a trial, again plagued by counting window issues, to “determine if COMIRNATY is safe and effective, and if there is a myocarditis/pericarditis association that should be noted”.

Would this information have been handy before you got jabbed, and before the jabs were universally declared “safe and effective”, and before people were fired for not submitting?
I conclude that there is more than enough here to “nullify the claim that the benefits of the vaccines still outweigh the risks in all populations”. Source.

Just remember that the claims about these COVID-19 vaccines being safe and effective were, at best, based on these clinical trials and observational studies.

https://principia-scientific.com/covid-vaccine-trials-show-counting-window-issues/

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Overwhelming Percentage of VA Patients Eligible, Not Given COVID-19 Antivirals

In the latest Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report (MMWR) titled “Underuse of Antiviral Drugs to Prevent Progression to Severe COVID-19—Veterans Health Administration (VA), March—September 2022,”

Boston-based rheumatologist Paul Monach, M.D, Ph.D., and colleagues from VA Boston Healthcare System/VA Boston Center for Healthcare Organization & Implementation Research, Harvard Medical School and Dana-Farber Cancer Institute report based on their observational study of electronic medical records that 80% of 110 immunosuppressed patients in the VA system with non-severe COVID-19 at risk for progression were not offered any antiviral drugs.

For nearly 50% of the participant cohort, the only rationale offered for the lack of access to antiviral drugs was that the SARS-CoV-2 symptoms were mild. Other reasons for withholding antivirals to COVID-19-infected at-risk persons include symptom duration of less than 5 days (22.7%), lack of symptoms (22.7%), and drug interaction concerns (5.7%). 20% of the study participants declined any antivirals.

The antivirals for COVID-19 include both nirmatrelvir/ritonavir (Paxlovid) as well as remdesivir (Veklury)–both approved by the Food and Drug Administration (FDA). Merck’s molnupiravir (Lagevrio) is authorized for emergency use.

Background

As the weight of the evidence suggests, FDA-approved or emergency-authorized antivirals can reduce risk of hospitalization and death and are recommended for patients with mild-to-moderate COVID-19 facing a higher risk of disease progression due to age or medical conditions. The study team was concerned that other research revealed that eligible at-risk patients were not being prescribed antivirals nearly enough.

The authors of this CDC-backed study report that the basis for this investigation concerned the fact that the VA reported the use of outpatient antiviral medications among 24% of all documented SARS-CoV-2 infections in 2022, remaining at that level through early 2023.

The authors expressed concern that many of the patients met the criteria for access to these drugs. Interestingly, similar overall rates of use (maximum = 34%) were observed in a large cohort from healthcare systems participating in the National Patient-Centered Clinical Research Network (PCORnet).

Purpose of this Study

The study authors tapped into a sample of VA patients with COVID-19, reviewing their records to better understand the barriers to antiviral use. What were the reasons for the non-treatment of these patients with mild-to-moderate disease at the time of initial evaluation and testing?

All of the patient cohort were deemed fully vaccinated and were associated with one of three relatively common conditions linked to severe immunocompromise, thus placing them in the at-risk category for COVID-19, vaccinated or not. These included 1) solid organ transplantation 2) chronic lymphocytic leukemia (CLL) or plasma cell malignancies.

Findings

This observational study identified 110 COVID-19 mild-to-moderate VA system patients during the period March to September 2022 with either solid organ transplantation, CLL, or plasma cell malignancies. They had previously received a COVID-19 vaccine but did not receive antiviral treatment after receiving positive SARS-CoV-2 test results, again during a mild-to-moderate or asymptomatic infection.

While 20% of the total study group were offered antivirals but declined, 80% of the study population were not offered treatment

The authors cannot be certain why so many patients who fit into an at-risk category are not administered antivirals for COVID-19. To further investigate this quandary, with a deeper probe into electronic medical record text, the authors propose “algorithms to determine these reasons.” As these algorithms would need to be textual in nature, they would be bias-prone, according to the authors.

The authors also point out that VA EMR data also underestimates antiviral use yet the percentage of eligible patients who are not offered an antiviral remains considerable.

https://www.trialsitenews.com/a/overwhelming-percentage-of-va-patients-eligible-not-given-covid-19-antivirals-3f11aca2

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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Email Reveals Why CDC Didn’t Issue Alert on COVID Vaccines and Myocarditis

The nation’s top public health agency didn’t send an alert about a connection between COVID-19 vaccines and heart inflammation because officials were concerned they would cause panic, according to an email obtained by The Epoch Times.

The U.S. Centers for Disease Control and Prevention in 2021 drafted an alert about the risk of heart inflammation, or myocarditis, resulting from Pfizer-BioNTech and Moderna COVID-19 vaccines. Officials prepared to release it to the public, taking steps including having the agency’s director review the language, internal documents show.

The alert would have been sent through the CDC’s Health Alert Network (HAN), which goes to state and local officials, as well as doctors, across the country.

The alert was never sent.

In the May 25, 2021, email, exclusively obtained by The Epoch Times, a CDC official revealed why some officials were against sending the alert.

“The pros and cons of an official HAN are what the main discussion are right now,” Dr. Sara Oliver, the official, wrote in the missive. “I think it’s likely to be a HAN since that is CDC’s primary method of communications to clinicians and public health departments, but people don’t want to appear alarmist either.”

Dr. Oliver was corresponding with an employee of either Pfizer or Moderna. The employee’s name and email were redacted in the copy obtained by The Epoch Times.

Dr. Oliver didn’t respond to a request for comment. Asked about the email, the CDC didn’t address Dr. Oliver’s statement.

The “CDC’s apparent decision to not immediately issue a formal alert to clinicians warning them about the increased risk of myocarditis and pericarditis in vaccinated individuals is not only inexcusable, it’s malpractice,” Sen. Ron Johnson (R-Wis.), the top Republican on the Senate Homeland Security Permanent Subcommittee on Investigations, told The Epoch Times in an email.

“CDC should never prioritize its own public perception over the public’s health, and those who made the decision to do so must be held fully accountable.”

It remains unclear which official or officials decided not to send the alert at the time, when doctors across the country were seeing patients with myocarditis report to emergency rooms with chest pain and other symptoms.

Kim Witczak, a drug safety advocate who helped convince regulators to add a suicide warning to antidepressants, said the CDC’s move to downplay the risk of heart inflammation fits into a longstanding pattern of transparency issues with agencies and drug companies.

“I can’t even believe that this was even a discussion where they’re like, ‘We don’t want to alarm them.’ We do need to alarm people. We need people to be aware that this is a real potential [problem] that could happen,” Ms. Witzcak told The Epoch Times.

Those kinds of choices have helped erode consumer confidence in public health, she said.

Dr. Tom Frieden, a former CDC director who now serves as president and CEO of the global health project Resolve to Save Lives, also reviewed the messages.

“It is important to carefully weigh the risk of COVID-19 against the risk and benefit of any treatment, including the vaccine. The vaccine safety systems worked—they found a very rare but real signal of myocarditis soon after distributing vaccines that were administered to adolescents,“ Dr. Frieden told The Epoch Times via email. ”When public health officials see a safety signal, they must investigate whether it is ‘true’ or ‘random.’ It is important to consider multiple data angles and gather evidence from partners on the ground, including clinicians. This needs to be done quickly but carefully and thoroughly.”

Moderna, Pfizer Given Heads Up

U.S. authorities identified myocarditis and a related condition, pericarditis, before the vaccines were cleared as events that could be caused by the vaccines. People who received the Moderna and Pfizer vaccines began reporting myocarditis and pericarditis to health authorities and the vaccine manufacturers shortly after the vaccines were rolled out in December 2020.
A signal in the Vaccine Adverse Event Reporting System (VAERS), which the CDC helps manage, was triggered in February 2021, the same month that Israel warned the CDC and U.S. drug regulators of a “large number” of cases, primarily among young males.

Dr. Rochelle Walensky, the CDC’s director at the time, first addressed the issue publicly in April 2021. She falsely said the agency had seen no reports and that no signal had triggered, while disclosing that the CDC was in touch with U.S. military officials on cases among service members.

In reality, hundreds of cases had been reported to the CDC, including some that resulted in death; the CDC either missed or ignored the signal in VAERS; and the CDC helped hide a signal that emerged from a Department of Veterans Affairs system, internal documents and other data reviewed by The Epoch Times show.

The CDC did communicate to certain state officials about myocarditis issues starting in April 2021 and told some doctors in a May 14, 2021, email that the agency was monitoring reports of inflammation following Pfizer and Moderna vaccination.

Shortly after that missive was sent, the CDC began considering its next steps, according to the newly obtained documents.

Dr. Oliver emailed representatives of Moderna and Pfizer on May 21, 2021, to warn them that the CDC was planning to go public with information on the myocarditis cases.

“Wanted to make sure you were aware before anything was made public,” Dr. Oliver wrote in one of the messages, which were obtained by The Epoch Times and are being reported for the first time. “You may be aware, but there have been concerns for myocarditis seen in adolescents and young adults after receipt of the mRNA vaccines. Thankfully, the cases appear relatively mild, but there is concern that we need to make providers aware of this issue. CDC is discussing communication options, and we may have more information tomorrow.”

Cardiologists say there’s no such thing as a mild case of heart inflammation, and research has since shown that in many cases, myocarditis doesn’t resolve for months, if at all.
The Moderna and Pfizer vaccines both use modified messenger RNA (mRNA) technology.

Moderna and Pfizer didn’t respond to requests for comment.

One representative from Pfizer sent information to Dr. Oliver and colleagues ahead of a planned meeting, the emails show. The information was redacted.

Moderna officials met with the CDC on May 22, 2021. The discussion covered how the CDC was considering saying there was a “possible causal relationship,” or that the vaccines might be causing the inflammation, according to the emails.

Moderna asked how government officials thought the myocarditis was being caused, or the mechanism of action.

“My current understanding is that it isn’t necessarily a defined mechanism, but that we’ve seen very similar/consistent findings where mRNA vaccines have been used all occurring within days of receipt of an mRNA vaccine (although it could be that systemic inflammation plays a role),” Dr. Oliver wrote.

A representative with one of the companies then checked in on May 25, 2021, asking if the CDC had decided how to communicate to the public about myocarditis.

“Apologies that there hasn’t been more solid communication on this. Unfortunately, I still don’t have a firm update to share. Things have been changing rapidly here,” Dr. Oliver wrote. In the next email, she wrote that some officials didn’t want to cause panic.

“I am not trying to be vague on purpose- I really don’t know,” she said. “If I had to guess, I would think it’s likely to be a HAN, but can’t say for sure yet. I anticipate there will be firm decisions within the next 24 hours so I'll let you know.”

Scaled-Down Response

A two-page draft of the alert obtained by The Epoch Times was completely redacted. The Epoch Times is working on acquiring an unredacted copy.

The draft was circulated internally, including to Dr. Walensky, emails show. The messages indicated that the CDC chose not to send the alert after consulting with the U.S. Food and Drug Administration (FDA).

The CDC said on its website on May 20, 2021, that a review of post-vaccination myocarditis found “relatively few reports” and that rates of myocarditis “have not differed from expected baseline rates.”

Instead of the alert, the CDC decided to publish a webpage called “Clinical Considerations.” The page, published on May 27, 2021, stated that “increased cases of myocarditis and pericarditis have been reported in the United States after mRNA COVID-19 vaccination (Pfizer-BioNTech and Moderna)” since April 2021.

The page also stated that the CDC and the agency’s partners were investigating the issue before recommending COVID-19 vaccination for everyone aged 12 and older.

A draft of the page was shared with Moderna and Pfizer at least several hours before publication, according to the emails.

A CDC spokeswoman said that safety data prompted the CDC to publish information on myocarditis online “for public awareness and to provide guidance to clinicians.” She said the clinical considerations webpage reached the same 300,000 provider recipients that a HAN alert would have.

“A clinical consideration is useful when information needs to be updated as circumstances evolve, and more data is collected and evaluated,” the spokeswoman said.

In a separate email, she said that “CDC’s focus and concern on myocarditis after COVID-19 vaccination is well known and documented.”

An FDA spokesperson declined to detail its influence on the shelved alert.

“The FDA continues to work collaboratively with the CDC to monitor for known safety risks related to vaccines and determine how best to ensure any relevant safety information is conveyed to the public, health care providers and clinicians,” the spokesperson told The Epoch Times in an email. “After thorough assessment and when the potential risk was clear, the FDA updated the fact sheets for the COVID-19 vaccines and communicated with the public in a manner that was determined to be appropriate for the assessed risk.”

Federal rules require the FDA to add a warning about a “clinically significant hazard as soon as there is reasonable evidence of a causal association with a drug; a causal relationship need not have been definitely established.”
The FDA added warnings about myocarditis to the labels for the Pfizer and Moderna vaccines on June 25, 2021.

https://www.theepochtimes.com/article/exclusive-email-reveals-why-cdc-didnt-issue-alert-on-covid-vaccines-and-myocarditis-5571675?ea_src=au-frontpage&ea_med=most-read-0

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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Public Skepticism Grows in China as Officials Downplay COVID-19 Amid "Pneumonia" Outbreak

Public skepticism is growing in parts of China as health authorities attribute an ongoing pneumonia outbreak to influenza while downplaying COVID-19 infections.

Interviews with The Epoch Times with local Chinese found that the official rhetoric regarding the outbreak has been unconvincing, with many suspecting the infections are another round of COVID-19.

Residents in major cities such as Shanghai and Tianjin have reported severe infections in their communities, including “white lung” symptoms, which are typical in severe COVID-19 cases.

China’s National Health Commission spokesperson, Mi Feng, said on Jan. 14 that the current respiratory diseases are still mainly influenza, adding that the COVID-19 infection rate is low.

On Jan. 18, China’s National Influenza Center released its latest weekly influenza surveillance report, which found that the number of emergency department visits for respiratory infectious diseases in major hospitals has increased.

The main pathogen is the influenza virus, which will still be in the epidemic period over the next few weeks, according to the report.

However, as pointed out by medical experts, COVID-19 has never disappeared in China. In recent months, pneumonia infection cases soared across the country, exhibiting similar symptoms as COVID-19, with hospitals constantly overcrowded.

Chen Yun (pseudonym), a medical worker in the mega port city of Tianjin in north China, told The Epoch Times: “The government does not report, test, or manage the current epidemic, and does not take the epidemic as a priority at all.”

She said that currently, more people are suffering from white lung symptoms.

Mr. Zhang, also a Tianjin resident, told The Epoch Times that many people have been infected in this wave of the epidemic, many of whom are seriously ill and have developed white lungs.

“There must be some deaths from it, but the government just doesn’t report them,“ Mr. Zhang said. ”There are currently no beds available in hospitals; people have to wait in line for at least a day to get admitted.”

He said that both his parents were infected and were hospitalized a few days ago.

“It should be pneumonia; the chest X-ray looks pretty serious,” he said.

“After the doctor saw the chest X-ray, he said that the patient’s lung infection was quite serious, but the doctor didn’t say what virus he was infected with. In fact, they knew it but just didn’t say it,” he said.

“The doctor just said that they should be hospitalized for IV (intravenous ) treatment as soon as possible. There is no effective treatment in the hospital, and they are just putting them on IV treatment.”

Mr. Zhang said that the official media is simply not reporting on the mass infections as they should.

Mr. Chen, a Shanghai citizen, told The Epoch Times that it is now the fourth year of the COVID-19 pandemic.

He said some people around him are currently infected, and their symptoms are quite severe.

A female colleague of his, who is about 35 years old and is the mother of two children, had an infection, and half of each lung became white.

“She requested to have a chest X-ray, and the X-ray revealed the white lungs. If she hadn’t requested, the hospital wouldn’t have taken a chest X-ray for her,” Mr. Chen said.

“As for the official data, I feel there are many problems. Sometimes they say it’s influenza A, and sometimes they say it’s influenza B. I think they must be covering something up.”

Mr. Chen complained about reporting on the issue in the state-run media, adding that reports on COVID-19 infections have been mentioned but given little attention.

Mr. Chen believed the intention of such official reporting is “in the future (when the epidemic gets very serious) it will say: ‘We reported it at the beginning’. But when they made the announcement, they couldn’t say it directly and tried to downplay it. The government needs pretty data in many aspects to make it look good, so it has to fake it, and it has ways to fake the data.”

https://www.theepochtimes.com/article/public-skepticism-grows-in-china-as-officials-downplay-covid-19-amid-pneumonia-outbreak-5573535?ea_src=au-frontpage&ea_med=world-left-0

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Could Serum Protein Changes Link to Long COVID?

Could serum protein changes be the culprit behind long COVID? Could this observation done via a study of blood samples lead to possible biomarker for a long COVID diagnosis and maybe even treatments? Carlo Cervia-Hasler with University Hospital Zurich, University of Zurich and colleagues from multiple academic medical centers report the findings of a longitudinal analysis of blood serum from 113 patients who either fully recovered from COVID-19 or developed Long Covid, as well as healthy controls. Using high-throughput proteomics approaches, Cervia-Hasler et al. measured serum levels of 6596 human proteins across study participants. Those with confirmed acute COVID-19 were followed for up to a year, and their blood serum was sampled again at 6 months and at 12 months where possible. Patients experiencing Long Covid exhibited changes to blood serum proteins, indicating dysregulated activation of the complement system, altered coagulation, and tissue injury, suggesting ongoing thromboinflammatory responses.

The Problem

Approximately 20% of patients diagnosed with COVID-19 and about 5% of all SARS-CoV-2–infected persons develop lingering symptoms, called Long Covid, that can persist for many months. Symptoms of Long Covid can include fatigue, post-exertional malaise, and cognitive impairment, and involve multiple organs. Although previous studies have shown that patients with Long Covid display signs of immune dysfunction, persistent immune cell activation, and autoimmune antibody production, the root cause of Long Covid is poorly understood, and diagnostic biomarkers for the condition aren’t well defined. Currently, Long Covid also lacks an effective treatment.

Study Findings

In this latest study published in the November 2022 study in Science Translational Medicine investigators identified persistent neutrophil-associated immune signatures in pulmonary Long Covid.

The study’s authors demonstrate that at the cellular level, the thromboinflammatory signature associated with Long Covid was linked with increased monocyte-platelet aggregates.

Dysregulation of complement proteins may contribute to the thromboinflammation associated with Long COVID. The findings of the study identify potential biomarkers for Long Covid and new treatment strategies that warrant further diagnostic and therapeutic investigation. “Although therapeutic interventions with coagulation and complement inhibitors in acute COVID-19 produced mixed results, the pathological features specific for Long Covid suggest potential interventions for clinical testing,” writes Wolfram Ruf in a related Perspective.

https://www.trialsitenews.com/a/could-serum-protein-changes-link-to-long-covid-c0fa567f

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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COVID Vaccines Could Trigger Vasculitis, Damaging Multiple Organs

Various diseases associated with COVID-19 vaccines have been reported. A recent case study indicated that COVID-19 vaccination may trigger the development of anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis, potentially damaging multiple organs. Among 29 patients, five underwent plasmapheresis treatment (the separation and replacement of plasma from blood), and five relied on dialysis therapy.

ANCA-associated vasculitis can cause damage to small blood vessels. Since these are distributed throughout the body, any part of the body can be affected, with the most common areas being the lungs, kidneys, joints, ears, nose, and nerves.
Neutrophils are a type of white blood cell that aids the body in fighting infection and healing injuries. ANCA are harmful autoantibodies that bind to neutrophils in the blood, releasing toxic substances and damaging the walls of small blood vessels. This can also result in the migration of neutrophils through blood vessel walls, inducing inflammation in the surrounding tissues. Additionally, it releases signaling factors that attract even more neutrophils, perpetuating inflammation and further damaging small blood vessels.

Case Report of ANCA-Associated Vasculitis

A case report published in Case Reports in Nephrology in April 2023 detailed an 82-year-old woman with high blood pressure who, after receiving her third booster COVID-19 vaccine booster, developed myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA)-associated vasculitis. MPO-ANCA is one of the primary autoantibodies in ANCA-associated vasculitis.

The patient received two doses of the Pfizer vaccine in May and June 2021, followed by a Moderna booster shot in early February 2022. The next day after the booster shot, she experienced a headache, which subsided after three days. However, starting in early March, her body temperature began to rise, accompanied by general malaise.

Upon examination, no apparent bacterial infection was found, but blood tests revealed an inflammatory reaction. The C-reactive protein level was elevated, and her white blood cell count was 13,000/microliters (the normal range is between 4,000 and 10,000/microliters), suggesting a bacterial infection. The doctor prescribed antibiotics for seven consecutive days, but there was no improvement.

The patient was later admitted to the hospital. Physical examination and imaging tests did not reveal fever, and kidney size and structure appeared normal. However, microscopic analysis uncovered hematuria (blood in the urine) and urinary protein. Additionally, the MPO-ANCA level was notably high. A kidney biopsy revealed cellular crescents in six glomeruli—the tiny filters inside the kidneys—and mild inflammation.

Furthermore, immunofluorescence confirmed pauci-immune glomerulonephritis. This is a rare small vessel vasculitis associated with rapidly progressive glomeruli inflammation, clinically characterized by kidney issues such as urinary abnormalities (hematuria and proteinuria) and high blood pressure resulting in kidney failure within days or weeks. Based on the pathological findings, the patient was diagnosed with renal-limited MPO-ANCA-associated vasculitis.

The patient was put on a steroid medication, and symptoms such as fever, malaise, and inflammatory reaction improved, while both hematuria and urinary protein disappeared. The doctor gradually reduced the steroid dosage, cutting it in half, and the patient’s condition stabilized.

The researchers stated that blood and urine tests conducted on the patient before her third vaccine dose did not reveal kidney damage or abnormalities, suggesting an association between the COVID-19 vaccine and the onset of MPO-ANCA-associated vasculitis.

The researchers suggested that the possibility of MPO-ANCA-associated vasculitis should be considered for patients experiencing fever, prolonged general malaise, hematuria, or kidney impairment after receiving a COVID-19 mRNA vaccine, especially Moderna, as was the case with this patient.

5 COVID-19 Vaccines Related to ANCA-Associated Vasculitis
An increasing number of reports indicate that widespread vaccination has led to the development of vasculitis in some people, resulting in damage to multiple organs.

A case-based review reported five types of COVID-19 vaccines linked to ANCA-associated vasculitis.

The study included cases from 29 patients, with 22 receiving mRNA vaccines (Moderna and Pfizer), four receiving AstraZeneca, two receiving Covaxin, and one receiving Johnson & Johnson. They all exhibited symptoms of ANCA-associated vasculitis after receiving one of these COVID-19 vaccines.

Specifically, 22 patients exhibited kidney damage, manifested as new-onset or recurrent glomerulonephritis. At least 24 individuals presented with hematuria. Ten experienced lung damage, with five cases involving alveolar hemorrhage. One person developed optic neuritis, and another had auricular chondritis. These are manifestations of organ damage following vaccine administration.

Most patients received immunosuppressive treatment, including steroid medications. Additionally, five underwent plasma exchange, and at least five patients continued to rely on dialysis at the last follow-up.

The study mentioned that mRNA vaccines may stimulate myeloid and dendritic cells to varying degrees, activating downstream pathways to generate autoinflammation. Furthermore, mRNA vaccines generate antiviral-neutralizing antibodies and activate CD8+ and CD4+ T cells, triggering strong immune responses. Compared to natural infection, mRNA vaccines may enhance innate and acquired immunity stimulation. In some individuals with compromised immune systems, the ability to clear nucleic acids may decrease, potentially impacting neutrophils.

Vasculitis May Lead to Multiorgan Damage

There are different types of ANCA-associated vasculitis, including microscopic polyangiitis, where the frequency of MPO-ANCA positivity is notably high.

According to data from the Japan Intractable Diseases Information Center, approximately 70 percent of patients with microscopic polyangiitis experience systemic symptoms, including fever, weight loss, and fatigue. Additionally, symptoms such as hemorrhage, ischemia, or infarction in body tissues may occur.
Necrotizing glomerulonephritis is the most common, presenting with symptoms like hematuria, protein in urine, and elevated serum creatinine.

Early diagnosis is crucial, as the condition often progresses rapidly to kidney failure within weeks to months. Other prevalent manifestations include rash, with livedo reticularis, purpura, skin ulcers, and subcutaneous nodules in approximately 60 percent of patients with necrotizing glomerulonephritis. Polyneuropathy is observed in about 60 percent, joint pain in around 50 percent, and muscle pain in roughly 50 percent of cases.

Additionally, interstitial pneumonia is seen in approximately 25 percent, and alveolar hemorrhage in about 10 percent. Both conditions are attributed to vasculitis affecting the pulmonary capillaries, leading to cough, shortness of breath, rapid breathing, coughing up blood, bloody sputum, and severely low blood oxygen levels. Gastrointestinal involvement occurs in around 20 percent of cases, and myocardial involvement resulting in heart failure occurs in approximately 18 percent.

ANCA-associated vasculitis can be life-threatening if not promptly treated. Early diagnosis and appropriate treatment lead to improvement in the majority of cases. However, delayed treatment or poor response to initial therapy may result in irreversible organ dysfunction, necessitating procedures such as blood dialysis for patients experiencing kidney failure. Moreover, due to the possibility of symptom recurrence, patients should undergo regular checkups with specialists.

https://www.theepochtimes.com/health/covid-vaccines-could-trigger-vasculitis-damaging-multiple-organs-5563233

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Senator Rand Paul Says Dr. Anthony Fauci “Should Go to Prison”

Senator Rand Paul and Dr. Anthony Fauci have a history. The senator from Kentucky has grilled the former chief medical advisor to the president and head of the National Institute of Allergy and Infectious Diseases (NIAID) multiple times. Paul has questioned Fauci over everything from royalties to the National Institutes of Health (NIH) for research grants and questioning the former NIAID head about the validity and vaccine risks of Covid boosters for children. Senator Paul has gone as far as writing a letter to the Department of Justice accusing Fauci of perjury. Paul claims Fauci lied to Congress regarding funding for the Wuhan Lab in China. Now, the senator is claiming Fauci deserves to go to prison.

Paul says Fauci is “dishonest”

“For his dishonesty, frankly, he should go to prison,” said Paul in an interview. “Do you think the scientific knowledge that was gained from this research was worth the deaths of 20 million people?” In June of 2023, the Government Accountability Office issued a report that said the NIH had contributed more than $1.4 million to Chinese research institutions between 2014 and 2019, in spite of biosafety concerns. This included the Wuhan Lab. Fauci denied, in testimony to Congress, the NIH-funded gain of function research in China.

Paul is astounded Democrats still treat Fauci as a “medical messiah” and protect him. Paul believes Fauci is a “symbol of big government.” “He’s never been held responsible,” says Paul. The senator added, “History should judge him as a deficient person who made one of the worst decisions in public health history — in the entire history of the world.” For his part, Anthony Fauci responded by saying putting him in jail is “irresponsible,” and he doesn’t have a response to this “craziness.” “I mean, prosecute me for what? What are they talking about? I mean, I wish I could figure out what the heck they were talking about. I think they’re just going off the deep end.”

Fauci “Doesn’t Recall”

In early January, Fauci testified in front of the House Select Subcommittee on the Coronavirus Pandemic. Fauci’s testimony was behind closed doors, but Congressman Brad Wenstrup (R-Ohio), chairman of the subcommittee, said in a statement after the first day of testimony the interview had uncovered “drastic and systemic failures in America’s public health systems.”

The chairman was also surprised by how much Fauci said he “doesn’t recall” about the early days of the Covid outbreak. Senator Paul jumped on the fact Fauci couldn’t recall. “A guy that’s smart enough to think that he can shut down the schools, shut down the economy, force everybody to get vaccinated, including children, including people who have already had COVID, including the military – we had mandates everywhere, and he was all for them – yet he can’t recall how the decision-making went or what the science is to support this,” Paul said.

Wenstrup’s statement added, “Dr. Fauci’s transcribed interview revealed systemic failures in our public health system and shed light on serious procedural concerns with our public health authority. It is clear that dissenting opinions were often not considered or suppressed completely. Should a future pandemic arise, America’s response must be guided by scientific facts and conclusive data.”

During the pandemic TrialSite came across various documents and artifacts that certainly contributes to the evidentiary weight of the lab leak hypothesis. According to interactions with the Department of Defense’s research arm (DARPA), they could not deny a memorandum summarizing the American origin of SARS-CoV-2. In an email interaction the head of communications for DARAP informed TrialSite while they could not verify or deny the veracity of the memo they could go on the record that they were not funding EcoHealth Alliance, the nonprofit that Fauci has a record of helping to fund. Of course, EcoHealth Alliance served as a way to outsource what was likely gain-of-function research to the Wuhan Institute of Virology.

How could Fauci not know?

Author Says US Needs a “Pentagon” for Diseases

Donald G. McNeil, Jr., the author of “The Wisdom of Plagues: Lessons from 25 Years of Covering Pandemics,” claims what is needed now is a Pentagon for disease. “I’ve reported on pandemics and plagues for nearly three decades in over 60 nations, and one thing has become unquestionably clear: our greatest flaw in the battle against disease is that, below the president, no one is in charge.” McNeil points out when a pandemic occurs too often it “becomes mired in denialism, fatalism, bigotry, rumormongering, profiteering and partisan politics.”

McNeil goes further by saying there is no provision in the Constitution for Health. Too often, it’s left to local governments and private industry. According to McNeil, private industry needs to be incentivized but also has to be reined in so it doesn’t prioritize profits over people’s lives. Also, hospitals have to be reorganized, resources have to be moved to the front lines, and McNeil advocates for the drafting of doctors. Additionally, the author says the director of the Centers for Disease Control (CDC) should not be a political appointee. But McNeil adds, given the polarization of the United States he “despairs” about the country’s ability to adopt new thinking.

https://www.trialsitenews.com/a/senator-rand-paul-says-dr.-anthony-fauci-should-go-to-prison-2d785b15

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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Injuries and Deaths Associated With the Very First Vaccines

Injurious side-effects were not always rare

This is Part 3 in the series “Revisiting the Historical Vaccines”
In this series, we will explore the multifaceted history of vaccines, examine historical data, and seek a nuanced understanding of vaccine efficacy and safety.

Deaths and injuries linked to vaccines were not only observed after the mass COVID-19 vaccination. There are records of severe adverse events since the first vaccines in human history were developed.

Deaths and Severe Injuries After Vaccination

The journey of smallpox vaccination, dating back to the late 18th century, is marred by numerous accounts of adverse effects and complications. Severe complications such as progressive vaccinia, an infection resulting from the vaccine virus itself, eczema vaccinatum, and encephalitis were rare yet grave adverse effects.
Official records from England from 1859 to 1921, as documented by J.T. Biggs in the 1912 book “Leicester: Sanitation versus Vaccination,“ reveal the disconcerting trend of vaccination-related complications that led to approximately 1,530 deaths directly attributed to the smallpox vaccine.

Notably, in the period from 1906 to 1922, the mortality rates from both smallpox and vaccination-related deaths were alarmingly similar.

The table, sourced from the Annual Returns of the Registrar-General, as recorded in Biggs’ book, was considered an indicator rather than a comprehensive record, omitting permanent or severe injuries.

It is well noted in the table above that due to the enforcement of vaccination, the nomenclature of the adverse events post-vaccination was limited to “cowpox” from 1898 through 1910. The causality of the smallpox vaccine in these death cases was further strengthened by a report in 1897 referring to the 36 deaths reported for that year as directly attributed to the effects of vaccination. Furthermore, the cause of death was either clearly stated in the medical certificate or was confirmed by investigation.

In June 1902, Dr. W. J. J. Stewart reported that out of 587 vaccinated men at Gore Farm Lower Hospital, over 28 percent ended up on sick leave as a result of vaccination, a significant finding not publicly disclosed. These individuals received public sick pay, and contractors were compensated for their loss of services.

“Fresh vesicles subsequently formed around the vaccination pocks coalescing with them and causing them to spread. They also developed on the face, head, body, and in the mouth; the [latter] prevented the child from suckling, and it died exhausted on the 45th day after vaccination. (Case of a healthy child after vaccination, March 13, 1891.)” This child was likely to die of a progressive form of disease following the vaccination.

The vaccine’s potential to cause serious harm was further underscored by specific cases of erysipelas, a severe form of skin infection resulting in a painful and prolonged death. Instances included a 13-week-old infant succumbing to “general erysipelas after vaccination” and a 4-month-old girl dying from the same condition post-vaccination. These cases were not isolated incidents but were part of a broader pattern of severe reactions to the smallpox vaccine, likely caused by the numerous pathogens the vaccine carried that led to severe skin infections.

Eczema vaccinatum, another serious condition linked to the vaccine, presented further evidence of the risks associated with smallpox immunization. In one case, a 15-month-old boy tragically died after developing this condition following his vaccination. This was likely caused by the inflammatory cytokines in those so-called “pure lymph” or other types of smallpox vaccines.

Encephalitis following vaccination, though uncommon, often results in fatalities, particularly in babies and young children. The death rate in reported cases varies between 9 to 40 percent. Unfortunately, 10 to 25 percent of those who survive this condition suffer from lasting neurological damage.

A 2003 systematic review of the risk for serious complications and death from smallpox vaccination in the United States from 1963 to 1968 found post-vaccinial encephalitis and vaccinia necrosum had life-threatening complication rates of at least 3 per million and 1 per million primary vaccinations, respectively. The death rate was 29 percent for post-vaccinial encephalitis and 15 percent for vaccinia necrosum cases.

Similar to smallpox vaccine failures, current COVID-19 “vaccine” issues involve adverse effects that are also closely linked to the components of the vaccine, including blood clots, brain bleeds, myocarditis, pericarditis, aggressive cancers, and autoimmune diseases.

‘The Heighth of Absurdity’

In a 1900 letter to the editor of “The Medical Brief,” Dr. Harman, a medical doctor, stated that introducing cowpox poison into the bloodstream of a healthy person was not only flawed logic but risky. “It would be the heighth of absurdity” to administer medicine to a person in good health and claim to prevent a disease they did not contract, he said.

The book ”The Value of Vaccination: A Non-Partisan Review of Its History and Results“ by Dr. George William Winterburn cited the following report from the March 4, 1882, Washington National Board of Health Bulletin:

“Our town authorities have employed a physician to vaccinate all persons who present themselves for the purpose.

“The result has been fearful. Nearly everyone vaccinated has suffered from Erythema or Erysipelas, the arms swollen from shoulder to wrist, and the point of puncture [where the person was vaccinated] presenting the appearance of sloughing ulcer [a separation of dead from living tissue], discharging freely sanious pus [blood and pus]. Many of the sufferers have been confined to bed, with high fever, from five to ten days, requiring the constant application of poultices [medicated treatment] to the arm, and the free use of morphia [morphine] for the relief of pain.

“Those who have tried it tell me they would much prefer to have smallpox.”

Ladies Played a Role

Regardless of the controversies over the effectiveness and safety of the smallpox vaccines, the vaccines were forced upon healthy people anyway. The first campaign for global smallpox vaccination took place from 1803 to 1813.

Smallpox was not only the most significant cause of blindness in the population, but it also left survivors with pockmarks. These physical aftereffects were particularly significant for women, as societal norms at the time placed a high value on a woman’s appearance. Smallpox scars could seriously diminish a young woman’s prospects for marriage, which was a critical aspect of a woman’s social and economic stability during that period.

The article “Jenner’s Ladies: Women and Vaccination against Smallpox in Early Nineteenth-Century Britain” by Michael Bennett highlights the significant role played by women in making vaccination fashionable and widely accepted in the early 19th century. They sponsored and encouraged vaccination through voluntary societies and used their influence in their respective spheres to promote this new prophylactic.

For example, Mrs. Bayley of Hope Hall near Manchester made a notable contribution by vaccinating the poor and offering a monetary reward to anyone who caught smallpox after her vaccinations.

In another instance, Dr. Lettsom highlighted that “ladies of rank” had vaccinated 30,000 children by the end of 1805. This is an aspect of medical history that has not been extensively studied.

Leicester Opposition

Although claimed to be infrequent, these complications presented a significant challenge in the widespread acceptance and administration of the vaccine.

The English government began enforcing mandated smallpox vaccination in the mid-19th century, specifically 1840 and 1853.

Despite high vaccination rates, a severe smallpox epidemic struck in the small manufacturing town of Leicester and other parts of England in the early 1870s, resulting in 3,000 cases and 358 deaths in Leicester alone. This led to public skepticism about the efficacy of vaccination, as reflected in an 1884 letter published in the Leicester Mercury newspaper.

Contradictorily, the government intensified its vaccination efforts, employing officers to prosecute those refusing to vaccinate their children. Opposition to vaccination was fueled by numerous instances of severe health complications and fatalities following vaccination. One notable case involved Arthur Ward, whose two children were harmed by vaccination; he refused further vaccination for his other child and faced legal penalties.

Despite serious health risks, the government’s unwavering support for mandatory vaccination spurred widespread revolt. Thousands protested in Leicester, drawing participants from various English countries and diverse professions. The demonstration was grand, with music, banners, and flags bearing messages championing liberty and criticizing vaccination. The procession, stretching 2 miles, received enthusiastic support from townspeople.

The scale of the protest, with attendance estimated between 80,000 to 100,000, signified a major public stance against compulsory vaccination. The event was led by Mr. Councillor Butcher of Leicester and included speeches and resolutions advocating personal liberty and parental rights. An evening meeting, attended by delegates from over 60 towns, further solidified the demonstration’s success.

Dr. Spencer T. Hall, a senior participant, expressed profound joy at the challenges to vaccination. This historical event marked a significant moment in public health, where thousands courageously opposed a prevailing medical belief and stringent government regulations, advocating for self-determination in health decisions.

70 Years of Laboratory Manipulation

According to modern vaccine quality standards, there are valid reasons to question the safety and efficacy of the smallpox vaccine, which has been highly praised for eradicating smallpox. The precise components of the smallpox vaccines remain a mystery.
The modern smallpox vaccine has gone through three generations of development. The first and second generations of the vaccine, developed between the 1950s and 1970s, used original live viruses grown on animal skin or in cell cultures. These versions carried a higher risk of severe or life-threatening side effects, including 1 to 2 fatalities per million vaccinations, 3 to 9 cases of postvaccinal encephalitis, 1 to 7 instances of progressive vaccinia, and 2 to 35 cases of eczema vaccinatum.

Because the viruses contained in the smallpox vaccine were still alive, they had to be maintained in lab animals and cell cultures. People may not be aware that modern smallpox vaccines have a complex 70-year history of passage in various laboratory animals, including rabbits, mice, goats, and cows, to make the modern attenuated smallpox vaccines.

This may be the first example in human history of the initial types of laboratory manipulation of a virus later used for vaccination.

For example, the most widely used Dryvax vaccine was from calf lymph derived from the New York City Board of Health strain. Dryvax, a vaccine licensed in the United States, is a lyophilized (freeze-dried), live-virus preparation of the infectious vaccinia virus, which was thought to play a significant role in eradicating smallpox.

Third-generation vaccines utilized attenuated strains of vaccinia and had limited usage before smallpox eradication. These vaccines have relatively milder side effects due to weakened virus strains, replacing Dryvax.

A Complex ‘Broth’ of Viruses

In the late 1990s, when researchers studied the genetic components of vaccines via advanced gene sequencing tools, they discovered that Dryvax was far more complex than initially thought.

The study suggested that Dryvax was made up of many different viruses. The sequencing identified an evolving mutation pattern, with some genes highly fragmented and others disrupted in specific strains.

The study emphasized the significant complex nature of the Dryvax vaccine, highlighting the huge impact of human laboratory interventions on orthopoxvirus populations (viruses that cause poxvirus diseases such as smallpox, cowpox, and monkeypox).

Even modern smallpox vaccines do not contain cowpox or smallpox virus but are a hybrid human and animal agent that never existed in nature until the era of vaccination. This is similar to the story of COVID-19 and the profound impact of human research on the evolution of wild-type viruses, drawing parallels to the origin of the SARS-CoV-2 virus responsible for the COVID-19 pandemic.

The COVID-19 virus has far more advanced gene editing technologies responsible for the origin of the SARS-CoV-2, while the smallpox vaccine used a simpler method of virus culture.

Propagating a False Narrative

The smallpox vaccine has been described as a magical medical invention. However, a closer look at the historical data reveals a more nuanced story of the disease’s prevalence and mortality, as well as the impact of the vaccine.

Nevertheless, this narrative was devised over hundreds of years. Propagating such a narrative is easier when there’s limited access to historical documentation of deaths and injuries after smallpox vaccination. This has made examining the causal relationships between the natural smallpox waves and the vaccination campaigns nearly impossible.

People also tend to trust public health authorities who have made this the official narrative. We have the same problem today with the COVID-19 narrative, which has been easier to propagate with control over the media.

https://www.theepochtimes.com/health/injuries-and-deaths-associated-with-the-very-first-vaccines-5541947

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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A pandemic mea culpa from Francis Collins

IT COMES three years too late. But Francis Collins, the former head of the National Institutes of Health, has finally admitted that the COVID-19 lockdowns caused a massive amount of harm — harm to which he and other government public-health experts, such as Anthony Fauci of the National Institute of Allergy and Infectious Diseases, were oblivious because they were obsessed with doing things their way.

The mea culpa came last summer during a conversation hosted by Braver Angels, an organization that promotes dialogue among Americans with sharply different ideologies and political loyalties. Collins, who as NIH director played a central role in shaping Washington's response to COVID-19, was paired with Wilk Wilkinson, a Minnesota trucking manager and podcast host who strongly opposed how government officials addressed the pandemic. The 90-minute exchange, moderated by Boston College professor Martha Bayles, was recorded six months ago but only recently attracted attention when excerpts were posted on social media.

The whole conversation was interesting, but one segment in particular was jaw-dropping. Collins described with remarkable candor just how narrow-minded, how willfully myopic, he and other high-level public health officials had been as they dealt with the crisis.

"As a guy living inside the Beltway, feeling the sense of crisis, trying to decide what to do in some situation room in the White House with people who had data that was incomplete, we weren't really thinking about what that would mean to Wilk and his family in Minnesota a thousand miles away from where the virus was hitting so hard," confessed Collins, who retired from the NIH at the end of 2021. "We weren't really considering the consequences in communities that were not New York City or some other big city."

That was a stunning admission. What he said next was even more scandalous.

"If you're a public health person and you're trying to make a decision, you have this very narrow view of what the right decision is, and that is something that will save a life. Doesn't matter what else happens. So you attach infinite value to stopping the disease and saving a life. You attach zero value to whether this actually totally disrupts people's lives, ruins the economy, and has many kids kept out of school in a way that they never recover from."

"Collateral damage," said Wilkinson.

"Collateral damage," Collins agreed. He and his colleagues were locked in what he now concedes was the "public health mindset" — a monomaniacal approach that blinded them to the injuries they were causing. "A lot of us had that mindset, and that was really unfortunate."

Was it ever.

As early as March 2020, Fauci recommended a nationwide lockdown and called for a "dramatic diminution of the personal interaction" in daily activities. He warned that "life is not going to be the way it used to be in the United States," while insisting that was "best for the American public." Collins said at the time that the only correct approach was "one that most people would find to be too drastic because otherwise it is not drastic enough."

Now, of course, it is far too late to mitigate any of the pain endured by millions of Americans hurt by the government's high-handed edicts and recommendations. Those curbs and controls began with the declaration of a federal emergency and travel ban, which in turn spurred many states to order their own restrictions.

The coast-to-coast lockdown destroyed tens of millions of jobs and at least 200,000 small businesses. It exacerbated numerous social ills, worsened mental illness, and took a deadly toll in missed cancer diagnoses and untreated heart disease. The prolonged school closures inflicted unprecedented damage on children. The social distancing and mask mandates were enforced with a ruthlessness that at times turned despotic. And countless men and women — from ordinary citizens to noted epidemiologists to elected state officials — found themselves demonized, censored, or shunned for challenging those who attached "zero value" to their concerns.

All this damage was caused not by the pandemic but by politicians who abdicated their judgment and left it to public-health experts. Whether out of panic, pigheadedness, or perversity, they declined to balance costs against benefits, a basic function of policymaking. Instead, they insisted they would "follow the science" — as though scientists were endowed with an infallible road map to navigate COVID's complex interplay of disease, economics, education, psychology, and politics in a nation of 330 million people.

The great economist and social historian Thomas Sowell has often observed that "there are no solutions, there are only tradeoffs." That is a fundamental reality in all policymaking. There are pros and cons to everything government does. For officials responding to the pandemic, there can hardly have been a more shocking intellectual failure than the one to which Collins now confesses: attaching "infinite value" to stopping the disease and no value at all to everything else.

The same sort of thinking can be a pitfall in many other areas. Focus on reducing fossil fuel use at any price, for example, and the results will be stunted economic growth and continued misery for many of the world's poorest people. Assign maximum importance to achieving racial diversity in student admissions and the result is affirmative action preferences so lopsided that they violate the Constitution. Allow the prevention of another 9/11 to override every other consideration, and the CIA ends up torturing prisoners in secret "black sites" beyond the reach of law.

From crime to homelessness to addiction to national defense, there are always costs to be weighed against benefits. And if acknowledging tradeoffs is indispensable to the work of government, it is especially so at times of crisis.

Toward the end of the Braver Angels conversation, Collins acknowledged another way in which he and many of his inside-the-Beltway colleagues blundered.

It was folly, he said, to think that Washington knew what was best for the whole nation. "The fact that we could put blanket recommendations across this incredible wide, broad, and diverse country and expect them to be right . . . obviously could not have been correct. And yet that's what was done."

COVID-19 would have been a terrible destroyer in any case. But it was made all the more catastrophic by the failure of politicians and experts who not only were sure they knew best but were unwilling even to consider other views. Americans' respect for public-health experts took a beating during the pandemic, and it is a black mark on Collins's legacy that he was so complacent about the harm the government's policies caused. For belatedly admitting where he went wrong, he certainly deserves credit. Let him continue to speak out, to warn other scientists against falling into the same trap, and he'll deserve a lot more.

https://jeffjacoby.com/27499/a-pandemic-mea-culpa-from-francis-collins

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UK Covid Inquiry Put on Hold

The Covid Inquiry in the United Kingdom initially looked like it was going to be just “window dressing”. The Inquiry, which began at the end of May in 2023, as an independent public investigation with many of the government ministers wanting trying to stop or dodge questioning. The Inquiry is headed by Baroness Heather Hallett, a former Court of Appeal Judge. The important aspect of the Inquiry is that it exists. In December of last year, alternative viewpoints to Covid and the vaccine were heard along with politicians, specifically testimony from former Prime Minister Boris Johnson. Johnson admitted mistakes in his handling of the pandemic but that he did his “level best” at the time. Now, it appears the UK Covid Inquiry is on “hold.”

Public Hearings Postponed

Last week, the UK COVID-19 Inquiry issued a statement formally announcing the Inquiry will be “rescheduled”. The hearings were scheduled to take place in the summer of 2024, but will now happen at a later date to allow organizations time to “prioritize” their materials for the inquiry’s third investigation on the impact of the pandemic.

Baroness Hallet, the chair of the Inquiry, said she knows people are disappointed with the postponement but said more time was needed to prepare for a separate investigation on how the pandemic impacted the British National Health Service (NHS). "I want to ensure our hearings in 2024 are as effective as possible and I recognize the increasing pressure on organizations to respond to requests and provide information to the inquiry," the Baroness said. "I remain committed to not allowing the inquiry hearings to run beyond my original aim of summer 2026," she added.

Different “Phases”

The UK Covid Inquiry has been split up into different phases. The first phase, which started in 2023, was set up to gather evidence in the planning for the pandemic. The findings and recommendations of this phase are due this summer. The second phase is looking at how political decisions were made after the Covid pandemic hit Britain. The second phase started in London in October of 2023, and will travel to the rest of the UK to collect evidence.

Public hearings will start again this September, to look at the impact the pandemic had on the NHS. There is also an investigation into vaccines which will cover the safety of the Covid jabs and the link between the serums and heart ailments. The investigation will cover whether reforms are needed. No timetable has been set for the return of the hearings, but the Inquiry has promised more details in the “coming weeks.”

Politics

The political implications of the Inquiry could influence the next election in Britain. First, Simon Case, the current cabinet secretary for the Conservative government, is expected to testify in a special hearing in the spring. Reportedly, Case was critical of British ministers during the pandemic and had said former Prime Minister Boris Johnson was “unable to lead.” Second, the publication of the independent Inquiry could cause election problems for British Prime Minister Rishi Sunak. The findings could reveal how the government was obsessed with Brexit and the pandemic was downplayed.

Already, former ministers have criticized the UK Covid Inquiry. Former Health Minister Lord Bethell complained the investigation was too focused on “office tittle tattle”. Reportedly, Bethell was involved in negotiating “controversial contracts.”

Rivka Gottlieb, a spokesperson for the COVID-19 Bereaved Families, UK said, the Inquiry’s findings “must be released as soon as possible so they can be put into action to protect us from a future pandemic.” Unfortunately for those most in need, such as individuals struggling with injuries or long COVID it will likely be too little too late, in other words, window dressing.

https://www.trialsitenews.com/a/uk-covid-inquiry-put-on-hold-2d0bb420

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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