Large 4.1m FDA Study Confirms small but significant Myocarditis/Pericarditis and Seizure Safety Signals in Young People

The results depend heavily on diagnostic accuracy, which can certainly not be assumed

Researchers from the Food and Drug Administration (FDA) as well as major pharmacy retail chains, payers and data-based companies investigated whether statistical signals detected health outcomes post-vaccination with ancestral COVID-19 vaccine in children aged 6 months to 17 years. Part of an active safety monitoring program involving COVID-19 vaccination, a bid to detect rare outcomes not identified in clinical trials involved researchers from the FDA, CVS Health/Aetna Blue Bell, Optum Epidemiology (part of UnitedHealthcare), IQVIA, Acumen LLC and Carelon Research led by Patricia C. Lloyd, Ph.D., ScM of the FDA.

An FDA-sponsored clinical trial with results published in the journal JAMA Network, the cohort study evaluated 21 prespecified health outcomes post-exposure before early 2023 to Pfizer (BNT162b2), Moderna (mRNA-1273), or Novavax (NVX-CoV2373) ancestral monovalent COVID-19 vaccines in children aged 6 months to 17 years by applying a near-real-time monitoring framework using healthcare data from three commercial claims databases in the US (Optum [through April 2023], Carelon Research [through March 2023], and CVS Health [through February 2023]).

Lloyd and colleagues analyzed and reported on increased rates of each outcome after vaccinations were compared with annual historical rates from January 1 to December 31, 2019, and January 1 to December 31, 2020, as well as between April 1 and December 31, 2020. The study involved 4,102,016 vaccinated enrollees aged 6 months to 17 years. 2,058,142 (50.2%) of the total were male, and 3,901,370 (95.1%) lived in an urban area.

Thirteen of 15 sequentially tested outcomes failed to meet the threshold for a statistical signal. However, as was reported on with the group’s preprint, statistical signals were detected for myocarditis or pericarditis after BNT162b2 vaccination in children aged 12 to 17 years plus seizure after vaccination with BNT162b2 and mRNA-1273 in children aged 2 to 4 or 5 years.

Conducting a post hoc sensitivity analysis, the study team reported that the statistical signal for seizure was observed only after exposure to the Moderna vaccine (mRNA-1273) when 2019 background rates were selected; no statistical signal was observed when 2022 rates were selected.

Real-Word Data

This study team tapped into what is known as a form of real-world data, from commercial administrative health claims including Optum (UnitedHealth and affiliated health plans), Carelon Research (Elevance Health, formerly Anthem, and affiliated health plans), and CVS Health (Aetna and affiliated health plans).

These databases contain longitudinal medical and pharmacy claims data supplemented with vaccination data from participating local and state Immunization Information Systems. Such sources are nationally representative of the commercially insured population aged 0 to 64 years and provide comprehensive capture of medical services submitted for insurance reimbursement.

Other factors make this a robust study. Broad geographical coverage across 3 commercial health insurance databases with vast representation across America. The commercial data (claims) were supplemented with immunization information systems data plus medical records reviews.

Findings

An FDA statistician since 2021, corresponding author Patricia C. Lloyd, and colleagues report on the study involving 4,102,016 vaccinated individuals aged 6 months to 17 years, with 3,920,563 (95.6%) receiving BNT162b2 vaccination, 174,427 (4.3%) receiving mRNA-1273, and 53 (<0.1%) receiving NVX-CoV2373.

As depicted above, a total of 8,444,?355 ancestral monovalent COVID-19 vaccine doses were administered to young people, including 8,121,591 BNT162b2 doses (dose 1: 3,843,778; dose 2: 3,235,442, dose 3 or monovalent booster: 1,033,036, and unknown or unclear: 9335), 322,628 mRNA-1273 doses (dose 1: 173,857; dose 2: 140,734; dose 3 or monovalent booster: 5284; and unknown or unclear: 2753) administered to children aged 6 months to 17 years, as well as 136 NVX-CoV2373 doses (dose 1: 63; dose 2: 43; dose 3 or monovalent booster and unknown or unclear: 30) administered to children aged 12 to 17 years.

Sequential Testing

Of the established 15 outcomes that the study team sequentially tested, two (2) outcomes met the statistical threshold for a signal, including myocarditis or pericarditis in children aged 12 to 15 years and 16 to 17 years, and seizure in children aged 2 to 4 or 5 years.

The study team found statistical signals for myocarditis or pericarditis during the primary analysis after Pfizer-BioNTech (BNT162b2) COVID-19 vaccination among children aged 12 to 15 years and 16 to 17 years in all three commercial databases.

The authors report dose-specific statistical signals for 1 or more definitions of the outcomes detected in children aged 12 to 17 years after dose 1, dose 2, and dose 3 of BNT162b2 vaccine in at least 1 of the 3 databases. See eTable 8 in Supplement 1.

According to Lloyd and colleagues:

“In the primary analysis, seizure met the statistical threshold for a signal in children aged 2 to 4 years after BNT162b2 vaccination in all 3 databases and in children aged 2 to 5 years after mRNA-1273 vaccination in 2 of the 3 databases. Dose-specific statistical signals for seizure were detected in 2 of the 3 databases after dose 1 and dose 2 BNT162b2 vaccination in children aged 2 to 4 years and after dose 2 of mRNA-1273 vaccination in children aged 2 to 5 years.” Again, see eTable 8.

Signal Characterization

The authors report 72 observed seizure cases among children aged 2 to 4 or 5 years; 51 (70.8%) of these cases met the definition of febrile seizures. Lloyd and the team found no differences in rates of seizure by sex. Based on the timing of cases, the team reports no indication of substantial clustering with cases distributed across the 0- to 7-day risk window; 23 (31.9%) of the seizure cases occurred within the 0- to 1-day period after COVID-19 vaccination. The median (IQR) time between vaccination and diagnosis of seizure was 2 (1-5) days.

Selection of comparator rates impacted statistical signals for seizure. For instance, when evaluating annual background rates of seizure demonstrates rates used in the primary analyses (2020) were lower than rates in 2022 and 2019.

“Background rates in 2022 and 2019 ranged from approximately 2.2 to 2.4 times and 1.7 to 1.9 times the 2020 rates, respectively, across 3 databases.”

As mentioned at the onset, “the post hoc sensitivity analysis, using 2022 background rates as the comparator in sequential testing, did not identify any statistical signals for seizure in any databases. Using 2019 background rates as the comparator resulted in a statistical signal for seizure after primary series vaccination with mRNA-1273 in 2 of the 3 databases and after dose 2 vaccination with mRNA-1273 in 1 of the 3 databases.”

Is the incidence of myocarditis considered rare?

Yes. The authors report a rate of reported mean incidence of 39.3 cases per 1 million vaccine doses administered in children aged 5 to 17 years within 7 days after BNT162b2 vaccination according to two CDC separate studies. However, TrialSite notes that some studies suggest the rates are higher.

What about the rate of myocarditis and pericarditis outcome measured in the inpatient and emergency department settings?

In the 1 to 7 days window post the COVID-19 jab, the team reports an observed rate of 27.0 inpatient or emergency department cases per million doses in days 1 to 7 after the primary series in children aged 12 to 15 years and 38.2 cases per million doses after the primary series in children aged 16 to 17 years. There was a lack of any myocarditis/pericarditis signal in children aged 12 and under.

A new seizure signal was reported.

Lloyd and co-authors report that such a seizure signal in children aged 2 to 4 or 5 years has not been previously reported for this age group in active surveillance studies of mRNA COVID-19 vaccines.

The authors point to reports in the Vaccine Adverse Events Reporting System (VAERS), which is a “passive reporting system” with “limitations,” hence the data there was all but ignored. TrialSite suggests there very well may be more signals buried in VAERS, but this must be proven in rigorous study.

But the authors point to only 8 identified seizures in VAERS after approximately 1 million mRNA vaccinations through August 2022, in children aged 6 months to 5 years. They note that out of all those, 8 of the seizures were afebrile.

Do the FDA-sponsored authors suggest interpreting the seizure data with caution?

Yes. They call for more robust epidemiologic study. We at TrialSite concur. How can the CDC relentlessly push for young people to continuously get the latest booster with such data available? Especially so, given the risk-benefit analyses continuously change given pre-existing infection, milder Omicron variants, etc.

Study Limitations

Like all such observational studies, the limitations must be understood. TrialSite bulletizes for summary.

Near-real-time surveillance method, which may be sensitive to comparator rate selection and does not include controlling for bias and confounding

The study only includes data from a commercially insured pediatric population and may not be nationally representative—meaning the generalizability could be quested despite the broad coverage

Here, small counts of NVX-CoV2373 prevented evaluation of most demographic factors due to privacy concerns

The authors report that they could not conduct medical record review for all outcomes included in the study due to resource, time, and legal constraints. For the myocarditis or pericarditis outcome, they reviewed medical records of a subset of identified cases of myocarditis or pericarditis that were obtained from the medical professionals.

2020 background rates as the historical comparator for the seizure analysis because this period was marked by behavioral shifts during the early pandemic that may have caused a sustained decrease in the underlying outcome rates. Hence the study team compared both prepandemic and peripandemic periods across data partners when selecting historical rates and generally selected the lower rate as the historical comparator.

For the Novavax vaccine, only 53 children aged 12 to 17 years who received at least 1 dose of NVX-CoV2373 and 4266 children aged 5 to 17 years who received at least 1 dose of mRNA-1273.

https://www.trialsitenews.com/a/large-4.1m-fda-study-confirms-myocarditispericarditis-and-seizure-safety-signals-in-young-peopleshould-boosters-continue-41e92005

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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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The British government downplayed 'gobsmacking' Covid lab leak information amid resistance from scientific advisers, sources claim

The UK Government downplayed the 'high likelihood' that Covid-19 emerged from a lab leak in China because of resistance from scientific advisers, it was claimed yesterday.

US officials shared their views on the origin of the virus in a call with other members of the Five Eyes intelligence alliance – the UK, Canada, Australia and New Zealand.

But the 'lab leak' theory was downplayed in Britain because of resistance from government scientists who favoured the idea that Covid 'jumped the species barrier' from animals to humans, according to US sources.

Taking part in the January 2021 phone call were Mike Pompeo, Donald Trump's secretary of state, and the UK's then foreign secretary Dominic Raab and their counterparts.

The call – previously reported by The Mail on Sunday – was 'open', meaning unencrypted, in the hope the Chinese government would intercept the call, it is claimed.

The allegations, made by unnamed officials speaking in The Sunday Telegraph yesterday, are likely to increase calls to open the Covid Inquiry to the question of where the virus originated.

One US source who worked on the intelligence said: 'We saw several pieces of information and thought they were gobsmacking.

'They obviously pointed to the high likelihood that this was indeed a lab leak.'

An intelligence dossier revealed the Chinese military worked with the Wuhan Institute of Virology in the years leading up to the pandemic, and some lab researchers fell sick shortly before the virus was first recorded nearby.

Other revelations showed Chinese scientists carried out 'gain of function' research, whereby a virus is genetically manipulated to show different behaviour, such as becoming more infectious, or to become infectious against different species.

The UK Government, including Boris Johnson, initially rejected the claim that Covid had been created by scientists, saying in June 2021: 'The advice that we have had is that it doesn't look as though this disease of zoonotic origin came from a lab.'

Two former officials said the evidence was not taken seriously because ministers saw lab leak claims as a 'radioactive American political issue' that was discredited by public disagreement between government scientists and Mr Trump.

One official said: 'Once the thing became fundamentally political, the ability to pursue it internationally really just collapsed because no one else was interested in touching it.

'I think [Five Eyes] were kind of annoyed by the way the issue had become treated in US politics.'

The two sources cited by The Sunday Telegraph both separately named Sir Jeremy Farrar, then a member of the Scientific Advisory Group for Emergencies, as a key opponent of the lab leak theory in the UK Government.

Sir Jeremy and 26 other scientists rejected the lab leak theory in February 2020, signing a statement which said: 'We stand together to condemn conspiracy theories suggesting that Covid-19 does not have a natural origin.'

While many scientific experts say an animal-to-human interaction is the most likely cause of the first infection, some figures, most notably Michael Gove, say the virus was 'man-made'.

Mr Gove told the Covid Inquiry in November there was a 'significant body of judgement that believes that the virus itself was man-made – and that presents its own set of challenges'.

Both the FBI and US Department of Energy have said they believe a lab leak is the most likely cause of the disease. UK ministers are facing calls to widen the Covid Inquiry to include an investigation into the origins.

A UK Government spokesman said: 'There are questions that need to be answered about the origin of Covid-19, not least so we can ensure we are better prepared for future pandemics.

'The UK supports the World Health Organisation in its study of the origins. It is important China and other countries co-operate fully.'

https://www.dailymail.co.uk/news/article-13385605/The-British-government-downplayed-gobsmacking-Covid-lab-leak-information-amid-resistance-scientific-advisers-sources-claim.html

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Thousands Demonstrate Against the WHO’s Pandemic Treaty in Japan

While dozens of U.S. senators representing the entire Senate Republican Conference called on the Biden administration to reject the World Health Organization (WHO) International Health Regulations (IHR) treaty, few Americans actually went to the level of protest. That was different in Japan last month, when protestors took to the streets. On April 13, 2024, thousands of demonstrators assembled across Japan to voice their opposition to the proposed pandemic treaty by the WHO’s IHR.

The protest which spanned the streets of Ikebukuro, Tokyo, to the Higashi-Ikebukuro Central Park, reflected growing concern that infectious diseases and public health are becoming tools used to justify the adaptation of an overly controlling surveillance system for governments. The demonstrators in Japan also expressed concerns over health officials overstepping their boundaries, plus their ties to multinational pharmaceutical companies. This reflects a growing sense of disenfranchisement.

TrialSite previously reported on the 7th meeting of the WHO Intergovernmental Negotiating Body (INB) that took place between November 6 and December 6, 2023, in a bid to fine-tune the proposed pandemic treaty.

The INB recently held its 8th and 9th INB meetings between February and March 2024. The final result of this treaty is yet to be decided as the INB plans to converge one last time from April 29 to May 10, 2024, to resume its negotiations on finalizing the pandemic treaty. However, some individuals supporting the demonstration in Japan have claimed that Japanese lawmakers are uninformed about the details of their country's proposal to the WHO regarding the pandemic treaty and revisions to the IHR. They emphasize the perceived lack of transparency in the process and have voiced these concerns.

How it began

The protests began on the streets of Tokyo, Japan, and were fueled by concerns raised by civil vaccine critic groups. As details of the treaty emerged, these groups sounded alarms over potential threats to Japanese sovereignty. Some individuals who addressed the crowd during the pre-demonstration include Toshie Ikeda, a member of the Hino City Council. Speakers including Professor Masayasu Inoue, a Professor Emeritus of Osaka City University Medical School and Chikatsu Hayashi, a modern history researcher, addressed the crowd before the demonstration. Their talks explored the relationship between global health organizations and the pharmaceutical industry. Inoue expressed concern about weaponizing health information in a way he likened to “a third world war.”

Professor Inoue called for public resistance to the introduction of genetic vaccines. He also alleged that the WHO receives funding from pharmaceutical companies and private foundations, like the Bill and Melinda Gates Foundation. Hayashi, in his address, emphasized the importance of taking a proactive stance against what he perceived as potential threats to individual freedoms, using the metaphorical term “stopping the third atomic bomb with our hands.”

What were the protesters calling for?

Some demonstrators demanded that the government inform the public about the pandemic treaty and IHR, stating that they wouldn’t agree to the WHO holding people as what they perceived to be “health hostages.” They added that they won’t tolerate all policies that ignore vaccine damage. These protesters alleged that the Health Minister, Keizo Takemi, was guiding the medical association to a “history of vaccines.”

Aside from the transparency concerns by the Japanese people, these demonstrators also raised concerns about two key issues: a reported rise in excess mortality and the need for more transparency regarding the side effects of vaccines. The organizers aimed to have about 100,000 protesters present for this rally. They rallied against the use of genetic vaccines for influenza and also the development of what they termed “dangerous replicon vaccines.”

Effects of the vaccines in Japan

As in many other countries, there are conflicting views on the effects of the vaccines in Japan. Did the COVID-19 vaccines fulfill their intended purpose of safeguarding public health or cause more harmful effects than beneficial ones? A 2023 study published in Nature evaluated the effect of the COVID-19 vaccines in Japan in 2021. It asserts that the COVID-19 vaccination program was effective, reducing the death rates by 97%, compared to what they could have been without the vaccines. The study also revealed that the timing of opening up vaccination to a wider population and those who received it played a significant role in reducing the disease burden.

However, some studies have shown that COVID-19 vaccines increased the risks for myocarditis and pericarditis in adolescent and young adult males. In October 2022, TrialSite reported a study on vaccine safety that showed that the COVID-19 vaccines increased myocarditis risks by four times. An opinion piece on TrialSite also reported a study on the death of a 14-year-old Japanese girl post-vaccination. The researchers attributed her death to myocarditis and pericarditis.

A cause for alarm?

The protests in Japan against the WHO's proposed pandemic treaty and the IHR reveal a growing concern and distrust among certain groups regarding the influence of global health organizations and their perceived ties with the pharma industries. The demonstrators' demands for transparency raise questions about the decision-making processes involved in the treaty negotiations.

The recent move by the entire Senate Republican Conference called for the Biden administration to withdraw its support for the two international agreements on the table at World Health Assembly seeking greater authority for what is perceived as a dysfunctional and even captured WHO.

While the intentions behind the pandemic treaty and IHR may be rooted in a desire to improve global preparedness and response to future health emergencies, the government cannot easily dismiss the concerns expressed by street level protests in Japan either. The perception that these health regulations can threaten individual freedoms and national sovereignty needs to be addressed.

Regarding the effects of vaccines, studies have shown high efficacy of COVID-19 vaccines in reducing mortality rates. However, reports of increased risks of myocarditis and pericarditis among certain age groups cannot be ignored.

As the negotiations for the pandemic treaty and IHR revisions continue, the officials involved may need to consider the voices of all stakeholders and concerned citizens.

https://www.trialsitenews.com/a/thousands-demonstrate-against-the-whos-pandemic-treaty-in-japan-89b14b0d

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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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Australia: Hundreds of patients died after catching COVID in Victorian hospitals, new data shows

When Dean's* father was rushed to hospital with a bad case of gastro in February, he assumed he'd be back on his feet in a few days.

Instead, he caught COVID, probably in the emergency department at the Monash Medical Centre, a major hospital in Melbourne's south-east. His 79-year-old dad became so unwell, so quickly, that Dean — who visited him in the infectious diseases ward wearing an N95 mask — was terrified he wouldn't survive.

"He was as sick as I'd ever seen him," said Dean, who was shocked that his father's COVID infection seemed to trigger symptoms of Huntington's Disease, a neurodegenerative condition he'd been diagnosed with many years earlier. "I'd say it was very touch-and-go. I've seen people with cancer a few days before they've died, and there was a look in his eye and he was completely emaciated. He couldn't speak, couldn't communicate — he was just croaking."

Dean was also shocked that most of the hospital staff were wearing surgical masks, some on their chin. It bothered him, he said, because surgical masks are much less effective at preventing COVID transmission than N95 respirators. "No one seemed to give a hoot about protecting themselves or the patients," he said. "From what I know about COVID, I believe all the staff in an infectious diseases ward should be wearing respirators … the fact that it is not standard is just bamboozling."

But perhaps he shouldn't have been so surprised. For months doctors and public health experts have been warning that too many patients are catching COVID in Australian hospitals with sometimes devastating consequences — though timely statistics are difficult to access because health departments do not publish them.

Now, new data shows thousands of patients caught COVID in Victorian public hospitals in the past two years — and hundreds died — fuelling concerns that hospitals are not taking strong enough precautions against airborne viruses, and calls for stronger leadership from the Department of Health.

Almost one in 10 patients who caught COVID in hospital died
Documents obtained by ABC News under Freedom of Information laws reveal at least 6,212 patients caught COVID in hospital in 24 months — 3,890 in 2022 and 2,322 in 2023. Of those, 586 died — almost six per week, on average — with men dying at a higher rate than women (11 per cent vs 8 per cent).

Though hospital-acquired infections and deaths declined in 2023 — in line with COVID mortality trends in the broader community — the proportion of patients who died after catching the virus in hospital hardly budged, dropping from about 10 per cent in 2022 to about 9 per cent in 2023.

It comes following the release of new research that shows screening hospital patients for COVID and staff wearing N95 masks can substantially reduce infections and deaths, saving the health system potentially hundreds of millions of dollars in the long term. Experts say the findings should spark a paradigm shift in the way hospitals approach COVID infection prevention — that's if the latest indicators of illness and death don't.

Too many patients are catching COVID in hospitals, doctors say
Hospitals have become a strange new battleground in the fight against COVID, with doctors and public health experts concerned that too many patients are catching the virus — and an alarming number are dying — as a result of inadequate infection control.

"The numbers indicate that there is a big problem here — these infections and deaths are potentially preventable," said Associate Professor Suman Majumdar, chief health officer for COVID and health emergencies at the Burnet Institute. "We're talking about a specific setting where people are sicker, more vulnerable and more at risk. We need to drastically reduce the risk of people catching COVID in hospital when they don't come in with it. I think we can all agree we can do better — that should be the starting point."

Alarmingly, the proportion of hospitalised COVID patients who caught the virus in public hospitals was much higher last year than in 2022 — up from 13 per cent to 20 per cent, on average — coinciding with a reduction in COVID screening and healthcare worker mask use across the state. Most Victorian hospitals began scaling back infection prevention measures in late 2022, when pandemic public health orders were revoked.

Now, because hospitals determine their own COVID policies, there is wide variation in how they approach the issue. For instance, in the past fortnight several health services — including St Vincent's in Melbourne and Barwon Health — announced they were no longer requiring staff to wear masks in clinical areas because community transmission had fallen (the latest available data shows it's increasing). Others dropped masking and scaled back testing months ago, while some still insist on routine testing and surgical mask use in particular wards.

With golden staph, 'we aim for zero'

"There's no consistency between health services," said Stéphane Bouchoucha, president of the Australasian College for Infection Prevention and Control and associate professor in nursing at Deakin University. "And there doesn't seem to be leadership from the Department of Health, saying, 'We want to reduce COVID infections in healthcare, therefore … we need to do universal testing, we need to mandate N95 masks for healthcare workers'."

As for the number of people catching COVID in hospital, Dr Bouchoucha said: "I think any hospital acquired infection is concerning". There isn't an "acceptable" number of golden staph or tuberculosis infections — "we aim for zero", he said. "So why don't we do that with COVID?"

He's not the only one asking that question. Staphylococcus aureus or golden staph bloodstream infections can be life-threatening, which is why hospitals track and report them and aim to prevent them using hand hygiene strategies — it's part of hospital accreditation standards and there are targets in every state. But there are no targets or reporting requirements for COVID, Dr Majumdar said.

As a point of comparison, he said, there are about 600 staph aureus bacteraemia infections in Victoria each year, with a similar death rate to COVID hospital-acquired infections. "So why aren't we applying the same mindset and measures for airborne infections such as COVID and influenza?"

At the hospital level, there are several possible answers. Many health services, under huge financial pressure, have rolled back COVID mitigations to try and save money — sometimes against the advice of their own infection prevention leads. Many hospital executives also subscribe to the myth that COVID is "just a cold" and does not warrant taking serious action against, while others have acted on complaints that staff are "sick of wearing" masks.

"Many people are telling me they're tired of wearing masks and some patients are saying they're tired of seeing their carers in masks, as well," Professor Rhonda Stuart, director of public health and infection prevention at Monash Health, told staff at an employee forum in February.

Professor Stuart pointed to a UK study that found removing a surgical mask wearing policy in some hospital wards did not significantly affect the rate of nosocomial COVID infections, or those caught in hospital. "I think we're starting to see that possibly happening across Monash at the moment," she said — "that maybe masks aren't making the difference in hospital-acquired infections".

Testing and N95s save lives and money

But the findings of a new preprint study pose a serious challenge to that claim. For the study, researchers from the Burnet Institute and the Victorian Department of Health, which funded it, used a mathematical model to simulate outbreaks in a hospital with various combinations of interventions in place: different kinds of masks worn or admission testing performed.

They also calculated the statewide financial costs of each intervention — N95 vs surgical masks, PCR vs rapid antigen testing (RAT), and patient bed costs and staff absenteeism — as well as the health outcomes for infected patients.

How scientists are protecting themselves from COVID
Three of Australia's leading COVID-19 experts share their personal safety strategies and reflect on what must happen if we're to blunt the growing health crisis the pandemic is causing — and prepare for the next one.

The results were striking: compared to staff wearing surgical masks and not screening patients on admission, the combination of wearing N95 masks and testing patients using RATs was the cheapest, saving an estimated $78.4 million and preventing 1,543 deaths statewide per year. Staff wearing N95s and screening patients with PCR tests was the most effective option, saving $62.6 million and preventing 1,684 deaths per year.

In other words, testing and wearing N95s to detect and prevent COVID can save lives and money because it reduces the costs of keeping patients in hospital for longer and replacing furloughed staff.

"I think it provides a very persuasive rationale that doing small things to reduce infections can add up to big positive impacts and cost benefits," said Dr Majumdar, a co-author of the study. "It then becomes an issue of how practical it is for hospitals to implement these interventions and change behaviours. We know improving ventilation, testing and wearing masks has been effective during the pandemic, so I don't think there's an argument to say it's not feasible or not worth figuring out how to do."

The Victorian Department of Health did not respond directly to questions about whether it would be acting on the study's findings, or if it was comfortable with current rates of illness and death in hospitals. "Since the pandemic began we have assisted health services to respond to increased impacts of COVID-19 — a roadmap to guide hospital responses was introduced and has remained in place since June 2022," a Department spokesperson said. "Modelling is one of many tools used when developing and evaluating healthcare policy."

Managing 'masking fatigue'

But hospitals don't always follow that "roadmap". Associate Professor Caroline Marshall, head of the Royal Melbourne Hospital's Infection Prevention and Surveillance Service, said her hospital uses a "hierarchy of controls" to prevent COVID transmission — strategies honed in the grim early years of the pandemic when patients and staff were infected in dizzying numbers.

Today, every patient is screened for COVID on admission with a PCR test — which few hospitals still do. COVID patients are generally cared for in single-bed negative pressure rooms by staff in N95 masks. Air purifiers are stationed around the hospital, an old building with not-so-great ventilation.

"To me … any sort of nosocomial infection is a disaster," Dr Marshall said. "So we do our utmost and we're not always successful, but we do as much as we reasonably can [to prevent them] based on the evidence we have and the factors we have to take into account."

One of those factors is the impact of masking on healthcare workers, who Dr Marshall said are "sick of wearing" N95 respirators because they're uncomfortable. At the moment Royal Melbourne Hospital staff must wear surgical masks in clinical areas unless they're caring for COVID, transplant or haematology patients, when N95s are required.

The decision to use surgical masks is influenced by a few things, Dr Marshall said, including the prevalence of COVID in the community, the severity of circulating variants, population levels of immunity and a new tolerance for risk among staff. "If a staff member wants to wear one for whatever reason, they can," she said. "But I think the reality is, at a practical level, you cannot continue to get staff to wear N95 masks forever."

Other infection prevention control experts disagree. For Dr Bouchoucha, masking fatigue is a challenge to be "managed", not succumbed to — including because addressing healthcare workers' concerns about respirator use improves compliance and patient safety. "It's definitely something to take into account," he said. "But we can mitigate it."

Catching COVID made Ruby sick and derailed her care
Many patients feel similarly. When Ruby* caught COVID in hospital earlier this year, she was fully prepared to feel terrible for a few days — but she didn't expect it to completely derail the care she was there to receive.

Ruby was admitted to Upton House, the adult psychiatric unit at Box Hill Hospital, in late January after experiencing family violence and a decline in her mental health. When she tested positive to COVID a few days later, she wasn't surprised: other patients with COVID were allowed to roam freely through the ward without masks, she said, and staff were either in surgical masks — many "below their nose" — or no masks at all.

"It made me really sick," said Ruby, who suffered mostly from gastrointestinal symptoms, brain fog and low mood. "I was pissed off that I'd caught COVID but I didn't realise it would affect my care as much as it did, and I was really shocked at the drop-off in psychiatric support as soon as I had it."

The exterior sign of the Box Hill Hospital, underneath which a bush of white flowers blooms next to a concrete staircase.
Ruby wasn't surprised when she tested positive to COVID during her admission at Box Hill Hospital.(ABC News: Patrick Rocca)
A doctor who prescribed Ruby antivirals dramatically reduced her dose of psychiatric medication without consulting her, she said, which triggered unpleasant side effects. Having COVID also meant her psychiatrist visited her less frequently than he was supposed to, she said, and if she went to the nursing station to ask for paracetamol, she was instructed just to go back to her room. "I also wasn't allowed to go to the kitchen for meals and my food was generally brought to me an hour late, cold, without cutlery," she said. "So most of the time I didn't eat."

Ruby was relieved to be discharged even though she was "in limbo" psychiatrically — feeling much worse than when she arrived — and still testing positive to COVID. "I can't imagine how hard it is to work in a psychiatric unit," she said, adding that the nursing staff were clearly very busy. "But there was a total lack of empathy and then as soon as I had a medical problem [COVID], absolutely no attention or compassion. Something as simple as not being able to get any Panadol was almost traumatic — even though I was in there for more severe trauma issues."

Long COVID will take your health, your wealth — then it will come for your marriage

Long COVID is not just destroying people's health. Behind closed doors, in homes across Australia and abroad, it is irreversibly changing relationships — sometimes for the better, too often for worse.

A spokesperson for Eastern Health told ABC News they were unable to comment on Ruby's case but said if a COVID outbreak occurs, "additional measures are put in place including requirements to wear N95 masks, reduced movement and access to certain wards and clinical areas, increased hand hygiene, taking breaks outside and meeting virtually where possible."

Monash Health also would not address specific questions about Dean's father's admission. "Monash Health provides N95 and surgical masks as part of its infection prevention precautions to protect its patients, visitors and staff," a spokesperson said. "Monash Health cares for COVID-positive patients … in single rooms with negative pressure or negative flow, in addition to requiring staff and visitors to wear appropriate PPE including N95 masks."

At least that's not what Dean observed. He's still upset that the hospital didn't alert him when his father tested positive to COVID, and that his dad blamed himself for catching it in the emergency department in the first place.

"In the whole time of his admission I only saw one staff member … wearing a respirator — I felt overdressed," Dean said. "I'm just horrified that vulnerable people go into a place where they expect to be safe and cared for but are given something that, in this case, potentially nearly kills them and there's no apology — not even acknowledgement."

ABC News requested interviews with infection prevention and control experts at Western Health, Barwon Health and Alfred Health — all declined.

https://www.abc.net.au/news/2024-05-06/hundreds-died-catching-covid-victoria-hospitals-testing-masking/103784896

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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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Neurosurgeon, 37, and nurse, 54, claim they were left brain damaged and paralyzed from Covid vaccines - as they say they've been 'dismissed and gaslighted' as anti-vaxxers

Americans who claim they were badly injured by the Covid vaccines feel they are being ignored and gaslighted by the government.

Over 13,000 formal complaints about adverse reactions to the shots have been filed since 2021 - but only 19 percent have been reviewed.

And just 12 patients have been compensated at an average of about $3,600, a figure which some have called insultingly low given the debilitating health issues they have been left with.

Experts say that researchers who've tried to investigate the little-understood side effect profile of Covid vaccines have been blocked by government officials and scientists who fear that even entertaining the possibility that vaccines can cause harm would fuel the anti-vax, which become bigger and louder during the pandemic.

Still, people are suffering from a range of conditions that came on soon after getting their first shot, including brain damage, tinnitus, neurological syndromes, facial paralysis, heart trouble, and shingles.

Unlike several countries like Australia, Canada, and Denmark, which have centralized health records compiled on a single database, the US has no such thing, leaving scientists to sift through reports of mild to severe side effects, of which there are more than four million lodged to the CDC’s voluntary adverse reporting website.

Before Michelle Zimmerman, 37, had to say goodbye to her career as a neuroscientist, her regular 20-mile bike rides, and her lectures on the latest in AI, she had received the Johnson & Johnson vaccine in 2021.

No longer able to stand up on her own for long periods of time, and eventually diagnosed with brain damage, Dr Zimmerman had to move back in with her parents. She is convinced the vaccine she got came from a contaminated batch.

She told the New York Times: ‘When I let myself think about the devastation of what this has done to my life, and how much I’ve lost, sometimes it feels even too hard to comprehend.’

Dr Zimmerman submitted her application for the Covid vaccine compensation program in October 2021, but it took two years for that claim to be acknowledged by the federal government. She has yet to receive any help from government officials.

She is far from the only one who has submitted such a claim. The Health Resources and Services Administration’s Countermeasures Injury Compensation Program (CICP), 13,116 claims have been filed, of which more than 10,000 are still in review.

Twelve claims have been compensated at an average of about $3,600. This is because the office recognizes so few side effects as stemming from the Covid vaccine.

Shaun Barcavage, a 54-year-old nurse practitioner in New York, said that merely standing up would make his heart race ever since he got his first Covid shot.

His symptoms suggested postural orthostatic tachycardia syndrome (POTS), a condition in which the body cannot regulate the flow of blood properly, causing lightheadedness, fainting, and rapid heartbeat.

POTS has been tenuously linked to the vaccines, but more often with Covid infection itself.

Mr Barcavage, who in his career has worked on clinical trials for both HIV and Covid, said: ‘I can’t get the government to help me. I am told I’m not real. I’m told I’m rare. I’m told I’m coincidence.’

And Dr Gregory Poland, 68, who edits the journal Vaccine, has had a loud whoosing sound in his ears accompany every single second since he got his shot, and now fears never having a silent moment again.

His colleagues at the CDC did not take on his pleas for further research into the post-vaccine phenomenon.

Covid vaccines from Pfizer and BioNTech as well as Johnson and Johnson – which is no longer available – have been credited with averted at least three million deaths in the US and around 20 million globally due to the virus.

But even the best vaccines are not perfect, and when given to more than 270 million Americans in nearly 677 million doses, adverse reactions are bound to crop up.

Scientists fear the minority of vaccine recipients who have experienced severe reactions that have upended their lives are being ignored by federal officials with the power to initiate and fund more research into the matter.

Dr Akiko Iwasaki, an immunologist and vaccine expert at Yale University, said: 'At least long Covid has been somewhat recognized', added people complaining of post-vaccine injuries are 'just completely ignored and dismissed and gaslighted.'

Dr Janet Woodcock, who headed the FDA from January 2021 through February 2022 during a crucial time which which early vaccines and treatments were being reviewed, told the New York Times that she wished government officials would hear those people out.

She said: ‘I feel bad for those people. I believe their suffering should be acknowledged, that they have real problems, and they should be taken seriously.

‘I’m disappointed in myself. I did a lot of things I feel very good about, but this is one of the few things I feel I just didn’t bring it home.’

The understaffed office heading the complaints database has left suffering Americans feeling let down by what was meant to be a highly specific, high efficient means of recourse for Covid shot recipients.

Renee France, 49 of Seattle, developed a form of facial paralysis called Bell’s palsy causing one side of her face to droop, which can be a reaction to a viral infection as well as the flu vaccine. She also developed shingles that caused a severe rash that crossed her face and debilitated her for weeks.

She submitted her claim to the database two times but heard nothing back. Like many other patients, her doctor dismissed her fears that the symptoms were side effects of her Covid shot. People have complained of being brushed off and labeled anti-vax by family and friends, despite their support for vaccines.

Dr. Buddy Creech, 50, who led several Covid vaccine trials at Vanderbilt University and suffered tinnitus and racing heartbeat for about a week after each shot, said: ‘When our patients experience a side effect that may or may not be related to the vaccine, we owe it to them to investigate that as completely as we can.’

Countries that store patient data in a single place have conducted more extensive research into side effects simply because they can spot them easier.

The CDC’s adverse events reporting system is voluntary, so anyone can file a report, and the reports are not verified by the agency as being true or unbiased.

In addition to poring over the CDC system, researchers have to sift through insurance claims, and even then there are gaps.

Shots given at mass vaccination sites that cropped up in parking lots across the country did not file vaccine claims with insurers.

Rebecca Chandler, a vaccine safety expert at the Coalition for Epidemic Preparedness Innovations, said: ‘It’s harder to see signals when you have so many people, and things are happening in different parts of the country, and they’re not all collected in the same system.’

But in China, Europe, and Israel, scientists have actively sought out instances of adverse reactions, even mild ones, in order to study them further.

Harvard and Yale scientists probing new condition linked to Covid shot

Patients with the condition appear to suffer from symptoms similar to 'Long Covid' - including persistent headaches, intense tiredness and abnormal heart rate and blood pressure.

The European Medicines Agency has uncovered and linked facial paralysis and numbness to the Pfizer and Moderna shots, which the US has not, despite there being nearly 3,000 reports of facial paralysis on the CDC’s voluntary database.

And Israeli authorities were first to spot an unusual side effect in April 2021 primarily among young men after a second dose of a Pfizer or Moderna shot – inflammation of the heart muscle, also known as myocarditis.

Meanwhile, the CDC maintained there was no strong link between heart inflammation and Covid vaccines. That continued until the agency decided the following May to investigate a smattering of reports of heart inflammation in teenagers that occurred just a few days after they got a dose of the Pfizer or Moderna vaccines.

But despite the 16,700 reports of tinnitus, the 9,000 reports of vertigo, the 7,000 reports of irregularly fast heart beat, the 3,800 reports of Bell’s palsy, or any of the other millions of adverse event reports submitted to the CDC’s system, the NIH is not conducting thorough research into the matter.

Dr William Murphy, a cancer researcher of 12 years at the NIH who has been pushing for these investigations, said that officials told him the same hackneyed phrase he had been hearing for years: the virus is worse.

He said: ‘Yes, the virus is worse, but that doesn’t obviate doing research to make sure that there may be other options.’

https://www.dailymail.co.uk/health/article-13379597/neurosurgeon-brain-damaged-paralyzed-covid-vaccines-anti-vaxxers.html

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Serious and Potentially Deadly Abdominal Blood Clots Reported after COVID-19 Vaccination

The mother of a close friend died last month after suffering blood clots in the veins that drain the intestines. She was in her seventies and vaccinated for COVID-19 and sadly she died after emergency abdominal surgery. The daughter wondered if the death was vaccine-related.

Maan et al reported on one year of data from the Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands. Their results in the vaccinated are truly alarming:

“Twenty-nine patients were identified with SVT occurring with a median of 11 days (range 2–76) after the first (48%), second (41%), or third (10%) vaccination (ChAdOx1 nCov-19 (n=12) or BNT162b2 (n=14), other (n=3) Only 2 patients(7%) fulfilled criteria for definite VITT. Twenty (69%) had SVT at multiple sites, including 4 (14%) with concomitant extra-abdominal thrombosis. Only 28% had an underlying prothrombotic condition, compared to 52% in the pre-COVID SVT cohort (p=0.01). Five patients (17%) underwent bowel resection for mesenteric ischemia, compared with 3% in pre-COVID SVT (p<0.001). Two patients died shortly after diagnosis (7%).”

Compared to a larger group of cases over many years before COVID, the vaccine blood clots were far more serious and deadly. The main teaching point from this paper is among the vaccinated to take abdominal pain seriously and have a low threshold to get imaging to diagnose splanchnic blood clots before they become fatal.

https://www.trialsitenews.com/a/splanchnic-venous-thrombi-after-covid-19-vaccination-7114be86

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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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CDC Found Evidence COVID-19 Vaccines Caused Deaths

U.S. Centers for Disease Control and Prevention (CDC) officials found evidence that the Pfizer-BioNTech and Moderna COVID-19 vaccines caused multiple deaths before claiming that there was no evidence linking the vaccines to any deaths, The Epoch Times has learned.

CDC employees worked to track down information on reported post-vaccination deaths and learned that myocarditis—or heart inflammation, a confirmed side effect of the vaccines—was listed on death certificates and in autopsies for some of the deaths, according to an internal file obtained by The Epoch Times.

Myocarditis was also described as being caused by vaccination in a subset of the deaths.

In other cases, the CDC workers found that deaths met the agency’s definition for myocarditis, that the patients started showing symptoms within 42 days of a vaccine dose, and that the deceased displayed no virus-related symptoms. Officials say that after 42 days, a possible link between the vaccine and symptoms becomes tenuous, and they list post-vaccination deaths as unrelated if they can find any possible alternative causes.

In cases with those three features, it’s “absolutely” safe to say that the vaccines caused the deaths, Dr. Clare Craig, a British pathologist and co-chair of the Health Advisory and Recovery Team Group, told The Epoch Times in an email.

Despite the findings, most of which were made by the end of 2021, the CDC claimed that it had seen no signs linking the Moderna and Pfizer messenger RNA (mRNA) vaccines to any deaths reported to the Vaccine Adverse Event Reporting System (VAERS).

CDC officials in a letter to The Epoch Times dated June 13, 2023, said that there were no deaths reported to the VAERS for which the agency determined “the available evidence” indicated Moderna or Pfizer vaccination “caused or contributed to the deaths.”

The agency also said that evidence from seven deaths from thrombosis with thrombocytopenia syndrome following the Johnson & Johnson vaccination suggested that the vaccine led to people dying.

“That’s a scandal, where you have information like this and you continue to put out this dishonest line that there’s only seven deaths and they’re all unrelated to the mRNA vaccines,” Dr. Andrew Bostom, a heart expert based in the United States, told The Epoch Times.

The CDC is “concealing these deaths,” he said.

A CDC spokeswoman, presented with the file and dozens of questions about it, said that “determining a person’s cause of death is done by the certifying official, physician, medical examiner, or coroner, who completes the death certificate.”

The spokeswoman declined to explain why the CDC doesn’t consider autopsies or death certificates as evidence of causality, the criteria that would establish vaccine-caused deaths, or whether the numbers have been updated since 2023. She also declined to answer questions about specific deaths outlined in the file, citing “privacy and confidentiality.”

People who die in the United States with confirmed or suspected COVID-19 are counted as COVID-19 deaths. That count has included a number of deaths from unrelated causes. The CDC also in 2023 advised death certifiers to include COVID-19 on certificates even if the deaths happened years after COVID-19 infection.

“They are taking the exact opposite approach to COVID deaths! Every death after a test was a COVID death. No death after a vaccine is a vaccine death!” Dr. Craig said. She questioned what it would take for the CDC to admit that the vaccines have caused some myocarditis-related deaths.

More People Died

The file, acquired by The Epoch Times through a Freedom of Information Act request, has never before been reported. The file was obtained after U.S. authorities rejected another Freedom of Information Act request for the autopsies themselves. The file outlines the agency’s investigation into reports submitted to VAERS of suspected cases of myocarditis or a related condition, pericarditis, following COVID-19 vaccination.

CDC employees, starting in April 2021, contacted health care providers and other agencies to obtain medical records, death certificates, and autopsies as they sought to confirm whether each report was legitimate.

The file shows the CDC examined 3,780 reports through April 13, 2023, a small number of which were duplicates. Among the reported cases, 101 resulted in death.

In one instance, a 37-year-old man started suffering symptoms that can be caused by myocarditis, such as shortness of breath, shortly after receiving a Moderna COVID-19 shot. The man collapsed three days after vaccination and was soon pronounced dead.

Dr. Darinka Mileusnic, the medical examiner who examined the man, said in an autopsy report that the patient died of “post vaccination systemic inflammation response” which caused, among other problems, acute myocarditis, according to the CDC file.

The CDC worker who was assigned to look into the death wrote that it was “evident of a sudden death post second dose of Moderna vaccine.”

“One of the factor[s] to death [sic] is acute myocarditis. There are other findings related to VAE [vaccine adverse event] and non vaccine related. Thus, it can’t be distinguished that only vaccine may have caused the death,” the CDC employee wrote.

Dr. Mileusnic declined a request for comment through her employer, the Knox County Regional Forensic Center in Tennessee. The center said it would only provide an autopsy report if the decedent’s name and date of death were provided. The CDC file did not include names.

After another man, 24, died on Oct. 27, 2021, about two months after receiving a second Pfizer injection, his health care provider diagnosed him with myocarditis. An autopsy listed “complications of COVID-19 vaccine-related myocarditis” as the cause of death, according to the file.

A post-mortem test for COVID-19 returned negative, there were no viral organisms found in post-mortem testing of the heart, and there were no other signs of viruses causing the myocarditis, the notes show.

Another vaccine recipient, a 77-year-old man, was found dead at home on Nov. 14, 2021. The autopsy confirmed the man had pericarditis and listed the cause of death as “complications from the COV-19 booster,” according to the file.

The CDC worker who looked at that case said it met the CDC’s definition of pericarditis based on the autopsy and death certificate but noted there were comorbidities such as coronary artery disease that were listed as contributing to the death. The patient also received shots against influenza and shingles about two months before death, so “it is difficult to say that COV-19 vaccine alone caused pericarditis,” the worker wrote.

A voicemail left for the man’s doctor was not returned.

Among other deaths in the CDC file are:

A male, whose age was redacted, suffered sudden cardiac death in April 2021 following a Johnson & Johnson vaccination. He was diagnosed with myocarditis, which was confirmed by the medical examiner. A CDC worker stated that the case did not technically meet the agency’s case definition, but they would “consider probable subclinical myocarditis, given the histopathological findings.”

A 21-year-old woman who died in 2021 after seizures and cardiac arrhythmias following Pfizer vaccination was found on autopsy to have lymphocytic myocarditis. The CDC listed her case as confirmed myocarditis with no evidence of viral causes.

A 45-year-old man was found dead in his bed in 2021 after Moderna vaccination but testing for myocarditis and pericarditis was not performed.

A 55-year-old woman who was “found unresponsive in [a] field” in 2021 after Johnson & Johnson vaccination was confirmed on autopsy to have myocarditis and to have suffered a cardiac arrest. The death met the CDC’s case definition but concurrent upper respiratory infection “makes viral myocarditis a potential alternative cause,” a CDC worker stated. The medical examiner declined to comment.

Pfizer, Moderna, and Johnson & Johnson did not return requests for comment.

Lot numbers for the vaccines injected into people who died were among the information in the file redacted by the CDC. Some vaccine lots have caused significantly more problems than others, according to CDC data obtained by the nonprofit Informed Consent Action Network.

Deaths in other countries from vaccine-induced myocarditis have been reported in journals, including deaths among young people. More deaths from vaccines in cases that didn’t include myocarditis have been confirmed by international authorities. Death certificates obtained by The Epoch Times from several U.S. states have also listed the COVID-19 vaccines as causing or contributing to dozens of deaths.

Overruling

The file and a tranche of emails also obtained by The Epoch Times shows the agency started intervening shortly after the vaccines were introduced in post-vaccination cases that led to death and sometimes overruled the certifier.

Take the case of a 23-year-old man who left home on April 13, 2021, to go for a jog and was found dead on the side of the road. His death occurred four days after receiving Johnson & Johnson’s COVID-19 vaccine.

An autopsy found myocarditis and the case met the CDC’s case definition for myocarditis. But the CDC’s Infectious Diseases Pathology Branch (IDPB) then weighed in. “Per IDPB evaluation, not myocarditis,” the notes for the case say.

The evaluation is one of the documents the CDC has refused to disclose. It also refused to answer questions about the man’s death or other specific cases, referring vaguely to privacy.

Dr. Bostom, after reviewing the notes on the case, said it was a “clear-cut” example of vaccine-caused myocarditis.

The CDC doesn’t conduct autopsies itself but gathers the files as part of the investigation. Autopsies aren’t perfect but are considered the gold standard in figuring out the cause of death, Dr. Bostom said.

“It’s about the strongest evidence we can get,” he said.

Two of the cases in the file were reported by Dr. James Gill, the chief medical examiner of Connecticut, and several other doctors in a February 2022 peer-reviewed paper. The doctors revealed findings of atypical myocarditis in two teenagers after Pfizer vaccination, describing it as a “post-vaccine reaction” that might have developed due to “an excessive inflammatory response.”

CDC officials issued a public response saying IDPB’s evaluation of the cases pointed to non-vaccine causes: a parvovirus in one case, and sepsis from a bacterial infection in the other.

“These omissions could lead incorrectly to the assumption that COVID-19 vaccines were directly responsible for the deaths of these 2 patients. We believe that providing these important pathologic findings will allow readers a fuller perspective of the causes of death in these cases,” the CDC said at the time.

Dr. Christopher Paddock, one of the officials, said in an email obtained by The Epoch Times that the CDC response detailed “the work we did to identify the actual cause of death in this young man.”

In a blunt reply, the doctors said the CDC “overstepped its role” with the response and explained why the CDC’s claims didn’t hold up. The parvovirus, they said, wouldn’t cause the type of heart injury seen in the boy who died. The presence of bacteria is “not the cause of death but a consequence of death,” they said.

The certificate for the boy who died in Connecticut mentioned vaccination, Dr. Gill has told The Epoch Times. The autopsy report of the other boy notes he died of “myocarditis of uncertain etiology.”

Another death of a minor was examined by CDC workers after being reported to VAERS. A 7-year-old in Washington state died on Feb. 26, 2022, about two weeks after receiving a Pfizer shot. The medical examiner identified myocarditis as a cause of death, but, “per IDPB, infectious causes [were] identified,” according to the file.

“CDC followed-up to assist in [the] investigation of the case. From the investigation, the cause of the myocarditis could not be clearly determined,” a spokesperson for Public Health – Seattle & King County told The Epoch Times via email.

Other emails obtained by The Epoch Times show that in addition to Washington state officials, authorities in multiple states asked the CDC to test tissue samples from people who died after vaccination. They also reveal that the CDC knew of several additional post-vaccination deaths in which myocarditis was found on autopsy—and at least some other possible causes were ruled out—before issuing its 2023 statement on zero deaths.

Details From Emails

A man on active duty in the Army, for example, “collapsed after a short run” and was unable to be resuscitated, Dr. John Su, the lead official for vaccine safety for the CDC’s COVID-19 vaccine task force, wrote on March 30, 2022. “On autopsy, the pathologist observed evidence of myocarditis.”

Testing for COVID-19 came back negative, and “toxicology and other analyses were unremarkable,” according to the email, although there were indications that an “anatomic variant in the vasculature of the heart” could have caused the sudden cardiac arrest.

The CDC around the same time received a request to analyze tissue from a 42-year-old New Hampshire resident who died in early 2022 after a Pfizer vaccine dose. The autopsy found “extensive acute and subacute myocarditis,” Dr. Jennie Duval, the chief medical examiner at the New Hampshire Department of Justice, told the CDC. Postmortem testing for COVID-19 returned negative.

A spokesperson for the department told The Epoch Times in an email that its Office of the Chief Medical Examiner “will not release cause and manner of death or any other information because autopsy reports, investigative reports and supporting documentation are confidential medical records.”

The CDC also in 2022 received autopsy reports for George Watts Jr., a 24-year-old from New York state who collapsed at home after receiving a Pfizer vaccine, died from “COVID-19 vaccine-related myocarditis,” and tested negative for COVID-19; and Joseph Keating, a 26-year-old man from South Dakota who, per an autopsy and death certificate, died from vaccine-induced myocarditis.

It’s not clear why the CDC doesn’t count the death certificates or autopsies as evidence that vaccines contributed to or caused the deaths.

The CDC’s position is not surprising since it was among agencies that “were the leaders of the disinformation campaign to convince the American public, including George Watts, Jr., that experimental vaccines were safe and effective even before they were licensed,” Ray Flores, an attorney representing the Watts family in a lawsuit filed against the government, told The Epoch Times via email.

“Now everyone knows they’ve unequivocally been shown to kill,” he said.

A CDC official said in one missive in early 2022 that the CDC’s IDPB had recently become “heavily involved in coordination, consultation, and laboratory evaluation of autopsy tissues from deaths occurring after COVID-19 vaccination, including cases of suspected myocarditis.”

The effort involved closely coordinating with the CDC’s Immunization Safety Office, state health officials, and CDC officials working on policy and communications, she said.

“When requested, CDC can provide consultation for analysis of tissue specimens,” a CDC spokeswoman told The Epoch Times.

The CDC’s 2023 statement of zero deaths being linked to the Moderna or Pfizer vaccines was attributed to the Immunization Safety Office.

The office was headed at the time by Dr. Tom Shimabukuro, who offered false information about COVID-19 vaccine safety during the pandemic. The CDC also hid the finding of hundreds of safety signals for the shots, including sudden death and tinnitus, and published a paper this month that was falsely promoted as debunking an association between sudden death and the mRNA vaccines.

More than 676 million doses of the vaccines have been administered to date, the CDC noted. While the Johnson & Johnson vaccine has been pulled from the market, the agency maintains that shots from Pfizer, Moderna, and Novavax are “safe and effective.”

“The authorized and approved COVID-19 vaccines are being administered under the most comprehensive and intensive vaccine safety monitoring effort in U.S. history,” the CDC spokeswoman told The Epoch Times.

The spokesperson said the agency “has not detected any unusual or unexpected patterns for deaths following COVID-19 vaccination that have not already been thoroughly described and made public in the published biomedical literature or public presentations.”

https://www.theepochtimes.com/article/exclusive-cdc-found-evidence-covid-19-vaccines-caused-deaths-5632265

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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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Key Ingredient in Pfizer and Moderna COVID Shots Aids Cancer Development, New Study Shows

Joe Wang

The role that a key ingredient in the COVID-19 mRNA vaccine plays in cancer development has been analyzed in a comprehensive review newly published in a peer-reviewed scientific journal. The conclusion: The specific form of this ingredient, pseudouridine, that Pfizer and Moderna use to make their vaccines aids cancer development.

N1-methyl-pseudouridine (I will call it pseudoU in this article) is a critical component of the mRNA vaccine. Pfizer and Moderna chemically introduce pseudoU into their vaccines to make the mRNA molecules last longer in the human body (escaping degradation by enzymes), and to avoid suppression by the innate immune system, the body’s first line of defense against foreign invaders.

The study, titled “Review: N1-methyl-pseudouridine: Friend or foe of cancer?” is authored by five scientists from Mexico, UK, Canada, United States, and Saudi Arabia and was published in the May 2024 issue of International Journal of Biological Macromolecules.

PseudoU Aids Cancer Development

Messenger RNA is a single-stranded molecule made up of four types of nucleotides: A, C, G, and U. In their vaccines, Pfizer and Moderna replace all the “U” nucleotides with pseudoU, a chemically modified version. The invention was praised by many in the field.

However, since pseudoU is not native to the human body, is it safe?

For their study, the five scientists analyzed data in an article published in the peer-reviewed journal Frontiers in Immunology in October 2022, where a group of researchers in Thailand, using a melanoma mouse model, tested cancer development with mRNA vaccines. They found that all mRNA vaccines in which pseudoU replaced “U” stimulated cancer growth and metastasis (spread of cancer cells). The higher the percentage of pseudoU, the more severe the cancer growth.

Both the Pfizer and Moderna mRNA vaccines replace “U” with pseudoU 100 percent. This greatly contributed to the effectiveness of the COVID vaccines compared to unmodified mRNA vaccines, according to a 2021study titled “The Critical Contribution of Pseudouridine to mRNA COVID-19 Vaccines.”

The body’s immune system can recognize the “U” component of foreign mRNA and trigger a cascade of immune responses. But substituting “U” with pseudoU removes that recognition and decreases innate immunogenicity, allowing cancer cells to grow uncontrollably.

Claims by Pfizer and Moderna

The review article concluded that Pfizer and Moderna emphasized only the positive aspects related to replacing “U” with pseudoU when launching their vaccines. The new design makes the mRNA more stable, leading to more S (spike) protein produced and a more desirable immune response against SARS-CoV-2. The vaccine makers did not, however, provide information on the potential harms of the S protein, which is a known toxin, or on the potential side effects of avoiding an innate immune response.

I, for one, felt misled.

When I first learned that Pfizer was developing an mRNA-based vaccine, my reaction was “Oh, at least it’s not going to do much harm, as mRNA normally lasts only a few minutes in the body.” As a messenger, mRNA’s job is to deliver the message (of making a protein) and then quickly disappear.

My assumption was reinforced when the Centers for Disease Control and Prevention claimed: “After the body produces an immune response, it discards all of the vaccine ingredients, just as it would discard any substance that cells no longer need.”

Well, it turns out the mRNA is not what I thought.

By replacing every “U” with pseudoU, Pfizer and Moderna designed their vaccines to stay in the body longer to produce the S protein to trigger immune responses. The problem is that the modification made the molecules too stable, and thus they stay in the body for far too long.

Some of the consequences of this are now beginning to emerge.

S Protein Causes Cancer

When we consider the possible harms from the COVID shot, we need to look at not only the components of the vaccine, i.e., the SARS-CoV-2 mRNA-LNP molecules that are being injected into human bodies, but also the recombinant S protein that the mRNA encodes for.

I wrote a column recently on the findings of a Japanese study on cancer development resulting from the COVID vaccine, in which I noted the additional harm caused by the S protein. A 2022 study by Oscar Solis and colleagues found that when the SARS-CoV-2 S protein is mixed with each of about 9,000 human proteins, the S protein binds well with human estrogen receptor alpha (ER-alpha).

ER-alpha is an important regulator in the body’s reproductive system. But when the cell carrying the vaccine molecules produces the S protein as encoded by the mRNA, the S protein then binds to ER-alpha, disrupting the cell’s normal function and leading to cancer development.

The mRNA vaccine is also found to weaken human cancer immunosurveillance, allowing easy growth of cancers.
As further proof, we now have the new review of N1-methyl-pseudouridine showing that pseudoU-containing mRNA vaccines foster cancer development.

Which Is Smarter, Science or Our Innate Immunity?
National Institutes of Health scientists Dr. Jordan Meier and Dr. Kellie Nance have praised the invention of the COVID-19 vaccine using pseudoU.

“The modified nucleobase helps cloak mRNA vaccines from the immune system, limiting their undesired immune stimulation, and in certain circumstances may also enhance the synthesis of antigens by the protein-producing machinery of the cell,” they concluded in a 2021 paper. “This allows these vaccines to tap into the natural process of mRNA translation without triggering harmful side effects such as anaphylaxis.”

I wonder if Drs. Meier and Nance would draw the same conclusion today, given that so much information is emerging on the harms of the mRNA vaccine, especially when it comes to replacing “U” with pseudoU in the mRNA molecules.

The human body is a near-perfect design with a comprehensive immune system that protects it from harm while keeping a balance of things within the body’s environment. Weakening the immune system for short-term gain is dangerous and almost certain to have long-term adverse effects.

Replacing “U” with pseudoU may successfully protect mRNA vaccines from the recipient’s own immune system like a trojan horse; however, this trojan horse may eventually release hostile forces that could kill the host.

The “undesired immune stimulation” (from the NIH scientists and the mRNA vaccine’s perspective) is exactly what the body needs to protect itself, but the immune system can’t attack the invader because it’s been suppressed by pseudoU.

When treating a terminally ill patient, the doctor may endeavour to achieve the “desired” immune response to ensure survival at all costs, regardless of the side effects. However, that approach should not be used when healthy people are the subject.

Modern science is not yet advanced enough to fully understand the human immune system. For scientists to make “desired” versus “undesired” immune response decisions for hundreds of millions of healthy people via the jab is irresponsible and arrogant, to say the least.

In my recent column I commended the Springer Nature Group for allowing one of its medical journals, Cureus, to publish the Japanese study on cancer deaths after the third COVID shot. Now I’d like to commend Elsevier, the Dutch academic publishing company that owns renowned journals like The Lancet and Cell, for allowing its journal, International Journal of Biological Macromolecules, to publish the review article on pseudoU and cancer.

I am hopeful that top journals such as The Lancet and Nature will soon follow their sister publications and accept research papers on the harms of the COVID shot.

It is becoming increasingly clear that the mRNA vaccine is not safe and must be stopped.

https://www.theepochtimes.com/opinion/key-ingredient-in-pfizer-and-moderna-covid-shot-aids-cancer-development-new-study-shows-5638998

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NZ Nurse Fined $18,000 and Suspended for Criticising Mandates, Lockdowns

A tribunal has told a New Zealand nurse she brought “discredit to the profession” for comments she made during an interview at a COVID-19 freedom demonstration in 2021.

At the rally, Debra Elizabeth Green spoke with Chantelle Baker, a self-styled social media journalist and a prominent opponent of government COVID-19 policy.

The rally was attended by those who opposed vaccine mandates, lockdowns, and were sceptical about the efficacy of vaccines.

Ms. Green, at the time working as a pool staff nurse at Christchurch Hospital, wore her uniform to the demonstration and commented to Ms. Baker about the “segregation” of unvaccinated people at the hospital.

She also said “vaccine-damaged” patients had been admitted, and that staff were “blind” to jab side-effects.

“The bulk of the patients would be vaccinated. If you’re not vaccinated you get segregated, you get put in a different part of ED, put into isolation,” she said.

“I had one consultant on my last night, she stood in front of our big board with everybody, all the patients and all their symptoms and she said, ‘What’s going on? Why have we got so many patients?’

“It’s all cardiac, cardiac, cardiac, short of breath, collapses, falls, and I just can say ... this is adverse reaction, adverse reaction,” she said in reference to myocarditis, a known side-effect of the jab.

“All of our wards are full of people having cardiac problems, people with flare-ups from their cancer, like you name it. I guarantee a hospital is full of vaccine damaged, it’s just, people were blind, people just cannot see it.”

The Nursing Council received seven complaints over Ms. Green’s appearance in the video concerning the spreading of misinformation about the vaccine, with one complainant saying her comments posed a “risk of public harm.”

Christchurch Hospital terminated her employment in November 2021 after Ms. Green refused to get vaccinated which was a breach of the health worker’s mandate as set down by the government.

Tribunal Hands Down Tough Penalties

Ms. Green was not present at the hearing, but had earlier defended her comments via a letter, in which she said her concerns were “appropriate to raise.”
“What I said regarding vaccine injuries/adverse reactions and how they were being treated by health professionals at the time, was truthful.”

She did concede however her claims were hyperbolic.

“That said … I did exaggerate the concerns I had, which I did not mean to do. For this I do wish to apologise,” she said in the letter.

The tribunal found Ms. Green’s comments were “misleading” and her conduct “carried a significant likelihood of undermining the public trust and confidence in both the public health response to the COVID-19 pandemic and the nursing profession.”

“Ms. Green was not an expert as she portrayed and had no legitimate authority to purport to whistleblow about the circumstances of the ED to Christchurch.”

A defence adopted by Ms. Green was that she had the right to freedom of expression, but this was rejected by the tribunal which stated those rights were not protected in the context of a public health emergency.

She was suspended from nursing for three months, ordered to pay $18,000, and for the next 12 months, must let prospective employers know about the tribunal’s findings.

https://www.theepochtimes.com/world/nz-nurse-fined-18000-and-suspended-for-criticising-mandates-lockdowns-5640215

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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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AstraZeneca admits to rare, deadly side effect of Covid jab as lawsuits mount

I had two shots of AstraZeneca and didn't even get a sore arm out of it -- nothing. So your mileage may vary

AstraZeneca has admitted that its Covid-19 vaccine could cause a rare but deadly blood-clotting condition, potentially exposing the UK pharmaceutical giant to lawsuits brought by loved ones of those injured or killed as a result of the jab, according to court documents.

Lawyers representing “dozens” of class-action claimants say some of their clients’ cases could be worth as much as $38 million, calling the Cambridge-headquartered pharma firm’s vaccine was “defective,” according to the Daily Mail.

Recent research from RMIT University and Monash University found Australia’s Covid-19 vaccination campaign likely prevented the death of 17,760 people aged over 50 in New South Wales between August 2021 and July 2022.

The AstraZeneca inoculation, which was also administered in Australia, has proven to be effective in combating Covid-19 with some estimates suggested it saved as many as six million lives worldwide. But it has also produced rare side effects in some people, reports the New York Post.

AstraZeneca, which is contesting the claims, acknowledged in a February legal document that its vaccine can “in very rare cases,” cause a condition called thrombosis with thrombocytopenia syndrome, or TTS.

TTS can cause patients to suffer from blood clots as well as a low blood platelet count, which in some cases have seriously harmed or even killed recipients of the company’s vaccine.

The potential complication was listed as a possible side effect from the time of the vaccine’s release, but AstraZeneca’s acknowledgment in February marks the first time the pharmaceutical titan has admitted it in court, according to the UK newspaper The Telegraph.

So far, 51 cases have been filed in London’s High Court, estimated to be worth around $190 million (GBP100 million) total, the outlet writes.

Due to a bargain AstraZeneca struck with the UK government at the height of the pandemic to indemnify the drugmaker against potential lawsuits, taxpayers will be on the hook for any payouts resulting from the claims.

One of the claimants who filed suit is Jamie Scott, an IT engineer and father of two left with a permanent brain injury resulting from a blood clot after he received the vaccine in April 2021.

His wife, Kate, told The Telegraph she’s hopeful the company’s admission will accelerate the outcome of their case.

“We need an apology, fair compensation for our family and other families who have been affected. We have the truth on our side, and we are not going to give up.”

In a statement, AstraZeneca expressed sympathy for anyone who was allegedly harmed by the vaccine, but defended it as a net positive and pointed out that complications are exceedingly rare.

“Patient safety is our highest priority, and regulatory authorities have clear and stringent standards to ensure the safe use of all medicines, including vaccines,” the statement reads in part.

“From the body of evidence in clinical trials and real-world data, the AstraZeneca-Oxford vaccine has continuously been shown to have an acceptable safety profile and regulators around the world consistently state that the benefits of vaccination outweigh the risks of extremely rare potential side effects.”

The AstraZeneca Covid vaccine was first approved for emergency use in December, 2020.

Of the 50 million doses administered in the UK during the crisis, 81 people have died from blood clots potentially linked to the jab, according to health data compiled by UK pharmaceutical watchdog the Medicines and Healthcare Products Regulatory Agency.

The odds of a recipient developing TTS as a result of the vaccine is calculated as somewhere in the range of 1 in 50,000.

In Australia, the government said the rate of TTS linked to the jab was around two people per 100,000 vaccinated.

In all, the AstraZeneca vaccine is credited with saving as many as six million lives globally during the pandemic, according to the University of Oxford, which partnered with the company in developing the jab.

https://www.news.com.au/lifestyle/health/health-problems/astrazeneca-admits-to-rare-deadly-side-effect-of-covid-jab-as-lawsuits-mount/news-story/5612826233eb8d6b4bc3783de575f8ae

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Small Chinese sample suggests link between Pfizer-BioNTech mRNA COVID-19 Vaccine and Kidney-Related Disease

A team of nephrologists and associated physician-scientists from Zhengzhou University in Zhengzhou, a city with over 10 million people in Northern China extracted the gene expression data of Peripheral Blood Mononuclear Cells (PBMCs) from 15 controls (day 0 post the second dose of Pfizer-BioNTech BNT162b2 COVID-19 mRNA vaccine) and 29 vaccinated samples (day 1–10 post second dose also of the same BNT162b2 COVID-19 mRNA vaccine) (GSE201535) from what is known as the Gene Expression Omnibus (GEO) dataset and normalization of the counts by log(x + 1) using Sangerbox.

Meanwhile, the gene expression data of glomeruli from 21 controls (living donors) and 27 IgAN were collected (GSE104948). Also in this study, focusing on the keyword “COVID-19 vaccine” was used to search the GeneCards database to screen the associated genes supporting this investigation into cases of glomerulonephritis, a kidney condition reported after the mass-scale use of COVID-19 countermeasures with IgA nephropathy (IgAN) emerging as particularly prominent.

The recent study results were published in Karger Kidney and Blood Pressure Research, and the study was conducted with the help of Henan Provincial People’s Hospital.

What is IgAN and glomerulonephritis?

Glomerulonephritis is a group of kidney diseases that cause inflammation of the glomeruli, the tiny filters inside the kidneys that remove waste and extra fluids from the blood, this condition can come on quickly or slowly, and mild cases often don’t cause any noticeable symptoms.

IgAN or IgA nephropathy is considered a rare kidney disease occurring when the body’s immune system generates antibodies in the kidneys, leading to inflammation and kidney damage. The inflammation makes it harder for the kidneys to filter waste and fluid from the blood. IgAN is also known as Berger disease.

Background to this study

The Chinese researchers point to “accumulating evidence” disclosing the risk of IgA nephropathy (IgAN) presenting shortly after the second dose of the COVID-19 mRNA vaccine. But not surprisingly, the undying mechanism remains unclear. Thus, the investigation here better understands potential molecular mechanisms.

The team downloaded both gene expression datasets of COVID-19 mRNA vaccination (GSE201535) and IgAN (GSE104948). Weighted Gene Co-Expression Network Analysis (WGCNA) in a bid to identify co-expression modules related to the second dose of COVID-19 mRNA vaccination and IgAN. Differentially expressed genes (DEGs) were screened, and a transcription factor (TF)-miRNA regulatory network and protein-drug interaction were constructed for the shared genes.

What did they find?

The use of WBCNA led to the identification of one module linked to the second dose of the Pfizer-BioNTech mRNA vaccine, with four modules linked to IgAN. Further analysis employing gene ontology (GO) uncovered “enrichment of cell cycle-related processes for the COVID-19 mRNA vaccine hub genes and immune effector processes for the IgAN hub genes.”

With 74 DEGs identified in relation to the second Pfizer dose, plus 574 DEGs for IgAN, “Intersection analysis with COVID-19 vaccine-related genes led to the identification of two shared genes, TOP2A and CEP55. The TF-miRNA network analysis showed that hsa-miR-144 and ATF1 might regulate the shared hub genes.”

Summary

The team shares in this paper a “common pathogenesis of COVID-19 mRNA vaccination and IgAN. The identified pivotal genes may offer new directions for further mechanistic studies of IgAN secondary to COVID-19 mRNA vaccination.”

https://www.trialsitenews.com/a/pfizer-biontech-mrna-covid-19-vaccine-collection-to-kidney-related-disease-35083eb8

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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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Mainstream Starts to Cover: NBC Affiliate Covers COVID-19 Vaccine Injured, Cautiously

Mainstream media has started to cover the topic of COVID-19 vaccine injury. Most recently, KARE 11 in Minneapolis thanks to Craig Norkus, a 22-year photojournalist at the media who became ill after receiving the COVID-19 jab in November 2022.

While the NBC affiliate for the Twin Cities area first acknowledges that the overall general safety of the COVID-19 vaccines has been established, this doesn’t necessarily mean that a “small group of Minnesotans claiming vaccine injury” aren’t hurting, in some cases, severely due to rare but real COVID-19 vaccine injuries.

Another TrialSite subscriber and vaccine-injured person sent the story to TrialSite, noting the NBC affiliate loaded the content with lots of accompanying vaccine-friendly information but points out that the local media finally covered the topic of COVID-19 vaccine injury.

Pointing out that recent studies evidence an overall safety profile, some questions remain unanswered. To date, KARE 11 states that no study has been able to prove that mRNA vaccines can induce neurological problems, the reality is that numerous such problems can and do ensue after vaccination.

Patient advocacy group React19, a TrialSite partner, established the Scientific Publications Directory for example. In this repository set up via a collaborative effort with TrialSite’s support, React19 now maintains 3,580 peer-reviewed studies (mostly case series) tracking various adverse event incidents post-COVID-19 vaccination.

How many of the studies involve neurological conditions? 656 studies cover some form of neurological condition associated with COVID-19 vaccination. This does not mean that each one of these studies prove that the vaccine caused the condition.

In fact, most of the studies in the online directory are case series, meaning a type of medical research design that involves the detailed examination of a small group of individuals (or just one patient) who share common characteristics or experiences. In a case series, researchers typically report on the clinical features, treatment, and outcomes of a series of patients with similar conditions or who underwent similar interventions. However, unlike a randomized controlled trial, these investigations are not designed to establish causation.

Unfortunately, the NBC affiliate doesn’t cite the React19 database, although they should. The media does refer to the recent study tracked by TrialSite involving the recent study from the National Academy of Sciences, Engineering and Medicine finding that only one adverse event with a proven link to the Pfizer and Moderna shots-- myocarditis—inflammation of the heart. The experts in the study determined the two mRNA vaccines do not cause Guillain-Barré syndrome, Bell’s palsy, thrombosis with thrombocytopenia syndrome (TTS) or heart attack. Researchers determined there's not enough evidence to accept or deny a link to any other neurological issues studied. Although, it’s clear from the React19 publication directory that incidence of GBS for example as well as Bell’s palsy are associated with these vaccines.

According to Norkus, who was a key force in getting this coverage of the COVID-19 vaccine injured after receiving the COVID-19 vaccine, “I felt like I was dying,” said Norkus. “I was lost, looking for answers, and no one had any.”

The injury presented just two days following a booster dose of the Pfizer COVID-19 vaccine. The photojournalist started suffering head and body aches, severe exhaustion, and confusion, along with cool and hot tingling in his fingers and legs.

As reported by Chris Hrapsky blood tests revealed his immune system was under attack, but five separate specialty doctors could not explain the source of his symptoms.

Yet by April last year, an osteopathic doctor diagnosed Norkus with immunosuppression and small fiber neuropathy. And Norkus’ physician now believes that Norkus’ conditions were triggered by the vaccine.

While the local media claims no study can prove an mRNA connection to Bell’s palsy, the React19 online database includes 45 peer-reviewed studies involving COVID-19 vaccination and Bell’s palsy. See the link.

TrialSite’s Brandon Bushong recently interviewed vaccine injury activist Wayne Rohde, author of “The Vaccine Court 2.0 Revised: The Dark Truth of America’s Vaccine Injury Compensation Program” who elaborates on all the ways bias impacts the system, to the detriment of those injured and in urgent need of care.

https://www.trialsitenews.com/a/mainstream-starts-to-cover-nbc-affiliate-covers-vaccine-injured-cautiously-296e7c90

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COVID-19 mRNA Vaccines Linked to Cutaneous [skin] Adverse Events—Most Non-Significant, However, Severe in Rare Cases

Dermatologist from the Department of Dermatology, Kagoshima City Hospital and University Graduate School of Medical and Dental Sciences Kagoshima, Japan investigate cutaneous adverse events (AEs) manifesting after COVID-19 vaccination.

Frequently described, the investigators led by Atsunori Baba M.D., and colleagues report the need for a larger case series and literature review and hence this specific study. Calling out for the urgent need for an extensive investigation of new cases and previous reports to better capture the unfolding evidence concerning post-COVID-19 immunization cutaneous AEs, the team sought to analyze patients with cutaneous AEs after COVID-19 vaccination in their specific hospital located in deep southern Japan on Kyushu island.

The team of physicians also reviewed studies of cutaneous AEs. Analyzing post-COVID-19 vaccination cutaneous AEs in the Kagoshima City Hospital department, the Japanese Registry, and previous literature, the investigators also enrolled 30 patients with cutaneous post-vaccination AEs in the department over 2 years (April 1, 2021, to March 31, 2023). Confirming cases registered in the Ministry of Health, Labor, and Welfare COVID-19 vaccine side effect reporting system (February 17, 2021–March 12, 2023), the study team reports 587 retrieved records, plus 93 articles were included for data extraction.

Dr. Atsunori Baba and colleagues report on the identification of a total of 28 non-injection-site cutaneous AEs and two injection-site AEs. Six (20.0%) patients developed new-onset erythematous eruptions, and five (16.7%) patients developed urticaria. Pruritic eruption, eczema, shingles, and sweating symptoms have also been reported.

Published in the peer-reviewed Journal of Dermatology, Atsunori Baba and colleagues point out that in previous studies on non-injection-site cutaneous AEs, individuals who received the BNT162b2 vaccine were older than those who received mRNA-1273 (P < 0.01).

Cutaneous AEs were mostly nonsignificant and self-limiting reactions; but the study authors report on rare, severe, or life-threatening AEs also linked to COVID-19 vaccination.

The findings lead the authors of this study to conclude that “Physicians should be aware of the various possible cutaneous AEs associated with the COVID-19 vaccination.”

https://www.trialsitenews.com/a/covid-19-mrna-vaccines-linked-to-cutaneous-adverse-eventsmost-non-significant-however-severe-in-rare-cases-a6fa4ec5

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Western Vaccines Outperform the Chinese with Significant More Protection Against Breakthrough Infection

A team of pharmacy researchers from University of Cyberjava in Persiaran Bestari, Selangor Malaysia and Serdang Hospital conducted a retrospective cohort study at a multispecialty tertiary hospital in Selangor, including 200 fully adult vaccinated patients, with confirmed SARS-CoV-2 infection, admitted from September 2021 to February 2022.

Participants were selected by simple random sampling. Infection severity was categorized as CAT 2–3 (mild–moderate) and 4–5 (severe–critical). Vaccinated with the Pfizer-BioNTech mRNA vaccine known as BNT162b2, the Malaysian team sought to learn more about mRNA vaccine performance. What were the clinical outcomes (time to breakthrough infection, intensive care unit [ICU] admission, and in-hospital mortality) of hospitalized patients with SARS-CoV-2 breakthrough infection concerning the Pfizer-BioNTech jab?

With results published in Heliyon, the authors report:
“The time to breakthrough infection was significantly longer for BNT162B2 recipients (128.47 ± 46.21 days) compared to CoronaVac (94.09 ± 48.71 days; P = 0.001) and ChAdOx1-S recipients (90.80 ± 37.59 days; P = 0.019).”

Also, the authors reported no associations involving SARS-CoV-2-related ICU admission, mortality, and the vaccines.

Based on a statistical multivariable analysis, the study’s authors point to the following as significant predictors of severity:

Vaccine type
Variant of concern
Ethnicity
Hypertension

Evidencing superior performance for the Western COVID-19 vaccines, “BNT162b2 and ChAdOx1-S recipients had significantly (81% and 74%, respectively) lower odds of CAT 4–5 infection compared to CoronaVac recipients.” The latter was developed in China.

Interestingly, from an ethnicity perspective, Indian patients faced a (83%) lower chance of CAT 4–5 infection compared to Malay patients.

For breakthrough infections, the Delta surge was more dangerous than Omicron. Patients with breakthrough infections during the latter period had a significantly (58%) lower risk of CAT 4–5 compared to those in the former (Delta). The CAT 4–5 risk was significantly (nearly threefold) higher in hypertensive patients.

https://www.trialsitenews.com/a/western-vaccines-outperform-the-chinese-with-significant-more-protection-against-breakthrough-infection-d69239f6

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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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