Friday, May 10, 2024

More censorship from Google

My article on this blog: "Key Ingredient in Pfizer and Moderna COVID Shots Aids Cancer Development, New Study Shows" has been deleted by Google. As host of Blogspot, they can do that. It appeared on May 1st and reported a study by an international group of authors that appeared in an academic journal. So it is a surprising bit of censorship. The article is still online at the site I got it from:


Thursday, May 09, 2024

New Study From Czech Republic Confirms Covid Vaccines Have Around Zero Efficacy Against Death

Dr. Eyal Shahar

In 2021, we were flooded with visuals showing us how effective the mRNA vaccines were against death from Covid.

We saw, for example, that the Covid mortality graph of those who completed the two-dose protocol was substantially lower than that of the unvaccinated. To strengthen the point, we were shown a consistent pattern across age groups or after age adjustment.

Much of this was an illusion. Back then, they did not display comparable graphs for non-Covid deaths. If they did, we would have seen that the vaccinated also fared better on non-Covid mortality. Of course, no one expects these vaccines to prevent death from cancer, heart disease, stroke and so on.

The pseudo-effectiveness of Covid vaccines against death from unrelated causes is not a new observation. The same kind of pseudo-effectiveness was discovered long ago for the flu vaccines. It is called the ‘healthy vaccinee effect’.

For various reasons unrelated to the vaccines, people who are vaccinated have better background health on average than people who are not, and therefore they are less likely to die from ‘anything’, including flu and Covid. Vaccinated or not, they would have had lower Covid mortality than their unvaccinated counterparts.

When we try to estimate the effect of Covid (or flu) vaccines, the healthy vaccinee effect becomes the healthy vaccinee bias, a source of distortion that must be removed. (Conversely, we may call it the ‘unhealthy unvaccinated’ bias.) Research on this topic has been sparse, however.

Neither the pharmaceutical industry nor public health officials have had an interest in discovering that common vaccines were not as effective as they claimed them to be, or perhaps not effective at all.

A recent study from the Czech Republic has made significant contributions to the scientific literature on Covid vaccines and the healthy vaccinee effect. First, the authors observe the phenomenon in an additional country, lending support to its universal nature. Second, they provide clear evidence that those who chose (or were coerced) to be vaccinated were indeed healthier.

Third, they show that the phenomenon is consistent along the sequence of doses, as was evident in U.K. data for booster doses: those who continued to the next dose were healthier than those who did not. Lastly, they demonstrate that the observed pattern in their data can be reproduced by simulated data when a vaccine has no effect and only the healthy vaccinee effect is operating. It is worth reading the paper in full, whether or not you are a science specialist.

What was done in the study?

The authors computed rates of all-cause death in periods of Covid waves and in periods of low (almost no) Covid deaths. The latter are essentially rates of non-Covid death, which means that any ‘effect’ of the Covid vaccines during these periods is a pseudo-effect: it is the healthy vaccinee phenomenon alone. In each period, they compared the mortality rate between the unvaccinated and various groups of vaccinated people.

I will discuss one key topic: the pseudo-effect of the two-dose protocol, starting four weeks after the second dose when people are considered fully protected. To focus on that group versus the unvaccinated, I added oblique arrows to Figure 2. Notice that these bars show rates, not counts, of deaths in a period with low Covid deaths (green panel). Again, although these are deaths from any cause, 99.7% were not related to Covid. Therefore, they may be considered rates of non-Covid death, and that’s what I will call them.

In each age group, the rate of non-Covid death in the effectively vaccinated (yellow) is much lower than the rate in the unvaccinated (black). Of course, that’s a pseudo-effect of the vaccines. That’s the healthy vaccinee effect, or bias when trying to estimate the true effectiveness against Covid death.

The authors kindly provided their data, which are summarised in my table for the low-Covid period.

As you can see from the computation, the ‘bias factor’ (last row) is simply the inverse of the pseudo-effect of vaccination. It tells us how much more likely the unvaccinated are to die ‘in general’, as compared with those who completed the two-dose protocol at least four weeks earlier. Formally, it should be called the bias correction factor, but we’ll keep it short.

My next table compares the results from the Czech Republic to data from the U.K. and the U.S. in similar age groups (my computation from the available data).

Notably, the bias factor in data from different countries and cultures varies in a narrow range: between 2 and 3.5. It is lower in the oldest age group but is still at least 2. Overall, the unvaccinated are two to three times more likely to die from various causes than the fully vaccinated.

Other data indicate that the gap narrowed over time (because unvaccinated survivors were ‘healthier’ as time went on and some of the less healthy died), but it lasted months, not a few weeks. When a third dose was introduced, the healthier moved to the three-dose group, leaving behind a sicker group of ‘only two doses’.

As a result, the two-dose group now appeared to have higher mortality than the unvaccinated. This observation was mistakenly interpreted as evidence of vaccine-related deaths (which unquestionably happened).

To remove the healthy vaccinee bias, we multiply the biased rate ratio of Covid death by the bias factor, as explained elsewhere. For example, if the biased rate ratio of Covid death is 0.4 (60% ‘vaccine effectiveness’) and the bias factor is 2.5, the correct effect on Covid death is 0.4 × 2.5 = 1, which is 0% vaccine effectiveness.

I will conclude with another example of the healthy vaccinee bias and the true effectiveness after correction.

A study of U.S. veterans presented survival graphs of fully vaccinated and unvaccinated elderly people following a PCR test (figure below). I will consider a death following a positive PCR as ‘Covid death’ and a death following a negative PCR as ‘non-Covid death’.

It is just an approximation, of course, but that’s all we can get from the paper to distinguish between the two types of death. Studies of Covid vaccines rarely report data on non-Covid death by vaccination status, so we often have to derive such data from whatever is provided.

I visually estimated the risk of death at three time points, where the survival probabilities for a pairwise comparison were close to the marks on the Y-axis (2% intervals). My rough estimates are summarised in the busy table below.

As you can see, correcting for the healthy vaccinee bias has changed estimates of effectiveness from around 70% to around 10%. And that’s not the only bias in observational studies of Covid vaccines. Differential misclassification of the cause of death is another strong bias. Would any effectiveness have remained if all the biases could have been removed? Were lives indeed saved by these vaccines?

Let me end with a comment not on Covid vaccines, but on flu vaccines.

If you look at the U.S. CDC website, you will find data on the effectiveness of the flu shot each year. Usually, it does not exceed 50% in the elderly (a risk ratio of 0.5). By now, you should be able to compute the correct effectiveness, say, with a bias factor of 2.


The Predictable Wastes of COVID Relief

If you ever had the vague sense that COVID relief funding worked in a manner akin to U.S. aid packages in failed Middle Eastern dictatorships, your instincts weren’t wrong.

First off, there were cases of just outright fraud nearing the $200 billion mark with drug gangs and racketeers collecting COVID unemployment benefits from the U.S. government, with some recipient fraudsters not even having the common decency of being honest American fraudsters.
Even worse, though, were some legitimate uses of COVID funds that actually counted as legitimate despite being laughably frivolous or clearly unrelated to nominal goals connected to public health or helping communities deal with the economic impact of the virus—or, more accurately, the lockdowns.

One of the most should-be-satirical-but-actually-real examples of a legitimate use of COVID cash was a researcher at North Dakota State University being awarded $300,000 by the National Science Foundation through a grant funded at least in part through the American Rescue Plan Act of 2021 to aid her in her 2023 efforts to reimagine grading in the name of equity. (If none of that makes sense, please don’t hurt yourself with mental pirouettes.)

Other more mundane projects pertained to prisons and law enforcement using COVID relief money for purposes that extended well-beyond simply paying salaries or keeping the lights on. In 2022 The Appeal and The Marshall Project reported on how large sums of COVID money went to prison construction and expansion projects and to outfit police departments with new weaponry, vehicles, and canines. Regardless of how you feel about law enforcement or our prison system, these probably did little to stop the spread of COVID or keep out-of-work bartenders afloat while public health bureaucrats consulted horoscopes or goat entrails or their equally useful models to divine the proper time to let businesses reopen safely at half-capacity to diners willing to wear a mask between bites but too afraid to leave their homes.

Yet, of course, that didn’t stop people from trying to make the case that these expenditures absolutely were essential to slowing the spread. Often coming off like precocious children explaining to their parents how a new puppy would help teach them responsibility or an overpriced pair of sneakers would facilitate their social-emotional development by ensuring the cool kids would like them, local sheriffs and city managers were reported as claiming prison expansions could help prisoners social distance from each other, new tasers would help officers social distance from suspects, and new vehicles would allow officers to take their cars home with them rather than share one with another officer who might end up contaminating it with their COVID cooties.

But even worse than the funds that were outright plundered or just snatched up as part of a cash grab were those that were used on projects that helped further erode the freedoms of American citizens.

As documented in a 2023 report from the Electronic Privacy Information Center, more than seventy local governments used ARPA funds to expand surveillance programs in their communities, purchasing or licensing gunshot detection systems, automatic license plate readers, drones, social media monitoring tools, and equipment to hack smartphones and other connected devices.

Sometimes EPIC reported that this was done with little, if any, public debate over the civil liberties and privacy concerns inherent to these tools. In one case from a town in Ohio, approval for ARPA-funded ALPRs—cameras that can create a searchable, time-stamped history for the movements of passing vehicles—came after only a 12-minute presentation by their police chief.

Similarly, schools also likely used money from ARPA, as well as the 2020 Coronavirus Aid, Relief, and Economic Security Act, for their own surveillance purposes, although documentation of how schools used their COVID money is said to be somewhat spotty at best.

Vice News in 2021 reported how Ed Tech and surveillance vendors such as Motorola Solutions, Verkada, and SchoolPass marketed their products as tools to help reduce the spread of COVID and allow schools to reopen safely.
Some attempts such as Vice’s description of SchoolPass presenting ALPRs as a means to assist with social distancing come off like police departments explaining the social distancing benefits of tasers.

Others, however, such as Motorola plying schools with lists of behavioral analysis programs that “monitor social distancing violations” and room occupancy while “automat[ing] the detection of students who are not wearing face masks,” seem to offer a glimpse of the dystopian future into which we are heading—as do the other surveillance tools bought with COVID cash.

Maybe at some point Disease X, about which our ruling class has been warning us, will hit and the additional drones, ALPRs, and social media monitoring tools bought by the law enforcement agencies reported on by EPIC will be used to monitor adults for social distancing violations and automatically detect who isn’t wearing a mask. Maybe those tools will just be used to keep a digital notebook of the daily activities of everyone while police reassure us that they promise only to look at it when they really really need to.

In either case, though, if you currently have the vague sense that post-COVID America is a little more like a Chinese surveillance state than in the Before Times, your instincts are dead-on.




Wednesday, May 08, 2024

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.


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.




Tuesday, May 07, 2024

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.'


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.




Monday, May 06, 2024

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 St├ęphane 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.

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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."

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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.




Sunday, May 05, 2024

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.’


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.