House Oversight Panel to Assess Efficacy of Vaccine Injury Reporting, Compensation Systems

The continued fallout from the COVID-19 vaccines’ introduction has raised questions about the effectiveness of the United States’ existing vaccine injury reporting and compensation systems.

On Feb. 15, a panel of the House Oversight and Accountability Committee will hold a hearing to examine those systems and how they might be improved for future victims. Witnesses will include officials at the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the Health Resources and Services Administration (HRSA).

“Vaccine safety systems were designed to protect public health. Unfortunately, the COVID-19 pandemic—and resulting vaccine mandates—appear to have exceeded the capabilities of these systems,” Subcommittee Chairman Brad Wenstrup (R-Ohio) said in announcing the hearing on Feb. 9.

“All the while, the Biden administration coerced healthy Americans into compliance with unscientific vaccine mandates, seemingly without having a sufficient system in place to protect and compensate individuals who were potentially harmed. This hearing is an important step to increase vaccine transparency and to ensure that victims of future vaccine injuries are properly compensated,” he said.

Caught Unawares

Since 1990, the nation’s early warning system for reporting vaccine injuries has been the Vaccine Adverse Event Reporting System (VAERS). The system is co-managed by the FDA and CDC, but anyone can submit a report, regardless of medical expertise.

And report they have. As of Jan. 26, more than 1.6 million adverse event reports have been submitted to VAERS in connection with the COVID-19 vaccines, according to OpenVAERS, a private organization that compiles and publishes VAERS data online.

Documents obtained through a Freedom of Information Act (FOIA) request also show that the sheer volume of those reports—though downplayed by health agencies—surprised officials in the months following the first vaccines’ rollout in December 2020.

More COVID-19 Vaccinations Linked to Higher Infection Risk: Study

“Two vaccines have been released since the last report. Since release the number of incoming COVID-19 reports has significantly exceeded the estimated maximum of 1,000 reports per day,” General Dynamics Information Technology (GDIT), a contractor hired to process VAERS reports, notified the CDC in a status report on Jan. 15, 2021. “As a result, GDIT is unable to meet processing and other timeframes (data processing, telephone inquiries, clinical [inquiries], etc.).”

A chart included in the report shows that the number of daily reports was substantially higher than predicted, even topping 4,500 on Jan. 10, 2021. The trend also continued for several months, resulting in a backlog of nearly 94,000 reports that took until the end of May to clear.

‘Don’t Want to Appear Alarmist’

At around the same time those reports began rolling in, the CDC was warned of a potential link between the Pfizer-BioNTech and Moderna COVID-19 vaccines and a “large number” of cases of myocarditis, a type of heart inflammation among healthy, young Israelis.

While the CDC initially planned to notify doctors and public health officials of that emerging link through its Health Alert Network (HAN), the alert was never sent.

The reason for the delay, according to an email recently obtained by The Epoch Times, was that officials did not want to incite a panic.

“The pros and cons of an official HAN are what the main discussion are right now,” wrote Dr. Sara Oliver in the May 25, 2021, missive. “I think it’s likely to be a HAN since that is CDC’s primary method of communications to clinicians and public health departments, but people don’t want to appear alarmist either.”

Other emails from that same week show that the FDA also played a role in canceling the alert in favor of issuing clinical considerations, which were published on the CDC website on May 28, 2021.

The considerations advised that “increased cases of myocarditis and pericarditis have been reported in the United States after mRNA COVID-19 vaccination (Pfizer-BioNTech and Moderna),” but still recommended COVID-19 vaccination for everyone aged 12 and older.

Compensation Complications

Cody Flint, an agricultural pilot in his 30s, was young and healthy when he received Pfizer’s COVID-19 vaccine.
That changed within an hour of getting the shot.

Mr. Flint soon began to experience intense head pressure—pressure that only worsened when he boarded a flight two days later.

“One second, I went from having burning in the back of my neck and tunnel vision to the very next second, I was slumped over in my airplane. The best way I know to describe it—it was like a bomb went off inside my head,” he said.

Four doctors diagnosed Mr. Flint as having a severe adverse reaction to the Pfizer vaccine. But for the U.S. Countermeasures Injury Compensation Program (CICP), which compensates those who can prove they have a COVID-19 vaccine injury, those diagnoses were not enough.

CICP administrators told Mr. Flint that “compelling, reliable and valid medical and scientific evidence does not support a causal association” between the Pfizer vaccine and the condition doctors diagnosed him with, perilymphatic fistula, which is a defect in the membranes separating the middle and inner ear.

They also wrote off his claim of having been injured by the vaccine as implausible “given the timeline of symptoms.”

“It’s just all comical to me,” Mr. Flint told The Epoch Times last April. “I get the shot, I’m injured within 48 hours, and they say that that makes it implausible.”

And Mr. Flint is not alone in his experience. Of the 2,214 COVID-19 vaccine injury claims the CICP had reviewed as of Jan. 1, only 40 were deemed eligible for compensation—just 11 of which have been compensated.

Decisions on CICP claims are made by the HRSA, which is housed under the Department of Health and Human Services—a fact some researchers have pointed to as a potential conflict of interest.

At its hearing next week, the House Oversight Committee will likely seek input from Dr. George Reed Grimes, director of the HRSA Division of Injury Compensation Programs, on whether that’s the case.

https://www.theepochtimes.com/article/house-oversight-panel-to-assess-efficacy-of-vaccine-injury-reporting-compensation-systems-5584419

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Adverse effects following COVID-19 vaccinations as reported in the Pubmed/Medline literature: Update and Expansion

Dr. Ronald N. Kostoff

On 24 December 2023, I published an Op-ed in Trial Site News titled “Adverse effects following COVID-19 vaccinations as reported in the Pubmed/Medline literature”. Its purpose was to demonstrate that, even with the extreme censorship of the biomedical literature (especially concerning papers that counter the official government narratives on Covid-19 issues), there exist sufficient papers in the premier biomedical literature that show the extent of myriad adverse effects following Covid-19 vaccinations. The query developed for this Op-ed retrieved ~6,200 Pubmed records.

The Gold Standard for biomedical publications focused on adverse effects following Covid-19 vaccinations is the REACT19 database. Currently, this database contains 3,580 records. My previous Op-ed (referenced above) analyzed the ~6,200 records that were retrieved from Pubmed/Medline as part of the study, and were focused on adverse effects from Covid-19 vaccinations. In the present Op-ed, I developed an expanded query to retrieve the relevant articles from Pubmed (based on lessons learned from the previous Op-ed). Use of the expanded query retrieved over 13,000 articles, of which over 90% were deemed relevant (by sampling) to adverse effects following the Covid-19 vaccinations.

The 12,000+ relevant articles retrieved for the present Op-ed and focused on adverse events following the Covid-19 vaccinations should be viewed as a very low “floor” of what exists in Pubmed. More articles could have been retrieved from a well-resourced study. Additionally, because of Pubmed proximity search limitations, the Abstracts were not searched to the full extent possible.

Because of the aforementioned censorship of the biomedical literature, credible papers on Covid-19 vaccination side-effects were retracted or rejected by the journal Editors. The number of Editorial rejections is unknown, since the public does not have access to what is submitted to the journals, and what fraction is accepted. Thus, the Pubmed published literature represents a fraction of the post-Covid-19 vaccination adverse events research has identified.

For additional background on this issue of Pubmed/Medline articles on Covid-19 vaccination after-effects, especially the limitations of the Pubmed/Medline database, see the previous Op-ed on this topic. The present Op-ed will focus on the structure of the expanded query that was developed to retrieve additional relevant articles, and will provide 1) estimates of numbers of Pubmed/Medline papers in different post-Covid-19 vaccination symptom/disease categories and 2) incidence frequencies of specific symptoms/disease terms that occurred following Covid-19 vaccinations. These results should complement the results from the text clustering categories that were generated in the previous Op-ed on this topic.

METHODOLOGY

Development of the query used to retrieve Pubmed/Medline biomedical articles on post-Covid-19 vaccination adverse effects is described in detail in Appendix 1. The 13,000+ articles that were retrieved from Pubmed were imported into Excel. Approximately 25 umbrella categories were identified by a combination of visual inspection and the text clustering categories from the previous Op-ed on this topic. A query was developed consisting of mainly root terms characteristic of each of the 25 umbrella categories, and applied to each category to extract the records from the total download that could be credibly assigned to that category. For example, if one of the 25 categories is Blood Clotting, then two of the query terms used to identify records related to blood clotting would be Thromb and Embol. If these terms are entered into the Excel filter “Contains” option, then all the records in the total download containing phrases that had a root of Thromb or Embol would be identified and selected for the Blood Clotting category. Assignment of records to multiple categories was allowed, if the records had multiple themes.

Using an excellent online N-Gram generator, Unigrams, Bigrams, 3-Grams, and 4-Grams of the Titles and Abstracts of the 13,000+ records were generated. Using visual inspection of these N-Grams, thousands of symptoms/diseases phrases in the downloaded records were identified.

The 25 categories are shown in the results, along with the titles of records in each category, the phrases used to generate these records for each category, and the main specific symptoms/diseases associated with each category (see Appendix 2, Tables 2A-1 to 2A-25, for each category). For the reader who wants to search the 13,000+ downloaded Pubmed/Medline articles for information not presented in this Op-ed, the Titles and Abstracts of the full download are contained in Table 3A-1 of Appendix 3)

RESULTS AND DISCUSSION

Table 1 summarizes the 25 umbrella categories, and the number of Pubmed records in each category. The number of records in each category should be viewed as a “floor”. The queries were developed, and the records retrieved, before the N-Grams were generated (because of the timing of major upgrades to the N-Gram generator). Some additional terms from the N-Gram results could have been added to the queries for retrieving records, resulting in greater numbers of records in each category. However, the hundreds or thousands of records that were identified for each of the 25 categories are more than enough to demonstrate the breadth of adverse events in each category that occurred post-Covid-19 vaccination.

https://www.trialsitenews.com/a/adverse-effects-following-covid-19-vaccinations-as-reported-in-the-pubmedmedline-literature-update-and-expansion.-5d876b25

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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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Real Driving Forces Behind the COVID Waves

“Stay 6 feet apart.” This unforgettable slogan was one of the first recommendations implemented when the world announced the first COVID-19 wave.

As the mysterious virus appeared and quickly spread throughout the world, countries sealed their borders, schools closed, travel was restricted, and people started working remotely. We were told to wear masks, social distance to “flatten the curve,” and get vaccines promoted as being “safe and effective.”

The COVID-19 waves have come and gone approximately seven to eight times during the last three years until May 2023, when the public health emergency and the national state of emergency for COVID-19 were officially declared over. What we experienced during that time will be etched in our minds forever.

Among a number of public health measurements taken during the COVID-19 pandemic, which factors affected the COVID waves? Social distancing? Masks? Vaccines? Or something else?

Researchers have analyzed these factors to determine their effectiveness.

Impact of Nonpharmaceutical Interventions

Many people attributed a reduction in COVID-19 cases to nonpharmaceutical health policies.

These included travel restrictions, stay-at-home orders, mask mandates, school closures, and social distancing measures. Since they have nothing to do with pharmaceuticals, they are classified as nonpharmaceutical interventions (NPIs).

More Than 400 Studies on the Failure of Compulsory Covid Interventions

However, a number of studies disagree and couldn’t find clear evidence that these interventions contributed to the decline in each COVID-19 wave.

For example, in terms of mortality, fatal cases were declining before the full United Kingdom lockdown on March 24, 2020.

A systematic review of 32 studies conducted in Europe and the United States concluded that lockdowns during the spring of 2020 had no substantial effect on reducing COVID-19 mortality.

A study that analyzed data across 169 countries covering 98 percent of the world population from Our World in Data between July 1, 2020, and Sept. 1, 2021, also did “not find substantial COVID-19-related fatality-reducing effects of the ten NPIs under investigation.”

A Nature study found no evidence that Japanese school closures significantly reduced the number of COVID-19 cases in the spring of 2020.

A randomized controlled study in Denmark indicated that mask use did not significantly reduce the infection rate compared to the control.

A newly published 2024 study analyzing COVID-19 data in six European countries (Ireland, the UK, Denmark, Sweden, Norway, and Finland) found no clear evidence indicating that NPIs effectively altered the course of the pandemic in these countries, despite common misconceptions about them.

Impact of COVID-19 Vaccine

Many have been forced to comply with overwhelming vaccine mandates, and the impact of vaccination on the pandemic has been extensively researched.

Vaccination recommendations started for people at high risk and now include everyone, even children. Initially, the expectation was to stop the virus from spreading. Later, the authorities admitted to the public that it was still possible to get COVID-19 after vaccination. We were later told it was important for reducing hospitalization rates.

Despite early promising results from clinical trials indicating significant effectiveness, it’s essential to consider that these findings were based on a relatively small number of COVID-19 cases in the vaccine trials.

For instance, the Pfizer/BioNTech trial had 43,548 participants, but only 170 confirmed symptomatic COVID-19 cases were identified across both the vaccinated and placebo groups. Although the relative risk reduction was reported as 95 percent, this was calculated from a modest sample size exerting little impact on the whole patient population, raising major questions about the reliability of the conclusions.

Countries such as Israel and the UK were leaders in rolling out vaccine campaigns during the pandemic. Yet the same nations have frequently faced new waves of the virus, often driven by emerging variants.

The previously mentioned study on six European countries concluded that despite initial high hopes, there was no clear evidence that the vaccine altered the course of the pandemic.

Impact of Seasonality

A 2021 Nature study shows that higher temperatures and higher relative humidity have consistently adversely impacted COVID-19 transmission across large geographic areas.
The European six-country study, while dismissing the role of NPIs and the vaccine in the COVID waves, concluded that the patterns of COVID-19 cases, hospital admissions, and the number of people in intensive care units were surprisingly consistent, forming a visible seasonal pattern.

SARS-CoV-2 has been shown to behave like other respiratory viruses—peaking in mid-winter and having a very low incidence during the summer.

A study on the survival of SARS-CoV-2 on surfaces found that the virus survives better in colder and drier environments.
Airborne transmission plays a significant role in spreading SARS-CoV-2. In winter, when the air is usually drier and colder, the virus is more likely to survive and spread easier.

The survival of other coronaviruses also depends on temperature and humidity, showing a clear seasonal pattern.
While seasonal patterns are a driving force behind the COVID waves, they are just one piece of the puzzle and not the entire picture.

Another Surprising Factor

There have been many unknowns with this microscopic virus that remain a mystery.

A breakthrough study in Japan published in Nature revealed an unexpected finding about the COVID-19 pandemic: how people’s changing behaviors, like isolation, might have influenced the virus’s evolution.

The researchers used detailed clinical data and complex mathematical models to understand the viral behavior during the past four years of the COVID-19 pandemic.

It was found that as the virus mutated into the Delta variant, the newer strains displayed higher and earlier peaks in the viral load within the body. However, the infection duration was relatively shorter.

This suggests that the virus mutates to become more transmissible, which counteracts the measures people take, such as self-isolation.

Researchers discovered that the virus transitioned from having a shorter incubation period to being more infectious without showing symptoms. A typical example of this is the Omicron variant.

This is the virus’s way of adapting to human behavior; it is intelligent and appears to know how to outsmart human intervention.

It’s not surprising that even the most intelligent scientists and virologists cannot predict mutations, as we have seen with recent strains like HV.1 and JN.1.

Unfortunately, this has resulted in a challenging battle between viruses and human intervention, and the variants’ microscopic tricks appear to be far superior.

Human Behavior Matters

There are other factors related to human behavior that are often ignored yet may be fundamental to driving COVID-19 waves.

In modern health care, Western medicine often fails to address the human soul, including a decline in moral values and behavior, which is linked to the root causes of disease.

Intriguingly, not everyone succumbs to viruses, even during a pandemic. This fact has been evident since the 1918 Spanish flu outbreak and has been further supported by recent COVID-19 human challenge studies. Many participants who were exposed to the virus remained infection-free.

This phenomenon points to the extraordinary capabilities of our God-given natural immunity. The real frontline where the battles between viruses and humans take place is at a microscopic level—our natural defense system, including mucosal epithelial cells on the surface of our nose, lungs, and gut.

A remarkable link exists between our thoughts, moral values and behaviors, and our body’s ability to fight viruses on this battlefield.

It’s not only about nutrition and exercise; our mental state also plays a crucial role. Science has shown that emotions such as stress, anxiety, and fear can impact our biochemistry.

Furthermore, our body, mind, and spirit interplay with each other. Positivity and purposeful living can actually boost our immune response.

A study reveals that striving for compassionate, noble goals can supercharge our body’s virus-fighting abilities. Honesty isn’t just a virtue, it strengthens our immunity by lowering stress hormones.

Embracing a positive, purpose-driven life can not only fill us with joy but can also arm us against illness. Traditional wisdom meets modern science—kindness, altruism, and calmness aren’t just good for the soul; they’re secret weapons for staying healthy.

A pivotal driving force for the virus waves may not be external but something within ourselves. In other words, our behaviors and values may have contributed to the spread of the virus.

https://www.theepochtimes.com/health/real-driving-forces-behind-the-covid-waves-5573822

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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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VAERS Data Reveals 223-Fold Increase in Myocarditis Reports Post-COVID-19 Vaccination

In the wake of the widespread distribution of COVID-19 vaccines, including Pfizer-BioNTech, Moderna and Janssen across the United States, a surge in adverse event reports was documented through the Vaccine Adverse Events Reports System (VAERS).

VAERS tracks vaccine side effects by allowing patients and healthcare professionals to report any unexpected reactions, helping authorities at the CDC and FDA to scrutinize and monitor vaccine safety. Concerns over safety issues with COVID-19 vaccination came as early as the beginning of 2021. Loss of medical licensure threatened doctors from voicing dissenting opinions. Medical professionals or news media who questioned short-term, or long-term safety with the novel vaccines, and strayed from the official public health messaging, were often censored—including this news media.

An analysis was recently published in Sage Journals, titled “Determinants of COVID-19 Vaccine-induced Myocarditis”. Myocarditis is inflammation of the heart muscle, often caused by viral infections or other immune-related conditions, and it can affect the heart's ability to pump blood effectively.

The creators of the investigation aimed to delve into VAERS data, specifically focusing on myocarditis cases, and explore the potential correlation between COVID-19 vaccines and the occurrence of myocarditis.

Utilizing statistical methods, the study assessed the frequency of myocarditis reports with respect to sex, age, and dose number, comparing them with historical values and vaccine administration data from the Our World in Data database.

The researchers uncovered troubling indications in the data. According to their analysis, myocarditis reports in VAERS following COVID-19 injection in 2021 were 223 times higher than the average of all vaccines in the past 30 years. This marked a 2500% increase in reports, with youths and males being most affected. Emergency care and hospitalization were required in 76% of cases, and 3% resulted in death. Myocarditis was more likely after the second dose, and individuals under 30 were at a higher risk.

They concluded that “COVID-19 vaccination is strongly associated with a serious adverse safety signal of myocarditis, particularly in children and young adults resulting in hospitalization and death. Further investigation into the underlying mechanisms of COVID-19 vaccine-induced myocarditis is imperative to create effective mitigation strategies and ensure the safety of COVID-19 vaccination programs across populations.”

Myocarditis and Vaccine-induced Myocarditis

Prior to the pandemic, four per million children were affected annually in the U.S., and it has been reported that 0.05% of all pediatric hospitalizations are attributed to myocarditis. This condition, more frequently identified in young males, has historical associations with various vaccines, including influenza and smallpox.

Myocarditis can present with symptoms such as chest pain, heart failure, or sudden death, posing a significant risk - especially among the young - making it the third leading cause of sudden cardiac death in children and young adults. In VAERS, myocarditis qualifies as a Serious Adverse Event (SAE).

The authors acknowledged that there were cases of myocarditis from SARS-CoV-2 infection before the rollout of vaccines. During severe COVID-19 illness, studies noted heart issues using certain codes. However, many reports didn't thoroughly check symptoms or use detailed diagnostic procedures like ECG or MRI: meaning that important diagnostic details associated with heart problems in COVID-19 might be missed in these studies.

Regarding COVID-19 vaccine-induced myocarditis, the authors wrote: “The prevalence of myocarditis reports in the VAERS system was significantly higher in the context of dose 2, males, and individuals under 30 years of age…Dose 2 was generally administered 3 weeks following the first dose – assuming the individual survives dose 1 without any major complications, including death. Figure 4 reveals five times more reports of myocarditis for dose 2 in 15-year-old males and regardless of age, myocarditis cases were more frequent following dose 2.”

The observation suggests a dose-response relationship, indicating potential cumulative and more damaging effects with each additional dose. “In such cases, it is possible that myocarditis was subclinical after dose 1 and became symptomatic after dose 2. We found 70% of all reports of myocarditis were filed within 7 days and 43% were made within 48 hours. Following dose 2, 77% of reports were filed within 7 days and 48% within 48 hours, thus providing more evidence of clinical concern and a temporal relationship with the injections.”

If signs of myocarditis are present after the first dose, the vaccinations should end there, and clinical monitoring should begin. “Because the duration of action of genetic material coding for spike protein is unknown, long-term follow-up with cardiology consultation may be advised in cases with possible repeat imaging and biomarkers.”

Why the Young and Athletic Might Be at Risk

Based on numerous autopsy studies involving suspected vaccine-induced myocarditis deaths, a theory has been formed that may explain why young males and athletes are particularly vulnerable.

Worldwide expert in both Endocrinology and Sports Medicine fields, Dr. Flavio A. Cadegiani, holds a unique endocrinological perspective to Physical Activity. In his Op-ed published by TrialSite News, Cadegiani examined multiple studies that provided evidence for a converging cause: that catecholamines, mostly represented by noradrenaline and adrenaline, are the “key triggers” of myocarditis and sudden deaths caused by COVID-19 mRNA vaccines.

This is more simply explained as an adrenaline surge feedback loop. With young males and athletes having the highest amount of catecholamines in their system, it’s likely the reason why this group experiences an overload after vaccination. This theory corroborates with the determination of Connecticut’s Medical Examiner who published a case-study on his autopsies of two teen boys who died in their sleep within days of COVID-19 vaccination.

Estimating the Bigger Picture

The article shared some disheartening information regarding “the spontaneous reporting nature of VAERS,” implying that the reported cases are likely not rare, but rather represent a fraction of the total occurrences. Acknowledging the significant under-reporting issue with VAERS, the study cautions against using it alone to estimate population incidence. With 3,078 reported myocarditis cases by August 11, 2023, and considering an under-reporting factor of 31, the study estimates the actual number of myocarditis cases in the United States to be around 95,418. If considering the under-reporting factor for the Foreign VAERS data-inclusive, this estimate becomes 564,696 since 83% of myocarditis reports are found in the Foreign VAERS data set.

https://www.trialsitenews.com/a/vaers-data-reveals-223-fold-increase-in-myocarditis-reports-post-covid-19-vaccination-prompting-heightened-scrutiny-c40e23c8

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AstraZeneca is facing tens of millions of pounds in compensation claims from 35 alleged victims of the Covid jab in High Court legal battle

The pharmaceutical giant, which developed its jab in partnership with the University of Oxford, is set to face a High Court battle over claims the vaccine is 'defective'.

It has been linked to a newly identified condition called Vaccine-Induced Immune Thrombocytopenia and Thrombosis (VITT) which causes blood clots.

At least 81 people have died due to complications linked to the very rare side effect while hundreds of others have also suffered illness as a result.

In what may be one of the biggest cases of its kind, more cases are expected to be lodged, meaning the vaccine manufacturer could face up to £80million in compensation payouts if it loses, according to The Telegraph.

The government indemnified AstraZeneca and other vaccine manufacturers as it sought to roll out vaccines during the pandemic.

Under Vaccine Damage Payment scheme, victims of certain vaccines, including ones used to beat Covid, are entitled to a one-off 'all-or-nothing' sum of £120,000 from the Government.

Tory MP Sir Jeremy Wright, whose constituent Jamie Scott suffered a 'significant permanent brain injury' from a blood clot after getting the job in 2021, has urged the government to take action.

The former Attorney General said: 'The public need the confidence to know they will be looked after if in the tiny, tiny minority of cases where the vaccine has gone wrong.

'And that confidence is damaged if the Government does not step in and settle these cases.'

The claimants are suing under the Consumer Protection Act, suggesting that the vaccine was not as safe as those who received it were led to believe.

AstraZeneca is fighting the claims, calling them 'confused' and 'wrong in law'.

The company has also pointed to the millions of lives the vaccine is believed to have saved in its first year of rollout.

The AstraZeneca vaccine is not being used as part of the UK's booster programme after experts recommended mRNA vaccines – such as the Pfizer or Moderna jabs – should be used instead.

Vaccine complications have been listed on the death certificates of a number of people who were administered the AstraZeneca jab.

Dr Stephen Wright, 32, died from a blood clot to the brain ten days after having his first dose of the AstraZeneca jab in January 2021.

In April last year, a coroner ruled the vaccine should be added to Dr Wright's death certificate.

In another case, a rock musician known as Lord Zion suffered a severe headache and was admitted to hospital eight days after receiving the jab.

His condition worsened and he passed away in hospital on May 19, with the preliminary death certificate listing a brain bleed caused by vaccine complications as the cause.

His partner Vikki said she is still 'pro-vaccine' following his death, but called on the Government to better educate medical staff on the side effects and rework the Vaccine Damage Payment Scheme.

https://www.dailymail.co.uk/news/article-12989257/AstraZeneca-millions-pounds-compensation-claims-Covid-jab-High-Court.html

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Also see my other blogs. Main ones below:

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

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

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

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

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

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

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

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

COVID-19 Vaccination Rates Near Collapse in Europe--Market for mRNA Vaccines in Danger

The European Center for Disease Prevention and Control (ECDC) releases the COVID-19 vaccination coverage data for the 2023-24 season vaccination campaigns. The ECDC by September 2023, updated its COVID-19 vaccination coverage data analysis process. The latest data report is an interim description of COVID-19 vaccination in the European Union/European Economic Area (EU/EEA) between September 2023 and January 2024.

What becomes clear is much like in America, a precipitous drop in COVID-19 vaccination rates. In fact, TrialSite suggests a collapse in market demand, such a collapse that the vaccine makers will consider their options as time progresses to the next vaccination season.

A handful of countries on the continent report high rates (Denmark for example) but the overall rates have plummeted. A pattern emerges in that eastern nations in Europe have all but dropped the mRNA vaccine product. Moderna is locked out of the lucrative European market, and while Pfizer’s partnership with Germany’s BioNTech ensured it the overwhelming lead position, its COVID-19 vaccine and antiviral sales all but collapsed.

During the reporting period, 24/30 EU/EEA countries reported data on COVID-19 vaccination coverage for at least one target group (people aged 60 years and above, people aged 80 years and above, healthcare workers, individuals with chronic conditions, pregnant women). Approximately 19.4 million people during this period, aged 60 years and up received one COVID-19 vaccine dose.

At least 5.5 million people aged 80 years and above opted to receive the jab. The median COVID-19 vaccination coverage among the most high-risk cohorts in Europe—persons aged 60 years and above equaled 11.1% (range 0.01-65.8%). This specific median indicates the rates skewed to the lower end. The even more high-risk cohort of 80 years of age and up were vaccinated at 16.3% (0.01-88.2%) with high variation among countries, but clearly among the whole content much like in America the demand for COVID-19 vaccination all but collapsed.

Only a handful of nations’ populations went out in force to get the COVID-19 jab during the 2023-2024 season. Of the 24 European countries reporting, three countries reported a vaccination coverage of ≥50% for the age group 60 years and above, while eight countries reported a vaccination coverage of ≥50% for the age group 80 years and above.

What was the most used vaccine brand? The Pfizer-BioNTech product was originally developed by Germany’s BioNTech. A majority of the 22.7 million COVID-19 vaccine doses administered in the EU/EEA during this period in the overall population were the Comirnaty Omicron XBB.1.5 (Pfizer BioNTech) vaccine (around 22 million doses; 97% of the total doses administered). Moderna’s all but cut out of the European market which should have a profound impact on its vaccine sales forecasts.

The ECDC reminds all analysts that the preliminary results herein must be interpreted with caution. A higher degree of data consolidation and data completeness is expected in the coming weeks and months.

https://www.trialsitenews.com/a/covid-19-vaccination-rates-near-collapse-in-europe-market-for-mrna-vaccines-in-danger-950cc45e

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Australian Employer Ordered to Pay Compensation for Vaccine Injured in ‘Significant Precedent’

An Australian court has ordered an employer to pay weekly compensation and medical expenses to an employee after ruling that a vaccine injury that occurred from a workplace directive is compensable under the law.

Daniel Shepherd, 44, worked as a child and youth support worker with South Australia’s Department of Child Protection when he developed pericarditis after receiving his third Pfizer COVID-19 vaccine in February 2022.

Pericarditis is inflammation of the pericardium, a thin sac that surrounds the heart. The condition is reported to be more common in males aged 18 to 49, with an estimated 27 cases per 100,000 doses.

Mr. Shepherd was told by his employer that his employment would be terminated if he did not receive the third dose of the Pfizer COVID-19 vaccine. The directions for the mandate were made under Section 25 of South Australia’s Emergency Management Act in January 2022, which required support and healthcare workers to receive a third dose of the COVID-19 vaccine to continue working.

Mr. Shepherd received two COVID-19 vaccinations on Aug. 19, 2021, and Sept. 9, 2021, respectively, according to documents submitted to the South Australian Employment Tribunal.
On the first dose, Mr. Shepherd experienced aching joints, cold, and flu symptoms, and minor chest pain for one to two weeks. He experienced similar symptoms on his second dose.

Mr. Shepherd then received his third booster dose on Feb. 24, 2022, after receiving a message from his employer saying that employees needed to have a third dose of vaccine within four months of having a second vaccine.

The following day, Mr. Shepherd experienced severe chest pain, which worsened over the next two weeks.

On March 11, 2022, the chest pain was so unbearable that he felt “like someone was kneeling on his chest.” Having thought he was experiencing a heart attack, Mr. Shepherd was taken by ambulance to the Ashford Hospital, where cardiologists diagnosed him with pericarditis.

The 44-year-old husband and father of a 5-year-old boy noted some improvement four to five months after the chest pain; however, further episodes of severe chest pain followed and symptoms returned.

Mr. Shepherd has not worked since March 2022, except for two months when he worked part-time in an administrative role.

Vaccine-Injured Files Claim Against the State

Mr. Shepherd filed a claim for compensation against his employer, the State of South Australia, which was initially rejected.

The state had initially contested the connection between the vaccine and the injury but later acknowledged that the third dose caused Mr. Shepherd’s pericarditis and subsequent incapacity to work.

Despite that, the state argued that the injury didn’t arise from his employment under the Return to Work Act, and that the injury was linked to the Emergency Management Act.

The state argued that if criteria under the Return to Work Act are met, they are exempt from liability in relation to the broader management of the pandemic under the Emergency Management Act.

But Tribunal deputy president Judge Mark Calligeros rejected those arguments.

“The injury was a direct consequence of an Emergency Management Act vaccination direction and of Mr. Shepherd’s employment,” Judge Calligeros said.

“The connection between employment and the injury is a strong one, given I have found that Mr. Shepherd would not have had a third dose of the vaccine if he had not been required to in order to continue working.

“The state required Mr. Shepherd to be vaccinated to continue working in a healthcare setting because it sought to protect and reduce the risk of infection to the public and general and those members of the public receiving healthcare services in particular.

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

“The rejection of Mr. Shepherd’s claim should be set aside, and it should be ordered instead that he receive weekly payments of income support and payment of medical expenses.”
Ongoing Pain

Currently, Mr. Shepherd tires easily, and becomes tired after walking his son to school, some 400 metres (437 yards) from his home. Prior to the injury, he was able to hike up and down Mount Lofty, walk, and do Chinese boxing, which he is now unable to do.

In an interview with 9News, Mr. Shepherd said he now has the heart of a 90-year-old. “Even today with just mild exertion [I get] chest pains and then it’s followed by fatigue, like severe fatigue,” he said. “It’s heartbreaking to have to say, ‘Sorry buddy, daddy’s tired’.”

In a social media post, Senator Gerard Rennick said the ruling is a “significant precedent.”

“[E]mployers are now going to think twice about forcing people to get a vaccine if they have to fork out for potentially significant medical costs if the employee then incurs a vaccine injury,” Mr. Rennick said.

“This is only one case, and I suspect it will be appealed.

“I hope the decision is upheld because it will then open up the option of employers suing governments who mandate vaccines or pharmaceutical companies for unsafe or ineffective vaccines.”

https://www.theepochtimes.com/world/australian-employer-ordered-to-pay-compensation-for-vaccine-injured-in-significant-precedent-5579036

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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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mRNA COVID-19 Vaccines Caused More Deaths Than Saved: Study

With considerably lower efficacy rates, mRNA COVID-19 vaccines cause more deaths than save lives, according to a new study whose researchers called for a “global moratorium” on the shots and “immediate removal” from childhood immunization schedule.

The peer-reviewed study, published in the Cureus journal on Jan. 24, analyzed reports from the initial phase 3 trials of Pfizer and Moderna COVID-19 mRNA vaccines. These trials led to the shots being approved under Emergency Use Authorization (EUA) in the United States. The study also looked into several other research and reviews of the trials. It found that the vaccines had “dramatically lower” efficacy rates than the vaccine companies claimed.

Moreover, based on “conservative assumptions, the estimated harms of the COVID-19 mRNA vaccines greatly outweigh the rewards: for every life saved, there were nearly 14 times more deaths caused by the modified mRNA injections.”

“Given the well-documented SAEs (serious adverse events) and unacceptable harm-to-reward ratio, we urge governments to endorse and enforce a global moratorium on these modified mRNA products until all relevant questions pertaining to causality, residual DNA, and aberrant protein production are answered.”

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

“It is unethical and unconscionable to administer an experimental vaccine to a child who has a near-zero risk of dying from COVID-19 but a well-established 2.2 percent risk of permanent heart damage based on the best prospective data available.”

Very Low Efficacy Rate

Following the first trials of Pfizer and Moderna, it was claimed that mRNA COVID-19 vaccines had a 95 percent reduction of symptomatic COVID-19. The study pointed out that this efficacy assumption was false

Pfizer’s claim was based on the fact that only eight out of 22,000 vaccine recipients contracted COVID-19 during the trial compared to 162 out of 22,000 people in the placebo group. In total, 170 confirmed COVID-19 cases were reported in both groups.

However, the researchers pointed out that a large number of infections fell under the “suspected” COVID-19 category, which was ignored. A total of 3,410 such suspected cases were identified in the trial, which is 20 times the 170 confirmed cases.

“There were 1,594 such cases in the vaccinated group and 1,816 in the placebo. When factoring in both confirmed and suspected cases, vaccine efficacy against developing symptoms drops to only 19 percent, far below the 50 percent RR (relative risk) reduction threshold required for regulatory authorization,” the study said.

“Thus, when considering both confirmed and suspected cases, vaccine efficacy appears to have been dramatically lower than the official 95 percent claim.”

The study’s authors declared no financial support from any organization for their work. A few conflict of interest disclosures were made.

One author received a grant from Quanta Computer Inc. Another author, cardiologist Peter A. McCullough, declared employment and owning stock/stock options in The Wellness Company. A third author is the founder of the Vaccine Safety Research Foundation (VSRF).

Lives Saved Versus Deaths

Researchers criticized the Pfizer and Moderna trial reports for “exclusive focus” on relative risk or RR measure while omitting absolute risk reduction. They argued that absolute risk reduction “gives a better indication of a drug’s clinical utility.”

“Both types of risk estimation are required to avoid reporting bias and to provide a more comprehensive perspective on vaccine efficacy. Omitting the absolute risk statistics leads to overestimation of the clinical benefits of the vaccines.”

In contrast with the 95 percent efficacy rate using the RR measure, absolute risk reduction for Pfizer and Moderna vaccines were 0.7 percent and 1.1 percent, respectively, the study stated.

“An absolute risk reduction of approximately 1 percent for the COVID-19 mRNA vaccinations meant that a substantial number of individuals would need to be injected in order to prevent a single mild-to-moderate case of COVID-19.”

To prevent one case of COVID-19 infection, 142 individuals would need to be vaccinated with Pfizer’s shot, the study said. When it came to Moderna, 88 people had to be injected.

Taking into account these numbers as well as the infection fatality rates of COVID-19, the researchers concluded that roughly 52,000 people would need to be vaccinated to prevent one COVID-19-related death.

This would mean two lives saved for roughly 100,000 injections of the Pfizer vaccine. However, there is a risk of 27 deaths per 100,000 doses of Pfizer shot, the researchers calculated. As such, for every life saved by the jab, almost 14 lives would be lost due to the mRNA vaccine, the study stated.

Authors noted that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) “did not include absolute risk reduction measures” when reviewing vaccine data.

This action deviated from FDA guidelines “which state that both approaches are crucial in order to avoid the misguided use of pharmaceuticals.”

Serious Adverse Events

Researchers cited a September 2022 analysis to detail the pervasiveness of serious adverse effects (SAE) among the vaccinated group in the trials. The analysis looked at both Pfizer and Moderna trial data, discovering roughly 125 SAEs per 100,000 vaccine recipients. This indicated one SAE per 800 vaccines.

“The Pfizer trial exhibited a 36 percent higher risk of serious adverse events in the vaccine group (compared to placebo) … The Moderna trial exhibited a 6 percent higher risk of serious adverse events in the vaccine group,” the analysis stated.

“These findings stand in sharp contrast with the FDA’s initial claim that SAEs reported by the two pivotal trials were ‘balanced between treatment groups,’” researchers from the Jan. 24 study noted.

This discrepancy could be because the FDA only counted the number of individuals with serious adverse events rather than the total SAEs experienced by the trial subjects, they said.

Since a single person can have multiple SAEs, counting only individuals would produce a lower number than the total number of such adverse events.

“When the SAEs were viewed collectively, the risks in the vaccine group were substantially elevated beyond those previously determined by the FDA,” the researchers wrote.

The analysis found that the excess risk of serious adverse events of special interest (AESI) among the placebo group was 10.1 per 10,000 individuals. However, the risk reduction for COVID-19 hospitalization in this group was only 2.3 per 10,000 people.

This meant that the subjects were at over four times the risk of suffering AESIs after getting vaccinated than they were of getting hospitalized from the infection. In the Moderna trial, subjects were more than two times at risk of experiencing AESI than being hospitalized.

“To put these findings in perspective, the official SAE rate for other vaccines is only 1-2 per million,” the Jan. 24 study said. The 2020 analysis’ “estimate based on the Pfizer trial data (1,250 SAEs per million) exceeds this benchmark by at least 600-fold.”

Rushed Vaccines

In the Jan. 24 study, researchers noted that the safety of mRNA products was “never assessed” in a manner consistent with scientific standards for vaccines or for gene therapy products (GPT), which they claim is “the more accurate classification” for these jabs. “Many key trial findings were either misreported or omitted entirely from published reports.”

The usual safety testing protocols and toxicology requirements were bypassed by the FDA and vaccine manufacturers. As the two trials were terminated prematurely, there was never an “unbiased assessment” of potential serious adverse events.

“It was only after the EUA that the serious biological consequences of rushing the trials became evident, with numerous cardiovascular, neurological, reproductive, hematological, malignant, and autoimmune SAEs identified and published in the peer-reviewed medical literature.”

In addition, the COVID-19 mRNA vaccines produced and evaluated in the trials were not the same ones that were manufactured and administered to people around the world. The global vaccination campaign used a vaccine produced by a different process, which has been shown to have “varying degrees of DNA contamination.”

The researchers pointed out that several excess deaths, cardiac events, strokes, and other serious adverse events have wrongly been ascribed to COVID-19 rather than the COVID-19 mRNA vaccines since early 2021.

Injuries from these vaccines overlap with both post-acute COVID-19 syndrome (PACS) and severe acute COVID-19 illness, which end up often obscuring the vaccine’s contribution to such conditions. “Multiple booster injections appear to cause immune dysfunction, thereby paradoxically contributing to heightened susceptibility to COVID-19 infections with successive doses.”

For the “vast majority” of adults below 50 years of age, the perceived benefits of the mRNA vaccines were dwarfed by their “potential disabling and life-threatening harm.” The study said older adults may be at higher risk of such harm.

CDC and FDA Criticized

Commenting on the study, Mat Staver, the founder and chairman of nonprofit Liberty Counsel, said that in the paper, scientists “confirm what sound scientific research has been showing for years, that these shots have never been safe nor effective.”

“The FDA and the CDC are supposed to protect the people, but they have become the lapdog of the pharmaceutical industry. This must change.”

The CDC is currently under scrutiny for suppressing an alert for myocarditis from COVID-19 vaccination. Myocarditis is an inflammation of the heart muscle called the myocardium.

A document recently obtained by The Epoch Times shows that in May 2021, the CDC had prepared a draft alert for myocarditis related to the jabs.

The agency was supposed to send the alert to federal, state, and local public health officials and doctors nationwide through its Health Alert Network (HAN). However, the alert was never sent as some officials were worried about appearing “alarmist.”

https://www.theepochtimes.com/health/for-every-life-saved-mrna-vaccines-caused-nearly-14-times-more-deaths-study-5579794

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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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Hiatus

Ill today.. Should be back Sunday

FDA minimizes side effects of Updated COVID-19 Vaccines

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

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

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

The signals were detected in a database from Carelon Research.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

“We found the number of myocarditis reports in VAERS after COVID-19 vaccination in 2021 was 223 times higher than the average of all vaccines combined for the past 30 years,” the researchers said.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Also see my other blogs. Main ones below:

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

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

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

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

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

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

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

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

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Before Pandemic Preparations, We Need Better Evidence Of Risk

Written by Meryl Nass MD

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

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

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

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

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

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

So, What Is The Evidence On Pandemic Threat?

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

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

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

while on page 20:

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

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

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

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

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

So, What Is The Quality Of The Evidence?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Also see my other blogs. Main ones below:

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

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

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

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

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

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

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

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

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COVID Vaccine Trials Show Counting Window Issues

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

Written by Raphael Lataster, PhD

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Background

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

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

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

Purpose of this Study

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

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

Findings

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

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

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

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

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

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Also see my other blogs. Main ones below:

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

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

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

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

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

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

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

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

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

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

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

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

The alert was never sent.

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

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

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

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

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

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

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

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

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

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

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

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

Moderna, Pfizer Given Heads Up

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Scaled-Down Response

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

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

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

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

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

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

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

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

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

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

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

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

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

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Also see my other blogs. Main ones below:

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

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

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

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

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

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

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

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

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