Thursday, February 01, 2024


Ill today.. Should be back Sunday

Wednesday, January 31, 2024

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.


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.




Tuesday, January 30, 2024

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.




Monday, January 29, 2024

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.


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.


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.


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.




Sunday, January 28, 2024

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.