Study: COVID-19 vaccination is 'strongly associated with a serious adverse safety signal of myocarditis'

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The U.S. government, the mainstream media, and so-called experts long downplayed the possibility of a link between heart inflammation and COVID-19 vaccines. Elements of the medical establishment and social media companies worked to shut up those who dared to press the issue.

Health officials and their stenographers in the media later admitted an elevated risk of myocarditis among mRNA COVID-19 vaccinees, especially among boys and young men. Despite belated advisories to this effect from the Food and Drug Administration and the Centers for Disease Control and Prevention, little changed in the way of the prevailing narrative: the supposed benefits of the vaccines outweighed the risks, which allegedly remained mild and rare.

A new peer-reviewed study published Saturday in the pharmacotherapy journal Therapeutic Advances in Drug Safety has thrown some more cold water on that persistent narrative, indicating 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."

"COVID-19 vaccines induce an uncontrolled expression of potentially lethal SARS-CoV-2 spike protein within human cells, have a close temporal relationship of events, and are internally and externally consistent with emerging sources of clinical and peer-reviewed data supporting the conclusion that COVID-19 vaccines are deterministic for myocarditis, including fatal cases," the study claims.

The study is the result of an effort on the part of Texas cardiologist Peter McCullough, biologist Jessica Rose, and researcher Nicolas Hulscher to further explore links between COVID-19 vaccination and heart inflammation using the vaccine adverse events report system.

On the basis of data in VAERS — a system created and implemented by the FDA and CDC in 1990 — the researchers examined the frequency of myocarditis reports in the aftermath of COVID-19 vaccination and compared their findings with past reports from other vaccines that have been rolled out over the years.

The researchers found that upon the massive rollout of the mRNA COVID-19 vaccines in 2021, there was a significant spike in the number of myocarditis reports, "far higher than the reports from all other vaccines combined over the previous 30 years. This side effect was mostly reported in young individuals, especially males."

The spike represented a 2,500% increase in the "absolute number of reports in the first year of the campaign when comparing historical values prior to 2021."

Contrary to governmental claims of mildness, the study found that most of those who reported myocarditis required emergency medical care or hospitalization, and 92 individuals reportedly succumbed to the apparently vaccine-induced affliction.

The study highlighted that the COVID-19 vaccines, which were rushed through safety and efficacy trials inside a 10-month period as opposed the years-long process that novel genetic products customarily undergo, continue to be recommended to everyone 6 months of age and older. The researchers suggested this recommendation should be axed, at the very least for children.

"Children have a negligible risk for COVID-19, and yet they are a high-risk group for myocarditis from COVID-19 vaccination," wrote the researchers. "The World Health Organization's current vaccination advice states that healthy young people ages 6 months to 17 years are a 'low priority group' and that vaccinating this group has limited impact on public health."

The researchers stressed further in their paper that "myocarditis resulting in hospitalization and death attributable to the COVID-19 vaccines may be viewed as an excess risk of the injection program" because, despite claims to the contrary, the vaccines never stopped transmission and there "are no prospective, double-blind, randomized, placebo-controlled trials of COVID-19 injectable products demonstrating reductions in COVID-19 hospitalizations and deaths as primary or secondary endpoints."

"We believe COVID-19 vaccination may pose more harm to children than theoretical benefit. This corroborates actions taken by Sweden, Norway, and Finland in 2021 when health officials suspended the use of Moderna injections in young people due to the detection of safety signals for an increased risk of myocarditis," added the researchers.

Europeans are not the only ones who have spared their children from the novel vaccines. Florida Gov. Ron DeSantis' administration has recommended against COVID-19 vaccination for children and young men since March 2022.

McCullough said of his study, "If vaccines cannot demonstrate acceptable safety profiles or be modified to improve safety, they must be removed from the market. Don't accept 'unavoidable harms' and freedom from liability for the manufacturers. These data demonstrate COVID-19 vaccines are not safe."

Dr. Jordan Peterson responded to the study on X, writing, "I think it's about time to lay some criminal charges." He added in a subsequent message, "This is utterly terrible."

Katy Faust, the head of the children's rights group Them Before Us, tweeted, "The pressure to vaccinate my teenagers was overwhelming. From schools, from doctors, from friends, from public establishments that shut them out. A pox on all the medical professionals who pushed this at the risk of children's lives and long-term health."

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WHO issues alert about 'unusual' cluster of deadly infant myocarditis cases in the UK

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The United Kingdom has been rocked by a cluster of deadly cases of myocarditis in babies.

The World Health Organization issued an alert Wednesday, indicating that there was an "increase in severe myocarditis in neonates associated with enterovirus infection in Wales" between June 2022 and March 2023.

The UK Health Security Agency (UKHSA) confirmed the report, noting that a "higher than average number of cases" of enterovirus had been seen in "very young babies" in the fall and winter months, reported the Telegraph.

The biggest spike in myocarditis cases occurred in November.

The International Committee on Taxonomy of Viruses noted that enteroviruses, a genus of single-stranded RNA viruses, "multiply primarily in the gastrointestinal tract or the upper respiratory tract or sometimes both, but they can also multiply in other tissues, e.g., nerve, muscle, etc. Infection may frequently be asymptomatic. Clinical manifestations include common cold, mild meningitis, encephalitis, myelitis, myocarditis and conjunctivitis."

While enterovirus infection in babies is reportedly common, the WHO acknowledged that the "increase in myocarditis with severe outcomes in neonates and infants associated with enterovirus infection is unusual."

Fifteen babies have been afflicted under these "unusual" circumstances. Nine babies are known to have been admitted to the hospital. One child has died. All were less than 28 days old. As of May 5, one patient remains hospitalized.

Several of the babies rushed to intensive care presented features of sepsis and cardiorespiratory arrest extra to having inflamed hearts.

Since there are no specific antiviral therapies available for enteroviruses, treatment focuses on prevention of complications, said the WHO.

Dr. Christopher Williams, consultant epidemiologist for Public Health Wales, said in a statement, "This cluster is unusual due to the number of cases reported in a relatively short time frame, and so investigations are now ongoing in collaboration with the paediatric team in the children’s hospital of Wales to understand the reasons why and to investigate any further cases that may be reported in the coming weeks and months."

Williams added, "Parents should be reassured that although there has been an increase in cases, this is still an extremely rare occurrence."

The Daily Mail detailed the case of one newborn, just a few weeks old, who died on March 9 in southwest England. While the boy, Elijah Edwards, tested positive for enterovirus, his case was not included in the official tally, suggestive that the problem may have affected more than the officially reported 15 babies.

Elijah's mother, Joann Edwards, said her family has been ignored and that she was "gobsmacked" to learn that other children were affected, especially after her family was "led to believe that we were a one-off."

"To be left in the dark made us feel then like as if there's something to hide," Joann Edwards told the BBC.

Dr. Shamez Ladhani, a consultant pediatrician at UKHSA, indicated that officials were looking into whether England had suffered similar cases and "whether there are any factors driving the increase in cases."

While some scientists reckon the cluster was an anomaly — perhaps the result of testing or diagnostic quirks — not all are convinced.

The Telegraph reported that some reckon "it could have been brought about due to changes in epidemiology as a result of Covid pandemic lockdowns."

Dr. Liz Whitakker, a consultant in pediatric infectious diseases at Imperial College Healthcare NHS Trust, said, "What I think is slightly unusual about this one, like with everything else, is there weren’t many in 2021. ... It may be that the epidemiology of everything has shifted a bit so they have occurred in a slightly different time period," noting various other contagions, such as group A strep, have undergone changes in infection patterns following the lockdowns.

A 2021 study in the infectious disease journal Eurosurveillance indicated there was a "rapid increase" in enterovirus infections following the COVID-19 lockdowns. Babies under 3 months accounted for 5% of enterovirus D68 infection cases; 4- to 12-month-olds represented 11% of the total number of cases detailed in the study.

An April 2022 study published in the journal Infection revealed "an extraordinary increase in the number of viral respiratory infections, predominantly caused by human Rhino-/Enterovirus and respiratory syncytial virus (RSV), was observed after relaxation of preventive measures," adding that enterovirus infections increased 16-fold after reopening.

Despite the uncertainty surrounding the unusual cluster, health officials continue to reassure parents that there is no need to be worried, reported the Telegraph.

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CBS News' medical contributor claims young people suffered unprecedented spike in heart attacks because of a lack of masking and vaccinations

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CBS News' medical contributor Celine Gounder insinuated Monday that the young people who suffered an unprecedented spike in lethal heart attacks during the first two years of the pandemic might only have themselves to blame.

While the Centers for Disease Control and Prevention is among the agencies and experts that have acknowledged a link between the COVID-19 vaccines and heart issues, Gounder suggested that the spike in heart attacks was instead likely resultant of young people with generally stronger immune systems not getting vaccinated and failing to wear masks.

What are the details?

Gounder, editor at large for public health at Kaiser Health News, spoke to CBS News about a recent national study conducted by doctors at Cedars-Sinai Hospital, which showed a spike in heart attacks during the pandemic across all age groups, but in the 25- to 44-year-old age group in particular — a demographic previously not regarded to be at high risk of cardiac arrest.

The study, based on data analysis from the Smidt Heart Institute at Cedars-Sinai and published in the Journal of Medical Virology, found that heart attack death rates "took a sharp turn" and spiked during the pandemic, including during the Omicron phase of the pandemic when mRNA COVID-19 vaccines were ubiquitous.

Dr. Yee Hui Yeo, the first author on the study, said, "The dramatic rise in heart attacks during the pandemic has reversed what was a prior decadelong steady improvement in cardiac deaths."

The researchers recognized that "infections such as the flu can increase risk for heart disease and heart attack," but noted that "the sharp rise in heart attack deaths is like nothing seen before."

The study ultimately showed that there were 143,787 heart attack deaths in the year prior to the onset of the pandemic. However, in 2020, this number increased by 14% to 164,096.

According to Cedars-Sinai, the "excess in acute myocardial infarction-associated mortality has persisted throughout the pandemic, even during the most recent period marked by a surge of the presumed less-virulent Omicron variant."

The relative rise in heart attack deaths was most pronounced in the youngest group. By 2021, "the 'observed' compared to 'predicted' rates of heart attack death had increased by 29.9% for adults ages 25-44, by 19.6% for adults ages 45-64, and by 13.7% for adults age 65 and older."

Cedars-Sinai appeared keen to attribute the spike in heart attacks to multiple factors, including trends that long predated the pandemic, but failed to mention the vaccines. Among the possible reasons given were that COVID-19 may have accelerated preexisting coronary artery disease or that chronic stress resultant of job loss and other financial pressures set them off.

Yeo noted, "There are several potential explanations for the rapid rise in cardiac deaths in patients with COVID-19, yet still many unanswered questions."

Blame game

Gounder joined CBS News' Tony Dokoupil and Lilia Luciano on Monday to discuss the study's findings.

"So the 25- to 44-year-olds — you saw this 30% increase in the risk of death from heart attack. And that really is quite striking," said Gounder. "That's not a group, an age group, in which you normally see heart attacks, much less dying from a heart attack."

Dokoupil said, "You look at the years prior to the pandemic and the typical rate of heart attack death in that age group, and then you see it increase and you wonder, what’s the new variable? And so the pandemic is that the new variable?"

"That's right," answered Gounder, reiterating the researchers' point that in the years leading up to the pandemic, heart attacks were actually on the decline.

When answering why younger people in particular suffered a spike in fatal heart attacks, Gounder admitted that there was no confirmation that many of the deceased had COVID-19 to begin with: "We don't know for sure. And in fact, these death certificates are probably not even capturing the fact that [the victims] had COVID. They're really just saying that you died from a heart attack or not."

"What we do know, however, is that younger people were less likely to protect themselves against COVID than older people, less likely to mask, less likely to take other mitigation measures, and they were also further back in line to get vaccinated. ... Those might have been a factor here," claimed Gounder.

\u201cHeart attack deaths in young adults rose during first two years of COVID-19 pandemic\nSource: CBS News (YouTube)\u201d
— Wittgenstein (@Wittgenstein) 1676409990

Gounder took to Twitter to double down on her speculations, concluding that people should get vaccinated and wear masks to minimize their risk of heart attacks.

\u201c7/ How can you reduce your risk of heart\ud83e\udec0attack from COVID?\n\ud83d\udc89getting vaccinated\n\ud83d\ude37wearing a mask, especially in indoor public spaces during COVID surges\ud83d\udcc8\n\ud83e\ude9fventilation & air filtration\u201d
— C\u00e9line\u00a0Gounder,\u00a0MD, ScM, FIDSA \ud83c\uddfa\ud83c\udde6 (@C\u00e9line\u00a0Gounder,\u00a0MD, ScM, FIDSA \ud83c\uddfa\ud83c\udde6) 1676414796

A recent study cast doubt on the benefits of one of Gounder's recommendations.

"Interestingly, 12 trials in the review, ten in the community and two among healthcare workers, found that wearing masks in the community probably makes little or no difference to influenza-like or COVID-19-like illness transmission," British epidemiologist Tom Jefferson, co-author of the Cochrane Library's report on masking trials, noted in the Spectator. "Equally, the review found that masks had no effect on laboratory-confirmed influenza or SARS-CoV-2 outcomes. Five other trials showed no difference between one type of mask over another."

The Telegraph reported on another study that found young men were "six times more likely to suffer from heart problems after being jabbed than be hospitalised from coronavirus."

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FDA advisory committee considers risk of heart inflammation from Moderna's COVID-19 vaccine

The U.S. Food and Drug Administration's vaccine advisory committee heard testimony Tuesday that Moderna's COVID-19 vaccine may carry a higher risk of heart inflammation in young men than the vaccine produced by Pfizer/BioNTech.

A panel of outside experts met Tuesday to consider whether the emergency use authorization for Moderna's mRNA vaccine should be expanded to include children ages 6 to 17 years old. The advisory committee will consider expert testimony from FDA scientists and then vote on whether Moderna's shot should be approved for children alongside Pfizer's COVID-19 vaccine.

Data presented to the committee by Dr. Tom Shimabukuro, a vaccine safety official at the U.S. Centers for Disease Control and Prevention, suggested that people ages 18 to 39 had a higher risk of myocarditis if they took the Moderna vaccine compared to those who had received the Pfizer shot.

But Shimabukuro cautioned that these findings were not consistent across U.S. databases, and he emphasized that heart inflammation remains a rare vaccine side effect.

According to the CDC, as of May 26, 2022, there have been 635 reports of myocarditis in children ages 5-17 who took the Pfizer vaccine. Putting that number in context, Shimabukuro said there have been nearly 55 million total Pfizer vaccine doses administered over the same period. Most of those that developed heart inflammation problems were adolescent boys who had received a second vaccine dose.

All children who reported having myocarditis recovered at least somewhat after it was diagnosed, and 80.1% of those diagnosed fully, or probably fully, recovered, according to a CDC survey of health care providers that treated them.

Comparing the Moderna vaccine to the Pfizer vaccine, Shimabukuro said there were slightly higher reporting rates of myocarditis for Moderna and that the reporting rate was higher in males.

Data from three U.S. vaccine safety databases showed the risk of myocarditis and pericarditis in young males aged 18-39 was 1.1 to 1.5 times higher after the Moderna shot, he said.

More CDC data on 18- to 39-year-olds showed 4.41 excess heart inflammation cases per 100,000 who took the Pfizer vaccine compared to 6.27 excess cases per 100,000 for Moderna. The Moderna vaccine is administered in higher doses than the Pfizer vaccine.

The FDA also reviewed Moderna's studies showing the efficacy of the vaccine in children 6 to 17. Officials said the vaccine was 93% effective among adolescents 12-17 and 77% effective in younger children. While these results met the agency's criteria for success, FDA officials warned that a booster shot will likely be needed for children, just like adults, because the vaccine's effectiveness wanes over time.

If the advisory committee votes to approve Moderna's vaccine for children, the question will go back to the FDA which must decide whether to take the committee's recommendation.

The committee will meet again Wednesday to consider whether the Pfizer and Moderna vaccines should be approved for use in infants under 5.

CDC considers adjusting COVID-19 vaccine schedules to lower risk of heart inflammation

The U.S. Centers for Disease Control and Prevention is considering changes to its COVID-19 vaccination schedule to reduce the risk of heart inflammation from mRNA vaccine shots.

During a meeting Friday, members of the CDC's Advisory Committee on Immunization Practices presented data that suggests there have been higher rates of myocarditis after receiving an mRNA COVID-19 vaccine, especially in young men. Advisory panel chairwoman Dr. Grace Lee said that a longer time period between vaccine doses could be safer and also improve the vaccine's effectiveness, according to the Washington Examiner.

“[The data is] ... fairly convincing that an extended interval is not only potentially safer from a myocarditis standpoint, but also potentially more effective,” Lee, a medical officer at the Lucile Packard Children’s Hospital at Stanford, said.

The advisory cited studies from Canada and England that suggested a longer period between vaccine doses reduced the risk of myocarditis and pericarditis, two kinds of heart inflammation that can be rare side effects of mRNA vaccination.

“The longer interval resulted in lower myocarditis rates, whereas the shorter interval had higher myocarditis and pericarditis rates,” Dr. Bryna Warshawsky of the Public Health Agency of Canada said.

Current CDC guidelines state that the two-dose Pfizer-BioNTech mRNA vaccine shots should be given three weeks apart, while the Moderna vaccine doses have a four-week period between shots.

The panel recommended that the guidelines be changed to allow for eight weeks between vaccine doses. The CDC has not yet decided whether to adopt the recommendations.

Increasing the time between primary vaccine doses would mean it will take longer for people who receive an mRNA vaccine shot to be considered "fully vaccinated" against COVID-19. It would also mean vaccinated individuals may have to wait longer to get a booster dose.

The CDC also on Friday released new recommendations for individuals with compromised immune systems.

The agency said that immunocompromised people who've completed the primary COVID-19 vaccine schedule and who have taken one booster shot should wait at least three months before receiving a second booster dose.

This is a reduction in time between booster doses from the previous recommendation, which was to wait at least five months after the third COVID-19 shot before getting a fourth shot.

The new guidelines apply to people age 18 and older who have taken the Moderna vaccine, as well as those 12 and older who have had the Pfizer shot.

Immunocompromised individuals who were vaccinated with the Johnson & Johnson vaccine are recommended to get an mRNA vaccine dose at least 28 days after the first shot, followed by a third booster dose at least two months later.

LIVE: CDC Advisors Meet on Moderna COVID-19 Vaccine

Study: Higher than expected rate of heart inflammation reported among vaccinated US military members

A study of U.S. military members who were vaccinated against COVID-19 found a higher than expected rate of heart inflammation reported by those who received the vaccine, though cases of this adverse effect are still extremely rare.

The study, published Tuesday, took a retrospective look at patients serving in the military who were vaccinated with an mRNA vaccine between January and April 2021. A total of 23 male patients ages 20-51, 22 of whom are currently serving and one who is retired, showed symptoms associated with myocarditis (heart inflammation) within four days after receiving their vaccine shots. These patients received either the Pfizer and BioNTech or Moderna vaccines.

Throughout this period, the military administered more than 2.8 million vaccine doses. Estimates predicted that eight or fewer patients would report heart inflammation out of the 436,000 male military members who received two COVID-19 vaccine shots.

"While the observed number of myocarditis cases was small, the number was higher than expected among male military members after a second vaccine dose," the study said.

All patients received brief supported care and had recovered or were recovering from their symptoms by the time the study was published.

The study notes that incidents of heart inflammation were not reported following vaccination in any of the clinical trials of current COVID-19 vaccines. "Adverse cardiac events of any kind were reported in less than 0.1% of trial participants, and rates were not higher in recipients of vaccine compared with placebo. The inability to identify rare adverse events is understandable in preauthorization testing since fewer than 20 000 participants received a vaccine in each trial," the study said.

The bottom line is that while some people who receive an mRNA COVID-19 vaccine may report chest pain and other symptoms of heart inflammation, those cases are extremely rare. The risks of the vaccines must be weighed against the benefits of immunization against COVID-19 — which is also known to cause heart inflammation.

"Recognition of the substantial morbidity associated with COVID-19 infection, including risk of cardiac injury, and the strong effectiveness of immunization in preventing infection provide important context for this topic," the study said. "Concerns about rare adverse events following immunization should not diminish overall confidence in the value of vaccination."

Last week, the U.S. Centers for Disease Control and Prevention issued an update on reported cases of heart inflammation in people who have received an mRNA vaccine.

"Since April 2021, there have been more than a thousand reports to the Vaccine Adverse Event Reporting System (VAERS) of cases of inflammation of the heart—called myocarditis and pericarditis—happening after mRNA COVID-19 vaccination (i.e., Pfizer-BioNTech, Moderna) in the United States," the CDC said.

The cases were mostly reported among male adolescents and young adults age 16 years or older within days after receiving their second vaccine shot.

"These reports are rare, given the hundreds of millions of vaccine doses administered," the CDC said. The agency continues to recommend COVID-19 vaccination for everyone 12-years-old and older given the risk of COVID-19 illness and possibly severe complications.

One-third of Big Ten athletes with COVID-19 have heart inflammation, Penn State doctor says

Penn State's director of athletic medicine said Monday that roughly one-third of Big Ten athletes who have tested positive for COVID-19 have heart inflammation, according to the Centre Daily Times.

Dr. Wayne Sebastianelli said during a State College Area school board of directors meeting that 30% to 35% of the infected athletes showed signs of myocarditis on their MRIs. Concern over the condition was at least part of the reason the Big Ten canceled its fall football season.

"When we looked at our COVID-positive athletes, whether they were symptomatic or not, 30% to roughly 35% of their heart muscles (were) inflamed," Sebastianelli said, the Centre Daily Times reported. "And we really just don't know what to do with it right now. It's still very early in the infection. Some of that has led to the Pac-12 and the Big Ten's decision to sort of put a hiatus on what's happening."

Myocarditis, Sebastianelli said, can have a noticeable impact on an athlete's performance capacity, and can be potentially fatal if it is not treated in a timely manner.

"You could have a very high-level athlete who's got a very superior VO2 max and cardiac output who gets infected with COVID and can drop his or her VO2 max and cardiac output just by 10%, and that could make them go from elite status to average status," Sebastianelli said. "We don't know that. We don't know how long that's going to last.

"What we have seen when people have been studied with cardiac MRI scans — symptomatic and asymptomatic COVID infections — is a level of inflammation in cardiac muscle that is just alarming," Sebastianelli continued.

The Big Ten released its fall football schedule on Aug. 5, with plans for a 10-game season beginning in early September. Six days later, the conference totally changed course, canceling the fall season and expressing hope that they could play in the spring.

At the time of the cancellation, Commissioner Kevin Warren explained to ESPN that concerns over testing and contact tracing capacity, as well as an increased number of cases, led to the cancellation.

"Trends have not improved, they've become worse," Warren told ESPN in August. "You add that up, and you're getting ready to go into more formal practice, it's just a level of not only concerns, but unknown risks are large. When you're dealing with the health of human beings, it's serious."

Between the release of the schedule and the sudden cancelation, a notable report came out — a report published by ESPN one day before the cancelation detailing concerns about myocarditis, which at that time had been found in five Big Ten athletes.

Interestingly, while Warren has canceled football for the Big Ten, his own son is set to play this fall at Mississippi State. The SEC, ACC, and Big 12 conferences did not cancel their fall schedules.