Dr. Robert Malone: ‘Rotten to the Core’ FDA Knew COVID Vaccines Could Spur Viral Reactivation, But Said Nothing

Authors:  Debra Heine May 17, 2022

American Greatness

The Food and Drug Administration (FDA) was aware early on that the COVID vaccines could spur viral reactivation of diseases like the varicella-zoster virus (shingles) in some people, but chose not to disclose it, according to renowned vaccinologist and physician Dr. Robert Malone.

“They knew about the viral reactivation,” Malone declared during a recent panel discussion hosted by Del Bigtree with fellow Global COVID Summit physicians Dr. Ryan Cole, and Dr. Richard Urso.

Malone, the original inventor of mRNA and DNA vaccination technology, explained that he had been “very actively engaged” with senior personnel at the FDA in the Office of the Commissioner when the vaccines were being rolled out. The group, he noted, included Dr. William DuMouchel, the Chief Statistical Scientist for Oracle Health Sciences.

“We were talking by Zoom on a weekly or twice a week basis,” he said, regarding the early data on what risks were associated with vaccines.

“This is the group that first discovered the signal of the cardiotoxicity, the doctor continued. “They also knew at that time—one of them actually had the adverse event early on of shingles. They knew that the viral reactivation signal—which the CDC has never acknowledged—was one of the major known adverse events.”

Malone told the panel that it was a mistake to assume that the CDC and FDA—because they stayed silent—were unaware of the risk of viral reactivation associated with the vaccines.

“They absolutely did know, and they did not acknowledge it. It’s another one of those things that is inexplicable,” he said.

Malone pointed out that there are supposed to be strict rules in place for clinical researchers developing “these types of products.”

“You have to characterize where it goes, how long it sticks around, and how much protein it makes, or what the active drug product is. None of that stuff was done very well. It wasn’t done rigorously, and there was a series of misrepresentations about what the data were,” he said. “And the thing is, the FDA let them get away with it. They did not perform their function. They’re supposed to be independent gatekeepers.”

Normally, he pointed out, the FDA pays close attention to the the process, and if there are any red flags, the research is halted.

“What happened here is the regulatory bodies gave the pharmaceutical industry a pass,” Dr. Malone said, adding that Big Pharma also “misrepresented key facts about their product.”

“On the basis of that, average docs just assumed that this was something that it wasn’t. They assumed that this was a relatively benign product that didn’t stick around in the body. All of that is false,” he said.

“Many of us have been wracking our brains as you have to understand how this could possibly happen, why it’s possibly happening, and why is our regulatory apparatus, which we as physicians had all come to assume had a function that actually did the job that we could believe in and trust, and what we find out now is the whole house of cards is rotten to the core,” Malone concluded.

On May 11, the Global COVID Summit, a symposium of 17,000 other physicians and medical scientists from around the world, released its fourth declaration demanding that the state of medical emergency be lifted, scientific integrity restored, and crimes against humanity addressed.

COVID policies imposed over the past two years “are the culmination of a corrupt medical alliance of pharmaceutical, insurance, and healthcare institutions, along with the financial trusts which control them,” the signatories declare. “They have infiltrated our medical system at every level, and are protected and supported by a parallel alliance of big tech, media, academics and government agencies who profited from this orchestrated catastrophe.”

This “corrupt alliance” continues, they state,  “to advance unscientific claims by censoring data, and intimidating and firing doctors and scientists for simply publishing actual clinical results or treating their patients with proven, life-saving medicine.”

“These catastrophic decisions came at the expense of the innocent, who are forced to suffer health damage and death caused by intentionally withholding critical and time-sensitive treatments, or as a result of coerced genetic therapy injections, which are neither safe nor effective,” the signatories said.

The Centers for Disease Control and Prevention (CDC) on Friday released new data showing a total of 1,261,149 reports of adverse events following COVID-19 vaccines that were submitted between Dec. 14, 2020, and May 6, 2022, to the Vaccine Adverse Event Reporting System (VAERS).

According to the data, there was a total of 27,968 reports of deaths in that time frame, and 228,477 serious injuries.

Despite these alarming safety signals, the FDA on Tuesday approved of a booster dose of the Pfizer-BioNTech COVID-19 shot for children 5 through 11 years of age, even though research shows that the shots provide no benefit to children, and can, in fact, cause serious adverse effects and death.

Latest CDC Data Shows FULLY Vaccinated Children Have Higher Covid Infection Rates Than Unvaccinated Children

Authors:  Julian Conradson Published May 18, 2022  The Gateway Pundit

As the Biden Administration green-lights another experimental jab of mRNA for 5-11-year-olds, the latest CDC data reveals children of that age have a higher Covid infection rate than their unvaccinated peers. In other words, kids who are jabbed are more likely to catch Covid, which also means the vaccinated are spreading the virus more than the unvaccinated.

So, these kids must take their boosters… Must be that dang science again.

According to the latest CDC data, children aged 5-11 have been contracting Covid at a higher rate if they have been fully vaccinated since February, which is the first time the agency recorded more vaccinated Covid cases than unvaccinated.

On Feb. 12, the CDC reported a weekly case rate among fully vaccinated children aged 5-11 of 250.02 per 100,000, compared to 245.82 among the unvaccinated children in the same age group.

Although the vaccines were billed as and promised to be ‘effective,’ they definitely aren’t living up to being anything close to it. Since February, the infection rate among vaccinated children remained higher through the third week of March, which is the latest available data published – and things are trending in the wrong direction.

As of March, the difference in the case rates has nearly doubled, with the most recent numbers showing a -11 gap (36.23 per 100,000 [vaxxed] / 26.98 per 100,000[unvaxxed]).

The breakdown of the case rate for 5-11-year-olds between Feb. and Mar. is as follows:

February 19: 136.61 per 100,000 [vaxxed] / 120.63 per 100,000[unvaxxed]

February 26: 71.81 per 100,000 [vaxxed] / 61.52 per 100,000[unvaxxed]

March 5: 56.67 per 100,000 [vaxxed] / 40.61 per 100,000[unvaxxed]

March 12: 42.56 per 100,000 [vaxxed] / 28.75 per 100,000[unvaxxed]

March 19: 36.23 per 100,000 [vaxxed] / 26.98 per 100,000[unvaxxed]

The Biden Administration and the FDA authorized the experimental vaccine for children in this age group in November of 2021. In just three short months, enough children had become vaccinated and the case rate flipped. Any protection the jab provided quickly wore off, making the fully vaccinated children more susceptible to and more likely to spread the virus than the unvaccinated.

In all, there are over 28 million children aged 5-11 in the United States. Unfortunately, a whopping ~8 million of them (or 28.8%) have been fully vaccinated already, according to the Mayo Clinic. Not only is the virus proven to be effectively non-lethal for children, especially ones of this young age (99.995% or higher recovery rate), but the experimental vaccine has proven to have negative effectiveness – aka higher infection rate – across multiple age groups.

In addition to the poor results, the mRNA vaccine has been directly linked to serious and life-threatening side effects that have become prevalent in the wake of its rollout. Most concerningly of which – myocarditis – is popping up at an unprecedented rate in otherwise healthy children and young people all across the world. According to heart experts like Dr. Peter McCullough, who is the most published Cardiologist in the world, “an extraordinary number of young individuals that are going to have permanent heart damage” because of this experimental jab. 

Keep in mind, Fauci, Biden, and the rest of the tyrannical public health bureaucracy just Ok’d boosters for 5-11-year-olds. Considering everything that’s publicly available, let alone what the federal government has compiled, this is beyond criminal. How much more data is needed to pull these shots off the market?

Japan reports first case of mysterious children’s liver disease as health experts explore possible Covid links

Authors: Karen Gilchrist PUBLISHED TUE, APR 26 2022 CNBC

KEY POINTS

  • Japan has detected its first probable case of a mysterious liver disease that has so far affected over 170 children, largely in Britain.
  • Health experts are exploring its possible links to Covid-19 or a common virus known as adenovirus.
  • Of those infected, one child has died and 17 have required liver transplants.

Japan has detected its first probable case of a mysterious liver disease that has so far affected over 170 children, largely in Britain, as health experts explore its possible links to Covid-19.

Japan’s Health Ministry said Tuesday that a child had been hospitalized with an unidentified type of severe acute hepatitis — or liver inflammation — in what is thought to be the first reported case in Asia.

As of April 23, at least 169 cases of the disease have been detected in 11 countries globally, according to the World Health Organization. The vast majority of those have been in the U.K. (114), followed by Spain (13), Israel (12) and the U.S. (9). The addition of Japan marks the 12th country to identify a case.

Of those infected, one child has died and 17 have required liver transplants.

The WHO said it is “very likely more cases will be detected before the cause can be confirmed.”

Health experts explore Covid links

Children aged five years old or younger have so far been the most widely affected by the disease, though cases have been detected in children aged one month to 16 years.

Common symptoms including gastroenteritis — diarrhea and nausea — followed by jaundice or yellowing of the skin and eyes.

Health experts are now investigating the likely cause of the outbreak, which was first reported in the U.K. in January 2022, and whether it bears any connection to the coronavirus.

Specifically, they are exploring if a lack of prior exposure to common viruses known as adenoviruses during coronavirus restrictions, or a previous infection with Covid-19, may be related. Alternatively, the genetic make-up of hepatitis may have mutated, resulting in an easier triggering of liver inflammation.

Crucially, experts say there is no known link to the Covid-19 vaccine.

A strain of adenovirus called F41 is so far looking like the most probable cause, according to the U.K. Health Security Agency.

“Information gathered through our investigations increasingly suggests that this rise in sudden onset hepatitis in children is linked to adenovirus infection. However, we are thoroughly investigating other potential causes,” Meera Chand, UKHSA’s director of clinical and emerging infections, said.

Adenovirus was the most common pathogen detected in 40 of 53 (75%) of confirmed cases tested in the U.K. Globally, that number was 74.

Covid (SARS-CoV-2) was identified in 20 cases of those tested globally. Adenovirus and Covid-19 co-infection was detected in 19 cases.

The new case from Japan tested negative for adenovirus and the coronavirus, though officials have not revealed other details.

What are the symptoms and how worried should we be?

Typically, children gain exposure — and immunity — to adenoviruses and other common illnesses during their early childhood years. However, pandemic restrictions largely limited that early exposure, leading to more serious immune responses in some.

Adenoviruses, which present cold-like symptoms such as fever and sore throat, are generally mild. However, some strains can display liver tropism, or a favoring of liver tissue, which can lead to more serious consequences like liver damage.

Just how serious this latest outbreak will be is not yet clear and will depend largely on how much it spreads over the coming months, according Dr. Amy Edwards, an assistant professor of pediatrics at the Case Western Reserve School of Medicine.

“Adenovirus is a ubiquitous virus and it’s not seasonal. If this is a more severe form of adenovirus that causes liver disease in children, that’s very concerning. But right now it’s isolated enough and few enough cases not to jump to conclusions,” she told CNBC.

Edwards said health authorities had been placed on alert and would be monitoring the situation.

In the meantime, parents and guardians should be alert to common signs of hepatitis, including jaundice, dark urine, itchy skin and stomach pain, and contact a health care professional if they are concerned.

“Normal hygiene measures such as thorough handwashing (including supervising children) and good thorough respiratory hygiene, help to reduce the spread of many common infections, including adenovirus,” UKHSA’s Chand said.

“Children experiencing symptoms of a gastrointestinal infection including vomiting and diarrhea should stay at home and not return to school or nursery until 48 hours after the symptoms have stopped,” she added.

Children get long Covid, too, and it can show up in unexpected ways

Authors: Jen Christensen, Fri May 6, 2022 CNN

November 10 is a day Kim Ford remembers too well. It was the day last year when her 9-year-old son, Jack, was scheduled to get his Covid-19 vaccine at the school clinic. They were excited that he’d finally have some protection, but on November 9, he had the sniffles. “When he woke up [November 10] and he was feeling even worse, I said, ‘You know what, let’s test you before you go in, because I don’t want you to get the Covid vaccine if you actually have Covid,’ ” the Michigan mom said.

Jack tested positive for Covid-19 that day and he’s lived with the symptoms ever since. it has kept him from staying at school all day. He has to limit how much he plays baseball with the other neighborhood kids. Even playing Fortnite for too long can leave him feeling sick the next day.

He’s one of potentially millions of kids with long Covid.

“My stomach hurts. It’s kind of hard to breathe. You have a stuffy nose. It’s just an absurd amount of things that you can feel,” Jack Ford said. “It’s really annoying at times. It’s not like a cold, you know, it feels like Covid.”People may think you’re feeling faking it, but you’re not faking it. You feel like you have Covid,” he added.

‘An undiagnosed issue’

It’s not clear how many children go on to develop long Covid, because there’s not enough research on it in this age group, some experts say.

Almost 13 million children have tested positive for Covid-19 since the start of the pandemic, according to the American Academy of PediatricsStudies suggest that between 2% and 10% of those children will develop long Covid, but the number may be larger. Many parents may not know their child has long Covid, or the child’s pediatrician hasn’t recognized it as such. In adults, some research puts the number around 30% of cases .”I personally believe that this is a very much an undiagnosed issue,” said Dr. Sara Kristen Sexson Tejtel, who helps lead a long Covid pediatric clinic at Texas Children’s Hospital in Houston. Many doctors treating children at long Covid clinics across the country say they have long waits for appointments. Some are booked through September.

An unusual range of symptoms

There are no specific tests for long Covid. It’s not clear which children will have it, as it can happen even when a child has a mild case of Covid-19.

“It’s startling how many of these children present and have a range of symptoms that we haven’t fully appreciated. Some are coming in with heart failure after asymptomatic Covid infections,” said Dr. Jeffrey Kahn, chief of the Division of Pediatric Infectious Disease at UT Southwestern Medical Center in Dallas. “What’s striking to me is that it usually occurs about four weeks after infection, and infection can be really asymptomatic, which is really startling. “Even when kids with long Covid are tested for ailments that might cause these symptoms, it’s possible nothing will show up.”The tested me, and it looked like nothing was wrong with me, but they tried their best to find something,” Jack Ford said. His pulmonary function test and EKG came back normal. “The Covid clinic said this is very common in kids with long Covid. Sometimes, all the tests come back normal,” Kim Ford said.

Dr. Amy Edwards, who runs the pediatric long Covid clinic at UH Rainbow Babies & Children’s Hospital in Cleveland, agreed that it happens a lot. “We also scoped them, and their GI tracts are normal. I do a big immune workup, and their immune system appears normal. Everything ‘looks normal,’ but the kids aren’t functioning like normal,” Edwards said. “I tell the families, ‘you have to remember, there are limits to what medical science understands and can test for.’ Sometimes, we’re just not smart enough to know where to look for it. Adults’ problems tend to be more obvious, Edwards said, because they are more likely to have organ dysfunction that shows up on tests. Doctors are still trying to understand why long Covid happens this way in children. They are also figuring out what symptoms define long Covid in children. Some studies in adults show a range of 200 symptoms, but there is no universal clinical case definition.

Public health leaders hope stories about long Covid will motivate more young people to get vaccinatedAt Sexson Tejte’s clinic in Texas, children tend to fall into a few categories. Some have fatigue, brain fog and severe headaches, “to the point where the some kids aren’t able to go to school, grades are failing, those types of issues,” she said.Another group has cardiac issues like heart palpitations, chest pains and dizziness, especially when they go back to their regular activities.Another group has stomach problems. A lot of these kids also have a change in their sense of taste and smell.Sexson Tejte said it isn’t totally different from the symptoms adults have, “but it’s not the mixed bag of different organ system involvement with adults.”

‘Once that bucket is empty, that’s it’

One of Jack Ford’s symptoms affects the amount of energy he has for typical activities.

“Long Covid patients have post-exertional malaise, which is Jack’s biggest issue,” Kim Ford said. “So if he overdoes it — and it doesn’t even have to be physically overdoing it. It could be he was really upset about something the day before, or he could be really mentally engaged with something like watching TV or playing video games sitting in his chair — will knock him out. “Energy has become such a problem that Jack can’t go to school for a full day. His parents started him back with one to two hours a day and have gradually increased it to about 5½ hours a day. “We’ve been trying to bump him up to six, but it hasn’t worked so far,” Kim Ford said. “He’s woken up pretty miserable the next day. “Edwards, who runs the long Covid clinic in Cleveland, says she has to talk to parents about carefully balancing how much energy their children expend. Most healthy people can push through if they’re tired, but those with long Covid can’t. “It’s like they have one bucket of energy, and it has to be used carefully for school, for play, to watch TV. Every single thing they do takes energy, and once that bucket is empty, that’s it,” Edwards said.

‘I barely function some days’: Covid ‘long haulers’ struggle to work amid labor of her teen patients are exhausted just dealing with typical drama at school. “Long-haulers have to think about every single aspect of their day and when they can expend that energy. They have to have that balance. Otherwise, they run out. “Many also have anxiety. Some of that may stem from the ailment itself or from the doubt they’ve heard from doctors or adults when they say they don’t feel well. Experts across the country say they’ve heard from patients whose complaints are ignored, even after a stark change in their health. They’ve been told that they are being dramatic or seeking attention, or that the symptoms are all in their head.

I don’t want to be too critical, but there are some doctors out there who just dismiss it outright,” said Dr. Alexandra Yonts, director of the post-Covid clinic at Children’s National in Washington. “The kids then just struggle. They get passed around from place to place.”Yonts thinks there needs to be better acknowledgment among doctors that long Covid can be a real problem .”I’ve got two kids in wheelchairs after having had Covid who were never in wheelchairs before. There’s one kid on crutches. I’ve got a kid who lost the use of her hands,” Edward said. “These kids should be believed.”

Help is available, but not all have access

There’s no specific treatment for long Covid, but most of these clinics are multi-disciplinary. Interactive: The things Covid victims left behind At Edwards’ clinic, which opened last year, experts can address pulmonary issues, digestive problems, physical rehabilitation, sleep issues, mental health problems and others. There’s a nutritionist on staff, as well as an acupuncturist and a pediatrician who is licensed in Chinese herbal medicine. In addition to working up a child’s schedule so they can determine where to spend their energy and when to take breaks, Edwards’ clinic teaches kids to meditate. They do massage therapy and mind-body exercises. “Children need multiple elements of help. They get significantly better, really they do, if we’re aggressive and they get intensive wraparound support and therapy,” Edwards said. But not all children are able to get into a clinic. “I’ve talked to so many people working with pediatric Covid recovery, and they all say the same thing: ‘We are worried about the kids who aren’t getting the help, who don’t have the parents who can advocate for them or navigate the medical system.’ It keeps me up at night,” Edwards said.

A lot of what her clinic does is to encourage kids to get enough sleep and to eat healthy food, but not all families can afford healthy food.”It terrifies me for those families in particular, because they’re already starting behind. And now they have kids with Covid long-haul,” Edwards said. “You just have to hope more people will become aware of the problem and try to help.”

What Happens When Kids Get Long COVID?

Authors: KATHY KATELLA  NOVEMBER 2, 2021

Yale’s pediatric post-COVID program provides care, while doctors aim to learn more.

Doctors are working to understand why some children and adolescents who get COVID-19 make a clean recovery, while others go on to develop long COVID, a condition marked by new, returning, or ongoing symptoms such as brain fog and chronic fatigue. The question of why some kids (just like some adults) wrestle with health problems for weeks or months is one of the pandemic’s biggest mysteries—and one that causes worry for parents.

With long COVID, many kids suddenly find themselves struggling to keep up with their schoolwork or skipping sports. Others can’t sleep or have difficulty walking, while yet others struggle with aches and pains, breathlessness, dizziness, and other troubling symptoms.

Yale Medicine doctors are treating children with long COVID, as well as studying the causes and potential solutions for it, in the Children’s Post-COVID Comprehensive Care Program, offered in the Pediatric Specialty Clinic in Yale New Haven Children’s Hospital. The program, which opened in June of this year, is one of a handful in the country specializing in treating pediatric long COVID patients. They’ve seen patients from infancy through the teenage years.

Severity of symptoms has ranged widely. Some of these patients didn’t even know they had COVID until their long COVID symptoms developed. Others had been diagnosed with Multisystem Inflammatory Syndrome in Children (MIS-C), a rare, but serious condition that affects multiple organs. Then, there are children who struggle with a long list of post-COVID-19 symptoms that include lingering physical, neurological, and mental problems.

Treatment for pediatric long COVID is a work in progress, but doctors have already learned a great deal about how to help these patients. Here are some common questions parents are asking about the condition and some answers, based on the most current knowledge.  

How common is long COVID in kids?

As of the end of October, nearly 6.4 million children had been diagnosed with COVID-19, according to the American Academy of Pediatrics (AAP)—but studies quantifying the number of cases of long COVID in kids have varied widely. Geography is one factor. “Different studies have shown different results, depending on what parts of the world or which parts of the country you’re looking at,” says Carlos Oliveira, MD, a pediatric infectious diseases specialist.

Another issue is the lack of a clear definition—or even a consistent name—for the disease. It has been called long-haul COVID, post-acute COVID-19, and post-acute sequelae of SARS-CoV-2 infection (PASC), the latter being a research term (“sequelae” means, simply, a medical condition that results from a prior disease). “If you include every child who has been hospitalized with MIS-C, [by definition a complication of acute COVID], you’ll come up with a higher prevalence,” Dr. Oliveira says. As of October 4, there had been more than 5,210 cases of MIS-C and 46 deaths, according to the Centers for Disease Control and Prevention (CDC).

Only a fraction of children with long COVID seek medical attention, which makes tracking its incidence very challenging, he adds. Also, because infants and toddlers can’t always verbalize what they are feeling, it makes matters more complicated. Symptoms like fatigue, for instance, can manifest in young children as hyperactivity rather than sluggishness, making it difficult for parents to detect the problem. “As a result, we are likely only identifying the adolescents who can self-report their symptoms,” he says. 

Are post-COVID symptoms different in kids than in adults?

Dr. Oliveira says that kids often display different symptoms than adults, with no single standout symptom that makes a case easy to identify. The AAP reports that children and adolescents have experienced chest pain, cough, exercise-induced dyspnea (or labored breathing), as well as changes to smell or taste (although this is more common in adolescents), among other things. Affected children and teens have reported fatigue, brain fog, anxiety, joint pain, headache, and sore throat, among other symptoms—all varying in intensity and duration, in some cases lasting for months. 

Ian Ferguson, MD, a Yale Medicine rheumatologist has been caring for pediatric patients with long COVID who have joint and bone pain. “What I tend to see is a generalized achiness and a decrease in physical conditioning,” Dr. Ferguson says. “They might say, ‘I just feel achy. I don’t feel right.’ An otherwise healthy child may say, ‘I don’t feel like I should get out of bed in the morning.’ Or they say, ‘I used to be on the high school cross country team. And now I can barely make it down the street before I have to take a break.’”

“Sometimes the expectation from a parent is that their pediatrician will know everything about this… But, this is a new disease, and doctors are still learning.”— Carlos Oliveira, MD, a pediatric infectious diseases specialist

Some children experience subtle symptoms but, when diagnostic testing is done, no abnormalities are found, Dr. Oliveira says. For example, a child may have pain, fatigue, or trouble concentrating, but their imaging and bloodwork come back normal. “Often, we call these symptoms ‘medically unexplained,’ but they are still obviously very significant to the patient’s health,” he says. “The child may not be able to go to school or may not be able to walk, and we can’t find a reason why.”

A very small percentage of children even develop serious complications, since COVID-19 can affect organs including the brain, heart, kidneys, and liver—and any of those organs can be damaged if the child doesn’t receive proper care. “The post-COVID clinic is meant to identify these symptoms caused by residual organ damage and treat them,” Dr. Oliveira says.

Is inflammation a cause of post-COVID symptoms in children?

Experts are still trying to figure out what causes long COVID in kids. “The main hypothesis—I say hypothesis because we don’t yet know—is that there’s some continual trigger of inflammation,” Dr. Oliveira says.

He explains that some of the different ways that COVID manifests in children may contribute to a greater likelihood of ongoing inflammation. For instance, when a child gets COVID, the virus is more apt to concentrate in the gut than in the lungs, making symptoms more likely to be gastrointestinal than respiratory. It may also take longer to clear the virus from a child’s system than it does for an adult, he adds. “We don’t fully understand why, but we know that with kids, if we were to test their stool three or four months post-infection, for many of them, we would still find noninfectious remnants of the virus. It may be nonviable virus, but the remnants are still there.”  

“You can look at the lab tests… and they’re not showing anything. But that doesn’t mean that the immune system didn’t ramp up… and cause those symptoms.”— Ian Ferguson, MD, a Yale Medicine rheumatologist

And those pieces of remnant virus can continually trigger inflammation. “The immune system will attack those pieces of remnant virus and cause inflammation, because it can’t distinguish between a live virus and the remnants of one. The immune system just sees viral antigens [the molecular structures on the surface of the virus] and wants to get rid of them,” Dr. Oliveira says.

The hypothesis is that there may be continual exposure of viral antigens to the immune system in some children with long COVID, triggering persistent or intermittent inflammation, albeit at a milder level since the remnant virus is not able to make copies of itself, he says. “This kind of inflammation is more like a ‘slow burn’ for a long period of time, rather than the acute inflammation of MIS-C,” he adds. Treatment with anti-inflammatories may be helpful in this situation, he says, but studies are still ongoing.

There is support for the “slow burn” theory in that some long COVID symptoms tend to improve after patients receive a COVID-19 vaccine, which triggers a boost in antibodies that presumably clears the viral antigens more effectively.

What is the treatment for kids with long COVID?

There is no typical case of long COVID in kids, and no one-size-fits-all treatment. Young patients who visit the Yale program come in with any combination of symptoms.

Typically, after a full evaluation, patients are referred to one or more subspecialists with expertise in a particular area. Long COVID can affect different organs and parts of the body, so in addition to pediatric infectious diseases specialists, the team can include cardiologists, neurologists, pulmonologists, rheumatologists, psychologists, and others.

Treatment tends to be most effective when it addresses each symptom individually. A child with chest pain and decreasing physical conditioning will be referred for a cardiac evaluation, for instance, while one with cognitive challenges will be seen by a neurologist. 

Treatment strategies can also draw from those used for other illnesses that bring lingering symptoms, such as the prolonged fatigue after mononucleosis (or ‘mono’). “In rheumatology, we see a lot of unexplained achiness, which provides us with a fairly reasonable framework,” says Dr. Ferguson. “You can look at the lab tests or at the imaging studies, and they’re really not showing anything. That doesn’t necessarily mean that the immune system didn’t ramp up at some point and cause those symptoms. Therefore, many of our recommendations are framed as, ‘Let’s figure out how to build this child’s health back up.’”

So, for example, once a cardiologist says a patient’s heart is fine and a breathing test shows their oxygen exchange is good, doctors may tell them to gradually increase their physical conditioning by adding aerobic and muscular exercise over time. “Physical therapy is a great resource because the physical therapists not only observe patients in the clinic, they give patients a home exercise program that will help them build back up over time,” Dr. Ferguson says. “We anticipate most people will be able to regain their conditioning—albeit on a timeline that we really can’t dictate.” 

What helps when children with long COVID have mental health symptoms?

It’s common for children with long COVID to face mental health challenges as well—although whether that’s a direct result of COVID-19 is still unclear. “There is a worldwide increase in children’s behavioral health needs, especially around anxiety and depression, and that’s not only in children who have had COVID,” says Linda Mayes, MD, chair of the Yale Child Study Center (CSC), which participates in treating patients in the post-COVID treatment program. “We just don’t really know yet how COVID impacts basic psychological development overall.”

But there are ways doctors can help, regardless of the cause, she adds. For children who have learning needs or challenges, or problems paying attention, CSC specialists might work with the child’s school to help adjust curriculum or educational approaches for that child. If there are behavioral health needs, they provide psychotherapy and medications, as needed, and work directly with parents and families. “None of this is COVID-specific,” Dr. Mayes says. “It’s what we do every day. Over time, what will be important to know is, are those issues greater among children who have had COVID-19?”

In addition, CSC counselors provide strategies to help children in the program manage unexplained medical symptoms, including chronic pain. Biofeedback, cognitive behavioral therapy, and mindfulness techniques can all help, Dr. Mayes says. “Regardless of the origin, if a problem is related to COVID or anxiety, we have well-tested, evidence-based approaches,” she says. 

How long do children with long COVID need treatment?

It’s impossible to predict a long-term recovery timeline for children with long COVID, since doctors have only had a year and a half of experience with it. But the good news is that, so far, the children treated in the program are doing well, Dr. Oliveira says. “By numbers, relative to the adults, kids usually recover faster, within a few months.”

That said, he notes that some patients may continue to need monitoring for cardiac issues, and cardiologists may restrict their activities until they are confident that a child’s heart function is back to normal.

The doctors encourage pediatricians and parents to contact Yale’s pediatric post-COVID program if they have any serious physical or mental concerns about a child that could be related to having had COVID-19.

Even if they aren’t sure the child has had the illness, there may be some unknown association that is worth investigating. “Sometimes the expectation from a parent is that their pediatrician will know everything about this, and be able to diagnose it and treat it, just as they would with an ear infection,” Dr. Oliveira says. “But this is a new disease, and doctors are still learning.”

Association of Myocarditis With BNT162b2 Messenger RNA COVID-19 Vaccine in a Case Series of Children

Authors: Audrey Dionne, MD1,2Francesca Sperotto, MD1,2Stephanie Chamberlain1,2et alAnnette L. Baker, MSN, CPNP1,2Andrew J. Powell, MD1,2Ashwin Prakash, MD1,2Daniel A. Castellanos, MD1,2Susan F. Saleeb, MD1,2Sarah D. de Ferranti, MD, MPH1,2Jane W. Newburger, MD, MPH1,2Kevin G. Friedman, MD1,2

JAMA Cardiol. 2021;6(12):1446-1450. doi:10.1001/jamacardio.2021.347

Question  What are the findings on cardiac imaging in children with myocarditis after COVID-19 vaccination?

Findings  In this case series of 15 children who were hospitalized with myocarditis after receipt of the BNT162b2 messenger RNA COVID-19 vaccine for 1 to 5 days, boys were most often affected after the second vaccine dose, 3 patients had ventricular systolic dysfunction, and 12 patients had late gadolinium enhancement on cardiac magnetic resonance imaging. There was no mortality, and all but 1 patient had normal echocardiogram results on follow-up 1 to 13 days after discharge.

Meaning  COVID-19 vaccine-associated myocarditis may have a benign short-term course in children; however, the long-term risks remain unknown.Abstract

Importance  The BNT162b2 (Pfizer-BioNTech) messenger RNA COVID-19 vaccine was authorized on May 10, 2021, for emergency use in children aged 12 years and older. Initial reports showed that the vaccine was well tolerated without serious adverse events; however, cases of myocarditis have been reported since approval.

Objective  To review results of comprehensive cardiac imaging in children with myocarditis after COVID-19 vaccine.

Design, Setting, and Participants  This study was a case series of children younger than 19 years hospitalized with myocarditis within 30 days of BNT162b2 messenger RNA COVID-19 vaccine. The setting was a single-center pediatric referral facility, and admissions occurred between May 1 and July 15, 2021.

Main Outcomes and Measures  All patients underwent cardiac evaluation including an electrocardiogram, echocardiogram, and cardiac magnetic resonance imaging.

Results  Fifteen patients (14 male patients [93%]; median age, 15 years [range, 12-18 years]) were hospitalized for management of myocarditis after receiving the BNT162b2 (Pfizer) vaccine. Symptoms started 1 to 6 days after receipt of the vaccine and included chest pain in 15 patients (100%), fever in 10 patients (67%), myalgia in 8 patients (53%), and headache in 6 patients (40%). Troponin levels were elevated in all patients at admission (median, 0.25 ng/mL [range, 0.08-3.15 ng/mL]) and peaked 0.1 to 2.3 days after admission. By echocardiographic examination, decreased left ventricular (LV) ejection fraction (EF) was present in 3 patients (20%), and abnormal global longitudinal or circumferential strain was present in 5 patients (33%). No patient had a pericardial effusion. Cardiac magnetic resonance imaging findings were consistent with myocarditis in 13 patients (87%) including late gadolinium enhancement in 12 patients (80%), regional hyperintensity on T2-weighted imaging in 2 patients (13%), elevated extracellular volume fraction in 3 patients (20%), and elevated LV global native T1 in 2 patients (20%). No patient required intensive care unit admission, and median hospital length of stay was 2 days (range 1-5). At follow-up 1 to 13 days after hospital discharge, 11 patients (73%) had resolution of symptoms. One patient (7%) had persistent borderline low LV systolic function on echocardiogram (EF 54%). Troponin levels remained mildly elevated in 3 patients (20%). One patient (7%) had nonsustained ventricular tachycardia on ambulatory monitor.

Conclusions and Relevance  In this small case series study, myocarditis was diagnosed in children after COVID-19 vaccination, most commonly in boys after the second dose. In this case series, in short-term follow-up, patients were mildly affected. The long-term risks associated with postvaccination myocarditis remain unknown. Larger studies with longer follow-up are needed to inform recommendations for COVID-19 vaccination in this population.Introduction

SARS-CoV-2 was first identified in China and evolved rapidly to a global pandemic. Vaccines to prevent SARS-CoV-2 infection are the current standard approach for curbing the pandemic. In the US, the BNT162b2 messenger RNA (mRNA) (Pfizer-BioNTech), mRNA-1273 (Moderna), and Ad26.COV2.S (Janssen) vaccines were granted emergency use authorization for adults. On May 10, 2021, the emergency use authorization for the BNT162b2 vaccine was extended to children aged 12 years and older.1

Myocarditis has been reported as a rare complication of vaccination against other viruses.2 It was not reported in the initial messenger RNA COVID-19 vaccine trials, although the ability to detect rare events was limited by sample size. Since the emergency use authorization, myocarditis in adolescents and young adults after COVID-19 vaccine has been reported.35 In this series, we detail the occurrence of myocarditis after COVID-19 vaccination in an adolescent population, including comprehensive cardiac imaging evaluation and follow-up.MethodsPopulation

This case series included all patients younger than 19 years admitted at our center with acute myocarditis after COVID-19 vaccination. Myocarditis was defined as chest pain and an elevated troponin level in the absence of an alternative diagnosis. The institutional review board at Boston Children’s Hospital approved this study and granted an exemption from informed consent owing to use of deidentified data and the requirements of 45 CFR §46. This study followed the reporting guideline for case series.Data Collection and Definitions

Clinical data elements including demographic characteristics, laboratory values, and hospital course were collected from the electronic medical record. Patients’ race and ethnicity were self-reported by patients or parents according to the US Census categories6 and were collected because of their known association with COVID-19–related illnesses. Elevated troponin T level was defined as a troponin value greater than 0.01 ng/mL. Cardiac evaluation for all patients included electrocardiogram (ECG), echocardiogram, and cardiac magnetic resonance (CMR) imaging. Ventricular systolic dysfunction was defined as a left ventricular (LV) ejection fraction equal to or greater than 55% on echocardiogram or CMR results. Echocardiographic peak global longitudinal strain was measured from an apical 4-chamber view and peak global circumferential strain from a parasternal short-axis view at the midpapillary level using software (Tom Tec Image Arena, version 4.6; TOMTEC). Strain values were considered abnormal if the z score was less than or equal to −2 for age. Diastolic dysfunction was defined as a z score less than or equal to −2 for age, for septal e′ tissue Doppler, LV free wall e′, or the E/e′ ratio. CMR assessment included LV ejection fraction, T2-weighted myocardial imaging, LV global native T1, LV global T2, extracellular volume fraction, and late gadolinium enhancement (LGE).Statistical Analysis

Descriptive statistics were calculated for all study variables. Quantitative variables were summarized as median and range and categorical variables as frequencies and percentages.Results

Fifteen patients were admitted at the Department of Cardiology, Boston Children’s Hospital for management of myocarditis after COVID-19 vaccination between May 1 and July 15, 2021. The median age was 15 years (range, 12-18 years), and most patients were male (n = 14 [93%]). Patients self-identified as non-Hispanic White (n = 8 [53%]), Hispanic White (n = 2 [15%]), other Hispanic (n = 1 [8%]), other non-Hispanic (n = 1 [8%]), and unknown (n = 3 [20%]) (Table). All patients received the BNT162b2 mRNA vaccine. Symptoms occurred after the second dose of the vaccine in all but 1 case. No patients had a known prior COVID-19 infection, although 1 had reactive SARS-CoV-2 antibodies to the nucleocapsid protein.

Chest pain in 15 of 15 patients (100%) started at median 3 days (range, 1-6 days) after receiving the vaccine and lasted 1 to 9 days. Other symptoms included fever in 10 patients (67%), myalgia in 8 patients (53%), and headache in 6 patients (40%). Seven patients (47%) were treated with intravenous immunoglobulins (2 g/kg) and methylprednisolone (1 mg/kg/dose twice a day, transitioned to prednisone at time of discharge). Hospital length of stay was a median of 2 days (range, 1-5 days), and no patients required intensive care unit admission.Troponin

Troponin levels were elevated in all patients at admission (median, 0.25 ng/mL [range, 0.08-3.15 ng/mL]) and peaked 0.1 to 2.3 days after admission (Table). At the time of discharge, the troponin level had substantially decreased but remained elevated in all patients (Figure 1).Echocardiogram

On admission echocardiogram, 3 patients (20%) had global LV systolic ventricular dysfunction (EF 44%, 49%, and 53%), one of whom also had regional wall motion abnormality at the apex. Two patients (13%) with systolic dysfunction had abnormal diastolic function indices, and 1 patient (7%) with borderline EF (55%) had evidence of diastolic dysfunction. Five patients (33%) had abnormal global longitudinal or global circumferential strain (Figure 2; eFigure 1 and eTable in the Supplement). No patients had a coronary artery aneurysm or pericardial effusion.Electrocardiogram

The most frequent finding was diffuse ST-segment elevation consistent with pericarditis, present on admission in 6 patients (40%), and at some time during hospital admission in 8 patients (53%). Four additional patients had nonspecific ST segment changes. One patient (normal systolic and diastolic ventricular function; LGE on CMR) had nonsustained ventricular tachycardia during hospital admission. ST-T wave changes persisted at time of hospital discharge in 9 patients (69%). No patient had PR interval, QRS duration, or QTc duration prolongation.Cardiac Magnetic Resonance

CMR imaging was performed in all patients 1 to 7 days after the onset of symptoms. Systolic LV dysfunction was present in 3 patients (25%). Findings consistent with myocarditis were found in 13 patients (87%). LGE was present in 12 patients, and most often found in the inferolateral (n = 3) and anterolateral (n = 4) regions (eTable and eFigure 2 in the Supplement). The extracellular volume fraction was borderline elevated (28%-30%) in 4 patients (27%) and elevated (>30%) in 3 patients (25%). LV global native T1 was borderline elevated (1080-1100 milliseconds) in 2 patients and elevated (>1100 milliseconds) in 2 patients. Two patients had regional hyperintensity on T2-weighted imaging. LV global T2 was borderline elevated (56-60 milliseconds) in 1 patient.Follow-up

Follow-up information after hospital discharge was available for all patients (virtual visit in 1 patient; in-person with testing in 14 patients) and occurred 1 to 13 days after discharge. Four patients (27%) were asymptomatic with normal troponin level, ECG, and echocardiogram results.

Four patients (27%) had persistent symptoms, including fatigue in 3 patients (25%) and continued chest pain in 1 patient (7%). None of the patients with persistent symptoms had decreased EF at time of initial presentation (1 with abnormal strain) and 3 patients (75%) had abnormal CMR results with LGE.

One asymptomatic patient (7%) had persistent borderline low LV EF (54%), reduced circumferential strain (z score, −2.3), and reduced lateral e′ velocity (z score, −2.8) measured by echocardiogram at 8 days after discharge; all other patients had normal echocardiogram results. Ventricular systolic function recovered (EF>55%) in 2 to 11 days (Figure 1).

ECG changes persisted in 4 patients (33%) and included nonspecific ST-T wave changes in 4 patients (33%) or new T-wave inversion in 3 patients (20%). One patient (7%) with nonsustained ventricular tachycardia during hospital admission had recurrence of nonsustained ventricular tachycardia on 6 days of ambulatory ECG monitoring, despite initiation of β-blocker therapy.

Troponin levels remained mildly elevated at follow-up in 3 patients (20%) (Figure 1). One patient (7%) with a persistently elevated troponin level (0.05 ng/mL) had continuing fatigue. All patients with persistently elevated troponin levels had had prior abnormalities on CMR (2 patients with LGE, 1 patient with elevated extracellular volume fraction).Discussion

In this early experience of 15 cases, myocarditis typically occurred in male patients after the second dose of the COVID-19 vaccine. All patients in this series had a benign course; none required intensive care unit admission and all were discharged alive from the hospital within 5 days. LV systolic function at presentation was normal in most patients and normalized within a few days in all but 1 patient who had persistent borderline low LV function. This finding differs from other forms of myocarditis in which LV systolic dysfunction and arrhythmias are more common, with 50% of children requiring intensive care unit admission, a mean hospital length of stay of 14.4 days, and a mortality rate of 7.8%.79

Although vaccine-associated cases of myocarditis to date have had uncomplicated short-term course, the long-term prognosis remains unclear. Of note, CMR LGE was a frequent finding at time of diagnosis. In this clinical setting, LGE reflects an increased volume of distribution of the gadolinium-based contrast agent in the affected region likely related to myocyte necrosis and/or extracellular edema. In nonvaccine-associated myocarditis, the presence of LGE is associated with increased risk for adverse cardiovascular events during follow-up.1012 Thus, longitudinal studies of patients with myocarditis after COVID-19 vaccine will be important to better understand long-term risks.

To date, there have been 1226 reports of myocarditis after messenger RNA vaccination to the Vaccine Adverse Event Reporting System (VAERS), including 687 in persons aged less than 30 years.13 Crude reporting rates using vaccine administration data estimates the highest rate among male individuals aged 12 to 17 years (62.8 cases per million), similar to our observations. Despite the risks of myocarditis associated with vaccination, the benefits of vaccination likely outweigh risks in children and adolescents. It is estimated that COVID-19 vaccination in males aged 12 to 29 years can prevent 11 000 COVID-19 cases, 560 hospitalizations, 138 intensive care unit admissions, and 6 deaths compared with 39 to 47 expected myocarditis cases.Limitations

This study has limitations. Limitations to this series include the lack of COVID-19 vaccine administration data, which does not permit calculation of incidence or identification of risk factors for myocarditis. Mild cases may have been missed due to the novelty of this complication and the lack of routine screening.Conclusions

Myocarditis may be a rare complication after COVID-19 vaccination in patients aged less than 19 years. In this case series study, the short-term clinical course was mild in most patients; however, the long-term risks remain unknown. Risks and benefits of COVID-19 vaccination must be considered to guide recommendations for vaccination in this population.Back to topArticle Information

Accepted for Publication: July 20, 2021.

Published Online: August 10, 2021. doi:10.1001/jamacardio.2021.3471