A rare heart risk warning must now come on COVID vaccines despite CDC's previous findings ...Middle East

The Food and Drug Administration said Wednesday it was expanded existing warnings on the two leading COVID vaccines about a rare heart side effect mainly seen in young men, despite previous guidance from the Centers for Disease Control and Prevention that said there was no increased risk.

The expanded warnings come as a new COVID variant “growing rapidly” in parts of the world was detected in the U.S.

Myocarditis, a type of heart inflammation that is usually mild, emerged as a complication after the first shots became widely available in 2021. Prescribing information from both Pfizer and Moderna already advises doctors about the issue, and health officials have said the benefits of receiving the vaccine still outweigh any risk.

“The risk of myocarditis and pericarditis appears to be very low given the number of vaccine doses that have been administered,” said acting FDA commissioner Janet Woodcock in 2021. “The benefits of Covid-19 vaccination continue to outweigh the risks, given the risk of Covid-19 diseases and related, potentially severe, complications.”

In April, the FDA sent letters to both drugmakers asking them to update and expand the warnings to add more detail about the problem and to cover a larger group of patients. While the FDA can mandate label changes, the process is often more of a negotiation with companies.

Specifically, the new warning lists the risk of myocarditis as 8 cases per 1 million people who got the 2023-2024 COVID shots between the ages of 6 months and 64 years old. The label also notes that the problem has been most common among males ages 12 to 24. The previous label said the problem mostly occurs in 12- to 17-year-olds.

Label change conflicts with prior findings from the CDC

The CDC previously concluded there was no increased risk of myocarditis detected in government vaccine injury databases for COVID-19 shots dating back to 2022. Officials also noted that cases tend to resolve quickly and are less severe than those associated with COVID-19 infection itself, which can also cause myocarditis.

The FDA announcement came as new vaccine advisers appointed by Health Secretary Robert F. Kennedy Jr. met to debate the continuing use of COVID-19 vaccines for key groups, including pregnant women. It’s the first meeting of the CDC advisory panel since Kennedy abruptly dismissed all 17 members of the group, naming a new panel that includes several members with a history of anti-vaccine statements.

The FDA’s label update is the latest step by officials working under Kennedy to restrict or undercut use of vaccines. FDA Commissioner Marty Makary and a top deputy recently restricted annual COVID-19 shots to seniors and other Americans at higher risk from the virus. They’ve also suggested seasonal tweaks to match the latest circulating virus strains are new products that require extra testing.

‘Wrong solution’

Outside experts said the new warning is the wrong approach.

“They are right to suggest that we need to consider myocarditis risks associated with the vaccine, but what they propose is exactly the wrong solution,” said Dr. Robert Morris, a public health specialist at the University of Washington. “We should be investigating who is prone to myocarditis to see if we can predict and mitigate that risk.”

Makary and several other FDA officials gained prominence during the pandemic by suggesting the federal government exaggerated the benefits of COVID-19 boosters and downplayed serious side effects, including myocarditis.

Before joining the government, Makary and two of his current FDA deputies wrote a 2022 paper that said mandating booster shots in young people would cause more vaccine-related injuries than prevented hospitalizations from COVID-19 infections. The conclusion contradicted that of many leading vaccine and public health experts at the time, including at the CDC.

What is myocarditis?

Myocarditis is an “inflammation of the heart muscle that decreases the ability of the heart to pump blood normally,” according to Harvard Health. Medical experts say the condition is usually caused by viral infections but can also be the body’s reaction to a drug.

In 2021, Chicago Department of Public Health Commissioner Allison Arwady said that there was no link between the condition and the coronavirus vaccination.

“It’s not been linked [to vaccines], but it’s been one of the things that, you know, younger people very occasionally can get. And so, you know, we’ve advised physicians here if they were to see that to make sure that… they’re reporting it.”

Dr. Richard Novak, chief of infectious diseases with University of Illinois Health, told NBC Chicago at the time there wasn’t a greater number of myocarditis that was expected in a young population — but since those ages were getting vaccinated for the virus, it “may be overlapping.” “

In fact, “COVID itself could cause myocarditis in young kids,” according to Dr. Wayne Franklin, a pediatric cardiologist with Loyola University Medical Center.

Novak also noted that summer months bring with them a number of viruses that can cause myocarditis.

“There’s a whole host of viruses that are more common in the summertime – we call them enteroviruses – that are associated with myocarditis,” he said.

Symptoms of myocarditis

Symptoms of myocarditis include chest pain, fatigue, shortness of breath, and arrhythmias, the Mayo Clinic reports, adding that when children develop myocarditis, they might have other symptoms including:

Health experts urge both children and adults who may be experiencing any of these symptoms to immediately seek medical attention.

In many cases of myocarditis, the inflamed heart condition can improve on its own, but medical experts at Mayo Clinic say myocarditis can be fatal if not treated immediately. Heart failure, heart attack, stroke, and sudden cardiac death can occur in severe cases.

Mayo Clinic doctors say treatment focuses on the cause of the condition and symptoms, such as heart failure and shortness of breath.

Doctors recommend getting a lot of rest and taking medication to help fight off the infection. Experts say that although antiviral medications are available, they are not proven effective in treatment for most cases of the heart condition.

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