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Wednesday, July 28, 2021

CDC: Emergency Meeting to Review Potential Link Between Heart Inflammation and mRNA COVID-19 Vaccines

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An advisory panel for the Centers for Disease Control and Prevention will hold an emergency meeting Friday to examine a possible link between the COVID-19 vaccine and a heart ailment that is showing up in some young people who have been vaccinated.

The CDC’s Advisory Committee on Immunization Practices will be examining a number of cases of myocarditis and pericarditis, or heart inflammation, that have shown up in some young people who have had the memory RNA vaccine.

“We’re still learning about the rates of myocarditis and pericarditis,” CDC safety expert Tom Shimabukuro said, according to Bloomberg News. “As we gather more information, we’ll begin to get a better idea of the post-vaccination rates and hopefully be able to get more detailed information by age group.”

According to Shimabukuro, 789 cases of myocarditis/pericarditis have been reported across all ages after the Pfizer/BioNTech and Moderna vaccines, most commonly after the second dose. Cases predominantly have been seen in males, Shimabukuro told the Food and Drug Administration’s vaccine advisory group. The median age for a case of myocarditis following dose two is 24.

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Shimabukuro also said that reports of myocarditis/pericarditis in young people ages 12-24 make up about 53% of the total reports of the inflammation after a second dose, while that age group makes up only 9% of the doses administered.

The Vaccine Adverse Event Reporting System (VAERS) has seen 475 people ages 30 and younger reporting myocarditis or pericarditis. The most common symptoms reported to VAERS were chest pain, elevated cardiac enzymes, changes in heart rhythm, difficulty breathing and abnormal echocardiography/imaging.

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Among the 285 cases where the outcome of the illness is known, 270 were discharged from the hospital with about 81% having made a full recovery. The other 19% had ongoing symptoms or unknown status. Fifteen are still hospitalized, including three in intensive care.

Shimabukuro told the committee that 79 cases of myocarditis/pericarditis have been reported in teenagers ages 16-17 after a second dose of the vaccine. The number expected in that age category would be two to 19 cases per million doses.

For ages 18-24, there were 196 cases reported. The number of cases expected in that age group would be eight-83 cases per million doses.

“It’s a bit of an apples to oranges comparison because again these are preliminary reports,” Shimabukuro said. “Not all of these will turn out to be true myocarditis or pericarditis reports. The expected (cases) are based on published literature.”

For the most part, the CDC said, cases have been mild and predominately seen in males.

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On average, 10 to 22 people per 100,000 population are diagnosed with viral myocarditis in the United States in a year. Many cases are mild and, often, people are not diagnosed with the problem. Symptoms can range from fatigue and chest pain to heart rhythm irregularities, cardiac arrest and even death in rare and severe cases. Mild cases resolve on their own.

“We look forward to seeing more data about these cases, so we can better understand if they are related to the vaccine or if they are coincidental,” Dr. Yvonne Maldonado, chair of the American Academy of Pediatrics’s Committee on Infectious Diseases told The New York Times. “Meanwhile, it’s important for pediatricians and other clinicians to report any health concerns that arise after vaccination.”

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Physicians were first alerted to the cases of myocarditis on May 14.

The U.S. Food and Drug Administration authorized the Pfizer-BioNTech vaccine for use in children as young as 12 on May 12.

Moderna announced Thursday it had requested an emergency use authorization for its COVID-19 vaccine in children ages 12-17.

According to the American Academy of Pediatrics, as of June 3, more than 3.9 million children have tested positive for the COVID-19 virus since the onset of the pandemic. Nearly 16,281 new child COVID-19 cases were reported the last week.

Both the Pfizer and Moderna vaccines were approved for emergency use in December for those over age 16 for Pfizer and over age 18 for Moderna.

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More than 141 million people have been fully vaccinated with mRNA vaccines made by U.S. firms Pfizer, with German partner BioNTech, and the Cambridge, Massachusetts-based company Moderna.

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