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FDA adds warning to Pfizer, Moderna vaccines over growing concerns of heart inflammation found in teens

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The FDA is adding a warning to the Pfizer and Moderna COVID-19 vaccines after the CDC announced a “likely association” between a rare heart inflammation found in teens and young adults and their second shot.

The Centers for Disease Control and Prevention made an announcement Wednesday during a presentation that over 1,200 cases of myocarditis or pericarditis have been diagnosed in individuals primarily under the age of 30 after receiving a Pfizer or Moderna vaccination. Myocarditis involves the inflammation of the actual heart muscle. Pericarditis entails the inflammation of the membrane surrounding the heart.

“Clinical presentation of myocarditis cases following vaccination has been distinct, occurring most often within one week after dose two, with chest pain as the most common presentation,” noted Dr. Grace Lee, who chairs the CDC’s safety group. Health officials are still determining if there are any long-term issues.

According to the COVID-19 Vaccine Safety Technical (VaST) Work Group, there have been 484 preliminary reports of myocarditis or pericarditis in young adults under age 30 as of June 11. To date, 323 have been confirmed by the CDC, and 148 are still currently under review. In total, 309 patients were hospitalized. Of those, 295 were discharged and 79 percent have reportedly recovered. Nine patients remain hospitalized with two being monitored in intensive care units. Five patients had no data available.

(Video Credit: CBS This Morning)

Approximately 300 million doses of the vaccine have been administered as of June 11. The Moderna and Pfizer vaccines use mRNA technology, while Johnson & Johnson uses the more traditional virus-based technology.

“This is still a rare event,” Dr. Tom Shimabukuro stated. For both vaccines combined, there were 12.6 heart inflammation cases reported per million doses. Occurrences were more prevalent with the Moderna vaccine. Moderna recipients stood at 19.8 cases per million versus eight cases per million for Pfizer.

The majority of cases are comprised of young men under the age of 30. Most appear to be mild in nature. The CDC is adamant that the benefits of getting vaccinated against the virus far outweigh the risks.

As of June 11, there were 9.1 per million reported cases of myocarditis or pericarditis in females adolescents 12 to 17-years-old compared to 66.7 per million in males of that age bracket. Rates among adolescent females 18 to 24-years-old and 25 to 29-years-old were 5.5 per million and 2.6 per million respectively. Rates for adolescent males were 56.3 per million for 18 to 24-years-old and 20.4 per million for 25 to 29-years-old.

Following the meeting and slide presentation on Wednesday, the Department of Health and Human Services released a statement that was co-signed by the CDC and a number of medical professional groups that emphasized the heart condition is extremely rare.

“Only an exceedingly small number of people will experience it after vaccination,” HHS stressed. “Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment. In addition, we know that myocarditis and pericarditis are much more common if you get COVID-19, and the risks to the heart from COVID-19 infection can be more severe.”

The CDC is working with the Food and Drug Administration, which authorized in May the Pfizer-BioNTech vaccine for adolescents who are 12 to 15-years-old. Symptoms of heart inflammation include chest pain, heart palpitations, and shortness of breath.

There was widespread angst on Twitter after the FDA/CDC announcement with many positing that the vaccine is more harmful than helpful to young adults:

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