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FDA says risk of rare vaccine side effect, myocarditis, is low

The heart inflammation side effect was not found in any children during the Pfizer vaccine 5 to 11 trials.

PENNSYLVANIA, USA — As the conversation continues regarding vaccinating kids aged 5-11 with the Pfizer vaccine, the FDA reviewed data and voted to endorse authorizing the vaccine, deciding its benefits outweigh recent concerns about rare heart-related side effects.

The rare side effect, known as myocarditis, is an inflammation of the heart that is seen in a small percentage of adolescent boys and young men taking mRNA vaccines like the Moderna or Pfizer.

Dr. John Goldman from UPMC says it typically resolves without major complications, but it’s the FDA’s job to leave no stone unturned when it comes to vaccine side effects.

“It would obviously be a concern if you start giving it to younger children who could also have myocarditis – so you want to make sure that the risks of the vaccine, didn’t outweigh the benefits," he said.

In yesterday’s meeting, the FDA said more than six million American children contracted Covid-19, but in making their emergency use authorization recommendation, the group of experts determined that the benefits outweigh the risks. 

The panel said zero cases of the rare heart condition were found in the 3,000 person trial of 5 through 11-year-olds for the Pfizer vaccine, but agreed further studies need to be done – and soon.

“They (FDA) did what they are supposed to do...which is carefully go over the evidence and make sure it didn’t appear as though there might be a higher incidence in that age group," Goldman said.

EdWeek found that researchers with the FDA saw at current infection rates, "vaccines could prevent nearly 45,800 COVID-19 cases and nearly 200 hospital stays for each million children ages 5-11 who are vaccinated."

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