The U.S. Food and Drug Administration has delayed a decision on whether to approve emergency use of Moderna’s COVID-19 vaccine in 12- to 17-year-olds until at least January, the company announced Sunday.
That’s because the agency told the company on Friday that it needs more time to assess emerging international data on whether the vaccine increases the risk of a rare heart side effect called myocarditis, Moderna said in a statement.
“On Friday evening, the FDA informed Moderna that the agency requires additional time to evaluate recent international analyses of the risk of myocarditis after vaccination. The FDA notified Moderna that this review may not be completed before January 2022,” the company says. “The safety of vaccine recipients is of paramount importance to Moderna. The company is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence.”
What is myocarditis?
Myocarditis is an inflammation of the heart muscle that occurs in rare cases after vaccination, typically after the second shot and particularly in young males.
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Symptoms of myocarditis
If you are in the early stages of myocarditis, you may experience chest pain, rapid or irregular heartbeats, or shortness of breath. However, the symptoms of this disease vary and some people may not experience symptoms at all.
The most common symptoms are:
- Chest pain
- Rapid or abnormal heartbeat (arrhythmias)
- Shortness of breath, at rest or during activity
- Fluid buildup with swelling of your legs, ankles and feet
- Fatigue
- Other signs and symptoms of a viral infection such as a headache, body aches, joint pain, fever, a sore throat or diarrhea
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Myocarditis in children
Children who develop myocarditis may exhibit the following conditions:
