US FDA Weighs Black Box Warning for COVID-19 Vaccines Over Myocarditis

• US FDA is considering adding a 'black box warning' to COVID-19 vaccines due to concerns over rare, severe side effects.
• A 'black box warning' is the FDA's strictest warning, highlighting potentially life-threatening reactions associated with a drug.
• The consideration follows concerns raised by experts regarding myocarditis (heart inflammation) in young individuals.
• The final decision is pending, and it's unclear if the warning will cover all COVID-19 shots or only mRNA vaccines like Pfizer and Moderna.
• Pfizer and Moderna maintain that their vaccines have been widely monitored globally, with no new issues observed in children or pregnant women.

Why It Matters: FDA may issue 'black box' warnings for COVID-19 vaccines, citing rare, serious risks.