❓WHAT HAPPENED: Reports suggest the U.S. Food and Drug Administration (FDA) plans to add a “black box” warning to COVID-19 vaccines, indicating potential severe health risks.
👤WHO WAS INVOLVED: The FDA, Dr. Vinay Prasad, Moderna, Pfizer, Novavax, and U.S. Department of Health and Human Services (HHS) spokesman Andrew Nixon.
📍WHEN & WHERE: The plans are reportedly under development and were disclosed by sources to CNN. Finalization details remain unclear.
💬KEY QUOTE: “Any claim not officially made by the FDA is pure speculation.” – Andrew Nixon, U.S. Department of Health and Human Services.
🎯IMPACT: In July of this year, the FDA updated the warning labels on Pfizer and Moderna’s COVID-19 mRNA vaccines to include new information regarding the risks of myocarditis and pericarditis, particularly in young males.
The U.S. Food and Drug Administration (FDA) is reportedly preparing to add a “black box” warning to COVID-19 vaccines, according to sources who disclosed the information to CNN. Black box warnings, the FDA’s most serious advisory, are typically reserved for medications with life-threatening or disabling side effects, such as opioids. It remains unclear whether the warning would apply to all COVID-19 vaccines or only to mRNA vaccines, such as those from Pfizer and Moderna.
Dr. Vinay Prasad, the FDA’s chief medical and scientific officer, is reportedly overseeing the plan, though it has not yet been finalized. However, Andrew Nixon, a spokesman for the U.S. Department of Health and Human Services (HHS), dismissed the reports, stating, “Any claim not officially made by the FDA is pure speculation.”
Common side effects of COVID-19 vaccines include mild arm pain, fatigue, and headaches, but there have also been cases of allergic reactions and heart inflammation—including myocarditis, which can cause heart failure. In July of this year, the FDA updated the warning labels on Pfizer and Moderna’s COVID-19 mRNA vaccines to include new information regarding the risks of myocarditis and pericarditis, particularly in young males.
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