No off-label prescribing COVID-19 vaccines to kids under 12: FDA
Fox News
Children under 12 should not yet receive COVID-19 vaccines, according to the Food and Drug Administration (FDA), as regulators await data on safety, efficacy and dosing.
"Ordinarily, as you know, when a medical product is approved, physicians often do use off-label prescribing," Dr. Janet Woodcock, acting FDA commissioner, told reporters over a call Monday. "However this is a different situation. The vaccine is being distributed under provider agreement by the U.S. government through the CDC and there are many considerations that would pertain to off-label prescribing for the recipient and so forth." Researchers at the Mayo Clinic previously explained that "off-label drug use involves prescribing medications for indications, or using a dosage or dosage form, that have not been approved by the US Food and Drug Administration."
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