FDA cautions against off-label use of Pfizer/BioNTech Covid-19 vaccine in younger children
CNN
Even though the US Food and Drug Administration has fully approved the Pfizer/BioNTech Covid-19 vaccine for people age 16 and older, and it remains authorized for people as young as 12, the agency is warning against using the vaccine "off-label" in children younger than 12. To do so, it says, "would not be appropriate."
Off-label refers to an approved product being used in a way or in a patient that it wasn't necessarily approved for; it happens commonly with some drugs, such as when a chemotherapy approved for one type of cancer is used to treat a different type.
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