Even though the FDA 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.
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.
Last month, the FDA asked Pfizer and Moderna to double the number of children ages 5 to 11 in clinical trials. The FDA also asked for six months of follow-up safety data, instead of the two months it asked for with adults."We know parents are eager to be able to give their children the protection of this vaccine, and the American Academy of Pediatrics shares that feeling of urgency," Beers said on Monday.
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