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The U.S. Food and Drug Administration is warning physicians that children under age 12 should not receive the Pfizer-BioNTech COVID-19 vaccine under “off-label” use just because the drug has been granted formal approval by the agency.

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The FDA expressed concern that the approval of the vaccine, which will now be called Comirnaty, may spur some physicians to give it to younger patients, something that is legal to do after a drug is approved by the FDA.

To give a drug “off-label” means prescribing the drug to be used for a disease or medical condition that it is not approved to treat. For instance, if you were to give a malaria drug to a person with a COVID-19 infection, like some did when prescribing hydroxychloroquine to some who contracted COVID-19.

It is not wrong or illegal to do that, it is just not what the drug was approved to be used for.

FDA Acting Commissioner Janet Woodcock, MD, warned during a press briefing Monday that children are “not just small adults” when it comes to administering drugs.

“We do not have data on proper dose, nor do we have full data on safety in children younger than what is in the EUA [emergency use authorization], so that would be a great concern that people would vaccinate children,” Woodcock said.

“So, we believe we need to get the … data on usage in younger children. They are not just small adults; we have learned that time and time again.”

Dr. David Kimberlin, a pediatric infectious disease expert at the University of Alabama at Birmingham, told MedPage Today that the dose for those 12 and up is 30 mcg, while the doses being tested in children ages 5-11 “is a third of that,” or 10 mcg.

Kimberlin said for children younger than 5, the dose being studied is 3 mcg, MedPage Today reported.

“We can’t have physicians writing for the approved 30 mcg dose to be used in someone under 12,” Kimberlin said. “It’s a much higher dose than what’s being studied.”

The American Academy of Pediatrics echoed the FDA warning, saying trials had not been completed nor results reviewed on testing the vaccine to those up to age 11.

“The clinical trials for the COVID-19 vaccine in children ages 11 years old and younger are underway, and we need to see the data from those studies before we give this vaccine to younger children,” AAP President Dr. Lee Savio Beers, a professor of Pediatrics and the medical director for Community Health and Advocacy at Children’s National Hospital, said in the statement.

Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 vaccine has been available under Emergency Use Authorization in those ages 16 and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021.

According to the FDA, “EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.”

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