No off-label prescribing COVID-19 vaccines to kids under 12: FDA

Physicians often use off-label prescribing when medical products are approved, a top FDA official said

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.

The Pfizer COVID-19 vaccine won full FDA approval on Monday for individuals 16 years and up, and in May the shot saw expanded emergency approval for use among adolescents ages 12-15. Children ages 8 and older may become eligible for vaccinations by September, sources previously told Fox News.

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"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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"We are not recommending that children younger than age 12 be vaccinated with this vaccine," she continued. "It would not be appropriate."

Pfizer CEO Albert Bourla told NBC’s Lester Holt on Monday that eligible populations reluctant to receive the vaccine under emergency approval should know the now-FDA approved vaccine is "effective and safe." 

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Bourla noted the vaccine does carry the risk of side effects, including potentially serious adverse events, though they are exceedingly rare. The vaccine also demonstrated 91% efficacy, with Bourla citing the need for a booster shot after several months.

"That will continue providing you the high level of efficacy that you observed immediately after the second dose," he said.