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FDA, other groups warn against off-label prescribing of COVID vaccine

Following full FDA approval, doctors have more flexibility in prescribing Pfizer's COVID vaccine, but don't expect it to happen often, especially with kids.

MINNEAPOLIS, Minnesota — With Pfizer's COVID-19 vaccine now fully approved by the FDA, doctors will have more flexibility to prescribe it off-label, but don't expect your doctor to give you the okay for an early booster shot or your child's pediatrician to vaccinate your kids under 12.

"I personally would not off-label prescribe it," said Dr. Scott Colson, a family medicine physician and president of Voyage Healthcare. "There is a lot of oversight for these vaccines from the state and the federal government. I don't know that there would be much of that."

Any decision to prescribe a shot off-label is complicated by the fact that Pfizer has a deal with the U.S. Government to distribute the vaccine through April of 2022. On Monday, the FDA warned against off-label use, especially when it comes to children younger than 12.

"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," said FDA Acting Commissioner Janet Woodcock, MD. "They are not just small adults, we have learned that time and time again."

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The American Academy of Pediatrics (AAP) also warned against off-label prescribing to young kids in a statement released Monday.

“We do not want individual physicians to be calculating doses and dosing schedules one-by-one for younger children based on the experience with the vaccine in older patients,” said Yvonne Maldonado, MD, FAAP, chair of the AAP Committee on Infectious Diseases. “We should do this based on all of the evidence for each age group, and for that we need the trials to be completed. I know parents are anxious to protect their children, but we want to make sure children have the full benefit of ongoing clinical trials.”  

Despite the warnings, Dr. Colson says some patients, and parents of patients, will likely continue to ask doctors to go off-label.

"I've had that conversation with my families," Dr. Colson said. "My kid's 11 and a half. That's close. Well, yes, but the Emergency Use Authorization is only good at age 12 and the studies are on-going. I think we will get there. I think by, hopefully this winter, we'll be able to vaccinate children, but we're not there yet."

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