With full FDA approval of Pfizer vaccine, pediatricians discourage parents from trying to get shots for kids 11 and younger

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Despite the Food and Drug Administration’s full approval Monday of the Pfizer-BioNTech COVID-19 vaccine for ages 16 and older, pediatricians are discouraging parents from trying to get shots for children ages 11 and younger until the completion of clinical trials in the coming months.

While the FDA approval means it is legally permissible for physicians to administer the vaccine “off-label” for children aged 11 and younger, who currently have no available vaccine, the American Academy of Pediatrics strongly discourages that practice, AAP officials said in a Monday statement.

“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 Dr. Yvonne Maldonado, 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,” Maldonado said. ”I know parents are anxious to protect their children, but we want to make sure children have the full benefit of ongoing clinical trials.”

AAP President Dr. Lee Savio Beers said the dose of the adult vaccine is much higher than the doses being tested in children younger than 12.

“We need to see the data from those studies before we give this vaccine to younger children,” Beers said.

The Itasca-based AAP strongly recommends all eligible adolescents be vaccinated as soon as possible, Beers said. The vaccine is approved under emergency use for children ages 12 to 15.

With the delta variant spreading rapidly among unvaccinated people, including children, the AAP has called on the FDA to work aggressively to authorize a vaccine for ages 11 and younger, officials said.

In the week ending Aug. 19, the AAP reported 180,000 new cases of COVID-19 among children and adolescents.

Increasing vaccination rates among all who are eligible now is important to protect children while the trials in younger children are underway, Beers said.

“We know parents are eager to be able to give their children the protection of this vaccine, and the AAP shares that feeling of urgency,” Beers said.