FDA Approval Opens Door for COVID-19 Vaccines for Children Under 12

Health experts warn against the practice called “off-label” use

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The Food and Drug Administration’s (FDA) full approval of Pfizer’s COVID-19 vaccine allows doctors to administer the vaccine to children under 12 years old. However, some health experts are warning the shot could be given to kids prematurely

The American Academy of Pediatrics (AAP) is warning parents and doctors against off-label use, where some children under 12 could be offered the vaccine. Dr. William Tseng with Kaiser Permanente in San Diego is concerned the vaccine hasn’t yet gone through the extensive trials necessary to prove it is safe for kids.

“You can’t cut their dose in half because they weigh half your size,” he said. “The metabolism is very different, the way you process medications is very different, the absorption is very different.”

Normally, the practice of off-label prescription for certain medications is safe. Tseng warns parents that vaccines work differently.

The FDA gave Pfizer-BioNTech’s two-dose coronavirus vaccine full approval on Monday for all Americans over the age of 16. The vaccine, which will now be marketed as Comirnaty, is the first COVID-19 vaccine to receive full approval by the agency.

“I know pediatricians across the country have gotten a lot of messages about this hoping they will qualify for the vaccine,” he said. “I know we want to help people, but we want to do it the right way, we don’t just want to estimate.”

National City resident and former nurse Karen Thomas has five grandchildren ranging from 6 weeks to 17 years old. Everyone in her family is vaccinated and she is anxiously awaiting the day her youngest grandchildren are eligible. But even after Monday’s approval, Thomas still thinks it is a good idea to wait for the necessary trials.

“Their time will come,” she said. “Just be careful, wear your mask, good hand sanitation and we will all get through this together.”

If any pediatricians decide to administer the vaccine to children anyway, they may be on the hook for administrative costs and could lose their liability coverage.

Tseng urges parents to be patient. He says children under 12 may be eligible to receive the vaccine as early as September.

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