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Pfizer COVID-19 vaccine not yet authorized for children under 12, trials still underway

Pfizer Vaccine
Posted at 10:42 AM, Aug 28, 2021
and last updated 2021-08-28 13:42:46-04

SAN DIEGO (KGTV)- After the Food and Drug Administration (FDA) issued full approval for Pfizer’s COVID-19 vaccine for people 16 and older, the question now as children return to school is, when will children under the age of 12 be able to get vaccinated? Kids 12 to 15 can still get the shot under the previous Emergency Use Authorization.

“Just because it worked for the adults, you can’t just use that and extrapolate to the kids; we need hard evidence, we need to follow where the science leads us,” said Dr. William Tseng, the vaccine lead at Kaiser Permanente in San Diego.

He said clinical trials need to be complicated before the vaccine can be authorized for the next age group. Those studies are still underway, and the FDA’s approval Monday doesn’t change that.

“They’re going to do their due diligence to make sure the vaccine is safe and effective for kids of that age,” said Tseng. “It’s very important to follow those guidelines because the dosing may be different.”

The FDA also made it clear that kids under 12 should not receive a COVID-19 vaccine yet.

“We want to reiterate, it is important that the unvaccinated get vaccinated where it is indicated, but we do not have data on the proper dose nor do we have full data on the safety in children younger than what is in the EUA,” said Dr. Janet Woodcock, the Acting FDA Commissioner, during a media call Monday.

Dr. Victor Nizet, a Distinguished Professor of Pediatrics at UC San Diego School of Medicine, said kids aren’t simply miniature adults. Ensuring there’s an effective dose for the 5 to 11 age group is key to having sustained protection.

“There’s special considerations in the way their body and immune system handle drugs or vaccines, and in particular, we want to get the dose right,” said Nizet.

After clinical trials in kids, the next step is to submit the safety and efficacy data collected to the FDA for evaluation.

Pfizer anticipates the studies will be completed and ready for FDA review sometime in September; authorization comes after that.

“No doubt they will apply the very same urgency that led to the record time frame for approval of the current vaccines,” said Nizet.

In the meantime, doctors say masking up in classrooms, maintaining social distancing, and having eligible populations vaccinated will be key to keeping the younger kids protected for now.