COVID Vaccines for Kids Under 12 Expected Midwinter: FDA Official

After emergency use authorization, the agency hopes to move quickly to full approval

NBC Universal, Inc. 9-year-old Daemo Gregorie-Cradick is one of the 250 kids ages 5 to 11 who are participating in a trial of the Pfizer coronavirus vaccine at the Children’s Hospital Colorado. If the trial is successful, experts say vaccines for kids under 12 could be just months away.

Emergency approval for COVID-19 vaccines in children under 12 could come in early to midwinter, a Food and Drug Administration official said Thursday, a move that could bring relief to many parents who have been unable to vaccinate their children. The agency hopes to then move quickly to full approval of the vaccine for this age group.

One sticking point for some families who remain hesitant, the official said, is that the vaccines currently in use are administered under emergency use authorization and have not been given full approval by the FDA. Full approval, if it comes quickly after the emergency round, could alleviate that concern.

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COVID-19 vaccines have only been authorized for people ages 12 and up in the U.S., and none has received full approval yet.

Both Moderna and Pfizer-BioNTech launched trials of their COVID-19 vaccines for kids under 12 in March. Results are expected in the fall, and it will take FDA officials time to review the drug companies' applications.

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9-year-old Daemo Gregorie-Cradick is one of the 250 kids ages 5 to 11 who are participating in a trial of the Pfizer coronavirus vaccine at the Children’s Hospital Colorado. If the trial is successful, experts say vaccines for kids under 12 could be just months away.
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