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What needs to happen before the vaccine can be approved for kids under 12?

Kids ages 12 to 15 can get the shot under the Emergency Use Authorization (EUA). Children 11 years old and younger are not approved to get the vaccine.

ATLANTA — The Food and Drug Administration (FDA) has fully approved the Pfizer vaccine, however, they still do not recommend children ages 11 and younger get the vaccine. 

There are still several steps before the vaccine is approved for kids.

As of Aug. 23, 2021, the Pfizer vaccine is fully approved for anyone 16 and up. Kids between the ages of 12 and 15 can get the shot, but it's under the Emergency Use Authorization (EUA). Children 11 years old and younger are not approved to get the vaccine.

Former FDA Commissioner Dr. Stephen Hahn told CNN, "We have more data about efficacy and safety than almost any other vaccine in the history of vaccination."

Still, vaccinating younger children requires extra scrutiny and study. Clinical trials testing the Moderna vaccine in children began at Emory University and Children's Healthcare of Atlanta earlier this year. 

"What we need to do for children is figure out what the right approach for them is. Their immune system works a little differently than adults. Their physiology is different, and so we need to figure out the right doses, intervals and right approach. That might be a little different than adults," Dr. Colleen Kelley of Emory University said.

Credit: 11Alive

RELATED: Emory, Children's Healthcare of Atlanta enrolling young children in Moderna vaccine trial

Emergency use authorization for younger children is expected in the fall or winter. Some reports say Pfizer may have enough data by the end of September. But several steps need to be taken first, including the completion of clinical trials. 

Dr. Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases, told CNN, "The companies will be able to present the data to the CDC by the mid-Fall or so."

Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said in a video news conference Monday that trials for vaccines for children continue and that the agency “has to wait for the company to submit the data from those trials so that we have a good safety dataset because we certainly want to make sure that we get it right in the children ages 5 through 11 and then even in younger children after that.”