UAB answers questions about FDA approval of Pfizer COVID-19 vaccine for 16+

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HUNTSVILLE, Ala. — The U.S. Food and Drug Administration has given full approval to the Pfizer COVID-19 vaccine for anyone 16-and-older. Understandably there’s a few questions about why ages 12-15 are left out of the FDA approval.

Note: Ages 12-15 are still able to get vaccinated with the Pfizer vaccine. That age group is still under Emergency use Authorization.

“We are in a very, very, very difficult place right now. Alabama is number one in the country in the rate of pediatric hospitalizations due to COVID,” said Dr. David Kimberlin, co-Director of UAB & Alabama Children’s Division of Pediatric Infectious Diseases.

Dr. Kimberlin says the timing of FDA approval of Pfizer’s vaccine for ages 16 and up comes at a critical moment. Leaving some questions about ages 12 through 15. Dr. Kimberlin says Pfizer and the FDA simply has had more data, for a longer period of time on those 16 and older, hence the approval.

“This full approval by the FDA is an even stronger affirmation of what we’ve known from the time these vaccines were authorized,” said Kimberlin.

There is not a single vaccine available to those under the age of 12. Studies are ongoing. UAB says it’s critical that Pfizer’s COVID-19 vaccine is not given to kids under 12.

“Here’s a strong cautionary statement I want to make. The dose of the Pfizer vaccine that is being studied in 5 through 11 year old’s is one third of the dose that is in the approved 16+ formulation of the vaccine,” said Kimberlin.

For children under 5-years of age, the dose is one 10th of the approved vaccine, says Kimberlin who adds there’s no room for shortcuts or rushing a vaccine for infants.

It’s not clear how much longer it will take for Pfizer’s vaccine to be upgraded from emergency use to approval for those 12 and up.

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