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May 5, 2021 (Children’s Health Defense) — The U.S. Food and Drug Administration (FDA) is preparing to authorize use of the Pfizer-BioNTech COVID vaccine in adolescents 12 to 15 years old by early next week, according to federal officials familiar with the agency’s plans. The vaccine is currently authorized in the U.S for emergency use in people 16 and older.
The decision, which is likely to be supported by the Centers for Disease Control and Prevention (CDC), would allow most middle and high school students to get vaccinated before summer camps and the start of the 2021-22 school year, USA TODAY reported.
The FDA will have to amend the Emergency Use Authorization (EUA) for Pfizer’s vaccine, but the process should be straightforward, said a federal official who was not authorized to speak about the process publicly and requested anonymity.
“While the FDA cannot predict how long its evaluation of the data and information will take, the agency will review the request as expeditiously as possible using its thorough and science-based approach,” the FDA said in an email to CNN last week.
The FDA is reviewing data submitted by Pfizer
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