Pfizer BioNTech has officially submitted its COVID-19 vaccine for emergency use authorization in children aged 5 to 12 to the Food and Drug Administration, according to a tweet posted Thursday.
So far, there are no COVID-19 vaccines approved for FDA use in children. As elementary schools reopened for in-person education this fall, this became a concern. While many schools required students to wear masks to prevent the spread of the virus, some parents, caregivers and even elected officials resisted these mandates.
Last month California became the first state to require children over age 12 get a COVID-19 vaccine to go to school in-person. Pfizer’s vaccine is already approved for use in children aged 12 and older in the U.S.
Dr. Antony Fauci, director of the National Institute of Allergy and Infectious Diseases and the Chief Medical Advisor to the President, said Wednesday that the FDA will meet in a few weeks to discuss the data about vaccines for children. Fauci said he could not predict when the vaccine could be approved.
Pfizer BioNTech announced Sept. 28 that initial data about its vaccine’s safety and efficacy for children under age 12 had been submitted to the FDA. Since Sept. 16, there has been an increase in childhood COVID-19 cases, said the company.
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