Pfizer and BioNTech have requested emergency use authorization from the FDA to administer their COVID-19 vaccine (Comirnaty) to children ages 5 to 11 years old, according to a Pfizer tweet.

The vaccine is already authorized for emergency use in children 12 through 15 years of age, and is FDA-approved for Americans age 16 and older.

Last month, Pfizer released data from a Phase 2/3 trial of the vaccine, which revealed a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of 10 µg administered 21 days apart, according to the companies. (The administered dosage in individuals 12 and older is 30 µg.)

Read more about the study data here.

The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) for October 26 to discuss data for the vaccine and a potential expansion of its emergency use authorization.

“We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults,” said Acting FDA Commissioner Janet Woodcock, MD.