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.)
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.