Pfizer plans to request emergency authorization for its COVID-19 vaccine for children ages 5-11 in September or October.
The vaccine is currently authorized for ages 12 and older. Pfizer is now conducting clinical trials in children ages 6 months to 11 years, and the data should be ready to submit to the FDA in the next few months.
Pfizer’s pediatric clinical trials are testing lower vaccine doses in younger age groups. Ages 5-11 will receive a 10-microgram dose, and those younger than 5 will receive a 3-microgram dose. About 4,500 children are participating in the trials in the U.S., Finland, Poland, and Spain. “What gets me up in the morning is the goal of having a pediatric vaccine ready to protect children and their communities as soon as safely possible,” Sabine Schnyder Ghamloush, MD, director of clinical development at Moderna, said during the virtual symposium.