FDA Clears Emergency Use of Comirnaty in Children Aged 5 to 11
The FDA on Friday authorized emergency use of Pfizer and BioNTech's Comirnaty for the prevention of COVID-19 to include children 5 through 11 years of age. The vaccine is administered as a two-dose primary series, 21 days apart, but at a lower 10-mcg dose than that used for individuals 12 years of age and older, according to a FiercePharma report.
"I know that parents, caregivers, school staff and children have been waiting for today's authorisation," remarked Janet Woodcock, acting FDA Commissioner, adding "vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy."
The FDA's decision comes a matter of days after an advisory committee voted 17-0 with one abstention that the benefits of Comirnaty outweigh its risks for use in children ages five to 11 years old. The agency noted that the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices is scheduled to meet next week to discuss further clinical recommendations for the vaccine.