FDA Authorizes COVID Vaccine For Youngest Children

The U.S. Food and Drug Administration authorized the Pfizer-BioNTech and Moderna COVID-19 vaccines for children as young as 6 months old, pending approval from the U.S. Centers for Disease Control and Prevention, the agency announced in a news release on Friday (June 17).

"Today, the U.S. Food and Drug Administration authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age," the news release stated.

The FDA amended its emergency use authorization for the Moderna COVID-19 vaccine to include children between 6 months and 17 years of age and the Pfizer-BioNTech COVID-19 vaccine to include children between the ages of 6 months and 4 years.

The Moderna vaccine had previously been authorized for adults age 18 or older, while the Pfizer-BioNTech vaccine was previously authorized for all individuals age 5 and older.

“Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to 6 months of age. As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death,” said FDA Commissioner Robert M. Califf, M.D. in the news release. “Those trusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in its evaluation of the data.”