The commissioner of the Food and Drug Administration, Dr. Robert Califf, spoke at a virtual press conference after the agency approved the emergency use authorization for the Moderna and the Pfizer-BioNTech COVID-19 vaccines for children as young as 6 months old.
ROBERT CALIFF: Today, the FDA authorized the emergency use of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine for children down to six months of age. We know that many parents, caregivers, and clinicians have been anxiously awaiting today's authorizations. We're acutely aware of the importance of having vaccines available for our youngest children, and as we've seen with the older age groups, we expect that the vaccines for younger children will provide protection for the most severe outcomes of COVID-19, such as hospitalization and death.
Today's actions are twofold. First, we authorized the Moderna COVID-19 vaccine to include use of the vaccine in an individual six months through 17 years of age. Prior to today, this vaccine has been authorized for use in adults 18 years of age and older. We also authorized the Pfizer-BioNTech COVID-19 vaccine to include use of the vaccine in children six months through four years of age. This vaccine has previously been authorized for use in individuals five years of age and older.