New York Daily News: MANHATTAN – The Food and Drug Administration cleared the use of the Pfizer-BioNTech COVID-19 vaccine for younger children Friday, leaving just one more hurdle to getting young kids inoculated.
The FDA said in a statement Friday afternoon it is authorizing the emergency use of the vaccine for children between the ages of 5 and 11.
The last step before shots can begin is approval from the Centers for Disease Control and Prevention. On Tuesday, an advisory panel for the CDC will make recommendations on which youngsters should get vaccinated. The agency is expected to make a final decision shortly afterward.
Friday’s FDA authorization was based on the agency’s “thorough and transparent evaluation of the data.”
Earlier this week, an FDA advisory committee voted 17-0, with one abstention, in favor of recommending emergency use of the vaccine for younger children in the US.
The vaccine will be administered in two doses, three weeks apart. Each dose of 10 micrograms will be one-third the dosage used for people 12 and older.
“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” Dr. Janet Woodcock, acting FDA commissioner, said in a statement.
“Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards,” she added.
Pfizer will begin shipping millions of vials of the pediatric vaccine to doctors’ offices, pharmacies and other vaccination sites. The kid-sized vials will have orange caps, as opposed to the full doses, which have purple caps.