"In anticipation of the FDA's independent advisory committee meeting on October 26 and the U.S. Centers for Disease Control and Prevention’s independent advisory committee meeting on November 2 to 3, today the Biden Administration is announcing a plan to ensure that, if a vaccine is authorized for children ages 5 to 11, it is quickly distributed and made conveniently and equitably available to families across the country," the White House announced.
The start of a vaccination program for children ages 5 to 11 will depend on the independent FDA and CDC process and timeline, said the White House, adding the country will be ready to begin getting shots in arms in the days following a final CDC recommendation. The Biden administration has procured enough vaccine to support vaccination for the country's 28 million children ages 5 to 11 years old, according to the White House.
White House coronavirus coordinator Jeffrey Zients said the Biden administration was aiming to "plan ahead so that we can hit the ground running," but that experts at the FDA and CDC would have the final say. Vaccine advisers to the FDA are scheduled to meet next week to discuss data about the safety and efficacy of the Pfizer-BioNTech pediatric vaccine.
If authorized by the FDA, the Pfizer-BioNTech vaccine would be the first COVID-19 vaccine for younger children. A CDC vaccine advisory panel is scheduled to meet on Nov. 2 and 3 to weigh a recommendation for use. If the CDC director signs off on a recommendation for use, the vaccine can be administered to children ages 5 to 11.
The Pfizer-BioNTech vaccine is currently fully approved for people age 16 and older, and has emergency use authorization from the FDA for children ages 12 to 15. Pfizer said last month that a Phase 2/3 trial showed its COVID-19 vaccine was safe and generated a "robust" antibody response in children ages 5 to 11.
The trial included 2,268 participants ages 5 to 11, and used a two-dose regimen of the vaccine administered 21 days apart. This trial used a 10-microgram dose, which is smaller than the 30-microgram dose that has been used for those ages 12 and older.