Food Drug Administration
The drugmaker said it will seek emergency use authorization for this age group in the U.S. by the end of the month.
Dr. Rochelle Walensky's timeline update comes shortly after new pediatric coronavirus cases hit a record high.
The announcement applies to several million Americans who are especially vulnerable because of organ transplants, certain cancers or other disorders.
The company says the bulk of its workers have already received their shots.
Vaccines provide lasting protection against severe cases of COVID-19 but studies show their effectiveness can diminish over time.
“We need to think about a different vaccine delivery strategy to get the people who are still reluctant or who still face challenges," Dr. Scott Gottlieb said Sunday.
The controversial drug, called Aduhelm, costs $56,000 a year and some patients could face copayments of $11,500 annually.
The FDA's decision to pause distribution of the one-dose vaccine is credited with damaging its reputation among Americans.