The U.S. Food and Drug Administration is expected to authorize Pfizer’s COVID-19 vaccine for youngsters age 12 to 15 by next week, according to a federal official and a person familiar with the process, setting up shots for many before the beginning of the next school year. The New York Times, Washington Post and other media outlets have also reported the news.
The announcement is set to come a month after the company found that its shot, which is already authorized for those age 16 and older, also provided protection for the younger group.
The federal official, speaking on the condition of anonymity to preview the FDA’s action, said the agency was expected to expand its emergency use authorization for Pfizer’s two-dose vaccine by early next week, and perhaps even sooner. The person familiar with the process, who spoke on condition of anonymity to discuss internal matters, confirmed the timeline and added that it is expected that the FDA will approve Pfizer’s use by even younger children sometime this fall.
The FDA action will be followed by a meeting of a federal vaccine advisory committee to discuss whether to recommend the shot for 12- to 15-year-olds. Shots could begin after the Centers for Disease Control and Prevention adopts the committee’s recommendation. Those steps could be completed in a matter of days.
Pfizer in late March released preliminary results from a vaccine study of 2,260 U.S. volunteers age 12 to 15, showing there were no cases of COVID-19 among fully vaccinated adolescents compared with 18 among those given dummy shots.