The U.S. Food and Drug Administration is expected to authorize Pfizer’s COVID-19 vaccine for children ages 12 to 15 by next week, according to a federal official and a person familiar with the process.
The authorization is set to come a month after the company announced that its shot, which is already being given to those age 16 and older, also provided protection for the younger group.
The federal official, speaking on 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 the FDA is expected to approve the vaccine’s use among even younger children some time 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.
The New York Times first reported on the expected timing of the authorization.
Pfizer in late March released preliminary results from a study of 2,260 U.S. volunteers ages 12 to 15 showing no cases of COVID-19 among fully vaccinated adolescents compared to 18 among those given dummy shots.
Kids had side effects similar to young adults, the company said. The main side effects are pain, fever, chills and fatigue, particularly after the second dose.
The study will continue to track participants for two years for more information about long-term protection and safety.
Pfizer isn’t the only company seeking to lower the age limit for its vaccine. Results are expected by the middle of this year from a U.S. study of Moderna’s vaccine in 12- to 17-year-olds.
The FDA has already allowed both companies to begin U.S. studies in children 11 and younger, working their way down to as young as 6 months old.
More than 131 million doses of Pfizer’s vaccine have already been administered in the U.S., where demand for vaccines among adults has slowed in recent weeks.
Young people are at a dramatically lower risk of serious side effects from COVID-19.
The U.S. has ordered at least 300 million doses of the Pfizer shot by the end of July, enough to vaccinate 150 million people.
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