FDA Expected to Authorise Pfizer COVID-19 Vaccine for Teens within the Week: Report

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WASHINGTON, May 3 (AP) - The US Food and Drug Administration is expected to authorise Pfizer's COVID-19 vaccine for youngsters ages 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 announcement is set to come a month after the company found that its shot, which is already authorised 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 authorisation 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.

The New York Times first reported on the expected timing for the authorisation.

Pfizer in late March released preliminary results from a vaccine study of 2,260 US volunteers ages 12 to 15, showing there were no cases of COVID-19 among fully vaccinated adolescents compared with 18 among those given dummy shots.

Pfizer is not the only company seeking to lower the age limit for its vaccine. Results also are expected by the middle of this year from a US study of Moderna’s vaccine in 12- to 17-year-olds.

More than 131 million doses of Pfizer's vaccine have already been administered in the US, where demand for vaccines among adults has dramatically slowed in recent weeks.

The US has ordered at least 300 million doses of the Pfizer shot by the end of July, enough to protect 150 million people.