FDA expected to lower age requirement for vaccine

WASHINGTON (AP) — The U.S. Food and Drug Administration is expected to authorize 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 authorized for those age 16 and older, also provided protection for the younger group.

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 ages 12 to 15, showing there were no cases of COVID-19 among fully vaccinated adolescents compared with 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 also are expected by the middle of this year from a U.S. study of Moderna's vaccine in 12- to 17-year-olds.

While younger people are at dramatically lower risk of serious side effects from COVID-19, they have made up a larger share of new virus cases as a majority of U.S. adults have been at least partially vaccinated and as higher-risk activities like indoor dining and contact sports have resumed in most of the country. Officials hope that extending vaccinations to teens will further accelerate the nation's reduced virus caseload and allow schools to reopen with minimal disruptions this fall.

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

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