FDA expected to OK Pfizer vaccine for teens within week

May 04, 2021 at 00:01

The U.S. Food and Drug Administration is expected to authorize Pfizer’s COVID-19 vaccine for young adults age 12 and older 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.
MODERNA PROVIDING 500M DOSES OF COVID-19 VACCINE TO COVAX FOLLOWING WHO APPROVALThe 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 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.
The New York Times first reported on the expected timing for the authorization.
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.
CORONAVIRUS: WHAT YOU NEED TO KNOWKids had side effects similar to young adults, the company said.
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.
More than 131 million doses of Pfizer’s vaccine have already been administered in the U.S., where demand for vaccines among adults has dramatically slowed in recent weeks.
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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