FDA would authorize Pfizer vaccine in 12-15 year olds 0:47
(CNN) -
The U.S. Food and Drug Administration (FDA) has expanded the emergency use authorization of Pfizer's covid-19 vaccine to include children between the ages of 12 and 15.
It is the first vaccine against covid-19 that is authorized in the United States for adolescents of these ages.
It had previously been approved for use for persons 16 years of age and older.
Moderna and Johnson & Johnson vaccines, meanwhile, are licensed for use in people 18 years of age and older.
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To support the expanded use, the FDA reviewed data submitted by Pfizer.
The company said in late March that a clinical trial involving 2,260 children ages 12 to 15 showed that the vaccine is 100% effective and well tolerated.
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The independent FDA Advisory Committee on Vaccines and Related Biologics did not meet to vote on the recommendation to expand the emergency use authorization.
However, the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices is scheduled to meet Wednesday to advise CDC on whether to recommend the vaccine for this group of age.
Dr. Rochelle Walensky, director of the CDC, will then decide whether the agency recommends the use of the vaccine in the new group.
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Vaccination of this group is not expected to begin until after the CDC recommendation.
The Biden administration has said it will move quickly to prepare vaccination for 12-15 year olds through the federal pharmacy program, pediatricians and family physicians.
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Expanding the authorization to people between 12 and 15 years of age enables vaccination to another 5% of the United States population, about 17 million more inhabitants.
The expanded authorization means that 85% of the country's population is eligible to receive the covid-19 vaccine.
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The FDA's decision "represents a significant step forward in helping the United States government expand its vaccination program and help protect adolescents ages 12-15 before the start of the next school year," it said in a statement. Albert Bourla, CEO of Pfizer, who thanked the volunteers and their families for their "courage."
"Together, we hope to help restore a sense of normalcy to young people across the country and eventually around the world."
Pfizer said last week that it expects to apply for emergency use authorization for children ages 2 to 11 in September.
Studies are currently underway on the safety and efficacy of the vaccine in children 6 months to 11 years of age.
Pfizer Coronavirus Vaccine