The United States Food and Drug Administration on Monday authorised the Pfizer-BioNTech COVID-19 vaccine for emergency use in kids from 12 to15 years of age.
Acting FDA Commissioner Janet Woodcock described the move as a “significant step in the fight against the COVID-19 pandemic.”
“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” Woodcock said in a statement, AFP reported.
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Now becoming the first COVID-19 vaccine authorised for use in adolescents in the US, the Pfizer jab is already in use for people age 16 and older.
But expanding the usage to people from 12 to 15 years of age opens vaccination to another 5% of the US population, nearly 17 million more people, according to US media reports.
Pfizer said at the end of March that a clinical trial involving 2,260 12-to-15-year-olds showed the vaccine’s efficacy is 100% and it is well-tolerated, CNN reported.
Meanwhile, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said, “Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic.”
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The FDA said some 1.5 million COVID-19 cases in individuals aged 11 to 17 years old have been reported to the Centers for Disease Control and Prevention between March 1, 2020 through April 30, 2021.
Although the course of the disease is generally milder in children, they can pass it on to older, more vulnerable adults.