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Reports: FDA Set to Authorize Pfizer’s Coronavirus Vaccine in Adolescents

The Food and Drug Administration will reportedly authorize Pfizer’s request to expand use of its COVID-19 vaccine to adolescents ages 12-15 by early next week.

The move, which was reported by multiple outlets, would open up vaccines to millions of children – a step that experts believe is key to increasing immunity in the population.

Pfizer announced last month that it submitted a request to the FDA to expand its coronavirus vaccine emergency use authorization to the age bracket after it reported that trial results of kids aged 12-15 “demonstrated 100% efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants aged 16 to 25 years old, and was well tolerated.”

The vaccine, developed by Pfizer and German company BioNTech, is currently authorized for emergency use in individuals aged 16 and older. Coronavirus vaccines from Moderna and Johnson & Johnson have been authorized for such use in those 18 and older.

Pfizer officials on Tuesday said that the company plans to file for full regulatory approval of its COVID-19 vaccine this month. If it gains FDA approval, Pfizer can market its vaccine directly to consumers. Approval would also allow the shot to stay on the market once the coronavirus outbreak is no longer considered an “emergency” in the U.S.

The company also expects to submit a request in September to the FDA to expand its vaccine use to children aged 2-11.

More than 105 million people in the U.S. – or nearly 32% of the population – are fully vaccinated, according to data from the Centers for Disease Control and Prevention.

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