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Pfizer requests FDA clearance for its COVID-19 vaccine in kids ages 12 to 15

  • Pfizer requests FDA clearance for its COVID-19 vaccine in kids ages 12 to 15
    The request asks the U.S. Food and Drug Administration to amend its Emergency Use Authorization, which was originally granted in December for people ages 16 and older. Pfizer requests FDA clearance for its COVID-19 vaccine in kids ages 12 to 15
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The request asks the U.S. Food and Drug Administration to amend its Emergency Use Authorization, which was originally granted in December for people ages 16 and older.

 

Pfizer-BioNTech on Friday requested to expand the emergency use of its COVID-19 vaccine in the United States for older children ages 12 to 15.

The request asks the U.S. Food and Drug Administration to amend its Emergency Use Authorization, which was originally granted in December for people ages 16 and older.

"Pending regulatory decision, our hope is to make this vaccine available to the 12-15-year-old age group before the start of the 2021 school year," Pfizer said in a statement.

Pfizer, which developed the two-dose vaccine with its German partner BioNTech, said it plans to submit a similar request to European regulators and other health officials worldwide in the coming days.

Last week, Pfizer said Phase 3 clinical trials found its COVID-19 vaccine was safe and 100% effective among this age group. The preliminary data showed there were no cases among the fully vaccinated adolescents compared to 18 among those given dummy shots.

The study involved 2,260 U.S. volunteers ages 12 to 15 and has not yet been peer-reviewed.

Overall, kids develop serious illness or die from COVID-19 at much lower rates than adults, but they do still get sick and can still spread the virus. 

Children make up roughly 13% of COVID-19 cases that have been documented in the U.S. At least 268 have died from COVID-19 in the U.S. alone and more than 13,500 have been hospitalized, according to figures shared by the American Academy of Pediatrics.