Pfizer officially asks the FDA to authorize its COVID vaccine for kids aged 5-11

"With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against COVID19."

  • By Joe Hernandez/NPR

(Washington) — Pfizer and BioNTech are officially asking the Biden administration to authorize the use of their COVID-19 vaccine for children ages 5 to 11.

Pfizer tweeted on Thursday that the companies had submitted their formal request for Emergency Use Authorization of the vaccine to the Food and Drug Administration.

“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19,” the pharmaceutical giant said.

In this April 5, 2021, file photo, Leanne Montenegro, 21, covers her eyes as she doesn't like the sight of needles, while she receives the Pfizer COVID-19 vaccine at a FEMA vaccination center at Miami Dade College in Miami. Nearly half of new coronavirus infections nationwide are in just five states, including Florida — a situation that puts pressure on the federal government to consider changing how it distributes vaccines by sending more doses to hot spots.

Lynne Sladky / AP Photo

In this April 5, 2021, file photo, Leanne Montenegro, 21, covers her eyes as she doesn’t like the sight of needles, while she receives the Pfizer COVID-19 vaccine at a FEMA vaccination center at Miami Dade College in Miami. Nearly half of new coronavirus infections nationwide are in just five states, including Florida — a situation that puts pressure on the federal government to consider changing how it distributes vaccines by sending more doses to hot spots.

The submission is the latest development in the push to expand use of the vaccine to younger children, a process being closely watched by many anxious parents as the new school year gets underway.

The Pfizer-BioNTech vaccine has full FDA approval for people ages 16 and older, and those between the ages of 12 and 15 can get the shot under the current emergency use authorization.

Last month Pfizer and BioNTech submitted data to the FDA showing that their vaccine produced a “robust” antibody response in kids from 5-11 and had “favorable” safety outcomes.

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