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Pfizer seeks emergency FDA approval for COVID-19 vaccine in children 5-11

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Pfizer seeks emergency FDA approval for COVID-19 vaccine in children 5-11
The drugmaker recommends that children be given one-third of an adult dose, which could require a new vial and syringe. File Photo by John Angelillo/UPI | License Photo

Oct. 7 (UPI) -- Pfizer and BioNTech said Thursday they have formally requested emergency authorization from the Food and Drug Administration to use its COVID-19 vaccine in children 5 to 11 years old.

Emergency use authorization would allow the companies to administer the vaccine in children nationwide, as it did for adults before it was fully approved.

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Pfizer noted a significant increase in child cases over the last half of September and that children account for 16% of total cases.

"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 [COVID-19]," the company tweeted.

"We're committed to working with the FDA with the ultimate goal of helping protect children against this serious public health threat."

The drugmaker recommends that children be given one-third of an adult dose, which could require a new vial and syringe.

According to the American Academy of Pediatrics, nearly 6 million children had tested positive for COVID-19 by Sept. 30. More than 173,000 cases were added over the past week and nearly 850,000 were added over the past four weeks.

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Pfizer and BioNTech said last month that a clinical study of more than 2,000 children showed the vaccine was safe and produces a significant antibody response in children 5 to 11. The study was the first based on late-stage clinical data in young children.

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