Thursday, October 28, 2021

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

October 7 (WNN) — Pfizer and BioNTech said Thursday that they have formally requested emergency authorization from the Food and Drug Administration to use their COVID-19 vaccine in children ages 5 to 11.

The emergency use authorization would allow companies nationwide to administer the vaccine to children, as was done before it was fully approved for adults.

Pfizer reported a significant increase in cases in the last half of September, with children accounting for 16% of the total cases.

“With the high number of new cases in children in the US, this submission is an important step in our ongoing effort against [COVID-19],” the company tweeted.

“We are committed to working with the FDA with the ultimate goal of helping to protect children against this serious public health threat.”

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The drug manufacturer recommends that children be given one-third of the adult dose, which may require a new vial and syringe.

According to the American Academy of Pediatrics, nearly 6 million children had tested positive for COVID-19 as of September 30. Over 173,000 cases were added in the last week and around 850,000 were added in the last four weeks.

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


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