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

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NEW YORK — Pfizer has filed an emergency use authorization application with the Food and Drug Administration for children ages 5 to 11 to receive the COVID-19 vaccine.

“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 said in a tweet.

“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.

Cases, hospitalizations and deaths in children have all increased since the Delta variant surge. Almost 6 million children have tested positive for the coronavirus in the United States since the start of the pandemic, representing 16.2% of all cases, according to the American Academy of Pediatrics. Children represented more than a quarter of all COVID cases in America for the last week of September.

There is no timetable for how long the process could take. Last year, Pfizer submitted its application for emergency use of the vaccine for adults on Nov. 20, and it was OK’d on Dec. 11 — three weeks later. (The vaccine got full FDA approval this summer.) Pfizer submitted the data for vaccine use in children to the FDA last month, before filing the emergency use application. Right now, it will depend on how quickly the FDA reviews the application and data.


ECRM_06-01-22


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