Pfizer Requests Vaccine Approval From FDA For Kids Aged 5-11

(Photo by FADEL SENNA/AFP via Getty Images)

Dylan Housman Deputy News Editor
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Pfizer and BioNTech have asked the Food and Drug Administration (FDA) to grant Emergency Use Authorization (EUA) to its COVID-19 vaccine for kids between the ages of 5-11.

Pfizer announced the move Thursday, and the FDA is tentatively scheduled to meet Oct. 26 to discuss the question. A ruling could come sometime in November, potentially granting vaccine access to an additional 28 million Americans who are currently ineligible to be vaccinated.

“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,” Pfizer tweeted Thursday. “We’re committed to working with the FDA with the ultimate goal of helping protect children against this serious public health threat.”

Of the more than 28 million American children who fall within the 5-11 age bracket, just 135 have died of the virus in the past 19 months, according to the Centers for Disease Control and Prevention (CDC). According to the American Academy of Pediatrics (AAP), the number of Americans under 18 who have been infected by COVID-19 is approaching six million. (RELATED: CDC Chief Overrules Her Own Advisers After Panel Doesn’t Recommend Booster Shots For Frontline Workers)

According to AAP, one in four new COVID-19 infections in the United States last month were in children. Still, roughly one-third of parents say they would “wait and see” before getting their child between age 5-11 vaccinated, according to a Kaiser Family Foundation poll.

Regulators will evaluate whether a pediatric vaccine dosage should be lower than that of adults, and how prevalent side effects more common in young people are in Pfizer’s clinical trial data. Myocarditis, inflammation of the heart muscle, has been a more common side effect of vaccination in young people, particularly males, leading Sweden and Denmark to pause their recommendations for Moderna’s vaccine for teens and young adults Wednesday.