Pfizer Requests Approval From FDA For A Controversial Age Group

Pfizer and BioNTech have requested for the Food and Drug Administration to grant Emergency Use Authorization to its COVID-19 vaccine for kids between the ages of 5-11.

Last week Pfizer made the announcement that the FDA will meet in late October and a decision could be expected as soon as November.

If approved, 28 million Americans who are currently ineligible to get the vaccine would qualify to have it.

“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 in the 5-11 age bracket, 135 children have died from 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), there have been nearly six million confirmed COVID-19 infections in Americans under the age of 18.

According to AAP, one in four new COVID-19 infections in the U.S. last month were in children, yet according to a Kaiser Family Foundation poll, an estimated one-third of parents say they will “wait and see” before vaccinating their children between ages 5-11.

Regulators will determine whether the pediatric dosage should be lower than adults, they will also look at prevalent side effects more common in young people in Pfizer’s clinical trial data. Myocarditis, inflammation of the heart muscle, has been a more concerning side effect in young people, particularly males, for the Moderna vaccine according to studies conducted in Sweden and Denmark prompting them to hold their recommendation for teens and young adults Wednesday.