FDA approves vaccine for children 5-11 years old

Pfizer COVID-19 vaccine with syringe
Pfizer COVID-19 vaccine with syringe
Lupmotion via Shutterstock

The U.S. Food and Drug Administration on Friday authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine for children 5 through 11 years of age.

The authorization was based on the FDA’s data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group.

Immune responses of children 5 through 11 years of age were comparable to those of individuals 16 through 25 years of age, the FDA reported in a press release. In that study, the vaccine was 90.7 percent effective in preventing COVID-19 in children 5 through 11.

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The vaccine’s safety was studied in approximately 3,100 children ages 5 through 11 who received the vaccine and no serious side effects have been detected in the ongoing study.

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices will meet next week to discuss further clinical recommendations.

Paul Myers, administrator for Florida Department of Health in Alachua County, called the news an encouraging step. 

“In Alachua County, we have been planning on vaccinating those 5 and up through our school program, in addition to collaborating with UF health and local pediatricians,” Myers said in an emailed statement. “There will be various options for parents to further protect their children from COVID-19 through vaccination, such as at school, drive-up locations and pediatric practices, in addition to the health department.”

The Pfizer-BioNTech COVID-19 vaccine for children 5 through 11 is administered as a two-dose primary series, three weeks apart, but is a lower dose (10 micrograms) than that used for individuals 12 years of age and older (30 micrograms).

In the U.S., COVID-19 cases in children 5 through 11 years of age make up 39 percent of cases in individuals younger than 18 years of age and, according to the CDC, about 8,300 COVID-19 cases in children 5 through 11 years of age resulted in hospitalization.

As of Oct. 17, 691 deaths from COVID-19 have been reported in the U.S. in individuals less than 18 years of age, with 146 deaths in the 5 through 11 years age group.

Drugmaker Moderna is also awaiting the review process for approval to administer its vaccine to younger children. 

Alachua County Public Schools spokesperson Jackie Johnson said she hopes the vaccine release will allow schools to operate without the stress of the pandemic.

“Vaccinations for younger students are critical to getting back to normal in our schools, whatever normal will look like post-pandemic,” she said. “We are working with the Alachua County Health Department to schedule clinics in our schools for students ages 5 to 11 so that we can be ready as quickly as possible when the approval process is complete. Our goal is to eliminate any obstacles for those families who want their children to be vaccinated.”

Editor’s note: This story has been updated with comments from Paul Myers.

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