FDA Authorizes COVID-19 Vaccine for Children 6 months to 5 years

June 28, 2022

Children from 6 months to 5 years old now have access to COVID-19 vaccines in the U.S.

The Food and Drug Administration (FDA) authorizes the Moderna and Pfizer-BioNTech  COVID-19 vaccines for infants, toddlers and preschoolers from 6 months to 5-years-old. Dr. Rochelle Walensky, the director of the Centers for Disease Control and Prevention, has also signed off on two COVID-19 vaccines for the age group.

The expert panel voted unanimously on the approval, stating that “the known and potential benefits of the Moderna and Pfizer-BioNTech COVID-19 vaccines outweigh the known and potential risks in the pediatric populations.”

Additionally, the Moderna COVID-19 vaccine, which until now was authorized for adults age 18 and older, was also approved for the 5 to 17 age group.

This recent approval by the FDA completes the vaccine coverage for all age groups, 6 months and older, under the Emergency Usage Authorization (EUA) enacted by the FDA to combat the COVID-19 pandemic.

“Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to 6 months of age,” FDA Commissioner Robert M. Califf, M.D. said. “As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death.”

There are about 18 million children in the 6-month to 5-year-old age group in the U.S.

Here are the administration plans for the two vaccines:

The Moderna COVID-19 vaccine for children and young adults, 6-months to 17-years-old will be  administered in two doses, one month apart. A third shot is available for those who have certain immunocompromised conditions.

The Pfizer-BioNTech COVID-19 vaccine for children and young adults, 6-months to 17-years-old will be administered in three doses, the first two three weeks apart, and the third shot at least eight weeks after the second dose.

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