FDA Authorizes COVID-19 Vaccines for Kids Under 5 Years Old

FILE – Oliver Estrada, 5, front left, waits with his brother Adriel, 2, after Estrada received the first dose of the Pfizer COVID-19 vaccine at an Adelante Healthcare community vaccine clinic at Joseph Zito Elementary School, Nov. 6, 2021, in Phoenix. Health systems have released little data on the racial breakdown of youth vaccinations, and community leaders fear that Black and Latino kids are falling behind. (AP Photo/Ross D. Franklin, File)

The U.S. Food and Drug Administration authorized emergency use of the Moderna and the Pfizer-BioNTech COVID-19 Vaccine for children down to 6 months of age on Friday.

The FDA amended Moderna’s emergency use authorization, also known as EUA, to include individuals 6 months to 17 years old. The vaccine was previously authorized in adults 18 years and older.

The FDA amended Pfizer’s EUA to include 6 months through 4 years old, the vaccine was previously authorized for individuals 5 years and older.

“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. 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,” said FDA Commissioner Robert M. Califf, M.D.

“Those trusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in its evaluation of the data,” he continued.

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