FDA Approves COVID Vaccines for Children Aged 5 and Younger

WASHINGTON — The Food and Drug Administration on Friday gave its approval for COVID-19 vaccines for children age 5 and younger. 

The shots could start as early as next week if, as expected, the Centers for Disease Control and Prevention agrees with the FDA assessment.

In an announcement posted on its website, the FDA said it had approved the use of the Pfizer and BioNTech vaccine for children aged 6 months to 4 years, and the Moderna vaccine for children up to age 5.

Even without CDC action, the vaccines can now be shipped to those states that pre-ordered an initial batch in anticipation of approval.

“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,” said FDA Commissioner Robert Califf in a written statement.

“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,” he continued.

“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,” Califf added.

The Moderna COVID-19 Vaccine is administered as a primary series of two doses, one month apart, to individuals 6 months through 17 years of age. 

The vaccine is also authorized to provide a third primary series dose at least one month following the second dose for individuals in this age group who have been determined to have certain kinds of immunocompromise. 

The Pfizer-BioNTech COVID-19 Vaccine is administered as a primary series of three doses in which the initial two doses are administered three weeks apart followed by a third dose administered at least eight weeks after the second dose in individuals 6 months through 4 years of age. 

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