Coronavirus: FDA authorizes first COVID-19 shots for children 5 and younger

The Food and Drug Administration on Friday authorized COVID-19 vaccines for children 5 and under and as young as 6 months.

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The approval clears a key hurdle in expanding eligibility for vaccines to babies, toddlers and preschoolers, CBS News and The Associated Press reported. The Centers for Disease Control and Prevention must still sign off on the FDA recommendation.

The move comes after an FDA panel on Wednesday endorsed recommending the COVID-19 vaccines developed by Moderna and Pfizer-BioNTech for use in children under the age of 5.

A final approval would come from CDC Director Dr. Rochelle Walensky, according to the AP.

The panel decided that the benefits of Moderna’s and Pfizer’s vaccination series outweigh the risks for children between the ages of 6 months and 5 years and 6 months and 4 years, respectively.

That means U.S. kids under 5 will be eligible for the shots, about 1 1/2 years after the vaccines first became available in the U.S. for adults, the AP reported.

The FDA also authorized Moderna’s vaccine for school-aged children and teens. Pfizer’s shots had previously been the only ones available for those ages.

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

As of Tuesday afternoon, 78% of the U.S. population -- 259 million people -- has received at least one dose of any of the available COVID-19 vaccines, according to the CDC. Nearly 67% of Americans, or 221.7 million people, have been fully vaccinated, and over 47% of those who have been fully vaccinated have gotten at least one booster shot, CDC data shows.

Pfizer’s vaccine for children younger than 5 is one-tenth of the adult dose and three shots are required, according to the AP. The first two are given three weeks apart, with the final shot to follow at least two months later.

Moderna’s vaccine only requires two shots, with each 25% of its adult dose, the AP reported. The shots are given about four weeks apart for children under 6.

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