FDA authorizes 1st COVID-19 shots for infants, preschoolers

U.S. regulators on Friday authorized the first COVID-19 shots for infants and preschoolers, paving the way for vaccinations to begin next week.

The Food and Drug Administration's action follows its advisory panel's unanimous recommendation for the shots from Moderna and Pfizer. That means U.S. kids under 5 — roughly 18 million youngsters — are eligible for the shots, about 1 1/2 years after the vaccines first became available in the U.S. for adults, who have been hit the hardest during the pandemic.

There's one step left: The Centers for Disease Control and Prevention recommends how to use vaccines and its vaccine advisers are set to discuss the shots Friday and vote on Saturday. A final signoff would come from CDC Director Dr. Rochelle Walensky.

At a Senate hearing Thursday, Walensky said her staff was working over the Juneteenth federal holiday weekend “because we understand the urgency of this for American parents.”

She said pediatric deaths from COVID-19 have been higher than what is generally seen from the flu each year.

“So I actually think we need to protect young children, as well as protect everyone with the vaccine and especially protect elders,” she said.

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

For weeks, the Biden administration has been preparing to roll out the vaccines for little kids, with states, tribes, community health centers and pharmacies allowed to preorder millions of doses. FDA's emergency use authorization allows manufacturers to begin shipping vaccine across the country. Vaccinations could begin early next week.

While young children generally don’t get as sick from COVID-19 as older kids and adults, their hospitalizations surged during the omicron...