FDA authorises first COVID-19 shots for infants, preschoolers

United States regulators on Friday authorised 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 US 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 US 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. Its independent advisers began debating the two-dose Moderna and the three-dose Pfizer vaccines on Friday and will make its recommendation 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 paediatric 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 authorised Moderna's vaccine for school-aged children and teens.

Pfizer's shots had been the only option for those ages.

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