Eighteen months after authorizing adults to use COVID-19 vaccines from Pfizer and Moderna on an emergency basis, the FDA has done the same for preschoolers who are at least 6 months old.
The endorsement comes two days after an independent FDA advisory committee voted unanimously—though with some reservations about efficacy—to recommend the shots.
All that remains before young kids start to receive the vaccines is for the CDC to sign off on the two jabs.
Also on Friday, the FDA gave a green light to the Moderna vaccine for use in children aged 6 to 17. For several months, the only vaccine available in the United States for kids in this age group was Pfizer’s, as Moderna struggled to gain sanction because of concerns that it increased the risk of heart inflammation.
The FDA nod gives some parents a measure of relief, as they have had no option for vaccination against the coronavirus. Most children who contract the virus are asymptomatic, though there have been more than 200 deaths from the disease among those 4 and younger in the U.S.
“Many parents, caregivers and clinicians have been waiting for a vaccine for younger children,” FDA Commissioner Robert M. Califf, M.D, said in a release. “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.”
The authorized dose for Moderna’s two-shot series for kids ages 6 months to 5 years is 25 micrograms. Children aged 6 to 11 years will get two 50 microgram doses, while those 12 to 17 receive two 100 microgram shots.
Moderna lauded the announcement, saying the blessing was particularly important for kids in the youngest age group.
“Children need to live highly social lives to develop and flourish. With this authorization, caregivers for young children ages 6 months through 5 years of age finally have a way to safeguard against COVID risks in classroom and daycare settings,” Moderna CEO Stéphane Bancel said in a statement.
As a two-shot series, Moderna’s shot for the youngest age group may be preferred by parents. Pfizer’s recommendation, which is for kids ages 6 months to 4 years, calls for two doses administered three weeks apart followed by a third dose provided at least eight weeks later.
In the FDA's independent expert advisory meeting on Wednesday, Jeannette Lee of the University of Arkansas for Medical Sciences, told the committee that some parents might be prone to skip the third dose.
“As we know, it’s a struggle to get people in for two,” she said.
There’s also the question of waning efficacy in the future. The panel based its recommendation on clinical data gathered early this year when the omicron variant was predominant. Months later, the BA.4 and BA.5 omicron subvariants are quickly changing the COVID landscape.
CDC data show that the new strains account for 21% of new infections. Just five weeks ago, BA.4 and BA.5 accounted for just 1% of cases. Early research indicates that BA.4 and BA.5 infections are more transmissible but do not cause more serious illness.
“We have to make decisions based on the best data we have, which is always going to be old data in an outbreak that’s constantly moving,” Paul Rubin, M.D., an infectious disease expert at Harvard, told the committee.