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Stressing that parents of young children now have “options,” the Food and Drug Administration announced Friday that it has unanimously approved emergency use authorization for the Moderna and Pfizer-BioNTech COVID-19 vaccines for children 6 months and older.
“We know that many parents, caregivers and clinicians have been anxiously awaiting today's authorizations,” FDA Commissioner Robert Califf said during a virtual press conference. “We're acutely aware of the importance of having vaccines available for our youngest children. And as we've seen with the older age groups, we expect that the vaccines for younger children will provide protection for the most severe outcomes, such as hospitalization and death.”
To date, COVID vaccines have not been authorized for children under the age of 5. And only Pfizer’s has been available for children ages 5 and up.
“With today’s authorizations, the public has options for COVID-19 vaccines for their children,” Califf said.
Pfizer's vaccine for younger children is a three-shot regimen, with the first two given three weeks apart and the last at least two months later. Moderna's is two shots, given about four weeks apart for kids under 6.
Dr. Peter Marks, the FDA's research director, said there are "subtle differences" between the vaccines. Moderna's, he said, might trigger a child's immune response “slightly more rapidly,” while Pfizer’s might “bring a greater response after the third dose." But parents should feel comfortable getting either one for their children, Marks said.
The Centers for Disease Control and Prevention’s advisory panel will vote Saturday on whether to recommend the vaccines for young children. If it does, the shots could be available as soon as next week.
Califf said the FDA's emergency use authorization followed "a standard, rigorous review process" and that parents "can have confidence that these vaccines have been thoroughly evaluated and meet the FDA's standards for effectiveness."
The FDA said both vaccines appear to be less effective against preventing symptomatic infections than when COVID vaccines were introduced for adults last year because new variants have proved adept at evading protection. But the regulators said they were confident that the vaccines are effective at preventing more serious illness.
“We understand that whenever a public health decision is made that involves children, there are strong opinions on both sides,” Califf said. “But it's important to know that while COVID-19 does affect older and immunocompromised populations more adversely than young children, young children can still suffer the severe consequences of COVID-19, including severe illness and death.”
He cited data showing that since the rise of the Omicron variant, children 4 years and younger have been hospitalized at a rate about five times higher than they were during the Delta surge.
And while the COVID death rate in children is small compared with that in adults, Califf added that "any death of a child is tragic and should be prevented if possible." According to CDC data cited by the New York Times, more than 200 children ages 6 months through 4 years old have died of COVID.
Assuming the CDC votes to approve the vaccines, the challenge for U.S. health officials will be getting parents to give them to their children. According to CDC data, nearly 67% of the U.S. population is considered fully vaccinated. But less than 30% of children ages 5 to 11 have received two doses of a COVID vaccine.
“The vaccination rates are too low, and it's a problem,” Califf said. “It's a real tragedy when you have something that is free and with so few side effects that prevents hospitalization.
"Children shouldn't have these outcomes," he added. "We have to redouble our efforts."