FDA authorization for updated Covid-19 boosters could be expanded to younger ages as soon as early October

By Jacqueline Howard, CNN

US Food and Drug Administration authorization for updated Covid-19 boosters could be expanded to younger age groups as soon as early October, a source close to planning discussions tells CNN.

Moderna and Pfizer both sought FDA emergency use authorization for their updated Covid-19 boosters for younger people in recent days. Moderna is seeking authorization for children as young as 6 years and Pfizer for children ages 5 through 11.

Shots can’t be administered until the FDA authorizes the updated vaccines for those age groups and US Centers for Disease Control and Prevention recommends them.

In a statement to CNN, the FDA said it “will review the requests as expeditiously as possible using our thorough and science-based approach.” If any questions or concerns emerge that require input from its independent vaccine advisers, it said it would schedule a meeting to discuss them.

The CDC told CNN that its Advisory Committee on Immunization Practices reviewed data around the updated Covid-19 boosters at its September 1 meeting. “Since ACIP has already reviewed the relevant data — and in order to avert delays in providing updated boosters for children ages 5 through 11 years — once manufacturing and production are complete and EUAs are available, we anticipate CDC will make a recommendation for use of these products, and help make them available to children ages 5 through 11 across the United States,” the agency said.

Like the boosters that became available for older people earlier this month, these bivalent boosters target the original coronavirus strain as well as the Omicron BA.4/BA.5 subvariants.

Pfizer’s updated booster is currently authorized for use in people 12 and older and Moderna’s is authorized for adults age 18 and older. People 12 and older who’ve had their primary vaccine series are eligible to get the updated boosters, which replace the original boosters in those age groups. People who have recently had Covid-19 may want to wait at least three months, as infection itself can act as a booster.

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CNN’s Naomi Thomas contributed to this report.