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



CNN

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

Moderna and Pfizer filed for emergency use authorization from the FDA for their updated Covid-19 boosters for younger people in recent days. Moderna is seeking authorization for children up to 6 years old and Pfizer for children 5 to 11 years old.

The shots cannot be given until updated vaccines are licensed by the FDA for those age groups and recommended by the US Centers for Disease Control and Prevention.

In a statement to CNN, the FDA said it “will review applications as quickly as possible using our comprehensive, science-based approach.” If any questions or concerns arise that require input from his independent vaccine advisers, he said he will schedule a meeting to discuss them.

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

Like the boosters that became available to seniors earlier this month, these bivalent boosters target the parent strain of the coronavirus, as well as the Omicron BA.4/BA.5 subvariants.

Pfizer’s updated booster is currently licensed for use in people 12 years and older, and Moderna’s is licensed for adults 18 years and older. Individuals 12 years of age and older who have received their primary vaccine series are eligible to receive 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 the infection itself can act as a booster.

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