Moderna asks FDA to clear updated COVID boosters for kids

Sep. 23, 2022 12:44 PM ETModerna, Inc. (MRNA)PFE, BNTXBy: Dulan Lokuwithana, SA News Editor4 Comments

Moderna To Request Emergency Authorization For Its Vaccine After Positive Trial Results

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Moderna (NASDAQ:MRNA) has requested the FDA to clear its Omicron-adjusted booster shots for children as the Centers for Disease Control, and Prevention (CDC) plans to recommend updated vaccines for kids next month.

Cambridge, Massachusetts-based biotech has submitted two separate emergency use authorization (EUA) requests for the vaccine identified as mRNA-1273.222: one for adolescents aged 12 to 17 and another for kids aged 6 to 11 years.

In August, the FDA authorized its updated booster shot for those aged 18 years and above. The bivalent vaccine is updated to protect against the original COVID strain and Omicron subvariants BA.4 and BA.5

Rival vaccine makers Pfizer (PFE) and BioNTech (BNTX) won FDA clearance to use their updated booster in those aged 12 and above.

At a CDC AdCom meeting early this month, PFE disclosed plans to seek FDA clearance for an Omicron-adapted booster targeting kids aged 5 to 11 in early October.

CDC has scheduled meetings for its vaccine advisory committee on October 19 and 20.

Previously, a federal health agency said that the U.S. government has sent over 25M doses of updated COVID-19 booster shots, mostly from PFE and BNTX, as MRNA continues to ramp up the production.

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