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Moderna Is Seeking FDA Authorization for Its Omicron Booster

3 minute read

Moderna Inc. completed its filing to request U.S. clearance for a booster shot that targets the latest Omicron COVID variants, a move to provide more protection against the persistent coronavirus.

In a statement, the company said it had wrapped up the submission for emergency authorization for the company’s bivalent COVID booster vaccine that targets the BA.4 and BA.5 strains along with the original version of COVID. The filing includes preclinical data for the booster against the latest strains, along with clinical data from the company’s other bivalent booster that targets the original Omicron strain.

Moderna said it would be ready to ship doses of the bivalent booster shot in September, if it were authorized in that time frame. Moderna’s booster application is for adults 18 years and older.

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Advisers to the Centers for Disease Control and Prevention will hold a two-day meeting next week to discuss booster shots for COVID-19 vaccines, an agency spokesperson confirmed in an email. The Advisory Committee on Immunization Practices posted notice of the meeting, which will be held Sept. 1 and 2, on its website on Tuesday. The panel of outside experts advises the CDC on how best to administer new vaccines. No agenda for the meeting was posted.

Vaccine makers are working to design shots that match the circulating strains of the coronavirus more closely in an attempt to give better protection against the pathogen that’s still spreading around the world more than 2 1/2 years after it was first detected in China. New cases in the US averaged about 95,000 in the seven days ending Aug. 17, according to the U.S. Centers for Disease Control and Prevention, but hospitalizations and deaths have fallen as more people gain immunity through vaccination and earlier exposures to the virus.

Rival vaccine partners Pfizer Inc. and BioNTech SE said Monday they had sent data to the Food and Drug Administration seeking authorization for their own bivalent booster against BA.4 and BA.5 for people 12 and older. Pfizer said Tuesday that a three-dose regimen of its existing COVID vaccine was 73.2% effective against the disease in a trial in children ages 6 months through 4 years of age, adding to data that led to the shot’s authorization in young children in June. The companies are working with the FDA to prepare an application in kids ages 6 months through 11 years old for a bivalent booster targeting BA.4 and BA.5.

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Moderna shares rose less than 1% in late trading.

Moderna said on Aug. 11 that it had started a clinical trial of the booster against BA.4 and BA.5. UK regulators have cleared another Moderna booster that focuses on the original Omicron strain.

–With assistance from Fiona Rutherford.

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