Moderna seeks FDA clearance for its Omicron booster


Moderna Inc. has completed its filing to seek US clearance for a booster injection targeting the latest variants of Omicron COVID, a measure aimed at providing greater protection against persistent coronavirus.

In a statement, the company said it has completed the emergency authorization application for the company’s bivalent COVID booster vaccine which targets the BA.4 and BA.5 strains as well as the original version of COVID. The dossier includes preclinical data for the booster against the latest strains, as well as clinical data from the company’s other bivalent booster that targets the original Omicron strain.

Moderna said it would be ready to ship bivalent booster doses in September, if cleared within that time frame. Moderna’s reminder app is intended for adults 18 and older.

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Advisors from 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, to be held September 1-2, on its website on Tuesday. The panel of outside experts advises the CDC on how best to administer the new vaccines. No meeting agenda was posted.

Vaccine makers are scrambling to design shots that more closely match circulating strains of the coronavirus in a bid to offer better protection against the pathogen which is still spreading around the world more than 2.5 years after its first detection in China. New cases in the United States averaged about 95,000 in the seven days ending August 17, according to the United States Centers for Disease Control and Prevention, but hospitalizations and deaths have declined as more and more people are gaining immunity through vaccination and previous exposures to the virus.

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

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Moderna shares were up less than 1% late in the session.

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

–With help from Fiona Rutherford.

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