Moderna Is Seeking FDA Authorization for Its Omicron Booster

MOrna Inc. filed its request for U.S. approval to use a booster shot to target the Omicron COVID versions, which is a step to increase protection against 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 indicated that they would ship bivalent booster doses in September if authorization was granted within the timeframe. Moderna’s booster application is for adults 18 years and older.

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A spokesperson for the agency confirmed that two-day meetings will be held next week by Centers for Disease Control and Prevention advisors to address booster shots for COVID-19 vaccinations. Notice of the meeting was posted by the Advisory Committee on Immunization Practices on Tuesday. The CDC receives advice from the panel of external experts on how to best administer new vaccines. There was no agenda.

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. The U.S. Centers for Disease Control and Prevention reported that there were about 95,000 cases, with deaths and hospitalizations falling as more people become immune through early exposure and vaccination.

Pfizer Inc. and BioNTech Se, rival vaccine partners, said Monday that they have sent data to FDA seeking approval for their bivalent booster for BA.4 and BA.5 in order to obtain authorization. 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. They are working closely with FDA to submit an FDA application for bivalent boosters targeting BA.4 or BA.5.

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Moderna shares gained less than 1 percent in the final trading session.

Moderna saidIt announced on August 11th that the company had begun a clinical study of the booster for BA.4 or BA.5. UK regulators cleared another Moderna booster which is focused on Omicron.

–With assistance from Fiona Rutherford.

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