Moderna booster application goes to FDA for authorization

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This updated formulation is a bivalent vaccine that will combine the original vaccine with one that targets omicron sublineages BA.4 and BA.5.

Moderna submitted its application to the U.S. Food and Drug Administration for emergency use authorization of its updated COVID-19 vaccine booster for use in people age 18 and older, the company said in a news release on Tuesday.

"We have worked closely with the FDA to ensure that Americans will have access to Moderna's updated, bivalent booster, which, if authorized, may offer higher, broader, and more durable protection against COVID-19 compared to the currently authorized booster," said Stephane Bancel, chief executive officer of Moderna.

"FDA will be using the totality of the available evidence to authorize the fall bivalent boosters," FDA spokesperson Abigail Capobianco said in a statement emailed to CNN last week. "There are data on many millions of individuals who have received the prototype component as a booster. As for the BA.

 

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