Moderna booster application goes to FDA for authorization

WASHINGTON -- 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.

This updated formulation is a bivalent vaccine that will combine the original vaccine with one that targets omicron sublineages BA.4 and BA.5, and would be administered as a 50 microgram dose.

SEE MORE: Pfizer asks FDA to authorize updated COVID vaccine adding protection from Omicron variants

The company says a phase 2/3 clinical trial on these boosters is now underway. The data they have submitted to the FDA comes from experiments in mice as well as data from humans using a different booster which was updated to protect against the BA.1 strain of omicron.

"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.

The announcement comes one day after Pfizer and BioNTech said they submitted their application to the U.S. Food and Drug Administration for emergency use authorization of their bivalent COVID-19 booster for use in people age 12 and older.

When could shots be available?

White House COVID-19 Response Coordinator Dr. Ashish Jha said recently the updated boosters should be available to the public early- to mid-September, but it is ultimately up to the FDA as to when the shot will get the greenlight.

"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.4/5 component, a combination of nonclinical data obtained in mice, data from prior variant vaccines (including those to beta, delta, and omicron BA.1), along with our extensive knowledge of the safety and efficacy of the mRNA platforms will be used for this decision-making."

The booster dose "elicited potent neutralizing antibody responses against the omicron subvariants BA.4 and BA.5 in all participants regardless of prior infection," according to data previously released by Moderna in June.

The FDA will now evaluate Moderna's data, but hasn't said whether it will convene its vaccine advisers before making a decision on authorization. Such a step could push back when shots can be administered.

Production of the updated shots is already underway. The U.S. government has purchased 105 million bivalent COVID-19 vaccine booster doses from Pfizer, and another 66 million updated shots from Moderna.

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