Moderna Asks FDA to Authorize Omicron-Specific COVID-19 Booster Shot

U.S. health officials have said they plan to roll out the updated booster shots next month, pending regulatory approval.

Moderna Asks FDA to OK Omicron-Specific Shot of Moderna COVID-19 vaccine rests on a table at an inoculation station next to Jackson State University in Jackson, Miss., Tuesday, July 19, 2022. (AP Photo/Rogelio V. Solis)

A vial of the Moderna COVID-19 vaccine sits on a table at a vaccination station near Jackson State University in Jackson, Miss., on July 19, 2022. (AP Photo/Rogelio V. Solis)(AP Photo/Rogelio V. Solis)

The company on Tuesday said it completed its application for an emergency use authorization for the shot for adults ages 18 and older.

“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,” Moderna CEO Stéphane Bancel said in a statement.

If authorized, the shots would be ready to ship in September, the company said.

The announcement comes a day after Pfizer completed an application for its updated booster for people ages 12 and older.
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U.S. health officials have pushed for vaccine makers to update their shots, citing waning immunity paired with rapidly emerging coronavirus variants as concerns.

The BA.4 and BA.5 subvariants are currently responsible for the vast majority of new infections in the U.S. Officials hope that updated shots will provide better protection against infection.

The Biden administration has been gearing up for a fall vaccination campaign with the updated shots. Ashish Jha, the White House COVID-19 response coordinator, said last week that the shots will be available to teens and adults “in a few short weeks,” adding that they should “work much better at preventing infection transmission and serious illness” than the current vaccines.

But it is unclear just how many Americans will be willing to roll up their sleeves for another shot, considering the majority of Americans are undervaccinated and only a third of people ages 50 and older who are eligible for a second coronavirus booster shot have gotten one.