Moderna Set to Seek FDA Approval of Booster Against Omicron Variants

Moderna Inc. said that the company plans to file data with US regulators very soon requesting clearance for a booster shot targeting the latest omicron Covid variants.

A filing is “imminent” for the company’s bivalent Covid booster vaccine that targets the BA.4 and 

BA.5 strains along the original version of Covid, company spokesman Chris Ridley said in an interview. 

The filing will include 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.

Ridley did not provide further details.

Pfizer Inc. and BioNTech SE said Monday they had filed data with the Food and Drug Administration seeking authorization for their own bivalent booster against BA.4 and BA.5.

Moderna tweeted on Aug. 11 that it had started a clinical trial of the booster against BA.4 and BA.5. 

Another Moderna booster was recently cleared in the UK that focuses on the original omicron strain.