Moderna Plans US Application Submission For COVID-19 Omicron Adapted Booster 'Very Soon'

Moderna Inc MRNA plans to file data with the FDA very soon, seeking approval for a booster shot targeting the latest omicron Covid variants, Bloomberg reported.
A filing is "imminent" for its 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.
Also Read: Boosters Are Coming For Dangerous Omicron COVID-19 Variant. Here's Who May Be Rolling Them Out.
The filing will include preclinical data for the booster against the latest strains and clinical data from the company's other bivalent booster targeting the original omicron strain.
Ridley did not provide further details.
Last week, Moderna tweeted that it had started a booster trial against BA.4 and BA.5 omicron variants.
Britain became the first country to approve the omicron variant-adapted shot that targets both the original and omicron versions of the virus.
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorization for using Moderna omicron-containing bivalent COVID-19 booster vaccine.
Price Action: MRNA shares are up 0.58% at $143.29 on the last check Tuesday.
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