Moderna has initiated the rolling submission process for the biologics license application for its COVID-19 vaccine mRNA-1273.
Moderna announced it is seeking full FDA approval for its COVID-19 vaccine mRNA-1273.
In a statement released on Tuesday, the company said it has initiated the rolling submission process for the biologics license application (BLA) and will continue to submit data from its phase 3 study to support the application for use of the vaccine in individuals 18 years and older. Once the rolling BLA submission process is completed, the FDA will notify Moderna when it is formally accepted for review.1
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Pfizer is applying for full approval of its COVID-19 vaccine, BNT162b2, for use in individuals aged 17 years and older.