Moderna wraps its BLA for their megablockbuster Covid vaccine. Chances are you won't have to wait long on the FDA
Two days after Pfizer and BioNTech landed a speedy full approval for their megablockbuster Covid-19 vaccine, Moderna is stepping up to the plate at the FDA with their first BLA submission.
Moderna announced Wednesday that it had completed the rolling submission to regulators, boasting a 93% efficacy through six months following the second jab.
Moderna says it is seeking a priority review for the vaccine, which earlier won an emergency OK, but regulators are already primed to blow the doors off this application — just as they did with the BLA from Pfizer/BioNTech. The first application took a grand total of 3 months on which to review and stamp an OK, as critics demanded fast action and officials in the Biden administration promised a quick response.
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.