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Pfizer seeks full FDA approval for its COVID-19 vaccine – Sydney Morning Herald
Pfizer and its partner BioNTech SE have asked US regulators for full approval of their COVID-19 vaccine, which could also help raise confidence in the vaccine.
The companies will first seek approval for the vaccines use in individuals 16 years of age and older, but also intend to submit a supplemental biologics license application for those aged 12 to 15 once the required data is available.
With full approval in hand, Pfizer and BioNTech would finally be able to advertise the product under its branded name, Comirnaty, and distribute the two-shot regimen directly to a wider marketplace.
Right now we can only commercialise the vaccine in the US through the…
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