Pfizer, BioNTech seek full FDA approval of COVID-19 vaccine
Pfizer and its German partner company BioNTech announced they started their request for the FDA to grant full approval of their COVID-19 vaccine after having emergency use authorization for almost five months.
The companies said they started their Biologics License Application (BLA) for the FDA to grant full authorization to give their vaccine to those 16 and older.
What does full approval mean? With the FDA’s full approval, the Pfizer-BioNTech vaccine could still be given to patients 16 and older after the public health emergency is declared over.
The Pfizer-BioNTech vaccine, which was the first to receive the FDA’s emergency use authorization in December, would become the first vaccine to be granted full approval in the U.S.
What’s next? The companies said they intend to submit data for the BLA “on a rolling basis over the coming weeks” and request priority review for a decision to be made in six months, instead of the typical 10 months.
Pfizer and BioNTech have to submit data on their manufacturing processes, facilities and pre-clinical and clinical trial data.
A planned decision date will be set after the FDA officially accepts the completed application.