The mRNA vaccine received Emergency Use Authorization (EUA) in December 2020: the first COVID-19 vaccine in the US to do so.
In May, Pfizer and BioNTech completed the rolling submission for the BLA. The application includes clinical data from the Phase 3 clinical trial of the vaccine, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose.
Priority Review Designation
A Priority Review designation 'directs overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.'
A priority review designation means the FDA’s goal is to take action on an application within six months (compared to 10 months under standard review). That would mean the Prescription Drug User Fee (PDUFA) goal date for a decision would be January 2022: however, the FDA may move quicker than that.
“The PDUFA Goal Date of January 2022 reflects the PDUFA deadline for Priority Review and does not mean approval will not happen before that time,” notes the agency. “Quite to the contrary, the review of this BLA has been ongoing, is among the highest priorities of the agency, and the agency intends to complete the review far in advance of the PDUFA Goal Date.”
In May, the FDA expanded the vaccine’s EUA to include individuals 12 through 15 years of age. The BLA submission, however, will remain for individuals aged 16+, given that a BLA requires six months of data (the topline results for a Phase 3 study were only released in March this year).
The companies intend to submit a supplemental BLA to support licensure of the vaccine in this age group once the required data are available.