Shots:
- The companies initiate the BLA with the FDA for approval of the COVID-19 vaccine in patients aged ≥16yrs. The data supporting the BLA will be submitted on a rolling basis over the coming wks., with a request for Priority Review
- Additionally, the companies will submit the required manufacturing & facility data for licensure to complete the BLA. The vaccine is currently available in the US under a EUA granted from FDA on Dec 11, 2020, while 170M+ doses have been delivered in the US
- The companies have also applied to expand the current EUA for the COVID-19 vaccine to include individuals aged 12-15yrs. and plans to submit sBLA in this age group once the required 6 mos. data are available
Click here to read full press release/ article | Ref: BUSINESS WIRE | Image: Pfizer
The post Pfizer and BioNTech Initiate Rolling Submission of BLA for the US FDA’s Approval of their COVID-19 Vaccine first appeared on PharmaShots.
