Pfizer and BioNTech Initiate Rolling Submission of BLA for the US FDA’s Approval of their COVID-19 Vaccine

 Pfizer and BioNTech Initiate Rolling Submission of BLA for the US FDA’s Approval of their COVID-19 Vaccine

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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