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

  Ref: BUSINESS WIRE | Image: Pfizer