7 BLA 125742 0 06 17 2021 Memo Other

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer 16 Plus Documents

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U.S. Food  & Drug  Administration  
10903 New  Hampshire  Avenue  
Silver  Spring,  MD 20903  
www.fda.gov   
Date:  June 17, 2021 
 
From: Christopher Joneckis, Associate Director For Review Management  
 
Subject: Issuance of BLA License Number in Advance of Approval  
 
To: STN 125742, COVID -19 mRNA Vaccine  
  I am authorizing release of the BLA license number for Pfizer/ BioNtech Covid v accine in advance of the 
typical notification in the approval letter. A significant consideration in this decision is that this product 
has been authorized under an Emergency Us e Authorization, and therefore CBER is familiar with and has 
reviewed much of the information provided in the BLA application.  This deviation from our normal 
practice is done to facilitate product labeling and distribution and is consistent with other Cen ter practices 
to facilitate vaccine delivery during the declared Public Health Emergency.  When providing the license 
number, we should communicate that this license number does not constitute any determination by FDA 
on the application.  
 
FDA-CBER-2021-56830652177