125742 S2 M3 32r reg info lot release documentation package

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TABLE OF CONTENTS
LOT RELEASE DOCUMENTATION PACKAGE ............................................................... 3
090177e196fd19b4\Approved\Approved On: 10-May-2021 08:42 (GMT)
FDA-CBER-2021-5683-1149282
Pfizer Global Supply , 
7000 Portage Rd.  
Kalamazoo,  
MIC 49001 USA  
 
 
 
  
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 Date:  
 
Food and Drug Administration  
Center for Biologics Evaluation and Research  
Sample Custodian  
10903 New Hampshire Avenue  
W075 -G707  
Silver Spring, MD 20993 -0002  
 
Please consider this as an official request for batch release for the following product:  
Trade Name:  COMIRNATY  
Type of Container:  Vial 
Storage Conditions:  -80˚C to -60˚C  
Marketing Authorisation 
Holder :  
Batch Number:  ER8735  
Date of Filling:   
Expiry Date:  31-Jul-2021  
Total Quantity:   
Site of Manufacture:  PGS Kalamazoo, 7000 Portage Rd., Kalamazoo, MIC 49001 USA  
Electronic Protocol 
Filename :  
 
Please find enclosed the Certificate of Anal ysis for the  Drug Substance and Drug Product lots for this 
batch . Pfizer hereby submits the following lot as an electronic submission by Electronic Submissions 
Gateway (ESG).  All tests conducted on this lot are reported and pass specifications as required.  
Sample Status  
 Sample Not Required due to COVID -19 Pandemic  
 Sample Submitted with Protocol  
 Sample Previously Submitted  (include date)  
 
 
 
Prepared By:        Approved By:  
  
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FDA-CBER-2021-5683-1149283
COVID -19 mRNA Vaccine BNT162b2  Genealogy Flowchart  
 
 
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Prepared By:          Approved By:  
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FDA-CBER-2021-5683-1149284
 
 
 
  
   
 
  
  
  
 
  
 
    
 
   
 
  
 
 
  
  
  
  
  
   
  
  
  
          
     
     
   
    
 
      
 
 
   
 
  
   
      
       
   
 
  
   
 
  
   
 
  
   
 
  
  
 
  
  
   
  
  
  
 
 
 
 
    
   
   
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
             
                 
  
 
 
  
  
  
 
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FDA-CBER-2021-5683-1149285
 
 
 
  
   
 
  
  
  
   
 
   
    
 
   
  
  
    
     
     
   
    
 
      
  
 
   
 
  
  
    
 
  
 
  
 
  
 
  
  
       
   
    
  
    
 
 
 
   
   
 
    
  
 
 
  
 
  
                  
              
       
  
 
 
  
 
 
                    
              
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FDA-CBER-2021-5683-1149286
   
Pharmaceutical Sciences
Worldwide Research & Development
Certificate of Analysis
Material Type:
Material Description or 
Name:
Material ID: Pfizer Lot Number: DS-001477PF-07305885 Drug SubstanceActive Pharmaceutical Ingredient
Authorized By
REGISTERED TESTS ACCEPTANCE CRITERIA RESULT
Appearance (Clarity)
Clarity
Appearance (Coloration)
Coloration
pH
UV Spectroscopy
Content (RNA Concentration)
RT PCR
Identity of Encoded RNA Sequence
Capillary Gel Electrophoresis
RNA
 Integrity
RP HPLC
5-Cap
ddPCR
Poly (A) Tail
qPCR
Residual DNA Template
Immunoblot
dsRNA
Endotoxin (LAL)
Bacterial Endotoxins
Bioburden
Bioburden
Page 1 of 1 Pfizer Confidential Report Created: 05-Mar-2021
1066271 / Last Modified: 09-Feb-2021
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FDA-CBER-2021-5683-1149287