125742 45 S211 M5 cdc 2020

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer 12 15 Documents

5

Document text

090177e1942b5c14\Final\Final On: 02-Jul-2020 16:51 (GMT)
FDA-CBER-2022-5812-0071288
     
                       
 
    
      
  
   
  
  
 
 
   
  
    
  
    
  
 
  
 
                                       
   
     
     
             
                    
          
            
         
          
             
        
         
           
         
        
     
        
        
        
           
        
        
        
         
         
          
         
       
            
         
       
        
         
           
            
         
        
          
         
       
           
      
        
         
         
         
        
        
        
         
        
       
        
        
         
         
         
         
        
         
           
   
                        
090177e1942b5c14\Final\Final On: 02-Jul-2020 16:51 (GMT)
FDA-CBER-2022-5812-0071289
     
          
        
        
 
      
 
 
   
 
  
  
 
 
  
     
  
  
  
 
 
 
  
  
  
  
 
    
  
  
  
  
  
  
  
  
  
  
               
          
               
           
           
             
    
           
         
 
         
           
           
          
          
       
        
           
       
        
          
        
          
         
       
         
  
         
         
          
            
       
        
          
        
         
         
            
              
        
 
  
  
   
 
 
  
  
 
  
 
 
 
     
   
     
     
            
                
           
                        
090177e1942b5c14\Final\Final On: 02-Jul-2020 16:51 (GMT)
FDA-CBER-2022-5812-0071290
     
 
       
        
           
         
    
      
         
        
         
         
   
        
         
       
          
         
    
        
          
         
          
           
           
          
         
         
        
          
         
          
           
           
         
        
         
        
          
           
         
        
          
          
        
          
         
                   
         
         
        
           
         
           
            
          
    
         
            
       
      
      
       
         
         
        
         
       
         
         
      
        
            
        
          
          
        
       
          
        
        
          
         
        
             
         
         
        
         
         
         
   
 
                        
090177e1942b5c14\Final\Final On: 02-Jul-2020 16:51 (GMT)
FDA-CBER-2022-5812-0071291
     
 
        
        
        
          
        
        
  
    
         
          
           
    
        
          
          
 
         
        
  
 
          
          
           
        
 
             
           
     
             
         
         
            
           
     
              
     
          
            
         
       
        
 
               
           
        
        
        
         
        
  
                        
090177e1942b5c14\Final\Final On: 02-Jul-2020 16:51 (GMT)
FDA-CBER-2022-5812-0071292