2006D-0088
  

  
 Guidance for Industry; Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC1
  



  

  
Submitter : 
  

  
Dr. Mary  Johnson
  

  
Date & Time: 
  

  
05/08/2006 03:05:53
  



  

  
Organization : 
  

  
Campbell University School of Pharmacy
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Q: Will the yearly flu vaccine production be compromised if a pandemic vaccine is produced using the same manufacturers?

Q: The avian flu causes mutation so quickly in human subjects.  How will this rate of mutation affect the effectiveness of the vaccine?

Q: Have there been any reports of human to human transmissions of avian flu?

Q: If there have not been any transmission, why is this such a pandemic concern?

Q: Would vaccine be available for anyone who needed it during a pandemic?