2006D-0383
  

  
 Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases

  


  

  

  


  

  


  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC3018
  



  

  
Submitter : 
  

  
Ms. Lauren Braun
  

  
Date & Time: 
  

  
12/12/2006 09:12:09
  



  

  
Organization : 
  

  
Ms. Lauren Braun
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Since this document concerns recommendations for choosing cell lines appropriate for the manufacture of vaccines, it would also seem appropriate to address ethical concerns inherent in various cell lines.  Certainly cell lines derived from animals sources are ethical; however, human cell lines derived from aborted children are another matter.  Many view cell lines like these such as MRC-5, WI-38, and PER-C6 to be morally reprehensible.  From the standpoint of ensuring public health, it would be best for the maximum number of individuals to be vaccinated. However, when vaccines derived from immoral cell lines are the only available vaccine, individuals are forced to choose between vaccinating themselves and their children or adhering to their moral convictions.  Since animal alternatives are available, it would seem to be in everyone's best interest if federal authorities recommended the use of these ethical vaccines.  I therefore encourage the FDA to amend these guidelines to include ethical considerations in choosing how to manufacture vaccines.