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 : 
  

  
EC5236
  



  

  
Submitter : 
  

  
Mrs. Louise Kopf
  

  
Date & Time: 
  

  
12/29/2006 08:12:18
  



  

  
Organization : 
  

  
Nevada Care Medical Centers
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Regarding FDA guidelines, Docket Number 2006D-0383, we are very concerned with the current practice of pharmaceutical companies producing certain vaccines using tissue obtained from fetuses procured from elective abortions. We contacted the Merck company about this matter,  and they confirmed that two of their vaccines are in fact produced this way. Their explanations for this are unacceptable and questionable. Our office performs immigration physicals for U.S.C.I.S., which require MMR and varicella vaccines for applicants. Unfortunately, the FDA has not approved rubella and varicella vaccines made by other companies which do not use tissue from aborted fetuses. Consequently, applicants are faced with the choice of obtaining tainted vaccines, contrary to their most sacredly held beliefs, or paying a $265.00 charge per family member to U.S.C.I.S. to apply for an exemption - a choice which many families cannot afford. Our office refuses to provide these vaccines to our patients, as we will not participate in elective abortions directly or indirectly.



Similarly, many people are refusing to obtain vaccinations for their children for this same reason. This could become a health problem as this information becomes more widely known. 



The FDA should not approve any vaccines produced this way for use in the U.S. to begin with. At the very least, the companies that produce them should be required to produce an alternative to these unethically produced vaccines. Otherwise, the FDA needs to approve vaccines that are used in Great Britain and other countries for use in this country immediately. Thank you for your attention to this serious matter.