1980N-0208 - Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review
  


  

  


  

  
FDA Comment Number : 
  

  
EC8
  



  

  

  



  

  
Submitter : 
  

  
Ms. Armaiti May
  

  
Date & Time: 
  

  
01/19/2005 09:01:53
  



  

  
Organization : 
  

  
Ms. Armaiti May
  



  

  
Individual Consumer
  


  

  
Category : 
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Military personnel should not be required to take the Anthrax vaccine, which has undergone multiple changes in its manufacturing process since it was originally tested in humans.  The Anthrax vaccine has also proven to cause serious adverse side effects including, blindness, convulsions, blackouts, Gulf War syndrome, and death.  It is unconscionable to require our Service men and women to get this vaccine which clearly has dangerous side effects and questionable efficacy.



Please see the following attachment for further details:



The safety and efficacy of anthrax vaccine have not been established, and the preponderance of the world?s literature shows the vaccine is unsafe, and a contributor to Gulf War Syndrome as acknowledged in the vaccine?s package insert



When the DOD?s Anthrax Vaccine Immunization Program was announced in late 1997, published evidence for both safety and efficacy of the anthrax vaccine was lacking.  Dr. Peter Turnbull, formerly head of anthrax research at Porton Down, and others had made this information available in the open literature.  Rodent challenge studies showed poor efficacy of the UK and US killed human anthrax vaccines against highly virulent strains, and there existed no published safety data, apart from a study of an earlier, unlicensed ?Brachman? (a.k.a. ?Merck?) anthrax vaccine.  It contained little information on systemic adverse effects.   A later, unpublished CDC `open label? study of the licensed US anthrax vaccine, purported to affirm vaccine safety, used report forms that only collected information on local reactions.  Although a nurse at the Alabama factory where the bulk of the study?s anthrax vaccinations were administered had expressed concern about the adverse reactions, and these concerns were discussed at the CDC, she was overruled by the mill?s doctor, and the documentary evidence suggests the matter was then dropped. 



Reports of several panels      that had been charged with investigating Gulf War Syndrome (GWS), and claimed the vaccine had nothing to do with it, were reviewed.  The evidence they relied on to draw conclusions about the role of anthrax vaccine was shaky at best.  The reports either cited no references to support their vaccine conclusions, or cited only briefings by military officers, not scientific studies.



Despite the finding by a Senate committee in 1994 that anthrax vaccine was being considered as a possible cause of GWS,  and the statement by the Persian Gulf Veterans Coordinating Board that ?all potential causes [of GWS] that have been identified are being investigated,?  when I reviewed the full portfolio of federal research on GWS in 1999, I found that of the 166 studies listed, none looked specifically at anthrax vaccine. Only because the Wessely/Unwin study was designed to investigate all potentially noxious exposures that GW soldiers had faced, had data on anthrax vaccine been captured. 



The low rate of GWS in French troops, who were unvaccinated, had used prophylactic doxycycline and consumed cleaner, bottled water, needed explanation.  The issue of whether small numbers of French troops who did develop GWS were in liaison positions, and were vaccinated alongside US and UK units, has been raised by the French Ministry of Defense, but has not been resolved. 


  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  








  

  
 

Numerous vaccinated but nondeployed Gulf War `era? soldiers in the US have developed similar multisystem illnesses as the deployed soldiers. Dr. Lea Steele was able to analyze this intriguing finding in a study of Kansas Gulf War veterans.   She found that nearly 4% of the veterans who had not been deployed, nor vaccinated in preparation for deployment, met her GWS case definition.  (She later concluded that this number is approximately the prevalence rate of a similar condition in civilians.)  But those who were vaccinated in preparation for deployment, but never actually deployed, had a rate 3 times higher, nearly 12%.