Section Three

FDA Testing Reveals Squalene in Anthrax Vaccine

For over a year, the DOD has been contracting with SRI International to test for squalene in vials
of the anthrax vaccine preparations which have been and are being given to military personnel.
For some time, DOD documents have made two claims regarding squalane:
1) The FDA verified that none of the vaccines used during the Gulf War contained squalene as an
adjuvant; and
2) they have found NO squalene in their testing of anthrax vaccine lots. (Appendix 13 und 22)
Documents on the DOD AVIP website from SIR International confirm their tests revealed no
squalene in the anthrax  vaccine sent to them for analysis (Example: Appendix 23)

• January 31, 2000               Congressman Metcalf wrote the FDA asking them to
  confirm the following DOD statement made to Congress, "The FDA verified that
  none of the vaccines used during the Gulf War contained Squalene as an adjuvant." (Appendix 24)
  
  
• March 20, 2000                The FDA responded to Congressman Metcalf and
  provided their official position. "In fact FDA did verify to the Senate Special
  Investigations Unit on July 23, 1997, in a telephone conversation with Committee staff
  of the SIU, not with DOD, that neither the licensed vaccines known to be used in the
  Gulf War, nor the one investigational product known to have been used, contained
  Squalene as an adjuvant in the formulations on file with FDA "

Most importantly, the FDA closed their letter with the following statement: "Very limited testing of Anthrax Vaccine, Absorbed, conducted by CDER in 1999 determined that there were only trace amounts of squalene in the lots tested.... (Appendix 25)

• Dr. Dorothy Lewis of Baylor College of Medicine sent a letter to Congressman
  Metcalf explaining that the test used by FDA which found low levels of squalene in
  Anthrax vaccine samples is a much more sensitive technique" than the one used by DOD. (Why would DOD use a less sensitive test procedure?)
  
  Dr. Lewis determined, "The real issue is whether squalene in parts per billion was
  added to the vaccine preparations given to the military, as well as whether this
  concentration of squalene could alter the immune response."
  
  While acknowledging the need for research to respond respond to the findings, she stated, "it is possible that very small amounts of a biologically active product could induce an immune response, either to the molecule itself or it could boost immune responses to other agents in the mixture." (Appendix 26)

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