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 :: Pre-renovation BioPort Production :: Squalene Test Reports

Squalene Test Reports

Between May 1999 and September 2000, Stanford Research International (SRI), under DoD contract, looked for squalene in anthrax vaccine. At the limit of detectability of SRIs test, 140 parts per billion, SRI found no squalene in anthrax vaccine.

In September 2000, DoD became aware of FDA test results finding trace amounts of squalene in diphtheria, tetanus, and anthrax vaccines. The level of squalene identified by the FDA test is so minute that it was likely introduced by lab workers performing the tests for squalene (e.g., from human fingerprints not fully washed off the lab equipment). The FDAs test is more sensitive than the original SRI test. The FDA test, which was developed later, can detect as little as 10 parts per billion. The FDA found squalene at 10 to 83 parts per billion in various lots of anthrax vaccine. The trace level of squalene found by the FDA in anthrax vaccine is less than the concentration naturally present in human blood (250 parts per billion). So trace amounts of squalene are unlikely to have any biological effect. In fact, without squalene in the body to manufacture cholesterol and hormones, we would die. In Congressional testimony on 3 October 2000, the FDAs Mark Elengold said that the trace quantities of squalene detected can be considered "both naturally occurring and safe."

DoD asked SRI to improve its test methods to match or exceed that of the FDA. SRI revised its tests, lowering its limit of detection to 1 part per billion. With this more sensitive test, SRI found no squalene in 32 out of 33 lot tests. SRI found squalene in each of the three vials of lot FAV008 between 1 and 9 parts per billion.

To view the PDF results of each test, please choose a lot from the drop-down menu.

For more extensive discussion of squalene, click here.

  • SRI Test  

  • FDA Test  

For more information about squalene, click here

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