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 SRI's test, 140 parts per billion, SRI found no squalene in anthrax vaccine.
The link above provides SRI's findings, as well as FDA's findings.
In September 2000, DoD became aware of FDA test results finding trace amounts of
squalene in three out of three US vaccines tested, including anthrax vaccine. The
level of squalene identified by the FDA test is so minute that it is likely a trace
natural component of bacteria. There are no live bacteria in these vaccines.
The FDA's test is more sensitive than the 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. FDA's findings are provided
at the link above.
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 FDA's 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. We
will report those results here when available. Our intent is to test all available
lots of anthrax vaccine, using the more sensitive test.