FDA Lot-Release Authorizations

These memos show the authority for the manufacturer to release anthrax vaccine from the manufacturing plant. Each lot of every vaccine produced in the United States must be individually released in this way, after having been tested for sterility, purity, potency, and general safety. Lot-release tests are performed by the manufacturer and audited by FDA.

Supplemental Testing Reports

The Secretary of Defense ordered supplemental testing of all lots of anthrax vaccine in the Lansing, Michigan, stockpile, when he authorized the Anthrax Vaccine Immunization Program in December 1997. Supplemental testing repeats the original FDA tests for sterility, purity, potency, and general safety. Supplemental tests are performed by the manufacturer and overseen by an independent contractor (Mitretek, Inc., McLean, Virginia). Supplemental tests are not performed on lots FAV 040 or higher, because these lots have undergone (or will undergo) the same tests for sterility, purity, potency, and general safety in the last several months and the data have (or will be) independently reviewed by the FDA to determine whether the lots meet approval criteria for FDA release.

SRI & Squalene Test Findings

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."

For more information about squalene and squalene testing see the Questions and Answers section.