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Supplemental Testing Reports
Former Secretary of Defense Cohen ordered supplemental testing
of all lots of anthrax vaccine in the Lansing, Michigan,
original stockpile, when he authorized the Anthrax Vaccine Immunization Program
in December 1997. Supplemental testing repeated the original FDA tests
for sterility, purity, potency, and general safety.
Supplemental tests were 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 were not part of the original stockpile and subsequently, underwent (or will undergo)
revised tests for sterility, purity, potency, and general safety and the data has been
(or will be) independently reviewed by the FDA to determine whether the lots meet
approval criteria for FDA release.
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