House report on THE DEPARTMENT OF DEFENSE ANTHRAX VACCINE IMMUNIZATION PROGRAM: UNPROVEN FORCE PROTECTION. This report is by the Government Reform
www.congress.gov
Findings in Brief
1. The AVIP is a well-intentioned but over-broad response
to the anthrax threat. It represents a doctrinal departure
overemphasizing the role of medical intervention in force
protection.
2. The AVIP is vulnerable to supply shortages and price
increases. The sole-source procurement of a vaccine that
requires a dedicated production facility leaves DOD captive to
old technology and a single, untested company. Research and
development on a second-generation, recombinant vaccine would
allow others to compete.
3. The AVIP is logistically too complex to succeed.
Adherence to the rigid schedule of six inoculations over 18
months for 2.4 million members of a mobile force is unlikely,
particularly in reserve components. Using an artificial
standard that counts only shots more than 30 days overdue, DOD
tolerates serious deviations from the Food and Drug
Administration [FDA] approved schedule.
4. Safety of the vaccine is not being monitored adequately.
The program is predisposed to ignore or understate potential
safety problems due to reliance on a passive adverse event
surveillance system and DOD institutional resistance to
associating health effects with the vaccine.
5. Efficacy of the vaccine against biological warfare is
uncertain. The vaccine was approved for protection against
cutaneous (under the skin) infection in an occupational
setting, not for use as mass protection against weaponized,
aerosolized anthrax.