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8 April 1998

INFORMATION PAPER

SUBJECT: Status of Anthrax Vaccination Plans (B-21-99)

ARMY POSITION: The Secretary of Defense approved the USCINCCENT request to accelerate the anthrax immunization program in the CENTCOM AOR on 2 Mar 98. DoD continues to fine-tune implementation plans to vaccinate the total military force. DoD actions with the Michigan Biologic Products Institute ~BPI) are designed to ensure an adequate supply of the vaccine to support the immunization program. These actions include a planned shutdown of anthrax vaccine production for about one year to allow a renovation of the production suite, contrary to the recent Newsweek article alledging that MBPI shut down because of FDA inspection results. MBPI's anthrax vaccine is licensed by the Food and Drug Administration (FDA) and tested in accordance with FDA and Code of Federal Regulation (CFR) guidelines. The vaccine should be effective against all anthrax strains, despite an unfounded report from Los Alamos National Laboratory (LANL)and recent news reports on Russian strains.

TALKING POINTS:

A press release from Los Alamos National Laboratory (LANL) suggested, incorrectly and without foundation, that a mixture of anthrax arains could overcome the anthrax vaccine. Recent news reports have also questioned, incorrectly, the anthrax vaccine's effectiveness against strains developed by Russian scientists.
The SECDEF has approved an acceleration of the anthrax immunization program in the CENTCOM AOR. The'SECDEF plane to immunize the total force after four conditions are met. DoD is moving forward to ensure each condition is met completely and rapidly.
DoD actions with MBPI are designed to provide an adequate supply of the vaccine to support the anthrax immunization polio.

BACKGROUND:

a. Department of Defense Announcement. On 15 Dec 97, Thc Secretary of Defense announced plans to vaccinate all US military personnel against the biological warfare agent anthrax. Vaccinations to the total military force will start only after four conditions are met:

(1) Supplemental testing of the vaccine stockpile at the sole manufacturer, MBPI; monitored by the Joint Program Office for Biological Defense 0PO-BD). The supplemental testing program was directed by DoD to provide an additional level of assurance of the already strict testing required by the FDA. The supplemental testing is scheduled to be completed for each lot prior to uso*under normal immunization conditions. Testing began on 5 Jan 98; completion is targeted for IQ, FY99.

(2) Implementation of an automated system for fully tracking personnel who receive the vaccinations; monitored by the loint Staff; J4(MRD). The Army's Immunization Tracking

System (1TS) that will track anthrax vaccinations for Army personnel is the Force MEDical PROtection System (MEDPROS). The AMEDD completed MEDPROS fielding and training at each point of immunization service throughout the Army on 27 Feb 98.

(3) Approval by thc DEP~ECDEI* of appropriate operational and communlcation plans to administer the immunizations and inform military personnel of the overall program; monitored by the Joint Staff, J5. The Army's plan completed Action Officer level staffing 7 Apr, will begin Army Principal staffing 9 Apr. then forwarded for CSA and SECARMY approval o/a 17 Apr 98.

(4) Review of health and medical issues of the program by an independent expert, Dr. Gerald N. Burrow, Special Advisor for Health Affairs to the Yale University President, is complete.

b. LANL and Other Press Releases: A press release on 3 Feb 98 from LANL suggested that AVA, the present anthrax vaccine intended for use in the US military forces, might be ineffective against a mixture of strains of Bacillus anthracis. Other recent news releases have questioned its effectiveness against strains possibly developed by Russian scientists.

The AVA vaccine produces protective immunity against multiple lethal aerosol doses of the Ames strain in non-human primates (NI-IP). The Ames strain, often categorized as "vaccine resistant" in rodents, is the US Army Medical Research Iratitute of Infectious Diseases' CUSAMRIID) standard challenge.

After discussions with US Army Medical Research and Materiel Command officials, the author of the press release, Dr. Walt Kirchner, DoD Programs Office, LANL, agreed to correct the press release. The modification stated, in part, "…there is no experimental data or evidence to suggest that such a mixture is resistant to the AVA licensed anthrax vaccine used by the US military."

c. Capacity to Supply the Vaccine. The capacity to supply the vaccine is classified; however, the planned renovation and subsequent expansion of the production capabilities at MBPI are designed to support implementation of the DoD anthrax immunization policy. MBPI did not shut down as a result of the FDA inspection in November 1996 as reported in a recent Newsweek article, and no shutdown was ever directed or contimplated as a result of any FDA inspection. Production stopped in Jan 98 when the production contract expired and was timed to accommodate the planned renovotion of the vaccine production suite as part of DoD's acquisition strategy. The renovations, expected to take one year, will ensure MBPI remains in compliance with stringent federal manufacturing practices. MBPI is currently the only FDA licensed anthrax vaccine manufacturer.

CONGRESSIONAL INTEREST:

Congress supports issues of force protection for the US military. Anthrax vaccination is an integral part of force protection. The plan, developed at the DoD level, is a systematic approach involving all the services.
Congress and the SECDEF intend to guarantee that DoD can provide a safe and potent product in adequate quantifies for protection of the US military against anthrax.

LATEST RECAP: None

BUDGET DATA: N/A