DEPARTMENT OF THE ARMY

OFFICE OF THE ASSISTANT SECRETARY

RESEARCH DEVELOPMENT AND ACQUISITION 103 ARMY PENTAGON

WASHINGTON DC 20310-0103

8 March 1996

MEMORANDUM FOR SEE DISTRIBUTION

SUBJECT: Minutes of the Anthrax License Amendment Issues Meeting - 9 February 1996

A meeting to discuss license amendment issues associated with the Anthrax vaccine was held on 9 February 1996, from 0900-I200 hours, at the Joint Program Office for Biological Defense (JPO-BD) located in Suite 1200, 5201 Leesburg Pike, Falls Church, Virginia,'22041. The meeting v-as hosted by the Joint Program Manager for Biological Defense (J'P'M-BD), Colonel (Prom0t. able) John C. Doesburg. A list of attendees is provided at enclosure 1.

COL(P) Docsburg provided opening remarks to the group. He stated he would be briefing immunization issues to the Requirements Review Council (RRC) on 16 February 1996, an event which was leading to the 1 March 1996 delivery of an Anthrax Implementation Plan. He explained that these events would eventually lead to a decision on Anthrax immunization. As the JPM, he needs a clear focus on the vaccine program with all available facts on immunization. His mission is to function as the central spokesman on biological defense vaccines and immunizations for DoD. He expected the participants in the meeting to educate him so he is armed with the "right" information going into his briefings.

Dr. Anna Johnson-Winegar, Director, Medical Biological Research Program, U.S. Army Medical Research and Materiel Command (USAMRMC), stated there were numerous issues surrounding anthrax vaccination; and people often come away from meetings with only part of thc story which then goes to senior levels in the Services and OSD. She wanted to preclude misinformation from getting to those levels by ensuring participants had the correct point of contact (POC) for the program as well as all of thc correct information.

She explained that thc implementation plan for anthrax vaccination stemmed from a Program Budget Decision 724 which tasked the Army to deliver the plan to OSD by 1 March 1996. The tusker was being worked as a joint venture between the Office of the Deputy Chief of Staff for Operations (DAMO-FDB) and Thc Office of the Surgeon General, Army (OTSG) who has tasked USAMR.MC. The DAMO-FDB POC is CPT Barnett, and the USAMRaMC POC is MAJ' George Korch.

Anthrax vaccine is licensed by the Food and Drug Administration, and is produced by the Michigan Department of Health (MDPH). Thc immunization schedule consists of 6 doses at 0, 2, and 4 weeks and 6, 12 and 18 months. An annual booster is given thereafter. The six dose schedule is a logistical burden, and the medic-al community has been asked to look at a reduced dosage schedule.

Dr. Johnson-Winegar elaborated on the fact that the meeting was to discuss amendment of the Anthrax vaccine license for a reduced schedule, and asked participants not to leave with the impression the Food and Drug Administration (FDA) would just approve a two dose schedule. Thc process of license amendment is a complex issues that must be coordinated by thc MDPH with support from the DoD.

Dr. Waiter Branalt, Science Applications International Corporation (SAIC) provided a briefing entitled "Michigan Department of Public Health (2vfDPH) Information Amendment to Anthrax Vaccine License File." The briefing focused on considerations for data submission to the-FDA as part of the license amendment process.