Pentagon Will Consider Building 'GO-CO' Vaccine Production Facility

by Catherine MacRae

Inside The Pentagon

November 2, 2000

The Joint Program Manager for Biological Defense Vicky Armbruster said last week that funding has been added to the fiscal year 2002 to FY-07 future years defense plan to examine the possibility of building a government-owned, contractor-operated vaccine production facility.

Armbruster addressed industry and government chemical and biological defense officials attending an Oct. 24 executive roundtable breakfast in Arlington, VA, sponsored by the National Defense Industrial Association.

"There is also a move afoot [with] interest in Congress as well as in the department to establish a GO-CO operation for the DOD vaccine production program," she said. "Monies have appeared in the FYDP through the military construction budget for such a facility."

Armbruster said the program management for biological defense would examine the costs and advisability of the idea. The Pentagon began considering the move this summer in light of concerns about anthrax vaccine shortages and the fact that Lansing, MI-based BioPort, the sole manufacturer of the vaccine, is still awaiting approval from the Food and Drug Administration to resume production following the renovation of its facility (Inside the Pentagon, July 13, p2).

Building a new government-funded facility would be a long-term approach to solving the vaccine shortage problem, Deputy Defense Secretary Rudy de Leon told the Senate Armed Services Committee during a July 12 hearing on the Pentagon's mandatory anthrax vaccine program. De Leon added that the Defense Resources Board, which he chairs, would meet within the following two weeks to decide whether the Pentagon should request funds for the plant.

"This budget may also include funds to continue development of recombinant vaccines designed to provide protection against multiple threats," he said. "One of these will likely be anthrax and serves as our long-term strategy to provide our troops the protection they will need from this deadly agent."

The FY-01 Defense Authorization Act, signed by President Clinton Oct. 30, directs the defense secretary to submit a report to Congress no later than Feb. 1, 2001, on the Defense Department's biological warfare defense vaccine acquisition plans, including the feasibility of building a GO-CO production facility.

According to the legislation, the report should include:

* "The secretary's evaluation of the implications of reliance on the commercial sector to meet the requirements of the Department of Defense for biological warfare defense vaccines;

* "A design for a government-owned, contractor-operated facility for the production of biological warfare defense vaccines that meets the requirements of the department for such vaccines, and the assumptions on which that design is based;

* "A preliminary cost estimate of, and schedule for, establishing and bringing into operation such a facility, and the estimated annual cost of operating such a facility thereafter;

* "A determination, developed in consultation with the surgeon general, of the utility of such a facility to support the production of vaccines for the civilian sector, and a discussion of the effects that the use of such a facility for that purpose might have on . . . the production of vaccines for the armed forces and the annual cost of operating such a facility; and

* "An analysis of the effects that international requirements for vaccines, and the production of vaccines in response to those requirements, might have on . . . the production of vaccines for the armed forces."

-- Catherine MacRae