The Pentagon's controversial effort to inoculate U.S. troops against anthrax bacteria suffered another setback yesterday with the disclosure that a new facility built to produce the vaccine had failed its first safety inspection.
As a result, Pentagon officials said, Defense Secretary William S. Cohen decided to halt the planned expansion of vaccinations next year.
Until deficiencies at the manufacturing plant are resolved, the officials said, military authorities will draw on stockpiled doses produced at a predecessor facility and administer shots only to the several hundred thousand troops who rotate periodically through such high-threat areas as South Korea and the Persian Gulf region. The delay in producing new doses could take up to a year and cost an additional $7 million to $10 million, officials said at a Pentagon news conference.
The announcement brought further embarrassment to the two-year-old vaccination effort, already battered by questions about safety and effectiveness. Touted initially by defense officials as a farsighted response to the rising threat of germ warfare, the program has become a source of some unrest in the ranks and political controversy on Capitol Hill.
Sue Bailey, the Pentagon's top civilian health official, said yesterday that the inoculations remained essential to protect U.S. forces. But with Congress weighing legislation that would either suspend the inoculations or make them voluntary, the latest development promises to generate fresh questions about the program's management and necessity.
Defense officials cited several reasons for the problems with the new production plant, which was built after the old facility--the nation's only source of the anthrax vaccine--was sold by the state of Michigan to a new company, the Bioport Corp. of Lansing, Mich. Bioport knocked down the old plant and built a larger, more modern one to handle the big jump in production required by the Pentagon's decision to inoculate all 2.4 million active-duty and reserve troops.
But getting the new facility certified by the Food and Drug Administration has proven more challenging than either the company or the Pentagon predicted. An FDA inspection in November found about 30 deficiencies that are being addressed, officials said.
"Frankly, it has been more difficult than the department and Bioport expected to move from a small state-regulated production facility to a large, modern production facility that meets the state-of-the-art FDA requirements," Bailey said.
Dave Oliver, a senior Pentagon acquisition official, told reporters that about 1 million doses of the vaccine made by the old plant had already been certified by the FDA and would be used to keep the inoculation program going on a limited basis. FDA approval of another roughly one million stockpiled doses is expected within the next three months, Oliver said.
So far, about 383,000 troops have started receiving the vaccine. With each recipient requiring a total of six shots in the first 18 months, plus annual boosters, the Pentagon has been consuming about 75,000 doses a month, Oliver said.
While acknowledging that the FDA's concerns had caught them by surprise, Defense officials also sought to portray the inspection process that leads to plant certification as often a lengthy one. Even before the FDA stumbling block, however, Bioport was running into financial problems over the low vaccine price that had been negotiated with the Pentagon.
In August, the Pentagon announced that it had agreed to a doubling of the price--from $4.36 a dose to $10.64 a dose--last year when Bioport purchased the laboratory for $25 million. The new agreement boosted the total cost of the Pentagon's contract from $25.7 million to $49.8 million over the next five years. The Pentagon also agreed to advance Bioport $18.7 million to help it cover debts.
Indicating that the vaccination program has suffered from weak or inadequate oversight, Defense officials said yesterday that Bioport had recently beefed up its management team and that the Army was putting a new one-star general in charge of supervising the program.