Pentagon Admits Vaccine Delay

A day after announcing a dramatic slowdown in its controversial Anthrax vaccine program, the Pentagon told a Senate committee Wednesday it should have begun looking for a new supplier much sooner.

The shortage in the vaccine will force the Defense Department to reduce shots from 75,000 a month to about 14,000, postponing vaccinations for personnel who aren't stationed in "High Threat Areas," like Korea and the Middle East.

The Pentagon will continue to vaccinate troops in those areas who have not begun the immunization process and will try to complete the vaccination cycles of other troops who have begun the process. But it won't start the vaccination regimen—six shots over 18-months—for troops elsewhere.

BioPort, the only licensed producer of the vaccine the Pentagon uses, is for waiting FDA approval before it can make the vaccine.

A November 1999 FDA inspection of the company's Michigan plant found numerous violations. BioPort has also suffered financial difficulties, and the Defense Dept. had to rework its contract for the vaccine last year.

To bolster its supply, the Pentagon began advertising July 3 for a second vaccine manufacturer, with whom BioPort has agreed to cooperate. In the DoD request for propsals, the Pentagon indicates that time is of the essence.

"Given the Department of Defense's critical need for this product start-up time will be minimal. The proposal process will be abbreviated with award before 1 October 2000 anticipated," the ad reads.

But Pentagon and Food and Drug Administration witnesses agreed it would take several months for BioPort's new vaccine to become available, from two to four years to get a second source and from five to six years to set up a government corporation that could produce the vaccine.

Deputy Defense Secretary Rudy de Leon said the Pentagon is taking every step it can to restore the immunization program, but added, "I concede we should have taken them sooner."

Anthrax vaccines also are produced in Britain and Russia, but neither has FDA approval for U.S. use.

Anthrax is a naturally occurring bacteria found in domesticated animals; it can be produced as dry spores that, when inhaled, cause death within a few days.

In May 1998 Secretary of Defense William Cohen approved a plan for vaccinating all 2.4 U.S. servicemembers and essential civilian employees by 2005.

The decision stirred controversy, as some servicemen and women refused to get vaccinated because of concerns the shots caused damaging side effects. At last count, 351 had refused.

Some blamed the anthrax vaccine for causing the Gulf War illness in veterans of the conflict in Iraq, who received the shots because Saddam Hussein was believed to have developed biological weapons.

n February, a House subcommittee recommended the shots be suspended until their safety was verified.

The Pentagon contends that minor to moderate local reactions to the shots—such as swelling and redness—occur in a minority of vaccine recipients, and that "There have been no patterns of long-term side effects from the vaccine, neither persistent side effects, nor delayed side effects."

At least 800 troops have complained of reactions to the vaccine.

According to the Centers for Disease Control and Prevention, as of April 7, the Pentagon's internal anthrax vaccine complaint system had received 428 reports from people who had taken the shots. Of these reports, 36 or 8.4 percent reported reactions that required hospitalization and caused the patient to miss 24 hours of duty.

"Anthrax remains the top biological warfare threat to U.S. troops, and the vaccine is our safest, most effective weapon to protect our people against that threat," Cohen said Tuesday.

So far, 455,000 soldiers and sailors have started their vaccinations. About 57,000 troops and other military employees have been fully immunized.