End of Anthrax Vaccine? 

Military May End Program to Inoculate Personnel

By Barbara Starr

W A S H I N G T O N, June 30 — ABCNEWS has learned that the Pentagon may be forced to temporarily suspend its highly controversial program to inoculate all military personnel against the deadly anthrax biological warfare agent.

A final decision could come as soon as next Friday, when Defense Secretary William Cohen is scheduled to be presented with the latest set of problems with the vaccination program.

The problem is simple. The Pentagon is running out of usable doses, and the Michigan production plant under construction that is supposed to be making new vaccine is so far behind schedule it cannot make new doses until January at the earliest.

This week, the Pentagon is conducting “reliability” testing on one of the last lots, about 200,000 doses, that have been in storage for some years. Known as “Lot 22,” it has already failed reliability testing once, so officials are fairly gloomy about its prospects.

The Guinea Pigs

The reliability testing is conducted by injecting guinea pigs with the vaccine in three separate strength levels, according to the Pentagon. Then the animals are exposed to anthrax. The ones receiving the strongest dose are supposed to live, and those receiving the weakest dose are expected to die. For the second time, Lot 22 has already been injected into a group of animals. Next Friday, the survival rate will be assessed.

If the death rate is not within accepted parameters, the inoculation program will be suspended, officials say. It may be six months before inoculations can resume.

And even if the death rate of the guinea pigs is “acceptable,” the program still faces serious problems, officials say. If the testing is successful on Friday, the Food and Drug Administration wants to wait an additional seven days to assess the surviving guinea pigs again.

Plus, because so many of the nearly 1 million doses in inventory have had high failure rates in the reliability testing, the FDA and the Pentagon remain concerned about whether the doses can “credibly” be used, one Defense Department official said. “All things being equal we would rather not use them,” he said of the material in inventory. Delays Are Likely. So even if after the seven-day waiting period the guinea pigs are still alive, it appears likely that Secretary Cohen, at best, will face a decision to trim back the effort until January, inoculating only those soldiers deploying immediately to the high- threat regions of the Korean Peninsula and the Persian Gulf.

At the current rate of usage, about 75,000 doses per month, the suspension would be almost immediate, because the military only has “tens of thousands” of doses left to administer. There is a “strategic reserve” in the event of war, which cannot be used routinely.

Congress is scheduled to hold two days of hearings on the anthrax vaccination program beginning July 12. The last thing the Defense Department wants to do is suspend the effort, officials say.

Although hundreds of thousands of doses have been successfully administered, a group of highly vocal soldiers, sailors, and airman have refused to take the shot and instead faced discharge — claiming the vaccine is unsafe.

 A History of Anthrax

1897 - Robert Koch is the first scientist to grow anthrax, a natural disease lethal to animals and humans, in the lab.

1970 - The FDA approves an anthrax vaccine for humans who might be exposed to animals carrying the disease, such as textile mill workers who handle contaminated wool.

January 1991 - More than 150,000 U.S. troops fighting in the Persian Gulf are inoculated against anthrax. Some Gulf War veterans have blamed the vaccine in part for the mysterious Gulf War syndrome, but no connection has been proved.

Aug. 6, 1991 - Iraq admits it was experimenting with anthrax as a biological weapon to be used in the Gulf War, but there’s no evidence it was actually used in the field.

March 1997 - The Michigan Biologic Products Institute, now BioPort Corp. , the sole maker of the anthrax vaccine, is cited by the FDA for improperly storing packaging materials. Over the next three years, the company comes under criticism for slow production of vaccines and for periodically demanding more money from the government to stay afloat.

May 18, 1998 - Defense Secretary William Cohen mandates that all active-duty and reserve military personnel get a six-shot, 18-month course of inoculation against anthrax.

January 1999 - U.S. Air Force Reserve Airman 1st Class Jeff Bettendorf refuses to be inoculated against anthrax. He is demoted and eventually discharged.

March 1999 - More military personnel refuse to take the anthrax vaccine, including 11 California Air Force Reserve pilots, two dozen Marines in Japan, and 23 sailors.

April 1999 - A preliminary study from the General Accounting Office says the vaccine has never been tested for long-term safety and that its effectiveness is also in question.

July 1999 - Rep. Ben Gilman, R-N.Y., introduces a bill to halt the vaccinations. The Pentagon says the vaccine is safe. By now, 200 troops have refused to take the vaccine.

Feb. 17, 2000 - A congressional panel says the Pentagon should halt the vaccinations and deems the anthrax vaccine experimental because its effectiveness against biological warfare is uncertain. Pentagon officials continue with the vaccinations, saying the vaccine is safe and anthrax is fatal.

April 14, 2000 - More than two years after the vaccination campaign was announced, only 420,000 of the 2.4 million military service members have completed the course of vaccination.

May 16, 2000 - Twenty-eight House members issue a letter asking the Department of Defense to stop the inoculations. By now, 570,000 service members have been immunized.

June 30, 2000 - The Department of Defense may have to suspend the inoculations.