Congress on Thursday launched an investigation into possible mismanagement of the Pentagon’s controversial anthrax immunization program amid warnings that the military will exhaust all usable supplies of the vaccine next month.
It could be months before new, safe and reliable supplies of the vaccine can be obtained and as long as two years before a total immunization of U.S. armed forces can get under way, according to a Defense Department spokesman.
Rep. Steve Buyer (R-Ind.), chairman of the House Armed Services military personnel subcommittee, said he will call Defense Undersecretary Rudy DeLeon and other Pentagon officials to testify on the growing crisis at a hearing July 13.
“Our concerns are the threat posed by weaponized anthrax, the safety of our servicemen and service women, and the potency of the vaccine,” Buyer said.
The Pentagon’s only source of the anthrax vaccine, Bioport Corp. of Lansing, Mich., has failed to pass recent government tests of its product for effectiveness and reliability, and the federal Food and Drug Administration has withheld approval of new batches of the vaccine.
Though Defense Secretary William Cohen ordered all 2.4 million active-duty and reserve uniformed personnel to begin inoculations two years ago, supply and reliability problems have compelled the Pentagon to restrict the shots to personnel assigned to Korea, Saudi Arabia and the Persian Gulf states–areas where U.S. troops might face the highest presumed threat of biological warfare attacks.
Pilots and air crews who could be ordered to fly into these areas have also been required to undergo the six-shot, 18-month series of immunizations.
Only about 570,000 armed service members have received even one of the shots since the program began.
“This is indeed a life-and-death issue,” said Rep. Neil Abercrombie (D-Hawaii), ranking Democrat on the military personnel panel.
According to Rep. Walter Jones (R-N.C.), another subcommittee member, the government has already paid Bioport some $100 million to produce the vaccine.
Buyer, who received two anthrax shots as an Army officer serving in the Persian Gulf war, said he was not siding with another group of 25 congressmen who have called for a halt to the immunization program because of concern over adverse health effects from the shots.
Though he suffered for three years from what is called gulf war syndrome following his Middle Eastern tour, Buyer said he believes there was no link between his ailments and the anthrax inoculations he received.
“The threat of weaponized anthrax is real,” he said.
But the failure of the Pentagon to obtain reliable new supplies of the vaccine after present stocks run out leaves the military in a precarious situation, he said.
“If it can’t get it from Bioport, where is the Pentagon to go for anthrax vaccine?” Buyer said. “This is a single-source item.”
Anthrax, which is believed to be in the military arsenals of North Korea, Iraq and several other nations, is a biological agent so toxic that a single inhalation is usually fatal. There is little or no effective treatment for victims who have not undergone immunization, according to Cohen.
In testing for reliability, the FDA requires the vaccine to be administered full strength to one set of laboratory guinea pigs, one-third strength to another set and one-27th strength to a third. The guinea pigs are then exposed to anthrax spores. To meet FDA standards, all the guinea pigs in the first set and nearly all those in the second set are supposed to survive, though all those in the last set die.
In the recent tests of Bioport vaccine, all the guinea pigs in the second set died as well.
More than 300 military personnel, including some veteran pilots, have refused to undergo the inoculations because of fears of permanent damage from side effects.
