Last Updated

13 Jul 2003

Source: Washington Post, May 20, 2002.

No Decision on Anthrax Vaccine Program

Pentagon Weighs Military, Civilian Needs Against Limited Supply, Says It's 'Close' to Resolving Issue

By Guy Gugliotta, Washington Post Staff Writer

The Defense Department is struggling toward a final decision on how to resume its controversial anthrax immunization program, balancing its need to protect U.S. troops with a desire to make the vaccine available to at-risk civilians.

Department sources say limitations on vaccine supplies and production capacity will make it impossible to start all 2.4 million of the nation's military personnel at once on the cumbersome six-dose course of injections required for full immunization.

The sources also said that department officials are in discussions with other agencies to assess civilian vaccination needs -- particularly for emergency "first responders" -- in the event of a bioterrorist attack.

As a result of these considerations, defense sources said, the department would likely give the military's first priority to forces sent to high-threat areas, especially in light of rising concern over a possible confrontation with Iraq, a nation known to possess biological weapons.

"We continue to assess the many factors involved in establishing this policy," Ed Wyatt, deputy assistant secretary of defense for health affairs, said Friday. "We do not have a final decision as yet."

The department in late February predicted a decision on the vaccine "within a month" but has offered little explanation for its delay. One Defense Department source said, "We are very close. We are dotting the i's and crossing the t's."

Sources at the Office of Homeland Security said that the Defense Department had outlined a tentative plan for an interagency working group but that several issues regarding civilian use of the vaccine remained unresolved.

"It is not clear whether first responders will need the vaccine," said a Homeland Security source, noting that the use of post-exposure antibiotics had been extremely effective in preventing the spread of the disease during last fall's anthrax attacks. "Issues are being looked at, and no decisions have been made."

The department's military leaders have supported the program's resumption but have clashed in the past with Bush administration officials and influential Republicans in Congress, who questioned the worth of a problem-plagued policy inherited from the Clinton administration.

The chief impediment to resumption of the program appeared to have been resolved in January when the Food and Drug Administration licensed BioPort Corp. of Lansing, Mich., to produce the vaccine.

Then, in early March, the independent Institute of Medicine released a long-awaited report endorsing the vaccine's safety, answering a major complaint against the program and providing "confirmation," Assistant Secretary of Defense for Health Affairs William Winkenwerder said, that the department uses "a protective measure that works."

But at an April 1 news conference, Defense Secretary Donald H. Rumsfeld told reporters only that he thought the program "might be reinstituted... . There are a series of technical questions that are being looked at as to how one might do it."

Defense Department spokeswoman Victoria Clarke said last week that "there are no particular concerns" about the vaccine, but she could give no estimate of when a decision might be forthcoming.

"Foot-dragging tells me the department has some disagreement," said Rep. Christopher Shays (R-Conn.), chairman of the House Subcommittee on National Security, Veterans Affairs and International Relations and a longtime opponent of the vaccination program. "I'd like to think there's at least some people who think this is a stupid idea."

During its brief life span, the Anthrax Vaccine Immunization Program has never lacked opponents. Concern about the safety and usefulness of the vaccine arose in the early 1990s when several veterans, some of whom had received anthrax shots, complained of illness after the Persian Gulf War.

Concern over anthrax heightened in 1995 when secrets of Iraq's bioweapons programs were revealed, including the existence of enormous stocks of anthrax that had been loaded into munitions for possible use against American troops in the Gulf War.

The immunization program was announced in late 1997 and launched in March 1998, with the Clinton administration requiring vaccination of all 2.4 million U.S. military personnel.

The program stalled immediately. BioPort could not get an FDA license because of faulty manufacturing practices.

But even as it was overhauling its procedures, BioPort was not allowed to sell any new vaccines, so immunizations slowed to a crawl as existing stocks of the licensed product dwindled. By the end of last year, 525,000 military personnel had been vaccinated at a cost of $33.5 million -- or $63.84 a person.

At the same time, the vaccine remained fiercely controversial. Several hundred service men and women refused to take the shots and left the armed forces, while about 100 others were court-martialed. At least three pending lawsuits question the legality of the program or seek damages because of adverse side effects.

Opposition from influential House Republicans such as Shays and Rep. Dan Burton (Ind.), chairman of the Government Reform Committee, left the program with a tarnish that carried over to the incoming Bush administration.

"A lot of people in the administration regarded the vaccine program as a Clinton holdover," said a former Defense Department official. "There was a little skepticism raised about whether to continue."

In an Aug. 10, 2001, memo, Edward C. Aldridge Jr., the undersecretary of defense for acquisition, technology and logistics, recommended to Rumsfeld that the program continue "at a minimum level" while it was reviewed.

Only 20 days later, however, Gen. Henry H. Shelton, then chairman of the Joint Chiefs of Staff, sent a memo to Rumsfeld telling him that the service chiefs and "combatant commanders are unanimous in their continued support for the military requirement to vaccinate our forces against anthrax."

The degree to which the disagreement persists is not clear. And even though the program appears set to resume in some form, Wyatt said the department has no plans to share the course of its deliberations. "When we ... have [a] decision, we will make an announcement," Wyatt said. "We will not, however, address the internal processes that led to our decision."