New Sources of Anthrax Vaccine Are Years Away

By John Whitesides

Wednesday July 12 5:53 PM ET

WASHINGTON (Reuters) - New sources of vaccine for the U.S. military's mandatory anthrax inoculations might be years away, Pentagon officials said on Wednesday, casting further doubt on the troubled vaccination program.

The Pentagon already has slowed its effort to inoculate all 2.4 million U.S. active and reserve troops against the deadly anthrax biological agent because of a shortage of vaccine.

With supplies dwindling, Food and Drug Administration approval of a Michigan plant to produce more vaccine is still six to 12 months away, and the search for new suppliers to help the lone manufacturer, BioPort Corp., could take at least two years and perhaps much longer, officials said.

``The lesson here is that we need to have more than one option,'' Deputy Secretary of Defense Rudy de Leon told the Senate Armed Services Committee, adding that steps should have been taken much sooner to secure new supplies of the vaccine.``In a perfect world, with 20/20 hindsight, I can see that we should have tried sooner,'' de Leon said.

Defense Secretary William Cohen said on Monday the Pentagon would limit vaccinations, giving them only to those troops headed for high-risk areas such as South Korea and the Gulf, where they could be threatened by biological agents developed by Iraq or North Korea.

``We will make every effort to continue vaccinating members who would be at greatest risk,'' de Leon said. Republican Rep. Christopher Shays of Connecticut, who heads a House subcommittee that earlier this year recommended the program be made voluntary until development of an updated vaccine, asked Cohen on Wednesday to suspend the mandatory elements of the program.

``Having now conceded no broad-based program using the current vaccine is available, you should suspend all mandatory elements,'' Shays wrote Cohen.

About 455,000 of the 2.4 million active and reserve U.S. troops have taken at least one of the series of vaccinations, but stored supplies of approved vaccines are running short and no new vaccine is being produced in the United States. ``Without an assured supply of vaccine, continuing to order any more soldiers, sailors, airmen and Marines to start the shots they may never finish constitutes military malfeasance and medical malpractice,'' Shays said in his letter.

Pentagon Seeks Bids

The Pentagon is hoping to receive bids by the end of the month for a second commercial manufacturing source of the vaccine to share the job with BioPort, but it would be two to four years for that source to be approved and operating, de Leon said.

The Pentagon also will decide later this summer on whether the government should attempt to take over vaccine development and production, de Leon added, but that effort could take five to eight years.

Senators criticized the Pentagon's handling of the vaccination program, which has been plagued by problems and complaints since it was launched in May 1998. ``For too long the Department of Defense has pursued a flawed acquisition strategy that is a disservice to both the American taxpayer and our men and women in uniform,'' said Sen. Tim Hutchinson, an Arkansas Republican. He said the Pentagon should have opted early for government manufacturing of the vaccine and blasted efforts to adjust BioPort's contract to help the struggling manufacturer, including granting an interest-free $20 million loan. ``I question the fitness of whoever negotiated such a horrendous arrangement on behalf of the American taxpayer,'' he said.

Concern About Health Consequences

The program has been controversial from the beginning, with widespread concern about the health consequences of the series of shots.

Shays, in his letter to Cohen, asked for a review of the more than 350 disciplinary actions against service members who refused the vaccine, saying ``they deserve the same deference DOD seems so willing to extend to BioPort.'' Kathryn Zoon, director of the FDA's center for biologics evaluation and research, told the Senate committee there had been 1,400 ``adverse events'' out of the nearly 2 million doses administered, a lower than normal reaction rate to vaccines.

Despite the problems, officials said there were no plans to back off the program as the threat from anthrax spores, which are odorless and invisible and 100 percent lethal if inhaled, continued to grow.