Anthrax Retreat Do You Still Have To Take The Shot?

By Deborah Funk

Air Force Times

July 24, 2000

The Pentagon is cranking back on the mandatory anthrax vaccination program, hoping to stretch out its dwindling supply of the vaccine.

New rules announced July 10 vastly reduce the number of troops who will receive the shots until the vaccine's sole manufacturer, BioPort Corp. of Lansing, Mich., can start producing approved vaccine.

That could take six to 12 months, officials admit, casting doubt on the future of the program in the waning days of the Clinton administration.

Pentagon officials insist, however, that this is a "temporary slowdown," and will not prevent the eventual vaccination of all 2.4 million members of the active and reserve components.

Defense Secretary William Cohen announced the changes July 10 via DefenseLink, the official military Internet site, just after he left the United States for a scheduled trip to China.

Already about a year behind schedule, the program suffered recent setbacks when 600,000 vaccine doses in government stockpiles failed potency tests, and testing on another 200,000 doses was declared invalid.

Only those at risk

What's left of the available vaccine supply, more than 160,000 doses, is being reserved for U.S. troops considered most at risk -- those on the ground in South Korea and Southwest Asia for more than 30 days.

Anyone deployed to Kuwait, Saudi Arabia, Qatar, United Arab Emirates, Bahrain, Jordan, Israel, Oman and Yemen will continue to receive the shots, provided their assignments keep them there a month or more.

Early published reports incorrectly suggested that only troops in Kuwait would get the shots.

Inoculations probably will be deferred for personnel aboard ships in contiguous waters who will not go ashore for more than 30 days.

But Navy SEALs and Marine Expeditionary Units in those areas will receive the anthrax shots, according to Marine Corps Maj. Gen. Randall L. West, senior adviser to the deputy secretary of defense for chemical and biological protection.Vaccinations will be temporarily discontinued for people who have begun the series but are no longer in the high-threat areas. Troops scheduled to return to a high-threat area in six months, however, will maintain their shot course, West said.

Exactly when the vaccinations will resume for the rest of the force depends on when more vaccine becomes available. Kathryn C. Zoon, director of the Food and Drug Administration's Center for Biologic Evaluation and Research, estimated that could be at least six to 12 months.

Since the program began in 1998, the Defense Department has administered 1.8 million shots to 455,378 service members. Some 56,725 have received all six shots in the vaccination series.

After the initial inoculation, shots are supposed to be given at two weeks, four weeks, six months, 12 months and 18 months. But the FDA does not object to the schedule deviation in light of the supply problem, Zoon said.

Most service members who have started but not completed the series probably will not get the next shot anytime soon.

The Pentagon implemented the anthrax vaccination program to protect troops against what it describes as the most likely biological warfare threat.

But the program has been controversial almost from the beginning. A small but vocal group of critics has repeatedly questioned the vaccine's safety and effectiveness, as well as the management of the program.

Steeped in controversy

About 350 service members refused to take the shots and were disciplined. Others, particularly in the reserves, left the military or transferred to nonmobility units to avoid the shots. Many were pilots.

The Defense Department is now searching for both short- and long-term solutions to the vaccine-supply problem.

Defense officials not only are seeking a second source for the current vaccine, but also are pursuing research into a second-generation anthrax vaccine.

All the vaccine in the Pentagon's stockpile was made by BioPort's predecessor, Michigan Biologic Products Institute. The plant closed for renovations in February 1998 and BioPort purchased it that fall. But the renovations ran months behind schedule, and the plant failed an FDA inspection in November 1998.

"We wish we were vaccinating the whole force now," West said during a July 11 press briefing at the Pentagon. "We were perhaps a little too optimistic about how long it would take the new manufacturer to pass all of its inspections and receive its certification from the FDA and the other people that work with them.

"We also thought a little more of the supply that had already been produced would become available."

BioPort and the Defense Department say they expect the plant to be ready for another FDA inspection this fall and predict the plant could be licensed by year's end or in early 2001.

Buying another nine months

Defense officials say the slowdown will result in the need to administer just 14,000 doses a month for the immediate future, down from the 75,000 doses a month it has been administering.

That level of use would stretch the available supply another nine months. "We're disappointed that we have to do it," West said. "We'll be working as hard as we can to remedy the shortfall as quickly as we can."

News of the dwindling supply sparked congressional hearings as members of the House and Senate Armed Services committees expressed concern over the Pentagon's ability to protect troops.

"I continue to be convinced that our soldiers, sailors, airmen and Marines are better protected with a safe and potent anthrax vaccine than they would be without it," said Rep. Steve Buyer, R-Ind., during a July 13 hearing of the House Armed Services personnel subcommittee, which he is chairman of. "However, I am concerned about the Department of Defense's short-, intermediate- and long-term strategies for providing that protection."Biological-weapon detectors and antibiotics also will be used for protection, defense officials said.

When the supply of vaccine flows again, service members whose vaccination schedule was interrupted will pick up where they left off, defense officials say. That follows guidelines of the Center for Disease Control's Advisory Committee for Immunization Practices and is the way the nation has handled other types of vaccine shortages in the past, said Public Health Service Rear Adm. J. Jarrett Clinton, acting assistant secretary of defense for health affairs.

To bolster their supply, defense officials are contracting with other companies to test, fill and package the vaccine.

Seeking a second source

The Defense Department is advertising in Commerce Business Daily to see if any companies are interested in producing the anthrax vaccine.

But civilian companies haven't shown much interest because the market is too limited to be worth the investment. The Defense Department has experienced similar problems with several vaccines that are strictly or largely used by the military, such as the vaccine for plague.

Later this month, the Defense Resources Board will decide whether to request funding to build a facility that would make a variety of vaccines, Deputy Defense Secretary Rudy de Leon told lawmakers. It would be owned by the government but operated by a contractor. Such a facility could take seven years to build, however, defense officials said.

Sen. John Warner, R-Va., chairman of the Senate Armed Services Committee, suggested during a July 12 hearing that the government buy BioPort Corp. in an attempt to avoid the delay.

"Every day there are corporate takeovers," Warner said, adding that those companies are swiftly up and running under new ownership.

Critics say the current dilemma underscores ongoing problems with the vaccination effort.

"This program was ill-conceived and has been poorly managed," said Rep. Walter Jones Jr., R-N.C., who wants the shots to be voluntary. "Now we face an unfortunate shortage of vaccine that undermines whatever potential benefit the Department of Defense had hoped to gain."

Rep. Christopher Shays, R-Conn., whose subcommittee launched an all-out offensive against the vaccine after a series of hearings, wants Cohen to order a review of disciplinary actions that stem from the vaccination program.

"If the forcewide order no longer stands, [neither] should disciplinary actions against those whose legitimate health concerns prompted a decision to opt out of the program," said Shays, who is chairman of the House Government Reform national security subcommittee.

Shays wants the program suspended until "a modern vaccine" is developed."Bringing the 1950s-era vaccine process up to current biologic manufacturing standards is like trying to get an Edsel through modern auto safety and emissions testing," he said. Continuing to order troops "to start the shots they may never finish constitutes military malfeasance and medical malpractice."