From Reuters Health, 12/2/00
U.S. Makes More Cuts to Anthrax Vaccine Program
By Kate Fodor

NEW YORK (Reuters Health) - Due to the continuing shortage of the vaccine that protects against the biological warfare agent anthrax, the US Department of Defense (DoD) is making further cuts in its already scaled-down inoculation program for military personnel.

Bioport, the sole US supplier of the anthrax vaccine, has struggled with quality control issues and is not currently licensed by the US Food and Drug Administration (FDA) to manufacture the product.

Once the DoD has set aside some of its existing stockpile of vaccine for use in case of domestic attacks, there will only be enough of the product left to vaccinate the small percentage of troops at the greatest risk of encountering anthrax, Assistant Secretary of Defense for Public Affairs Ken Bacon told reporters at a briefing in Washington, DC on Thursday.

As a result, the only military personnel to be inoculated will be ground troops being sent into the Persian Gulf for at least 30 days ``and personnel afloat in contiguous waters, who have the potential to be committed ashore,'' including the Marines, he said. New vaccinations, as well as yearly booster shots for the personnel who have already received the initial six-vaccine regimen, have been stopped in other regions.

Anthrax ``is a clear and present threat, we believe, in Southwest Asia,'' Bacon said. ``We have not had United Nations inspectors in Iraq since 1998 to monitor what, if anything, they've done with their biological weapons supplies.''

Asked by a reporter whether the situation in North Korea is not equally worrying, Bacon acknowledged that the country has ``an active biological and chemical weapons program.'' However, he said, ``given the fact that Saddam Hussein has used chemical weapons in the past against Iran and against the Kurdish minority in his own country, we assess the risks to be greater in Iraq than we do right now in the Korean Peninsula.''

Minus the emergency reserve, there are about 60,000 doses of the vaccine left, he noted--or enough to continue vaccinations in the Gulf at the rate of 5,000 a month for a year. ``Our current expectation and hope is that (Bioport will be) producing FDA-compliant vaccines of the absolute highest safety level in the third or fourth quarter of next year,'' he added.

An FDA inspection of the Bioport facility in October found a wide array of infractions. However, Bacon called the inspection ''more encouraging than some of the earlier ones.''

In addition, the DoD is ``making some progress with an alternate source,'' he said.

Although some of the vaccine that Bioport is currently generating as it attempts to bring its Lansing, Michigan-based production facility up to snuff may eventually prove usable, it cannot be injected into troops until the company is licensed, another DoD spokesperson told Reuters Health.

The shortage could be alleviated somewhat in the future based on the possibility of a regimen that requires less than 6 shots, Bacon mentioned at the briefing. However, ``right now, we're sticking with the tried and true, which is six shots over 18 months and then annual boosters,'' he said.

In a press release issued in conjunction with the briefing, the DoD stressed that it continues to believe that the vaccine ''is the safest most reliable way'' to protect against ``the top biological warfare threat to US troops.''