Pentagon Shifts Anthrax Vaccine to Civilian Uses

By JAMES DAO with JUDITH MILLER
NEW YORK TIMES

WASHINGTON, June 28 - The Bush administration announced a new anthrax vaccination policy today, including plans to continue vaccinating some military personnel and to stockpile for civilian use a large part of all the anthrax vaccine being produced for the Pentagon.

Under the new policy, which reverses an earlier plan to vaccinate all military personnel, the Pentagon intends in the next two weeks to begin vaccinating those who are expected to spend at least 15 days a year in regions where the threat of anthrax attack is considered high. That would include Iraq and other Persian Gulf countries, the Korean peninsula and possibly Afghanistan, officials said.

But at least a third of the vaccine to be produced will be stored by the Department of Health and Human Services in secret warehouses scattered around the country for use after a domestic anthrax attack, administration officials said. In the event of such an attack, most of those doses would probably be given to police officers, firefighters, rescue squads and others required to respond, as well as to people who lived or worked in areas exposed to the anthrax bacteria, administration officials said.

The new policy reflects in part a mounting concern within the Bush administration and among intelligence officials about reports that Iraq has well over 2,650 gallons of liquid anthrax, and could be making more in more than half a dozen laboratories.

The Iraqi anthrax could be used in biological weapon attacks in the region, posing a threat to military personnel, intelligence officials said. But some administration officials said they could not rule out such attacks in the United States.

The officials said that this conclusion was based on recent assessments by United States intelligence officials, who are constantly monitoring Iraq's ability to produce chemical, biological and nuclear materials, and by United Nations weapons inspectors, who have also been re-examining their estimates of Iraqi stockpiles of unconventional weapons based on information dating from as early as 1991, foreign and American officials said.

The Pentagon's review of its vaccination policy has dragged on for months, and concern about whether the administration was perceived to be moving fast enough to protect soldiers was a factor in the announcement of a new policy today. The Pentagon said it would immediately begin vaccinating some soldiers at greatest risk and would significantly expand stockpiles of the vaccine for civilian use.

The new vaccination policy reflects a reversal of one instituted in 1997 by Secretary of Defense William S. Cohen. That plan required that all 2.4 million active and reserve military personnel be inoculated by 2003. The Pentagon declined to say how many people it expects to vaccinate in the coming year.
" This is a shift from our earlier policy, which was to vaccinate everyone," Dr. William Winkenwerder Jr., the assistant secretary of defense for health affairs, told reporters today. "This is a policy that's focused on those in higher-threat areas."

The Pentagon acknowledged in interviews this week that only 69,000 soldiers had received the full six-shot anthrax vaccine series.

During the Persian Gulf war, intelligence officials argued that Saddam Hussein would not use his stockpile of anthrax and other chemicals unless he and his regime were clearly threatened. The administration's recent statements about the need for "regime change" in Iraq, its inclusion of Baghdad in the "axis of evil," and President Bush's articulation of a pre-emption doctrine that would justify American military action against any hostile nation that makes unconventional weapons, however, have increased the threat that Mr. Hussein might use his large arsenal, some officials say.

United States military planners and United Nations weapons inspectors have been re-examining their estimates about the amount of anthrax that Iraq may have stockpiled, and the amount that Mr. Hussein has been able to make since he expelled inspectors three years ago.

A recent analysis by the United Nations inspectors says there is compelling evidence that Iraq has large stocks of liquid anthrax that could be used at any time.

The new policy clearly reflects the thinking that civilians in this country are as susceptible to anthrax attacks as soldiers in combat zones, as was demonstrated by the death of five people last year from anthrax spores sent through the mail.

But it also underscores the problem the government has had in producing enough vaccine for the entire military. In December 1999, the Food and Drug Administration ordered the lone manufacturer of anthrax vaccine in the United States, the BioPort Corporation of Lansing, Mich., to halt production after inspectors found dozens of violations in safety, consistency, record-keeping and sterility at its Michigan plant. The agency authorized BioPort to resume production again in January.

"I think the shift was driven by a couple of factors," Dr. Winkenwerder said. "The first is that we are dealing in a constrained supply situation."

Some administration officials have also raised questions about whether BioPort could produce enough vaccine in the coming year to support a major military operation, such as an invasion of Iraq. Some senior military planners have argued that ousting Saddam Hussein would require 200,000 troops.

BioPort officials asserted today that they could produce enough doses to vaccinate the entire military, and they expressed dismay at Pentagon suggestions that the new policy was being driven by supply constraints.
" We can make millions on an annual basis," said Robert Kramer, the company president. "We were disappointed to hear at the press conference that the vaccination schedule is supply driven, that policy was being driven by supply. We're ready, willing and able to partner with anyone to produce enough doses under our license."

Mr. Kramer said, and administration officials confirmed, that despite the Pentagon announcement today there was not yet a specific agreement on how much vaccine Bioport would sell the government and at what price. Under a contract reached three years ago, the Pentagon pays $10.64 a dose, and both Pentagon and company officials said the price could rise significantly, perhaps doubling.

Pentagon officials have declined to say how much vaccine BioPort is capable of producing, but administration officials said the government wanted to buy about three million doses in the next three years. Administration officials said the military would receive about a third of the vaccine, the civilian stockpile about a third and the last third would go to other government agencies, like the State Department, that have employees who could be in danger.

Other officials say the new policy reflects a desire to provide sufficient vaccine for civilians. "At this point in time we do not have a large enough stockpile to pre-vaccinate, so the stockpile will be reserved for post exposure," said Jerome M. Hauer, acting assistant secretary for emergency preparedness at the Department of Health and Human Services. "The stockpile for civilians will be used for post-exposure vaccination and as the stockpile grows we will re-evaluate our policy as to whether certain first responders should be pre-vaccinated."

Full inoculation against anthrax requires a regimen of six shots administered over 18 months, followed by annual booster shots. Pentagon officials say a person must receive at least three shots to gain at least partial protection.
The Pentagon estimates that about 525,000 soldiers have received at least one anthrax vaccination over the last four years, but the vast majority have not received all six shots.

In addition to questions about BioPort's production, the Pentagon's mandatory anthrax vaccination program has been slowed by opposition from a small but vocal group of soldiers who contend the vaccine has potentially dangerous side effects.

Since the program began in 1998, more than 450 people in the military have been disciplined for refusing to be vaccinated. Those opponents won support from some Republicans on Capitol Hill, where the House Government Reform Committee held hearings airing their complaints.

Today, Representative Christopher Shays, a Connecticut Republican who championed the critics of the mandatory vaccination program, applauded the new policy, calling it a vindication of people who were forced out of the military for refusing to participate.

"The scaled-back approach announced today reflects a clear-eyed view of the threat and a responsible application of the limited medical countermeasures available," Mr. Shays said in a statement.

The analysis of Iraq's liquid anthrax stockpile, a summary of which has circulated in recent weeks among senior United Nations officials and selected Western governments, including the United States, says there must now be a "presumption" that Baghdad concealed at least 10,000 liters, or 2,650 gallons, of anthrax after the 1991 Persian Gulf war, officials said.

The seven-page report, an analysis of evidence that was gathered for a 1991 C.I.A. report on Iraqi biological weapons, the officials said, builds a circumstantial case that the anthrax remains potent and available.

http://www.nytimes.com/2002/06/29/politics/29ANTH.html?todaysheadlines