http://www.nytimes.com/2001/10/22/national/22SMAL.html

October 22, 2001

THE STRATEGY

Sept. 11 Attacks Led to Push for More Smallpox Vaccine

By JUDITH MILLER and SHERYL GAY STOLBERG

n late September, in the days before a series of anthrax-tainted letters made bioterrorism a reality in the United States, President Bush decided that the federal government should acquire enough vaccine to protect every American against an even more menacing biological threat: smallpox.

Although smallpox was eradicated as a disease in the 1970's, American intelligence had suspected for years that Iraq and North Korea, and possibly other rogue nations, had maintained clandestine stocks of the deadly smallpox virus.

But officials say it was the attacks on the World Trade Center and the Pentagon, and not any new information, that prompted the president's decision to greatly expand the nation's smallpox vaccine stockpile.

The decision, which was not publicly announced, gained urgency when letters containing potentially lethal anthrax powder began arriving at news organizations and on Capitol Hill. The anthrax scares produced widespread fears that the nation would run short of the antibiotic Cipro. So senior administration officials quietly sped up their timetable for acquiring the smallpox vaccine.

Last Wednesday, Tommy G. Thompson, the secretary of the Department of Health and Human Services, announced the plan, which calls for stockpiling the vaccine so that it can be used in the event of an outbreak of smallpox, a highly contagious disease for which there is no treatment, and that kills one-third of all people infected with it.

"I think the American people will feel much more comfortable knowing they have their name on a vaccine shot in our inventory," Mr. Thompson said in an interview. "It's the security of knowing you have enough for every American."

The decision to buy 300 million doses will vastly accelerate an existing vaccine program that, in the view of many scientists and federal officials, was hampered by bureaucratic inefficiency and was moving much too slowly. It also illustrates just how concerned officials have become about the nation's preparedness for a bioterrorism attack.

Despite Mr. Thompson's public pronouncements on Sept. 30 that the government "can handle any contingency right now," interviews with nearly a dozen administration officials, scientists and bioterrorism experts make clear that in the aftermath of the Sept. 11 attacks, both the health secretary and the White House privately were acutely aware of the nation's vulnerabilities.

Even so, it was not until Oct. 4 — just hours before Mr. Thompson announced to the nation that a Florida man had become sick with pulmonary anthrax — that he secured Mr. Bush's commitment to pay for his entire $1.6 billion bioterrorism preparedness package.

"It was the double whammy of the World Trade Center and the anthrax attack that made everybody realize that these are real problems that need to be dealt with," said Peter B. Jahrling, an Army scientist who is one of the nation's leading smallpox researchers. "In all my years of government service, I have never seen anything move this fast."

Mankind's triumph over smallpox is considered public health's greatest accomplishment. After the World Health Organization officially declared in 1980 that the disease had been eradicated, countries were supposed to destroy their stocks of the smallpox virus and transfer any samples of it two repositories, one in Russia and the other in the United States, at the Centers for Disease Control and Prevention in Atlanta.

By the early 1990's, the United States had about 15 million doses of aging smallpox vaccine that had been made by Wyeth Laboratories. It was too little to protect civilians and military forces, but few civilian scientists believed that the disease would ever re-emerge.

The military, however, thought otherwise. In 1989, Vladimir Pasechnik, a top Soviet biologist, defected to Britain. In briefings later shared with American military intelligence analysts, he described the Soviet Union's empire of thousands of scientists and dozens of secret cities and facilities devoted to turning germs and viruses, including smallpox, into weapons. And he said Moscow was trying to modify smallpox into an even more efficient killer.

These accusations, bolstered by the 1992 defection to the United States of Ken Alibek, the No. 2 scientist in the secret Soviet program, led American scientists at the Army's biological defense laboratory at Fort Detrick, Md., to press for the development of a more modern vaccine.

In 1997, the Pentagon awarded a contract to DynPort, an American- British company, to do just that.

The next year, a special panel of experts urged President Bill Clinton to start a vaccine program for civilians. Because vaccination was stopped in 1972, and immunization against smallpox lasts only 15 to 20 years, Americans are especially vulnerable, experts say.

At the Department of Health and Human Services, Margaret A. Hamburg oversaw the smallpox effort. Administration officials worried that they would not get support for the plan in Congress. "A lot of people thought this was a crazy idea, to make new vaccine when the disease didn't exist," Dr. Hamburg said.

At the White House, Richard A. Clarke, President Clinton's counterterrorism coordinator, wanted the Pentagon and the health agency to join forces. But the Pentagon refused to share the seed strain for its program with the civilian program.

In an interview last summer, a spokesman for the office charged with making the vaccine, the Joint Vaccine Acquisition Program, said there were legal impediments to cooperating with a civilian contractor. Among other factors, he said, product liability was a concern.

"These were two diametrically opposite bureaucracies that had no history of dealing with one another," said Mr. Clarke, who now leads Mr. Bush's office to protect the nation against Internet threats.

The result was two separate smallpox vaccination programs. The military contract with DynPort called for 300,000 doses at a cost of $22 million, or initially about $70 a dose, to be delivered around 2005 or 2006. The civilian contract, which was awarded to OraVax, a Massachusetts-based company that has since been acquired by Acambis, a British concern, called for 40 million doses to be delivered by 2005, at a cost of $343 million, at about the same time as the military vaccine.

One senior administration official called the situation "an utter mess."

Even before the Sept. 11 terrorist attacks, the Bush administration was determined to straighten the problem out. In June, a team of bioterrorism experts, led by the Johns Hopkins University Center for Civilian Biodefense Studies, conducted an exercise code-named Dark Winter that simulated an outbreak of smallpox in the United States. As the imaginary epidemic spread, growing grimmer and grimmer, the government quickly ran out of vaccine.

"After Dark Winter, there was a whole spate of briefings, so that a whole lot of people suddenly began to realize just how serious an epidemic of this sort could be," said Dr. Donald A. Henderson, who directs the center at Johns Hopkins and led the global effort to eradicate smallpox.

On Sept. 16, Mr. Thompson brought Dr. Henderson into his inner circle of advisers. The men met for the first time that day.

"This was a man deeply troubled and very worried," Dr. Henderson recalled. Mr. Thompson acknowledged as much. "Where will they hit us if they're going to hit us again?" he remembered thinking.

By this time, Mr. Thompson was already pressing the White House to improve the nation's bioterrorism defenses. He found allies there among several officials who were steeped in biodefense.

I. Lewis Libby, a top Pentagon lawyer in the first Bush administration who is now Vice President Dick Cheney's chief of staff and national security adviser, arranged for his boss to see a video of the Dark Winter exercise on Sept. 20. Lisa Gordon-Hagerty, who directs a National Security Council program to defend against weapons of mass destruction, was also supportive.

Officials said the vice president was so alarmed by the exercise that he raised the smallpox vaccine issue at a National Security Council meeting later that day. "The vice president was pushing it, and the president was going along with it," a senior administration official said.

Within Mr. Thompson's circle of advisers, however, there was serious debate about whether 300 million doses were actually needed. Dr. Henderson's group at Johns Hopkins had estimated that only 100 million to 135 million doses would be needed to curtail an outbreak, and people familiar with the discussion say Dr. Henderson argued that money might be better spent on improving the public health infrastructure.

Others argued that the government needed a dose for every American, if only to avert panic. Among them was Michael T. Osterholm, a public health expert who is also advising Mr. Thompson. He declined to talk about the deliberations, but said, "There is a certain psychological benefit to knowing that, in this country, there is a dose of vaccine for everybody if we need it."

The secretary agreed and, sometime after Sept. 20, secured verbal approval from the president for the program. On Oct. 3, Mr. Thompson announced that his agency had arranged for Acambis to speed up its work and deliver the doses by the end of next summer.

The next day, anthrax hit America.

As the news was breaking in Florida that a man there was sick with pulmonary anthrax, a disease not seen in this country for a quarter- century, Mr. Thompson was at the White House, briefing the president and vice president on his bioterrorism plans.

Officials say that briefing was a pivotal moment. The president committed the $1.6 billion for the broad antibioterrorism package. When it was over, Mr. Thompson briefed the press about the anthrax infection. Over the next several days, it became clear that the case was a deliberate attempt at anthrax poisoning.

"When the anthrax hit, it was like, whoof!" Dr. Henderson said. "Sort of like a blow in the stomach." The next Monday, Oct. 8, Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, received an order from Mr. Thompson's chief deputy, Claude Allen. His mission, Dr. Fauci said, was "to determine the scientific and technical feasibility of rapidly expanding the production of smallpox vaccine."

That Friday, a collection of the nation's top scientists and public health officials gathered in Dr. Fauci's office on the campus of the National Institutes of Health in Bethesda, Md. They included representatives from the Food and Drug Administration, the disease control centers and Dr. Fauci's institute, as well as Dr. Jahrling, the Army scientist.

"It was a high state of adrenaline," Dr. Fauci recalled. He remembered telling the assembled scientists: "We have been given a task. We are going to get it done, and we are going to get it done on time. Failure is not an option." One concern, he and others said, was that the administration was taking a risk by relying on just one company, Acambis, to make the smallpox vaccine. So by this time, officials from Mr. Thompson's office were already meeting with other vaccine manufacturers, including Merck and Baxter International, which has a 20 percent stake in Acambis, to determine whether they would help in the effort.

"I think you want to diversify the risk," Dr. Jahrling said. "In a world where planes hit trade centers and the whole thing comes crashing down, I think you probably want to make this stuff in more than one place." And while Dr. Fauci's institute was already running tests to see if the existing stockpile of 15 million doses could be safely diluted to create 75 million, everyone at the meeting agreed that was not good enough. By the time it was over, they had agreed to get a draft proposal for buying 300 million doses to Mr. Thompson by Oct. 17.

"We were on a very fast track," Dr. Fauci said.

So fast, in fact, that Mr. Thompson did not even wait for the draft to announce his plans. He did not need to, he said. The decision had already been made.

ALL INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR LEGAL ADVICE.  THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.