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Last Updated

13 Apr 2003

Source: Washington Post, April 13, 2003

U.S. Smallpox Vaccine Program Lags

Workers Decline Immunizations

By Ceci Connolly, Washington Post Staff Writer

ATLANTA -- Four months after President Bush summoned millions of doctors, nurses, firefighters and police officers to form a nationwide network of smallpox response teams, officials running the immunization program concede it has fallen far short of expectations.

The campaign, portrayed as the centerpiece of the administration's efforts to protect against bioterrorism, has proven to be more expensive, less popular and medically riskier than initially thought, said experts in and out of government. And as a result of overly optimistic projections, tens of thousands of doses of the precious vaccine are in danger of spoiling if states cannot quickly recruit more volunteers.

The disappointing response, coupled with mounting doubts Iraq will launch a smallpox attack against the United States, has prompted a growing chorus of public health leaders to call for a halt.

"Everything should be on hold," said Frank Judson, director of Denver Public Health and a veteran of the smallpox global eradication campaign. "There should be no further effort to vaccinate Americans unless by some totally improbable action it shows up in Iraq."

He and other critics warn that the overwhelming emphasis on smallpox has left the nation vulnerable to other weaponized germs such as anthrax and naturally occurring outbreaks such as the new severe acute respiratory syndrome, or SARS.

A smaller, but equally passionate, cadre of medical experts fears the slow pace of smallpox inoculations suggests a complacency that could have severe repercussions.

"The threat is definitely real. This is a dangerous time," said Daniel Lucey, director of the Center for Biologic Counterterrorism and Emerging Diseases at the Washington Hospital Center. He said it is crucial for health care workers to be immunized "for ourselves to be protected, and to then be able to take care of patients and contribute to a large-scale vaccination program."

Since Bush rolled up his sleeve to be among the first vaccinated, health professionals have debated whether the risk of a smallpox attack outweighs the known risks of what is described as the most dangerous vaccine in use today.

Over the objections of the government's own vaccine advisory committee and despite some private doubts, the highest-ranking federal health officials defend the aggressive immunization campaign. "Our country's probably never been at higher risk for a terrorist attack," said Julie Gerberding, director of the Centers for Disease Control and Prevention here.

She and Health and Human Services Secretary Tommy G. Thompson said the nation's ability to respond to a smallpox attack depends on immunizing millions of people now.

"We have plans for post-exposure vaccination to vaccinate every man, woman and child in 10 days in America," he said. "For that plan to work you have to have a mass of individuals that can do the vaccinations, set up the clinics."

When asked to assess the program, doctors closest to the program highlight the great strides made in educating and training the medical community. Many doctors and nurses have learned how to diagnose smallpox, administer the vaccine and run large immunization clinics, said Walter Orenstein, director of CDC's National Immunization Program.

Other administration officials expressed relief that Congress approved a bill that includes about $40 million to compensate anyone seriously harmed by the vaccine. Unions have complained that without adequate financial protections for people suffering severe, sometimes fatal, complications, it was unfair to ask their members to volunteer.

"We will put on a great communications program with the nurses about this compensation to encourage them to sign up," Thompson said.

Yet even Thompson has said in interviews that he is "disappointed" and "frustrated" that the campaign has lagged, and he acknowledged Friday that he will be happy if in the end 2 million people are immunized -- just one-fifth of his original goal.

Of the 450,000 health care workers states hoped to vaccinate, fewer than 32,000 have volunteered. Abandoning their original plan to complete and evaluate that first phase before moving on to inoculate millions of emergency responders, administration officials casually mentioned last month they had decided to meld the two stages. Some critics say the shift was an attempt to boost the participation figures, while many at CDC said they were baffled by a major policy change that was instituted with no formal announcement or written guidelines.

In its latest report on the program, the Institute of Medicine also homed in on the change, questioning the purpose and wisdom of moving to vaccinate first responders.

An analysis by the Association of State and Territorial Health Officers found that immunization -- from screening through follow-up -- is costing an average of $249 per person, far above the $85 budgeted by federal officials.

Perhaps most alarming, a vaccine already known for its dangerous side effects now appears to be linked to three dozen cases of heart inflammation, known as myocarditis, and could be related to a handful of heart attacks and cases of angina.

Although myocarditis often subsides with pain medication, the 1993 death of Reggie Lewis showed it can be more serious. Medical examiners said the former Boston Celtic's "terminal arrhythmia" was caused by inflammation of the heart muscle, or myocarditis. More than a dozen states have suspended vaccination until more is learned about the recent heart episodes.

On Thursday, the New York brokerage firm C.E. Unterberg Towbin downgraded its stock rating of vaccine maker Acambis, citing concerns over the heart complications.

"It's like putting straws on the camel's back," said CDC's terrorism coordinator Joseph Henderson, who acknowledged the program has faced hurdle upon hurdle. Henderson and Orenstein said they are revamping the program and plan to give states benchmarks for evaluating preparedness that will focus less heavily on the number immunized.

"A state can tell me it has 10,000 people vaccinated, but if it is not tied to a response system then the only thing that means is those 10,000 people are vaccinated," said Henderson. Still, he too uses numbers as one gauge. If a smallpox case appeared in a hospital emergency room today, with just 31,000 medical workers inoculated nationwide, "the chances of that doctor being vaccinated are low," he said. "If we were at 150,000 people, the odds would be greater that doctor would be vaccinated."

Another figure on Henderson's mind is 284,000 -- the number of doses that have been shipped by CDC to the states since late January. With an average shelf life of 60 days after a vial is opened, much of the distributed vaccine is in danger of losing its potency, he said.

After long resisting the idea, CDC is considering moving vaccine stockpiles closer to hospitals, said Deputy Director David Fleming. That way, they could begin immunizing almost immediately if an attack occurs.

The CDC team understands -- and to some extent privately agrees -- with physicians who voice skepticism about large-scale vaccination. But they say it is equally dangerous to put too much stock in counter-arguments, such as the notion that vaccination within four days of exposure will protect people. Orenstein said the scientific literature is mixed on that point, while Henderson said a multi-city attack would make mass vaccination a Herculean challenge. "You better hope the system can deliver for you," he said. "What if it takes five or six days?"

Even with a compensation package, many health experts see little reason for pressing ahead on such a large scale.

Michael Lane, a world authority on smallpox who is assisting CDC, said he fears politics and the war with Iraq overruled sound medical advice favoring a modest immunization program. "We believed Saddam Hussein and his henchpersons had smallpox," he said. "That issue is going to be cleared up shortly, and then we will know whether we need to vaccinate several million people."