US REVIVES SMALLPOX SHOT



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Last Updated

14 Dec 2002

Source: Washington Post, December 14, 2002.

U.S. Revives Smallpox Shot

Bush Says He Will Receive Vaccine With Military, Emergency Workers

By Ceci Connolly and Dana Milbank, Washington Post Staff Writers

The federal government began vaccinating military personnel against smallpox yesterday as President Bush unveiled an unprecedented campaign to try to protect millions of Americans from the once-eradicated virus that has reemerged as a potential biological weapon.

After months of deliberations, Bush said that he would be vaccinated as commander in chief, had ordered nearly half a million people in the armed forces inoculated and would encourage as many as 10 million medical workers and emergency responders to quickly follow suit.

By summer, administration officials said, the vaccine would be available to any healthy American adult who demands it. Because of the vaccine's dangerous side effects, however, they strongly discouraged average citizens from being inoculated.

Bush's decision to begin the inoculations represents the first time in history that public health officials will give vaccinations for a disease that no longer exists in nature and has not been seen in a patient in more than 20 years. Despite the advice of experts to move cautiously, Bush opted for a more aggressive policy, citing national security concerns.

"To protect our citizens in the aftermath of September the 11th, we are evaluating old threats in a new light," he said. "Our government has no information that a smallpox attack is imminent. Yet it is prudent to prepare for the possibility that terrorists who kill indiscriminately would use diseases as a weapon."

The administration fears that Iraq or terrorist groups might possess the highly contagious, deadly virus. The inoculation program is designed to protect the emergency workers most likely to encounter the first victims of an outbreak in the United States and enable them to open mass vaccination clinics for the rest of the population. In the event of an outbreak, researchers say, authorities can safely dilute the current vaccine stocks to inoculate everyone.

The decision reflects pressure from Vice President Cheney and other defense hawks, who argued for the strategic necessity -- and deterrent effect -- of vaccinating a larger part of the public.

Bush and his advisers labored to play down the risk of an attack, pointing out that Bush's own family and staff -- including Homeland Security Director Tom Ridge -- are not being vaccinated. Still, the sense of urgency in the new program, the known side effects and the possibility that vaccinations could coincide with the start of a war in Iraq have raised anxiety about smallpox, a disease that kills one of three people infected.

Mandatory vaccination of the half-million military personnel -- which began yesterday with several dozen medical personnel at Walter Reed Army Medical Center -- is the first step of an incremental program that will extend quickly to 10 million medical workers and emergency responders.

The official unveiling of the policy yesterday brought a somber tableau to a lecture room in the White House complex: Eight officials from the State, Defense and Homeland Security departments and health agencies stood at attention while Bush read his carefully worded statement. Watching from the front row -- and not participating in the subsequent briefing -- was D.A. Henderson, the public health adviser who led the effort that eradicated smallpox worldwide. Henderson had argued for much more limited vaccinations.

"It's been quite a while since this nation saw the need to vaccinate so many people in such a limited amount of time," Health and Human Services Secretary Tommy G. Thompson said yesterday, calling the effort "a public health partnership like no other we've seen."

The White House plan to offer inoculations to every American represents a break with the recommendations of the government's own vaccine advisory panel. That group, known as the Advisory Committee on Immunization Practices, first suggested in June that no more than 20,000 medical workers be inoculated, and in October increased that figure to 500,000.

Many in the medical community voiced concern yesterday over the large number of people who will be put at risk by the vaccine while the extent of the danger is unknown.

"Why not present information [about a threat] to the advisory committee and define the risk more explicitly so folks in the community as well as the professionals can understand better why it is we're doing this?" asked William Schaffner, a nonvoting member of the committee and a professor at Vanderbilt University Medical Center. "I wonder whether it's prudent, let alone wise."

Jeffrey Koplan, former head of the Centers for Disease Control and Prevention and one of a handful of practicing physicians who have treated smallpox, said it will be a "tough sell" with many doctors and nurses.

"I'm not a security expert, but if you are going to ask people to use a vaccine with known and significant side effects, then you've got to make a very good case that the risk of exposure to the disease is real, tangible, quantitative and worth the risk you are going to take with your patients," he said.

Historical data show that of 1 million people vaccinated, 14 to 52 will experience life-threatening complications such as encephalitis, and one or two will die. To treat dangerous side effects, the government has stockpiled an antidote called vaccine immune globulin; officials said they have enough to treat side effects in 27 million people and by summer should have enough for 300 million.

Pregnant women, young children and people with skin conditions or weak immune systems should not receive the vaccine. That includes most cancer patients, individuals who test positive for the AIDS virus and people who have received organ transplants. Recent studies suggest that about a quarter of Americans would be excluded from vaccination because they or a close family member are in those groups, said Raymond Strikas, director of smallpox preparedness at the CDC.

The American Medical Association and the American Public Health Association issued statements yesterday endorsing the conservative approach advocated by the advisory committee and urging federal officials to wait before offering vaccine to others.

"States haven't even done plans for vaccinating the 10 million yet," said Georges C. Benjamin, executive director of the public health group.

Even though HHS believes fewer than 1 million people are needed to inoculate the country within 10 days of an attack, Thompson said that there is no way to know where in the country an attack might take place and that the vaccination of 10 million emergency workers "would be a broader deterrent."

The surprise in yesterday's announcement was the rapid implementation of the plan and a relatively broad willingness by the government to let ordinary Americans receive the vaccine even if they will not be carefully monitored through clinical trials.

A risky but effective live vaccine first developed by Edward Jenner in the late 1700s, the smallpox shot was once a common part of every toddler's trip to the doctor. Routine vaccinations ended in the United States in 1972, and the disease was declared eradicated worldwide eight years later. Today, about half the U.S. population has never been vaccinated. People vaccinated more than 30 years ago have little, if any, lingering immunity.

Vaccination within a few days of exposure should provide protection from the disease; however, because the incubation period of the virus averages 12 days, individuals may not immediately realize that they have been exposed.

Administration officials presented a rapid timetable for the inoculation campaign:

Vaccine has been shipped to several overseas military bases, where it will be given to 500,000 military personnel, including emergency response and medical workers and "mission critical" troops. Vaccinated military personnel would also help during a domestic smallpox outbreak.

Beginning in late January, 439,000 civilian emergency workers who are not at high risk of side effects will be encouraged to receive the vaccine as part of a voluntary program that the government hopes can be completed in 30 days.

Next, federal and state governments will move "as quickly as we can" to inoculate a broader group of 10 million health care workers, according to CDC Director Julie Gerberding. Officials estimate that about half that number will choose to be vaccinated during a second phase that will take 45 to 90 days. American diplomats in the Middle East would also have the option to be vaccinated, and the State Department will "consider" requests from allies for the vaccine.

In late spring or early summer of 2003, vaccine will be available to any American adult who is not in a high-risk group for complications and who insists on having the vaccine. The government is not encouraging average Americans to receive the vaccine, and "it's going to take a process" of questionnaires and consent forms to receive it, Thompson said. This group would receive unlicensed vaccines until more become available in 2004.