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http://www.nytimes.com/2002/12/13/health/13CND-SMALL.html?tntemail0

President Bush Announces Smallpox Vaccination Plan

By RICHARD W. STEVENSON and SHERYL GAY STOLBERG

ASHINGTON, Dec. 13 - President Bush today set in motion his plan for smallpox inoculations for 500,000 frontline military personnel and as many as 10 million civilian health care and emergency workers. But Mr. Bush strongly recommended that the general public not seek vaccination for now.

The president's long-awaited decision, coming as the nation prepares for possible war with Iraq, underscored how seriously the Administration takes the threat that smallpox, a disease declared eradicated two decades ago, might be used by terrorists as a biological weapon. But Mr. Bush said there was no evidence that terrorists were planning an immediate smallpox attack.

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``These vaccinations are a precaution only, and not a response to any information concerning imminent danger,'' Mr. Bush said. ``Given the current level of threat and the inherent health risks of the vaccine, we have decided not to initiate a broader vaccination program for all Americans at this time.''

Public health experts, hospital officials and infectious disease experts generally applauded the decision. But union officials said that Mr. Bush's plan does not adequately protect health care workers who might be injured by the vaccine, which can cause serious complications and even death, particularly among people with immune deficiencies.

Mr. Bush, who as commander-in-chief will be inoculated, ordered that half a million members of the armed forces, including those most likely to be involved in any war with Iraq, be immunized immediately.

Vaccinations were already under way at the Walter Reed Army Medical Center, moments after Mr. Bush spoke, officials said.

The president also authorized a voluntary program to inoculate as many as 439,000 doctors, nurses and emergency workers who would be the first to respond if t terrorists obtain the smallpox virus and introduce it into the United States.

The voluntary program will begin in late January, federal officials said, with states opening vaccination clinics, and could end as early as March.

Then the vaccine will be offered to as many as 10 million health care workers, police, firefighters, paramedics and other emergency workers, said Jerome M. Hauer, assistant secretary for emergency preparedness at the Department of Health and Human Services. The voluntary immunizations could be complete by the summer, Mr. Hauer said.

The general public will not have easy access to the vaccine, at least until a new version of it licensed, probably in 2004. But Tommy G. Thompson, the secretary of health and human services, pledged to develop an ``orderly process'' for making vaccine available sooner to adults, possibly as early as the summer, officials said.

One option for people who demand to be vaccinated right away is to enroll in ongoing clinical trials of the smallpox vaccine, said Dr. Julie Gerberding, director of the Centers for Disease Control and Prevention in Atlanta. The government is also considering creating a special protocol for the public.

Mr. Bush's announcement today is the culmination of what Tom Ridge, the president's domestic security adviser, called ``an exhaustive process that lasted more than nearly 15 months,'' beginning with the terrorist attacks of last Sept. 11.

It was an extremely delicate decision. Because the risk of an attack using smallpox is impossible to estimate, experts had no way to know if the vaccine's benefits outweighed its risks in the absence of an actual smallpox outbreak. Smallpox is a particularly fearsome biological weapon because the virus is highly contagious and because 30 percent of people infected with it die.

``We had to assess the risk from terrorists or hostile governments, along with the potentially devastating consequences on our people and our way of life,'' said Mr. Ridge. Those risks, he said, had to be weighed against ``the fact that the vaccine itself, a highly protective preventive measure, has potentially serious adverse effects.''

Secretary Thompson said Mr. Bush's plan ``strikes the right balance.''

People involved in making the decision said Vice President Dick Cheney, along with officials from the Defense Department and national security experts, favored widespread vaccination. But public health experts, including Dr. Gerberding, director of the Centers for Disease Control and Prevention, were more cautious, and worried about the vaccine's side effects.

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``There was a lot of broken glass and a lot of cracked eggs along the way, with people yelling and screaming at each other,'' said one person who was involved. But over time, this person said, the two sides began to see eye to eye. ``In the end, the president took in all the information and made the final decision himself.''

The smallpox vaccine is made from a live virus, vaccinia, that is a close cousin of the smallpox virus. People who take it receive a series of pricks on the shoulder with a bifurcated needle that creates an open sore. Until the sore forms a scab, the vaccinia virus can spread and cause infection, either in the person who received the vaccine or family members and other close contacts.

Routine vaccinations for smallpox were suspended in this country in 1972, and the disease was declared officially eradicated in 1980. The last case in the United States was in 1949.

Based on data from 1968, when immunization was still routine, Dr. Anthony S. Fauci, director of the National Institute for Allergy and Infectious Diseases, predicted that for every million people vaccinated today, there would be 14 to 52 life-threatening reactions. They included vaccinia encephalitis, an inflammation of the brain, or eczema spread throughout the body in people who have a history of the condition.

In addition, Dr. Fauci said, there would be anywhere from 49 to 935 serious but not life-threatening reactions. The studies showed that 1 or 2 people per million vaccinated died as a result of the complications.

In announcing that he would receive the vaccination, Mr. Bush said that he could not require that members of the military receive the vaccine if he was not willing to assume the risks himself.

Administration officials said that neither Vice President Dick Cheney nor members of the Cabinet and Congress would be vaccinated if there was not a smallpox attack.

Officially, the smallpox virus is supposed to exist in only two laboratories, the federal Centers for Disease Control and Prevention in Atlanta, and a Russian government repository in Moscow. But intelligence officials have long suspected that rogue nations, including Iraq and North Korea, have illicit stocks of smallpox, and that unauthorized stocks also exist in Russia.

For decades the government has maintained a stockpile of aging smallpox vaccine, called DryVax, that was manufactured in the 1970's, and today has roughly 15 million doses, Mr. Thompson said.

In the wake of last year's terrorist attacks and the anthrax attacks that followed them, Mr. Thompson, the health and human services secretary, decided the stockpile needed to be expanded. Today the White House said there is enough vaccine available to inoculate every American in the event of a smallpox attack.

The vaccine is effective up to four days after exposure to the virus. But only the DryVax stockpile is licensed by the Food and Drug Administration; that is the vaccine that will be given to the military and health care workers and other emergency personnel, Dr. Fauci said. Members of the public who insist on being immunized will be inoculated using a different, unlicensed, stock of aging vaccine.

Because of the vaccine's risks, those who take it must be carefully screened for conditions including eczema, atopic dermatitis, AIDS and other immune conditions. Pregnant women should not take the vaccine. Nor should organ transplant recipients or cancer patients, who take immune-suppressing drugs.

Dr. Gerberding said people who take the vaccine will also be given very specific and careful instructions about how to care for the vaccine wound. And she said the government will create a system for monitoring reactions, with the states maintaining records of people who are vaccinated.

``As this program unfolds, vaccine safety is a top priority,'' Dr. Gerberding said. ``We intend to do everything that we can to minimize the risk.''

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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.