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http://www.nytimes.com/2002/12/12/politics/12VACC.html?tntemail1

Smallpox Shots Will Start Soon Under Bush Plan

By RICHARD W. STEVENSON with LAWRENCE K. ALTMAN

ASHINGTON, Dec. 11 — President Bush intends to announce a plan on Friday to start vaccinating military personnel, health care and emergency workers against smallpox within weeks, and to offer immunization to the public on a voluntary basis starting in 2004, administration officials said tonight.

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The announcement comes after months of debate within the administration over how to respond to the threat that terrorists or hostile governments might use the smallpox virus on the battlefield or against civilians in the United States.

Mr. Bush had to weigh the relative risks of vaccination, which can cause serious side effects and even death in rare cases, against the possibility that the disease, once one of the world's great scourges, could be deliberately spread through large populations.

Administration officials described the plan after ABC News broadcast excerpts from an interview with Mr. Bush in which he said he would eventually offer all Americans a chance to be vaccinated.

"I think it ought to be a voluntary plan," Mr. Bush told Barbara Walters in the interview, which will be broadcast on the program "20/20." "In other words, I don't think people ought to be compelled to make the decision which they think is best for their family. And what's going to be very important is for us to make sure that there's ample information for people to make a wise decision."

Government officials have estimated that about 500,000 military personnel and 500,000 civilians — mostly health care and emergency workers who would be most likely to be exposed to someone who had contracted smallpox — would be covered by the plan's initial phases.

Eventually as many as 10 million people involved in law enforcement, health care and emergency response could be offered the vaccine, administration officials said.

Administration officials said they expected the Pentagon to order the military to vaccinate within weeks. They said that the vaccinations of health care and emergency workers would be carried out under plans submitted by each state to the Centers for Disease Control and Prevention and that they were likely to start around the first of the year.

The officials said it would be 2004 before there would be enough of a newly manufactured vaccine to offer it to the public.

A critical decision remaining to be made is whether the vaccine could be offered to the public sooner, before licensing, on an experimental basis. Polls show a majority of the public is willing to be vaccinated.

"The question is what do you do about John Q. Public between now and when licensed vaccine is widely available?" a person familiar with the deliberations said tonight. "That's what the president hasn't decided."

The vaccine could simply be kept from the public until it is licensed. Another option would be to let people apply for the vaccine under the "investigational new drug" rules of the Food and Drug Administration. Under those rules, people who make a compelling case that they need experimental medicines can be given permission to take them by the F.D.A. But the process is cumbersome.

Existing stockpiles of the vaccine, which are decades old and much of which is not currently licensed by the government, will be used for the first phases of vaccination. In case of an attack, there is enough old vaccine to inoculate all Americans, administration officials said.

Smallpox was declared eradicated in 1980, and there have been no routine vaccinations in the United States since 1972. In recent years, however, the United States has come to fear that smallpox could be a potent biological weapon, and officials have identified several nations, including Russia, Iraq and North Korea, as possibly having hidden stocks.

The administration began debating whether to offer vaccines again after the Sept. 11 terrorist attacks last year. But the vaccine is made from a live virus, and in some cases can cause fatal complications, especially among people with immune deficiencies.

In the interview with ABC, Laura Bush, the first lady, was asked whether she would want her twin 21-year-old daughters vaccinated.

"If the vaccine were available, which I think it will be, I would feel like that was certainly safe for them to do," Mrs. Bush said. "All of us were. I know there's a slight risk. That's what people will weigh when they make the decision whether or not to have their children vaccinated."

Throughout the debate over whether to vaccinate, decisions have been closely held by the White House. Top federal health officials said in October that they favored a plan like the one the president will announce on Friday and for months they have said his decision was imminent. But Mr. Bush's remarks to Ms. Walters appeared to catch top government health officials by surprise.

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Tonight, Dr. Julie L. Gerberding, the director of the disease control centers, said, "We have no confirmation of the policy decision yet."

The C.D.C. is the federal agency responsible for monitoring diseases like smallpox and overseeing the states' plans to vaccinate health care workers.

"At this time, C.D.C. is not anticipating that any immunizations of health care workers will be given until January," Dr. Gerberding said in a telephone interview.

Meanwhile, she said, the agency is evaluating the plans for immunizing health care workers that the states and large cities were supposed to file by Dec. 9.

"We have almost all the states' plans and we are very pleased with the preliminary evaluation of them," Dr. Gerberding said.

The plans call for vaccinating "from 400,000 to 500,000 health care workers," which is in keeping with earlier federal estimates, she said.

The vaccine that will be given first to military personnel and then to the health care workers is the same one that has been stored since 1972. It is also the same one used to eradicate smallpox in a worldwide campaign that ended in 1980.

Since then, the vaccine has been given only to a few thousand qualified scientists who work with the smallpox virus and the vaccine, which is made from a closely related live virus, under top security precautions in approved laboratories.

After eradication, the former Soviet Union and the United States were allowed to keep stores of the smallpox virus for research, one in Russia and one at the disease control agency in Atlanta. Original plans called for destroying the stores of the virus, but they have been deferred, largely because of disclosures that the former Soviet Union secretly weaponized smallpox virus.

Another aim of eradicating smallpox was to end permanently the need for smallpox vaccinations.

Smallpox vaccine is the most dangerous human immunization. Before the United States stopped routine smallpox vaccinations, life-threatening complications occurred at a rate of 15 per million among those who received their first smallpox vaccination, and the number included about one to two deaths.

Those at risk for such complications include people whose immune system has been weakened by cancer, AIDS or other diseases. The risk also includes two common skin conditions, eczema and atopic dermatitis. These conditions could disqualify as many as 50 million Americans.

Smallpox vaccine contains a live virus that can be transmitted to other people, in effect involuntarily vaccinating them and putting some at risk of complications.

Immunizing 500,000 health care workers will present huge logistical challenges.

Most doctors now in practice have had no experience with making the 15 scratches used in administering the vaccine to the skin, and relatively few have treated, or seen, the complications that can occur.

Sore arms, fever and swollen lymph nodes are common after a vaccination. Doctors must take care in examining vaccine recipients to ensure that their reactions are the expected ones that require no treatment, not secondary infections that may require antibiotics.

Many health workers who are vaccinated may take sick time and stay out of work because of the reactions. So policy makers have urged hospitals to schedule their vaccinations in stages to avoid sudden widespread absenteeism in emergency rooms, particularly if an outbreak of influenza occurred.

Screening potential recipients for medical conditions that could disqualify them will be another logistical problem. For example, more than 300,000 Americans are believed to be infected with H.I.V., the virus that causes AIDS, but do not know it. H.I.V. tests are voluntary and findings are confidential.

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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.