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http://www.nytimes.com/2002/12/15/health/15SMAL.html?tntemail0

Smallpox Shot Will Be Free for Those Who Want One

By LAWRENCE K. ALTMAN and DENISE GRADY

new smallpox vaccine will be provided free to Americans who want it if the vaccine, now being manufactured, passes licensing tests as expected in 2004, Tommy G. Thompson, the secretary of health and human services, said yesterday.

But in a news conference, Mr. Thompson repeated President Bush's strong recommendation made on Friday that the public not seek vaccination now with an older vaccine because there is no imminent danger of a bioterrorist attack.

On Friday, Mr. Bush announced his long-awaited decision to give smallpox vaccinations for the first time in 30 years to select groups of Americans.

In the first stage, about 500,000 frontline military personnel and 500,000 civilian health care workers will get the vaccine. The military began vaccinating on Friday afternoon. Vaccination of health care workers will begin in late January.

Immediately after the first stage is completed, up to 10 million health care workers, firefighters, police officers and emergency medical technicians will be offered the vaccine. Despite tremendous logistical challenges, officials hope to finish this second stage in summer.

These people will receive the same vaccine that was used to eradicate smallpox from the world in 1980 and has been stored since then.

When a vaccine made by newer techniques is licensed, probably in 2004, the government will offer it to Americans through clinics but not through private doctors.

Mr. Bush said that public health agencies would work to accommodate some Americans who insist on being vaccinated now.

As long as there are no smallpox cases, the vaccine is unlikely to be given to children, even if parents request it, because it has not been tested on them, said Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases. Researchers had hoped to conduct such studies in children, but ethics panels at medical centers refused to allow them, citing federal regulations banning human experiments in which risks outweigh benefits, he said.

How many Americans will choose to get the vaccine now, or in the future, is unknown, federal health officials said in a news conference.

Dr. Julie L. Gerberding, director of the Centers for Disease Control and Prevention, said that her federal agency had conducted focus groups that found "mismatches" between the public's desire to be protected and its understanding of the vaccine's risks. Smallpox vaccine is the most dangerous of all human immunizations, and the virus it is made from can be inadvertently transmitted to others.

More than 140,000 doctors have signed up to participate in educational programs to help them answer questions from patients, Dr. Gerberding said. The disease prevention agency is preparing to send about 150,000 educational CD-ROMs to doctors by the end of the year.

To illustrate the point about misunderstandings, Dr. Fauci said that when participants in focus groups were asked if they wanted to be vaccinated, about 60 percent said yes. But after health workers explained the dangers of the vaccine, the number dropped to 15 to 20 percent, Dr. Fauci said.

Federal officials participating in the news conference initially said that Americans might be able to get the new vaccine at their doctors' offices.

But Mr. Thompson interrupted and said emphatically that individual doctors would not be permitted to keep the vaccine in their offices.

"It will not be in your doctor's office," Mr. Thompson said. "We will not give it up out of our custody. It will not be willy-nilly handed out to doctors across America. We will retain custody of the vaccine."

Plans are still being worked out to provide vaccine for Americans who want it now. Dr. Fauci said that one way was for people to enroll in clinical trials being conducted to study smallpox vaccine.

But there are caveats — not everyone is accepted into clinical trials, the number of participants is limited and participants must meet certain medical requirements and agree to certain conditions.

For people who cannot get into a clinical trial, the government may create a program in which the vaccine can be given as an experimental drug, Dr. Fauci said.

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