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http://www.nytimes.com/2002/12/16/health/16SMAL.html

Smallpox Vaccine Transmission Raises Liability Issue

By LAWRENCE K. ALTMAN

f a smallpox vaccine recipient inadvertently transmitted the virus in the vaccine to other people and they fell ill, who would pay for the sick people's medical care?

The question arose over the weekend after President Bush announced a plan to vaccinate about 10 million health care and emergency workers with smallpox vaccine, which contains a live virus that is closely related to the one that causes smallpox. Smallpox vaccination differs from other immunizations because recipients can accidentally transmit vaccinia, the virus in the vaccine, to others, in effect involuntarily vaccinating them and putting some at risk of life-threatening complications.

General recommendations are that people who have recently been vaccinated stay out of close contact with others or cover the vaccine site with a bandage, because the virus can be shed from the site for several weeks after inoculation. Some hospital officials say that newly vaccinated workers who take care of patients will be required to wear special semipermeable bandages at work, because they are better than gauze at containing the virus.

Smallpox vaccine is the most dangerous of all human immunizations, and the risks of adverse reactions are higher for 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 affect as many as 50 million Americans.

Complications include rashes that can destroy the skin, blindness, brain inflammation and even death. Before the United States stopped smallpox vaccinations in 1972, life-threatening complications occurred at the rate of 14 to 52 per million. The rate of other serious complications was 49 to 900 per million.

Tom Ridge, the president's domestic security adviser, said on Friday that the vaccine was essential only for those on the front lines of emergency response and patient care. "Consistent with the national strategy, I will not be vaccinated," Mr. Ridge said. He recommended that the general public — and that included Congress and the cabinet — not be vaccinated either.

President Bush's decision on Friday to offer smallpox vaccinations to up to 10 million health care workers, firefighters, police officers and other emergency workers suddenly makes relevant the question of who pays the medical costs of illness from accidental infection.

Tommy G. Thompson, the secretary of health and human services, and other federal experts on smallpox were asked on Saturday who would pay. They said they expected standard health insurance to pay for such medical care.

But they left unanswered the question of who would pay if the accidentally infected individual was among the estimated 41 million Americans who had no health insurance.

In recent weeks, many states voiced concern that workers' compensation would not cover the costs of illness to health care workers who became ill after vaccination.

But after checking, "we have not yet identified a single state which has refused to cover this program under the workmen's compensation program," said Dr. Michael T. Osterholm, a former Minnesota state epidemiologist who now is an adviser to Mr. Thompson.

Successful vaccination produces a sore that recipients will be told to cover with a gauze bandage and tape for two to three weeks.

If secretions from a smallpox vaccination soak into clothing or blankets, the vaccinia virus may survive in the fabric for a day or two and could theoretically infect someone else who comes into contact with the item, said Dr. Donald A. Henderson, the epidemiologist who led the global smallpox eradication program and who now is a senior science adviser to Mr. Thompson.

To prevent transmission of the vaccine virus, the Centers for Disease Control and Prevention recommends that clothing soiled by secretions be washed in hot water and detergent and, if possible, bleach.

Mr. Bush's plan calls for vaccinating 500,000 health care workers by spring, followed quickly by offering vaccinations to the 10 million more workers. Only about half are expected to be vaccinated, the officials said.

Many health care experts have warned the government to proceed cautiously with the larger group.

Colorado is the only state not to meet the Dec. 9 deadline that the agency set for filing full plans for smallpox vaccinations, Mr. Thompson said.

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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.