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http://www.nytimes.com/2003/01/18/health/18SMAL.html?tntemail1

Officials Press Ahead With Smallpox Shots

By DENISE GRADY

he government's smallpox vaccination program will proceed as planned, federal health officials said yesterday, despite concerns raised by an expert advisory group and calls for delay by unions representing health care workers.

"We intend to make this program happen on time," Dr. Julie Gerberding, director of the Centers for Disease Control and Prevention, said.

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"We live in a dangerous world these days where a terrorist attack with smallpox is possible," Dr. Gerberding said. "We must be prepared."

Dr. Gerberding made her remarks during a telephone news conference in which she and other health officials responded to a report issued yesterday by the Institute of Medicine. The report suggested that the vaccination program was rushed and lacking important safeguards.

The report, first described on Thursday in The New York Times, which had obtained a confidential draft, was written by a panel of 15 independent experts, mostly medical school professors. The group was formed by the institute at the request of the disease centers, which sought advice on putting the vaccination program into effect.

The program, announced by President Bush on Dec. 13, calls for up to 500,000 health care workers to be vaccinated in the coming weeks. Those inoculations can begin on Jan. 24, when a provision of the Homeland Security Act will take effect, protecting the government, vaccine makers and those who administer the vaccine from liability, except in the case of negligence. A second phase of inoculations is to include 10 million more people: health care workers, firefighters, police and emergency personnel.

Dr. Gerberding said that 11 states were ready to begin vaccinating health workers and had requested vaccine, which she said the disease centers would begin shipping on Tuesday.

"This is a good sign," she said. "Clearly, the states are going ahead. We will do what we need to do, to get the show on the road here."

She declined to specify which states had asked for vaccine, saying it was up to them to announce their own plans.

But on Thursday and Friday, several large unions criticized the program and wrote to President Bush, asking that it be delayed. The groups include the Service Employees International Union, which has 750,000 health care workers among its members, and the American Nurses Association, which has 153,000 members. One of the unions' concerns is that the federal government will not compensate workers for medical expenses or lost wages if they are harmed by the vaccine, instead leaving the issue of compensation to employers, private insurers and state worker's compensation plans.

The Institute of Medicine also urged the disease centers to help clarify questions about compensation, and to ensure that consent forms in each state spelled out whether compensation would be available. The report said that fears about medical bills and lost wages might discourage some people from being vaccinated.

Dr. Gerberding said the C.D.C. was "working with all parties" to sort out the issue. But, she added, "We are certainly not going to delay this program because of concerns about compensation."

Medical experts' reservations about the program are based on risks from the vaccine, which has more serious side effects than other vaccines, and caused one or two deaths per million vaccinations when it was in routine use. Pregnant women, infants and people with skin disorders or weakened immune systems are especially vulnerable to adverse reactions. The Institute of Medicine report estimated that about 30 percent of the population should not receive the vaccine.

Recently vaccinated people may also pose a threat of infection to others, because for several weeks they shed the live virus used in the vaccine, vaccinia, a relative of smallpox.

The institute's report made 23 recommendations, calling for certain changes in the program. It called for better education of vaccine recipients, the general public and health workers, and said the present plans did not allow enough time to provide adequate instruction.

The panel said that special educational materials should be developed for household contacts of people being vaccinated, keeping in mind that some household members might be hiding risk factors from their families, and would want information about how to protect themselves from being infected by a vaccinated person.

Dr. Gerberding said the disease centers had embarked on extensive education programs that she thought would fulfill those needs.

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The report also urged the disease centers to set out specific criteria, like a certain number of adverse effects, that would prompt changes in the guidelines for who should and should not be vaccinated, how potential recipients should be screened, and whether newly vaccinated health workers should take time off to avoid exposing patients to vaccinia. Current guidelines say that health workers do not have to stay home and can protect patients by covering their vaccinations with special bandages and by washing their hands frequently.

The expert panel also recommended that there be a pause between the first and second phases of the vaccination program, so that lessons from the first phase could be applied to the second one. The group also said that the disease centers needed to gather information about adverse effects, rather than being passive and waiting for doctors to report them.

Dr. Gerberding and other officials at the disease centers said that they would be gathering and processing information about the program continuously and did not need to pause between phases. They said that since the disease centers control the supply of medicines needed to treat serious adverse reactions, they would hear about those problems.

In a telephone briefing on the institute's report, Dr. Brian Strom, who led the panel, and Dr. Alta Charo, a panel member, said they were concerned that health workers might feel pressured to accept the vaccine. They said the disease centers and the states needed to tell potential vaccine recipients that vaccination would be voluntary.

Moreover, they said, recipients should be reminded that the inoculations are part of a biodefense program, not a public health program, and, unlike other vaccinations, offered risk but no benefit to recipients in the absence of an attack, since smallpox has been eradicated.

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