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http://www.nytimes.com/2002/08/25/politics/25SMAL.html

Health Workers Await Official Smallpox Policy

By LAWRENCE K. ALTMAN

ore than two months after a national advisory panel recommended vaccinating thousands of health care and emergency workers against smallpox as a precaution against a bioterrorist attack, state and local health officials are waiting for the government to announce its official policy. No vaccinations have taken place.

The advisory panel's recommendations are routinely forwarded through the Centers for Disease Control and Prevention to the secretary of health and human services. A spokesman said on Friday that Tommy G. Thompson, the secretary, had made no decision.

The government has never rejected or significantly modified any recommendation from the panel, known as the Advisory Committee on Immunization Practices, C.D.C. officials said.

In responding to a federal government request, the advisory panel sped up the end of its deliberations to June from October. Now "it's a hurry up and wait" situation, said the panel's chairman, Dr. John F. Modlin of Dartmouth Medical School.

Responsibility for carrying out any plan and approving who gets the vaccine will fall on state and local health departments. But no state can begin until the federal government, which owns all stocks of the vaccine, releases it.

On June 20, the panel unanimously rejected a proposal to offer vaccine to every American and recommended immunizing only about 15,000 "first responders" — the health care and law enforcement workers who would be most likely to respond to a biological attack.

But in early July, some federal officials said that they would soon vaccinate 500,000 first responders.

Jerome M. Hauer, acting assistant secretary for emergency preparedness at the Department of Health and Human Services, said at that time that the agency hoped to send planning documents on how best to conduct mass vaccinations to cities and states within two weeks.

Officials now say that announcement was premature.

"Jerry was jumping the gun" and the material has not been sent, said William Pierce, a spokesman for the department. The decision has been slowed in part by the vacation period and is expected within weeks, Mr. Pierce said.

Bush administration officials have debated whether to offer smallpox vaccinations to all Americans, as some people have advocated, or to limit them as the committee recommended.

President Bush faces a health issue that is believed to be a first — weighing the risks of administering a dangerous vaccine to protect against a disease that exists only as an unquantifiable threat.

Last month, Mr. Bush said that in considering his options he was concerned about calling for a national vaccination program that could cause death.

Smallpox vaccine can lead to serious and potentially fatal complications, especially in people with impaired immune systems. The virus from which the vaccine is derived, a cousin of the smallpox virus, can spread from recipients to people with whom they come in contact and can cause life-threatening complications among them.

Because the United States stopped routine smallpox vaccinations in 1972, tens of millions of younger Americans have never been vaccinated against a disease that can kill up to 30 percent of its victims. It is unclear how well protected those people who received vaccinations decades ago are.

The World Health Organization declared smallpox eradicated in 1980 and has allowed the United States and Russia each to freeze a stock of smallpox virus. But because the former Soviet Union is believed to have weaponized smallpox virus, the fear is that terrorists or a few countries like Iraq have obtained the virus.

In light of the new threat, Bush administration officials have recently taken a fresh look at data concerning the complications from vaccinations when they were routine in this country. The focus was on the risk of a vaccine recipient inadvertently transmitting the virus to other people, and the data were both reassuring and disconcerting.

The review showed that adults who were vaccinated rarely transmitted the vaccine virus to other people. But experts say they do not know how valid the findings are today when many more people are vulnerable to such infection because they have impaired immune systems from treatment for cancer, H.I.V. infection and other conditions.

More disturbing were the data concerning risks among people with a common skin condition, eczema. People with it, or who have had it, are at higher risk of complications from the smallpox vaccine. The rate was one case of complications per 100,000 vaccinations, a figure that exceeds the risk of paralysis from the oral polio vaccine. The government stopped oral polio vaccinations because it considered the risk too high.

Now state officials want "what amounts to political clearance" before vaccinating health care workers, said Dr. J. Michael Lane, a retired C.D.C. smallpox epidemiologist who now consults with the agency's bioterrorism defense program. "Everyone says we don't want to be the first, but we don't want to be the last" to begin, Dr. Lane said.

Dr. Marcelle Layton, the assistant commissioner of the New York City Department of Health for communicable diseases, said that "it's hard to plan at the detail level until the federal decision is made" and that "it's not going to be a simple thing to do regardless of what the numbers are."

Dr. Layton said her department had begun to work with its advisory panels and with the Police and Fire Departments and emergency medical services to identify the groups of workers to vaccinate. The list includes a core group of Health Department staff members who would investigate the first calls about a case of suspected smallpox and who would trace their contacts.

The list is also expected to include some medical specialists who would be the most likely to see a case — emergency room staff members, ambulance workers, dermatologists, infectious disease doctors, nurses, laboratory workers and support staff members.

No consensus has been reached, largely because until health departments learn how much vaccine they will receive, they cannot make more detailed plans, Dr. Layton said.

"Unless it's an emergency where we may need to vaccinate everyone within a couple days, we need to go slow in the initial rollout, work out the kinks and get some experience in giving the vaccine," Dr. Layton said. The problems include who will have legal liability for adverse reactions and risks in administering the vaccine, which is considered the most dangerous of all immunizations. Training doctors and health workers how to administer the vaccine properly and recognize a successful smallpox vaccination reaction, known as a "take," could also be a challenge. Last fall, when the C.D.C. vaccinated nearly 200 staff members as part of its smallpox response team, it canceled plans to vaccinate more in part because the doctors who performed the vaccinations became alarmed at the severity of the reactions and the accompanying fever, sore arms and swollen lymph nodes. The doctors prescribed antibiotics in the mistaken belief that some vaccination takes had become infected.

The Food and Drug Administration classifies smallpox vaccines as investigational in part because the standards used to make the vaccines are no longer current. Government policy requires each person to give written consent before receiving the vaccine.

To protect Americans against unethical and hazardous research, the government also requires institutional review boards to approve the information on the forms that each person must sign before receiving an investigational drug. Health officials say they will have to translate the consent forms into plain English, Spanish and other languages. Health officials are also trying to determine whether separate boards will be needed at each vaccination site.

Another challenge is to set up vaccination clinics to handle a very large patient flow and to use vaccine efficiently, Dr. Layton said.

The vaccine is stored in 100 dose vials, which can be diluted to 500 doses. Because the diluted vaccine remains effective for only a few days, the 500 vaccinations would have to be scheduled relatively close together to avoid waste.

In screening for people at risk for complications, health workers are expected to ask about personal information that many people may not be willing to disclose, such as whether they have been tested for the AIDS virus. Another issue is whether to require an H.I.V. test before vaccination.

Health officials are uncertain about the safety of allowing hospital workers to return to work, where they might inadvertently pass the vaccine virus to patients with weakened immune systems, even if a vaccination take is covered with a bandage.

Officials are also considering allowing work furloughs for up to two weeks for vaccine recipients who suffer reactions and to help prevent wider transmission of the vaccine virus.

Among the questions that health officials are raising are what effect such furloughs would have on the health care system, who would pay for the lost time, who would oversee management of patients who have adverse reactions and who would field calls from family members of vaccine recipients.

Dr. Modlin said he expected the C.D.C. to ask his panel for more advice on such issues.

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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.