http://www.nytimes.com/2002/05/10/health/10VACC.html

Smallpox Vaccine Knowledge Found Lacking

By LAWRENCE K. ALTMAN

TLANTA, May 9 — Doctors and the public poorly understand the dangers of the smallpox vaccine and need to be better informed if vaccinations are to be reintroduced after an absence of 30 years, federal health officials and infectious disease experts said here today.

Focus groups conducted for a panel of scientists advising the government uncovered a catalog of misinformation about the smallpox vaccine — the first vaccine to be developed (in 1796) and considered to be the most dangerous. Unlike most other immunizations, smallpox vaccine can harm recipients and their contacts. Resumption of vaccination on a large scale would probably lead to thousands of serious complications and hundreds of deaths, as it did when millions of Americans were routinely vaccinated.

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Today, the focus groups found, some doctors mistakenly believe that the disease still occurs naturally. Many doctors, particularly those under 40, know little about the vaccine's complications or how to use two-pronged needles to administer it. The doctors also expressed concerns about liability if they were to give the vaccine.

Many nonphysicians said they assumed that the vaccine was safe, provided lifelong protection and was still given to children. (Before 1972, many Americans were periodically revaccinated.) Many participants said they believed that exposure to the smallpox virus was always fatal; in fact, the death rate is about 30 percent.

Dr. Glen Nowak, from the Centers for Disease Control and Prevention, reported the findings to the panel, known as the Advisory Committee of Immunization Practices and the National Vaccine Advisory Committee. The government asked it to determine by June 20 whether to continue the policy of prohibiting vaccinations unless the disease returns in a bioterrorism attack or to allow smallpox vaccine to be offered to everyone who wants it.

"The current knowledge levels of physicians and the public likely limit understanding" of strategies intended for determining smallpox vaccine use before or after a bioterrorist attack, Dr. Nowak said.

The disease control centers and the committee plan to hold forums around the country over the next few weeks to discuss the risks and benefits of reintroducing smallpox vaccination.

Current guidelines, published in June 2001, do not recommend smallpox vaccine for the public. Vaccination is limited chiefly to laboratory workers directly involved with smallpox virus or its close virological cousins. The limits were based largely on the lack of enough vaccine. At the time, the government had only 15 million doses.

But in the wake of the anthrax attacks last fall, the government has expanded its stockpile of smallpox vaccine. Tests have shown that the 15 million doses can be diluted to 75 million. The drug company Aventis Pasteur has donated about 80 million doses that have been frozen since 1958 and that the government says would be used only in an emergency. The government is also buying 220 million doses made by a new laboratory technique. Delivery is expected by year's end.

Dr. D. A. Henderson, who led the worldwide smallpox eradication program in the 1970's and is now an adviser to Tommy G. Thompson, secretary of health and human services, told the panel that there was no information to suggest that a smallpox attack was likely.

Yet, Dr. Henderson said, "there is a tremendous demand for smallpox vaccine from every quarter," including parents and health-care and other workers who would be the first to respond in an attack.

If an outbreak occurs, the disease control agency says it will respond with the technique known as ring vaccination, which was used to eradicate the disease.

In the event of an attack, the agency's current policy — based on the advisory committee's recommendations last June — is to give priority for vaccination to individuals who had face-to-face contact with smallpox patients in a household, workplace or during transportation to a hospital; contacts of cases; or exposure to a deliberate release of the virus.

Dr. Henderson and other speakers at the meeting cited myriad problems if smallpox vaccine were to be offered to all Americans who want it.

A crucial problem is that the Food and Drug Administration has approved none of the smallpox vaccines for marketing and classifies all of them as investigational. The classification requires that each individual give consent before receiving the vaccine. Even the new generation of vaccine will require informed consent until at least late 2003, said Dr. Phil Russell, a health and human services official.

The standard smallpox vaccine can cause a variety of severe, even fatal, reactions. People with AIDS and other diseases that damage the immune system are one particularly vulnerable group.

Millions of individuals with skin disorders like eczema, atopic dermatitis and acne are at risk for potentially fatal complications. The panel was told that serious reactions can occur in someone who had eczema years ago, a problem complicated by the fact that many adults may not know they had it as a child.

A recipient of smallpox vaccine may infect another person through transfer of the virus by hand or bathing, and the infection can be far more severe in such contacts than in the vaccine recipient.

Other complications include impaired vision from infection of an eye, heart or bone; anemia; and encephalitis.

The blood supply could shrink if smallpox vaccinations became widely used because donors are rejected for one year after a vaccination.

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.