Smallpox Vaccine Data Show Small but Serious Risk of Infecting
Others
By DENISE
GRADY and LAWRENCE K. ALTMAN
new report on millions of smallpox vaccinations given in the 1960's
confirms that there is a small but significant risk that newly
vaccinated people can make others seriously ill by infecting them
with vaccinia, the virus used in the vaccine.
Scientists said the findings were reassuring, since the risk was
so small — a few cases for every 100,000 vaccinations — but
cautioned that the risk today might be higher than in the past,
because more people have disorders of the skin or immune system that
predispose them to adverse effects from the vaccine or close contact
with those who have been vaccinated.
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Smallpox vaccine has long been regarded as the most dangerous of
all vaccines, both to recipients and their close contacts. For every
million recipients, 15 will have life-threatening reactions,
including 1 or 2 deaths, and hundreds will have severe rashes or
other illnesses.
The risk to those who are unvaccinated but are in contact with
those who are occurs because vaccinia, a relative of smallpox, is
shed from the vaccination site for about three weeks and can make
some people very sick. But the degree of risk to unvaccinated people
has not been clear.
An author of the report, Dr. John M. Neff, a professor of
pediatrics at the University of Washington, said the risk from
vaccination or contact was "small, and it is significant."
"It is significant," he said, "because some of these adverse
effects can lead to death. And it is significant because if you have
a death or just one really serious adverse effect and the
vaccination efforts were ill advised, you bear a heavy burden of
responsibility, and it becomes very tragic."
The new analysis of the 60's data was prepared by Dr. Neff and
three other experts in infectious disease and smallpox vaccination.
Its purpose was to help clarify the issues as the United States,
fearing a bioterror attack, prepares to vaccinate hundreds of
thousands of soldiers and health care workers, and considers whether
to offer the vaccine to the public. Routine smallpox vaccination
ended in this country in 1972, as the disease was being wiped out.
Now, as public health experts consider resuming vaccination, a major
concern is the possibility that newly vaccinated people might
inadvertently infect others, particularly people with a high risk of
being harmed by vaccinia.
The analysis, being published today in The Journal of the
American Medical Association, is based on rates of adverse reactions
in 11.8 million Americans vaccinated for the first time in 1963 and
1968.
For every 100,000 people vaccinated for the first time, the study
found, vaccinia spread by close contact to two to six others who had
not been vaccinated. Most unvaccinated people who caught the virus
developed "accidental infections," sores that healed on their own
and most likely acted like secondhand vaccinations and gave them
immunity.
But one or two became very ill with a condition called eczema
vaccinatum, which can cause fever and a severe extensive rash and
scarring. The condition, which affects some people who have the skin
disorder eczema or even a history of it, is occasionally fatal. The
worst cases tended to occur in people with active eczema when they
were exposed to vaccinia.
Newly issued government guidelines said people should not be
vaccinated for smallpox if they had eczema or a related disorder,
atopic dermatitis, or lived with someone who did. Other skin
conditions that rule out vaccination include impetigo, or pustules;
unhealed burns; contact dermatitis; and chickenpox. But people with
such risk factors may have to be vaccinated if there is an attack
and they are exposed to the disease, which can kill 30 percent of
its victims.
Eczema vaccinatum can be treated with vaccinia immune globulin,
but it is in very short supply.
The researchers found that those being vaccinated for the first
time were most likely to transmit the virus.
Many of the infections in contacts, 68.5 percent, occurred in
children younger than 5 who caught the infection from a recently
vaccinated sibling or close relative. But one baby was infected by a
nurse, and two children by contacts at day care. Several adults were
infected by vaccinated children, and one woman developed eczema
vaccinatum after sleeping with a recently vaccinated soldier. A
wrestler infected his opponent.
Another author, Dr. Donald A. Henderson, a government adviser on
bioterrorism, said: "I think transmission is possible, but based on
the records of 1963 and 1968, it's almost entirely kid to kid,
mostly within a household. Adult to kid or adult to adult was rare.
This is a very close contact phenomenon."
Dr. Henderson called the low transmission rates reassuring. But,
he added, "It's a different population today, and so we're still
looking at uncertainties."
What makes the population different today is that eczema is two
to three times as common as in the past; the reason is not known.
Also, more people have lowered immunity, from H.I.V., other immune
system diseases or drugs used to treat cancer or prevent transplant
rejection. People with immune disorders are at risk, either through
being vaccinated or through contact, for a potentially fatal
condition called progressive vaccinia, in which the sore at the
vaccination site keeps growing and spreading, and systemic illness
develops.
Dr. Neff noted that the risks of vaccination were real, whereas
the threat of a smallpox attack was theoretical — no one knows
whether Iraq, another country or a terrorist group has the smallpox
virus. He said his greatest concern was the threat of progressive
vaccinia in immunocompromised people, either those vaccinated when
they should not be or contacts of vaccinated people. The Centers for
Disease Control and Prevention estimates that 300,000 Americans have
H.I.V. and do not know it. In addition, more than 23,000 health care
workers have AIDS.
There is no cure for progressive vaccinia, Dr. Neff said.
Dr. Neff and other researchers said they knew of only one case in
which a person with H.I.V. was given a smallpox vaccination. The
patient was a 19-year-old soldier who did not know he had H.I.V.
when the military vaccinated him in 1984. He developed progressive
vaccinia and AIDS, and died.
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.
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.