BIOTERRORISM
Doctors Urge Caution on Smallpox Vaccinations
By DENISE
GRADY
eading
medical groups are urging caution in the use of smallpox vaccine,
particularly if no cases of the disease occur.
Their concerns stem from the risks of the vaccine, which is
significantly more likely than any other vaccine to cause serious
side effects.
On Friday, government health officials said for the first time
that they favored offering smallpox vaccine to the public even if
there was no bioterror attack, though only after some 10 million
health workers were immunized and a vaccine was licensed for general
use, possibly in 2004.
The medical groups have not criticized the government, though
they have generally taken more conservative positions on
vaccination, while emphasizing that their views would change if a
bioterror attack occurred or seemed likely.
The American Medical Association issued a statement yesterday
saying that it endorsed government recommendations issued in June.
Those guidelines called for immunizing health workers and, if an
outbreak occurred, using a strategy called "ring vaccination," which
seeks to control an outbreak by isolating infected people and
vaccinating a ring of contacts around each infected person.
Another group, the American Academy of Family Physicians, has
expressed a similar view.
The American Medical Association said in its statement, "The need
for further voluntary vaccination beyond front-line health care
workers is a very complex issue," and noted that the potential
health risks of a smallpox attack had to be weighed against the
risks of mass vaccination. The association also expressed concern
about who would bear "the responsibility for injuries and deaths"
caused by mass vaccination.
The American Academy of Pediatrics said it, too, favored ring
vaccination in the event of an attack. Dr. Robert Baltimore, a
professor of pediatrics and epidemiology at Yale, and the leading
author of a policy statement by the pediatricians' group, said it
was concerned that the public was uninformed about the dangers of
the vaccine. The statement, in the current issue of the journal
Pediatrics, is also posted on the academy's Web site, aap.org.
A co-author of the statement, Dr. Julia A. McMillan, a professor
of pediatrics at Johns Hopkins, said: "If enough people are
vaccinated with this vaccine, people will die. And it's important to
keep in mind that this is a disease we haven't seen since the
1970's. To have people die preventing a disease that doesn't exist
is a difficult concept. The problem is, we don't know that it
doesn't exist. There is some potential that it could exist, and so
we're in a difficult quandary."
The group's statement, based in part on studies from the 1960's,
when smallpox vaccination was routine, reports that for every
million people more than a year old who were vaccinated, 1 or 2
died, 9 suffered from a brain infection and more than 100 developed
eczema vaccinatum, a severe illness and skin rash that can leave
deep scars and can occasionally turn life-threatening. Hundreds of
others developed other rashes, skin problems and infections.
Today, the rates of complications are expected to be higher
because many more people are vulnerable to adverse reactions to the
vaccine. Those people include those on chemotherapy or steroid drugs
and those with H.I.V. infection or other diseases that weaken the
immune system, autoimmune diseases, skin diseases like eczema or
organ transplants. Eczema is more common today than in the past,
though researchers do not know why. Pregnant women and babies less
than a year old are also at risk.
Vulnerable people are at risk not just from being vaccinated
themselves, but also from being in close contact with someone who
has recently been vaccinated. The risk from contact occurs because
the vaccine contains a live virus, which is shed for several weeks
from the vaccination site and can infect others.
Another concern of the pediatricians' group is that the vaccine
now available has not been tested in children.
The government's current stockpile consists of old vaccine that
will be used in a diluted form. The diluted doses have been tested
in adults, but not in children. The pediatricians' group says the
vaccine should be tested in children to make sure it is safe and
effective for them.
"This is somewhat controversial," Dr. Baltimore said, because
children cannot give informed consent and their parents must be the
ones to volunteer them for testing.
Dr. James R. Baker, a spokesman for the American Academy of
Allergy, Asthma and Immunology, also urged restraint in considering
widespread vaccination, noting that the group had concerns about the
risks to people with the skin conditions called atopic dermatitis
and eczema, which affect up to 15 percent of Americans.
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