BIOTERRORISM
Close Monitoring Is Planned for Smallpox Vaccinations
By
LAWRENCE K. ALTMAN
TLANTA,
Oct. 17 — Federal health officials said today that a network of
experts would be made available for consultation at any hour in case
of bad reactions to smallpox vaccine, which may be given soon to a
half-million hospital workers.
The network would be part of the most comprehensive system ever
to monitor the safety of a vaccine, officials of the federal Centers
for Disease Control and Prevention here said.
It would also be the first formal program in which doctors
treating a patient with a vaccination complication could immediately
consult with designated experts at selected medical centers around
the country. Such consultations have been done informally, with the
disease centers relying on reports from doctors that were not
collected in a standard way.
"We are responding to criticism that we have not had
comprehensive, standard clinical evaluations" of adverse reactions
to vaccines, Dr. Walter Orenstein, an official at the disease
centers, said.
The monitoring system will help determine the frequency of
complications caused by the smallpox vaccine, the riskiest of all
vaccines.
The network will also be used to determine who will get the
scarce and dangerous drugs needed to treat complications of the
smallpox vaccine, and when, said Dr. Gina Mootrey, another official
at the centers, in announcing the monitoring plan to a panel
advising the government on smallpox vaccinations.
On Wednesday, the advisory panel recommended offering the
immunization to an estimated half-million emergency room and other
hospital workers because of the possibility of a bioterrorist
attack.
Today, the panel recommended that anyone with either of two
common skin conditions — eczema and atopic dermatitis — not receive
a smallpox vaccination. The exclusion also applies to anyone who has
had either condition in the past, even a mild case.
Such individuals are at increased risk of developing a severe and
potentially fatal illness known as eczema vaccinatum.
The panel also recommended not giving smallpox vaccine to anyone
who has a family or household member with either skin condition
because the virus in the vaccine could be transmitted to them.
The panel's chairman, Dr. John F. Modlin of Dartmouth Medical
School, said the criteria might exclude an estimated 7 percent to 17
percent of Americans from receiving the vaccine.
Individuals infected by the AIDS virus and women who are
pregnant, or who are trying to become pregnant, should also not be
given the vaccine, the panel said.
Modern knowledge about the safety of the vaccine is limited
because the government stopped standard use of smallpox vaccine in
1972 as the disease was being eradicated from the world.
Earlier this year, researchers reported that 36.4 percent of
volunteers in a study missed school, work or recreation or had
difficulty sleeping after receiving a dose of the smallpox vaccine
that was used before smallpox was declared eradicated in 1980.
Individuals with severe reactions might be treated with either of
two drugs. One is vaccinia immune globulin, a drug that is derived
from the blood of individuals who have been immunized against
smallpox and that is now in short supply. The government owns the
only stores.
The other is cidofovir, a drug that experts hope might be
effective against vaccinia, the virus in the vaccine that protects
against smallpox. Cidofovir must be injected, is dangerous and its
only approved use is for a different virus.
Another reason for instituting the monitoring system is to
maintain credibility and public confidence, Dr. Mootrey said. Last
year during the anthrax attacks, the centers were widely criticized
for failing to communicate pertinent information about anthrax in a
timely manner to health officials, doctors and the public.
The monitoring system will require extensive cooperation from
state and local health departments and hospitals to resolve a number
of issues, including liability for the health professionals
involved. The centers plan to start discussions with state and
territorial health officials on Friday.
Most experts at the meeting were cautiously optimistic about the
plan.
Dr. Guthrie S. Birkhead , an official of the New York State
Health Department, called the plan comprehensive but underscored the
need for health officials and hospitals to immediately talk through
the issues.
Dr. Kent Sepkowitz, an infectious disease expert at Memorial
Sloan-Kettering Cancer Center in Manhattan, complimented the center
for developing "a good system," but added that "it will take months
for it to go right and that is a reason to go slowly at first."
Under the monitoring system, each hospital worker will be given a
personal identification number at the time of vaccination.
The recipients will also receive a telephone hotline number to
report any possible adverse effect like fever, a spreading rash or
altered mental status caused by encephalitis.
An estimated 35 percent, or 175,000, of the recipients are
expected to call the hotline, where the staff will provide advice
and refer those needing immediate care to their doctors.
Of these, about 17,500 are expected to need care from a
designated local specialist in dermatology, allergy, neurology and
infectious diseases. In turn, about 30 percent of this group will
need referrals for more extensive consultation with experts at
designated hospitals around the country.
The experts are at Columbia-New York Presbyterian Hospital in
Manhattan; Boston University; Johns Hopkins; the University of
Maryland; the Northern California Kaiser Permanente hospital;
Stanford University and Vanderbilt University.
About 100 recipients are expected to need treatment with vaccinia
immune globulin, cidofovir or both.
The disease centers plan to conduct a telephone survey involving
15,000 to 20,000 vaccine recipients on the tenth and twenty-first
days after vaccination.
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