Vaccination eligibility questioned
Health risks could keep 20% from smallpox shots
M.A.J. McKenna -
Staff
Friday, October 18, 2002
At least 20 percent of Americans and possibly many
more will not be able to receive smallpox vaccinations because their
underlying medical problems make the vaccine unsafe, health officials said
Thursday.
The assessment is one of several pieces of evidence suggesting that the
federal plan to vaccinate about 500,000 hospital staff may not go smoothly
or quickly. The prediction came as a volunteer panel that shapes federal
vaccination policy wrapped up a two-day meeting in Atlanta.
The plan to vaccinate approximately 100 staff members each in 5,000
hospitals is intended to create a group that would care for the first
victims of a bioterrorist smallpox attack. But those attending the meeting
of the Advisory Committee on Immunization Practices, including academic
medical experts and representatives of state health departments, said a
number of barriers stand in the way.
The hurdles include the large number of medical conditions that could
trigger severe side effects; liability protection for vaccine manufacturers;
uncertainty over compensation payments for victims of side effects; and the
ability to build a national patient-tracking and record-keeping system that
must be completed before the first vaccinations begin.
In addition, health officials have begun to worry that publicity about
side effects, which range from rashes and scarring to encephalitis and death
in rare cases, may deter health care workers from volunteering to take the
vaccine.
"If we really educate people about the risks, we may find people saying
that they would rather wait and see," said Dr. Guthrie Birkhead of the New
York State Department of Health.
No decision has been made regarding how many Americans, if any, will be
vaccinated against a possible future attack. A ruling by the White House is
expected within weeks.
The major federal health agencies --- the Centers for Disease Control and
Prevention, National Institutes of Health and Department of Health and Human
Services --- have outlined options for the White House that range from
500,000 hospital staff to 10 million health care workers and first
responders to the entire population. On Wednesday, the advisory committee
endorsed the 500,000-person recommendation.
That group should include not only doctors and nurses in emergency rooms
and intensive care units, but radiology technicians, respiratory therapists,
surgeons, specialists in eye and skin disorders, lab and housekeeping staff
and security guards, the committee said.
The committee also added a list of conditions that could disqualify
people from receiving the vaccine. No one should be vaccinated, the group
said, if she is pregnant or intends to get pregnant shortly; has an impaired
immune system from leukemia, long-term drug therapy, or transplants; or is
infected with HIV, the virus that causes AIDS, or lives with someone
infected.
Vaccinations also should not be given to anyone who has ever been
diagnosed with eczema or atopic dermatitis, two broad categories of scaly
rash disorders, or lives with anyone who has; or if the potential recipient
or anyone in his or her household is having an outbreak of psoriasis,
shingles or severe acne, or other breaks or wounds in the skin.
Skin disorders alone are expected to rule out 20 percent of potential
recipients. That prediction is based on estimates from dermatologists,
combined with data from a recent vaccine trial at St. Louis University in
which one of every five volunteers was disqualified, said committee chairman
Dr. John Modlin.
Privately, some meeting attendees put the number of potential recipients
who would be ineligible under the panel's rules at 35 percent or higher.
That would change, they added, if an attack began --- because the risk of
actually contracting smallpox, a disease that kills one-third of victims and
disables another third, would outweigh the risk of side effects.
Once the White House approves a plan, state health departments will have
60 days to meet with hospitals, recruit volunteers and design their
vaccination campaigns. Each state will be allowed to send five staff members
to the CDC for a week of training.
But the vaccinations cannot begin until a nationwide tracking network ---
comprising doctors and other health workers and hotlines and computerized
records --- is assembled. In addition to hardware, the network will need to
recruit roughly three staff members at every hospital with a vaccinated
team, plus more than 100 at federal agencies and regional medical centers,
said Dr. Gina Mootrey of the CDC.
States also have not been told how to handle financial liability for
vaccination side effects. That burden is usually handled by the federal
government; so far this year, the National Vaccine Injury Compensation
Program has paid almost $62 million in claims, none of them for smallpox
vaccination.
Given the many concerns, panel members urged that any vaccination
campaign be rolled out slowly, either state by state or in small steps
within states. Some were clearly troubled by the sense of launching an
unstoppable process: Once vaccinations begin, authorities will have to track
hospital staff changes, vaccinate new hires and possibly give boosters every
few years.
"It is possible over the next few years, as we immunize several hundred
thousand people and see several deaths and a number of adverse events, that
no disease will enter the country," said Dr. Paul Offit, a panel member who
is chief of infectious diseases at the Children's Hospital of Pennsylvania.
"So I would ask that we start to consider now what our stop criteria would
be."