Smallpox vaccine still a safety, liability concern
Additional guidance is sought if a large-scale vaccination campaign is
launched.
By
Susan J. Landers, AMNews staff. Nov. 11, 2002.
Additional information
Washington -- If emergency department physicians and nurses are to be
among the first to roll up their sleeves for a smallpox vaccination, they
want a few more questions answered by the Bush administration first.
A Centers for Disease Control and Prevention advisory committee met
Oct. 17 in an attempt to offer guidance related to some of these specific
issues. The panel also broadened its June recommendations by expanding the
number of medical professionals who would be eligible for the vaccine.
But many concerns -- ranging from how much pressure to be vaccinated
workers might face, to liability for the vaccine's possible adverse
effects -- persist.
Physicians and others favor providing the vaccine on a broad, but
voluntary, basis in order to establish first-responder teams in the event
of a smallpox outbreak.
But what if the physicians decide to receive it and the nurses do not?
Or vice versa?
"That's an issue that has not been worked out," said Nancy Auer, MD,
chair of the American College of Emergency Physicians' Task Force on
Terrorism.
Since smallpox vaccine was last used in 1972, the population has
become more vulnerable to its side effects.
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And, "if a health care worker decides against getting the vaccine, will
there be reprisals?" asked Cheryl Peterson, RN, senior policy fellow at
the American Nurses Assn. What about needlestick injuries? What's the
safety record of the bifurcated needles used to administer the vaccine?
Liability concerns also rank high with both hospitals and physicians.
The federal government has absolved the vaccine manufacturers of
liability, but those who administer the vaccine wonder if they could be
held liable for illnesses among the people they inoculate. And those in
line to receive the vaccine are concerned about who will help pay the
bills if they have an adverse reaction.
"We know in the past we've had significant adverse reactions to the
vaccine," noted AMA Trustee Timothy Flaherty, MD. If the decision is made
to conduct a mass immunization of the general population, the threat of
liability could include primary care physicians who will be inoculating
their patients, he said.
James Bentley, PhD, the American Hospital Assn.'s senior vice president
for strategic policy planning, would like to see the community come
forward and offer to protect those health care workers who receive the
vaccine. "We're all in this together and we believe we need a strong
liability and indemnification program so those who participate in the
program are not liable," he said.
The Bush administration has yet to finalize plans on how best to
vaccinate large numbers of people, or whether to even conduct a
pre-exposure program of inoculations in preparation for a smallpox attack.
The danger of the vaccine requires even more caution today than it did
when it was last used in 1972. Today's population, which includes many
with AIDS, organ transplants or cancer, as well as an increased number
with atopic dermatitis, is more vulnerable to the vaccine's severe side
effects.
The administration has been moving cautiously in crafting a plan to
begin using the vaccine, and with that in mind, asked the CDC's vaccine
advisory committee to come up with a few more specifics concerning a
vaccination program for first responders.
Who's on first
At last month's meeting, the committee targeted approximately 500,000
physicians and other health care workers as the largest group in decades
to receive the smallpox vaccine. Among them are emergency department
physicians and nurses, intensive care unit staff, infectious disease
specialists, medical personnel with smallpox experience as well as
dermatologists, pediatricians, ophthalmologists, pathologists and
surgeons.
Radiology technicians, respiratory therapists and security and
housekeeping personnel were also included among those first to be
vaccinated.
A CDC committee has targeted 500,000 health care workers as
first-responders to any smallpox crisis.
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Given the dangers of the vaccine, the committee recommended that those
with eczema or atopic dermatitis not receive the vaccine. And because of
the risk of transmission from the vaccination site, the committee urged
that anyone who has a family member with those skin conditions not receive
the vaccine.
Additionally, women who are pregnant or may become pregnant within four
weeks should not receive the vaccine.
Among the other recommendations made by the committee for the
inoculation of physicians and other health care workers before an actual
outbreak occurs:
- People with HIV/AIDS should not receive the vaccine as they would be
placed at increased risk of progressive vaccinia or vaccinia necrosum,
serious complications that can lead to death. Although the committee did
not recommend mandatory HIV testing before vaccination, it did recommend
that HIV testing be made readily available to those with any history of
risk factors.
- Those administering smallpox vaccine should themselves be vaccinated
beforehand to minimize the impact of inadvertent inoculation.
- Those receiving the vaccine should keep the site covered with gauze
until the scab falls off. This would help prevent inadvertent
person-to-person transmission.
There was no specific discussion about responders who would have been
vaccinated as children.
While hospitals aren't ready today to vaccinate their workers, most are
working hard toward that end. And the federal government has made funds
and guidelines available to help states and localities prepare.
"Hospitals are stepping up to the mark and are meeting guidelines,"
said Dr. Auer, who is overseeing hospital planning in Washington state.
People with eczema or atopic dermatitis should not receive smallpox
vaccine.
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She began work by assembling all hospital CEOs in one room for an
overview of what they needed to do.
While every hospital has its own disaster plans, a shift has occurred
as hospitals were designated the first responders of the 21st century, Dr.
Auer noted, and the necessity of hospitals working together became
apparent.
There have already been gains from this enterprise, she said. "We are
creating a wonderful surveillance network," which was tested during
protest demonstrations held when Seattle hosted World Trade Organization
meetings recently.
The hospitals are also developing a common standard for personal
protective equipment.
"That way, if my hospital doesn't have victims but the hospital a mile
away is overwhelmed, we can send personnel and personnel protective
equipment to them and they will have already been trained on the same
kind," she said.
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ADDITIONAL INFORMATION:
Vaccination strategy
Recommendations made by the Centers for Disease Control and
Prevention's Advisory Committee on Immunization Practices regarding
smallpox vaccinations:
- First to be vaccinated against smallpox should include such first
responders as emergency department physicians and nurses, intensive care
unit staff, infectious disease specialists and others.
- Hospitals should establish at least two response teams to ensure
adequate care.
- Administrative leave is not required for first responders who
receive the vaccine but do not become ill as a result.
- The vaccination site should be kept covered with gauze or a similar
absorbent material.
- Those with eczema or atopic dermatitis should not receive the
vaccine.
- Women who are pregnant or intend to become pregnant in four weeks
should not be vaccinated.
- Those with HIV/AIDS should not be vaccinated.
- The vaccine can be administered at the same time as inactivated
vaccines such as the flu vaccine, and, at the same time as other
vaccines that contain live viruses, with the exception of the chicken
pox vaccine.
Source: CDC Advisory Committee on Immunization Practices
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Weblink
AMA Disaster
Preparedness and Medical Response page (http://www.ama-assn.org/go/disasterpreparedness)
Transcript of CDC Advisory Committee on Immunization Practices
smallpox vaccine meeting briefing (http://www.cdc.gov/od/oc/media/transcripts/t021017.htm)
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Copyright 2002 American Medical Association. All
rights reserved.
