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.

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.

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.

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.

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

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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