Small Pox Vaccine - weighing the risks

[-jt]

lots of people are wondering whats the big deal with getting vaccinated? maybe it wasnt such a big deal when we were kids but because of the job we do, there are other things to consider this time:

Smallpox Vaccinations: Weighing the Risks

New York State Nurses Association Urges Protections for Nurses Who Volunteer

by Nancy Webber

NYSNA Report

On December 13, 2002, the Bush administration announced that healthcare workers would be among the first to participate in a voluntary smallpox vaccination program.

By that time, county public health departments were already making plans to inoculate these volunteers, who would give vaccinations to other healthcare workers and to the general public in the event of a smallpox emergency. Acute-care facilities were designating smallpox response teams made up of a cross-section of hospital workers and specialties.

These fast-moving events left nurses facing the difficult decision whether to be vaccinated. There are many factors to be considered. As healthcare professionals, nurses recognize the need to prepare for a smallpox outbreak possibly generated by a bioterrorism attack. The risks of the vaccine itself, however, raise concerns about severe side effects, the possibility of endangering the health of family members and patients, and issues related to potential liability and compensation for lost time at work.

Responding to these concerns, the New York State Nurses Association (NYSNA) recently sent a letter to hospitals where the association represents RNs for collective bargaining, putting them on notice that they would have to negotiate certain aspects of the vaccination program.

"Being vaccinated could have a serious impact on a nurse's health and livelihood," said Lorraine Seidel, director of NYSNA's Economic and General Welfare (E&GW) Program. "Before facilities implement their vaccination programs, we must be assured that RNs will be protected in every way possible."

NYSNA outlined six major areas of concern, noting that more could arise as the program develops --

* Nurses must be properly educated about smallpox and the vaccine. Before nurses volunteer to be vaccinated, employers must provide complete and accurate information about the relative risks of contracting smallpox and the possible side effects of the vaccine both for nurses and for unvaccinated people with whom they come in contact.

* There must be no reprisal for refusing to volunteer. Nurses should not be harassed or experience discrimination if they refuse to be vaccinated. They should not have to divulge the reason for their refusal.

Nurses should not be vaccinated, for example, if they have a history of eczema or atopic dermatitis, HIV infection, a compromised immune system, allergies to antibiotics used in development of the vaccine, and pregnancy. People with these conditions are more likely to experience severe reactions. Nurses also may be at risk if they have a history of dermatitis associated with latex allergy.

In the vaccination plan it submitted to the state, the New York City Department of Health will require all volunteers in the city to receive confidential HIV testing before being vaccinated.

* Specific pre-vaccination information must be provided for those who do volunteer. If nurses do decide to volunteer, they must be fully informed about their rights as workers, possible side effects, the treatment available in the event of a severe reaction, care of the inoculation site, and precautions to prevent accidental inoculation of patients and household members.

* Nurses must be paid for lost time from work due to reaction to the vaccine. The smallpox vaccine contains a live vaccinia virus. Vaccinia, known as cowpox in earlier centuries, is a weaker relative of smallpox and provides immunity from the more deadly disease. In fact, it is the source of the word "vaccination" (the Latin word for "cow" is "vacca"). Typically, a person vaccinated against smallpox for the first time may experience flu-like symptoms: fever, malaise, and swollen lymph nodes. In clinical trials at the University of Iowa, about a quarter of those vaccinated missed at least one day of work or school.

The smallpox vaccine can cause more severe side effects in a small percentage of cases, which were outlined in the December 2002 issue of Report. It is estimated that 15 people out of a million will experience life-threatening complications and one or two out of a million will die.

* NYSNA is telling employers that if nurses volunteer to be vaccinated as part of a public health initiative, they should not have to use sick time or other personal time for missed workdays. In addition, treatment for severe side effects must be provided at no additional cost to the nurse volunteer.

* Nurses must not be held liable for accidental inoculation of patients or others. Because the smallpox vaccine contains a live virus, the virus can be shed from the vaccination site for up to three weeks. There are measures that can be taken to minimize the risk of accidentally inoculating others. Special care must be taken to cover the sore that develops after vaccination. Frequent handwashing also will prevent the vaccinia virus from being passed on. But despite these precautions, potential liability remains.

* Facility vaccination plans must address the risks of having recently vaccinated employees care for patients. Hospitals have already expressed concern about their liability if employees or patients are harmed by the vaccine. As Report went to press, many of these legal questions had not been resolved.

* Plans must be provided for staffing support and coverage for staff who may be absent from work following vaccination. NYSNA proposes that vaccinations be administered on a staggered basis to minimize impact on staffing levels, with a group being vaccinated every three weeks. Most absences due to typical vaccine reactions will occur eight to ten days after inoculation.

If you are represented by NYSNA for collective bargaining and have questions or concerns about how your facility is implementing its smallpox vaccination program, contact your NYSNA nursing representative. Information is also available at NYSNA's Web site, http://www.nysna.org, and at http://www.smallpox.gov.

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[rncountry]

Yes, dawn. Tegederm, opsite etc... the same as is used on a CVL.

The risks need to be weighed, that makes only common sense. The screening process is to be heavy, you would not be eligible as you would be working with those under a year of age.

At my hospital we are in the midst of the education process as we will be asking for volunteers next month. The ID doc wants only those that have already been vaccinated to get it again, at this time anyway.

I just want those that have questions, myself among them, to go to the CDC website and read. There is a great deal of material, and as an infection control nurse I haven't gotten through all of it yet. I expect that there are going to be many questions and I need to be prepared to answer them.

But I also think it is important to not get everyone riled up about this without the education to go with it. I don't mean this particular thread as much as I do some others. The best place to get questions answered is not here, but at the CDC site.

[hoolahan, ASN, RN]

Here is another interesting article in the news today...

http://www.nj.com/news/times/index.ssf?/base/news-1/1042455695102080.xml

Medical workers opting out of smallpox vaccination

Monday, January 13, 2003

By TRACEY L. REGAN

Even amid fearful talk of a bioterror attack, Priscilla Searfoss, a critical care nurse at Virtua Memorial Hospital in Mount Holly, has decided she will not be immunized under the government's anti-smallpox program.

Searfoss recalls her traumatic trip to the hospital four decades ago after she accidentally rubbed serum from her smallpox vaccination into one of her eyes, causing it to swell to the size of a tennis ball.

She was temporarily blinded, until experimental treatments for side effects from the vaccination reduced the swelling, restored her eyesight and allowed her to go home. She was 4 at the time and spent 11 days in a hospital bed.

"I think that's why I became a nurse. I was so frightened to be at the hospital that I wanted to be on the safe side of things," she said, adding, "I will not be vaccinated again. There are too many questions still. What if there are side effects? Are we more susceptible now? Is the vaccine too old?"

Searfoss is not alone among health care workers in shunning voluntary vaccination in the absence of a tangible threat of attack.

"A lot of our members are saying they are not going to do it. Some of them are at significant risk," said Sharon Rainer, legislative affairs director for the New Jersey State Nurses Association, who is herself a trauma care nurse and unlikely to get the vaccination.

She has eczema, a skin condition that can worsen complications from the vaccination. And she has a toddler at home.

The reservations of health care workers such as Searfoss and Rainer are among the hurdles faced by state health officials, who are under pressure to launch a statewide vaccination program for acute care facility workers within the next few weeks.

The state is expected to provide a list of volunteers to the Centers for Disease Control and Prevention in two weeks and to begin giving the vaccination by the end of January or early February.

Hospital officials said the timetable to administer one of the world's most potent and procedurally complicated inoculations to thousands of doctors, nurses, emergency room technicians and support staff is unrealistic.

While many facilities have started the enormous outreach initiative to inform, screen and counsel potential volunteers, there are serious doubts about how many of them will have completed the preparations by the end of January, as urged by the CDC.

Physicians are also questioning their participation, some said, in the absence of recent data on the effectiveness of a vaccine that is now decades old and its potential side effects.

"A lot of doctors are reluctant to take it. Many want to see the data on people in the military, the (CDC) and the State Department who are getting the vaccination," said Robert Rigolosi, a Bergen County nephrologist and president of the Medical Society of New Jersey.

Rigolosi, director of the dialysis unit at the Holy Name Hospital in Teaneck, said he will have to "think carefully about it."

There are also a substantial number of unresolved questions that go beyond the safety of the vaccine, including liability protection for workers and hospitals, workers compensation for people who get sick from the vaccination and the costs of the program, such as replacing staff who miss days of work to get the shot.

As it now stands, hospitals, which operate on razor-thin profit margins, said they would bear the costs of replacing staff.

There are several outstanding liability issues as well.

It is unclear, hospitals said, if people who are not direct employees of the hospitals, such as emergency personnel hired through an outside agency, are covered by workers compensation programs.

New Jersey Health Commissioner Clifton Lacy said the state clearly covers hospital workers and volunteers but is still determining how contract workers would be covered.

Hospitals are concerned about their liability if an employee who is inoculated with the live vaccinia virus, used in the vaccine, passes on the infection to others. Vaccinia is closely related to the smallpox virus.

"We live in a litigious society," said Valerie Sellers, senior vice president for the New Jersey Hospital Association.

-- -- --

Some health officials believe that only Congress, which included liability protections for vaccine maker Eli Lilly in the recently passed Homeland Security Act, can provide the needed assurances to hospitals and workers, although it is unclear how quickly lawmakers will act.

"I am skeptical about their ability to do so, but I'm also hopeful," Sellers said.

She noted she has heard preliminary reports that the numbers of volunteers - estimated by the state Department of Health at between 10,000 and 15,000 workers at 85 acute-care facilities in the first wave of vaccinations - appear to be dropping off. Individual hospitals, however, said they have no hard numbers yet.

"No one is saying definitively that they won't do it, but the numbers might not be what was expected," she said.

Lacy agreed that the number of volunteers may be fewer than at first projected, but said "there will be enough" to treat potential victims of a smallpox attack. Should one occur, he said, the entire population would be vaccinated.

He also acknowledged the hospitals' concerns over liability and said his agency is working closely with the attorney general to resolve unanswered questions.

"We will have all these issues addressed before the first person is vaccinated," he said.

After mulling its vaccination policy for months, the Bush administration announced in mid-December that some military personnel and government workers would be vaccinated and that the states should recruit and inoculate enough health personnel to treat smallpox victims infected in a potential terrorist attack.

While the news was not a surprise, most hospitals did not begin mobilizing for the vaccinations until they got the official word from the CDC.

Because the smallpox vaccination carries risks, including death in a tiny number of cases, hospitals are proceeding very carefully.

Kathy Hill, infection control director for The Medical Center at Princeton, said the hospital is devising separate information sessions for workers who do not have a medical background and ready access to pertinent data.

-- -- --

Besides the elaborate recruitment and screening process, hospitals are also required to set up a system for monitoring the vaccinations daily for at least a week and to plan for the disruption of absent staff.

St. Francis Medical Center in Trenton is considering whether it will have to provide accommodations for a few days for vaccinated volunteers who have small children at home or who live with people with compromised immune systems.

"We're wondering whether we open up a mothballed wing here or get a cut rate at the (Trenton) Marriott (at Lafayette Yard) here," laughed Judith Persicheilli, the hospital's CEO.

The federal government issued few guidelines to the states about how many people to vaccinate, so state plans vary widely. Some states submitted plans to the CDC to vaccinate as few as 200 to 300 people, while other states planned for up to 40,000, said Lance Rodewald of the CDC.

"We did not have per-capita target numbers (for the states)," Rodewald said. "We're not there yet to say how many people we want to see in the initial phase of the plan.

"There will be some variation in states' ability to carry this out in a rapid manner," he added. "We're trying to build capacity."

Not all costs of the program have been fully tabulated yet, health officers said.

"There are a whole set of costs associated with the follow-up and the responses for things that are outside the normal," said Patrick Libbey, director of the National Association of County and City Health Officials.

Libbey also expressed concerns about smallpox programs eating up the bulk of federal bio-terrorism funds the states received last year.

"We've gotten money to improve epidemiology, disease surveillance, our lab capacity and our communications, and the message is now to stop that and redirect. It begs the question about the use of that money, which has started to make a positive difference," he said.

Health care workers said it is difficult to justify the vaccine's risks without knowing how significant the threat of an attack is. Some also question why it has to be done so quickly, although they acknowledge it is being timed to a possible attack on Iraq, which is thought to possess biological weapons.

"We're used to giving vaccines when the disease was more present, so our notion of the risk was different," said Libbey. "So we are much more cautious in looking at the risk conditions."

Contact Tracey L. Regan at [phone] or [email protected]

[JNJ]

I urge all healthcare workers to visit http://www.cdc.gov/smallpox. There is detailed information in video format and written in a clear manner outlining to whom it is appropriate to give vaccine and who should not receive it. The vaccine does not contain smallpox virus, but vaccinia. It still needs handling with great care.

Screening potential vaccinees is vital for conditions such as pregnancy, any history of eczema or atopic dermatitis etc. A history of eczema in a household contact is enough to withhold vaccine.

After exposure to smallpox, (called an 'emergency situation') there are usually no contraindications to receiving vaccine - the disease of Variola major is so severe that 30% of people with smallpox die.

Vaccine is effective to some extent up to seven days after exposure. A 'major reaction' is required in order for the vaccine to have conferred immunity. This involves caring for the site for at least 21 days until the scab falls off.

All vaccinators need to be vaccinated. The effects of vaccination last only 3-5 years, although subsequent vaccination responses tend to be less severe.

I believe we should get informed so that we do not add to the scare mongering. Let's be the ones disseminating facts. Having said that, I have grave reservations about getting (re)vaccinated.