Smallpox vaccination: Risk is hard for experts to quantify

Side effects are just one of many serious concerns

The White House’s smallpox vaccination plan, especially its assertion that health care workers should be among the first immunized, was certainly welcomed by many occupational health professionals.

But the devil is in the details, and some of those details have left observers confused and concerned. Chief among those concerns is the possibility — albeit slight, according to the government — of serious side effects and the potential impact this has on frontline workers. The fact that inoculation will be voluntary, both for individual workers and facilities, raises other issues such as whether to inoculate at all, who should get the vaccine, and what to do if people refuse to be inoculated?

"Clearly, I believe it is positive to be preparing for a bioterror event," says Robert McLellan, MD, MPH, chair of the American College of Occupational and Environmental Medicine’s (ACOEM) special committee on disaster preparedness and response. "It’s pulling together the private health community with the public health community in a way that hasn’t happened in over 30 years. I believe quite strongly all these preparations will have a positive spin-off, improving public health and clinical medicine not only for bioterror events, but also for a range of population-based medical events."

Jack Richman, MD, medical director of AssessMed Inc., in Mississauga, Ontario, says the policy is good in terms of prevention for terror attacks as the people who will be looking at sick people will be health care workers "My only concern is that if health care workers, in doing their work, fall ill, the government is not covering them. They need to be covered."

Jean Randolph, RN, COHN-S, a member of the Board of the Atlanta-based American Association of Occupational Health Nurses (AAOHN) thinks the best part is that it’s a voluntary immunization of frontline health workers and that the government is providing it. "That means there are some liability protections under the Homeland Security Act. But you also have to look at the risk factors," she adds.

However, says McLellan, the level of risk is difficult to quantify. "Here we are, spending huge amounts of money we may be diverting from other activities that are important in terms of public health, be it obesity, diabetes, or cardiac disease," he says. "Plus many of us in the field of disaster response believe we need be prepared for an all-hazards response. By preparing so much for smallpox, we could be ignoring something else."

On the other hand, Randolph notes, "the government probably has some information I don’t, and maybe they think the threat is bigger than before. From their current position, the direction we’re getting from government is that this is a fairly serious threat."

McLellan strongly emphasizes that he approves of the approach being taken as opposed to offering mass vaccinations. "What is happening here is a phased response," McLellan adds. "We are initially trying to inoculate the people most likely to be involved in caring for individuals with smallpox and asking for volunteers."

This helps address side effects, he explains. "This way, we have the luxury of time. We can screen people so we will have the least likelihood of side effects. Technically, they could be immunized within three days of exposure and have protection. There is some concern that as many as one-third of those immunized will feel sick enough to miss work, which is not a good thing, but we can get the side effects out of the way."

Not a clear-cut decision

The decision as to whether you should inoculate frontline workers is not as cut and dried as it may first appear, says Randolph. "There are several issues involved. First, there can be complications. The world today is different."

A big part of that difference is the large number of immunosuppressed individuals — those most susceptible to side effects. Some observers say there may be as many as 100 times as many immunosuppressed people in the population as there were the last time the vaccine was administered.

"Of all the vaccines available this is probably the one with the nastiest side effects," says Randolph. "It’s also the toughest one to give and to get, and we haven’t got the most skilled workers to give it. The people who gave it before did it routinely."

"I certainly wouldn’t recommend the current plan of treating all hospitals the same," says Edward P. Richards, JD, MPH, a professor at the Louisiana State University Law School in Baton Rouge, and director of the program in law, science, and public health. "I would like to see the government be a little more clear on why they are recommending this strategy, if they want to prepare every hospital. So if there is a big outbreak, we’ll be greeted by immune personnel. A voluntary system where about half the frontline staff is opting out is not good."

Richards is clear that he is not recommending that hospitals not inoculate staff. "For hospitals that have frontline care, they ought to figure out their own plan for why they are doing it," he advises. "In Louisiana, for example, smallpox cases will only be cared for at regional hospitals. The feds did not involve hospitals in the development of the plan and they do not care for criticism. Therefore, it would be useful to develop your own answer as to why you’re doing it — why you are only immunizing some people, and how to handle the volunteer situation."

The biggest problem, he says, is that you can’t deal with a smallpox outbreak and have other patients. "A lot of hospitals don’t have negative-pressure rooms or ways to get people in and out. Once you have smallpox patients and you have staff going in and out, well, this is a dangerous infectious disease. When the government is worried, they place people into level three and four military facilities. Yet the CDC [Centers for Disease Control and Prevention] expects hospitals to do the same thing. Hospitals should be screaming about setting up a regional plan, identifying a smallpox hospital, and evacuating people to that facility."

Screening comes first

If you do decide to inoculate hospital staff screening becomes a critical issue, says Richards. "The occ-med staff would need to decide the right type of screening." The screening used in the clinical trials for developing the vaccine would be a useful model, he adds. "They could do an HIV test — a regular blood count would go a long way [toward identifying immunosuppressed staff]," he suggests. "I’m really concerned that not enough attention is being paid to family members at home — something else the clinical trials did."

Does this raise potential privacy issues? The potential is definitely there, says Richards. "The ideal situation is to have the health department handle both the screening and the immunizations — then it all falls under public health, which helps the hospital," he explains. "But absent that, you could still work out a system for privacy. Occ-med deals with this all the time. It’s not really a special issue, but you have to pay attention to it."

McLellan agrees. "This is confidential medical information, and needs to be treated as a medical document," he asserts. "You have to have a clear policy, so that anyone volunteering knows what they’re getting."

Will it impact productivity?

Inoculating frontline staff may for a short time have the opposite of the intended effect. Initially, a certain percentage of them will likely become ill and miss work. There is even the chance of a fatal reaction to the vaccine. "About 30% of those who have never been inoculated will have some chance of a reaction," says Randolph. "That likelihood is reduced tenfold if they had the vaccine in the past. In other words, if you’re under 30, you’re not really in the best company."

What about fatalities? "In a 1947 study done in New York City, more people died from the vaccine than from smallpox," she observes. "If you have two cases of smallpox and you vaccinate 6 million people prophylactically, lo and behold, you will see people die."

But, says McLellan, "the likelihood of serious side effects is very low." However, he concedes, "reactions can be uncomfortable and disabling. People can have a high temperature for a few days."

This raises a number of issues, including recruitment, for hospitals that are inoculating frontline staff.

"Who really wants to feel sick?" McLellan asks. "If I do get sick and am out of work, who pays for this? And solo practitioners who are sick for three days will also lose revenue. You have to explore whether and when the employee comes back to the work force — it depends on their job and how they feel. Generally, you will see 60%-80% with fever. As an employer, you shouldn’t penalize these people by making them use vacation time. Verify the side effects and pay them regular hours for those days. In the long run, they will be the ones working in the hospital and seeing patients should smallpox become weaponized. And how much is that work to you?"

Which raises a point that’s important to remember: Not all hospital staff will be immunized.

"We’re just looking at frontline workers — emergency departments and ICUs," says Randolph. "First responders are second tier — and that’s OK. Keep in mind — the vaccine has not even been released yet. We have studies that have been done on vaccines when they were given in the past, but we do not know a lot about what happens in a large population with a component of immune-compromised people that had not been there before."

The progression of those to be vaccinated is very specific, notes McLellan.

"This is spelled out clearly on the CDC web site [www.cdc.gov/smallpox]," he notes. "Only very specific categories of people will be immunized. The first phase will be people on the smallpox response team — those directly involved in the clinical care of an identified smallpox case. In my hospital, as the occ-med physician, I will sit down and list them. It could include infectious disease specialists, support personnel, transport personnel, diagnostic imaging, and so on. But this would be no more than about 100 people per medical center and 500,000 in the country."

When the inoculation process begins, it has to be accomplished in 30 days," says McLellan. "You’ll have as many as one-third of those people out of work, so you will need to stagger the inoculations, but there will still be scheduling challenges."

Follow-up is essential

Follow-up is an equally critical element of the process, not only to look for harmful side effects but also to ensure proper site care. "Once you have been immunized you will get an ugly blister, which is potentially infectious," McLellan explains. "There are ways to cover and clear that." The American Council of Immunization Practices and HICPAC, says McLellan, recommend site-care checks. "Before you report back to work you should go to a site care team, have your bandage checked, and see if it needs to be replaced," he says. "So, you have to identify staff to do that for three shifts, seven days a week."

"It should be normal to follow up when pustules start to form, or at about five to seven days, to make sure the inoculation took and to be sure it’s being managed appropriately," adds Richman. "You want be sure the bandages were used appropriately and that staff clearly understood they must not touch the pustules because you can self-inoculate."

For staff that is being re-vaccinated, follow-up should take place in three to five days, he adds. A special consideration for health care workers who have been inoculated is that they do not accidentally inoculate sick people. "They don’t have to remove themselves from seeing people, but they must avoid direct contact," says Richman.

The vaccine is a 5:1 dilution compared to what was used before and more people are compromised now that before, Randolph says. "With that in mind, we’ve got be careful be around those people, make sure the dressing is clean and nothing is leaking. Some places will make the decision to furlough these people for 21 days while going through this inoculation period."

Richards finds it hard to argue with the FDA’s stance that inoculated workers should be furloughed unless they are essential. Still, there are steps than can be taken to lesson such concerns.

"In health care workers we’re talking about utilizing a dressing called Tegaderm that’s 98% impervious to the virus coming through it," notes Randolph, saying this will help alleviate some of those fears. "This makes the situation better, but we still have a big question mark. After all, where do you find more immune-compromised people than in a hospital?"

With caution, the chances of complications are very minimal, counters Richman. "Proper hygiene and proper technique should allow safe vaccination and remove fear."

Yet it’s only natural that some concerns remain among health care workers. "Some people are very nervous about taking care of patients who are immunosuppressed," notes McLellan. "Some institutions are nervous about liability and there’s still some fuzziness about the Homeland Security legislation."

No need to hurry

At present, however, there’s no rush to go out and vaccinate health care workers, Randolph says. "There’s no cases of smallpox in the world," she notes. "If it is used as a weapon, the vaccine is available and could get to any part of the U.S. that needed it; we’d then have four days from exposure to get immunized." However, she concedes, should smallpox be weaponized and we need to vaccinate thousands of people, "Everybody can’t be off for three weeks. It’s a thoughtful decision on the part of the institution as well as the individual. The individual has to consider their family, as well as the job they have to do. That’s why it’s reasonable to leave it as a voluntary option."

[For more information, contact:

Robert McLellan, MD, MPH, Chair, Special Committee on Disaster Preparedness and Response, American College of Occupational and Environmental Medicine. Telephone: (603) 766-8255. E-mail: bmclellan@her.org.

Jack Richman, MD Medical Director, AssessMed Inc., Mississauga, Ontario. Telephone: (905) 678-2924.

Jean Randolph, RN, COHN-S, American Association of Occupational Health Nurses, Atlanta, GA. Telephone: (404) 906-5126.

Edward P. Richards, JD, MPH, Professor, Louisiana State University School of Law, Baton Rouge, LA 70803. Telephone: (225) 578-7595. E-mail: Richards@lsu.edu.]