So far, so good: As vaccinations begin, few serious smallpox reactions emerge
So far, so good: As vaccinations begin, few serious smallpox reactions emerge
Screening adds safety to smallpox vaccination
Despite widespread fears about the smallpox vaccine, there were few serious adverse reactions and no known spread to contacts in the first month of the vaccination program.
Careful screening has greatly reduced the risk of the vaccine, public health authorities say. Based on the vaccination experience in the 1960s, they had estimated there could be 14 to 52 life-threatening events and as many as 1,000 "serious" reactions for every million vaccinees.
In the first month of the program, 7,354 health care workers received the vaccine. A 39-year-old female nurse suffered from a suspected case of generalized vaccinia, and a 60-year-old man with a history of hypertension suffered from angina four days after being vaccinated.1 Angina has not previously been associated with the smallpox vaccine, and that case was being investigated. Both health care workers had been vaccinated previously, and both live in Florida, one of the first states to begin health care worker vaccination.
Even more reassuring news came from the military after the vaccination of 10,000 health care workers and more than 250,000 military personnel. The Department of Defense reported two possible cases of vaccine-related encephalitis, six possible cases of generalized vaccinia, four possible cases of vaccine-related myocarditis, and one possible case of ocular vaccinia. All have recovered.
Only 3% of military personnel took sick time due to vaccine reactions, and "we’ve had zero cases of transmission of vaccinia in the health care setting," says Lt. Col. John Grabenstein, RPh, PhD, deputy director of clinical operations for the Military Vaccine (MILVAX) Agency in Falls Church, VA. "We expected the serious events to be rare," he adds. "What we’re seeing is they’re very, very rare."
In fact, screening appears to greatly reduce the risk of the vaccine. In the 1960s, the benchmark for the current program, screening might have prevented as many as two-thirds of the complications, according to a Centers for Disease Control and Prevention (CDC) report.2
"However, screening will not eliminate risk, because the risk factors for certain adverse reactions have not been clearly defined and screening success is subject to recall bias and the participant’s willingness to disclose personal information," the report concluded. "Stringent medical screening of potential vaccinees for risk factors for adverse events, coupled with improved infection-control measures to prevent vaccinia transmission, will probably decrease preventable complications of vaccination."
Swelling, itching, and even fever and malaise are common reactions to the live-virus vaccine. But one reaction has proved vexing for some health care workers: a sensitivity reaction to the semipermeable bandage or its adhesive.
A survey of vaccinated military personnel found that 18% had a reaction to the bandage. Those were resolved by changing the tape or bandage type, Grabenstein says.
The Healthcare Infection Control Practices Advisory Committee (HICPAC), an advisory panel to CDC, is drafting an algorithm that advises health care workers with a sensitivity to latex or adhesives to use an alternate dressing.
In fact, two of the HICPAC members had a reaction to the bandage adhesive after vaccination. "It was so bad on the seventh day, at first I thought I might have superinoculation or satellite lesions," says Loretta Fauerbach, MS, CIC, a representative from the Association for Professionals in Infection Control and Epidemiology.
HICPAC members advised asking potential vaccinees whether they are sensitive to bandage adhesives or latex. They also should avoid unnecessarily irritating the area, says HICPAC co-chair Jane Siegel, MD, a professor of pediatrics at the University of Texas Southwestern Medical Center in Dallas. "If there is no fluid accumulation, it is not necessary to remove the dressing," Siegel says. If a vaccinee has a reaction to the adhesive and no adequate alternative can be found, she or he may need to keep the site open and refrain from patient care until the scab separates, Siegel says.
"If they absolutely cannot tolerate the semi-permeable dressing, I don’t think it would be appropriate for them to have continuing patient contact," she says.
Meanwhile, vaccination programs in many states were scheduled to begin in March, six weeks after the official start date of the vaccination program. By the end of February, 488 hospitals had participated — about 10% of the nation’s acute care hospitals. About half of those vaccinated were public health workers who would administer the vaccine or respond to a smallpox event.
Continuing concerns about compensation for health care workers or household contacts suffering from adverse events have affected the program, CDC officials acknowledged. But the slow start also has provided time for extensive screening and education.
"We’re actively screening right up to the moment of vaccination to make sure people don’t fall through the cracks," says Allen Craig, MD, state epidemiologist with the Tennessee Department of Health in Nashville. Tennessee had vaccinated 881 public health and health care workers with no serious adverse events. Three vaccinees developed vesicles on other parts of the body, which may have been due to autoinoculation, but none posed a risk, Craig says. "This is a very different program than was in place in the ’50s and ’60s, in which there wasn’t so much rigorous concern about transmission [of vaccinia]," he notes.
The relative safety of the program may encourage other health care workers to be vaccinated. But for now, it appears that the numbers will be far lower than the 500,000 originally projected by CDC. State plans called for the creation of 4,532 health care teams with 396,062 people vaccinated. It appears that less than half that number may actually be vaccinated.
For example, Tennessee had requested 13,000 doses for response teams at 130 hospitals, but Craig anticipates that just 5,000 to 6,000 health care workers will receive the vaccine at 108 hospitals.
In Connecticut, the first state to begin vaccinations, numbers were likewise lower than projected. At Yale-New Haven Hospital, about 20 health care workers received the vaccine in the first day. "We are shy of the originally envisioned 100 to 150 [members of a response team]," says Mark Russi, MD, associate professor of medicine and public health at the Yale University School of Medicine and director of occupational health at Yale-New Haven Hospital. "I’m not sure what our final numbers will be once we finish this."
Thanks in part to the lackluster response, the logistics of smallpox vaccination have been smooth. Yet the program is still placing great burdens on employee health.
For JoAnn Shea, MSN, ARNP, director of employee health and wellness at Tampa (FL) General Hospital, it’s as if she’s been on extended leave. All her regular duties piled up as she spent her time preparing for smallpox vaccination. "It’s been almost like a full-time job in the last month for me. We’ve had to create all these consents and agreements and follow-up forms. I had to create an educational program suited to our hospital."
Although CDC has a wealth of educational information on its web site (www.cdc.gov), the education had to be streamlined and specific to Tampa General. What kind of dressing would employees wear? Who do they call after hours? Who do they contact during regular hours?
Shea also addressed various issues to reduce the likelihood of vaccinia transmission to patients. The hospital didn’t want contaminated scrubs mixed in with the hospital laundry. Operating room personnel bring freshly laundered, long-sleeved T-shirts in a bag to work and wear them under their scrubs. "There are a lot of little things that came up that we didn’t realize were issues," she says.
Monitoring vaccination sites
Shea set up a system of site checks, with an emphasis on monitoring the site during days six through eight to determine if there was a "take." Any employee who might be on vacation during those days would not be eligible to get the vaccine, she says. Employees on scheduled days off would need to come into the hospital for a site check. Shea selected the semipermeable bandage that she thought would provide the best protection. "I paid almost $1,000 just for these Tegaderm dressings, and I need to order more," she says. "It’s a very costly program for us in staff time and materials."
Employee health professionals can’t even imagine a second phase of the program, in which the vaccine would become available to emergency responders, law enforcement personnel, and all health care workers who want it.
In a press briefing earlier in February, CDC director Julie L. Gerberding, MD, MPH, said she envisioned a smooth transition between Phase 1 and Phase 2. "There is not going to be a stop date where we say, OK. Stage 1 is over; now Stage 2 begins," she said. "Rather, each jurisdiction will be able to expand to accommodate the larger group of people volunteering for vaccination at their own pace."
However, a broader vaccination program would escalate the concerns about nosocomial transmission, adverse reactions, cost, and compensation. "I’m actually very hopeful that we don’t find it necessary to progress to Stage 2," says Russi, who says that the Stage 1 response teams may provide a sufficient infrastructure.
"If you vaccinate 10 million health care workers, you have to contemplate 10 to 20 deaths," he says, based on CDC estimates of adverse events. "It’s awfully serious for something when we don’t know if there’s even smallpox out there."
While occasionally health care workers who are not designated for response teams have requested the vaccine, there hasn’t been a groundswell of demand. "Given the fairly tepid response on the part of health care workers to Stage 1, I’m just not sure anything will change that much in progressing to Stage 2 vaccination," he says. "I have to wonder, is it realistic to think there would be 10 million health care workers and first responders who would want to be vaccinated?"
State public health departments are unsure even how to conduct a Phase 2 program. Tennessee will submit a Phase 2 plan by May 1, but Craig notes, "We’ve not been told that Phase 2 will happen at this point. Until we get guidance from CDC, our plans can’t be finalized." Public health clinics would need to create an ongoing smallpox program that would last for months. "The size of this effort would probably be 20 times greater than our current effort," he says. "We would probably have to institutionalize this into our current operation."
Hospitals would need financial resources from the federal government to pay for extra staff and other costs, Shea says.
"Imagine if we had a Phase 2, and anyone could get it, and we had to check them [daily]," she says. "This is uncharted territory."
[Editor’s note: Clinical consultation on possible adverse reactions is available from state public health departments or CDC’s Clinician Information line: (877) 554-4625.
Health care providers should report smallpox vaccine adverse events to their state/ local health department and to the Vaccine Adverse Event Reporting System (VAERS) at www.vaers.org or (800) 822-7967. Clinical evaluation tools are available at www.bt.cdc.gov/agent/smallpox/vaccination/clineval/. Other guidance on adverse reactions is available at www.cdc.gov/mmwr/preview/mmwrhtml/rr5204a1.htm.]
References
1. Centers for Disease Control and Prevention. Smallpox vaccine adverse events among civilians — United States, February 18-24, 2003. MMWR 2003; 52:156-157.
2. Cono J, Casey CG, Bell DM. Smallpox vaccination and adverse reactions: Guidance for clinicians. MMWR 2003; 52(RR04):1-28.
Screening adds safety to smallpox vaccination. Despite widespread fears about the smallpox vaccine, there were few serious adverse reactions and no known spread to contacts in the first month of the vaccination program.
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