Two decades ago the World Health Organization declared smallpox eradicated from the earth. Routine vaccinations stopped in the United States in about 1972, ending worldwide in 1980. The only known stockpiles of the virus are in the United States and Russia.
This doesn't mean the threat is dead, however. The U.S. government has acknowledged the possibility that terrorist groups or rogue nations may have acquired the smallpox virus. Groups that wish to attack the United States or its allies and interests abroad may use smallpox as a biological weapon.
With those possibilities in mind, first responders nationwide soon will be asked to make a personal preparedness decision and decide whether they should receive the smallpox vaccination.
The country's plan
Nationwide a three-stage plan is being put into effect to immunize Americans against a smallpox attack. The first phase involves immunization of health care workers, the second involves first responders, and the third will include the general public.
Last December, a Tampa Fire Rescue occupational health nurse realized that first responders had special needs to be met for a large-scale vaccination effort to be a success. Those included:
Educating a large number of people with diverse levels of medical knowledge and extreme job duties with corresponding cultures, command structures and labor unions.
Vaccinating a work force that couldn't permit a decrease in staffing due to its responsibility to public safety.
Monitoring the post-vaccination site and work status of people who perform strenuous, dangerous duties in uncontrollable environments; who spend a third of their lives in a communal living arrangement; and who wear potentially compromising gear for undetermined amounts of time.
During the early planning stages of the smallpox vaccination program, the Tampa Fire Rescue Occupational Health Office worked closely with the local health department to identify the needs of their agencies and the community in general.
The first problem came when the health department realized that if an outbreak of smallpox occurred, it didn't have enough personnel to begin mass inoculations of the public. As a result, it was decided that those who administered the vaccinations would have to have been recently vaccinated themselves.
Tampa gets on board
Florida's Gulf Coast is home to Tampa, where the population of 300,000 can swell during the workday to well over one million. Tampa Fire Rescue serves the needs of this area by providing response to fire, EMS, hazardous materials, and any other type of natural or manmade emergencies. The department has about 530 uniformed career personnel responding from 22 fire stations located throughout the community.
As the vaccination program began, 18 Tampa Fire Rescue personnel — 15 firefighter/paramedics and the occupational health staff — were sworn in as volunteer health department workers and given the smallpox vaccination.
One of the benefits of involving these firefighter/paramedics so early in the first phase of the national smallpox vaccination campaign was that they could use their combined knowledge and experience, in conjunction with the local health department, to establish policies and procedures for later phases of the vaccination program.
Designated as the smallpox task force, this team then divided into three groups:
The education group would research and create resources to inform first responders about smallpox and the vaccination process.
The vaccination group would decide where to offer vaccinations, what equipment would be needed and how to staff the vaccination sites.
The monitoring group would create monitoring forms and care plans for vaccinees. Care plans would address duty status, post-vaccination followup care, and confidentiality and workers' compensation issues.
These groups would meet regularly, with their efforts chaired by the Occupational Health Office, County Health Department and the Tampa Fire Rescue medical director. Recommendations from the task force would likely guide the vaccination process for Tampa Bay first responders, as well as for other departments.
On Feb. 13, only three days after the first Phase 1 vaccinations began in Florida, the Tampa Fire Rescue smallpox task force members received their vaccinations at the Hillsborough County Health Department offices.
From questions to answers
The firefighter/paramedics in the education group conducted informal focus groups to determine what questions their peers had about smallpox and the vaccination process.
In addition to going into fire stations and talking to police officers on the streets about their concerns, this group's members took into account their own personal experiences, biases and concerns about the vaccination process. They also realized that they needed to speak to family members of potential vaccinees.
Most of the apprehension seemed to focus on the vaccination process:
After receiving the vaccine, would I have to be quarantined from family?
What are the risks of cross-contaminating people in my fire station?
Can I get smallpox from the vaccine?
What are the vaccine's side effects?
What if I don't get the vaccine?
What if I take the vaccine and can't work?
To answer these questions, the education group is creating a video, a PowerPoint presentation and a handout. Informational sessions will be conducted at fire stations and police roll calls or during regularly scheduled classes.
Most of the information and statistics for the smallpox training sessions will come from Centers for Disease Control and Prevention material. The general format will include explaining the positions of the International Association of Fire Fighters and the, the risk of a terrorist attack by smallpox, signs and symptoms of smallpox infection, risk versus benefit of the vaccination, vaccination site care, and home- and work-related concerns.
“The most important ethical obligation of this group,” says Lt. Brian Riley, who is also a registered nurse, “is to present both sides of the vaccination issue, the risks and benefits, so that each individual can make an informed decision as to what is best for their own personal situation.”
Training for the vaccinators
Current estimates assume that Florida will vaccinate about 400,000 career and volunteer first responders during Phase 2 of the National Smallpox Vaccination Program.
In the Tampa metropolitan area the vaccination will be offered to several thousand first responders. To handle this phase of the program, the vaccination sub-group had to determine the best locations to offer vaccinations, as well as how to equip and staff the remote vaccination sites. The group also had to consider the work schedule of firefighters, paramedics and law enforcement officers in Tampa and neighboring communities.
Based on their experiences and CDC recommendations, the group selected four accessible Tampa-area locations, one site in each geographical area of the city. According to Lt. Terry Hall, “We'll need four people at each site. One screener, two vaccinators and one post-screener, each person knowing the importance of their roles.”
Those administering the vaccine must already have completed the vaccination process themselves and be personally convinced of the need for this program. “If they are not convinced, then how can they be expected to administer the program to others who may not be as informed as they are?” says Dr. Doug Holt of the Hillsborough County Health Department.
Additionally, the vaccinators will have practiced giving the vaccine using the bifurcated (two-pronged) needle and sterile water, first on a mannequin arm and then on each other. Some of the vaccinators may have gained some on-the-job training by shadowing health department workers during Phase 1 of the program.
The vaccination process
Once it's time for the vaccinations to begin, each team will report to the Tampa Fire Rescue Occupational Health Office before going to the remote vaccination site. The office will have prepared a kit that includes needles, vaccine, bandages, gloves and appropriate paperwork. Each site also will have an emergency kit in case an unforeseen reaction or medical problem arises.
The screener will be responsible for positively identifying the person receiving the vaccination by looking at a driver's license and comparing that information against what is on the form. The screener also will complete the required paperwork and ensure that the potential vaccinee is informed of all current advisories to the vaccine.
The screener then will ask the vaccinee to sign an informed acceptance or declination form. These forms have statements along the lines of those recommended by the IAFF and are similar to the forms used during hepatitis vaccinations. If a Tampa Fire Rescue member does not wish to be vaccinated, the form will acknowledge that this is well within his or her rights. If first responders change their decisions in the future and wish to be vaccinated, they will be accommodated.
The two vaccinators, in addition to administering the vaccine, also will ensure that the vaccinee has no lingering questions or concerns. After vaccination, the post-screener will once again ask if the vaccinee has any questions or concerns, double-check the required paperwork, issue home-care kits and remind the vaccinee of site care. The post-screener will provide a schedule to the vaccinee for required followups.
At the end of the shift no paperwork or materials will be left at the remote site. For safeguarding and confidentiality purposes, all of these materials will be transported back to the Occupational Health Office.
The vaccination site should be kept covered at all times. The typical dressing that will be used on the site includes a clean piece of gauze placed directly over the vaccination site beneath a semipermeable or waterproof/occlusive dressing. The size of the dressing should be based on the size of the lesion being covered.
Tampa Fire Rescue used Tegaderm for its semipermeable dressing, which was worn by the vaccinee at all times, including in the shower. The semipermeable dressing has to be worn and remain intact during work periods and when close personal contact is likely.
The vaccinee should evaluate the semipermeable dressing to ensure that it's intact. If a family member or other non-vaccinated person, such as a co-worker, helps to examine the dressing, it should be a visual inspection only; there should be no contact with the dressing.
After the initial vaccination and each subsequent mandatory dressing change/site check, the vaccinee is given a home-care kit. The kit is in a sealable plastic bag to dispose of old bandage materials and includes exam gloves, gauze and a fresh semipermeable dressing. If while at home or at the workstation the dressing is leaking or damaged and needs to be replaced, the dressing change can and should be done by the vaccinee. The vaccinee can return to the vaccination clinic for assistance.
If skin irritation occurs from the adhesive portion of the dressing, another brand should be tried. Paper tape also would be an option, and if irritation continues the gauze may need to be secured with a self-clinging wrap such as Kerlix or Kling.
Although there are recommendations that the dressing should be changed daily, Tampa's experience showed that a changing every few days was adequate, even on those who exercised regularly. Several Tampa Fire Rescue recruits, who had not been vaccinated, wore the Tegaderm patch for several days of very physical activity to test the patch's durability. The patch held up very well under the extreme conditions of heat, bunker gear and perspiration.
Reams of paperwork
The monitoring group tackled establishing procedures to observe and control the longest phase of the process, post-vaccination.
The group's goal was to determine the variations in vaccinee experiences, as there could be considerable differences. The team created three forms to help with this process: a personal diary, a monitoring form and a duty-status form.
The personal diary is kept by the vaccinee on a form that includes emergency contact phone numbers in case questions or problems arise during odd hours. The form uses a simple chart for the vaccinee to document signs and symptoms during the 20 days following vaccination. By using this form, vaccinees can help document their experiences with the vaccination so that health care professionals evaluating the program can identify trends and traits.
The post-vaccination process is also tracked by professionals with a monitoring form kept in confidential medical files. Based on one recommended by the CDC, this form documents the vaccinee's progress as assessed by trained paramedics on various dates throughout the process. It's important to perform routine medical evaluations to ensure that the site of the vaccination is progressing properly. These evaluations are typically called mandatory dressing changes.
During these dressing changes, the site must be inspected by medical personnel trained to look for early signs of complications. The importance of these dressing changes can't be overemphasized. It will take coordination with the line officers responsible for staffing the street units to ensure that all vaccinees return for their dressing changes in a timely manner. Because Tampa Fire Rescue is on the 24-on/48-off hour work schedule, mandatory changes are scheduled every third day so the vaccinee can be checked while on duty.
Because vaccinee paperwork is stored at the Occupational Health Office and moved to remote vaccination locations when those sites are open, vaccinees must return to the same location for dressing changes because that's where their paperwork will be maintained. It's important to maintain this paperwork trail for proper documentation and confidentiality.
On the sixth day following vaccination, the paramedic doing the dressing change will also perform a take-check. If the vaccination has taken, the site of injection will be red and a pustule will have formed. This is normal and will be recorded as a take. If there's only a small red spot or no reaction at all, the vaccination may not have taken and the vaccinee will be referred to the Occupational Health Office for evaluation. If a no-take is confirmed, the vaccinee may be vaccinated again, under guidance from the health department and with the vaccinee's approval. A no-take most likely means that the person wasn't exposed to enough of the vaccinia virus to start an immunity reaction.
One member of the Tampa smallpox task force was a no-take twice. The health department advised against a third try. Although this person may have some immunity to smallpox, there's no way of knowing. This member will stay on as a part of the task force but won't be allowed to participate on a vaccination team.
Return to duty
The paramedic checking the vaccination site will complete a duty-status form after each mandatory dressing change. This form is meant to help communicate a vaccinee's duty status to the line officers responsible for staffing the street units.
There have been criteria established to determine whether a person can be on full-duty, light-duty or off-duty status. Full-duty status will be for any person who has received the vaccine and, with proper vaccination site precautions, completed all tasks expected of their duty station.
At Tampa Fire Rescue, line-of-duty light duty is defined as still being assigned to a rotating shift schedule but not responding to alarms. During the day, members on light duty may be assigned to training, administrative, or other non-physical or clerical duties. At night they return to the stations and can assist with station duties.
Vaccinees may choose to use sick time instead of being assigned to light duty. Medical conditions that prompt assignment to light duty include:
Need for frequent dressing changes.
Swelling at the site without pain.
Significant site pain with fatigue.
Itching that requires medications.
Pain requiring prescribed medications.
Based on the experiences of the smallpox task force members, it's anticipated that most people will spend about one duty day on light duty. That day can differ for primary and secondary vaccinees. Because secondary vaccinees have been vaccinated before, their symptoms will peak about three days after vaccination. Primary vaccinees, who never have been vaccinated, seem to have symptoms peak on days four through seven.
Because the person receiving the vaccine is being exposed to a live virus, the typical body reactions are not unlike any other minor body infection. Fever, soreness at the site and itching are the most common and are typically handled with a non-aspirin pain reliever. Some task force members also took over-the-counter oral antihistamine medications to help relieve some of the itching. Rest and fluids were helpful for the few days when symptoms were at their peak.
If a vaccinee needs to be off-duty, the following criteria should be met, and the Occupational Health Office will be notified:
Temperature over 100.7°f.
Headache that does not respond to over-the-counter medications.
Severe joint pain.
Significant swelling at the site associated with pain.
There are several potential adverse reactions to the smallpox vaccination, the most serious being death. However, with proper pre-screening and good post-vaccination site care, most reactions can be avoided.
To prevent the most common problems, the vaccinee must fully understand that all site-care precautions must begin at the moment of vaccination and last until the scab that forms on the site falls off about three weeks later. For example:
The vaccinee should be cautioned against scratching the site or putting any lotions or ointments on it.
Clothing that covers or comes into contact with the vaccination site should be kept in a separate hamper and laundered in hot water with detergent and/or bleach. Sharing of towels also should be avoided.
The vaccinee should wear a shirt that covers the site at all times. In Tampa, two people were placed on full duty immediately following their vaccinations. To protect the public and other emergency personnel, they were required to wear a long-sleeved shirt at all times while on duty.
“If you choose to accept the smallpox vaccine,” says Lt. Mark Bogush, Tampa Fire Rescue, “then you also choose to accept the responsibility of caring for the site. Proper care protects you, your family and everyone that you come into contact with.”
The vaccination site and any fluids draining from it have the live vaccinia virus in them. If the fluid goes from the vaccination site to any other site on the vaccinee's body or the body of someone else, another scarring pustule will form. This complication, called autovaccination, can occur on any part of the body, but it's most common at the eyes, face, nose, mouth, genitalia and rectum. By far the worst location for this to occur is the eye. If a pustule forms, blindness may ensue.
Hand-washing is the most important measure to prevent inadvertent contact spread from vaccination sites. After any touching of the vaccination site area, hands must be washed with soap and water or, if unavailable, with an alcohol-based waterless antiseptic solution.
The experience continues
Most of the smallpox task force members were vaccinated on Feb. 13, and all of the original vaccinees were placed on light-duty status.
Using the knowledge gained from the task force members over the prior two weeks, on March 3 two additional members of the task force were vaccinated and placed on full-duty status, Capt. Eric Hull and Paramedic John Oliver. These rescuers were to determine how well the semipermeable patch would hold up under fire-rescue work conditions. They also were tracked to see if or how their reaction to the vaccination would compromise their ability to work. At the beginning of their process Hull and Oliver were to wear long-sleeved undershirts as an additional layer of protection against spreading the virus.
The very day of his vaccination, Hull spent several hours on scene at a hazmat incident. He had to put on and take off his firefighting bunker gear and air pack several times as he worked in the decontamination line or stood by with a charged hoseline in case a fire or explosion occurred. Both he and the semipermeable patch held up well. On another day both of these personnel participated in a foam operations drill at one of the tank farms in the Port of Tampa. The drill lasted a couple of hours and required the participants to wear full turnout gear, including air packs.
At first Oliver and Hull wore the larger semipermeable dressings, which measured 10cm by 12cm, over their vaccination sites and long-sleeved undershirts. A few days later, with the agreement of the task force, they tried wearing short-sleeved shirts.
“The disadvantage to the long sleeves was the feeling of being uncomfortable in the warm Florida weather,” Hull says. “I never became overheated, just not as comfortable as I would have been with short sleeves.” Average temperatures in Tampa during March run from the upper-50s at night to the 70s during the day. This March saw daytime temperatures in the mid- to upper-80s and overnight lows some nights above 70°.
Once the change was made to short-sleeved shirts, the only problem encountered was that the dressing's edges would peel up slightly, possibly caused by the friction of pulling the bunker coat on and off. Hull then started using a smaller dressing that measured 6cm by 7cm with great success.
After further evaluation by the task force it was determined that properly adhering semipermeable dressing with a short-sleeved undershirt and a short-sleeved uniform shirt provided adequate protection to the vaccination site.
As for the response to their smallpox vaccination from other members of the fire station, most of the crew's concerns centered on whether they could contract the virus and take it home to their families. About a week after vaccination Hull and Oliver did a dressing change in the fire station so crew members could see the vaccination sites and better understand proper site care.
Probably one of the biggest concerns the firefighters voiced, after concern for their families, was the workers' compensation issue: “If I have a severe adverse reaction from the vaccine, am I covered?”
In Tampa the issue was addressed before the vaccination process began. Tampa Fire Rescue Personnel Chief Bob Weiss and Occupational Health Nurse Tiffany Melton met with representatives of the City Risk Management Office, which believed the smallpox vaccination program was necessary and agreed to support the firefighters and paramedics. Weiss and Melton also met with representatives of Commercial Risk, the company the city contracts with to administer the workers' compensation program. Both parties were informed of the potential adverse reactions and the statistical risks involved.
Meetings also were held with trustees of the Police and Fire Pension Board. The pension trustees didn't want to create a blanket policy, but the board did agree to look at each claim that might arise on a case-by-case basis. The department also was concerned about the cost of overtime needed to cover those vaccinees who couldn't work, because original estimates had all vaccinees on light duty or off duty for nearly three weeks. The lessons learned by the task force significantly reduced that prediction.
Despite these bumps in the road, the project has gone well and should continue to do so. None of the task force members suffered any adverse reactions. The medical community believes that with proper pre-screening and training of vaccinees, adverse reactions will be few and relatively minor. The primary concern focuses on autoinoculation and unintended vaccination, the spreading of the vaccinia virus to other parts of the vaccinee's body or to other persons. To avoid complications and adverse reactions a program of on-going training and proper follow-up evaluations of all vaccinees will be strictly followed.
The men and women of Tampa Fire Rescue have sworn to serve and protect the residents of the City of Tampa and the greater Tampa Bay community in general. Most members of the smallpox task force see their efforts as a natural extension of that commitment.
The task force members, although they have no particular insight, agree with the CDC statement that the probability of a smallpox attack is slight, but the ramifications of an outbreak could be severe. Therefore it's incumbent that plans and preparations are made before an event so that this department has personnel trained to respond and assist the public.
A 30-year veteran of the fire service, Capt. Bill Wade began his career as a volunteer firefighter and ambulance corps member in the Philadelphia area. He spent five years as a medic in the Air Force. He received his first EMT certificate in 1975 and became a paramedic in 1980. Hired by Tampa Fire Rescue in 1981, he has worked as a firefighter, paramedic, hazmat technician and member of the department's tactical response team. Wade has been the department's PIO since 1995. Most of his time is spent working with the five local TV news stations, two daily regional newspapers, and various radio stations and weekly newspapers. The Tampa Bay area is the largest local media market in Florida and the 13th largest in the nation.
Smallpox progression and prevention
Smallpox is caused by the variola virus. Historically, nearly a third of those who became infected by variola died. Those who survived suffered scarring from the skin lesions or developed other disabilities, including blindness.
Variola is transmitted most readily by person-to-person contact, not unlike the common cold virus. Once exposed to the virus, the incubation period is generally seven to 17 days.
The smallpox illness is characterized by a high fever, fatigue, headaches and backaches. Its most notable feature is a rash that starts as small red spots on the tongue and in the mouth. These spots develop into sores that break open and spread large amounts of the virus into the mouth and throat. About this time the rash also starts showing on the skin, first on the face, arms and legs before spreading rapidly to the trunk.
Initially this rash can be mistaken for chicken pox, a disease caused by the varicella virus. The typical chickenpox rash begins most prominently on the trunk of the body and moves outward to the extremities.
The smallpox rash turns into raised bumps that fill with thick, opaque fluid. The bumps then become pustules, sharply raised, round and firm to the touch. The pustules form a crust, then scab.
A person with smallpox is contagious and can pass the virus to others from the time of rash onset until the last of the pustules scabs over and the scabs fall off.
There is no cure for smallpox. Medical treatment includes supportive measures for the signs and symptoms. Since smallpox was declared eradicated in 1980, any outbreak of the disease is considered to be a worldwide health threat and most likely a terrorist event.
People who received the smallpox immunization in their youth may have some limited immunity from the virus. The CDC states that vaccination provides high-level immunity for three to five years and decreasing immunity thereafter. If a person is vaccinated again later, immunity lasts even longer.
The CDC has determined that receiving a smallpox vaccination before exposure is effective in preventing the disease about 95% of the time. Additionally, if a person is exposed to smallpox and receives the vaccine within three days, the effects of the disease can be minimized or prevented.
Some should wait on vaccinations
The smallpox vaccine is made from the cowpox virus, vaccinia, which is related to the smallpox virus but is much less harmful. Vaccinia is not smallpox, therefore a person getting the smallpox vaccine can't contract smallpox. However, vaccinia is a live virus that has risks.
The smallpox vaccination is administered using a bifurcated (two-pronged) needle that is dipped into a vial of the live virus. The needle is then used to prick the skin, usually on the upper arm, several times to cause a superficial wound.
If the vaccination is successful, a red and itchy bump develops at the vaccine site in three or four days. In the first week, the bump becomes a large blister, fills with pus and begins to drain. During the second week, the blister begins to dry up and a scab forms. The scab falls off in the third week, leaving a small scar.
Under routine conditions when there is no smallpox outbreak, the CDC has determined that certain people should not take the smallpox vaccination or should wait. For example, recent reports indicate that people with cardiac disease should not be vaccinated because fatal heart attacks have been linked to vaccinations in such patients.
People with skin conditions such as eczema or allergy-related dermatitis or a past history of either of these diseases shouldn't be vaccinated. Also, anyone with breaks in the skin such as an allergic rash, severe burn or severe acne, should wait to take the vaccine until the condition clears.
People with a weakened immune system from such conditions as HIV/AIDS or certain cancer treatments, as well as pregnant women, should not take the vaccine. Potential vaccinees who have close physical contact with anyone in these categories should be cautioned against taking the vaccine.
With these potential problems in mind, first responders should address specific questions about their personal conditions to their health care provider before accepting the vaccination.
During an actual smallpox outbreak, most of these restrictions may not apply. Getting smallpox is worse than most potential complications caused by vaccinating a person with one of these conditions.
First call puts knowledge to test
Education of emergency responders seems to be key in protecting them as they protect the public. As recently as a few months ago most members of Tampa Fire Rescue had little to no knowledge of smallpox, the vaccination process or its consequences. Now many members of the department have gleaned the knowledg