A Special Report on Smallpox

Vaccination and Dressings

By Ron Stoker

Smallpox is probably the most devastating and contagious infectious disease in history.  The disease was eradicated more than two decades ago by a global vaccination program of unprecedented proportions.  Although the smallpox virus is technically extinct, its continued existence as a potential weapon of mass destruction is well documented.  

While the disease is devastating, with a mortality rate in excess of 30%, the vaccine is not without its own risks.    Those at risk include the healthcare provider, the recipient of the vaccination, and the vaccine recipient’s casual and intimate contacts.  Every vaccination needle contains live virus and presents an infection danger to the provider.   Every successful vaccination site is a vaccinia virus colony capable of spreading to other places on the recipient’s body or to other people from the recipient.  Vaccinia in the eyes can lead to blindness, in the nose to paralyzing encephalitis.  Some recent events indicate that it may cause transient endocarditis or even heart attacks.   If the vaccinia virus is transferred to young children, or to someone with a chronic skin disease or a compromised immune system--such as occurs with HIV and cancer and anti-rejection drugs--it can be fatal.

 The following presents a picture of smallpox’s virulence and some of its history.  It concludes by presenting two new devices introduced in March 2003 at the CDC Immunization Conference in Chicago.  These two devices promise to make the smallpox vaccination program safer for everyone involved. 

 During the 20^th Century, smallpox killed at least 300 million people. The disease had claimed around one billion lives before being declared extinct in 1980.  Smallpox has been found in ancient Egyptian mummies.  The disease has infected populations in every portion of the earth.  It was spread as part of the great Islamic expansion across North Africa and Spain.   The Crusades brought it to the rest of Europe.  The introduction of smallpox into the New World by infected Spaniards in 1518 precipitated a decline in the population of Mexico by almost 90% within a century. Explorers brought it to the American colonies where smallpox epidemics were devastating to the American colonists but were much worse for Native American populations.  Later, blankets purposefully contaminated with the disease were given to Native Americans in a shameful intentional act of biological warfare.

The smallpox virus is explosively contagious and travels through the air. Virus particles in the mouth become airborne when the host talks, sneezes, or coughs.    It only requires the inhalation of a single particle of smallpox to transmit the disease.   A person within six feet of an individual carrying the disease can inhale the aerosolized virus and manifest clinical smallpox.   The incubation period of smallpox is between 10 to 12 days.  Symptoms include fever and a pock-like rash all over the body, appearing between seven and 17 days after exposure to the virus. Individuals are contagious from the time the rash appears until the scabs fall off. A smallpox vaccination provided within four days of exposure will usually protect the person exposed.

 Exposed individuals feel fine during the incubation period. Symptoms typically begin with a high fever, backaches and vomiting. Then tiny red spots appear all over the body. The spots turn into exudate-filled blisters, called pustules.  As the pustules fill with exudate, the pressure increases. The pustules ultimately erupt, splitting horizontally and tearing away from the deeper layers. The pustules become hard and bloat up to the size of large peas. 

The overall mortality rate of infected individuals is 30-35% -- and higher during some epidemics.  The survivors are left with pockmarks covering their body. Many become seriously disfigured or paralyzed and some become permanently blind.  

Under normal conditions, the smallpox virus does not replicate nor does it survive long outside of an infected human host.  This one fact made it possible to eradicate the virus in nature.  During the mid-20^th century, a multi-governmental global cooperative vaccination effort eradicated the disease, which was declared extinct by the World Health Organization in 1980.

Officially, smallpox virus lives in only two repositories in the entire world. One smallpox repository is located at the Centers for Disease Control and Prevention in Atlanta, and the other can be found at State Research Institute of Virology and Biotechnology, located outside the city of Novosibirsk in Siberia.  Although only these two locations officially hold smallpox, it is feared that secret stockpiles exist. Government intelligence has indicated that smallpox was "weaponized" in Russia.  In fact, the former Soviet Union manufactured tons of smallpox virus. Much of this potent stockpile is currently unaccounted for. When the Soviet empire fell apart, much of the smallpox virus was sold and it is feared that it has ended up in the hands of terrorists. Recent news reports speculate that Iraq and North Korea could possess smallpox.

Since September 11, 2001, the fear of a biological weapons attack has increased anxieties of health and political leaders. The deliberate release of smallpox to create an epidemic   is now regarded as a real possibility. The United States has begun taking precautions to deal with this possibility.  The United States is not alone in this smallpox vaccination program.  In the last few months, Israeli officials and emergency workers have begun a rush smallpox vaccination program, based on fears they are in the range of Iraqi Scud missiles.  The NHS in the United Kingdom is working on a plan to vaccinate their entire population as well.

Vaccinating for  Smallpox was discontinued in the United States in 1973 since the vaccine itself caused adverse reactions in a small minority of patients and the disease was considered essentially extinct. Vaccinations in any event provide immunity only for 15 to 20 years, so all Americans are now susceptible to the disease.

Because the vaccination itself is not without risk, many initiatives have been taken by the Department of Health and Human Services to further enhance public health and medical capabilities for responding to a bio-terror attack. Among these was the procurement of substantial quantities of smallpox vaccine. Until now, the limited quantities of available vaccine have been reserved for emergency use to combat an outbreak should smallpox recur; small amounts have been made available to those working with pox viruses in laboratories. 

The CDC began shipping smallpox vaccine to some states on January 22, 2003, launching the first phase of a federal program to vaccinate a half-million U.S. healthcare workers. In addition, President Bush directed 500,000 members of the U.S. military to receive vaccinations against smallpox.

Because smallpox vaccinations can cause serious sickness or death in extremely rare cases, some healthcare workers have been thinking twice about getting inoculated.

As of early March, fewer than 22,000 individuals in the private sector in the United States had been vaccinated.  This is a big concern with the government. So far about 300,000 military personnel have been vaccinated.  Without more vaccinated nurses and doctors, there will not be enough personnel willing to treat smallpox patients or to vaccinate others in an outbreak of this deadly virus.

There is a great need for healthcare workers to be vaccinated.  Dr. William Bicknell of Boston University developed a computer program to estimate the size of a smallpox outbreak triggered by a terrorist attack.  He estimated that five terrorists, mixing with crowds at airports and subway stations in five different cities, could create 93,000 smallpox cases around the country in 30 to 40 days.  This scenario made Bicknell believe that federal officials are being far too conservative. He has recommended that a wider range of first responders--from the medical community to civil workers who keep a city running--be vaccinated. 

There are ways to minimize the dangers associated with the vaccination. People with low immunity can be screened out.  A special plastic bandage (see below) over the vaccination site can cut down on accidental infections.

The vaccinia virus is the live virus used in the smallpox vaccine. It is a virus, so closely related to smallpox that, when given to humans as a vaccine, it helps the body to develop immunity to smallpox. This vaccine, however, does not contain the smallpox virus and it cannot cause smallpox. The virus multiplies in the superficial layers of the skin, causing a pustule to form. The infection causes the body to produce protective antibodies that are effective in preventing smallpox.  In response to this infection, most patients experience only a mild fever and local discomfort usually accompanied by localized redness and swelling. Some, however, may have much more severe symptoms with a more extensive rash and pustules on other parts of the body. Occasionally, the vaccinia virus is transferred to persons with whom they have had close contact. Vaccinia can also infect those who touch someone else's vaccination site. The appropriate dressing of a smallpox vaccination site, therefore, becomes extremely important.

How is the Smallpox Vaccine Administered?

The following recommendations come from the CDC in regards to the proper method of vaccinating and dressing an injection site.

The bifurcated needle is dipped into the vaccine vial and withdrawn. The needle is designed to hold a small drop of vaccine.  The needle is held perpendicular to the site of insertion. The needle is pushed just under the skin 15 times in an area no larger than 5 mm in diameter.   The injections are vigorous enough so that a trace of blood flows from each insertion. The bifurcated needle should be discarded in an appropriate sharps container immediately after vaccinating each patient.

Following the vaccination, excess vaccine and blood on the patient’s arm should be absorbed with sterile gauze. The gauze should be discarded into a hazardous waste receptacle so that it will not contaminate and infect others who might come in contact with it. 

The vaccination site is then covered to prevent release of the vaccinia virus to other sites on the patient or to other individuals.  Hands should always be washed immediately after touching the site or materials that contacted the site such as dressings, and clothing, etc.

CDC recommends that clean or sterile gauze be loosely secured by tape.  Healthcare workers should cover the site with gauze and then a semi-permeable dressing during patient care activities.  The patient should be instructed to wear clothing that covers the site so that it will provide added protection.

One of the big concerns is the inadvertent infection of non-inoculated individuals.  In March 2003, the CDC reported that two women had contracted vaccinia infections of the eye as a result of contact with military personnel who had been vaccinated against smallpox. One of the two women that received the ocular vaccinia infection shared a bed with a military vaccinee several times over the three-week period after he was vaccinated. The vaccinee often left his vaccination site uncovered. The woman suffered swelling, pain, and a discharge in the right eye, progressing to facial swelling and impaired vision. She was hospitalized Feb. 22, 2003, and diagnosed with preseptal cellulitis.

The CDC also reported that an 18-year-old woman became ill after she handled the bandage of a military vaccinee. She developed skin pustules three and five days after contact, and then had swelling in her right eye eight days after contact.

Until a scab has formed, the vaccination site covered should be kept covered and the patient should be taught not to touch, scratch or rub the vaccination site. The patient should avoid touching, rubbing or otherwise performing any maneuvers that might transfer vaccinia virus to the eye or surrounding skin.   The dressing covering the vaccination site should be discarded appropriately.   After handling the vaccination site covering, the hands should be thoroughly washed with soap and running water or other hand disinfectant.  All contaminated materials should be should be placed in an appropriate biohazard container and treated as infectious waste.

NEW DRESSING PROTECTS PATIENTS AND OTHERS

Two innovative new products that can be used to make smallpox vaccinations safer were introduced in March at the 2003 CDC National Immunization Conference.  The new dressings, the Invasive Site Patch™ and After-Patch from Biomedical Safety Technologies, LLC, were designed to make the smallpox vaccination safer.  Using a new medical concept called "Pre-Procedure Bandaging," or “Preemptive Bandaging™”  the Invasive Site Patch covers a proposed injection or procedure site prior to the procedure. The dressing enhances provider and patient safety from needlestick injury and exposure to bloodborne pathogens, because completion of bandaging the site occurs within an instant after the procedure is completed.

The Invasive Site Patch™  (ISP™) is a simple, elegant solution to protect healthcare workers, patients receiving vaccinations, and others. The steps of use are very simple.  First, the patch is placed on the vaccination site by peeling off the backing and adhering the patch to the patient. In the center of the patch is an open window . (See figure 1)

The healthcare worker inoculates the patient through this open window.  The door is then closed to isolate the site  (See Figure 2)

With the site fully protected by a viral barrier of polyurethane, the practitioner’s full attention can be focused on the proper disposal of the contaminated sharp. Once the contaminated sharp is safely disposed of, a tab on the patch door is pulled to permanently seal the door over the vaccination site.  Using the ISP, the entire vaccination process can be completed safely, in less than one minute.

Just as the ISP protects the site during and for several days after the vaccination, the After-Patch protects the smallpox vaccination site while the pustule is maturing until the scab falls off.  The After-Patch provides a polyurethane film and polyethylene protective-cap viral barrier over the site (See Figure 4)

The clear, hard plastic site protects the site from impact and keeps the virus in. Developed with the cooperation of the U.S. Military, the After-Patches were designed to protect the vaccination sites of soldiers and police whose jobs put the delicate pustules most at risk.

The polyethylene cap deflects most impacts that might otherwise crush or rupture the pustule.  In addition, using a capillary action system, it also redirects moisture from the center where the lesion resides, to the periphery to keep the site as dry and undisturbed as possible. 

Biomedical Safety Technologies is making the two patches available as a kit which also includes biohazard bags so that the used patches can be disposed of safely.

Victoria Yeatts, RN BSN, a Clinical Services Manager, of Garland, Texas, recently used this product to vaccinate healthcare workers.   She said, “The…dressing has met our expectations primarily in securing our 'peace of mind' of keeping any vaccinia viral particles encapsulated within the dressing, while attending to our patients, and again around our household members.  The dressing does not need to be changed on a daily basis and, therefore, keeps any exposure down to a minimum – as well as the cost of having to change a daily dressing.”  

“Having a window to view the lesion on a daily basis allows healthcare workers the ability to keep the dressing intact and still assess the site without consuming a lot of time to change the dressing. “

Hoping that our worst fears will not be confirmed

We all hope and pray that terrorists do not do the unthinkable.  The events of past few years with September 11^th, and the anthrax scare, however, should help us to take pause and to apply the adage “an ounce of prevention is worth a pound of cure.”   With smallpox there is no cure.  More than 30% of those infected will die. Homeland security has taken the position that the appropriate action is to prepare for a smallpox attack.   A universal vaccination program would protect a majority of the population and render smallpox virus impotent as a weapon of mass destruction.    

It is important to minimize any accidental vaccine cross-vaccination to other sites from the transfer of vaccinia virus from the primary site to other parts of the body or to other individuals.  This is the most frequent complication of smallpox vaccination accounting for approximately half of all complications of primary vaccination and revaccination.  These complications can be reduced dramatically by the use of innovative safety products.

These new safety products not only protect but increase efficiency.  The time needed for healthcare workers to vaccinate more than 200 million people could be cut in half.  In a post-event, emergency vaccination program, that could translate into saving hundreds of thousands of lives.  

Using current dressings, a healthcare worker must maintain possession of the contaminated sharp until the dressing is completed.  Needlestick injuries will increase in direct proportion to the amount of time the needle is in the possession of the practitioner, especially if the focus of that practitioner is on dressing the site rather than on the sharp. If the healthcare worker focuses first on disposing the sharp, the patient is left unattended by the practitioner for a time with the fresh vaccination site exposed.    Unfortunately, in this scenario, the patient has ample opportunity to scratch or touch the site and spread the vaccinia and/or blood to other surfaces or other parts of their bodies.  Once the hands are contaminated, a touch to the eyes can result in blindness, a finger in the nose can proceed to encephalitis or the patient could spread the pathogens to intimate or even casual contacts.  The Injection Site Patch decreases the required sharp possession time to almost zero.

One thing we know, when the vaccines are given, there will be problems; our responsibility is to minimize the dangers the best we can. The potential 250 million citizens needing vaccinations in a short period of time provides countless opportunities for something to go terribly wrong.  Healthcare agencies must decrease the dangers inherent in the vaccination process and stay in compliance with the laws that mandate needlestick and bloodborne pathogen safety. New safety dressings are one tool that can help to minimize those dangers.

Author bio:

Ron Stoker, a frequent contributor to Managing Infection Control magazine, is the Executive Director of ISIPS, the International Sharps Injury Prevention Society.  He is a frequent speaker on sharps safety and occupational blood exposure at national and international events. For more information about ISIPS and sharps safety products, visit www.isips.org, or email Mr. Stoker at ron@isips.org.