Since the terrorist attacks on the nation on September 11, 2001 and the anthrax attacks that followed, the United States government has had heightened concerns about the potential for agents such as smallpox, anthrax and plague being introduced into the United States as biological weapons.
Smallpox is a serious, highly contagious, and sometimes fatal infectious viral disease caused by the variola virus. Smallpox outbreaks have occurred episodically for thousands of years, but the disease became extinct after a successful worldwide vaccination program. The last naturally acquired case of smallpox in the United States was in 1949 and in the world was in Somalia in 1977. The last cases of smallpox, from laboratory exposure, occurred in 1978. In the United States, routine vaccination against smallpox ended in 1972 and the World Health Organization declared smallpox globally eradicated in 1980 (CDC, 2001 and October 2002a).
For research purposes, samples of the virus have been kept in research facilities in the United States and Russia, formerly the Soviet Union. There is concern that some of this research stockpile has been obtained by terrorist organizations. During the summer of 2002, Israel began immunizing emergency and healthcare workers against smallpox in anticipation of a possible bioterrorist attack. Smallpox remains a biological threat because of its potential ease of large-scale production (CDC, October, 2002b).
Smallpox is an acute communicable disease that has no proven treatment and a case fatality rate of up to 30% if spread through a population with no immunity. The average incubation period (the interval between exposure and first symptoms) is 10-14 days with a range as short as 7 days and as long as 19 days. The highest concentration of the variola virus is found in saliva and it can remain viable outside of the body for several days. Smallpox progresses through the following stages: incubation period, pre-eruption, macules, papules, vesicles, pustules, scabs and scars. In the pre-eruptive stage, the individual is very sick during the first two days, with a fever (38.5-40.5 °C or 101.3-104.9 °F) and malaise. The person becomes infectious with the onset of lesions that begin in the mouth, is most infectious during the first week and remains infectious until all scabs have separated, approximately 3-4 weeks after the onset of the rash (ACIP, 2001).
Healthcare practitioners must be prepared to recognize a vesicular rash as potentially smallpox (variola) and to initiate appropriate countermeasures. The only known reservoir for the variola virus is humans and the most frequent mode of transmission is person-to-person, spread through direct deposit of infective droplet nuclei onto the nasal, oral, or pharyngeal mucosal membranes, or the alveoli of the lungs from close, face-to-face contact with an infectious person. Transmission does not occur before the rash appears. The greatest risk of infection occurs among household members and close contact of persons with smallpox, especially those with prolonged face-to-face exposure.
Vaccination and isolation of contacts of cases at greatest risk of infection have been shown to successfully interrupt transmission of smallpox. In the past, poor infection control practices resulted in high rates of transmission in hospitals (ACIP, 2001). Droplet and airborne precautions with strict hand washing are needed for a minimum of 17 days following exposure for all persons in direct contact, especially the unvaccinated. The primary strategy to control an outbreak of smallpox and interrupt disease transmission is surveillance and containment, which previously included isolation of persons at risk of contracting smallpox and ring vaccination (ACIP, 2002a). This strategy involves identification of infected persons through intensive surveillance, contact tracing, isolation of infected persons, vaccination of household and other close contacts of the infected person (primary contacts) and vaccination of close contacts of the primary contacts (secondary contacts). This was the strategy that was instrumental in the ultimate eradication of smallpox as a naturally occurring disease.
There is no proven treatment for smallpox. Patients with smallpox benefit from supportive therapy (intravenous fluids, medicine to control fever or pain) and antibiotics for any secondary bacterial infections. Antivirals, such as Cidofovir, are under investigation. Infected patients will need to be admitted to hospitals and confined to rooms that are under negative pressure and equipped with high-efficiency particulate air filtration, with care being administered by vaccinated healthcare practitioners using gowns, gloves and masks.
On December 13, 2002, President Bush announced a national smallpox vaccination program to protect the American people against the threat of smallpox attack by hostile groups or governments. Under the plan, the Department of Health and Human Services (HHS) will work with state and local governments to form volunteer Smallpox Response Teams who can provide critical services to their fellow Americans in the event of a smallpox attack. To ensure that these teams can mobilize immediately in an emergency, healthcare workers, first responders and other critical personnel will be asked to volunteer to receive the smallpox vaccine.
The President also announced that the Department of Defense (DOD) would vaccinate certain military and civilian personnel who are or may be deployed in high threat areas. Some United States personnel assigned to certain overseas embassies will also be offered vaccination. While the federal government is not recommending vaccination for the general public at this time, HHS is in the process of establishing an orderly process to make vaccine available to those adult members of the general public without medical contraindications who insist on being vaccinated either in 2003 with an unlicensed vaccine or in 2004 with a licensed vaccine (CDC,2002c) The smallpox vaccine is a highly effective protection against the disease when given before or shortly after exposure to the virus. The government believes that pre-event vaccination of Smallpox Response Teams will allow it to better protect the American public against a smallpox attack. HHS is working with states to identify healthcare workers and first responders to serve on the Smallpox Response Teams.
Smallpox vaccination uses the vaccinia virus, not the variola virus, to confer immunity against smallpox. Smallpox vaccination occurs when the vaccine is scratched onto the superficial skin layer utilizing a bifurcated needle. The vaccination produces a reaction called a “take” that provides full immunity for 3-5 years, and then gradually fades. The vaccine protects 95% of those vaccinated and may provide some protection for years. The usual clinical response to vaccination includes significant itching at the inoculation site with the papule forming in three days with scab separation in 21 days, swelling and tenderness of the axillary nodes during the second week, and fever, malaise and body aches. It is anticipated that there will be 1 to 2 deaths per million vaccinated. If exposed to smallpox, one must be vaccinated, as the risks of the disease are far greater than the risks of vaccination. Vaccination within three days of exposure to smallpox provides protection and vaccination as late as five to seven days after exposure may reduce the fatality rate.
The major complications of smallpox vaccination include inadvertent autoinoculation, eczema vaccination, generalized vaccinia, progressive vaccinia, post-vaccinal encephalitis and other dermatological conditions. Vaccinia virus may be recovered from the site of vaccination from development of the papule and until the scab separates from the skin. Household contacts are at the highest risk of accidental contact transmission. Routine mass inoculation increases the rate of adverse reactions due to unrecognized contraindications. The contraindications and risk factors for vaccination include any history of eczema in the individual or household members; age less than one year; a history of sensitivity to polymycin B, neomycin, streptomycin, or tetracycline; pregnancy or breastfeeding, and immunosuppression (cancer disease/therapy, HIV, transplant) in the individual or household contacts. Vaccinia immune globulin (VIG), the immunoglobulin fraction of plasma from persons vaccinated with vaccinia vaccine, is generally effective in the treatment of eczema vaccinatum, progressive vaccinia, severe generalized vaccinia and ocular vaccinia.
In October 2002, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) made recommendations for the use of smallpox vaccine in case of a bioterrorist event. The federal government’s plan is based on these ACIP recommendations that include:
Since the ACIP recommendations and the Bush administration’s announcement of a smallpox vaccination program, nursing organizations and other healthcare groups have raised concerns about the plans. The American Nurses Association (ANA) in its testimony to the Institute of Medicine’s Committee on Smallpox Vaccination Program Implementation stated that ANA does not believe that the risks warrant vaccination of the general population in a pre-event scenario. ANA also raised concerns about the planned vaccination of registered nurses and other healthcare workers urging a more measured and deliberate process to ensure that the program is implemented appropriately and that the screening for those at risk is thorough. In January 2003, ANA requested that the Bush Administration delay the implementation of the first phase of the smallpox vaccination program.
The ANA stated that significant policy issues remain unresolved or not adequately addressed. These include: the potential transmission of the vaccinia virus to patients and family members; maintaining sufficient staffing during the voluntary, pre-event vaccination program; clarifying the “voluntary” nature of participation in the program; the right of coverage of medical costs associated with receiving the vaccine; utilization of safer bifurcated needles and the critical need to establish a monitoring, tracking and reporting system. In addition, the American Association of Occupational Health Nurses (AAOHN) has stated that it does not support vaccinating the general population unless a bioterrorism event has occurred. It also urges the Centers for Disease Control and Prevention to protect the health and safety of healthcare workers, by staggering the vaccination of the volunteer healthcare workers, providing proper training and use of personal protective equipment (PPE) and understanding the impact of the vaccination program upon staffing. AAOHN does support ring vaccination as an appropriate vaccination strategy for containing a smallpox outbreak.
The New York State Nurses Association (NYSNA) fully supports the nation’s efforts to achieve national emergency preparedness. The focus should be on establishing and supporting sound public health policy and avoiding attempts to politicize such an important issue.
Nurses have a long history of selflessly responding to disasters and emergencies. Nurses are an integral component of the nation’s healthcare system and can be expected to respond if the nation is confronted again with terrorism. Nursing care must be available to anyone who is a victim of bioterrorism.
In 2001, NYSNA’s Voting Body passed a resolution to support the availability of smallpox vaccine. ANA has been working closely with HHS to develop a National Nurse Response Team and NYSNA is participating in a similar effort with the NYS Department of Health to identify nurses who can respond to emergencies within New York State.
NYSNA commends the CDC’s efforts to make it a priority to address the multifaceted issues associated with bioterrorism events such as the re-introduction of smallpox. It is critical that the smallpox pre-event vaccination program not divert or diminish the nation’s resources and preparedness for essential public health services, as well as chemical, biological and radiological events or any other potential threat.
Registered nurses must be educated on how to respond to the use of biological agents or other weapons of mass destruction. Nurses understand that there are significant occupational health and safety risks that will need to be considered when deciding whether or not to be vaccinated for smallpox. ANA has developed a “decision-making tree” for nurses to utilize when considering volunteering to receive the smallpox vaccination.
NYSNA agrees with the federal and state governments that a single smallpox event will constitute a public health emergency that will need to be addressed immediately and aggressively with an appropriate vaccination program. In addition, as the government has begun vaccinating, it will be a public health necessity for some registered nurses and other healthcare workers to be vaccinated in order to provide care for those individuals who present with side effects or adverse reactions to the vaccine.
NYSNA shares the concerns of the American Nurses Association, other nursing and public health organizations and certain healthcare facilities and agencies that pre-event smallpox vaccination is not an intervention to be undertaken lightly or without a clear understanding of the benefits and risks of such a program to the health and safety of registered nurses, other healthcare workers and the public at large. There are substantial unresolved policy issues and serious potential health concerns that must be addressed before the New York State Nurses Association can support full implementation of the government’s proposed three-stage pre-event smallpox vaccination program.
The New York State Nurses Association (NYSNA) believes that:
Approved by the NYSNA Board of Directors, March 19-20, 2003
Advisory Committee on Immunization Practices (2001). Vaccinia (Smallpox) Vaccine:
Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR, June 22, 2001, 50 (RR10); 1-25.
Advisory Committee on Immunization Practices (2002a). Draft Supplemental Recommendations of the ACIP on the use of Smallpox (Vaccinia) Vaccine. April, 2002.
Advisory Committee on Immunization Practices (2002b). Summary of October, 2002 ACIP Smallpox Vaccination Recommendations. October, 2002
Centers for Disease Control and Prevention (CDC). Smallpox: What Every Clinician Should Know. Dec., 2001
Centers for Disease Control and Prevention (CDC) (2002a). Smallpox Vaccination and Adverse Events Training Module. October, 2002
Centers for Disease Control and Prevention (CDC) (2002b), Public Health Emergency Preparedness and Response. Smallpox Overview. October 24, 2002
Centers for Disease Control and Prevention (CDC) (2002c), Protecting Americans: Smallpox Vaccination Program. Health Alert Network, December 13, 2002.
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United States Army Medical Research Institute of Infectious Diseases (USAMRIID) (February, 2001). USAMRIID Medical Management of Biological Casualties Handbook (4th Edition).
Veenema, TG. The Smallpox Vaccine Debate. American Journal of Nursing. September, 2002. Vol.102, No.9, 33-38.
For more information on nursing practice, contact NYSNA's Education, Practice and Research Program at 518.782.9400, ext. 282 or by e-mail.