Humanitarian Resource Institute:  A U.S. & International Resource on the Scope of Humanitarian Assistance
March 16, 2003

Stephen M. Apatow
Director of Research and Development 
Humanitarian Resource Institute Biodefense Reference Library
Eastern USA: (203) 668-0282   Western USA: (775) 884-4680

Smallpox Discussion: Organ Transplants, Congenital or Acquired Immunodeficiencies, HIV

The article "Preventing a WMD September 11" (discussion points related to international law) [1] references smallpox and the potential international threat associated with bioterrorism:

The dialogue established during the development of this presentation has drawn attention to several areas that need to be addressed on the World Health Organization level.  Key issues associated with a bioterrorism response plan to smallpox encompasses complex challenges for persons with organ transplants, congenital or acquired immunodeficiencies and HIV. 

In the United States, according to the October 2000: Youth and HIV/AIDS 2000 Report:

Since 1996, an estimated 80,000 teens and young adults have become infected with HIV in the United States and out of 40,000 new HIV infections every year, government officials estimate that 50% of the cases occur in young people between the ages of 13 to 24. [2]

According to the U.S. Centers for Disease Control:

In the presence of an outbreak, everyone who has been in contact with a case of smallpox or determined to have been exposed to a biological weapon disseminating the smallpox virus is advised to get smallpox vaccine regardless of medical condition.

In the absence of exposure, smallpox vaccination is not recommended for persons with compromised cell-mediated immunity (CMI), including organ transplant recipients [3], immune deficiency, including those with congenital or acquired immunodeficiencies [4], persons with HIV infection regardless of CD4 cell count [5].

Points of concern:

A. For patients who cannot mount an antigenic response due to severe immunodeficiency, the prophylactic use of VIG would be considered (but this presupposes an adequate supply and must be done with the knowledge that there is no experience or FDA approval for VIG use in this manner). The current supply of VIG is limited to 600 doses and is controlled by the CDC [4]. 

VIG is in very short supply and, in fact, the value of its administration as a prophylactic agent has never been demonstrated.  VIG itself has adverse reactions associated with it.

According to the world Health Organization:

Vaccination is contraindicated for certain groups. These include pregnant women, persons with immune disorders or experiencing therapeutically-induced immunosuppression, persons with HIV infection, and persons with a history of eczema. 

Should national authorities decide that the risk of epidemic spread is so great that such groups should receive protection, it may be advisable to attempt to limit adverse effects through intramuscular administration of vaccinia immune globulin, if available, from vaccinia-infected sheep or calves. 

B. HIV screening should be available IF REQUESTED BY THE PARTICIPANT and that rapid tests for HIV should be considered if available and FDA approved. [If the person chooses not to be HIV tested, is HIV positive and receives vaccine they will be at risk for (1) activation of CD4 cells that harbor HIV, thus increasing HIV viral load and (2) progressive enlargement of the primary site of inoculation and viremic spread to other sites with new disseminated lesions [5]. 

Clarification of the potential benefit of VIG appears to be of vital importance as does the production of adequate resources that might be needed to minimize the complications associated with a vaccination strategy.

The complexity of the comparative risk analysis in the presence of an outbreak, with everyone who has been in contact with a case of smallpox or determined to have been exposed to a biological weapon disseminating the smallpox virus being advised to get smallpox vaccine regardless of medical condition, includes the following:

1.  The severity of a smallpox infection in the patient with Congenital or Acquired Immunodeficiencies, HIV (mortality rate very high causing an intensification of the infection impacting transmission rate/spread, containment and control of an outbreak).
2. Vaccination: The risk is presumably greatest in patients with a CD4 count <50 cells/mm3 and may be minimal in those with CD4 counts >200 cells/mm3, though there is no data to support this supposition.  There is one case report of progressive vaccinia in a 19-year-old military recruit who received  smallpox vaccination in 1984, before HIV serology was available [N Engl J Med 1987;316:673]. In the review of this experience, it was later estimated that about 350 other HIV-infected military recruits had received smallpox vaccination without known complications [7]. 

AIt is critical that solid contingency plan exists for a vaccination strategy, potential complications, containment, control and eradication in countries with high rates of HIV infection  including African countries south of the Sahara, South or South-East Asia, Eastern Europe, Caribbean or Latin America.


1. Stephen M. Apatow, Preventing a WMD September 11, Humanitarian Resource Institute Legal Resource and Assistance Center.
2. October 2000: Youth and HIV/AIDS 2000 Report, White House Press Office.
3. Smallpox Vaccination and the Patient with an Organ Transplant, Lesia K. Dropulic, MD and John G. Bartlett, MD. 
4. Smallpox Vaccination and the Patient with Congenital Or Acquired Immunodeficiency, Jerry Winkelstein, MD, Howard Lederman, MD, PhD, and John G. Bartlett, MD.
5. Smallpox Vaccination and the Patient with HIV/AIDS, John G. Bartlett, MD.
6. WHO Fact Sheet on Smallpox, October 2001.
7. Smallpox Vaccination and HIV Infection, John G. Bartlett, M.D. 

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