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No Small Issue: the Smallpox Vaccine

Bioterrorisrnlnational security and smallpox vaccine issues were also raised at the conference. The National Vaccine Information Center is concerned with the govermnent's mass release of the live smallpox vaccine before there is a confirmed smallpox virus release by terrorists. The Advisory Conunittee on hmmmization Practices (ACIP) of the CDC recommendations state that under current circmnstances, with no confirmed smallpox, and the risk of an attack assessed as low, vaccination of the general population is not recommended, as the potential benefits of vaccination do not outweigh the risks of vaccine complications.11 The NVIC reportl2 warns of the following risk factors: - Very serious complications are likely in) in 4,000 persons who get vaccinated.I3 If 280 million Americans were vaccinated pre-attack, there could be a mininllnn of 70,000 people who risk injury or death, requiring vaccinia inunune globulin (VIG) emergency therapy.12 Currently, there is enough VIG available to treat about 600 serious adverse events. Contracts for additional supplies ofVIG are in progress.11 - Almost all who get vaccinated will suffer some kind of mild to moderate reaction, which may include high fever, fatigue, irritability, and swollen lymph glands. More serious smallpox vaccine complications include encephalitis; progressive vaccinia leading to death after the internal organs, tissue, and bones disintegrate; eczema resembling third-degree burns; and smallpoxlike lesions.13 Approximately half of all smallpox vaccine complications are for "autoinoculation," in which the recently vaccinated person touches or scratches the lesion at the site and spreads the live vaccinia virus to the eye, nose, mouth, or genitalia where more lesions form. The CDC reports that autoinoculation occurs in 1 in 1,890 first-time vaccinations.14 The risk of serious adverse events with currently available vaccines is assumed to be similar to those previously observed and could be higher today due to the increased prevalence of persons with altered inunune systems.11 - The recently vaccinated become infected with the vaccinia virus-the live virus used in the vaccine--and can transmit it to others by direct person-to-person and close contact (within 6 feet) through autoinoculation.15 - Children today receive up to 37 doses of multiple vaccines in early childhood.I6 fu 1971, most American children were only receiving DPT, polio, measles, and rubella vaccines.17 The currently available smallpox vaccine was never tested for safety or efficacy,I4,18 and there is no information on how the vaccine will interact with the many other vaccines routinely given to American children today or how it will impact their long-term health. Those genetically or otherwise biologically vulnerable to vaccine-induced neuroinunune dysfunction will be at special risk. 12 CDC warns that some people are at greater risk for serious side effects from the smallpox vaccine. Unless they have been exposed to the smallpox virus, individuals who have the following conditions, or who live with someone who does, should NOT get the smallpox vaccine:19 - People with a weakened inunune system. Cancer treatment, an organ transplant, IllV, or medications to treat autoimmune disorders and other illnesses can weaken the inunune system.19 - Women who are pregnant or who may become pregnant within a month of vaccination because of the risk of developing fetal vaccinia-a very rare, but serious, complication of smallpox vaccination during pregnancy or shortly before conception.15 - Smallpox vaccine should not be administered to people with a history of eczema or atopic dermatitis, irrespective of disease severity or activity, and to their household contacts, due to the increased risk fromwplantation of vaccinia, virus into the diseased skin, sometimes with a fatal outcome. 15 - Persons with other acute, chronic, or exfoliative conditions (e.g., burns, impetigo, varicella zoster, herpes, severe acne, or psoriasis) are at higher risk for in.advertent inoculation and should not be vaccinated until the condition resolves. Reports show that persons with Darier's disease can develop eczema vaccinatnm and therefore should not be vaccinated.15 In addition, individuals should not get the smallpox vaccine if they: - Are allergic to the vaccine or any of its ingredients. - Are currently breastfeeding. - Are younger than 12 months of age. However, the ACIP advises against non-emergency use of smallpox vaccine in children younger than 18 years of age. 19 The CDC reports that about 1 in 2,500 infant vaccinations results in generalized vaccinia infection and about 1 in 24,000 results in brain inflauunation.14 - Have a moderate or severe short-term illness. These people should wait until they are completely recovered to get the vaccine.19 Currently, there are no licensed smallpox vaccines. Smallpox vaccines previously produced by Wyeth (Dryvax) and AventisPasteur are available under fuvestigationalNew Drug (IND) protocols held by CDC. :Both vaccines were prepared from calf lymph with a seed virus derived from the New York City Board of Health (NYCBH) strain of vaccinia virus. fu October 2001, the federal govermnent contracted with Acambis and AcambisBaxter Pharmaceuticals for at least 209 million doses of smallpox vaccine produced in cell-culture. These vaccines use a clone of the same NYCBH strain of vaccinia virus.11

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