COMMENTARY |
The US Smallpox Vaccination Plan
American Academy of Pediatrics, Committee on Infectious Diseases, Department of Pediatrics, Wake Forest University School of Medicine, Winston-Salem, NC 27157
American Academy of Pediatrics, Committee on Infectious Diseases, Department of Pediatrics, John Hopkins University, Baltimore, MD 21287
American Academy of Pediatrics, Committee on Infectious Diseases, Department of Pediatrics, Yale University School of Medicine, New Haven, CT 06510
Abbreviations: AAP, American Academy of Pediatrics
The American Academy of Pediatrics (AAP) recently published a policy statement on the use of the smallpox vaccine in children.1 This commentary expands on issues raised by Congress2 regarding the implementation of a smallpox vaccination program in children.
AAP policy states that children should not be offered the smallpox vaccine at this time. This recommendation is based on weighing the fact that infants and children are particularly vulnerable to serious complications caused by the smallpox vaccine, including death, versus the government’s own assessment that the current risk of a smallpox attack is low.3 When the risk of a smallpox attack is low, a ring-vaccination policy that includes a plan for rapid distribution of smallpox vaccine and strategies for urgent vaccination of large numbers of the population, if needed, is preferable to a voluntary or mass vaccination program. However, if the risk of attack increased or actually occurred, then a recommendation to vaccinate everyone, except those with high-risk contraindications, would make sense.
A pre-event voluntary vaccination program for the public, while appealing on the surface, makes the least sense from a public health and scientific standpoint and in actuality is a misnomer. Parents who did not want their child to be vaccinated could find that the child was accidentally inoculated via cross-inoculation from another vaccinated person. Before 1972, when smallpox vaccine was routinely used in those without a known contraindication, 
25% of people who developed serious side effects were those unintentionally inoculated. Semipermeable dressings are unlikely to be practical for large-scale vaccination because they are expensive, can cause allergic reactions and compliance with their proper use will vary. The large numbers of children currently in child care settings makes cross-inoculation even more likely.
Currently there is no Food and Drug Administration-licensed smallpox vaccine approved for use in children. Recent studies have shown that the 30-year-old Dryvax vaccine can be effectively administered to adults at a 1:5 dilution, but equivalent pediatric clinical trials have not been done. Furthermore, we are aware of planned studies in adults, but not in children, with the new tissue culture-derived smallpox vaccine. Both the AAP and the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention have recommended these studies be done in children. Childrens’ distinct physiologic responses must be studied before large numbers of children are exposed to the vaccine. In 1997, Congress passed the Food and Drug Administration Modernization Act so that children would be much less likely to receive drugs that had not undergone testing to ensure safety and effectiveness in children. Are we really willing to potentially allow >70 million children to be part of an emergency experiment because we did not do the necessary studies to prove that these smallpox vaccines are safe and effective in children?
The high cost of the smallpox vaccination program also impacts the health of children. Public health officials have indicated that the vaccination plan has already diverted funds from other health programs such as routine childhood immunization and some public health facilities may close altogether. Programs that protect against ongoing and preventable diseases should not be sacrificed for a currently nonexistent disease (ie, smallpox).
Advocates for children must ensure that the appropriate research, therapeutic provisions, and policies are in place to protect children against the threat of a biological, chemical, or nuclear attack, while continuing the programs needed to maintain the health of children. Anything less and the terrorist groups have already won a victory.
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FOOTNOTES |
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Received for publication Mar 17, 2003; Accepted Mar 17, 2003.
Address correspondence to Jon S. Abramson, MD, Department of Pediatrics, Wake Forest University School of Medicine, Department of Pediatrics, Medical Center Boulevard, Winston Salem, NC 27157-0001. E-mail: jabrams{at}wfubmc.edu
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REFERENCES |
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 TOP REFERENCES |
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- American Academy of Pediatrics, Committee on Infectious Diseases. Smallpox vaccine.
Pediatrics.2002; 110
:841
–845
[Abstract/Free Full Text] - Senate Committee on Health, Education, Labor and Pensions. Testimony regarding the United States smallpox vaccination policy. January 30, 2002
- Centers for Disease Control and Prevention. Summary of October 2002 ACIP smallpox vaccination recommendations. Atlanta, GA: US Department of Health and Human Services, Centers for Disease Control and Prevention; 2002. Available at: http://www.bt.cdc.gov/agent/smallpox/vaccination/acip-recs-oct2002.asp
PEDIATRICS (ISSN 1098-4275). ©2003 by the American Academy of Pediatrics
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