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Smallpox Vaccinations and Adverse EventsSmallpox Vaccinations and Adverse Events

JAMA. 2006;295(16):1897-1898. doi:10.1001/jama.295.16.1897-c
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AUTHOR INFORMATION

Letters Section Editor: Robert M. Golub, MD, Senior Editor.

SMALLPOX VACCINATIONS AND ADVERSE EVENTS

To the Editor: Dr Casey and colleagues1 describe 100 serious adverse events, including 3 deaths, in US volunteer civilian smallpox vaccinees that were reported to the Vaccine Adverse Event Reporting System between January and October, 2003. Although the authors state that these associations may not be causal, their characterization of these as “low rates” does not address the point that any adverse event may have been unnecessary. World Health Organization policy opposed pre-event smallpox vaccination.2 Only a few months before the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practice changed its policy,3 it too recommended no vaccination (other than for personnel working with the virus) unless a smallpox case was found because “ . . . the vaccine effects are acceptable only in the face of disease.”4 We are not aware of new evidence of risk to justify the reversal of this long-standing policy. A committee of the Institute of Medicine has described “ . . . lingering confusion about the vaccination program's aims.”5 Without evidence of benefit, the program should not have happened and no adverse events risked.

Financial Disclosures: None reported.

This letter was shown to Dr Casey, who declined to reply on behalf of the authors.—ED.

References
Casey CG, Iskander JK, Roper MH.  et al.  Adverse events associated with smallpox vaccinations in the United States, January-October 2003.  JAMA. 2005;2942734-2743
PubMed
Brundtland GH. Statement to the press by the Director-General of the World Health Organization, Dr Gro Harlem Brundtland, October 26, 2001. Available at: http://www.who.int/inf-pr-2001/en/state2001-16.html. Accessed February 28, 2006
Wharton M, Strikas RA, Harpaz R.  et al. Advisory Committee on Immunization Practices; Healthcare Infection Control Practices Advisory Committee.  Recommendations for using smallpox vaccine in a pre-event vaccination program: supplemental recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Healthcare Infection Control Practices Advisory Committee (HICPAC).  MMWR Recomm Rep. 2003;52(RR-7)  1-16
PubMed
Centers for Disease Control and Prevention Advisory Committee on Immunization Practice.  Records of the meeting held on February 20-21, 2002, Atlanta, Georgia. Available at: http://www.cdc.gov/nip/ACIP/minutes/acip-min-feb02.pdf. Accessed December 8, 2005
Institute of Medicine; Committee on Smallpox Vaccination Program Implementation, Board on Health Promotion and Disease Prevention.  Review of the Centers for Disease Control and Prevention's Smallpox Vaccination Program Implementation. Washington, DC: National Academy Press; 2003

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Casey CG, Iskander JK, Roper MH.  et al.  Adverse events associated with smallpox vaccinations in the United States, January-October 2003.  JAMA. 2005;2942734-2743
PubMed
Brundtland GH. Statement to the press by the Director-General of the World Health Organization, Dr Gro Harlem Brundtland, October 26, 2001. Available at: http://www.who.int/inf-pr-2001/en/state2001-16.html. Accessed February 28, 2006
Wharton M, Strikas RA, Harpaz R.  et al. Advisory Committee on Immunization Practices; Healthcare Infection Control Practices Advisory Committee.  Recommendations for using smallpox vaccine in a pre-event vaccination program: supplemental recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Healthcare Infection Control Practices Advisory Committee (HICPAC).  MMWR Recomm Rep. 2003;52(RR-7)  1-16
PubMed
Centers for Disease Control and Prevention Advisory Committee on Immunization Practice.  Records of the meeting held on February 20-21, 2002, Atlanta, Georgia. Available at: http://www.cdc.gov/nip/ACIP/minutes/acip-min-feb02.pdf. Accessed December 8, 2005
Institute of Medicine; Committee on Smallpox Vaccination Program Implementation, Board on Health Promotion and Disease Prevention.  Review of the Centers for Disease Control and Prevention's Smallpox Vaccination Program Implementation. Washington, DC: National Academy Press; 2003
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