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April 26, 2006

Smallpox Vaccinations and Adverse Events

Author Affiliations

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

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

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.

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