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November 6, 2002

U.S. IMMUNIZATION NEWS

"Proposal to Test Smallpox Vaccine in Young Children Sets Off Ethics Debate" New York Times (www.nytimes.com) (11/05/02) P. A14; Stolberg, Sheryl Gay

The Food and Drug Administration is taking public comment on a proposal to test the smallpox vaccine--which is a live-virus vaccine that carries a risk of serious complications and even death--on toddlers and preschoolers, due to widespread ethical debate concerning the issue.  The study, if approved, will involve 40 children between the ages of two years and five years at Children's Hospital Medical Center and Harbor-UCLA Medical Center.  The study will require the children to stay home for a month following the vaccination to ensure that the vaccinia virus does not spread.  The tested vaccine will come from a stockpile made by Wyeth-Ayerst and will determine if diluted versions of the vaccine remain effective against the disease; similar adult trials are already underway.  The debate will focus on whether the risk to the children in the study is greater than the need to test the vaccine and prepare for bioterrorism.

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