170474 Eliminating risk: Rotavirus, vaccine safety, and global health policy

Tuesday, October 28, 2008: 9:15 AM

Jason L. Schwartz, MBE, AM , Center for Bioethics and Department of History & Sociology of Science, University of Pennsylvania, Philadelphia, PA
On October 22, 1999, an influential advisory committee at the U.S. Centers for Disease Control and Prevention announced that it no longer recommended the use of a vaccine against rotavirus, a leading cause of severe pediatric gastroenteritis and death worldwide. Data compiled in the months prior to this decision suggested an increased likelihood of intussusception, a very rare but potentially fatal intestinal blockage, among recipients of the vaccine. These findings were pointed to by CDC as the sole reason for their action. The announcement was moot, however, as the vaccine, RotaShield, had been withdrawn from the market a week earlier by its manufacturer. A close analysis of the RotaShield story – the questions asked by policymakers and scientific experts, the questions omitted, the discussions held, and the decisions made – reveals a great deal about the values and principles that shape the role of vaccines in U.S. public health efforts. The events provide insight into the ways in which scientific experts grapple with issues of risk, safety, and ‘acceptable risk', doing so in a tense political environment and under the constant gaze of vocal critics. Likewise, the RotaShield story provides a particularly clear example of the immense influence of U.S. health policy decisions on the global health landscape, even when epidemiological and other circumstances might suggest the need for different responses in different parts of the world. This paper will use the story of RotaShield to explore these questions and their implications for public health and global health efforts.

Learning Objectives:
1. Articulate the major events and decisions that led to the withdrawal of the first rotavirus vaccine. 2. Discuss the risk analysis performed by officials at the Centers for Disease Control and Prevention when examining reports of vaccine-associated adverse events. 3. Describe and evaluate the framework by which issues of vaccine risk and safety vaccines are considered by federal public health officials. 4. Recognize how decisions by public health policy-makers in the United States regarding the use of vaccines can impact global health through the subsequent actions of international officials.

Keywords: Immunizations, Rotavirus

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I have been studying and writing about vaccine ethics, history and policy for several years, including organizing a series of international meetings on these topics, co-authoring the chapter titled "Ethics" in the most recent edition of _Vaccines_ (Plotkin, Orenstein, Offit, eds.), and being the first author of an analysis of HPV vaccine policy in the December 2007 issue of _Clinical Pharmacology and Therapeutics_.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.