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

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 The announcement was moot, however, as the vaccine, RotaShield, had been withdrawn from the market a week earlier by its manufacturer.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.