223.687.01 VACCINE POLICY ISSUES

Examines current national and international policy issues in vaccine research, development, manufacturing, supply, and utilization. Topics include development of orphan vaccines, ensuring an adequate supply of safe and effective vaccines, vaccine injury compensation, and disease eradication. Emphasizes the identification of important vaccine policy issues and the development and evaluation of policies to address these issues. Presents the roles, responsibilities, and policy positions of key immunization stakeholders via guest lectures by a wide array of experts who have worked for important vaccine groups (i.e., FDA, GAVI, Vaccine Industry, US Vaccine Injury Compensation Program, Consumer Group). Readings include relevant scientific papers and reviews, and publications of U.S. and international agencies.

Following this course, the students will be expected to: 1) identify the key stakeholders and institutions involved in formulating vaccine policy in the United States and globally; 2) describe the 'value chain' in vaccine policy domestically and globally as it progresses from basic research all the way to procurement and implementation; 3) describe the different factors that influence the policy-makers in each stage of the 'value chain' and the factors that constrain their ability to enact policy changes; and 4) use a 'policy analysis' perspective to analyze a vaccine policy issue and recommend a policy action.