1. DEPARTMENT OF HEALTH AND HUMAN SERVICES Monitoring Anthrax Vaccine Adverse Events Defense Medical Surveillance System (DMSS) Michael McNeil, MD, MPH National Immunization Program NVAC, February 4 th, 2004

2. DEPARTMENT OF HEALTH AND HUMAN SERVICES Background  CDC was charged by Congress to undertake collaborative studies regarding the safety and efficacy of the anthrax vaccine adsorbed (AVA)  NIP is working collaboratively with the DoD and FDA to investigate potential adverse events associated with AVA using the DoD’s Defense Medical Surveillance System (DMSS) database

3. DEPARTMENT OF HEALTH AND HUMAN SERVICES Purpose  To perform hypothesis testing and hypothesis generation with the DMSS  Examine the possibility that long term adverse effects are associated with AVA

4. DEPARTMENT OF HEALTH AND HUMAN SERVICES Overview of the DMSS Project  How were the Topics Selected?  Potential Topics  Criteria for Prioritizing Topics  Suggested Priority Topics  Timeline  Next Steps

5. DEPARTMENT OF HEALTH AND HUMAN SERVICES Sources for Topic Selection:  Institute of Medicine (IOM)  Anthrax Vaccine Expert Committee (AVEC)  Vaccine Adverse Event Reporting System (VAERS)  Medical and Public Health Literature  Vaccination Healthcare Center (VHC)  CDC, FDA, DoD  Public Opinion

6. DEPARTMENT OF HEALTH AND HUMAN SERVICES Possible Topics for Investigation Endocrine SystemIntegument System Diabetes mellitus Rash with mucosal involvement Nervous SystemMusculoskeletal System Peripheral neuropathyJoint disorders Guillain-Barre SyndromeMyositis Demyelinating conditions

7. DEPARTMENT OF HEALTH AND HUMAN SERVICES Possible Topics for Investigation Cardiovascular System Atrial fibrillation Vasculitis Psychiatric Disorders Mood disorder Other Topics Syndromic illness Loss of duty Death Medical encounters Unintentional injury

8. DEPARTMENT OF HEALTH AND HUMAN SERVICES Criteria for Prioritizing Topics  Frequency of Occurrence  Feasibility  Severity of Effect  Likelihood of Association  Programmatic Interventions  Public Health Concern

9. DEPARTMENT OF HEALTH AND HUMAN SERVICES Additional Considerations  Strengths and limitations of database  Effect of weighting (e.g., injuries)  Effect of deployment (e.g., atrial fibrillation)  Other topics (e.g., systemic lupus erythematosus, multiple immunizations)

10. DEPARTMENT OF HEALTH AND HUMAN SERVICES Proposed High Ranking Topics for Full Protocols  Arthritis  Erythema multiforme  Optic neuritis  Systemic lupus erythematosus  Multiple immunizations

11. DEPARTMENT OF HEALTH AND HUMAN SERVICES Timeline for the NVAC Vaccine Analytic Unit Workgroup  NVAC Meeting  Select members  Topic papers  Prioritize topics February 2004 July 2003 June 2003 June 2004  Protocol Review (June 2004)

12. DEPARTMENT OF HEALTH AND HUMAN SERVICES Next Steps  Continue DMSS data validation  Award contract for chart abstraction  Draft full protocols for selected topics for IRB approval/clearance  Continue NVAC workgroup review

13. DEPARTMENT OF HEALTH AND HUMAN SERVICES Acknowledgements DOD Mark Rubertone John Grabenstein John Brundage DMSS Staff CDC Ben Schwartz Dan Payne Chuck Rose Stacey Martin Aaron Aranas Laura Franzke Paul Stehr-Green Roseanne English- Bullard FDA Bob Ball Dale Burwen Jane Woo FOH Wayne Grant Richard Horn AVEC VHC