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Monitoring Anthrax Vaccine Adverse Events Defense Medical Surveillance System (DMSS)

Monitoring Anthrax Vaccine Adverse Events Defense Medical Surveillance System (DMSS). Michael McNeil, MD, MPH National Immunization Program NVAC, February 4 th , 2004. Background.

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Monitoring Anthrax Vaccine Adverse Events Defense Medical Surveillance System (DMSS)

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

  2. 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. Purpose • To perform hypothesis testing and hypothesis generation with the DMSS • Examine the possibility that long term adverse effects are associated with AVA

  4. Overview of the DMSS Project • How were the Topics Selected? • Potential Topics • Criteria for Prioritizing Topics • Suggested Priority Topics • Timeline • Next Steps

  5. 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. Possible Topics for Investigation Endocrine SystemIntegument System Diabetes mellitus Rash with mucosal involvement Nervous SystemMusculoskeletal System Peripheral neuropathy Joint disorders Guillain-Barre Syndrome Myositis Demyelinating conditions

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

  8. Criteria for Prioritizing Topics • Frequency of Occurrence • Feasibility • Severity of Effect • Likelihood of Association • Programmatic Interventions • Public Health Concern

  9. 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. Proposed High Ranking Topics for Full Protocols • Arthritis • Erythema multiforme • Optic neuritis • Systemic lupus erythematosus • Multiple immunizations

  11. Timeline for the NVAC Vaccine Analytic Unit Workgroup • NVAC Meeting • Select members • Topic papers • Prioritize topics • Protocol Review (June 2004) June 2004 February 2004 June 2003 July 2003

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

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