Tuesday, March 18, 2008

Update from the Vaccine Analytic Unit (VAU): A Unique Post Marketing Vaccine Safety Research Infrastructure Using the Defense Medical Surveillance System (DMSS)

Michael M. McNeil1, Susan Duderstadt2, Jill C. Davila2, Jennifer Sabatier2, Yujia Zhang2, Guihua W. Ma2, and Andrew N. Hill2. (1) Division of Bacterial Diseases, CDC, MS C-25 CDC, 1600 Clifton Road NE, Atlanta, GA, USA, (2) Division of Bacterial Diseases, CDC/Logistics Health Inc, MS C-25 CDC, 1600 Clifton Road NE, Atlanta, GA, USA

Learning Objectives for this Presentation:
By the end of the presentation participants will be able to describe the role of the VAU in vaccine safety and the status of the projects.

The VAU is a collaboration between CDC, DoD and FDA to assess unusual, longer term anthrax vaccine adverse events utilizing the DMSS. The VAU is a critical component of the CDC's Anthrax Vaccine Safety and Efficacy Research Program.

The DMSS is an active surveillance system administered by the DoD to integrate data from military treatment facilities, vaccination centers, and military personnel offices worldwide. Inpatient and outpatient diagnosis data are coded using ICD-9-CM codes. The DMSS is a valuable resource for investigating vaccine adverse events. The DoD also maintains a serum repository, which holds great potential for the assessment of specific identified adverse events for biologic plausibility and possible causative mechanisms.

All U.S. active duty and reservist service personnel.

Project Description:
The VAU's research agenda was established with input from the NVAC. Completed and ongoing research activities include quality assessments of immunization data in DMSS, database hypothesis testing studies (optic neuritis, concurrent vaccinations, type 1 diabetes mellitus, and atrial fibrillation), and a pilot hypothesis generation/data mining study to evaluate a possible association of concurrent vaccinations and military hospitalizations. Ongoing and planned activities include hypothesis testing studies with medical chart diagnostic validation (Stevens Johnson syndrome, diffuse connective tissue diseases, and Guillain Barré syndrome) and an evaluation of Rapid Cycle Analysis for vaccine adverse event monitoring in DMSS.

Results/Lessons Learned:
The VAU has increased understanding of the safety profile of anthrax vaccine and complements other post-marketing vaccine safety systems (Vaccine Adverse Event Reporting System and the Vaccine Safety Datalink). The VAU shows great potential for conducting timely investigations to assess whether specific adverse events are associated with anthrax or other biodefense vaccines.