# Presentation: 351043

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

**Michael McNeil, MD, MPH**
**National Immunization Program**
**NVAC, June 4****th****, 2003**

## Overview of the DMSS Project

**How were the topics selected?**
**Potential Topics**
**Criteria for Prioritizing Topics**
**Timeline**
**Next Steps**

## Sources for Topic Selection:

**Institute of Medicine (IOM)**
**Anthrax Vaccine Expert Committee (AVEC)**
**Vaccine Adverse Event Reporting System (VAERS)**
**Medical and Public Health Literature**
**CDC, FDA, DoD**
**Public Opinion**

## Possible Topics for Investigation

_**Endocrine System**_**	****	**_**Integument System**_
**Diabetes mellitus ****	****	****Rash with mucosal ****	****	****	****	****	****	****involvement**
_**Nervous System**_**	****	****	**_**Musculoskeletal System**_
**Peripheral neuropathy****	****	****Joint disorders**
**Guillain-Barre Syndrome****	****Myositis**
**Demyelinating conditions**

## 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**

## Potential Criteria for Prioritizing Topics

**Frequency of Occurrence**
**Feasibility**
**Severity of Effect**
**Likelihood of Association**
**Programmatic Interventions**
**Public Health Concern**

## Frequency of Occurrence

**Reports from VAERS**
**Reports from DMSS**
**Reports from other sources**

## Feasibility

**Well-characterized natural history**
**Established pathophysiology**
**Practical issues (e.g., obtaining medical charts)**
**Basis for making the diagnosis**
** ****Subjective (e.g., symptoms)**
** ****Objective findings (e.g., laboratory tests)**

## Feasibility (cont’d)

**Universally accepted case-definition**
** ****Specificity**
** ****Sensitivity**
** ****Positive predictive value**
**Existence of a specific ICD-9 code**
**Identifiable/available study and comparison groups of adequate size**
**Ethical concerns**

## Severity of Effect

**Acute vs. chronic course**
**Impact on functional status and/or quality of life**
**Life-threatening**
**Hospitalization**

## Likelihood of Association or Causation

**Published studies – strength of findings**
**Consistency of findings**
**Biological plausibility**
**Temporal association of effect with putative cause**
**Demonstration of dose-response effect**

## Programmatic Interventions

**Permits screening and possible deferral of AVA recipients**
**Availability of treatment(s)**
**Altered use of AVA**
** ****Reformulation of vaccine**
** ****Change in site, dosage, route of administration, and pre-treatment/site care**

## Public Health Concern

**Sources of Concern:**
**AVEC**
**VHC**
**CDC**
**Advocacy groups**
**News media**
**Level of Concern**

**Congress**
**Data Safety Monitoring Board (DSMB)**
**IOM**
**DoD**
**FDA**

## Timeline

-  **MOU**
** ****Office space**
** ****Equipment**
** ****Oct. 15****th**** IOM**

**January**
**2003**

**July**
**2002**

## Timeline

-  **MOU**
** ****Office space**
** ****Equipment**
** ****Oct. 15****th**** IOM**

** ****Jan. 30th Meeting**
** ****Recruitment**
** ****Tasks created**
** ****Topics selected**
** ****Criteria**
** ****Committees**

**March**
**2003**

**January**
**2003**

**July**
**2002**

## Timeline

-  **MOU**
** ****Office space**
** ****Equipment**
** ****Oct. 15****th**** IOM**

** ****Jan. 30th Meeting**
** ****Recruitment**
** ****Tasks created**
** ****Topics selected**
** ****Criteria**
** ****Committees**

**April**
**2003**

**January**
**2003**

**July**
**2002**

**March**
**2004**

** ****Criteria papers ****(April-May)**
** ****Hire Staff (May-June)**
** ****Prioritize topics (July)**
** ****Protocol (July-Mar)**

## Timeline for the External Consultative Committee

** ****NVAC Meeting **
** ****Select members**
** ****Topic papers**

** ****Prioritize topics**
** ****(July – August 2003)**

**August**
**2003**

**July**
**2003**

**June**
**2003**

**March**
**2004**

** ****Protocol Review **
**  ****(March 2004)**

## Acknowledgements

**DOD**
**Mark Rubertone**
**John Grabenstein**
**John Brundage **
**Jeff Lange**
**DMSS Staff**

**CDC**
**Ben Schwartz**
**Bruce Tierney**
**Phil Rhodes**
**Stacey Martin**
**Paul Stehr-Green**
**Betsy Cadwell**
**Roseanne English-Bullard**
**Kelly Bell**

**FDA**
** ****Bob Ball**
**Dale Burwen**
**Jane Woo**
**FOH**
**Wayne Grant**
**Richard Horn**

**AVEC**