# Presentation: 414351

## DoD Smallpox Vaccination Program

Policy – Training – Standards – Communication – Safety Assurance – Safety Assessment

Science – Quality – Confidence – Care 

29 Jan 03

COL John D. Grabenstein, RPh, PhD
Deputy Director for Military Vaccines
Office of the Army Surgeon General

**Policy – Training – Standards – Communication – Safety Assurance – Safety Assessment**
**Science – Quality – Confidence – Care **
- 29 Jan 03
- COL John D. Grabenstein, RPh, PhD
- Deputy Director for Military Vaccines
- Office of the Army Surgeon General

**Notes:**
This presentation provides a brief summary of issues related to a broader military pre-attack smallpox vaccination program.

## DoD Smallpox Vaccination Policy

- Announced by President Bush, 13 Dec 02.
- Vaccinating troops before an attack is best way to ensure they are protected and can continue their missions.
- Several Stages:
- Stage 1a: Smallpox Epidemic Response Teams (SERTs).
- 2,000 to 5,000 people, beginning mid-Dec 02.
- Stage 1b: Medical Teams for Hospitals & Large Clinics.
- 10,000 to 25,000 people, beginning early Jan 03.
- Stage 2: Mission-Critical Forces, especially CENTCOM.
- Up to 500,000 troops, beginning early Jan 03.
- Clinical policies consistent with FDA, CDC, and ACIP.

## DoD Smallpox Vaccination Program as of 31 Jan 03:

- Healthcare workers vaccinated:			3,665 *
- * # of combat troops vaccinated not released publicly; 		provided to CDC & FDA, along with all other safety-surveillance data.
- People exempted from smallpox vaccine:	10% to 40%  *
- 	 * Includes both admin + clinical exemptions, varies by setting
- Self > household       Skin > immune > pregnancy > allergy
- Take:            Primary—   3 jabs,	96%	(186/194)
- Revaccination—15 jabs, 	99%	(297/298)
- Adverse Events:  Expected temporary reactions seen.
- 3% overall lost one or more days of work.
- Primary—4% to 5%. Revaccination—1% to 2%
- Significant Adverse Events: Encephalitis-1-recovered. GV-1-mild.
- Patients needing vaccinia immune globulin (VIG):  zero.
- Deaths: zero.

## 	Vaccinia Safety Assessment

** ****Screen & Vaccinate    Acute Events    Chronic, Rare, Delayed, Unexpected**

***	******Vaccinia Safety Assessment***

**	****	****	****Day   6 to 8 (“take”)****	**
**	****Vaccination Day ****	****Days 0 to 30****	****Months to Decades**
**	****	****	****Sick-call surveillance**
***	*****Exempt?****	****Take?  **Rate?**	****Inadvertent inoculation**
**	****	**How many? Why?**	****Symptoms:****	****Eczema vaccinatum**
**	****	****	****	**Which?  Rate?  Severity?**	****Progressive vaccinia**
**	****Allergic reactions?****	****Sick call:****	****Encephalitis**
**	****	****	****	**Why?  How often?**	****Hospitalizations, etc.**
**	****How many doses / vial? ****	****Limited duty:****	****Vaccinia immune globulin **(VIG)** requests**
**	****	****	****	**Why?  How long?
- 				Time course?**	**CDC:**  Prospective pregnancy registry**
**	****	****	****	****	****Vaccine Adv Event Rpt System **(VAERS)
**	****Analyzable medical notes****	****Analyzable medical notes ****	****Defense Medical Surveillance System**
**	****	****	****30-day diary cards****	****Vaccine Healthcare Ctr **(VHC)** referrals**
**	****	****	****Def Med Surveillance System ****	****VIG requests**
**	****	****	****	**(DMSS)**	****Millennium Cohort Study **
**	****Thousands****	****Thousands****	****All**

**Sociologic Studies **
**Human Factors**

- 17 Dec 02

## Slide 5

## Slide 6

## Slide 7

## Slide 8

## Slide 9

## Precautions in Vaccination

- Education up front and throughout process
- Screening for contraindications (same as FDA and ACIP)
- Periodic HIV screening
- Pregnancy screening and testing
- QA of Vaccinator: Evaluate take rates among first cohort of people (e.g., 50 to 100) vaccinated by each vaccinator
- Healthcare Workers: Bandages, sleeves, hand-washing, site-evaluation stations
- Military-Unique Settings: No hot-bunking with vaccine exempt
- Documentation: Screening, Vaccination, Take Confirmation, Adverse Events
- VIG prepositioned around globe, regionally

## Tools & Resources

**Notes:**
The Vaccine Adverse Event Reporting System, referred to as VAERS, was initiated in 1990 to oversee vaccine safety issues across America. This system is managed jointly by FDA and Centers for Disease Control and Prevention (CDC). It is a ‘passive’ surveillance system. This means that it relies on health care professionals, guardians and patients to submit reports of adverse events following vaccination. Filing a VAERS report does not prove that the reaction was caused by the vaccine but only reflects an association. 

Consult the Walter Reed Vaccine Health care Center (VHC) for assistance with preparing and submitting a VAERS report or vaccine adverse event consultation.

## Smallpox Vaccination Program – Lessons 

- SVP medical training essential: www.smallpox.army.mil
- Screening forms, handouts revised: www.smallpox.army.mil
-  Take due care in conducting screening
- Ample time for questions, screening. Have MD/PA/NP on site
- Accept verbal history of prior vaccination (supplement with scar, birth date, military entry)
- Team of 2: The vaccinator and the bandager/documenter
- Confirm “trace of blood” at vaccination site
- Place open vial at back of vaccination station, use cool tray
- Operate bandage-check station for healthcare workers
- Notify local health departments
- Check “take” 6-8 d later, triaged, decentralized

## 
Chain of Command 
Website:  www.smallpox.army.mil, www.anthrax.mil
E-Mail:  vaccines@amedd.army.mil
Toll-Free:  877.GET.VACC
CDC National Immunization Hotline: 800.232.2522
CDC Bioterrorism Information: www.bt.cdc.gov
Walter Reed Vaccine Healthcare Center, for help with complicated adverse-event management: 202.782.0411
Askvhc@amedd.army.mil     www.vhcinfo.org
For information on civilian health-care services for members not enrolled to a Military Treatment Facility: 
Call: 888.MHS.MMSO (888.647.6676)

**Chain of Command **
**Website:  ****www.smallpox.army.mil, www.anthrax.mil**
**E-Mail:  ****vaccines@amedd.army.mil**
**Toll-Free:  ****877.GET.VACC**
**CDC National Immunization Hotline:**** 800.232.2522**
**CDC Bioterrorism Information****: www.bt.cdc.gov**
**Walter Reed Vaccine Healthcare Center, for help with complicated adverse-event management:**** 202.782.****0411**
**Askvhc@amedd.army.mil     www.vhcinfo.org**
**For information on civilian health-care services for members not enrolled to a Military Treatment Facility: **
**Call: ****888.MHS.MMSO (888.647.6676)**

***Communication & Information ***