# Presentation: 280355

## Smallpox Vaccination:Federal ActivitiesWalter A. Orenstein, M.D.National Immunization ProgramCenters for Disease Control and Prevention

## Smallpox Preparedness Definition

**Enhance community awareness and clinician expertise **
**Perform disease surveillance and laboratory analysis **
**Implement public health interventions **
**Provide vaccination **
**Provide for the capability to rapidly vaccinate greater numbers of responders or the entire population**

**Notes:**
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## Strategies

- 1.		Surveillance and containment
- 2.		Mass Vaccination
- 3.		Cadre of workers to facilitate 1 and 2

## December 13, 2002 Announcement of U.S. Smallpox Plan

## The Federal Plan

- Vaccinate civilian smallpox response teams
- Vaccinate Department of Defense personnel
- Vaccinate selected staff in overseas assignments
- Vaccination not recommended for the general public at present

## Advisory Committee on Immunization Practices Supplemental Recommendations, 2002

- Definition of response teams (to follow)
- Vaccination site care
- Administrative leave for vaccinated health care workers (not necessary)

## Advisory Committee on Immunization Practices Supplemental Recommendations, 2002

- Screening for contraindications
- 	-	Atopic dermatitis, eczema:  screening
- 		questions suggested
- 	-	Pregnancy
- 	-	Immune suppression, including HIV/AIDS

## Smallpox Public Health Response Teams

**Public health and medical personnel needed to investigate initial suspected cases and initiate control measures**
**Includes medical, public health, epidemiologic, laboratory, and nursing personnel, vaccinators, others**
**Each state should have at least one team**

## Why Vaccinate Health Care Workers?

- Over 50% of transmission by imported smallpox cases in Europe, 1950-71, occurred in health care settings
- About 20% of secondary cases were in health care workers

**Mack J, JID 1972;125:161-9.**

## Why vaccinate Health Care Workers?

- Mathematical models suggest contagiousness of smallpox is reduced by about half if health care setting transmission is eliminated
- Reason: smallpox spreads from very sick persons, who are usually in hospitals

- Gani R, Leach S.  Nature 2001;414:748-51

## Smallpox Healthcare Response Teams

**Healthcare personnel from participating hospitals who will be asked to **_**evaluate**_**, **_**manage**_**, and **_**treat**_** the initial suspect/diagnosed cases**
**Hospitals who choose to participate -- identified by state (and local) public health officials.**
**Hospitals with assistance from state (and local) public health officials will identify participating healthcare personnel.**

## Suggested Composition of Healthcare Response Team

**ER****: ****MDs, RNs****                 **
**ICU**:** ****M.Ds, RNs**
**General medical: ****RNs; MDs: hospitalists, internists, pediatricians,  FP**
**Housestaff**: **primary care**** **

**Subspecialist**s**: ****I.D, smallpox experts,  dermatologist, ophthalmologist, pathologist **
**Infection control staff**
**Respiratory therapists              **
**Radiology techs**
**Security**
**Housekeeping**

## Post-attack Program Guidance

- Guidance issued October 29, 2002
- Plans due to CDC December 2, 2002
- Plans presently under review

## Post-attack Program Guidance Elements

- Isolation, treatment of cases
- Diagnosis
- Vaccination of public health, healthcare responders
- Surveillance
- Containment Activities (contact tracing, vaccination)
- Epidemiologic investigation
- Large Scale vaccination
- Information Management
- Communications

## Pre-attack Program Guidance

- Guidance issued November 22
- Plans due to CDC December 9
- Supplements plans for smallpox post-attack control submitted December 2

## Pre-attack Program Guidance Elements

**Organization and Management**
**Identification of public health smallpox response teams**
**Identification of Healthcare Smallpox Response Teams**
**Selection of Clinic Sites and Vaccination Teams**
**Scheduling**

## Pre-attack Program Guidance Elements (continued)

**Vaccine Logistics and Security**
**Clinic Operations and Management**
**Vaccine Safety Monitoring**
**Training and Education**
**Data Management**
**Communications**** **

## Declaration, Administration of Smallpox  Countermeasures, 1/24/03

- From Secretary, HHS:  reiterated President’s vaccination recommendations; to last one year
- Notes liability protection for those “Determining  who is contraindicated; monitoring, management, and care of the countermeasures ...”
- Countermeasures include vaccine, VIG, cidofovir
- Covers health care entities, their employees, agents, and officials

## Pre-attack vaccination plans status

**Plans approved for all states, D.C., 3 urban areas (54/62 CDC cooperative agreement recipients; 2/3/03)**
**Vaccine shipments scheduled for 42 states and cities, 213,700 doses (1/31/03)**
**165,900 doses already shipped to 30 states and cities (1/31/03)**
**10 states, 1 city have vaccinated 382 people (1/31/03)**

## Vaccine Safety Monitoring and Response System

- Vaccination site monitoring in hospitals, with take checks, summary review at 21-28 days (all vaccinees)
- Telephone survey of ~10,000 vaccinees re: common adverse events, work time lost
- Clinician Information Line (1-877-554-4625) available 24/7:
- 	-	links to CDC for VIG, cidofovir release
- 	-	links to VAERS for reporting
- ACIP workgroup monitors system weekly

## Pre-vaccination Materials

- Cover letter
- Vaccine Information Statement (VIS)
- VIS supplements:
- 	-	Reactions after vaccination
- 	-	Vaccination site care
- 	-	Skin conditions/contraindications
- 	-	Weakened immune system
- 	-	Pregnancy

## Pre-vaccination Materials (continued)

- Screening worksheet
- Contacts’ information sheet
- VIG information
- Cidofovir information
- 11 minute video
- Medical history and consent form
- Post-vaccination followup sheet

## Training and Education

- 19 training and education sessions through 1/30/03
- Reached an estimated 800,000 health care professionals
- Conducted via classroom, satellite broadcast, CD-ROM, internet, videotape, audioconference
- 30 different training products available

## To Be Determined

- Process for vaccination of
- 	-	traditional first responders
- 	-	additional health care workers
- 	-	general public