# Presentation: 059478

## National Smallpox Vaccination Program

**Presentation before the National Vaccine Advisory Committee**
**June 3, 2003**
**Marcia Crosse, Ph.D.**
**Acting Director, Health Care—Public Health and Science Issues**
**U.S. General Accounting Office**

## GAO Report

- 	SMALLPOX VACCINATION: Implementation of National Program Faces Challenges
- 	(GAO-03-578)
- 	April 30, 2003
- 	available at:  _[www.gao.gov](http://www.gao.gov/)_
- 	Prepared at the request of Senator Susan M. Collins, Chairman, Senate Committee on Governmental Affairs

## Major Challenges

- Program schedule
- Hesitancy on the part of the two main groups involved in the program
- Implementers
- State and local public health authorities
- Hospitals
- Volunteers

## Program Schedule Challenged CDC 

- Program schedule required CDC to develop extensive guidance, training and educational programs, and other materials to support implementation in very short time frame
- Schedule made it difficult for the agency to resolve all issues prior to the start of vaccination
- Detailed guidance on adverse event monitoring system not issued until 2 weeks after vaccination had begun

## Program Schedule Challenged the Jurisdictions

- Jurisdictions had less than 3 weeks to develop their plans
- Some jurisdictions had still not submitted plans as of late April
- Jurisdictions had less than 2 months to prepare to begin vaccination
- Training for adverse event monitoring hosted by CDC just 2 days before program began

## Hesitancy to Participate by Implementers

- State and local public health authorities were concerned about insufficient resources to support the program
- Estimates of costs of the vaccination process—from planning through follow-up—ranged from $79 to $1,784 per vaccinee
- Concerned that resources were being pulled from other bioterrorism preparedness efforts and other public health functions
- Hospitals were also concerned about insufficient resources

## Hesitancy to Participate by Implementers

- Many hospitals have judged the risks of vaccination as too high in comparison with the benefits
- Risks considered include potential for secondary transmission to patients from vaccinated hospital workers
- Some hospitals have opted not to participate in the program
- Hospital have been concerned about liability protection
- Concerned that legislation providing liability protection is not sufficiently explicit and does not cover all affected entities

## Hesitancy to Participate by Volunteers

- Potential volunteers concerned about safety and protection for themselves and their co-workers, families, and patients
- Concerned about potentially serious adverse reactions
- Concerned about adequacy of screening process for ruling out those at greater risk of severe reactions
- Concerned about secondary transmission to family members and patients
- Concerned that type of needle used for vaccinations is not equipped with safety sheath

## Hesitancy to Participate by Volunteers

- Potential volunteers were also concerned about compensation for adverse events and lost income
- Concerned about compensation for themselves and their families should they suffer an adverse event that resulted in disability or death
- Concerned about compensation if they suffered an adverse event that required time off from work or medical treatment
- Great variability in benefits available through workmen’s compensation and health insurance

## Some Challenges Have Been Addressed

- Program schedule modified
- Resources to support the program have been increased
- Supplemental appropriations providing additional funding
- Cooperative agreement funding can be used for smallpox vaccinations
- Liability protections have been clarified
- Smallpox Emergency Personnel Protection Act of 2003 signed into law on April 30, 2003
- Provides compensation for serious adverse events and death benefits to families

## Program Proceeding

- 62 jurisdictions covered by the program
- Program goals remain to develop Smallpox Response Teams that can
- Investigate an outbreak
- Care for patients
- Vaccinate members of the public
- As the program has evolved, CDC has discussed revising the target numbers for individuals to be vaccinated

## Implementation Is Slower Than CDC Planned

- Initial announcements regarding the program called for Phase I to be completed in 30 days
- Many  jurisdictions expected from the outset that it would take longer
- Average planned duration for Phase I was 55 days (range 7-126 days)
- Today is 130 days from start of vaccinations
- After slow start, vaccinations increased, but then rate slowed and appears to have leveled off
- In late March CDC announced that volunteers with heart disease should not be vaccinated and issued revised guidance

## Slide 13

## Jurisdictional Differences in Plans

- Jurisdictions planned very differently
- Plans for number of volunteers to be vaccinated varied from 323 to 40,000 (average 7,997)
- Variation in numbers to vaccinate not just a function of population size--plans for number of vaccinees per million population varied from a low of 81 to a high of 8,772 (average 1,903 per million population)
- Planned number of Public Health Smallpox Response Teams varied from 1 to 107 (average 21)
- Planned number of Healthcare Smallpox Response Teams varied from 2 to 375 (average 92)

## Slide 15

## Jurisdictional Differences in Execution of Plans

- Jurisdictions vary greatly in how completely they have been able to execute the planned vaccinations
- Average jurisdiction has completed just over 8 percent of its planned vaccinations for Phase I
- Wide variation, from high of 80 percent to low of <1 percent
- Most of the jurisdictions achieving highest rates of planned vaccinations completed had planned for lower numbers of vaccinees per million population

## Slide 17

## Small Number of States Account for Majority of Vaccinations

- Nine states account for over 50 percent of the vaccinations
- Not just a function of number of vaccinations planned
- Nine states ranged from 1,560 to 40,000 planned vaccinees
- Not just a function of percent of planned vaccinations completed
- Nine states range from 80 percent complete to 4 percent complete
- Result is that jurisdictions vary tremendously in how prepared they are

## Slide 19

## Program Has Been Ambitious

- CDC and the jurisdictions have mounted a large effort in a short time
- Program is complex
- Public health system has not had experience with smallpox or smallpox vaccination in over 30 years
- Context is one of great uncertainty about the risks of a smallpox attack and the risks involved in vaccination

## Some Concerns Remain

- CDC has not set a new nationwide target or requested that the jurisdictions adjust their targets
- Not clear how well jurisdictions are tracking extent to which complete response teams are being formed
- Not clear how patchwork of volunteers vaccinated to date would be deployed in the event of an outbreak
- Jurisdictions have not revised plans to meet program goals with fewer, smaller, or differently distributed response teams

## Some Concerns Remain

- Some jurisdictions are proceeding to Phase II of the program without having completed Phase I
- CDC has provided little guidance for Phase II
- Unclear whether jurisdictions have developed plans for Phase II of the program
- Major concern of potential volunteers over safety of vaccination remains

## GAO Recommendations

- 	To ensure that the National Smallpox Vaccination Program successfully develops adequate response capacity for a potential terrorist attack involving smallpox, we recommend that CDC:
- Provide guidance and specific parameters to the jurisdictions for estimating response capacity needs and work with the jurisdictions to revise local and national targets for the first stage, and
- Provide guidance to the jurisdictions for implementing the second stage of the program.