1. Delivering Clear, Consistent & Timely Vaccine Safety Messages Introduction
National Immunization Conference
April 19, 2010
Stephanie Marshall, National Vaccine Program Office, Department of Health and Human Services

2. Training Objectives
Discuss vaccine safety communications principles, messages, and strategies
Provide an overview of the federal vaccine safety monitoring system
Describe the role of HHS and its agencies in vaccine safety monitoring
Identify federal resources available to health care providers and communications staff

3. Background
Numerous complex and inter-related factors influence immunization decision-making:
risk perception & disease severity
perceptions re: the safety and value of vaccination
access to information (both credible and false)
relationship with the health care provider
peer pressure (social environment, interpersonal)
product encounter
voluntary vs. mandatory requirements
insurance coverage
alternate health beliefs

4. Vaccine Safety Communications Challenges
Growing concerns and scrutiny
Proliferation of information (credible and inaccurate)
Coverage recommendations
A history of complex messaging

5. Guiding Principles Be transparent, timely, and accurate
Acknowledge and respect concerns
Provide regular communication and context for adverse event reports
Coordinate activities with Federal partners (e.g., HHS agencies; DoD; VA) and others (e.g. providers, academia)

6. Key Audiences General public Health care professionals
Women
Teens
Seniors
Caregivers
Health care professionals
Vulnerable populations
Policy makers
Media – both an audience and channel

7. Overarching Strategies
Leverage all outreach and media opportunities
Rapidly respond to concerns
Provide key stakeholders with evidence-based information
Give regular updates on ongoing safety monitoring efforts

8. Overarching Messages
The benefits of immunization outweigh the risks. Many individuals and children can die from the diseases vaccines protect against.
Some people experience minor side effects, such as fever or soreness after getting vaccinated. These side effects, especially in children, can be alarming but they are typically mild and go away quickly.
Serious side effects, such as allergic reactions, are rare but they are investigated by the CDC.

9. Overarching Messages Cont.
All vaccines are held to the highest standard of safety and are continually monitored.
All vaccines are tested and approved by the FDA before they are made available to the public.
The federal government and health care professionals work closely together to monitor all vaccines for safety. These systems help physicians, scientists, and public health officials more rapidly identify rare side effects associated with vaccination.

10. Federal Vaccine Safety Monitoring
Agencies and systems
HHS (VAERS, VSD, PRISM, CISA, RTIMS, EIP, VAMPSS)
Department of Defense (DMSS)
Department of Veterans Affairs
Activities coordinated by HHS National Vaccine Program Office
Federal Immunization Safety Task Force

11. HHS Agencies and Vaccine Safety Monitoring
Roles and Responsibilities
National Vaccine Program Office (NVPO)
Coordinates federal vaccine safety activities, reporting to the Assistant Secretary for Health, and bridges federal vaccine safety activities with non-federal partners
FDA
Regulatory authority over vaccine approval, manufacturing and usage, and post approval surveillance
CDC
Makes vaccine recommendations, conducts post-licensure surveillance for adverse events, explores individual variation in vaccine associated adverse events, and conducts risk communication activities to a broad range of groups.

12. HHS Agencies and Vaccine Safety Monitoring Cont.
NIH
Conducts and supports basic research and clinical trials in areas important for vaccine safety
HRSA
Operates the Vaccine Injury Compensation Program (VICP) with the Department of Justice and the US Court of Federal Claims
CMS
Conducts vaccine safety studies in Medicare population
AHRQ
Studies background rates of medical conditions

13. Vaccine Safety Monitoring Partners
State public health departments
Health care providers
Academic researchers
Vaccine manufacturers
Institute of Medicine
Parent groups and advocacy organizations
World Health Organization
Foreign regulators
Philanthropic organizations

14. Agency Presentations FDA – approval process & ingredients
CDC – vaccine safety communications strategies and messaging
CDC – VAERS system and other monitoring systems