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

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

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

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

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)

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

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

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.

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.

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

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.

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

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

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