1. Welcome and Introduction John Iskander MD MPH Acting Director Immunization Safety Office

2. Objectives of Talk Introduce field of vaccine safety and some relevant terminology Provide introductory resources

3. What is vaccine safety? Scientifically, part of a broader science called pharmacoepidemiology –Also related to vaccinology Other terms you may encounter: –Pharmacovigilance –Spontaneous reporting system (think VAERS) Less frequently used: –Vaccine vigilance, vaccinovigilance

4. Why monitor vaccine safety? Protect the public’s health Develop safer vaccines and vaccination practices Maintain public confidence in vaccines

5. Key Definitions Adverse Event Following Immunization (AEFI) –Internationally accepted terminology –We will often use “vaccine adverse event” instead –Does not imply a causal connection between the event and vaccination –Note: modifiers such as “possible” “suspected” etc are not needed Terms such as “adverse reaction” and “side effect” do imply causality

6. Selected Online Resources and References ISO website –www.cdc.gov/vaccinesafetywww.cdc.gov/vaccinesafety Brighton Collaboration –www.brightoncollaboration.org/internet/en/index.htmlwww.brightoncollaboration.org/internet/en/index.html International Society for Pharmacoepidemiology –www.pharmacoepi.orgwww.pharmacoepi.org Public Health Surveillance for Vaccine Adverse Events. Iskander J, Chen RT. In: Infectious Disease Surveillance by Nkuchia M. M'ikanatha et al, eds, 2007Infectious Disease Surveillance