Welcome and Introduction

John Iskander MD MPH

Acting Director

Immunization Safety Office

Objectives of Talk

• Introduce field of vaccine safety and some relevant terminology

• Provide introductory resources

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

Why monitor vaccine safety?

• Protect the public’s health

• Develop safer vaccines and vaccination practices

• Maintain public confidence in vaccines

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

Selected Online Resources and References

• ISO website– www.cdc.gov/vaccinesafety

• Brighton Collaboration– www.brightoncollaboration.org/internet/en/index.html

• International Society for Pharmacoepidemiology– www.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, 2007