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Welcome and Introduction

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?.

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Welcome and Introduction

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  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/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

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