Vaccine Pharmacovigilance Fellowship

Introduction

Background of the Vaccine PV Fellowship

Vaccination remains one of the most important and most remarkable public health interventions in all countries. However, despite their obvious and acknowledged benefits, vaccines and vaccination have been associated with adverse events. Whilst the relation between vaccines and adverse events following immunization (AEFI) is not straight forward, the mere temporal association between immunization (or vaccination) and the vaccine product have often led to safety concerns which have sometimes had deleterious public health implications.

AEFIs may be caused by the vaccine product itself, by the process of vaccination or may be completely and totally unrelated to vaccination and immunization. When AEFIs occur therefore, it is extremely important that they are recorded, investigated, understood and the whole process well communicated so as to maintain confidence in the immunization programme and assure the safety of the public including that of vaccines.

Whilst nearly all countries have an immunization programme delivering millions of doses of vaccines to infants, children and sometimes adults, not all countries have the capacity to assess and assure the safety of this vaccine. To this end, the World Health Organization through the Global Vaccine Safety Initiative (GVSI), and in collaboration with partners and other global initiatives including the Global Vaccine Action Plan, has a goal to ensure that there are “effective vaccine safety systems in all countries”. This goal is met through the activities of the GVSI with the Global Vaccine Safety Blueprint outlining the mission, strategic objectives and goals to be attained.

The Global Vaccine Safety Blueprint has a Mission “to optimize the safety of vaccines through effective use of pharmacovigilance principles and methods” with a Vision that Effective vaccine pharmacovigilance systems are established in all countries.

Fellowship Goals

What we hope to achieve with this Fellowship

  • To assist low and middle-income countries (LMIC) to have at least minimal capacity for vaccine safety activities
  • To enhance capacity for vaccine safety assessment in countries that introduce newly developed vaccines, that introduce vaccines in settings with novel characteristics, or that both manufacture and use prequalified vaccines
  • To establish a global vaccine safety support structure

The activities of the Blueprint are coordinated by the Planning Group of the GVSI with a call for all stakeholders to submit activities to be incorporated in the portfolio of activities that are designed to achieve the aims of the GVSI.

One of the aims of the GVSI is capacity building for vaccine pharmacovigilance.

Whilst pharmacovigilance as a science and activity is weak in several low and middle-income countries, vaccine pharmacovigilance is even weaker. To build capacity in low and middle-income countries (LMICs) and to aid in achieving the universal goal of having effective

Pharmacovigilance (PV) systems in all countries across the globe, the World Health Organization (SAV, Vaccine Safety, Geneva) with financial support from the Global Alliance for Vaccines and Immunization (GAVI Alliance) and with technical support by the WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance (WHO-CC, Accra Ghana), proposes to run a 2-week Vaccine Pharmacovigilance Fellowship in September 2016.

Participants undergoing the two-week Fellowship will gain a full knowledge on pharmacovigilance and vaccine pharmacovigilance, understand the application of vaccine pharmacovigilance principles in all settings. Participants will obtain both theoretical and hands-on experience in managing AEFI data, investigating AEFIs, causality assessment, undertaking vaccine research and will spend a significant amount of time undertaking exercises in effective communication and crisis management. There would also be field visits to research centres undertaking vaccine research as well as to both the national EPI Centre and community immunization clinics.

Fellowship Information

Entry Requirements and Fellowship take-aways

At the end of the 2-Week Vaccine Pharmacovigilance Fellowship, participants would be expected;

  1. To have obtained training and exposure in the main theoretical aspects and philosophical underpinnings of vaccine pharmacovigilance
  2. To have gained hands-on experience in the tools and methods used in vaccine pharmacovigilance
  3. To have undertaken theoretical and practical exercises in AEFI investigation and causality assessment
  4. To have a knowledge of the methods that can be used in studying vaccine safety concerns and/or signals
  5. To have gained an appreciation of the importance of epidemiological methods in vaccine safety
  6. To have gained theoretical and hands-on practical experience on effective communication, crisis management and media skills and would have networked for a full day with senior professional journalists
  7. To undertake field visits to immunization centres and to interact with officials of the Ghana National Expanded Programme on Immunization

The Vaccine PV Fellowship is open to practitioners in Vaccine PV from EPI, National Regulatory Authorities, Government, Industry, Donors or Research settings. Participants should have a degree in any subject area related to vaccine pharmacovigilance, pharmacovigilance or pharmaco-epidemiology including but not limited to medicine, pharmacy, biological sciences, immunology, statistics, mathematics etc.

The Fellowship is designed for both new entrants into vaccine pharmacovigilance as well as experienced practitioners who want to brush up on general topics whilst at the same time obtaining in-depth knowledge on contemporary developments.

Certificates of completion will be issued to each participant who successfully completes the Vaccine PV Fellowship.

Fellowship Curriculum

The following modules would be covered in the Vaccine Pharmacovigilance Fellowship in both theoretical and practical sessions.

Introduction to Vaccine Safety

  1. Importance of immunization programmes
  2. History of vaccine development
  3. How vaccines work
  4. Vaccine-preventable diseases
  5. Types of vaccines

Vaccines and Drugs: similarities and differences

  1. Essential and peculiar features of vaccines
  2. Similarities between drugs and vaccines
  3. Differences between drugs and vaccines
  4. The importance of vaccines in global health

Vaccine Pharmacovigilance

  1. Introduction to vaccine pharmacovigilance
  2. Regulation of vaccines – production, importation, exportation and use
  3. Role of EPIs and national regulatory authorities in vaccine pharmacovigilance
  4. How to set up a Vaccine Pharmacovigilance System
  5. Key considerations and critical players in an effective Vaccine Pharmacovigilance System
  6. National AEFI Technical Advisory Committees

Adverse Events Following Immunization

  1. Introduction and overview
  2. Types of AEFIs
  3. Vaccination Failure
  4. Case Definitions for AEFI
  5. Investigating AEFI

Case causality assessment

  1. The new WHO Causality Assessment process
  2. Causality assessment of AEFIs
  3. Vaccination Failure
  4. Case definitions for AEFI

Signal identification in vaccine pharmacovigilance

  1. Definition of signals in vaccine pharmacovigilance
  2. Detection of signals
  3. Communication of signals
  4. Signal strengthening
  5. Actions to take following signal identification

Methods for Vaccine Pharmacovigilance and Pharmacovigilance

  1. Passive Surveillance
  2. Stimulated Reporting
  3. Active Surveillance
  4. Targeted Clinical Investigations
  5. Descriptive Studies
  6. Epidemiological studies

Communication, Crisis Management and Media Relations

  1. Introduction to communication in public health
  2. Principles of effective communication
  3. Crisis Management
  4. Media Relations
  5. Developing communication and crisis management resources – human and material

Global Organizations and Initiatives in Vaccine Pharmacovigilance

  1. World Health Organization
  2. Global Vaccine Safety Initiative
  3. Global Advisory Committee on Vaccine Safety
  4. Strategic Advisory Group of Experts on Immunization
  5. Global Alliance for Vaccination and Immunization
  6. Brighton Collaboration
  7. Global Vaccine Safety Net
  8. CIOMS and its working groups
  9. Bill and Melinda Gates Foundation
  10. PATH, IVI, MVI et

Tools and Resources for Vaccine Pharmacovigilance

  1. AEFI forms
  2. Managing vaccine safety data
  3. Template budgets
  4. Vaccine PV Toolkit
  5. Pharmacovigilance Toolkit
  6. National AEFI Centres and Systems
  7. Organizations involved in Vaccine Pharmacovigilance

Work Plan Development

  1. Personal work plan development
  2. Template work plan for National Vaccine PV System
  3. Template for activities to be undertaken to strengthen national Vaccine PV System