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.
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.
At the end of the 2-Week Vaccine Pharmacovigilance Fellowship, participants would be expected;
To have obtained training and exposure in the main theoretical aspects and philosophical underpinnings of vaccine pharmacovigilance
To have gained hands-on experience in the tools and methods used in vaccine pharmacovigilance
To have undertaken theoretical and practical exercises in AEFI investigation and causality assessment
To have a knowledge of the methods that can be used in studying vaccine safety concerns and/or signals
To have gained an appreciation of the importance of epidemiological methods in vaccine safety
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
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.
The following modules would be covered in the Vaccine Pharmacovigilance Fellowship in both theoretical and practical sessions.
Introduction to Vaccine Safety
Importance of immunization programmes
History of vaccine development
How vaccines work
Types of vaccines
Vaccines and Drugs: similarities and differences
Essential and peculiar features of vaccines
Similarities between drugs and vaccines
Differences between drugs and vaccines
The importance of vaccines in global health
Introduction to vaccine pharmacovigilance
Regulation of vaccines – production, importation, exportation and use
Role of EPIs and national regulatory authorities in vaccine pharmacovigilance
How to set up a Vaccine Pharmacovigilance System
Key considerations and critical players in an effective Vaccine Pharmacovigilance System
National AEFI Technical Advisory Committees
Adverse Events Following Immunization
Introduction and overview
Types of AEFIs
Case Definitions for AEFI
Case causality assessment
The new WHO Causality Assessment process
Causality assessment of AEFIs
Case definitions for AEFI
Signal identification in vaccine pharmacovigilance
Definition of signals in vaccine pharmacovigilance
Detection of signals
Communication of signals
Actions to take following signal identification
Methods for Vaccine Pharmacovigilance and Pharmacovigilance
Targeted Clinical Investigations
Communication, Crisis Management and Media Relations
Introduction to communication in public health
Principles of effective communication
Developing communication and crisis management resources – human and material
Global Organizations and Initiatives in Vaccine Pharmacovigilance
World Health Organization
Global Vaccine Safety Initiative
Global Advisory Committee on Vaccine Safety
Strategic Advisory Group of Experts on Immunization
Global Alliance for Vaccination and Immunization
Global Vaccine Safety Net
CIOMS and its working groups
Bill and Melinda Gates Foundation
PATH, IVI, MVI et
Tools and Resources for Vaccine Pharmacovigilance
Managing vaccine safety data
Vaccine PV Toolkit
National AEFI Centres and Systems
Organizations involved in Vaccine Pharmacovigilance
Work Plan Development
Personal work plan development
Template work plan for National Vaccine PV System
Template for activities to be undertaken to strengthen national Vaccine PV System