Adverse Events Following Immunization (AEFI)
Course on Adverse Events Following Immunization held at University of Cape Town (UCT) in South Africa, National Pharmacovigilance Centre in Tunisia, Epidemiological Unit, Ministry of Health in Sri Lanka and Tarassevich Institute in Russia
AEFI course in French, 5-10 November 2007, Tunis, Tunisia
Vaccines are amongst the safest of pharmaceuticals, yet the occasional severe adverse event or cluster of adverse events may rapidly become a serious threat to public health. It is essential that the national monitoring and reporting systems for vaccine safety are efficient and adequately coordinated with those that conventionally deal with non-vaccine pharmaceuticals. Equally important, is the need for an informed national system that can deal with public concerns and rapidly evalutate the risk to public safety when adverse events occur.
This WHO Global Training Network training course is designed to provide national regulatory officials, national immunization programme staff and other appropriately selected public health workers with the necessary skills and information needed to deal effectively with Adverse Events Following Immunization.
By the end of the training programme trainees should:
- An appreciation of the importance of a national immunization safety programme;
- The knowledge and skills to:
- Develop or strengthen the detection and reporting system for AEFIs within a country;
- Investigate an AEFI or clusters of AEFIs;
- Analyse and assess data on AEFIs including published data;
- Decide on and carry out corrective and other action in response to an AEFI; cluster of AEFIs or published information on vaccine safety;
- Evaluate the actions taken in response to an AEFI or cluster of AEFIs.
- An understanding of the importance and the respective roles of the National Regulatory Authority (NRA), the National Immunization Programme and other role-players in ensuring the safety of vaccines used in immunization programmes;
- The ability to promote collaboration and communication between:
- the NRA;
- the NIP;
- the Ministry of Health;
- the health professions;
- the media;
- patients and parents; and
- the public.
- The opportunity to consider and present a draft plan for developing or strengthening a national immunization safety programme for implementation on return to his or her country.
This 5.5 day training programme combines teaching, problem-based workshops and intensive trainee participation. The objectives of the training will be accomplished through various techniques including slide presentations, discussions, workshops, assignments, role-playing activities and individual presentations.
The problem-based component of the course involves actual cases of vaccines "scares" and other AEFIs which have been reported in a number of countries. They have been selected to provide a broad range of experiences. Trainees will be required to develop and present action plans and communication reports such as press statements and expert reports. Mock television interviews with journalists are included. The training affords the opportunity for participants to deal with specific immunization safety issues in a collaborative and constructive way using the skills, resources and training provided.
By the end of the training, the participants will have created a clear action plan of how they plan to implement the objectives of the course in their respective countries and institutions. Participants will be further assisted by WHO through follow-up activities after the training.
Agenda/topics (structure of the training programme)
The training workshop is approximately 5.5 days long and consists of approximately 17 short modules. A module deals with a specific topic (e.g. case investigation, causality assessment, risk-benefit assessment and decision-making). Each module has a specific set of objectives which are accomplished through various activities. The modules are as follows:
Module 1: Introduction and welcome
Module 2: Introduction to immunization safety
Module 3: Understanding the similarities and differences between vaccines and other medicines
Module 4: Overview of AEFI profile of vaccines used in immunization programmes
Module 5: Presentation by participants of existing national systems
Module 6: Overview of daily activities
Module 7: Conducting a case investigation
Module 8: Critical review of actions taken during past experiences with vaccine safety concerns
Module 9: Understanding and applying the basic priniciples of causality assessment
Module 10: Understanding and applying the basic principles of risk-benefit assessment, and decision-making
Module 11: Discussion on risk perception by patients, parents and health care providers
Module 12: Critical evaluation of the vaccine safety literature
Module 13: Communications and media planning
Module 14: Communication skills: working with the media
Module 15: Networking with partners
Module 16: Developing a strategy and plan of action for a national AEFI monitoring system
Module 17: Forging a way forward, thanks and closure.
The following individuals are likely to benefit from this training: Persons in the national drug regulatory authority dealing with biologicals and vaccines, especially their safety. National Immunization Programme Manager, Ministry of Health. Persons in the Ministry of Health responsible for post-marketing surveillance of vaccines. Persons in the Ministry of Health's national immunization programme responsible at national level for the management of disease surveillance. Persons in the Ministry of Health responsible in the event of an emergency with respect to immunization practices. Persons in the Ministry of Health responsible for press releases/media reports or reactions to reports in the media. Persons in the Ministry of Health responsible for public education, social mobilization and support for vaccination especially with respect to the National Immunization Programme.
- Persons in the national drug regulatory authority dealing with biologicals and vaccines, especially their safety.
- National Immunization Programme Manager, Ministry of Health.
- Persons in the Ministry of Health responsible for post-marketing surveillance of vaccines.
- Persons in the Ministry of Health's national immunization programme responsible at national level for the management of disease surveillance.
- Persons in the Ministry of Health responsible in the event of an emergency with respect to immunization practices.
- Persons in the Ministry of Health responsible for press releases/media reports or reactions to reports in the media.
- Persons in the Ministry of Health responsible for public education, social mobilization and support for vaccination especially with respect to the National Immunization Programme.
Each country is not expected to send participants in all the above categories, however a minimum of two to three trainees from each country, representing at minimum; the National Immunization Programme (preferably the individual responsible for the AEFI programme) and the National Regulatory Authority (preferably the individual involved in adverse reaction monitoring).
All selected participants should be fluent in the language in which the course is held.
The training is approximately 5.5 days long. Training programmes have taken place in different countries and regions in suitable conferencing venues. Generally, no more than six countries within a region can be trained during one training programme. At least two and no more than four participants from each country should be represented at the training.
Courses are held in English at the University of Cape Town in South Africa and at the Epidemiological Unit, Ministry of Health in Sri Lanka, in French at the National Pharmacovigilance Centre in Tunisia and in Russian at the Tarassevich Institute in Russia.
For further information please contact:
Dr Ushma Mehta
National Adverse Drug Event Monitoring Centre
Medicines Control Council
c/o Department of Pharmacology
University of Cape Town
Tel: (+27-21) 447 1618
Fax: (+27-21) 448 6181
Dr Umit Kartoglü
World Health Organization
20, Avenue Appia
CH-1211 Geneva 27
Tel: 41 22 791 4972
Fax: 41 22 791 4384