JIIAJNfHO WCMKS.HOP ON A.DYQt5!1 .VWH115 fOLI.OWINO IM.UIUZATIOM (.ACFIJ
SUav.n.&.IUIIC. AND
IN(D.
IIIANAGIIIIDIT FUII~IC fSL.Aie IC'OUfltflaiiS ANO Nf.-.Aa
10 .tMIUAit't • 2 f .....MY :1012 -FUI
(WP)/ICP/IVD/1.1/00 1-A Report series number: RS/2012/GE/03(FJI)
English only
REPORT TRAINING WORKSHOP ON ADVERSE EVENTS FOLLOWING IMMUNIZATION (AEFI) SURVEILLANCE AND DATA MANAGEMENT FOR PACIFIC ISLAND COUNTRIES AND AREAS Nadi, Fiji 30 January-2 February 2012
Convened by: WORLD HEALTH ORGANIZATION REGIONAL OFFICE FOR THE WESTERN PACIFIC
Not for sale Printed and distributed by: World Health Organization Regional Office for the Western Pacific Manila, Philippines 14 August 2012
NOTE
The views expressed in this report are those of the participants in the Training Workshop on Adverse Events Following Immunization (AEFI) Surveillance and Data Management for Pacific Island Countries and Areas and do not necessarily reflect the policies of the World Health Organization.
This report has been prepared by the World Health Organization Regional Office for the Western Pacific for the participants of the Training Workshop on Adverse Events Following Immunization (AEFI) Surveillance and Data Management for Pacific Island Countries and Areas, which was held in Nadi, Fiji from 30 January to 2 February 2012.
SUMMARY
The first Training Workshop on Adverse Events Following Immunization (AEFI) Surveillance and Data Management for Pacific Island Countries and Areas was convened by WHO at the Tanoa International Hotel, Nadi, Fiji, from 30 January to 02 February 2012. There were 24 participants and observers from 18 Pacific countries and territories. One observer each from the United Nations Children's Fund (UNICEF) and Japan International Cooperation Agency (JICA) also participated. Objectives: To acquire the necessary understanding, skills and information to develop or (1) strengthen systems to monitor and address Adverse Events Following Immunization (AEFI). To exchange information about AEFI activities and lessons learnt in the field, (2) which will help improve the quality and responsiveness of AEFI surveillance across Pacific island countries and areas. To understand issues related to the WHO-United Nations Children's Fund (3) (UNICEF) Joint Reporting Form (JRF), completion and use of the JRF and enhanced data management skills for monitoring and surveillance of vaccine-preventable diseases. The first two and half days of the training workshop focussed on AEFI surveillance and provided the participants with the tools necessary to develop or strengthen AEFI surveillance systems within their countries, as well as the skills to develop, strengthen and manage AEFI detection and reporting, to analyse data to understand the respective roles of key players in AEFI surveillance, and improve communication and collaboration across the Pacific and the Region. The remainder of the workshop was devoted to the WHO-UNICEF Joint Reporting Form (JRF) on Immunization and management of data on vaccine-preventable disease, focusing on the need to complete the JRF properly every year and enhance skills and understanding on data management and surveillance of vaccine-preventable diseases. At the end of the training workshop, all the participating countries agreed to establish functional AEFI surveillance systems. The following conclusions were reached: Action plans: country participants will finalize their action plans by April2012 and submit (1) them to the WHO Fiji office. Political commitment for action plan: Participants will pay advocacy visits and/or include (2) their action plans on the agendas of meetings with high-level health authorities to facilitate decision-making on establishing, strengthening and sustaining AEFI surveillance. Subregional mechanism for causality assessment: (a) The Pacific Ministers meeting will (3) be used as a forum to formulate a proposal and to reach consensus on establishing an intercountry panel of experts on AEFI causality assessment. (b) PacNet will be used for exchange of information. (c) There should be an annual meeting of the expert panel. Monthly report: Countries agreed on monthly AEFI reporting. WHO will modify the (4) reporting forms, analyse the data and share with others through PacNet. In-country training: A proposal for in-country training will be finalized and shared for (5) technical support by partners.
LIST OF ACRONYMS
AEFI BCG DNA DPS DPT EPI GAVI GIVS GFIMS HIB HCWS IM IPV JICA JRF MDGS MMR NRA PICS RD
sc
SOP UNGASS UNICEF VAERS VPDS
Adverse Events Following Immunization Bacille Calmette-Guerin De-oxv ribo Nucleic Acid Division of Pacific Technical Support Diphtheria-pertussis-tetanus Expanded Program on Immunization Global Alliance Global Immunization and Vaccine Strategy Global framework on Immunization Monitoring and Haemophilus influenzae type B Health care workers Intra muscular Inactivated polio vaccine Japan International Cooperation Agency Joint reporting form Millennium Development Goals Measles/Mumps/Rubella vaccine National Regulatory Authority Pacific island countries and areas Regional Director Sub cutaneous Standard Operating procedure United Nations General Assembly Special Session United Nations Children's Fund Vaccine adverse event reporting system Vaccine Preventable Diseases
CONTENTS LIST OF ACRONYMS
I.
INTRODUCTION ................................................................................................................. ! 1.1 Objectives ..................................................................................................................... 1 1.2 Opening ceremony ................................................... ........................ ............................. 1
2.
PROCEEDINGS ................ ................... ............. ................................................................... 2 Objectives of the workshop .... ................. ...... ....................................... ~ ................ ....... 2 Update on the AEFI surveillance system in the Pacific island countries and areas ...... 2 Introduction on immunization safety ............................................................................ 3 Vaccine characteristics relevant to AEFI... ........................................ ............... ............4 Elements of an AEFI surveillance system ........... ........ ............ ............ .... .............. ....... 6 AEFI case investigation ................................................................................................ 8 WHO E-learning course on Vaccine Safety Basics ............... ............ ........................... 8 Basic principles of causality assessment ...................................................................... 9 Roles and responsibilities of different levels in an AEFI surveillance system ........ ... l 0 Methods for monitoring AEFI surveillancethankGod ............................ .................... 11 AEFI case management .............................................................................................. 12 AEFI data analysis ...................................... .... ................................... ......................... 14 Communication .......................................................................................................... 15 Developing a plan of action for strengthening an AEFI surveillance system ............. 15 Collaboration in AEFI surveillance ............................................................................ 15 Conclusions on AEFI surveillance .......... ........ ............................ ............................... 16 Global and regional BPI goals: the role of WHO in collecting, .................................. . managing and reporting data .............. ........................................................................ 17 2.18 WHO/ UNICEF Joint Reporting Form: history, timeline, purpose and data use ....... 19 2.19 WHO-UNICEF Joint Reporting Form: data quality ...................................................20 2.20 WHO/UNICEF Joint Reporting Form 2011 ............................................................... 20 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2. 8 2.9 2.10 2.11 2.12 2.13 2.14 2.15 2.16 2.17
ANNEXES: Annex 1 Annex2 Annex 3 TIMETABLE ANNOTATED AGENDA LIST OF PARTICIPANTS, OBSERVERS AND SECRETARIAT
Data collection/ Immunization - adverse effects, standards/ Health personnel- education/ Pacific islands/ vaccination
1. INTRODUCTION
The first Training Workshop on Adverse Events Following Immunization (AEFI) Surveillance and Data Management for Pacific Island Countries and Areas (PICS) was convened by WHO at the Tanoa International Hotel, Nadi, Fiji, from 30 January to 02 February 2012. There were 24 participants and observers from 18 Pacific countries and territories. One observer each from the United Nations Children's Fund (UNICEF) and Japan International Cooperation Agency (JICA) also participated. The timetable for the workshop is attached as Annex I. 1.1 Objectives To acquire the necessary understanding, skills and information to develop or (1) strengthen systems to monitor and address Adverse Events Following Immunization (AEFI). To exchange information about AEFI activities and lessons learnt in the field, (2) which will help improve the quality and responsiveness of AEFI surveillance across PICS. To understand issues related to the WHO-United Nations Children's Fund (3) (UNICEF) Joint Reporting Form (JRF), completion and use of the JRF and enhanced data management skills for monitoring and surveillance of vaccine-preventable diseases. 1.2 Opening ceremony
The opening ceremony was chaired by Dr Sergey Diorditsa, Team Leader, Expanded Programme on Immunization (EPI), WHO Western Pacific Regional Office. Dr Diorditsa gave the opening remarks on behalf of Dr Shin Young-soo, WHO Regional Director for the Western Pacific, who was unable to join the workshop due to previous commitments. He welcomed all participants to the Training Workshop and extended his sincere thanks to the Government of Fiji for its hospitality and support. He noted that, like all drugs, vaccines may cause adverse events. Vaccine safety issues can arise from the inherent properties of the vaccines themselves, or at any point along the immunization process, including vaccine manufacturing, storage, reconstitution or administration. The aim of AEFI surveillance is to maintain the confidence of the public and health workers by minimizing the occurrence and impact of AEFI. In developing countries especially, it is important to identify and correct programme errors so they can be prevented in the future. Although all vaccines supplied by WHO/UNICEF are pre-qualified and their quality is assured, increasing numbers of vaccines are being purchased in the private market. The promotion of new vaccines, including vaccines specific to the Pacific, such as those for Japanese encephalitis and pandemic influenza, also highlights the growing importance of each and every country having a functioning AEFI surveillance system. There is a misconception that a sound AEFI reporting system, in which many reports are received and investigated, will result in decreased coverage because of community fear of the vaccine. In fact, a sound AEFI reporting system demonstrates a commitment to ensuring the safety of vaccines, and can actually reassure the community that the government is open and serious about the issue. WHO sincerely hopes that the training provided at the workshop will provide all participants with the skills and motivation to accelerate the implementation of AEFI surveillance in their respective countries;
2
the ideas and confidence to undertake advocacy with leaders, the community and health workers; and the knowledge to argue for a broader surveillance system that covers both adults and children, and EPI and non-EPI vaccines. He expressed his gratitude to WHO colleagues from UNICEF, who are vital partners in AEFI communication and advocacy, a collaboration that reflects the strong partnership that should exist at all levels. He looked forward to seeing the productive outcome of the deliberations and wished everybody a pleasant stay in Nadi. Dr Philip Lambach, Medical Officer, Quality, Safety and Standards, WHO Headquarters, made introductory remarks on behalf of Headquarters. 2. PROCEEDINGS
2.1
Objectives ofthe workshop
The session on the workshop's objectives was in two parts. First, Dr Md. Shafiqul Hossain, Technical Officer, EPI, WHO Western Pacific Regional Office, requested participants to write on cards and paste on the wall their expectations of the workshop, which were then reviewed. He was delighted to see that the expectations were in line with the objectives of the workshop and fitted the areas to be covered. Dr Diorditsa then presented the areas to be covered during the workshop. Areas to be covered during the workshop: (I) Importance of an AEFI monitoring and management system as part of a national immunization safety programme. Evaluating, developing and strengthening the surveillance system for AEFI within a country. Safety profile of vaccines commonly used in National Immunization Programme (NIP) investigation of an AEFI case. Analysing and assessing data on AEFI. Corrective actions in response to an AEFI or cluster of AEFI. Strengthening understanding on the relevance of the WHO-UNICEF JRF. Widening the understanding of vaccine-preventable disease (VPD) surveillance and data analysis.
(2)
(3)
(4) (5) (6) (7)
During the discussion session, the Chairperson observed that the objectives and areas to be covered fitted very well with the expectations of the participants. 2.2 Update on the AEFI surveillance system in the Pacific island countries and areas
Dr Jayaprakash Valiakolleri, Technical Officer, EPI, WHO South Pacific, gave an update on the AEFI surveillance system in the Pacific, based on a questionnaire sent previously to all the countries and information received from the countries. He noted that 15 countries had responded to the questionnaire. An AEFI surveillance system has been established in nine countries, the
3
year of establishment and the type of system varying from country to country. In territories affiliated with the United States of America, the Vaccine Adverse Events Reporting System (VAERS) is being followed. In New Caledonia, a system was established in 2011and guidelines are available. In most countries where a system is available, it was established during the HIN1 vaccine deployment plan and vaccination in 2009. The administrative level of establishment was mostly at national level with only a few countries, American Samoa, Fiji, Guam and Tokelau, having the system at all levels. All countries have indicated that the functionality of their systems is inadequate and weak. All have a focal point for the AEFI surveillance, usually the EPI programme manager and/or the surveillance focal point. The reporting of data regarding AEFI is inadequate. Training on AEFI and establishment/ strengthening of an AEFI surveillance system was requested by many countries during the Seven Pacific Immunization Programme Strengthening (PIPS) Meeting in 2011, and training on basic AEFI training has been conducted in American Samoa, Cook Islands, Fiji, Guam, the Federated States of Micronesia Nauru and New Caledonia, mostly at the national level. Advanced training on AEFI (causality assessment) has not been carried out in any of the countries. AEFI guidelines are available in American Samoa, Cook Islands, Fiji, Guam, Kiribati, the Federated States of Micronesia, New Caledonia and Palau. Planning for in-country basic training has been indicated in all countries and plans for development of standard operating procedures have been indicated from American Samoa, Fiji, Kiribati, the Federated States of Micronesia, Nauru, Niue, Samoa, Solomon Islands, Tokelau and Tuvalu. During the discussion, two more countries informed the workshop that they had brought their completed questionnaire and, by the end of the workshop, data from all the 18 countries had been received. 2.3 Introduction on immunization safety
Dr Hossain gave an introductory presentation on immunization safety. The presentation was designed to achieve the following learning objectives for the participants: ( l) (2) Describe the impact of vaccine safety concerns on immunization programmes. Explain the importance of AEFI monitoring at the national and international levels.
Describe the global initiatives being undertaken to ensure (improve) the safety of (3) vaccines. Explain the importance of an effective national regulatory system in ensuring the (4) safety of vaccines. (5) (6) Explain the basic elements of an AEFI surveillance programme. Know the key terminology and definitions relating to vaccine safety.
Vaccination is one of the most important public health interventions, and vaccines are biological products. Although vaccines used in national immunization programmes are extremely safe and effective, no vaccine is perfectly safe and adverse events can occur following immunization. In addition to the vaccines themselves, the process of immunization is a potential source of adverse events. Dr Hossain outlined his presentation under three areas: the adverse events following immunization; the national regulatory authority (NRA); and storage and transport. The latter two contribute to immunization safety. The objectives of monitoring AEFI includes identification of urgent problems for investigation and action; detection of signals for potential follow-up and research; estimation of rates for serious AEFI; identification of
4
programmatic errors and batch problems; and creation of awareness of risks among health professionals. Unsafe injections and unsafe injection practices continue in many countries. With new technologies, new safety concerns are raised. Regulations are changing and, at the same time, there is a lack of access to new and safer technologies and the anti-immunization lobby has been growing. With globalization and the Internet, public concerns about harm from vaccines have increased. The overall function of the NRA is to ensure that all medicines, including vaccines, used within the country are safe, effective and of good quality. The six critical regulatory functions include marketing authorization and activities; licensing; post-marketing surveillance; lot release; laboratory access; regulatory inspection; and supervision of clinical trials. To achieve these critical functions, the NRA needs to have a sound regulatory infrastructure, with the ability to enforce regulations; good epidemiological capability, to assess risk; an understanding of the critical parts of the production process; competent inspectors; the ability to evaluate documentation; technical expertise, with research training; government funding and commitment; and good communication systems. The importance of injection safety and waste management was addressed. Dr Hossain went through the key vaccine safety terminology and definitions. 2.4 Vaccine characteristics relevant to AEFI
The presentation of Dr Philip Lambach, Medical Officer, EPI, WHO Headquarters, was designed to achieve the following learning objectives for the participants: State the nature of vaccines used in immunization programmes and their (1) characteristics that are relevant to adverse events. (2) (3) Describe the known safety profile of selected vaccines. Explain special precautions in, and contraindications to, the use of vaccines.
Recognize certain clinically important vaccine reactions following immunization, (4) such as anaphylaxis. The goal of vaccination is to prime the recipient's immune response in order to generate memory cells, so a heightened immune response (both cell-mediated and humoral) will be elicited upon exposure to the specific pathogen. The vaccine itself should produce limited undesirable effects and be relatively inexpensive and able to be mass-produced for population vaccination. These factors are as important as efficacy when regulatory bodies and pharmaceutical companies are considering possible vaccines. A good vaccine should elicit an appropriate immune response. Ideally, the effect should be durable, offering long-term protection. The vaccine should have minimal and non-serious side-effects. The product should be stable at extremes of temperature, over a prolonged period of time and under various exposures to light. lmmunogenicity should be achieved with a minimal number of booster injections, and the maximum number of antigens that are likely to confer the broadest protection against infection should be provided. The vaccine characteristics relevant to adverse events depend on type of vaccine, route of administration and other ingredients in the vaccine. The various types of antigen used in the preparation ofvaccines include:(!) live attenuated (oral polio, BCG); (2) killed vaccine (influenza, inactivated polio vaccine (IPV), hepatitis A,
5
pertussis); (3) toxoid (tetanus, diphtheria); (4) purified (sub-unit) antigen (meningococcal vaccine, Haemophilus influenzae vaccine); (5) recombinant antigen (hepatitis B); (6) deoxyribonucleic acid (DNA) vaccines (in investigation phase); and (7) synthetic peptides (in investigation phase). Live attenuated vaccines were developed in the 1950s and 1960s. The positive attributes of these are the immune response, which is almost as good a response as having a real infection; memory cell production; the capability of replication within the host cells; and the fact that they are cheap. On the negative side, there is the question of safety and stability. Killed vaccines are derived from live virus culture that has been inactivated by heat or chemical means. The final concentrate is tested for sterility, virus inactivation, potency, endotoxin, pH and concentration of residuals, etc. The characteristics ofkilled/inactivated vaccines are that they are grown in bulk, inactivated by heat or chemical means and adjuvants may be added to improve the immune response. The positive attributes are that there is no potential for pathogenicity due to the removal of the toxic component and they are often more stable than live vaccines. On the negative side, there is a need to give repeated doses to generate a protective immune response and they are often more expensive. Several hundreds of different types of adjuvant are being used or being studied in vaccine technology. Before new adjuvants are used in vaccines, their safety has to be tested in separate animal and clinical trials. The different methods used to enhance immunity include: (I) Conjugation
Many bacterial pathogens are protected by a polysaccharide capsule. This polysaccharide capsule, however, is not very immunogenic. If the polysaccharide is bound to a carrier protein, the immune response improves dramatically, as does the memory response. The success of the Haemophilus influenza B (Hib) vaccine is proof of how well this technique works. (2) Adding adjuvants
Adjuvants are substances that are incorporated into or injected simultaneously with an antigen and that potentiate the immune response. This allows smaller quantities of antigen to be used, and fewer dose are needed to elicit a long-term immune response. Adjuvants are most often used in killed/inactivated vaccines. The most commonly used adjuvants are aluminium adjuvants, which slow the escape of the antigen from the site of injection, thereby lengthening the duration of contact between the antigen and the immune system i.e., macrophages and other antigen-receptive cells. Although generally recognized as safe, aluminium salts do cause sterile abscesses and nodules at the site of injection. The formation of a small granuloma is inevitable with alum-precipitated vaccines by virtue of its very action. However, it is important that it is administered intra-muscularly (IM) and not subcutaneuosly (SC) since SC administration can result in necrotic breakdown and cyst and abscess formation. (3) Combination vaccine
A combination vaccine consists of two or more antigens that are in the same preparation. This approach is used in many vaccines, including measles-mumps-rubella (MMR) and diphtheria-pertusssis-tetanus (DPT) vaccines. It is very important, however, that these combination vaccines are tested and tried out carefully before introduced. For instance, adjuvants in a combination could reduce the activity of one vaccine and excessively
6
increase the reactivity of the other vaccine. Also, there could be interactions with the buffers, stabilizers, etc. (for example, thiomersal in DPT and Hib vaccines can inactivate the IPV). Live vaccines can interfere with each other as well. The immune response to one vaccine can inhibit the replication of another virus. (4) Carriers
Carriers provide T cell help e.g. bacterial toxoids, living vectors and fatty acids. (5) Vehicles
Vehicles include mineral oil emulsions, liposomes, biodegradable oil emulsions (e.g. squalene, squalane, and emulsions containing peanut oil), non-ionic block copolymer surfactants, and biodegradable polymer microspheres. The various inactive ingredients in vaccine formulations include: Suspending agents, such as water/saline. Incorrect administration or use of (a) a suspending agent could be a cause of AEFI. Antibiotics, which are used during the manufacturing phase to suppress the (b) growth of any extraneous contaminants that may be introduced during various processing steps. Antibiotics such as kanamycin and neomycin are commonly recommended for plasmid DNA vaccines. Preservatives, which are added to vaccines when there is a risk of (c) contamination (e.g. multidose vials). In combination vaccines, the preservative/stabilizer of one vaccine may affect the potency of other. Thiomerosal adversely affects the potency of IPV combination with DTP vaccine. Whether or not a preservative is used, the manufacturer still needs to evaluate vaccine potency and reversion to toxicity. Stablilizers. Stability is essential, especially where the cold chain cannot (d) be guaranteed. Instability can cause the loss of antigenicity and decreased infectivity of live vaccine. Factors affecting stability include temperature and pH. Bacterial vaccines can become unstable due to hydrolysis and aggregation of protein and carbohydrate molecules. Stabilizers include: magnesium chloride (OPV), magnesium sulphate (measles), lactose-sorbitol and sorbitol-gelatin. The ideal route of administration should elicit an immune response with minimal risk of adverse effects during injection. Deep IM injection is preferable for vaccines containing adjuvants (this provides a depot effect and granuloma formation is less likely). The SCI intradermal route is preferable for live vaccines to lessen the risk of neurovascular injury, but is still immunogenic (e.g. BCG). Dr Lambach went through various vaccine reactions and their frequency. While serious adverse events are uncommon, they need to be remembered, investigated and managed properly. True contraindications and unproven associations and concerns were also addressed. A vaccinologist quiz was conducted at the end of the presentation. 2.5 Elements of an AEFI surveillance system
DrYoshikuni Sato, Medical Officer, EPI, WHO Western Pacific Regional Office, gave an overview of the elements of an AEFI surveillance system.
7
The potential objectives of an immunization safety surveillance system include: (1) (2) (3) To detect, correct and prevent programme errors. To identify problems with vaccine lots or a brand. To prevent false blame from coincidental events.
To maintain confidence by responding properly to parent/community concerns (4) while increasing awareness (public and professional) about vaccine risks. To generate new hypotheses about vaccine reactions that are specific to the (5) population. To estimate rates of occurrence of AEFI in the local population, compared with (6) trial and international data (particularly for new vaccines being introduced). All these objectives require sound detection, reporting, investigation, analysis, corrective action and communication/feedback. Detection involves establishing: (a) who should recognize/detect AEFI (This could be parents, health workers at immunization facilities, emergency room staff in hospitals.); (b) which events should be detected (There is need to establish criteria and case definitions and to identify all cases responding to the case definitions and all other events believed to be due to immunization.); and (c) how they should be detected, which requires training and education. Reporting of AEFI requires further decision-making regarding which events are to be reported, who should report them and to whom, how the reporting should occur, the route of reporting, when they should be reported and, finally, how to improve/encourage reporting of AEFI cases. Generally, the health care worker recognizes cases of AEFI, reports them and treats or refers the patients for treatment. The supervisor stimulates reports, investigates, filters, provides feedback, manages data and proposes classification. The national immunization programme (NIP) manager receives and transmits reports, triages, works with the environment, manages data and ensures response. The NRA receives and transmits reports, shares database, evaluates reports, takes action, checks products and notifies. Although vaccines in general use in national immunization programmes are extremely safe and effective, adverse events can occur following vaccine administration, and no vaccine is perfectly safe. In addition to the vaccines themselves, the process of immunization is a potential source of adverse events. An adverse event following immunization (AEFI) is any adverse event that follows immunization that is believed to be caused by the immunization. Using this terminology allows description and analysis of the event without pre-judging causality. Immunization will naturally be blamed for any event that happens after immunization. Reported adverse events can either be true adverse events, i.e. really a result of the vaccine or immunization process, or coincidental events that are not due to the vaccine or immunization process but are temporally associated with immunization. For the purpose of these guidelines AEFI are classified into five categories. Immunization can cause adverse events due to the inherent properties of the vaccine (vaccine reaction), or some error in the immunization process (programmatic error). The event may be unrelated to the immunization, but have a temporal association (coincidental event). Anxiety-related reactions can arise from the pain of the injection, rather than the vaccine. In some cases, the cause of the AEFI remains unknown. A cluster of AEFI means two or more cases of the same adverse event related in time, place or
8
vaccine administered. The exact nature of the relationship between the adverse events (e.g., duration of "time", proximity of "place") will differ according to the nature of the events and the circumstances within which they occur. Dr Sato illustrated a classical example of a programmatic error in which, in Country X, insulin was inadvertently administered to 70 infants instead ofDTP. There were 21 deaths due to complications related to hypoglycaemia. A similar incident in Country Y, however, was associated with no deaths due to prompt detection and effective management by health staff. When an incident is detected and reported, there is a need to assess and investigate with appropriate urgency and to possibly quarantine suspect vaccines. When investigation starts, it is necessary to ensure adequate resources for investigation, increase surveillance to identify other cases, and define any suspect vaccine. The investigator should develop a working hypothesis and takes precautionary corrective action. When the investigator confirms a working hypothesis, the investigator advises the community of the cause and the planned response. 2.6 AEFI case investigation
This topic included a plenary session presented by Dr Valiakolleri, and a group work (three working groups) session, wherein a case scenario was given and the groups presented their findings. The key points regarding investigation include: (1) understanding the safety profile of commonly used vaccines and background rates of AEFI. The safety profile of a vaccine depends, in some cases, on the risk factors concerning the person being vaccinated; (2) understanding the possible mechanisms, treatment and prevention of vaccine reactions; (3) verification of reported event(s) early in the investigation and establishing that onset occurred after vaccination. The steps in case investigation include: (1) receiving the report and taking action, including verification of information in the reporting, classification and assessment of AEFI, deciding if further investigation is needed and if investigation is warranted, and deploying appropriately trained staff; (2) investigating and collecting data, including asking for details regarding the patient, the vaccine and other drugs, other vaccines, cases in unvaccinated persons and immunization services, observing the service in action, establishing a more specific case definition (if needed), and formulating a working hypothesis; (3) collecting specimens, if appropriate, from the patient and of the vaccine; (4) dispatching specimens to the laboratory, if needed; (5) dispatching specimens to the appropriate facility, and analysing the data based on epidemiological, clinical and laboratory findings, and summarizing and reporting findings; (6) taking corrective action by communicating with health staff, communicating findings and actions to the public, correcting problems as appropriate, and replacing vaccines if indicated. The roles of different categories of health worker have to be clearly defined and understood. It is important to recognize the multiple roles played by vaccine providers, immunization programme staff and other health care workers. 2.7 WHO E-leaming course on Vaccine Safety Basics
Dr Lambach gave an overview of the WHO e-leaming course on Vaccine Safety Basics, which was introduced to help establish a shared understanding among all stakeholders involved in vaccine pharmacovigilance regarding issues related to the safety of vaccines. It was therefore designed to serve a broad of range institutions and individuals involved in vaccine safety, from vaccinating health professionals to national regulatory staff, immunization staff and staff of other agencies.
9
The content of the course was compiled by leading international vaccine experts committed to the promotion ofbest practice in the implementation of immunization programmes across the world. The course was designed for easy distribution online, via CD Rom or by e-mail. Users are invited to disseminate it to all their peers. Wide distribution of the course will help build a common core knowledge base of vaccine safety expertise, and help improve vaccine safety practices in countries in a cost-effective manner. The course is divided into six modules that, ideally, should be studied in sequential order, starting with Module 1. Module 1 explains the importance of vaccination in the control of infectious diseases, describes the basic principles of vaccination and the main types of vaccine. Module 2 covers immunological aspects (modes of action of types of vaccine and component, including adjuvants and preservatives). Module 3 further defines the main types of adverse events following immunization (AEFI) and their underlying causes. Module 4 is the surveillance module, explaining basic principles ofpharmacovigilance and the special considerations that apply to vaccination programmes. This module outlines how AEFI reports are investigated and how vaccine testing can contribute to vaccine surveillance. Module 5 identifies the main roles and responsibilities of vaccine safety stakeholders at national and international levels. It also describes reporting mechanisms at national level and through international bodies and vaccine manufacturers, purchasers and distributors. Module 6 helps trainees to understand the need for improved communication on vaccine safety and to assess new information about vaccines before communicating to the target audience. It provides training on media communication and outlines the typical fears and concerns of different stakeholders. The trainee also learns to expect rumours and to handle safety crisis situations. After completing each of the six modules, assessment is done before moving to the next module. After completing all six modules, a final assessment is carried out. The course will become available during 20 12. Participants were invited to subscribe to a mailing list through which they will be informed as soon as the course becomes available. 2.8 Basic principles of causality assessment
Dr Hossain started off by defining causality assessment as the systematic review of data about an AEFI case to determine the likelihood of a causal association between the event and the vaccine(s) received. He outlined the key differences affecting causality assessment of vaccines VS drugs. Causality assessment of AEFI should be carried out only by national AEFI committees (expert committee for AEFI) after very careful review of the findings of the investigation. Use may be made of an existing drug causality assessment team, but it needs to be modified and adapted to fit vaccines. Thus, a causality assessment committee for serious AEFI review needs
10
specific expertise. The expert committee should: have a broad range of expertise, from paediatrics/child health care to vaccinology, infectious diseases, epidemiology, microbiology, pathology, immunology, neurology and vaccine programmes; be transparent viz., free of real or perceived government or industry conflicts of interest; have terms of reference; and liaise with the national immunization programme. The WHO systematic approach to vaccine causality assessment comprises five criteria and two points. The five criteria include: consistency of findings, strength of association, specificity of association, temporal relationship and biological plausibility. The two points are previously known reaction and concomitant or preceding condition. The challenges of assessment issues are complex and include: (1) no systematic process: review, code, triage, collation, analysis and storage; (2) a backlog of cases for review; (3) a poor quality and/or unsystematic screening process; (4) a lack of criteria for AEFI referral for a formal causality assessment process; (5) a poor quality and/or unsystematic formal process; (6) inadequate expertise; (7) conflicts of interest; and (8) a lack of analysis of cumulative data. These challenges may undermine programme credibility, quality and timeliness. 2.9 Roles and responsibilities of different levels in an AEFI surveillance system
Dr Sato outlined the roles and responsibilities of different levels in an AEFI surveillance system in a country. The goals of AEFI surveillance are to minimize the negative impact of AEFI on public health, monitor the quality of vaccines used for immunization, ensure and monitor the quality of immunization services and reduce morbidity and mortality due to AEFI. The roles at health-centre level include: proper handling of vaccine following best injection practices, including recording the particulars of the vaccine and diluents before beginning the routine immunization session; treating mild symptoms, like fever and pain, providing immediate first aid and referring other cases to the appropriate level of care if needed ; referring AEFI and reporting serious events/cluster of events immediately; reporting AEFI details in the monthly report; assisting in investigation of AEFI and taking corrective action in response to guidance from the national level; following up with beneficiaries to identify AEFI; and supporting the building of community confidence. The roles of the provinciaUdivisional manager or nursing supervisor include: coordinating and strengthening the AEFI surveillance system in the division/province; maintaining AEFI documentation; ensuring that national AEFI guidelines and reporting formats are disseminated; assisting in responding to AEFI cases at the health-centre level; encouraging AEFI reporting from the government and private sectors; reviewing and analysing AEFI reported through reporting channels and checking to ascertain if similar adverse events have occurred in other places by reviewing data; coordinating with public health nurses and providing technical assistance; ensuring that the divisionaVprovincial communication plan is activated to handle any crises; ensuring the completion of the AEFI reporting form in a timely manner; and sharing feedback with lower and upper levels of the government system. The national EPI manager/surveillance office is responsible for: investigating AEFI cases; monitoring for previously unrecognized signals and vaccine-related adverse events and making recommendations for further investigation; reviewing the overall pattern of reports and investigations; developing/revising guidelines and standard operating procedures (SOPs); maintaining the national database of serious AEFI cases and providing feedback to the division/provinces; formulating a national AEFI expert committee and arranging and coordinating the meetings of the committee on a regular basis; conducting periodic evaluations of the national AEFI surveillance system; assisting in the collection of specimens and their shipment, if requested by the expert committee/panel; and coordinating with other departments,
11
such as drug authorities and hospitals, to deal with any referraV or other procedures following AEFI. The private sector plays a vital role in the immunization programme. Private practitioners should be encouraged to report AEFI to the nearest government hospital. Performance indicators have to be established to ensure that the system is sensitive enough to identify and respond to AEFI rapidly. 2.10 Methods for monitoring AEFI surveillancethankGod The objectives of Dr Hossain's presentation on methods and management for monitoring AEFI surveillance were to enable the participants at the end of the session to: list and explain the basic elements of surveillance systems applicable to monitoring and management of vaccine safety; describe different types of AEFI surveillance and provide examples of these; and explain why and how mass campaigns, introduction of newly licensed vaccines or expanded use of existing vaccines to new populations and potential for different risks/benefits within different countries would impact on the AEFI monitoring system. Types of AEFI surveillance include: (l) passive surveillance, which is the reporting of AEFI by health care workers and the public (This depends on AEFI being recognized and so underreporting is common.); (2) stimulated passive surveillance, which is passive surveillance with ongoing reminders and education of health care workers to be vigilant for AEFI cases (This may be focused on selected AEFI.); and (3) active surveillance, which involves a systematic search or scan for defined AEFI in a target population (clinic, hospital, community). The sensitivity level goes up from the passive to the stimulated passive to active surveillance system. All countries need to have at least a passive surveillance system. The passive surveillance system is the foundation of safety monitoring and occurs at local points of care. Health care workers need education and supervision on recognition of AEFI, the importance of reporting AEFI and the use of AEFI reporting forms and procedures. The AEFI case-reporting pathway to higher levels needs to be clear and there needs to be timely feedback for corrective action, if needed, to reinforce the value and usefulness of reporting and to reassure patients and the health care workers themselves. The responsibilities at national level include: the development of national AEFI guidelines and standard operating procedures (SOPs), including definitions and forms; provision of an AEFI training programme for health care workers; establishment of a national system to process AEFI reports; provision of feedback to community level; development of a mechanism for timely action, when indicated; and reporting to the international level. Development of standard AEFI case definitions may solve problems encountered in a passive surveillance system concerning the quality of data collected and reported, while conducting training will help to avoid incomplete filling of forms and improve the quality of case-reporting. Stimulated passive surveillance is carried out by giving periodic reminders, education and feedback regarding being vigilant for and reporting cases. This is useful where AEFI surveillance is new. It involves doctors/nurses in hospitals/clinics, and can increase reporting of serious AEFI. "Zero-reporting" may be a useful adjunct to ensure the system is functioning. Active surveillance involves systematic searching/scanning for defined AEFI in target populations (health unit, clinic, hospital, community), and active searching for safety signals, such as cases, risks or syndromes (intussusceptions ). This type of surveillance system is time- and resource-consuming. It has higher sensitivity, but lower coverage. The system is prone to bias unless observers are blinded. To conduct AEFI active surveillance, the AEFI target
12
for monitoring has to be defined (medical conditions that may represent AEFI of interest, specific vaccines selected for follow-up), the surveillance site has to be selected, with the sample size, detailed specific reporting forms for each condition of interest have to be developed and dedicated health care workers have to be trained to find cases at each surveillance site (based on AEFI or vaccine received). If the surveillance is based on a search for AEFI, then hospital and clinic records have to be reviewed for the selected AEFI, along with completion of a reporting form when a patient meets the criteria. If surveillance is based on a search for a specific vaccine received, patients have to be followed up after vaccination, inquiries made about any AEFI (specific targets) and reporting forms completed. Detailed report forms then need to be sent to the national centre for review, collation and analysis. Country-relevant performance indicators have to be developed, along with products for feedback and communication to enable analysis and feedback. During mass campaigns, large populations are immunized over a short period of time and coincident illness is therefore more likely to be noted. Programmatic errors may be more likely to occur due to the use of non-regular health care settings with which vaccinators are less familiar. In addition, actual vaccinators may not be health care workers. There could be clustering of adverse events. In such a situation, the time frame for detection, response and communication would be short. It is necessary therefore to prepare in advance for crisis events and to plan for serious adverse events in mass campaigns, establishing a review committee and designating and training focal points to deal with rumours and coordinate messages. Health care workers need to know how to investigate, and background rates for serious events have to be ascertained. When a new vaccine is introduced, AEFI will be suspected for any adverse effect, although any effect may be due to changes in the schedule, the vaccine manufacturer or the target population, who may have new underlying health issues like pregnancy would be limited. Use in a new population may also change the response to the vaccine and the potential for adverse events to occur. Underlying disease increases the difficulty in determining if AEFI is causally related to the vaccine, to the disease or to treatment. In order to address these challenges, it is imperative to obtain (and provide) information from pre-licensure studies; to collect and disseminate data from other countries where the vaccine is licensed; and to train health care workers about the new vaccine, how to address parents' questions and how to tell the difference between rumours and crises, and how to respond to both. Expert review of AEFI causality assessment is particularly important. 2.11 AEFI case management
The presentation on AEFI case management was given by Dr Valiakolleri. The minor reactions likely to occur are local, like pain, redness and swelling, fever >38°C and irritability malaise and systemic symptoms. Serious rare reactions were detailed, specific to each of the vaccines, along with time intervals for onset and rate per million doses. It is very important to know what these are and how to manage them. Most of the rare and more serious vaccine reactions (e.g., seizures, thrombocytopaenia, hypotonic-hyporesponsive (HHR) episodes, persistent inconsolable screaming) do not lead to long-term problems. Anaphylaxis, while potentially fatal, is treatable without leaving any long-term effects. Although encephalopathy is included as a rare reaction to measles or DTP vaccine, it is not certain that this is in fact caused by these vaccines. Seizures are mostly febrile and the risk depends on age, with a much lower risk in infants under the age of four months or over the age of six years. Reactions to measles/MMR (except allergic reaction and anaphylaxis) do not occur if already immune (~90% of those receiving a second dose). Management of minor reactions is simple. In cases oflocal reaction, a cold cloth may be placed on the injection site and paracetamol may be given. When fever >38°C, extra fluids should be given orally and tepid sponging should be carried out, along with administration ofparacetamol. For irritability, malaise and systemic symptoms, extra fluids
13
should be given orally with paracetamol. When prescribing paracetamol, it is important to ensure the correct dose is given. Anaphylaxis is very rare, occurring after less than one per million doses of measles vaccine, but is a severe and potentially fatal allergic reaction. When anaphylaxis occurs, the patient must be diagnosed properly, treated and managed urgently by trained staff and transferred to a hospital setting. Vaccinators and physicians should be adequately trained to enable them to distinguish anaphylaxis from fainting (vasovagal syncope), anxiety and breath-holding spells, which are common benign reactions. During fainting, the individual suddenly becomes pale, loses consciousness and collapses to the ground. Fainting requires no specific treatment or investigation. The signs and symptoms are progressive. Early mild warning signs can include skin itchiness, rash and swelling around the injection sit, dizziness and a general feeling of warmth, progressing to flushed, itchy skin, nasal congestion, sneezing, tears and painless swelling in part of the body. There may also be hoarseness, nausea and vomiting, swelling in the throat, difficulty in breathing and abdominal pain; if left untreated, this may progress to life-threatening symptoms like wheezing, noisy difficulty breathing, collapse, low blood pressure and weak pulse. It has to be noted that a strong central pulse (e.g. carotid) is maintained during a faint, but not in anaphylaxis. While anaphylaxis usually involves multiple body systems, symptoms may be limited to only one body system (e.g., skin itching), leading to a delay in diagnosis. Training on recognition of anaphylaxis and differentiation from fainting attacks need to be carried out for all health care workers. Once anaphylaxis is suspected, an ABC (airway, breathing and circulation) assessment should be carried out. If anaphylaxis is diagnosed, the patient should be considered as being in a potentially fatal condition, regardless of the severity of the current symptoms. Treatment should be started immediately, and plans made for immediate transfer to a hospital. AEFI treatment kits should be readily available. Management of anaphylaxis involves administration of adrenaline l: 1000 (age-appropriate dose) by deep intramuscular injection, giving an additional half dose around the injection site (to delay antigen absorption). If there is no improvement, this should be repeated within 10-20 minutes of the first injection, up to a maximum of three doses in total. Hydrocortisone should be given by intramuscular injection or slow IV. If the patient is conscious after adrenaline is given, his/her head should be placed lower than the feet and the patient kept warm. Oxygen should be given via face mask, if available. The immunization card must be marked clearly to prevent a future repeat dose of the offending vaccine. Anaphylaxis must be reported to the appropriate officer. Seizures are particularly associated with measles and DPT vaccination (pertussis component), and may be febrile or afebrile. Febrile seizures are more common with pertussis. Association with non-febrile seizures has not been proven. These are self-limiting and only supportive care is needed. Anticonvulsants are rarely needed. Hypotonic hypotensive episode (HHE or shock-collapse) are mainly associated with DTP. This is defmed as an event of sudden onset occurring within 48 (usually less than 12) hours of vaccination and lasting from one minute to several hours, occurring in children < 10 years of age. Such symptoms as limpness (hypotonic), reduced responsiveness, pallor or cyanosis or failure to observe/ recall will be presented. HHE is a transient, self-limiting reaction of unknown pathogenesis. It is not a contraindication to further vaccination. Adverse reactions to BCG vaccination include disseminated BCG, a widespread infection with Mycobacterium bovis that may develop 1-12 months after BCG. This usually occurs in immunocompromised individuals. It may be confirmed microbiologically by isolation of theM bovis BCG strain. Patients with disseminated BCG should be treated with an antituberculous
14
regimen, including rifampicin and isoniazid. Osteitis/osteomyelitis, infection of the bone with the Mbovis BCG strain, may also occur. Patients developing this complication are managed in the same manner as those with disseminated BCG. Suppurative lymphadenitis occurs within 2-6 months ofBCG vaccination. This is defined as one lymph node> 1.5 em in size or draining sinus over a lymph node. Suppurative lymphadenitis usually occurs in the axilla, on the same side as immunization. The lesion will heal spontaneously over months. It only needs to be managed actively if the involved nodes stick to the skin or form draining sinuses. Management in such cases would involve surgical drainage and local installation of an antituberculous drug. Systemic treatment with antituberculous drugs is ineffective in such cases. Tetanus vaccine may cause brachial neuritis. This presents with pain in the shoulder and upper arm. This is followed by weakness, with or without wasting of the arm and shoulder muscles. Sensory loss is not prominent. Dysfunction is limited to the nerve plexus of the arm, without involvement of other peripheral or central nervous system structures. Brachial neuritis occurs 2-28 days after vaccination. The pathogenesis is not clearly understood. It is possibly a manifestation of immune complex disease. This is usually associated with the administration of multiple doses. Management is symptomatic. The development of encephalopathy and encephalitis are possibly associated with measles and pertussis vaccines. However, it is not certain that these vaccines are causative. Symptoms include: seizures; alteration of consciousness, lasting for one day or more; and a distinct change in behaviour for one day or more. The case definition of encephalopathy stipulates that two out ofthe three above- mentioned symptoms should be there. This occurs within 48 hrs with DPT and within 7-12 days after measles or MMR. Treatment is limited to supportive care. 2.12 AEFI data analysis Dr Jorge Mendoza Aldana, Technical Officer, EPI, WHO Western Pacific Regional Office gave an overview of AEFI data analysis. The general principles of AEFI data analysis include: (1) all reported AEFI data need to be line-listed, followed by tabulation according to place, person and time; (2) analysis needs to be carried out according to antigen and type of reported adverse event (high fever, abscess) (The number of doses administered for each antigen is the denominator for calculating reported AEFI rates for each antigen in a given time period, by month, quarter or year.); ( 3) analysis should be expanded to the AEFI rates for first or second or third dose when the antigen is administered more than once (For this, the number of doses administered for the given antigen as first, second or third dose need to be used as the denominator.). Giving inadequate attention to the "case definition" of reported AEFI is often a weak point in a surveillance system. This may lead to either overreporting or underreporting of AEFI. Therefore, caution needs to be taken in comparing reported AEFI at Ministry of Health or district level with background rates. Measures of association include: (1) risk, which is the probability that an event will occur, for example, that an individual will become ill or die, within a period oftime; (2) relative risk, which is a measure of association between the outcome and a risk factor in the exposed and in the non-exposed (It indicates the probability that a member of an exposed group will develop a condition relative to the probability that a member of an unexposed group will develop the same condition); (3) attributable risk, which is the portion of the incidence of disease in the exposed population that can be attributed to the exposure; (4) attributable risk percentage, which is the percentage of the incidence of a disease in the exposed that is due to the exposure; ( 5) population-attributable risk, which is the portion of the incidence of a disease in the population (exposed and non-exposed) that is due to exposure; (6) population-attributable risk percentage,
15
which is the percentage of the incidence of a disease in the population (exposed and non-exposed) that is due to exposure; and (7) contingency table, which is a table commonly used in epidemiology to calculate measures of disease frequency and association with dichotomous categorical variables. The background rate is often low and is defined as some condition, event or agent occurring, at a particular time or in a particular place, in the absence of a specific hazard. The observed rate is the background rate plus the additional rate caused by the vaccine. 2.13 Communication This module was handled in two parts by Dr Lambach, with a presentation and with role play. Dr Lambach addressed challenges in risk-benefit communication and the importance of understanding how the public perceives vaccines and vaccine safety issues. The importance of understanding "who is the audience" and their perceptions and expectations was explained. The public may be confused, concerned and afraid, overloaded with complex information, tired and overworked, harassed and intimidated by health workers, or they may act out of religious, cultural and personal belief. Risk is perceived in terms of the voluntariness of exposure, familiarity with the risk, control over the risk, the catastrophic potential, fatal outcomes, an unequal balance between risk and benefit and an unequal distribution of risk. Experts, on the other hand, see risk in terms of morbidity and mortality levels. Parents perceive risk in a broad religious, social and personal context e.g. mistrust of the medical system. Voluntary, controllable risks are more acceptable to them, like: "If there were no vaccination given to my child, I could prevent the disease". Risks distributed fairly are more acceptable than unfair distribution of risk. It is essential to evaluate information before communicating it; critical review of the vaccine literature is a responsibility of the national AEFI coordinator. This facilitates effective management of rumours and community concerns arising from poor science; facilitates detection, assessment and action on new safety concerns arising from other parts of the world; and ensures up-to-date vaccination policies are applied at a national level. Before responding to new information from scientific literature, the manager has to ensure that the information is critically reviewed by himself or an expert qualified and trained to do so. In cases where such expertise is limited, it is essential to obtain guidance from international sources.
2.14 Developing a plan of action for strengthening an AEFI surveillance system Dr Hossain gave an introduction on developing a plan of action for establishment/ strengthening of the AEFI surveillance system in participants' respective countries. The countries were asked to work individually. By the end of the session, participants were advised to design (or improve) their existing national AEFI systems to ensure their practicality, sustainability and efficiency; to identify activities necessary to improve AEFI surveillance in their countries (i.e. an action plan); and to develop timelines and identify key responsible individuals for their plans of action. A sample plan of action was designed and provided for guidance. All countries where an AEFI surveillance system had not been established, such as Vanuatu, concluded that there is an urgent need to establish such a system. Most countries requested in-country basic training on AEFI surveillance systems, while none considered causality assessment a priority, although they would like to have it later. The need for financial assistance in conducting the training and other activities was indicated in most of the plans. 2.15 Collaboration in AEFI surveillance
16
Dr Diorditsa gave a presentation on collaboration in AEFI surveillance. He started by informing the participants that there are now 33 different types of vaccine formulations offered to countries in the WHO Western Pacific Region. He noted that at least three to four countries have plans to introduce, or have introduced, new and underutilized vaccines in 2011/2012, while other potential new vaccines, like vaccines for malaria, HIVI AIDS and tuberculosis, are in the pipeline. All20 of the Pacific countries introduced pandemic vaccine in 2009/2010. SIAs are still planned in countries in the Region for 2012-2015. Analysis of AEFI surveillance in the Pacific has shown that functional NRAs are non-existent or are limited; the AEFI surveillance system is relatively weak in many countries, or there is no system; and there are no, or limited, human resources for vaccine/drug regulation and AEFI surveillance, or facilities and capacities to develop or strengthen the regulatory system, including the AEFI surveillance system. The systems that do exist are inadequate and there is limited exchange of expertise or sharing of information among Pacific countries. Most countries in the area have expressed a need to exchange information more efficiently and effectively and have shown interest in harmonizing their regulations and sharing their competencies and resources for regulation and AEFI surveillance, and have asked that mechanisms be set up to strengthen their national expertise through collaborative exchange programmes. There is a clear need for collaboration, the objectives of which Dr Diorditsa outlined as follows: (1) To develop and/or strengthen the AEFI surveillance system in every country in the Pacific. To obtain government commitment and partner support to develop/strengthen the AEFI surveillance system in every country. To share information and best practices, and establish communication among countries in the Pacific. To minimize the negative impact of AEFI on public health. To ensure safe, effective and good quality vaccines are used.
(2)
(3)
(4) (5)
During the discussion, country participants expressed their appreciation of WHO efforts in this area and requested further technical and financial assistance. 2.16 Conclusions on AEFI surveillance All countries agreed on the need for a functional AEFI surveillance system in the Pacific and reached the following conclusions: Action plans: country participants will finalize their action plans by April 2012 and (1) submit them to the WHO Fiji office. Political commitment for action plan: Participants will pay advocacy visits and/or (2) include their action plans on the agendas of meetings with high-level health authorities to facilitate decision-making on establishing, strengthening and sustaining AEFI surveillance. Subregional mechanism for causality assessment: (a) The Pacific Ministers meeting (3) will be used as a forum to formulate a proposal and to reach consensus on establishing an intercountry panel of experts on AEFI causality assessment. (b) PacNet will be used for exchange of information. (c) There should be an annual meeting of the expert panel.
17
Monthly reporting: Countries agreed on monthly AEFI reporting. WHO will (4) modify the reporting forms, analyse the data and share with others through PacNet. In-country training: A proposal for in-country training will be finalized and shared (5) for technical support by partners. 2.17 Global and regional EP1 goals: the role of WHO in collecting. managing and reporting data Dr Aldana gave an overview of the global and regional EPI goals, with a focus on the role of WHO in collecting, managing and reporting data. Global goals: World Health Assembly and United Nations General Assembly Special Session (UNGASS) goals by 2005: ( 1) (2) (3) Polio eradication Measles mortality reduction Maternal and neonatal tetanus elimination (MNTE)
UNGASS goals by 2010: ( 1) Ensure full immunization of children under one year of age at 90% coverage nationally with at least 80% coverage in every district or equivalent administrative unit Vitamin A deficiency elimination
(2)
Millennium Development Goals (MDGs): ( 1) Two-thirds reduction in child mortality between 1990 and 2015
Global Immunization Vision and Strategy (GNS): ( 1) (2) Reduce measles mortality by 90% between 2000 and 20 10 Reduce childhood morbidity and mortality due to vaccine-preventable diseases by at least two-thirds between 2000 and 2015
The Global Framework on Immunization Monitoring and Surveillance (GFIMS). An extension of GNS, published in 2007 Regional goals: WHO Regional Committee for the Western Pacific resolution (WPR/RC/56.R8) under which, by 2012 Member States to: ( 1) achieve measles elimination;
18
(2)
reduce chronic hepatitis B infection rates to < 2% in five year-old children as an interim milestone towards the final goal of< 1%. in addition, maintain polio-free status through high-quality AFP surveillance and high immunization coverage.
(3)
The regional EPI coverage goals include: By 2010: GIVS: (1) (2) ~90% ~80%
national coverage coverage in all districts
By 2012: regional twin goals: (1) (2) (3) ~95%
with two doses ofMCV coverage with HepB birth dose (<24 hrs) coverage with HepB3
~80% ~85%
The Technical Advisory Group (TAG) recommends that Member States and areas provide WHO with complete and timely programme monitoring and VPD surveillance data, including the core variable data needed to monitor disease trends and surveillance quality. TAG requests that the Western Pacific Regional Office report on status at the next TAG session. Data collection for EPI Annual data collection Annual (WHO-UNICEF Joint Reporting Form on Immunization [JRF]) Surveillance data collection Epidemiological and laboratory data for selected vaccine-preventable diseases (quarterly, monthly, weekly) Ad hoc data collection Supplementary inununization activities The instruments for data collection include: (1) standard forms; (2) electronic data transfer -predefined file format (for monthly data collection); and (3) manual data entry (from e-mails, reports) for ad hoc data collection. The timeliness and completeness of measles surveillance in the Western Pacific Region has increased over the years. Coverage data is a trigger for Global Alliance for Vaccine Initiative support, investment decisions, modeling of mortality and disease burden, and timing of follow-up campaigns (e.g. measles), including routine second dose of measles.
19
2.18 WHO/ UNICEF Joint Reporting Form: history, timeline, purpose and data use Dr Aldana informed the participants that the WHO/UNICEF Joint Reporting Form (JRF) on immunization is for the period from January to December. This is an annual process. The forms are sent to and received from all Member States, filled in by Ministry of Health. The Joint WHO/UNICEF process started in 1998. The form includes a core set of items, with additional regional adaptations. Prior to 1998, two separate data collection forms, one from WHO and one from UNICEF, with two separate timelines for data collection and two different datasets on coverage, was the practice. The JRF form is revised every two to three years: the headquarters of WHO and UNICEF propose global core data elements and a consensus meeting with all stakeholders (WHO and UNICEF headquarters and regional offices) is held to agree on the core dataset and the timeliness of data collection and dissemination. The JRF has the following sheets: Cover page 1. 2. 3. Reported cases Schedule - source School and additional immunization delivery
4A. Routine coverage 4 B. Coverage surveys 5. Official estimates
6A. Indicators-! 6B. Indicators-2 8. 9. Supplementary immunization activities Measles-rubella, HepB
10. General comments Instructions Instructions - schedule The JRF, at the global level, is the primary monitoring tool. It allows consistency between international agencies (same data submitted to both UNICEF and WHO); reduces the reporting burden on national programmes, as annual collection only; has one format; has a single schedule (January each year); and has the same core set of questions, with regional modifications. In 2010, the last date for submission to the WHO Regional Office was changed to 15 March. It has been noted that the timeliness of submission by countries was only 14% at the regional level. None of the Pacific countries and areas submitted their data on time. Data may be used for the following: Consolidation and dissemination of national immunization data Monitoring programme indicators (WHO, UNICEF and other agencies) Monitoring global goals (WHO, UNICEF, MDG) WHO/UNICEF immunization coverage estimates
20
Vaccine-preventable disease (VPD) burden estimates Criteria for multi/bilateral funds 2.19 WHO-UNICEF Joint Reporting Form: data quality Dr Aldana, in his presentation, focussed on data quality issues arising from JRFs submitted by Pacific island countries and areas. Data quality means that the data collected adequately represent or reflect the programme's activities. Adequately means that the data are accurate and reliable. Accurate is interpreted as measuring what is intended to be measured (that data reflect the reality). Reliable implies that data have been collected and measured in the same way (consistently) by all involved during all reporting periods. Data quality can be described in different dimensions. Accuracy: The extent to which the data are free from significant error. The measure or degree of agreement between a data value or set of values and a source. Validity: The degree to which data values satisfy the acceptance requirements of the validation criteria or fall within the respective domain of acceptable values. Completeness: The extent to which enough of the required data elements are collected. Consistency: The extent to which data are collected using the same procedures and definitions across collectors and times. Timeliness: Whether data about recent performance are available when needed to improve programme management. Ease of use: How readily intended users can access data, aided by clear data definitions, user-friendly software and easily used access procedures. Examples of data from some countries, like the Federated States of Micronesia, Nauru, Niue, Palau and Vanuatu, were discussed and clarifications given. 2.20 WHO/UNICEF Joint Reporting Form 2011 Dr Aldana went through the JRF by line item to ensure that the participants understood the correct details to be entered on the form. This session evoked a lot of discussion and clarifications were given by Dr Aldana, with inputs from other members of the Secretariat. By the end of the session, participants were more comfortable in filling in the form.
I