NATIONAL IMMUNIZATION STRATEGY

TIMOR-Leste November 2006

CONTENTS

Introduction and Background _______________________________________ 3 Purpose Statement _______________________________________________ 3 Objectives of the Immunization Program ______________________________ 4 Immunization Strategy Components _________________________________ 5 Policy Statement____________________________________________ 5 Components and Implementation Strategies ______________________ 6 Component 1: Improving access and service delivery _______________ 6 Component 2: Develop capacity for planning and monitoring _________ 8 Component 3: Availability of quality vaccines and other supplies ______ 8 Component 4: Build communication support for immunization _______ 8 Component 5: Monitoring and evaluation ________________________ 9 Institutional Support ____________________________________________ 10 Vaccine Supply _________________________________________________12 Strategy Review ________________________________________________12 Annexes ______________________________________________________ 12 ANNEX A Immunization Schedules ___________________________ 13 ANNEX B Contraindications to Immunization ___________________ 16 ANNEX C - Open/Multi-Dose Vial Policy _________________________ 18 ANNEX D - Cold Chain _____________________________________ _19 ANNEX E - Safe Injection, Side Effects, and Adverse Events ________ 21 25 ANNEX F - Provision of Vitamin A Supplements ______________

The Ministry of Health of Timor-Leste extends appreciation to UNICEF, WHO and USAID/TAIS for their support in reviewing the national immunization strategy.

National Immunization Strategy

National Immunization Strategy

Introduction and Background

Prior to the civil unrest of 1999, Timor-Lestes Expanded Program on Immunization (EPI) was well established with a high coverage of over 80%. However, as a result of the crisis, the program was affected and the coverage dropped to low levels ranging from 20% to 40%. Over the past five years, UNICEF, WHO and USAID/TAIS have joined the government in restoring the immunization infrastructure of the country. The EPI focuses on the six major vaccine-preventable diseases and, in addition, will introduce hepatitis B (HepB) vaccine in 2007. The program provides vaccinations and other cost-effective interventions, including vitamin A supplementation, that have a high impact on maternal and child mortality and morbidity. A central distribution system for vaccines, along with cold chain facilities and a logistics network, were established in all the 13 districts of the country to provide immunization services. A revised immunization strategy is now required to provide a platform for the Ministry of Health to further strengthen its national immunization program in a sustainable manner. Linked to the development of a sound immunization policy and strategy for Timor-Leste are efforts to strengthen the health information and surveillance systems in the country so that diseases can be detected early and appropriate and timely actions can be taken to respond to outbreaks of vaccine-preventable diseases.

Purpose Statement
The purpose of this document is to provide direction and guidance for the implementation of immunization activities in Timor-Leste. This document will form the basis for developing immunization plans (i.e., Multi-Year and shortterm plans, including a financial sustainability plan) within the context of the delivery of the Basic Package of Services and further standard procedures and guidelines (i.e., injection safety, waste management, case investigations/surveillance, laboratory procedures, etc.) to support the objectives of the immunization program. The strategy will be used by decisionmakers, health managers, educators and health staff to implement national immunization activities. In addition to general strategy statements and components stipulated in this document, specific technical details and issues are annexed for reference. Further guidance can be found in the Mid-Level Management Course for EPI Managers and Immunization in Practice modules for health staff. This document is a revision of the National Immunization Strategy paper prepared in July 2004.

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Objectives of the Immunization Program

The Government of Timor-Leste, through the Ministry of Health, is committed to ensuring that all Timorese children are reached and provided with high quality immunization services and vitamin A supplements. The Ministry of Health, together with its partners, will strive to strengthen the national immunization program to ensure sustained routine immunization services for children and women. A sustained routine immunization program, reinforced by periodic accelerated disease control activities, will protect the children of Timor-Leste from mortality and morbidity due to vaccine-preventable diseases. Overall objective: To reduce under-five morbidity and mortality caused by vaccine-preventable diseases among children in Timor-Leste. Specific objectives: (a) To achieve and sustain a coverage rate of 85% for seven antigens (BCG, DTP, HepB, measles, and OPV) for children under the age of one year and TT2+ for all pregnant women at the national level and at least 80% in all districts by 2010 o At least 80% of districts and sub-districts should achieve coverage for all antigens of more than 80% by 2008. o At least 80% of districts and sub-districts should have a dropout rate of less than 10% by 2008 (DPT1/DPT3 and BCG/measles). o At least 80% of districts and sub-districts should achieve TT2+ coverage of pregnant women of more than 80% by 2008. (b) To sustain polio-free status and achieve certification of polio eradication in Timor-Leste by 2010 (c) To eliminate maternal and neonatal tetanus by 2010 (d) To reduce estimated measles mortality by 90% in 2009 compared to 2000 (e) To strengthen the quality of immunization services so that every immunization is given correctly according to national EPI guidelines and with potent vaccines (f) To improve program coverage and service quality through regular monitoring and supervision as well as periodic evaluations (g) To establish a strong AEFI (adverse events following immunization) surveillance system, including appropriate response to severe AEFI, with the objective of improving the quality of immunization service delivery (h) To improve capacity for prompt response to disease outbreaks by strengthening the disease surveillance system, including laboratory facilities (i) To increase public utilization of immunization services by intensifying promotional activities and community participation (j) To increase coverage of vitamin A supplementation to at least 90% of the children 659 months of age by 2010 through routine immunization services, supplemental immunization activities (SIAs) and Child Health Weeks (k) To combine distribution of ITNs, de-worming tablets, iron folate tablets, etc. with immunization services whenever feasible.

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Immunization Strategy Components

Policy Statement The Ministry of Health affirms the populations right to protection from preventable diseases and that it is within the governments collective capacity to realize that right. It is therefore the governments responsibility that every child benefits from one of the most cost-effective health interventions available, and that all children are vaccinated safely with potent vaccines. Every pregnant woman will be provided with a LISIO (MCH booklet) in which to record maternal and child immunizations. The Ministry of Health recognizes the crucial role that immunization and vitamin A supplementation play in preventing child morbidity and mortality. The first priority for implementation is primary immunization against the seven main vaccine-preventable diseases. All infants should be fully immunized against tuberculosis, diphtheria, pertussis (whooping cough), tetanus, poliomyelitis, hepatitis B and measles by the age of one year. Pregnant women will be vaccinated with tetanus toxoid (TT). This is in recognition that tetanus threatens mothers as well as babies during pregnancy and delivery. Children 6-59 months should be supplemented twice annually with appropriate doses of vitamin A. As much as possible, health interventions such as distribution of de-worming tablets, iron/folate tablets and ITNs will be offered along with vitamin A during Child Health Weeks. In order to increase immunization coverage rapidly, the Ministry of Health policy is to provide routine immunizations on a daily basis in all health facilities with functioning refrigerators. All community health centers (CHC) and selected health posts should have cold chain equipment. Priority should be given to health posts with high population catchments and health posts serving remote areas. Health facilities providing immunization services should vaccinate eligible children at every opportunity available. Immunization should be reinforced through the Integrated Management of Childhood Illnesses (IMCI) approach to ensure that there are no missed opportunities. Introduction of new/under-used and combination vaccines should be done carefully, in a phased manner, considering the resources and capacity of the health system, burden of the disease through evidence-based study, impact of immunization and public health priority. Emphasis should continue on the expansion of immunization coverage and consolidation of achievements of basic immunizations. All immunizations should be provided according to the Ministry of Health immunization schedules (see annexes to this document).

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Vitamin A supplements will be provided through a combination of bi-annual distribution activities, routine EPI contacts and supplementary immunization activities as appropriate. Components and Implementation Strategies The EPI is an integral component of the Basic Package of Services of the Ministry of Health. The major components of the EPI include: Component 1: Improving access and service delivery The prime objective of the Immunization Strategy is to improve access and increase coverage among target populations in a sustained manner through the provision of quality routine immunization services and related interventions. Planning in relation to routine services should be a part of the Multi-Year Immunization Plan, and a resource management system must be in place to cover recurring budgets, human resources, supplies and infrastructure. The following types of services should be organized: (a) Health center-based delivery or fixed site services All health facilities with functioning refrigerators should provide immunization services daily or, in the case of health posts, at least once a week. All children eligible for immunization should be vaccinated, and health care workers follow the Open/Multi-Dose Vial Policy while using safe injection practices in providing immunization services (see annexes). All health staff should practice opportunistic vaccination through integrated initiatives such as the IMCI approach. (b) Mobile services This activity can help accelerate increases in immunization coverage by providing immunization services for those populations living beyond walking distance from the fixed health facilities. Mobile services should be conducted by a team and should include other health intervention such as ante-natal care, growth monitoring, and distribution of vitamin A supplements, de-worming tablets, iron/folate tablets and ITNs, wherever feasible. Mobile activities should be carried out at least once a month in each suco in a regular manner.

(c) Remote area outreach services In areas where monthly services are not feasible due to extreme difficulty in reaching the children, immunization services should be given at least 3-4 times a year, together with other health interventions. Special arrangements for transportation of supplies and human resources should be made for this activity. The MoH will provide extra resources for reaching hard-to-reach populations with low immunization coverage, such as migrants or other transient populations who

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are internally displaced, returnees, minority groups, people living in remote areas and in populations in unstable situations or emergencies. (d) Increased collaboration with private health care providers to improve access As there is private sector supporting the MOH for provision of immunization services to the public (i.e., NGOs, private clinics), it is important that this private sector and the MOH strengthen their collaboration for the implementation of the national immunization program and other services. The Ministry of Health, with the assistance of development partners, will provide vaccines and vaccine carriers to NGO health facilities and private clinics whenever possible to ensure availability of quality vaccine. The private service providers, in turn, should agree to provide regular information on their services delivered. All immunization services should be provided free of charge. (e) Accelerated disease control: Supplementary Immunization Activities Supplementary Immunization Activities (SIAs) are required in order to rapidly and effectively reduce the childhood morbidity and mortality and to achieve the national and regional goals of reaching polio eradication, measles mortality reduction, and maternal and neonatal tetanus elimination (MNTE). Given the countrys high fertility rates, low skilled-attendant delivery rate and low tetanus toxoid coverage, special MNTE activities will be required in the near future and thereafter as needed Given measles vaccine efficacy, not every child who receives measles vaccine at 9 months of age is completely protected from the disease. In addition many children do not get measles vaccination at 9 months. Therefore, there is a need for second opportunity of measles immunization through SIAs to prevent the accumulation of unprotected children. The frequency of SIAs should be based on coverage of measles immunization at 9 months and the epidemiology of the disease. Once routine immunization coverage is uniformly above 80%, second opportunity could be introduced in routine immunization schedule. The surveillance system and outbreak response will be strengthened and ensure completeness and timeliness of weekly reporting of acute flaccid paralysis, measles and neonatal tetanus cases. Surveillance reports will be linked with the health management information system. Vitamin A supplementation and distribution of such items as ITN, de-worming tablets, iron/folate tablets, will be provided during SIAs and other special health activities.

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Component 2: Develop capacity for planning and monitoring The Ministry of Health will ensure development of national immunization plans and mobilize resources to reduce disease burdens and reach national and global goals of the immunization program. The following will be used: A comprehensive and costed Multi-Year Plan (2007-2010) using Global Immunization Vision and Strategy (GIVS) as a framework 2) Interagency Coordinating Committee (ICC) 3) Annual EPI work plans 4) Regular monitoring of the implementation of the action plan by a national technical advisory group 5) Plans for introduction of new and under-utilized vaccines 6) Human resources development and training 7) Districts micro-plans and coverage improvement plans using the RED (Reaching Every District) strategy, which will be prepared by districts as part of their annual planning process 8) A Plan of Action for the Integrated Disease Surveillance system to guide the monitoring of VPD cases 9) A Preparedness Plan for Outbreak of Polio in case of importation of wild polio virus case or occurrence of a vaccine-derived polio virus case. 10) Strengthened institutional capacity of pre-service and in-service training on immunization; Mid-Level Management training for District EPI Managers and Immunization in Practice for health workers 11) Monitoring of routine immunization activities using the Continuous Coverage and Quality Improvement process. Component 3: Availability of quality vaccines and other supplies The Ministry of Health will ensure that high-quality vaccines and other supplies are readily available and sustainable in the long term. This will be achieved through: Ensuring the availability of potent vaccines and adequate supplies at all levels through proper forecasting and management of supplies Having a cold chain expansion and replacement plan in place Preparing a cold chain inventory and updating it quarterly Preparing an annual supply distribution plan for vaccines and supplies Organizing periodic assessments of the cold chain and vaccine management system and modifying strategies and taking corrective actions as required. 1)

Component 4: Build communication support for immunization The Ministry of Health will develop effective communication strategies and implement interventions for the immunization program that will address the following areas: (i) demand creation; (ii) reaching children in hard-to-reach areas, (iii) accelerated disease control initiatives; (iv) vitamin A supplementation; (v) hepatitis B introduction and (vi) immunization safety.

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Information, education and communications (IEC) will be developed and implemented within the Ministry of Healths promotion strategies. The following specific actions will be advocated in the EPI communication strategy: Developing national and district/sub-district-level communication plans for immunization and vitamin A supplementation Strengthening the link between the community and service delivery so that the community is engaged in service planning and delivery Disseminating information on the benefits of immunization among communities through health workers; family health promoters; school teachers; religious, political and community leaders; community-based organizations; media and other government and non-government organizations Promoting immunization safety, including injection safety, and appropriate waste disposal Raising awareness raising on potential AEFIs (adverse events following immunization) and steps to be taken when an AEFI occurs Training health care workers to strengthen interpersonal communication skills.

Component 5: Monitoring and evaluation Monitoring and evaluation of EPI activities will take place at all levels. Implementation of activities as well outcomes will be monitored. The routine health information system will be linked with the disease surveillance system. EPI recording and reporting will be improved and routinely compared for accuracy. Copies of reports will be kept at all levels. The EPI unit, hospitals and District Health Offices will ensure that MCH booklets, immunization registers and reporting forms are available at all times. EPI staff at all levels will ensure that EPI indicators are routinely graphed and monitored. Targets for identified indicators will be reviewed at the district level to ensure that national targets are achievable. EPI coverage surveys, assessments of the national immunization program and other evaluation studies will be conducted from time to time as the need arises. The main indicators for EPI will be: Outcome indicators at all levels Immunization: Immunization coverage rates for all antigens % of DPT1 and DPT3 by district and sub-district % of dropout (DPT1/DPT3 and BCG/measles) by district and sub-district % of TT 2+ in pregnant women by district and sub-district Vitamin A: % of children 6-59 months old who received vitamin A supplements (one capsule within the last 6 months) % of post-partum women who received vitamin A supplement within 6 weeks of their last delivery

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Output indicators at all levels: Program Quality: % of functioning freezers at district storage level % of health centers with refrigerators that have temperature between 2-8 degree Celsius % of planned mobile and outreach services conducted monthly % of health facilities using AD (auto-disable) syringes and safety boxes % of health facilities that graph cumulative DPT1 and DPT3 coverage each month % of children aged 9-11 months who receive measles immunization during a visit to a health facility Surveillance: % of AEFI cases investigated out of all reported AEFI cases Completeness/timeliness of AEFI reporting % of AFP cases investigated out of all reported AFP cases Completeness/timeliness of AFP reporting

Institutional Support
(a) National level The planning, implementation and evaluation of the national immunization program is the responsibility of the EPI Project Manager under the supervision of the Maternal and Child Health Department, which reports directly to the Director of Health Services Delivery. The EPI unit co-ordinates and facilitates the organization of EPI services, formulates policy, develops standards, undertakes national level planning and supports district activities. EPI unit staff should be adequately trained in planning, management and monitoring of EPI services. (b) District level Districts are directly to be involved in the planning and implementation of EPI through the annual district planning process. The EPI focal persons are designated District Public Health Officers (DPHOs) who are responsible for the implementation of the immunization program activities at the district level. District Health Management Teams (DHMTs) are responsible for planning, implementing, supervising, monitoring and evaluating EPI activities at the district level. DHMT and health facility staff should be appropriately trained in all aspects of EPI implementation and supervision. (c) Sub-District level As members of the DHMT, the Community Health Centre Managers are responsible for planning immunization activities through the annual district planning process as well as for detailed immunization service provision planning at CHC level. This planning includes the responsibility for organizing sufficient

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(and widespread) fixed, outreach and mobile service sites in the sub-district so that all eligible children and pregnant women have routine access to high-quality immunization services. Immunization plans and implementation are to be built around defining the geographical catchment area for each service site and monitoring coverage using population statistics available from the Ministry of State Administration by suco and aldeia. Health workers in the various facilities will be expected to know their catchment population, participate in planned mobile and outreach activities and monitor coverage achievement in their assigned catchment areas. (d) Community level At the community level, households and communities will be targeted for relevant information. Family health promoters will be trained to facilitate community action. Communities will be encouraged to keep lists of pregnant women and newborns to assist health staff in tracking women and infants for immunization and vitamin A supplementation. Strengthening the link between the community and service delivery will enhance community demand on immunization services, engagement in service planning and encourage community members and volunteers to assist staff during service delivery activities. (e) Intersectoral collaboration Intersectoral collaboration and the mobilization of all stakeholders to support EPI activities should be undertaken. The role of district administrators, suco chiefs and other ministries is crucial in the implementation of the immunization programme. The role of nongovernmental, church, media and other grassroots organizations in promoting community involvement in health development is recognized.

(f) Interagency coordination Co-ordination of EPI activities will be undertaken within the framework of Ministry of Health structures at the national and district/sub-district levels. A technical committee for EPI consisting of members from the Ministry of Health, WHO, UNICEF and USAID/TAIS was formed and started functioning from September 2006. EPI technical committee members meet every 2-3 weeks where EPI related issues are discussed and consensus reached. Under the guidance of Ministry of Health, an Inter-agency Coordinating Committee (ICC) will be established. The terms of reference for the ICC are under preparation and will include coordination of immunization related activities.

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Vaccine Supply
The quality of vaccines used in immunization program cannot be compromised. Hence, the government must establish a regulatory body and mechanism to ensure safety, efficacy and quality of all vaccines imported into the country. Vaccines and other supplies for the national program on immunization may be procured through UNICEF Global Procurement Mechanism, or only from suppliers/manufacturers duly certified by UNICEF/WHO. In order to ensure that the children and women of Timor-Leste receive the highest standard of quality vaccines: The Multi-Dose Vial Policy should be implemented wherever a functioning cold chain is available. Outreach sessions should discard opened vials of OPV, DPT and hepatitis B vaccine at the end of the day. Health staff should discard BCG and measles 6 hours after the reconstitution or when they leave the immunization session, whichever comes first.

Strategy Review
Recognizing the potential rapid changes in both the health situation and the evolving health delivery infrastructure in Timor-Leste, this strategy document will be reviewed within two (2) years of approval by the Minister of Health.

Annexes
A - Immunization Schedules B Contraindications to Immunization C - Open/Multi-Dose Vial Policy D - Cold Chain E Safe injection, Side Effects, and Adverse Events F Provision of Vitamin A Supplements

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ANNEX A Immunization Schedules

The Expanded Program on Immunization is aimed at the following target groups: All children under 1 year of age (0-11 months) All women of childbearing age (including pregnant women)

The recommended vaccines are the following: BCG OPV DPT HepB TT Measles DT DTP-HepB Bacillus Calmette-Guerin Oral Polio Vaccine Diphtheria, Pertussis, Tetanus Hepatitis B Tetanus Toxoid Measles Diphtheria and Tetanus Diphtheria, Tetanus, Pertussis, and Hepatitis B

Immunization Schedule for Infants <1 (At birth up to 12 months of age) In case of monolavent HepB vaccine Type of vaccine When administered BCG, OPV 0 At birth (or as soon as possible after birth) OPV1, DPT1, HepB1 At 6 weeks OPV2, DPT2, HepB2 At 10 weeks (or 4 weeks after OPV1, DPT1, HepB1) OPV3, DPT3, HepB3 At 14 weeks (or 4 weeks after OPV2, DPT2, HepB2) Measles At 9 months In case of tetravalent (DTP+HepB) vaccine Type of vaccine When administered BCG, OPV 0 At birth (or as soon as possible after birth) OPV1, DTaP-HepB1 At 6 weeks OPV2, DTaP-HepB2 At 10 weeks (or 4 weeks after OPV1, DPT1, HepB1) OPV3, DTaP-HepB3 At 14 weeks (or 4 weeks after OPV2, DPT2, HepB2) Measles At 9 months Note: The first dose of DPT (1) should not be given when an infant is less than 6 weeks old due to sub-optimal antibody response. OPV0 should be given only within 2 weeks of birth. BCG may be given till 12 months of age. The interval between doses of DPT, HepB and OPV should be at least 4 weeks. In cases where the subsequent doses of DPT, HepB and OPV are delayed, there is no need to repeat the (previous) dose. All EPI antigens are safe, even if administered simultaneously at the same day, but should be in different injection sites. OPV1, DPT1, HepB1 should be given at 6 weeks of age or as soon as possible after 6 weeks of age.

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Measles vaccine should be given at 9 months or as soon as possible after 9 months of age. All child immunizations should be recorded in the register and reported in two age groups (under 1 year of age and above 1 year of age).

If a child fails to come back for his/her subsequent doses of DPT, HepB or OPV or does not take measles immunization as scheduled, it is the responsibility of the health staff to follow up and complete the full course of primary immunization before one year of age or as soon as possible thereafter before the child reaches two years of age. Booster Doses Booster Immunization will be part of the routine immunization to be delivered by all health facilities. Booster doses should give to the children who complete the primary series of immunization may receive booster doses of the following vaccines to maintain or prolong the immunity against the antigens: DT booster 1 DT booster 2 OPV booster after a year of DPT3 or at 2 years of age at primary school entry or at 6 years of age at primary school entry or at 6 years of age

Note: DT should not be used in children of seven years of age and older. Tetanus Toxoid Immunization for Women Dose TT1 TT2 TT3 TT4 TT5 Schedule first contact, or as early as possible during pregnancy least 4 weeks after TT1 least 6 months after TT2 least one year after TT3 or during subsequent pregnancy least one year after TT4 or during subsequent pregnancy Protection None 1 to 3 years At least 5 years At least 10 years Reproductive years

At At At At At

Vaccination Doses and Sites Vaccine BCG OPV DPT Measles TT Hep B Dosage 0.05 ml 2 drops 0.5 ml 0.5 ml 0.5 ml 0.5 ml Site R-upper arm Mouth Outer thigh L-upper arm Upper arm Outer thigh Method Intradermal Oral Intramuscular Subcutaneous Intramuscular Intramuscular

NB: Always read manufacturers instructions prior to mixing or giving injections.

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Administration of Vaccines 1. Freeze-dried vaccines (i.e., BCG, measles) must only be mixed with their own diluents provided by the manufacturer. The diluents for BCG should only be used for BCG vaccines; the diluents for measles should only be used for measles vaccine. Always read the manufacturers instructions before mixing or injecting vaccines. Reconstituted vaccines such as (BCG and measles) must be discarded at the end of the immunization session or 6 hours after reconstitution, whichever comes first. Do not use expired vaccines or if VVM readings are in stages 3 and 4 (discard point). Please refer to EPI training manual on how to read Vaccine Vial Monitors. Use one sterile syringe and needle for every injection given to a child or woman, preferably using the auto-disable (AD) syringes. Do not recap needles. Put the used syringes/needles in safety box container for safe disposal. Mild illness or fever is not a contraindication to immunization (see Annex B). However, if the child is very ill with high fever (>38.5 C), then a senior health staff may postpone the vaccination. Children with symptomatic HIV infection should not be immunized with BCG vaccine. Explain to the caregiver of the child and to the woman receiving vaccines that, although very unusual, some unwanted events may occur, although most of them are very mild; if this happens, they should immediately report to the health worker or to the nearest health facility.

2.

3.

4. 5. 6.

7. 8

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ANNEX B Contraindications to Immunization

There are few valid contraindications to immunization. All infants should be immunized except in three rare situations: 1. Anaphylaxis or a severe hypersensitivity reaction is an absolute contraindication to subsequent doses of a vaccine. Persons with a known allergy to a vaccine component should not be vaccinated. 2. Do not give BCG vaccine to an infant who exhibits the signs and symptoms of AIDS. 3. If a parent strongly objects to an immunization for a sick infant, do not give it. Ask the mother to come back when the infant is well. Immunize Sick Infants Many health workers do not like to immunize an infant who is ill. Young infants have many illnesses, and immunization is often delayed. Many infants catch one of the target diseases because they missed being immunized due to illness. However, we now know that it is safe to immunize infants even if they are ill. Children with a mild illness: Immunize them as usual. Children with a fever Immunize them as usual. You can give any vaccine, including DPT there is no danger from adding the reaction to vaccine to a moderate fever. Very ill infants who need to be hospitalized, or infants who have a very high fever Immunize them if possible. A senior health worker should decide for each individual infant. Remember that sick infants need protection against diseases that they may catch in hospital, especially measles. Malnourished infants You must immunize them they can develop good immunity although they are malnourished. They are more likely than other infants to die from the diseases (especially from measles). Immunize infants with the following conditions (these conditions are not contraindications). Immunize children who have: Allergy or asthma (except if there is a known allergy to a specific component of the vaccine mentioned above) Any minor illness, such as respiratory tract infections or diarrhea with temperature below 38.5C Family history of adverse events following immunization Family history of convulsions, seizures, or fits Treatment with antibiotics Known or suspected HIV infection with no signs and symptoms of AIDS

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Signs and symptoms of AIDS, except as noted above Children being breastfed Chronic illnesses such as chronic diseases of the heart, lung, kidney, or liver Stable neurological conditions, such as cerebral palsy or Downs Syndrome Premature or low-birth weight (vaccination should not be postponed) Recent or imminent surgery Malnutrition History of jaundice at birth.

If a reaction does occur, health workers should report the problem immediately to a supervisor. Children who have a severe reaction to a vaccine should not receive additional doses of that vaccine. There is no evidence of risk to the foetus from immunizing pregnant women with tetanus toxoid.

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ANNEX C Open/Multi-Dose Vial Policy

The open/multi-dose vial policy has the potential to reduce vaccine wastage rates by up to 30%, resulting in a significant annual savings in vaccine costs. The policy is as follows. 1. OPV, DPT, TT, DT and hepatitis B vaccines a. Multiple-dose vials of OPV, DPT, TT, DT and hepatitis B vaccines from which one or more doses of vaccine have been removed during an immunization session at a static immunization site (health facility) may be used in subsequent immunization sessions for up to a maximum of 4 weeks, provided that all of the following conditions are met: The expiry date has not passed The vaccines are stored under appropriate cold chain conditions (2-8 degrees centigrade) The vaccine vial septum has not been submerged in water Aseptic technique has been used to withdraw all doses The vaccine vial monitor (VVM), if attached, has not reached the discard point The vials have been marked with the date opened in order to track the 4week use period. b. Multiple-dose vials of OPV, DPT, TT, DT and hepatitis B vaccines from which one or more doses of vaccine have been removed during an outreach immunization session MUST BE DISCARDED at the end of the day. 2. Measles and BCG vaccines Reconstituted vials of measles and BCG vaccines MUST BE DISCARDED at the end of each immunization session or at the end of six hours, whichever comes first. Six hours after reconstitution, measles and BCG vaccines must be discarded. 3. All vaccines An opened vial of any vaccine MUST BE DISCARDED immediately if: Sterile procedures have not been followed OR The presence of floating particles or a change in the appearance of the vaccine shows that it has been contaminated OR It is suspected that the vaccine has been contaminated OR It is suspected that the vaccine in the vial has been exposed to unacceptably high temperatures (or has been frozen in the case of DPT, HepB, TT and DT) If the vaccine vial monitor on a vial shows that the vaccine inside has been exposed to unacceptably high temperature. REMEMBER: Any opened vials that are kept after an immunization session at a health facility must be dated (the date the vial is opened is to be written on the label) and placed in a special box marked returned in the refrigerator. This vaccine should be used before any others during the next session.

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ANNEX D- Cold Chain

Care of Vaccines and Cold Chain All vaccines are sensitive to heat; they need to be preserved within recommended temperature range. Vaccine should be stored at various levels with 25% buffer stock at each level. The First-in First-out rule must to be followed. However, if any vaccine is nearer expiry date or the VVM is darker than the others, it should be used first.

Vaccine Stock OPV BCG Measles DTP HepB DTP-HepB TT DT/Td

National Central Cold Room 6 months - 15 to -25 C -15 to - 25 C (if cold chain space permits)

District 1 month

Community Health Centre 1 month

Health Post (if fridge is available) 1 month

+2 to +8 C

At the District and Sub-district level The upper part is a freezer compartment used for freezing icepacks. This section should be kept below 0 degree Celsius. No vaccines should be kept or stored at the freezing compartment at the health center level. The lower part is the main compartment for storing all vaccines and diluents. The temperature in this compartment should be kept between +2 and +8 degrees Celsius. Dos and Donts Refrigerator/freezer 1. The temperature at the bottom portion of top-loading refrigerators or icelined refrigerators (ILR) falls below 0C. So DPT, TT & HepB vaccines should not be stored in the bottom part or touching the inside wall of such fridges. It is always better to store these vaccines in the baskets or separated by a wooden block or styrofoam pads. However, front-loading

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2. 3.

4. 5. 6.

refrigerators usually have the cooling unit on the top. Therefore, the top of the refrigerator is the coldest part and so freeze-sensitive vaccines should be stored on the middle shelf in the refrigerator As much as possible, try not to open the door more than three (3) times per day. Never freeze diluents. Diluents do not need to be stored in the fridge. However, they should be at vaccine temperature at the time of reconstitution. Therefore, keep the required quantity of diluents in ILR one day ahead of the immunization session. EXPIRED/ DAMAGED VACCINES should not be stored in the cold chain equipment. Maintenance of the unit by regular defrosting and minimizing the times in opening the door of the refrigerator will help temperature stability. DO NOT keep any food, drinks or any drugs in a vaccine refrigerator.

Cold Box 1. DPT, HepB, TT, and DT vaccines are sensitive or damaged by freezing. Ice packs should be conditioned before loading vaccines in a cold box and vaccine carrier. Conditioning means leaving ice packs out of the freezer until you see water drops on the surface of the ice pack. 2. Avoid opening the lid when not necessary. 3. Keep a thermometer with the vaccines. Vaccine Carriers 1. Some vaccine carriers are provided with a foam pad fitted under the lid. This has slits which safely hold opened vials in use and protect the other unopened vials inside the carrier. 2. Keep a thermometer with the vaccines. Review of the cold chain There should be a review at least monthly of each refrigerators temperature records. Temperature should be recorded twice a day, once in the morning and once in afternoon. The district health office, CHC and health post should assign a person in each health facility to be responsible for the cold chain. If the fridge is not functioning well, this person should immediately report to district health officer though his or her supervisor. The district should inform the EPI unit at the central level for necessary action. EPI cold chain technicians and field supervisors should conduct regular monitoring and supervision in the field to assess the performance of the refrigerators. Cold chain equipment should be recorded in the stock register.

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ANNEX E - Safe Injections, Side Effects and Adverse Events

Safe Injections An injection is considered safe for the: Mother or child, when a health worker uses a sterile syringe, a sterile needle, correct injection techniques and potent vaccine for each immunization Health worker, when he or she avoids needle-stick injuries Community, when waste created by used injection equipment is disposed of correctly and does not cause harmful pollution and injuries.

A. Safe injections for mothers and children 1. Wash hands before the immunization session. Wash hands between clients when possible. 2. Prepare injections in a clean area where there has been no blood or body fluid. Prepare each dose immediately before administering; do not prepare several syringes in advance. 3. Never leave the needle in the top of the vaccine vial. 4. Follow safe procedures to reconstitute vaccines. a) Make sure you have the CORRECT diluent for each freeze-dried vaccine check that both diluent and vaccine come from the same manufacturer. b) When reconstituting, both the freeze-dried vaccine and the diluent must be at the same temperature (between 2C and 8C). c) Use a new sterile syringe and needle to reconstitute each unit of vaccines. Use the amount of diluent specified by the manufacturer to reconstitute the vaccine provided for the vial. After use, dispose of the syringe into a safety box. NOTE: All reconstituted vaccines should be discarded at the end of the session or after six hours, whichever happens first. 5. When giving an immunization, use a new (sterile) syringe and needle for every injection. a) Open a new auto-disable syringe and needle for each injection. b) Inspect the packaging very carefully. Discard a needle or syringe if the package has been punctured, torn or damaged in any way. 6. When giving an immunization, any part of the syringe that you touch becomes contaminated. Do not touch the adaptor, shaft or bevel of the needle. Discard a needle that has touched any non-sterile surface. 7. Position each child correctly for injections and ensure the caretaker controls the movements of the child. Unexpected motion at the time of injection can lead to accidental needle-sticks.

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B. Prevent needle-stick injuries and infections Needles frequently injure health workers. Small but dangerous amounts of blood infected with hepatitis B, hepatitis C, HIV, or other viruses can be transmitted by needle-stick injuries. There are simple steps health workers can follow to reduce the risk of needle-stick injuries: Allow only one child at a time is in a health workers work-space. Place a safety box close to where you give vaccinations so used syringes and needles can be disposed of immediately without setting them down or moving far. Do not recap the needle after immunization. Immediately after the immunization, place the used syringe/needle into the safety box. Close the safety box securely when it is three-quarters full (about 100 AD syringes)

C. Dispose used syringes & needles All used injection equipment except reusable syringes and needles should be placed in a safety box immediately after use. Used syringes and needles must NEVER be dumped in open areas where people might step on them or children might find them. They should never be disposed of along with other kinds of waste. The following methods can be used to destroy filled safety boxes or to keep them away from people. Make sure a qualified staff member supervises the process. Do not leave this vital task to unqualified people. 1. Incinerate Where possible, use an incinerator to destroy syringes and needles. Properly functioning incinerators ensure the most complete destruction of syringes and needles. The area in which incineration takes place must be fenced off from the rest of the compound. Staff members conducting the incineration should wear gloves. 2. Burn and bury in a pit Used injection equipment may be burned and buried in a disposal pit. Choose the site carefully and dig a pit large and deep enough for bulky boxes. Choose a site where people will not dig or establish latrines in the future. Fence off and clear the area. Dig a pit at least two meters deep. Take the filled safety boxes to the pit site just before burying. Do not open or empty the boxes. Warn people to stay away and avoid smoke, fumes, and ash from the fire. Place the filled safety boxes in the pit and burn until all boxes are completely destroyed.

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Cover the boxes with at least 30 cm of soil. If possible, cover the site with concrete when the pit is full.

Potential Side Effects There can be side effects (reactions) to immunization. Always explain to caretakers about the potential side effects of immunization and what to do about them. Advise the caretakers on how to tell when they need to bring the infant to the health centre or hospital in case of a rare, serious side effect (adverse event). When giving immunization, EPI guidelines require that health workers: Explain which disease or diseases the vaccine prevents. Reassure the parent that reactions are common and not a threat to the infant; they show that the infant is responding to the vaccine. If the infant suffers fever, pain, or swelling at the injection site, or is irritable, loses his or her appetite, or is off colour: o Give extra fluids (more breastfeeds if child is under 6 months; additional breastfeeds and clean water to drink if child is over 6 months of age). Paracetamol may be given one 100 mg tablet crushed, three times in 24 hours. Keep pressure off the injection site(s). Place a cloth dampened with cool, clean water on the injection site.

o o

Tell the parent to bring the infant to the health center if the infants condition gets worse or the reaction continues for more than a day or two.

Potential side-effects after giving BCG vaccine: Explain to the parent that the flat-topped swelling on the infants arm is normal and indicates that the vaccine is working Ask the parent to return with the infant if he or she develops any side effects such as abscesses or enlarged glands.

Potential side-effects after measles vaccine: A rash or fever may develop after 612 days. Other people will not catch the rash and it goes away. Give extra fluids and keep child cool.

Adverse Events Following Immunization (AEFI) An adverse event following immunization (AEFI) is defined as a medical incident that takes place after immunization which causes concern and is believed to be caused by immunization. An AEFI is not necessarily a vaccine reaction. It can be coincidental (simply happening some time after immunization) but have absolutely nothing to do with

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the vaccination. Each adverse event should be investigated and efforts made to determine its cause. The detection of adverse events should be followed by appropriate treatment and communications with parents, health workers and the community. If the adverse event was determined to be due to program errors, operational problems must be solved through appropriate logistical support, training and supervision. The immunization program in all districts should monitor at least the following AEFIs: All injection site abscesses Cases of BCG lymphadenitis Severe or unusual medical incidents that are thought by health workers, or the public, to be related to immunization All cases requiring hospitalization that are thought by health workers, or the public, to be related to immunization All deaths that are thought by health workers, or the public, to be related to immunization.

All reported AEFIs should receive immediate attention and should be reported as soon as they are detected through the DPHO/DHO to the National EPI Manager. Investigations of AEFI should commence within 24 hours of detection. The preliminary investigation can be made by the health worker who detected the AEFI and information forwarded to his/her supervisor for follow-up using a standard AEFI reporting form.

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ANNEX F - Provision of Vitamin A Supplements

Supplementation of vitamin A is important to prevent blindness, and it dramatically increases the chances of survival of children aged 6-59 months. It reduces all-cause mortality by 23%, measles mortality by 50% and diarrhoeal disease mortality by 33%. Vitamin A supplementation can improve child health and save health care costs. It is one of the most cost-effective health interventions for reducing infant and child mortality. There is a wide range of possible ways in which children can receive adequate supplementation of vitamin A. One of the best ways is to link this to immunization program or activities. The strategies in distributing vitamin A can be carried out in three ways through: Routine immunization services Supplementary immunization activities, such as national immunization days, and Treatment of measles and xerophthalmia.

The following are the recommended activities for vitamin A supplementation: 1. Target group for vitamin A supplementation during routine contacts All lactating mothers should receive a dose of vitamin A (200,000 IU), irrespective of their mode of infant feeding, up to six weeks post-partum if they have not received vitamin A supplementation after delivery. The health worker must therefore ask the mother when she gave birth. Health workers must ask mothers regarding her vitamin A intake while taking her child for BCG vaccination and provide supplementation when appropriate. Infants at 611 months of age should receive vitamin A (100,000 IU) given once every 4-6 months in Vitamin A Week/Child Health Week in February and August. To monitor the dose given to the child and avoid multiple dosing, the health worker must record vitamin A supplement administration in the Lisio (MCH booklet) for routine health service visits. Health workers should always evaluate vitamin A intake of infants receiving their measles vaccination at 9 months old and provide supplementation when appropriate. Children 14 years old should receive vitamin A (200,000 IU) with a minimum interval of 4-6 months, possibly in Vitamin A Week/Child Health Week in February and August. Any available contact with the health system should be utilised. Supplementary Immunization Activities

2.

Every opportunity must be taken to provide vitamin A to eligible children. Even if a dose is given closer than four weeks apart, the danger of undesirable effects is low, and of serious adverse effects is negligible. During SIAs, only screening for age is necessary, to determine the correct dose for the age of the child. The correct dose of vitamin A is age-specific, hence the following doses:

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Recommended age-specific dose of vitamin A SIAs: Age group Dose to be given Amount of vitamin A If 100 000 IU capsules are used give: DO NOT GIVE All drops in one capsule All drops in two capsules If 200 000 IU capsules are used give: DO NOT GIVE Half of the drops in one capsule All drops in one capsule

Below 6 months 611 months 1259 months 3.

DO NOT GIVE 100 000 IU 200 000 IU

Surveillance and monitoring

Surveillance and monitoring are essential for assessing both program performance and progress towards the goal of eliminating vitamin A deficiency as a public health problem. The EPI information systems should be adapted to monitor vitamin A distribution and administration. Coverage of vitamin A supplementation for routine immunization should be reported and are measured as VA 1 (percentage of targeted children <1 year receiving 1 dose of vitamin A) and VA 2 (percentage of targeted children < 1 year receiving a second dose of vitamin A) in the first year of life. Coverage of older age group children and lactating mothers must also be recorded and reported. 4. Training

Training on vitamin A supplementation should be integrated with the EPI program training plan. Training and advocacy materials must be developed for various target audiences. 5. Vitamin A supplements to measles cases

It is important that measles cases, whether isolated or in outbreaks, receive vitamin A supplementation as part of the measles treatment. Administration of vitamin A during measles episode reduces case fatality and the severity of the disease. Vitamin A should be given to all measles cases, two doses of 200,000 IU two consecutive days or one on admission and the second dose before discharge from the hospital.

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