3 National EPI Strategy Timor Leste

7/31/2019 3 National EPI Strategy Timor Leste

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NATI ONAL I MMUNI ZATI ON

STRATEGY

TI MOR-Les te

N o v em b e r 2 0 0 6


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C O N T E N T S

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 _______ 8Component 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

ANNEX F - Provision of Vitamin A Supplements ______________ 25

The M in ist r y o f Hea l th o f T imor -Les te ex tends app rec ia t ion t o UNI CEF, WHO and

U SAI D / TA I S f o r t h e i r s u p p o r t i n r e v i e w in g t h e n a t i o n a l im m u n i z at i o n s t r a t e g y .


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National Immunization Strategy

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N at i o n a l I m m u n i za t i o n St r a t e g y

I n t r o d u c t i o n a n d Ba ck g r o u n d

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 Sta t em en t

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 short-

term 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 decision-

makers, health managers, educators and health staff to implement nationalimmunization 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 Managersand I mm unization in Practicemodules for

health staff. This document is a revision of the National Immunization Strategy

paper prepared in July 2004.


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Ob je c t i v es o f t h e I m m u n i z at i o n P r o g r a m

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 andwomen. 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.

Overal l ob jec t i ve :

To reduce under-five morbidity and mortality caused by vaccine-preventable

diseases among children in Timor-Leste.

Speci f i c ob ject ives:

(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 coveragefor all antigens of more than 80% by 2008.

o At least 80% of districts and sub-districts should have a dropoutrate 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 inTimor-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 monitoringand 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 bystrengthening the disease surveillance system, including laboratory facilities

(i) To increase public utilization of immunization services by intensifyingpromotional activities and community participation

(j) To increase coverage of vitamin A supplementation to at least 90% of thechildren 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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I m m u n i z at i o n St r a t e g y Co m p o n e n t s

Pol i cy S ta tem en t

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 childbenefits 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 policyis 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 ofimmunization 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.

Com ponen ts and I m p lemen t a t i on St ra t eg ies

The EPI is an integral component of the Basic Package of Services of the Ministryof Health. The major components of the EPI include:

Com ponen t 1 : I m prov ing access and se rv i ce de l i ve ry

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 servicesAll 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 servicesThis 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) I ncreased collaboration w ith private h ealth care providers t o im prove accessAs 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 I mm unization Activit iesSupplementary 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 mortalityreduction, 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 andthereafter as needed

Given measles vaccine efficacy, not every child who receives measles vaccine at9 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 theaccumulation 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 healthactivities.


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Com ponen t 2 : Deve lop capaci t y fo r p lann ing and mon i t o r i ng

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:

1)

A comprehensive and costed Multi-Year Plan (2007-2010) using GlobalImmunization Vision and Strategy (GIVS) as a framework

2) Interagency Coordinating Committee (ICC)3) Annual EPI work plans4) Regular monitoring of the implementation of the action plan by a national

technical advisory group

5) Plans for introduction of new and under-utilized vaccines6) Human resources development and training7) 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 themonitoring of VPD cases

9) A Preparedness Plan for Outbreak of Polio in case of importation of wild poliovirus case or occurrence of a vaccine-derived polio virus case.

10) Strengthened institutional capacity of pre-service and in-service training onimmunization; Mid-Level Management training for District EPI Managers and

I mm unization in Practicefor health workers

11) Monitoring of routine immunization activities using the ContinuousCoverage and Quality Improvement process.

Com ponen t 3 : Ava i l ab i l i t y o f qua l i t y vacc ines and o the r supp l i es

The Ministry of Health will ensure that high-quality vaccines and other suppliesare readily available and sustainable in the long term. This will be achieved

through:

Ensuring the availability of potent vaccines and adequate suppliesat 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 vaccinemanagement system and modifying strategies and taking corrective

actions as required.

Compon en t 4 : Bu i l d com m un ica t ion suppo r t fo r im m un iza t ion

The Ministry of Health will develop effective communication strategies and

implement interventions for the immunization program that will address thefollowing 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 communicationplans for immunization and vitamin A supplementation

Strengthening the link between the community and service deliveryso that the community is engaged in service planning and delivery

Disseminating information on the benefits of immunization amongcommunities 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, andappropriate waste disposal

Raising awareness raising on potential AEFIs (adverse eventsfollowing immunization) and steps to be taken when an AEFI occurs

Training health care workers to strengthen interpersonalcommunication skills.

Com ponen t 5 : Mon i to r i ng and eva lua t ion

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 identifiedindicators 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 (onecapsule within the last 6 months)

% of post-partum women who received vitamin A supplement within 6weeks 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 immunizationduring 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

I n s t i t u t i o n a l Su p p o r t

(a) National levelThe 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 beadequately trained in planning, management and monitoring of EPI services.

(b) District levelDistricts 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-Distr ict levelAs 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 levelAt 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) I ntersectoral collaborationIntersectoral 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 ofnongovernmental, church, media and other grassroots organizations in

promoting community involvement in health development is recognized.

( f) I nteragency coordinationCo-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 weekswhere 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 areunder preparation and will include coordination of immunization related

activities.


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Vaccine Sup p ly

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 functioningcold chain is available.

Outreach sessions should discard opened vials of OPV, DPT and hepatitis Bvaccine at the end of the day.

Health staff should discard BCG and measles 6 hours after thereconstitution or when they leave the immunization session, whichevercomes first.

St r a tegy Rev iew

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 PolicyD - Cold Chain

E Safe injection, Side Effects, and Adverse EventsF Provision of Vitamin A Supplements


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ANNEX A I m m un iza t ion Schedu les

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 - Bacillus Calmette-Guerin OPV - Oral Polio Vaccine DPT - Diphtheria, Pertussis, Tetanus HepB - Hepatitis B TT - Tetanus Toxoid Measles - Measles DT - Diphtheria and Tetanus DTP-HepB - Diphtheria, Tetanus, Pertussis, and Hepatitis B

I m m u n i zat i o n Sch ed u l e f or I n f a n t s < 1 ( A t b i r t h u p t o 1 2 m o n th s o f ag e )

In case of monolavent HepB vaccine

Type o f vaccine When admin is te red

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) vaccineType o f vaccine When admin is te red

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 6weeks 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 aredelayed, there is no need to repeat the (previous) dose.

All EPI antigens are safe, even if administered simultaneously at the sameday, but should be in different injection sites.

OPV1, DPT1, HepB1 should be given at 6 weeks of age or as soon as possibleafter 6 weeks of age.


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Measles vaccine should be given at 9 months or as soon as possible after 9months of age.

All child immunizations should be recorded in the register and reported in twoage 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 ofthe health staff to follow up and complete the full course of primaryimmunization 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 theprimary series of immunization may receive booster doses of the following

vaccines to maintain or prolong the immunity against the antigens:

DT booster 1 after a year of DPT3 or at 2 years of ageDT booster 2 at primary school entry or at 6 years of ageOPV booster 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.

Te ta n u s To xo i d I m m u n i za t i o n f o r W o m e n

Dose Schedu le Pro tect i on

TT1 At first contact, or as early as possible during pregnancy None

TT2 At least 4 weeks after TT1 1 to 3 yearsTT3 At least 6 months after TT2 At least 5 years

TT4 At least one year after TT3 or during subsequent pregnancy At least 10 years

TT5 At least one year after TT4 or during subsequent pregnancy Reproductive years

Vaccina t i on Doses and Si tes

Vaccine Dosage Si te Method

BCG 0.05 ml R-upper arm Intradermal

OPV 2 drops Mouth Oral

DPT 0.5 ml Outer thigh Intramuscular

Measles 0.5 ml L-upper arm SubcutaneousTT 0.5 ml Upper arm Intramuscular

Hep B 0.5 ml Outer thigh Intramuscular

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


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Admin is t r a t i on o f Vacc ines

1. Freeze-dried vaccines (i.e., BCG, measles) must only be mixed with theirown diluents provided by the manufacturer. The diluents for BCG should

only be used for BCG vaccines; the diluents for measles should only beused for measles vaccine. Always read the manufacturers instructions

before mixing or injecting vaccines.

2. 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.

3. 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.

4. Use one sterile syringe and needle for every injection given to a child or

woman, preferably using the auto-disable (AD) syringes.

5. Do not recap needles. Put the used syringes/needles in safety boxcontainer for safe disposal.

6. 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 seniorhealth staff may postpone the vaccination.

7. Children with symptomatic HIV infection should not be immunized with

BCG vaccine.

8 Explain to the caregiver of the child and to the woman receiving vaccines

that, although very unusual, some unwanted events may occur, althoughmost of them are very mild; if this happens, they should immediately

report to the health worker or to the nearest health facility.


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ANNEX B Con t ra ind ica t ions to I m m un iza t ion

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 absolutecontraindication 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 ofAIDS.

3. If a parent strongly objects to an immunization for a sick infant, do not giveit. Ask the mother to come back when the infant is well.

I m m u n i ze Si ck I n f an t s

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 oneof 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

feverImmunize them if possible. A senior health worker should decide for eachindividual infant. Remember that sick infants need protection against

diseases that they may catch in hospital, especially measles.

Malnourished infantsYou must immunize them they can develop good immunity although

they are malnourished. They are more likely than other infants to die fromthe diseases (especially from measles).

I m m u n i ze i n f an t s w i t h t h e f o l lo w i n g con d i t i o n s ( t h e se co n d i t i o n s a r en ot con t r a i n d i ca t i o n s) . I m m u n i ze ch il d r e n w h o h ave :

Allergy or asthma (except if there is a known allergy to a specificcomponent of the vaccine mentioned above)

Any minor illness, such as respiratory tract infections or diarrhea withtemperature 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 notreceive additional doses of that vaccine.

There is no evidence of risk to the foetus from immunizing pregnant women withtetanus toxoid.


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ANNEX C Open/ Mul t i -Dose V ia l Po l icy

The open/multi-dose vial policy has the potential to reduce vaccine wastagerates by up to 30%, resulting in a significant annual savings in vaccine costs.

The policy is as follows.

1 . OPV, DPT, TT, DT and h epat i t is B vaccin esa. 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 immunizationsession at a sta t i c imm un iza t ion s i te ( hea l th fac i li t y ) 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 discardpoint The vials have been marked with the date opened in order to track the 4-

week use period.

b. Multiple-dose vials of OPV, DPT, TT, DT and hepatitis B vaccines from whichone or more doses of vaccine have been removed during an ou t reachim m un iza t ion sess ion MUST BE DISCARDED at the end of the day.

2 . Measles and BCG vaccinesReconstituted vials of measles and BCG vaccines MUST BE DISCARDED at the

end of each immunization session or at the end of six hours, whichever comesfirst. Six hours after reconstitution, measles and BCG vaccines must be

discarded.

3 . Al l vacc inesAn opened vial of any vaccine MUST BE DI SCARDED 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 hasbeen 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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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 refrigerator2. As much as possible, try not to open the door more than three (3) times

per day.3. Never freeze diluents. Diluents do not need to be stored in the fridge.

However, they should be at vaccine temperature at the time ofreconstitution. Therefore, keep the required quantity of diluents in ILR oneday ahead of the immunization session.

4. EXPIRED/ DAMAGED VACCINES should not be stored in the cold chainequipment.

5. Maintenance of the unit by regular defrosting and minimizing the times inopening the door of the refrigerator will help temperature stability.

6. 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. Icepacks should be conditioned before loading vaccines in a cold box andvaccine carrier. Conditioning means leaving ice packs out of the freezeruntil 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 otherunopened vials inside the carrier.

2. Keep a thermometer with the vaccines.Review o f th e co ld cha in

There should be a review at least monthly of each refrigerators temperature

records. Temperature should be recorded twice a day, once in the morning andonce 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 isnot 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 fieldsupervisors 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 I n j ec t ion s , Side Ef fec ts an d Adv erse Event s

Safe I n jec t i ons

An in j ect i on i s conside red safe fo r t he :

Mothe r o r ch i l d , when a health worker uses a sterile syringe, a sterileneedle, correct injection techniques and potent vaccine for each

immunization

Hea l t h w o r ke r , when he or she avoids needle-stick injuries Co m m u n i t y , when waste created by used injection equipment is disposed of

correctly and does not cause harmful pollution and injuries.

A. Sa fe i n jec t i ons fo r m o the rs and ch i l d ren1. 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 bodyfluid. Prepare each dose immediately before administering; do not prepareseveral 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 mustbe 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 reconstitutethe 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 forevery 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 touchbecomes 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 controlsthe movements of the child. Unexpected motion at the time of injection can

lead to accidental needle-sticks.


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B. Preven t need le - s t i ck i n ju r i es and in fec t i onsNeedles frequently injure health workers. Small but dangerous amounts of blood

infected with hepatitis B, hepatitis C, HIV, or other viruses can be transmitted byneedle-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 theimmunization, place the used syringe/needle into the safety box.

Close the safety box securely when it is three-quarters full (about 100 ADsyringes)

C. D ispose used syr ing es & need lesAll 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 peoplemight 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 keepthem away from people. Make sure a qualified staff member supervises the

process. Do not leave this vital task to unqualified people.

1. IncinerateWhere possible, use an incinerator to destroy syringes and needles. Properly

functioning incinerators ensure the most complete destruction of syringes andneedles. The area in which incineration takes place must be fenced off from therest of the compound. Staff members conducting the incineration should wear

gloves.

2. Burn and bury in a pitUsed injection equipment may be burned and buried in a disposal pit. Choosethe 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 withconcrete when the pit is full.

Potent ia l Side Ef fect s

There can be side effects (reactions) to immunization. Always explain to

caretakers about the potential side effects of immunization and what to do aboutthem. 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).

o Paracetamol may be given one 100 mg tablet crushed, three timesin 24 hours.

o Keep pressure off the injection site(s).o Place a cloth dampened with cool, clean water on the injection site.

Tell the parent to bring the infant to the health center if the infants conditiongets 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 isnormal and indicates that the vaccine is working

Ask the parent to return with the infant if he or she develops any side effectssuch 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 Even ts Fo l l ow ing I m m un iza t ion (AEFI )

An adverse event following immunization (AEFI) is defined as a medicalincident 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 thecommunity. 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 thepublic, to be related to immunization

All deaths that are thought by health workers, or the public, to be related toimmunization.

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 astandard AEFI reporting form.


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ANNEX F - P rov is ion o f V i tam in A Supp lem en ts

Supplementation of vitamin A is important to prevent blindness, and itdramatically increases the chances of survival of children aged 6-59 months. Itreduces 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 andchild 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 vitaminA 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 ifthey 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 herchild 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 infantsreceiving their measles vaccination at 9 months old and provide

supplementation when appropriate.

Children 14 years old should receive vitamin A (200,000 IU) with aminimum interval of 4-6 months, possibly in Vitamin A Week/Child HealthWeek in February and August. Any available contact with the health

system should be utilised.

2. Supplementary Immunization Activities

Every opportunity must be taken to provide vitamin A to eligible children. Evenif 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 g roup Dose to be

g iven

Am o u n t o f v i t a m i n A

If 100 000 IU

capsules are usedgive:

If 200 000 IU

capsules are usedgive:

Below 6months

DO NOT GIVE DO NOT GIVE DO NOT GIVE

611 months 100 000 IU All drops in one

capsule

Half of the drops in

one capsule

1259months

200 000 IU All drops in twocapsules

All drops in onecapsule

3. Surveillance and monitoring

Surveillance and monitoring are essential for assessing both programperformance and progress towards the goal of eliminating vitamin A deficiency

as a public health problem. The EPI information systems should be adapted tomonitor 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

Documents

3 National EPI Strategy Timor Leste