JIMMA UNIVERSITY

INSTITUTE OF HEALTH
FACULITY OF PUBLIC HEALTH
DEPARTMENT OF EPIDEMIOLOGY

Course:- Disease Prevention and Control

Immunization programs & strategies; Vaccine development as a strategy for
disease Control & Prevention

By:- Mekonen Beyene and Tsehaynesh Legesse

May,
1 2023
Jimma, Ethiopia
Outlines
 Introduction
 History of vaccine development
 Vaccine Development
 Expanded program for immunization in Ethiopia
 Immunization Strategies
 Vaccine-Preventable Diseases
 Cold chain management systems
 Planning, monitoring & evaluation of EPI Program

2
Objectives of the presentation
At the end of this presentation you will be able to:
 Discuss the role of immunization in disease prevention.
 Describe the steps in the vaccine development
 Describe EPI and its delivery strategies
 List vaccine preventable diseases in Ethiopia
 Explain the performance indicators of vaccination program
 Describe cold chain management systems
 Explain planning, monitoring & evaluation methods of EPI service

3
Introduction

Definition of term:-
Immunity:
 Is the resistance to the development of infection and/or clinical disease.

Immunization:
• Is the process where by a person is made immune typically by the
administration of a vaccine.

4
Introduction…

Vaccine:
Artificially altered microorganism or its product and used for
vaccination.

Vaccination:
The deliberate administration of vaccine to susceptible individual to
stimulate immunity.

5
 Introduction…

• Immunization is the most cost effective intervention in public health and it is one
of the indicators of development in most developing countries.

• It also prevents from debilitating illness & disability and saves millions of lives
every year.

• Immunization programs have contributed substantially to reductions in childhood

morbidity and mortality.

• Vaccine prevent more than 2-3 million child deaths each year (WHO, 2016)
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Introduction…

• Global immunization coverage in 2016 is estimated to be 86%

(WHO/UNICEF 2017)
• Global DPT burden declined by >90% since 1980
• Global measles deaths decreased by 79% from 2000 to 2014
• The decline in measles deaths is among the three main contributors to
the decline in overall child mortality during this time period with
pneumonia and diarrhea
• The Sustainable Development Goal (SDG) target 3.8: Achieving UHC
means ensuring “access to safe, effective, quality and affordable
essential medicines and vaccines for all”.
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Introduction…

Global vaccine initiatives

• Expanded program on immunization in 1974

• Global immunization and vaccines strategy 2006-2015

• The Global Vaccine Action Plan 2016-2020

• The immunization agenda 2030

• Global alliance for vaccines and immunization GAVI, mainly on funding

and vaccine development
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 History of vaccine development
• The 18th century: vaccines for smallpox

• In 1796, Dr Edward Jenner created the worlds first successful vaccine.

• He found out that people infected with cowpox were immune to
smallpox.

• WHO officially declared eradication of smallpox in 1982,

approximately 200 years after Jenner first developed the vaccine. 9
History of vaccine …
• The 19th century: vaccines for rabies

• In 1885, Louis Pasteur successfully prevents rabies through post-exposure

vaccination

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History of vaccine …

The 20th century: many vaccines are developed

 1918/19 vaccine for Spanish flu pandemic
 1937 yellow fever
 1939 pertussis
 1945 influenza
 1952-55 polio
 1971 MMR

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History of vaccine …

The 21st century: vaccine protect against more than 20 diseases

• 2006 HPV
• 2019 Malaria and Ebola
• 2021 Covid-19
(WHO, https://g.co/historyofvaccination)
• In the 21st c, vaccines are also being used to enhance existing
immune mechanisms with the development of vaccines as
treatments, so-called therapeutic vaccination

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Vaccine development

• Vaccines represent a relatively small proportion of the

entire pharmaceuticals industry.

• But there has been an increasing interest from both

public and private sector groups in developing new
vaccine products for a range of infectious and
noninfectious diseases.
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Vaccine development…

• The time line for development and approval of most vaccines is,
however, long usually in excess of 15 years.

• It also requires millions of dollars as the candidate vaccine moves

toward regulatory approval.

• Vaccine development is made by considering licensure of a safe,

immunogenic and effective product.

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Vaccine development…
• A product is manufactured in a consistent way and isolation of the
protective antigens of a specific pathogen.
• It begins with the “infancy” of the vaccine, usually in the laboratory,
where its components are tested for criteria such as purity and potency.

• It continues with clinical testing for safety and efficacy in humans,

followed, after licensure, by post-marketing testing of vaccine batches
for consistency of the production process and AEFI

15
Vaccine development…

• The primary considerations in the eventual approval of vaccine

product are:

-safety

-immunogenicity

-efficacy

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 Vaccine development…

Stages of Review and Regulation :

Phase 1 - Safety, Immunogenicity

Phase 2 - Safety, Immunogenicity, Dose

Phase 3 - Efficacy, Safety, Immunogenicity

Phase 4 - Safety, Efficacy, Inspection

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Vaccine development…

Phase I studies
 Initial introduction of investigational new drug into humans
 Closely monitored and may be conducted in patients or normal
volunteer subjects(20-80)

 Designed to determine metabolism and pharmacologic actions of

drug in humans, the side effects associated with increasing doses.

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Vaccine development…
Phase II studies
 Are typically well controlled and closely monitored

 Conducted to evaluate the effectiveness of the drug

 Determine the common short-term side effects and risks

associated with the drug.
 Usually involve no more than several hundred subjects.

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Vaccine development…
Phase III studies
 Usually include several hundred to several thousand
subjects.
 To confirm its effectiveness, monitor side effects,
and compare it with standard

 Are intended to gat her additional information about

effectiveness and safety (to evaluate risk-benefit
relationships).

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Vaccine development…

Phase IV studies :

 Delineate additional information, including: the drug's risks, benefits,

and optimal use once a vaccine is being used on a population level.

 Post marketing studies

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Types of vaccines

1. Live-attenuated vaccines

2. inactivated vaccines

3. sub-unit vaccines

4. recombinant vaccines

5. conjugate vaccines

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Types of vaccines…

1. Live-attenuated vaccines
• Are prepared from viruses or bacteria that are whole, active and able
to cause infection, but they have been weakened in the laboratory.
• Example:- Measle, OPV, BCG, Rota virus …
2. Inactivated vaccines
 Whole-cell inactivated vaccines are produced by first growing viruses
or bacteria in the laboratory and then inactivating (killing) them with
heat or chemicals.
 Example: - pertussis

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Types of vaccines…

3. Sub-unit vaccines
 Are made from parts of infectious agents, or certain chemicals produced
by bacteria.
 Examples:- toxoid vaccines (Diphtheria and tetanus)
4. Recombinant vaccines
• Are produced by inserting genetic material from a disease-causing
organism into a harmless cell, which then makes lots of copies of the
antigens of the infectious agent.
• Example: - HBV

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Types of vaccines…

5. Conjugate vaccines
• Are made by conjugating (joining together by chemical bonds) an
antigen from an infectious agent and a large ‘carrier’ protein.
• The combination makes the antigen more immunogenic than it would
be on its own.
• Example: - Haemophilus influenzae type b (Hib) vaccine

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 Types of immunity

Summary of different types of specific immunity

Type of specific immunity Example of how immunity might be acquired

Naturally acquired Active Infection

immunity
Passive Maternal antibodies crossing the placenta, or in
breastmilk

Artificially acquired Active Intentional exposure to antigens in a vaccine

immunity

Passive Injection or transfusion of someone else’s

antibodies

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 Herd Immunity
 Is immunity that occurs when the vaccination of a significant portion of a
population provides a measure of protection for individuals who have not
developed immunity.

 Resistance of population to the spared of infectious agent based on high

proportion of immunity in the individual.

 When a certain percentage of a population is vaccinated, the spread of the

disease is effectively stopped.

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Herd immunity …..
• This critical percentage is called the herd immunity threshold.
(HIT= 1-1/R0)
R0 = P x C x D
where R0=basic reproductive number
P= Probability of transmission per exposure
C=Number of Contact/unit time
D=Duration of infectiousness period
• The higher the threshold, the greater the vaccination coverage and
vaccine effectiveness required to interrupt disease transmission.

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Herd immunity…

29
Herd immunity…

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Herd immunity …..

Factors needed for herd immunity to operate:

• A single reservoir

• Direct transmission

• No shedding of the agent by immune hosts

• A uniform distribution of immunes, and

• No overcrowding

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Herd Immunity Threshold For Some Diseases

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Expanded program on immunization (EPI)

Expanded indicates:

• The number of diseases to be covered

• The number of children and target population to be covered

• The coverage to all corners of the country and spreading services to

reach the less privileged sectors of the society

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EPI……

• Experience with smallpox eradication program showed the world that

immunization was the most powerful and cost-effective weapon
against vaccine preventable diseases.

• Aims to provide free immunization for children against the important

childhood infections.

• In 1974, the WHO launched EPI against six most common preventable
diseases.
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EPI……
The six targeted diseases were:
1. Diphtheria
2. Pertussis
3. Tetanus
4. Poliomyelitis
5. Measles
6. Tuberculosis
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EPI……

In 1977 EPI set three long-term objectives:

 Prevent childhood mortality and morbidity from six major diseases
by 1990
 Provide high quality vaccines (production and quality control)
 Surveillance of these diseases

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37
 EPI in Ethiopia

 EPI started in Ethiopia in 1980 to protect children against six targeted disease

 Pentavalent vaccine (containing hepatitis B and human influenza virus type B

antigens) was introduced in 2007.

 PCV and Rota virus vaccine were added to EPI in 2011 and 2013 respectively.

 IPV included in EPI in 2016

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EPI in Ethiopia……
 HPV vaccine was demonstrated for its safety in Ethiopia from
December 2015 through June 2017.

 As introductory phases in Ethiopia, the vaccine was given to girls of

14 years age in 2018.

 MCV 2 was launched early 2019.

 According to Mini DHS 2019, only 4 in 10 children aged 12-23

months have received all basic vaccinations.
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EPI in Ethiopia……

• The immunization coverage figures vary largely between regions, from

more than 100% penta3 coverage in Addis abeba to 74% in Afar

regions, resulting in a national penta3 coverage of about 97%.

• Measle first vaccination national coverage is 93% (highest coverage in

Addis abeba >100% and lowest coverage in Afar 72%)
(source: MOH, 2021)

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EPI in Ethiopia……

• Currently the FMOH developed Comprehensive Multi Year Plan

(cMYP) (2021-2025)

• cMYP provides a framework to plan activities to achieve global

Immunization Agenda/IA2030/ which envisioned as “a country where
everyone, everywhere, at any age should fully benefit from all
vaccines for good health and well-being”
• Primary objective is to achieve at least 90% national coverage and
85% in every district with all vaccines by 2025.

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 EPI in Ethiopia……

Strategy:-

• specific strategies was developed to each area by the

implementation of new approaches:
 Reach Every District (RED) and
 Sustainable Out-reach Services (SOS)

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EPI in Ethiopia……

Reach Every District:

 This approach has been implemented in Ethiopia

since 2004 in districts with:

-poor immunization coverage and

-high dropout rates.

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EPI in Ethiopia……

RED has five operational components:

 re-establishing of outreach

 supportive supervision

 monitoring for action

 linking services with the community

 planning and management of services

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EPI in Ethiopia……

• Because of large variation in coverage among regions, the RED

strategy is re-formed.

• Now, the RED strategic approach is recast to reaching every

children/community strategic approach in order to deal with
inequities within districts.

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EPI in Ethiopia……

Sustainable Out-reach Services (SOS):

SOS is a strategy for reaching those segments of the unreached

population that are too physically remote to be effectively reached by

the present infrastructure of immunization services

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 National EPI Schedule
Age Time Route &dose Site
OPV Birth ,6,10 Mouth( 2 drop) Mouth
&14weeks
BCG Birth up to one year Intra-dermal(0.05ml) Right Upper Arm
Penta At 6,10 and 14weeks Intra-muscular(0.5ml) Antero-lateral side of
left mid-thigh
PCV At 6,10 and 14weeks Intra- Antero-lateral side of
muscular(0.5ml) right mid-thigh
Rota 6 and 10weeks Mouth (1.5 ml) Mouth

IPV At 14 week Intra-muscular(0.5ml) Left (outer) mid-thigh

Measles At 9 and 15 month Sub-
Left Upper Arm
continuous(0.5ml)
HPV 14 years for girls
(9-14 years) Intra-muscular(0.5ml) Left Upper Arm 47
EPI in Ethiopia……

Immunization Strategies: based on approach

1. Direct/selective strategy
 Primary objective – protecting individual
 Method of protection – personal immunization
 Target group – limited value for young infants

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EPI in Ethiopia……

2. Indirect strategy
 Primary objective - interrupt circulation of pathogen
 Operates by herd immunity
 The attainable level control-may aim at any of the levels
E.g. – Poliomyelitis

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 EPI in Ethiopia……
EPI delivery strategy:
1. Static
 Every health institution gives EPI service on daily basis
2. Outreach
 Staffs of health unit go out and administer vaccine at regular weekly
or monthly basis.
3. Mobile
 Temporarily opened services especially during epidemics
4. Campaign :
 Immunization approach conducted by mobilizing the community
E.g. National campaign on polio and measles vaccination
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EPI in Ethiopia……

EPI strategies are used to:

• Increase and sustain high immunization coverage rates
• Increase the quality of immunization services
• Reduce missed vaccination opportunities and trace defaulters
• Improve public awareness and community participation in
immunization programs
• Ensure prompt reporting and improved control of vaccine-
preventable diseases.

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EPI in Ethiopia……

Five key operations for an effective immunization service

1.Service delivery:

2.Logistics:

3.Vaccine supply and quality:

4.Disease surveillance:

5.Advocacy and communication: 

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EPI in Ethiopia……

Delivering other health interventions integrated with EPI:

 Vitamin A supplementation
 Deworming
 GMP

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Challenges associated with achieving EPI

1. Drop Out

2. Missed opportunities

3. Geographical barriers

4. Never reached despite having access

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Challenge……

Drop Out
 It is defined as a child or a woman who failed to return for subsequent doses for
which he or she is eligible.
 Possible Reasons are:
 Mothers usually busy on other engagements
 Inconvenient day, time, place of vaccination center
 Family left the place for a while
 Child develops side effects or was sick on the appointed date
 Cultural barriers
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 Challenge……
2. Missed opportunities
• Occur when women or children who need immunizations are not
immunized even if they are at the health facility (for e.g. if they are there to
obtain curative services).
• Current strategy is that all children and mothers at the health facility for
any reason should be screened for immunization status & vaccinated if
eligible.
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Challenge……
Possible reasons:
• Workers do not know the policy
• Workers screen but tell patients/people to return later
• HW only vaccinate women with TT if they are pregnant
• The will only open a vial if there are enough clients who need it
• False contraindications
• Vaccine not available

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Solution to the problem

• Social mobilization

• Dropout tracing mechanisms

• In service training to community health workers and utilization of

other motivation mechanisms
• High level advocacy

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Solution…..

• Get commitment by the local leaders

• Monitoring and supervision the program

• Ensure financial and logistics support for the health institutions

• Daily integrated health service for all women and children attending
the health units

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Vaccine preventable disease

• WHO recommends current usage of vaccine against 26 VPDs

• Vaccines for 23 diseases are under development with active

overseeing of WHO

• Ethiopia introduced 11 vaccines in to its EPI program

• Meningococcal vaccine is under use during threats of epidemic

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 Vaccine preventable disease in Ethiopia
1. tuberculosis (TB) 11. N. Meningitis (during outbreak)
2. poliomyelitis (polio) 12. Cervical cancer (HPV)
3. Diphtheria 13. Covid-19
4. pertussis (whooping cough)
5. tetanus
6. measles
7. pneumonia and meningitis caused by Haemophilus influenzae type b bacteria
8. liver disease caused by hepatitis B viruses
9. pneumonia and other infections caused by Streptococcus pneumoniae bacteria
10. diarrhoeal diseases caused by rotaviruses
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 Poliomyelitis
• Suspected case definition: Any child under 15 years of age with acute
flaccid paralysis or any person with paralytic illness at any age in whom
the clinician suspects Poliomyelitis.
• Agents- Poliovirus types 1, 2 or 3 (WPV)
• Transmission- mainly by feco-oral
• Predisposing factor
Not being immunized
Poor sanitation and hygienic practices
Overcrowding

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Measles
Case definition:
 Generalized maculopapular rash, usually lasting three or more days,
 Fever (at least 38°C if measured) present at the time of rash onset,
plus
 Cough, coryza or conjunctivitis (3Cs) and
 Koplik’s spots (The characteristic red, blotchy rash)

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Measles…

64
Measles….

• Agent is Measles virus

• An acute respiratory viral infection

• CFRs estimated to be 3-30%

• Approximately 125 million cases and 1.8 - 2 million deaths per year
would be expected in the absence of vaccination

65
Hepatitis B

• Caused by hepatitis b virus that infects the liver

• Transmission:
 mainly transmitted by parenteral (via blood and blood
products)
 The virus is found in all body fluids and excreta.
 Occupational exposure
• CFR is estimated to be 1-25%
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Neonatal tetanus

• Case definition: Any newborn with a normal ability to suck and cry
during the first two days of life, and b/n the 3rd and 28th day of age,
who cannot suck normally, and becomes stiff or has convulsions or
both.

• Agent : Clostridium tetani

• CFR 25-90%
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NNT……

• It is a most common presentation in developing countries. (umbilical

stump, circumcision)

• Estimated based on skilled delivery rate and TT immunization rate of

pregnant ladies .

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NNT……
• The strategies to achieve the maternal and neonatal tetanus (MNT)
elimination goal are:
Improved vaccination of pregnant women with TT-containing
vaccines,
Vaccination of all WRA in high-risk areas
Promotion of clean delivery and cord care practices and
Improved surveillance and reporting of neonatal tetanus cases
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Diphtheria
 Agent- Corynebacterium Diphtheriae

 Transmission : through close physical contact and

respiratory droplet

 Predisposing factor
 Non immunized

 CFR 10% (2-20%)

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TB
• Agent: Mycobacterium tuberculosis, M.bovies
• Usually attacks the lungs, but can also affect other
parts of the body, including the bones, joints and brain

• Transmission :
Respiratory route: droplet nuclei

Alimentary route: Ingestion of infected raw or non pasteurized

milk.

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TB….
• Predisposing factors
 Poor nutritional status
 Not being immunized
 Infection with HIV/AIDS
 Overcrowding & contact with Pulmonary Tuberculosis Cases

• The recommended method of TB prevention for children is:

BCG vaccine given at, or as soon as possible after, birth and
before 12 months of age.

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Pertussis
• Pertussis, or whooping cough, is a disease of the respiratory tract
• caused by Bordetella pertussis

• Transmission
Respiratory droplets

• CFR 0.04% - 0.20%

• Prevention involves immunization with pertussis vaccine, which is

available in pentavalent combination form.
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Rota virus
• Rotavirus gastroenteritis is a highly infectious diarrheal disease caused
by strains of rotavirus infecting the small intestine resulting in vomiting,
diarrhea, and dehydration.

• Present in an infected person's stool several days before symptoms

appear and for up to 10 days after symptoms subside.

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Rota virus…
• Transmission: faeco-oral

• It is the most common cause of severe and fatal diarrhea in young

children worldwide, takes the lives of more than 28,000 Ethiopian <5

children each year.(WHO, 2008 rotavirus deaths)

• Prevention- Improvements in sanitation and access to safe water

- vaccination

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Haemophilus Influenza

• Causative agent: H.influenza

• Transmission: by respiratory droplets
• CFR 5-90%
• Hib is an important cause of morbidity and mortality from
pneumonia, meningitis and other invasive infections among infants
and young children in the African region (4 months and 12 months are
the most at risk).
• The most effective way to prevent Hib is to maintain a high level
of immunization

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Pneumococcal disease
• Agent :Streptococcus pneumonia (pneumococcus)

• Transmission: through respiratory droplet and close contact

• The pneumococcus is a common cause of serious diseases, such

as (pneumonia, empyema, meningitis and septicemia) and milder,
such as otitis media and sinusitis.

• It can be prevented by vaccination using pneumococcal vaccines &

improved living conditions.
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HPV
• HPV is a common sexually transmitted virus that causes genital
warts and various cancers.

• There are more than 100 types of HPV.

• Type 16, 18,35 and 38 are incriminated for Cervical ca

• HPV is now known to be the cause of 99% of cervical cancers.

• Primary prevention: HPV vaccination

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Prevention and Control of EPI target
diseases
At community level
 Health Information about the importance of immunization
 Avoid harmful traditional health practices
 Integration of nutrition education with health services
 Ensuring hygiene and sanitation.
 Training of VCHW
 Mass mobilization.
 Integrated package of school health interventions

79
Prevention and Control……

At health facility level

 Proper management and inspection of vaccines.

 Early diagnosis and treatment.

 Provision of services and expansion of outreach sites.

80
Performance indicators of EPI
1. Vaccine coverage
Coverage

DOR

2. Vaccine efficacy/Effectiveness

3. Incidence of diseases that are preventable by vaccination

4. Incidence of vaccine related adverse events

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Performance indicators…….

1. Vaccine coverage
i. EPI coverage
 is the percentage of eligible population who got the vaccine appropriately

 The number of under one children who has been fully vaccinated
among eligible target population
Fully immunized <1 children X100
Total <1 children in catchments area

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 Performance indicators…….

ii. Drop Out Rate

1. Over all drop out rate
= Coverage with penta1 -Coverage with measles X100
Coverage with penta1

2. Drop out rate of single antigen (e.g. penta1)

= Coverage with penta1- Coverage with penta3 x 100
Coverage with penta1

83
Performance indicators…
2. Vaccine efficacy
• It is the reduction in the incidence of a disease among people who have
received a vaccine relative to the incidence in unvaccinated people.

• Vaccine efficacy measures direct protection (i.e. protection induced by

vaccination in the vaccinated population).

• Efficacy-vaccine’s ability to protect against disease under ideal setting

84
Performance indicators…

 VE = 1 – RR
 VE (%) = (ARU - ARV)/ ARU x 100%

 RR = ARV / ARU

 ARV = attack rate in vaccinated

 ARU = attack rate in unvaccinated
 VE= Vaccine efficacy
 RR = relative risk of developing the disease for vaccinated people
as compared to unvaccinated people
85
 Performance indicators...
Example:
Mothers were asked about any immunization received by interviewing the
mother regarding morbidity during the previous two weeks. Total of 160
children's mothers were interviewed and 70 children were unvaccinated
and 90 children were Vaccinated. Among these 11 Cases in unvaccinated
children and 5 Cases in vaccinated children.
Calculate
a. attack rate in unvaccinated
b. attack rate in vaccinated
c. RR
d. Vaccine efficacy
05/12/2023 86
 Performance indicators...
Answers:

unvaccinated vaccinated
 Vaccinated children =90
• Unvaccinated children =70  Cases in vaccinated children =5
• Cases in unvaccinated children =11
ARu= 11/70=15.7% ARv = 5/90=5.56%

RR =ARv / ARu = 5.56/15.7 =0.354

VE %= 1- RR= 1-0.354 =64.6%

05/12/2023 87
Performance indicators…….

Vaccine Effectiveness:
 It measures direct and indirect protection (i.e. protection to non-
vaccinated persons by the vaccinated population).
 Effectiveness=(1-RR)x100%

 Effectiveness= measures actual level of protection achieved in the

field.
88
Performance indicators…….
Determinants of vaccine effectiveness

 Vaccination coverage

 Cold chain

 Intrinsic protective properties of the vaccine

 Spectrum of recipients (age and immune-competence of the vaccine

recipient)

89
Cold Chain Management

 Is a system of storing, transporting and distributing of vaccines in the

correct temperature and way from the factory to the person being
immunized.

 It is a corner stone of the EPI, because the vaccine loses the efficacy if
incorrectly kept.

 Vaccines are damaged by exposure to excessive cold, heat &/or light

90
Cold Chain Management……

Cold chain management includes:

1. Cold chain
2. Cold chain equipment
3. Cold chain monitoring equipment
4. loading cold chain equipment

05/12/2023 91
Cold Chain Management…

1. Cold chain
 Is the system that ensure vaccine potency by keeping vaccine cold all
the way from the manufacturer to site where vaccine is administered
 Consists of a series of storage and transport links

05/12/2023 92
 Cold chain
Vaccine manufacturer
Vaccine International Transport

National air port cold room(+2 to +8 0c) and freeze room( -15 to -25 0c)

Primary vaccine storage cold room(+2 to +8 0c) and freeze room( -15 to -25 0c)

Intermediate vaccine cold room(+2 to +8 0c) and freeze room( -15 to -25 0c)

Health center cold room(+2 to +8 0c) and cold boxes

Health post refrigerators(+2 to +8 0c) and cold boxes

Child and mother refrigerators (+2 to +8 0c) and cold box/ vaccine carries 93
Cold Chain Management…
2. Cold chain equipment

Refrigerator trucks : used for transporting and storing vaccines

Refrigerators Shelf arrangements of vaccines

Cold boxes

Vaccine carriers

Foam pads

Ice packs
94
Cold Chain Management...
2.1 Refrigerator trucks
 are equipment used for transporting and storing Vaccines

05/12/2023 95
 Cold Chain Management...
2.2 Refrigerators
 Used for storing vaccines
 May be powered by electricity, kerosene or solar energy
 Two most common refrigerator
Front opening
refrigerator
Top opening refrigerator

05/12/2023 96
 Cold Chain Management...
2.3 Cold boxes
 used to transport vaccine from Zonal store to health facility
 store vaccine for short period of time (from two to seven days).

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Cold Chain Management...
2.4 Vaccine carrier
 used to carry vaccine to out reach site and used during campaign
 Stay cold maximum for 48 hours with the lid closed

05/12/2023 98
 Cold Chain Management...
2.5 Ice pack
 Used to keep vaccines cool inside the cold box and vaccine carrier
 Only fill 80% with water
 6 large and 12 small in a refrigerator per day
 At least 24 hrs to freeze solid

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Cold Chain Management...

2.6 Foam pad

 a piece of soft foam that fits on top of the ice-packs in a vaccine
carrier during transportation.
 protects vaccine from heat during an immunization session

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 Cold Chain Management...

3. Cold chain monitoring materials & equipment

Purpose of Cold chain monitoring is to keep track of the temperature
to vaccines and diluents stored
 major cold chain monitoring equipment in HF
Vaccine vials monitoring
Thermometer
Temperature monitoring Chart
Freeze indicators
Vaccine cold chain monitoring

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3.1. Vaccine vial monitors (VVM): is a label that changes color when
the vaccine vial or ampoule has been exposed to temperatures above 8
0
c over a period of time. 

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3.2. Thermometer
• used to monitor temperature
• Dial thermometer- the needle moves around the
scale, pointing to plus (+) numbers when it is
warmer and to minus (-) numbers when it is colder.

• Stem/bulb thermometer- colored fluid in the bulb

moves up the scale as it becomes warmer and down
the scale as it becomes colder

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30-day electronic temperature loggers (30 DTR)

• Alarms are triggered if the temperature of the refrigerator drops to

<= -0.5°C for 60 minutes or if it exceeds +8°C for a continuous period
of 10 hours

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3.3. Temperature monitoring Chart

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3.4. Freeze Indicators: are devices used to monitor the exposure of
vaccines to freezing.  A small blinking dot of light in the corner of the
display shows that the freeze-tag is functioning correctly.

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3.5 Vaccine monitor card
• It is card with different color background that
changes color when vaccines are exposed to too high
temperature.
• It is used to estimate the length of time that vaccine
has exposed to high temperatures.
• Usually the cold chain monitor is only used for large
shipments of vaccine.

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What damages vaccine?

A. Heat &/or sunlight
-Heat and sunlight damage all vaccine but especially polio, measles and BCG
-BCG and measles vaccine are equally sensitive to light and heat
B. freezing
-Freezing damages pentavalent and TT.
C. Chemical, disinfectants, antiseptics and detergents

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Cold chain management levels

• The central level.

• Regional level.

• Health facility level.

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Three major element for an Effective Cold-Chain:

1. Personnel
 who use and maintain the equipment and provide service

2. Equipment
 safe storage and transportation of vaccine

3. Procedures & Protocols

Every day and “What to do if … happens”

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Planning , M&E of EPI program

Planning EPI vaccine by vial

–No. of vial = No of dose x No. of surviving infant
No. of child per a vial
BCG = 1x No. of live births
20
OPV = 4x No. of surviving infant
10
Penta = 3x No. of surviving infant
1
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Planning , M&E………
Monitoring and Evaluation
1. Monitoring tools :

 Maps: shows catchment population distribution

 Child health card: EPI card

 Immunization register

 Immunization tally sheets

 Monthly immunization monitoring chart

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2. Managing immunization problems

 Measuring immunization coverage

 Measuring drop out rates

 Vaccine wastage rate

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Planning , M&E………

Measuring immunization coverage:

 is the number of eligible population who got the vaccine among

target group.

Example : Measles coverage

 Coverage indicates access
-High coverage indicates good access

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Planning , M&E………

Measuring drop out rates:

 It is comparison of number children start immunization schedule and

who complete it.

 drop out rate indicates utilization

-Low drop out rate indicates good utilization (<10%)

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Planning , M&E………

Vaccine wastage rate

This indicator provides a measure of the quality and efficiency of the
immunization service delivery system.
- Used as financial monitoring indicator
Possible reasons for vaccine wastage
• poor stock management
• cold chain failure
• poor store room

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Planning , M&E………

 Vaccine wastage rate = 100-vaccine usage rate OR

Dose supplied –does administered x100
Dose supplied

Doses supplied = (Starting balance + doses received) – balance

remaining

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Planning , M&E………

 vaccine usage rate = 100-vaccine wastage rate

=Dose given x100
Dose opened

 Vaccine multiplication factor = 100

UR

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 References

 https://academic.oup.com/jid/article/224/Supplement_4/S452/6378083 by guest on 04 May 2023

 Caddell A.The children’s vaccine initiative. Afr Health 1997;2015WHO(1991). Identify Missed
Opportunities. Training Manual For Middle Level Managers. WHO/EPI/MLM.91.7

 Federal Ministry of Health, Comprehensive multi-year plan 2021–2025, Addis Ababa April, 2021

 WHO (2000), Sustainable outreach services (SOS), A strategy for reaching the unreached with

immunization and other services

 National Center for Immunization and Respiratory Diseases September 1, 2021

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 Summary

• Immunization is the most cost effective intervention in public health

• Vaccine prevent more than 2-3 million child deaths each year (WHO, 2016)
• EPI started in Ethiopia in 1980 to protect children against six targeted disease

• Ethiopia introduced 11 vaccines in to EPI program

• Vaccine efficacy measures direct protection
• Vaccines are damaged by exposure to excessive cold, heat &/or light
• Planning monitoring and evaluation is important for immunization program

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THANK YOU !

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