<?xml version="1.0" encoding="UTF-8"?><!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.2 20190208//EN" "http://jats.nlm.nih.gov/publishing/1.2/JATS-journalpublishing1.dtd"><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" article-type="other" dtd-version="1.2" xml:lang="en">
    <front>
        <journal-meta>
            <journal-id journal-id-type="pmc">F1000Research</journal-id>
            <journal-title-group>
                <journal-title>F1000Research</journal-title>
            </journal-title-group>
            <issn pub-type="epub">2046-1402</issn>
            <publisher>
                <publisher-name>F1000 Research Limited</publisher-name>
                <publisher-loc>London, UK</publisher-loc>
            </publisher>
        </journal-meta>
        <article-meta>
            <article-id pub-id-type="doi">10.12688/f1000research.165169.1</article-id>
            <article-categories>
                <subj-group subj-group-type="heading">
                    <subject>Policy Brief</subject>
                </subj-group>
                <subj-group>
                    <subject>Articles</subject>
                </subj-group>
            </article-categories>
            <title-group>
                <article-title>Reforming organisational structures in Ethiopia&#x2019;s immunisation programme: A policy brief&#x202f;</article-title>
                <fn-group content-type="pub-status">
                    <fn>
                        <p>[version 1; peer review: 1 not approved]</p>
                    </fn>
                </fn-group>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Negeri</surname>
                        <given-names>Keneni Gutema</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Data Curation</role>
                    <role content-type="http://credit.niso.org/">Formal Analysis</role>
                    <role content-type="http://credit.niso.org/">Funding Acquisition</role>
                    <role content-type="http://credit.niso.org/">Investigation</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Project Administration</role>
                    <role content-type="http://credit.niso.org/">Resources</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Validation</role>
                    <role content-type="http://credit.niso.org/">Visualization</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <contrib contrib-type="author" corresp="yes">
                    <name>
                        <surname>Likka</surname>
                        <given-names>Melaku Haile</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Data Curation</role>
                    <role content-type="http://credit.niso.org/">Formal Analysis</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Software</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Validation</role>
                    <role content-type="http://credit.niso.org/">Visualization</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <uri content-type="orcid">https://orcid.org/0000-0001-5650-728X</uri>
                    <xref ref-type="corresp" rid="c1">a</xref>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Ferede</surname>
                        <given-names>Tomas Yeheyis</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Data Curation</role>
                    <role content-type="http://credit.niso.org/">Investigation</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <uri content-type="orcid">https://orcid.org/0000-0002-5482-8060</uri>
                    <xref ref-type="aff" rid="a2">2</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Asseffa</surname>
                        <given-names>Netsanet Abera</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Data Curation</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Resources</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <uri content-type="orcid">https://orcid.org/0000-0001-8848-2822</uri>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Melke</surname>
                        <given-names>Ayantu</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Data Curation</role>
                    <role content-type="http://credit.niso.org/">Formal Analysis</role>
                    <role content-type="http://credit.niso.org/">Investigation</role>
                    <role content-type="http://credit.niso.org/">Resources</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Sako</surname>
                        <given-names>Sewunet</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Data Curation</role>
                    <role content-type="http://credit.niso.org/">Formal Analysis</role>
                    <role content-type="http://credit.niso.org/">Investigation</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <uri content-type="orcid">https://orcid.org/0000-0003-0126-0165</uri>
                    <xref ref-type="aff" rid="a3">3</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Abdilwohab</surname>
                        <given-names>Mustefa Glagn</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Data Curation</role>
                    <role content-type="http://credit.niso.org/">Formal Analysis</role>
                    <role content-type="http://credit.niso.org/">Investigation</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <xref ref-type="aff" rid="a4">4</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Fikadie</surname>
                        <given-names>Berhanu</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Formal Analysis</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <xref ref-type="aff" rid="a5">5</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Wordofa</surname>
                        <given-names>Mulumebet Abera</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Formal Analysis</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <xref ref-type="aff" rid="a6">6</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Taye</surname>
                        <given-names>Girma</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Data Curation</role>
                    <role content-type="http://credit.niso.org/">Formal Analysis</role>
                    <role content-type="http://credit.niso.org/">Investigation</role>
                    <uri content-type="orcid">https://orcid.org/0000-0002-5488-4636</uri>
                    <xref ref-type="aff" rid="a7">7</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Abera</surname>
                        <given-names>Admas</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Data Curation</role>
                    <role content-type="http://credit.niso.org/">Formal Analysis</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <xref ref-type="aff" rid="a8">8</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Mohammed</surname>
                        <given-names>Mesoud</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Funding Acquisition</role>
                    <role content-type="http://credit.niso.org/">Resources</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <xref ref-type="aff" rid="a9">9</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Wondirad</surname>
                        <given-names>Naod</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Funding Acquisition</role>
                    <role content-type="http://credit.niso.org/">Resources</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <xref ref-type="aff" rid="a9">9</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Lakew</surname>
                        <given-names>Yohannis</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Funding Acquisition</role>
                    <role content-type="http://credit.niso.org/">Resources</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <xref ref-type="aff" rid="a10">10</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Zelalem</surname>
                        <given-names>Meseret</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Funding Acquisition</role>
                    <role content-type="http://credit.niso.org/">Resources</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <xref ref-type="aff" rid="a10">10</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Ayalew</surname>
                        <given-names>Melkamu</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Funding Acquisition</role>
                    <role content-type="http://credit.niso.org/">Project Administration</role>
                    <role content-type="http://credit.niso.org/">Resources</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <xref ref-type="aff" rid="a10">10</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Niguss</surname>
                        <given-names>Mulat</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Funding Acquisition</role>
                    <role content-type="http://credit.niso.org/">Resources</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <xref ref-type="aff" rid="a10">10</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Solomon</surname>
                        <given-names>Sileshi</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Funding Acquisition</role>
                    <role content-type="http://credit.niso.org/">Investigation</role>
                    <role content-type="http://credit.niso.org/">Project Administration</role>
                    <role content-type="http://credit.niso.org/">Resources</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <xref ref-type="aff" rid="a10">10</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Debiso</surname>
                        <given-names>Alemu Tamiso</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Data Curation</role>
                    <role content-type="http://credit.niso.org/">Funding Acquisition</role>
                    <role content-type="http://credit.niso.org/">Investigation</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <aff id="a1">
                    <label>1</label>School of Public Health, Hawassa University College of Medicine and Health Sciences, Hawassa, Sidama, 251, Ethiopia</aff>
                <aff id="a2">
                    <label>2</label>Nursing School, Hawassa University College of Medicine and Health Sciences, Hawassa, Southern Nations, Nationalities, and People's Region, 251, Ethiopia</aff>
                <aff id="a3">
                    <label>3</label>Department of Health Informatics, Arba Minch University, Arba Minch, Southern Nations, Nationalities, and People's Region, 251, Ethiopia</aff>
                <aff id="a4">
                    <label>4</label>School of Public Health, Arba Minch University, Arba Minch, Southern Nations, Nationalities, and People's Region, Ethiopia</aff>
                <aff id="a5">
                    <label>5</label>University of Gondar Institute of Public Health, Gondar, Amhara, Ethiopia</aff>
                <aff id="a6">
                    <label>6</label>Department of Population and Family Health, Jimma University Institute of Health, Jimma, Oromia, Ethiopia</aff>
                <aff id="a7">
                    <label>7</label>School of Public Health, Addis Ababa University School of Medicine, Addis Ababa, Addis Ababa, Ethiopia</aff>
                <aff id="a8">
                    <label>8</label>School of Public Health, Haramaya University College of Health and Medical Sciences, Dire Dawa, Dire Dawa, Ethiopia</aff>
                <aff id="a9">
                    <label>9</label>Strategic Affairs, Ministry of Health Ethiopia, Addis Ababa, Addis Ababa, Ethiopia</aff>
                <aff id="a10">
                    <label>10</label>Maternal and Child Health, Ministry of Health Ethiopia, Addis Ababa, Addis Ababa, Ethiopia</aff>
            </contrib-group>
            <author-notes>
                <corresp id="c1">
                    <label>a</label>
                    <email xlink:href="mailto:likkamelaku@gmail.com">likkamelaku@gmail.com</email>
                </corresp>
                <fn fn-type="conflict">
                    <p>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>5</day>
                <month>8</month>
                <year>2025</year>
            </pub-date>
            <pub-date pub-type="collection">
                <year>2025</year>
            </pub-date>
            <volume>14</volume>
            <elocation-id>766</elocation-id>
            <history>
                <date date-type="accepted">
                    <day>15</day>
                    <month>7</month>
                    <year>2025</year>
                </date>
            </history>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2025 Negeri KG et al.</copyright-statement>
                <copyright-year>2025</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <self-uri content-type="pdf" xlink:href="https://f1000research.com/articles/14-766/pdf"/>
            <abstract>
                <p>The Expanded Programme on Immunisation (EPI) in Ethiopia, established in 1980, has reduced child mortality and illnesses. Despite expanding immunisation services from 6 to 13 antigens, the EPI programme continues to operate under an organisational structure unchanged for over 40 years&#x2014;posing significant challenges to its effectiveness. The current EPI structure, which places the EPI under a single desk within the Ministry of Health - Ethiopia (MoH-E) and even narrower at regional, zonal, and woreda (an administrative division in Ethiopia that is roughly equivalent to a district in other countries) levels is unable to accommodate the increasing demands of immunisation services. A national evaluation study conducted in August 2023 revealed critical staffing shortages. The study also identified operational inefficiencies at regional, zonal, local, and facility levels, where immunisation services are often integrated into other health units, leading to neglect and diffusion of responsibility.</p>
                <p>To address these challenges, this policy brief suggests restructuring the EPI at all administrative levels of the health system in Ethiopia, considering both current and future demands for EPI services. This includes establishing a dedicated National Vaccine and Immunisation Services Directorate, enhancing community-level engagement, and ensuring a clear delineation of roles and responsibilities.</p>
            </abstract>
            <kwd-group kwd-group-type="author">
                <kwd>Expanded program of immunization</kwd>
                <kwd>organizational structure</kwd>
                <kwd>Ethiopia</kwd>
            </kwd-group>
            <funding-group>
                <award-group id="fund-1">
                    <funding-source>Ministry of Health, Ethiopia</funding-source>
                </award-group>
                <funding-statement>This research was funded by the MoH-Ethiopia and the African Medical and Research Foundation (AMREF) Health, which covered the costs of data collection and research activities. The funder had no role in the study design, data analysis, decision to publish, or manuscript preparation.</funding-statement>
                <funding-statement>
                    <italic>The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.</italic>
                </funding-statement>
            </funding-group>
        </article-meta>
    </front>
    <body>
        <def-list>
            <title>Acronyms</title>
            <def-item>
                <term id="G1">EPI</term>
                <def>
                    <p>Expanded Programme on Immunisation</p>
                </def>
            </def-item>
            <def-item>
                <term id="G2">IRB</term>
                <def>
                    <p>Institutional Review Board</p>
                </def>
            </def-item>
            <def-item>
                <term id="G3">MoH</term>
                <def>
                    <p>Ministry of Health</p>
                </def>
            </def-item>
            <def-item>
                <term id="G4">PHCU</term>
                <def>
                    <p>Primary Healthcare Unit</p>
                </def>
            </def-item>
            <def-item>
                <term id="G5">RMNCAH-N
</term>
                <def>
                    <p>Reproductive, Maternal, New-Born, Child, and Adolescent Health and Nutrition</p>
                </def>
            </def-item>
            <def-item>
                <term id="G6">VPD</term>
                <def>
                    <p>Vaccine Preventable Diseases</p>
                </def>
            </def-item>
            <def-item>
                <term id="G7">WHO</term>
                <def>
                    <p>World Health Organisation</p>
                </def>
            </def-item>
        </def-list>
        <sec id="sec1" sec-type="intro">
            <title>Introduction</title>
            <p>An organisational structure outlines how a service is delivered, including the delivery methods, the responsible team, the steps involved, and the performance metrics.
                <sup>
                    <xref ref-type="bibr" rid="ref1">1</xref>
                </sup> In the context of an immunisation programme, a well-designed structure enhances service effectiveness and efficiency by defining clear lines of authority and decision-making, facilitating streamlined and two-way communication, allocating tasks and responsibilities across teams, enabling accountability, and optimizing resource distribution.
                <sup>
                    <xref ref-type="bibr" rid="ref2">2</xref>
                </sup>
            </p>
            <p>The immunisation programme is a cost-effective intervention aimed at preventing illness, disability, and death among children, adolescent girls, and women.
                <sup>
                    <xref ref-type="bibr" rid="ref3">3</xref>
                </sup> Established in 1980, Ethiopia&#x2019;s Expanded Programme on Immunisation (EPI) has reduced child mortality and illness.
                <sup>
                    <xref ref-type="bibr" rid="ref4">4</xref>
                </sup> However, the programme faces challenges, including organisational structural deficiencies that limit its efficiency and effectiveness.
                <sup>
                    <xref ref-type="bibr" rid="ref5">5</xref>
                </sup>
            </p>
            <p>This policy brief examines the organisational structure challenges of EPI in Ethiopia and proposes policy options for optimisation. The brief is informed by findings from the Ethiopian National Immunisation Programme Evaluation research conducted in August 2023.
                <sup>
                    <xref ref-type="bibr" rid="ref5">5</xref>
                </sup>
            </p>
        </sec>
        <sec id="sec2">
            <title>Findings from the EPI evaluation research concerning the organisational structure of EPI in Ethiopia</title>
            <sec id="sec3">
                <title>The existing EPI organisational structure in Ethiopia</title>
                <p>Ethiopia&#x2019;s EPI is managed through a decentralised system, distributing responsibilities across different government levels. Nationally, the EPI is overseen by a desk within the Reproductive, Maternal, Neonatal, Child, Adolescent Health, and Nutrition (RMNCAH-N) Directorate of the Ministry of Health (MoH) Ethiopia. In 2023, this desk&#x2014;responsible for serving a country of over 128 million people
                    <sup>
                        <xref ref-type="bibr" rid="ref6">6</xref>
                    </sup>&#x2014;was staffed by only three regular professionals, with additional support from partner-seconded staff. It also receives guidance from bodies, including the National Immunisation Technical Advisory Group (E-NITAG), the Immunisation Task Force (ITF), the Interagency Coordinating Committee (ICC), and various Technical Working Groups (TWGs). The EPI Desk also collaborates with the Ethiopian Public Health Institute (EPHI) for research and programme monitoring, the Ethiopian Pharmaceutical Supply Service (EPSS) for vaccine supply and cold chain management, and the Ethiopian Food and Drug Authority (EFDA) for emergency services and public awareness.</p>
                <p>Regionally, EPI implementation falls under the purview of health bureaus&#x2019; RMNCAH-N Directorates, typically with only one dedicated EPI expert in almost all regions. At the zonal level, child healthcare units, via designated EPI focal persons, manage immunisation activities. Woreda-level EPI are overseen by focal persons within maternal and child healthcare units. Primary hospitals and health centers rely on one or two focal persons, while health extension workers at health posts deliver immunisations alongside other duties.</p>
            </sec>
            <sec id="sec4">
                <title>Organisational structure challenges within EPI in Ethiopia</title>
                <p>Although immunisation services in Ethiopia have expanded to thirteen antigens beyond the original six, the structure of the EPI, established over four decades ago, has remained largely unchanged. This outdated system poses significant challenges to key programmatic areas, including supervision and performance monitoring, service delivery, vaccine and immunisation supply chain management, immunisation quality and safety, vaccine-preventable disease surveillance, demand generation and communication strategies, and the monitoring and evaluation of programme outcomes. Consequently, Ethiopia&#x2019;s EPI effectiveness and efficiency lag behind other sub-Saharan African nations with more robust structures. These organisational structural weaknesses also contribute to decreased data utilisation, ineffective planning, and inadequate monitoring and evaluation at all administrative levels, deviating from the World Health Organisation (WHO)&#x2019;s functional units&#x2019; recommendations.
                    <sup>
                        <xref ref-type="bibr" rid="ref7">7</xref>,
                        <xref ref-type="bibr" rid="ref8">8</xref>
                    </sup> The introduction of new antigens, dose shift and increasing population will further strain this already overburdened system.</p>
                <p>The findings of the current evaluation study found that Ethiopia&#x2019;s national EPI unit, structured as a single desk rather than a department with units, severely limits its number of professional staff employed. This critical staffing shortage is currently filled by partner-appointed staff, a solution dependent on funding and therefore unpredictable. One major consequence of the outdated structure of Ethiopia&#x2019;s EPI is the inadequate allocation of human resources. Currently, only three professionals manage the National Immunisation Programme (NIP) for a population exceeding 128 million&#x2014;an evident disparity when compared to Kenya, which has 20 professionals for 56 million people,
                    <sup>
                        <xref ref-type="bibr" rid="ref9">9</xref>
                    </sup> and Rwanda, with 12 professionals for 14 million.
                    <sup>
                        <xref ref-type="bibr" rid="ref10">10</xref>
                    </sup> This limited staffing undermines critical functions such as supervision, performance monitoring, service delivery, vaccine supply chain management, and demand generation. These structural constraints underscore the urgent need for reform to improve the efficiency and effectiveness of immunisation services.
                    <sup>
                        <xref ref-type="bibr" rid="ref10">10</xref>
                    </sup> Revising the organisational structure of Ethiopia&#x2019;s NIP is therefore essential to meet the growing demands of the programme.</p>
                <p>Similarly, the study
                    <sup>
                        <xref ref-type="bibr" rid="ref5">5</xref>
                    </sup> found that the immunisation programme&#x2019;s inadequate organisational structure at lower levels (regional, zonal, woreda and facility), with immunisation subsumed within other units and managed by single focal persons, has created critical workforce shortages, a lack of ownership and accountability, and obscure roles and responsibilities.</p>
                <p>Despite the expansion of the immunisation programme&#x2019;s scope and objectives at the regional, zonal, and woreda levels, its organisational structure has not evolved accordingly. At the regional level, immunisation activities are housed within the Maternal and Child Health (MCH) unit and managed by a single focal person. At the zonal level, there is no dedicated immunisation lead; instead, one individual is responsible for child health, nutrition, and immunisation collectively. Similarly, at the woreda level, a single focal person oversees the entire MCH portfolio, including immunisation. This lack of dedicated EPI personnel at each level leads to operational strain, role ambiguity, and excessive workload. As immunisation responsibilities are added to the already broad mandates of general health professionals, program oversight and accountability are weakened, limiting the programme&#x2019;s effectiveness.</p>
                <p>The structural inadequacy continues at the health facility level (primary hospitals, health centres, and health posts). EPI focal persons are often burdened with additional responsibilities beyond immunization, such as working in outpatient departments. This diffusion of duties compromises the dedicated attention required for effective immunization services. The challenge of workload and inadequacy of the structure to accommodate additional work force for specific immunization service is even prominently seen at health post level. Moreover, community structures, such as the health development army, are reported to be loosely functioning, failing to adequately support HEWs in community engagement. This turnover and frequent rotation create inconsistent staffing and variable assignment timeframes for immunisation focal persons, negatively impacting service delivery.</p>
            </sec>
            <sec id="sec5">
                <title>Actionable recommendations</title>
                <p>To address the organisational structural challenges of the EPI in Ethiopia, the following areas of improvement have been identified:
                    <list list-type="bullet">
                        <list-item>
                            <label>&#x2022;</label>
                            <p>The organisational structure at all levels needs to be revised to be more responsive to the demands of immunisation services by all stakeholders.</p>
                        </list-item>
                        <list-item>
                            <label>&#x2022;</label>
                            <p>Current evidence indicates that the majority of zones&#x2014;sub-regional administrative units situated between regions and woredas&#x2014;and woredas&#x2014;third-level administrative divisions functioning as woredas&#x2014;in Ethiopia, along with many health facilities, do not have designated focal persons for the EPI. This lack of clearly assigned personnel undermines accountability and weakens responsibility for immunisation service delivery. In the minority of health facilities where focal persons are present, they are often tasked with multiple responsibilities and receive no additional incentives. This excessive workload may reduce their motivation and limit efforts to improve the quality and reach of immunisation services in their areas.</p>
                        </list-item>
                        <list-item>
                            <label>&#x2022;</label>
                            <p>Community-level immunisation programmes require increased attention and strengthened community structures to enhance demand generation and vaccine administration. The health extension workers should increase the time they allocate for immunisation services.</p>
                        </list-item>
                    </list>
                </p>
                <p>Based on the identified areas of improvement, the following policy options have been recommended for consideration in Ethiopia:</p>
            </sec>
        </sec>
        <sec id="sec6">
            <title>Option 1: Restructuring the immunisation programme</title>
            <p>
In alignment with WHO recommendations,
                <sup>
                    <xref ref-type="bibr" rid="ref9">9</xref>,
                    <xref ref-type="bibr" rid="ref10">10</xref>
                </sup> best practices in immunisation and vaccine programme structures from socioeconomically comparable countries,
                <sup>
                    <xref ref-type="bibr" rid="ref7">7</xref>,
                    <xref ref-type="bibr" rid="ref8">8</xref>
                </sup> and findings from the current evaluation,
                <sup>
                    <xref ref-type="bibr" rid="ref5">5</xref>
                </sup> there is a need to revise the current organisational structure of Ethiopia&#x2019;s immunisation programme. Specifically, we recommend establishing a more efficient and functional structure capable of supporting the necessary operational units at all administrative and facility levels.</p>
            <p>At the ministry level, we propose upgrading the existing EPI Desk&#x2014;currently situated within the RMNCH-N Directorate of the MoH-Ethiopia&#x2014;into an independent EPI Directorate. This new directorate would centralize all immunisation and vaccine-related activities, including vaccine production, logistics, and supply chain management. Establishing a dedicated directorate is expected to enhance coordination, improve responsiveness, and better meet the increasing demand for immunisation services.</p>
            <p>The proposed national-level structure is illustrated in 
                <xref ref-type="fig" rid="f1">
Figure 1</xref>. Aligned structural changes are also proposed at the regional (
                <xref ref-type="fig" rid="f2">
Figure 2</xref>), zonal (
                <xref ref-type="fig" rid="f3">
Figure 3</xref>), woreda (
                <xref ref-type="fig" rid="f4">
Figure 4</xref>), and primary health care unit (PHCU) levels&#x2014;including primary hospitals, health centres, and health posts (
                <xref ref-type="fig" rid="f5">
Figure 5</xref>).</p>
            <fig fig-type="figure" id="f1" orientation="portrait" position="float">
                <label>
Figure 1. </label>
                <caption>
                    <title>The recommended organisational structure of the immunisation program at the Ministry of Health, Ethiopia.</title>
                </caption>
                <graphic id="gr1" orientation="portrait" position="float" xlink:href="https://f1000research-files.f1000.com/manuscripts/181771/2eb307b1-5768-4cf7-8658-2e655bd9c173_figure1.gif"/>
            </fig>
            <fig fig-type="figure" id="f2" orientation="portrait" position="float">
                <label>
Figure 2. </label>
                <caption>
                    <title>The recommended organisational structure of the immunisation program at the regional levels in Ethiopia.</title>
                </caption>
                <graphic id="gr2" orientation="portrait" position="float" xlink:href="https://f1000research-files.f1000.com/manuscripts/181771/2eb307b1-5768-4cf7-8658-2e655bd9c173_figure2.gif"/>
            </fig>
            <fig fig-type="figure" id="f3" orientation="portrait" position="float">
                <label>
Figure 3. </label>
                <caption>
                    <title>The recommended organisational structure of the immunisation program at the zonal level in Ethiopia.</title>
                </caption>
                <graphic id="gr3" orientation="portrait" position="float" xlink:href="https://f1000research-files.f1000.com/manuscripts/181771/2eb307b1-5768-4cf7-8658-2e655bd9c173_figure3.gif"/>
            </fig>
            <fig fig-type="figure" id="f4" orientation="portrait" position="float">
                <label>
Figure 4. </label>
                <caption>
                    <title>The recommended organisational structure of the immunisation program at the woreda level in Ethiopia.</title>
                </caption>
                <graphic id="gr4" orientation="portrait" position="float" xlink:href="https://f1000research-files.f1000.com/manuscripts/181771/2eb307b1-5768-4cf7-8658-2e655bd9c173_figure4.gif"/>
            </fig>
            <fig fig-type="figure" id="f5" orientation="portrait" position="float">
                <label>
Figure 5. </label>
                <caption>
                    <title>The recommended organisational structure of the immunisation program at the PHCU level in Ethiopia.</title>
                </caption>
                <graphic id="gr5" orientation="portrait" position="float" xlink:href="https://f1000research-files.f1000.com/manuscripts/181771/2eb307b1-5768-4cf7-8658-2e655bd9c173_figure5.gif"/>
            </fig>
            <p>At the primary hospitals and health centres, the proposal calls for merging existing EPI units within primary hospitals and health centres into a unified structure. Each unit would be staffed by two healthcare professionals, who will plan, coordinate, and implement immunisation activities within their respective facilities. These professionals will allocate 50% of their working hours to EPI-related duties, with the remaining time dedicated to other clinical responsibilities. This approach differs from the current system in two key ways:
                <list list-type="order">
                    <list-item>
                        <label>1.</label>
                        <p>The EPI responsibilities are formally allocated half of each staff member&#x2019;s workload.</p>
                    </list-item>
                    <list-item>
                        <label>2.</label>
                        <p>These professionals will be held directly accountable for the performance of the immunisation programme in their facility.</p>
                    </list-item>
                </list>
            </p>
            <p>The restructuring will also involve strengthening the immunisation services at the community level. One of the shortcomings of the current structure at the health posts is the lack of adequate task division among the workers. In the new structure, a health extension worker will be assigned as an EPI focal person in health posts. The focal person will be solely responsible for immunisation services, and 100% of their time will be allocated to immunisation services. Additionally, strengthening community organisations such as health and women&#x2019;s development armies in the communities to support vaccine-preventable diseases (VPD) surveillance, identifying zero doses, and other immunisation-related issues will be crucial.</p>
            <p>It is anticipated that implementing these changes will enhance the effectiveness of Ethiopia&#x2019;s immunisation programme. However, a potential limitation is an increase in administrative and programme implementation costs. If additional funding for immunisation cannot be secured from domestic sources, the implementation of this proposed structure may face challenges.</p>
        </sec>
        <sec id="sec7">
            <title>Option 2: Restructuring the immunisation programme at the national level: Establishing the National EPI Institute</title>
            <p>The alternative to Recommendation 1 is to establish a National EPI Institute comprising various directorates and divisions (
                <xref ref-type="fig" rid="f6">
Figures 6</xref>-
                <xref ref-type="fig" rid="f9">9</xref>) to handle immunisation services. However, extending this at facility level has to be considered in this case.</p>
            <fig fig-type="figure" id="f6" orientation="portrait" position="float">
                <label>
Figure 6. </label>
                <caption>
                    <title>The proposed organisational structure of the National EPI Institute to be established.</title>
                </caption>
                <graphic id="gr6" orientation="portrait" position="float" xlink:href="https://f1000research-files.f1000.com/manuscripts/181771/2eb307b1-5768-4cf7-8658-2e655bd9c173_figure6.gif"/>
            </fig>
            <fig fig-type="figure" id="f7" orientation="portrait" position="float">
                <label>
Figure 7. </label>
                <caption>
                    <title>The proposed organisational structure of the Regional EPI Institute to be established.</title>
                </caption>
                <graphic id="gr7" orientation="portrait" position="float" xlink:href="https://f1000research-files.f1000.com/manuscripts/181771/2eb307b1-5768-4cf7-8658-2e655bd9c173_figure7.gif"/>
            </fig>
            <fig fig-type="figure" id="f8" orientation="portrait" position="float">
                <label>
Figure 8. </label>
                <caption>
                    <title>The proposed organisational structure of the Zonal EPI Desk under the auspices of the regional EPI Institute to be established.</title>
                </caption>
                <graphic id="gr8" orientation="portrait" position="float" xlink:href="https://f1000research-files.f1000.com/manuscripts/181771/2eb307b1-5768-4cf7-8658-2e655bd9c173_figure8.gif"/>
            </fig>
            <fig fig-type="figure" id="f9" orientation="portrait" position="float">
                <label>
Figure 9. </label>
                <caption>
                    <title>The proposed organisational structure of the Woreda EPI Units under the auspices of the regional EPI Institute to be established.</title>
                </caption>
                <graphic id="gr9" orientation="portrait" position="float" xlink:href="https://f1000research-files.f1000.com/manuscripts/181771/2eb307b1-5768-4cf7-8658-2e655bd9c173_figure9.gif"/>
            </fig>
        </sec>
        <sec id="sec8">
            <title>Conclusion</title>
            <p>Despite notable achievements since its inception, the current organisational structure of EPI services in Ethiopia, which has largely unchanged for over four decades is no longer aligns with the expanded scope and increasing complexity of EPI services. The findings from the recent national evaluation underscore the need for structural reform to enhance service delivery, improve accountability, and ensure sustainability. Implementing either of the two proposed organisational structure changes&#x2014;the establishment of an EPI Directorate or a National EPI Institute&#x2014;Ethiopia can better meet the immunisation needs of its growing population and strengthen its health system&#x2019;s outcomes.</p>
            <sec id="sec9">
                <title>Ethical approval statement</title>
                <p>This study received ethical approval from the Institutional Review Board (IRB) of the College of Medicine and Health Sciences, Hawassa University, Ethiopia. The IRB reviewed and approved the research protocol under Ref. No: IRB/288/15 on 07 April 2023. The approval was valid from 07 April 2023 to 06 April 2024. Ethical clearance was granted after ensuring that the research adhered to the principles stated in the Declaration of Helsinki and that the objectives and methods were ethically sound.</p>
                <p>The data presented in this brief were collected through in-depth interviews and focus group discussions with adults aged 18 years and older. Each participant received comprehensive information about the purpose of the study, data collection procedures, confidentiality, and their right to withdraw at any point without penalty. Given the minimal risk involved, the IRB explicitly approved the use of verbal informed consent in lieu of written consent. Verbal informed consent was obtained from all participants prior to data collection.</p>
                <p>The IRB is affiliated with Hawassa University, and the study was conducted in collaboration with the Consortium of CBPM Universities in Ethiopia (Addis Ababa, Haramaya, Hawassa, Jimma, and Gondar Universities).</p>
            </sec>
        </sec>
    </body>
    <back>
        <sec id="sec10" sec-type="data-availability">
            <title>Data availability</title>
            <p>The data analysed during this study consists of in-depth interviews and focus group discussions that contain potentially identifiable information. Due to ethical considerations and the need to protect participant confidentiality, public sharing of the full transcripts is not permitted. The IRB of the College of Medicine and Health Sciences, Hawassa University, which approved the study, did not grant permission for unrestricted public access to the raw qualitative data. The IRB requires that any data sharing must ensure participant anonymity and be subject to additional ethical oversight.</p>
            <p>Anonymised transcripts may be made available upon reasonable request, contingent upon a formal written request outlining the purpose and intended use of the data; ethical approval or data sharing agreement from the requester&#x2019;s institution; and compliance with data protection regulations and review by the Hawassa University IRB. To request access, please contact the corresponding author, Melaku Haile Likka (
                <email xlink:href="mailto:likkamelaku@gmail.com">likkamelaku@gmail.com</email>). Each request will be reviewed on a case-by-case basis to ensure ethical compliance and data security.</p>
            <sec id="sec11">
                <title>Extended data</title>
                <p>The qualitative data collection tool, participant information sheet, and informed consent form used in this study are publicly available via Figshare (
                    <ext-link ext-link-type="uri" xlink:href="https://doi.org/10.6084/m9.figshare.29235623.v1">https://doi.org/10.6084/m9.figshare.29235623.v1</ext-link>).
                    <sup>
                        <xref ref-type="bibr" rid="ref11">11</xref>
                    </sup> This dataset is licensed under a 
                    <ext-link ext-link-type="uri" xlink:href="https://creativecommons.org/licenses/by/4.0/">Creative Commons Attribution 4.0 International (CC BY 4.0) license</ext-link>.</p>
            </sec>
        </sec>
        <ack>
            <title>Acknowledgements</title>
            <p>The authors would like to acknowledge the MoH-Ethiopia and AMREF Health for funding and supporting this research. We also extend our gratitude to the data collectors and all the respondents who participated in this study for their time and valuable contributions.</p>
        </ack>
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    <sub-article article-type="reviewer-report" id="report441939">
        <front-stub>
            <article-id pub-id-type="doi">10.5256/f1000research.181771.r441939</article-id>
            <title-group>
                <article-title>Reviewer response for version 1</article-title>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author">
                    <name>
                        <surname>Aggarwal</surname>
                        <given-names>Sumit</given-names>
                    </name>
                    <xref ref-type="aff" rid="r441939a1">1</xref>
                    <role>Referee</role>
                    <uri content-type="orcid">https://orcid.org/0000-0002-0652-1611</uri>
                </contrib>
                <aff id="r441939a1">
                    <label>1</label>Indian Council of Medical Research, New Delhi, Delhi, India</aff>
            </contrib-group>
            <author-notes>
                <fn fn-type="conflict">
                    <p>
                        <bold>Competing interests: </bold>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>8</day>
                <month>1</month>
                <year>2026</year>
            </pub-date>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2026 Aggarwal S</copyright-statement>
                <copyright-year>2026</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access peer review report distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <related-article ext-link-type="doi" id="relatedArticleReport441939" related-article-type="peer-reviewed-article" xlink:href="10.12688/f1000research.165169.1"/>
            <custom-meta-group>
                <custom-meta>
                    <meta-name>recommendation</meta-name>
                    <meta-value>reject</meta-value>
                </custom-meta>
            </custom-meta-group>
        </front-stub>
        <body>
            <p>The primary concern is that the manuscript states that findings are informed by an evaluation</p>
            <p> conducted in August 2023, but the methods are insufficiently described. The study design,</p>
            <p> sampling strategy, number of interviews, and data analysis approach are unclear. These</p>
            <p> criteria are essential for readers to assess the robustness of the evidence underpinning the</p>
            <p> policy recommendations. The paper cites WHO recommendations and international best</p>
            <p> practices but provides only limited concrete examples from comparable countries. The</p>
            <p> methods section is not adequate.</p>
            <p>Does the paper provide a comprehensive overview of the policy and the context of its implementation in a way which is accessible to a general reader?</p>
            <p>Partly</p>
            <p>Is the discussion on the implications clearly and accurately presented and does it cite the current literature?</p>
            <p>Partly</p>
            <p>Are the recommendations made clear, balanced, and justified on the basis of the presented arguments?</p>
            <p>Partly</p>
            <p>Reviewer Expertise:</p>
            <p>Public Health Research, Health System Strengthening, Epidemiology, and Implementation Science</p>
            <p>I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.</p>
        </body>
    </sub-article>
</article>
