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Study Protocol
Revised

Vulnerability and childhood immunization in Kenya. A systematic review of policy documents protocol.

[version 2; peer review: 1 approved, 1 approved with reservations]
Previously titled: Equity, vulnerability and childhood immunization in Kenya and Uganda. A review of policy documents protocol.
PUBLISHED 27 May 2025
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OPEN PEER REVIEW
REVIEWER STATUS

Abstract

Introduction

Whereas improved full immunization coverage for childhood vaccines have been witnessed globally in the past decades, countries in sub-Saharan Africa have registered slow progress, with variations between and within countries. This has been attributed to several challenges/vulnerability factors. However, lacking is a documentation of how governments are conceptualizing and addressing these vulnerabilities. We therefore plan to systematically review policy documents to examine the extent to which vulnerability issues are framed and addressed in the general health sector and immunization policy documents in Kenya.

Methods

The review will focus on the general health sector and immunization policy documents covering the period between 2000 and 2023. Documents in the English language will be reviewed. Data sources will include official Ministry of Health website, websites of key international organizations working on immunization, checking reference lists of already identified documents, general Google searches and requesting relevant documents from stakeholders and officials. Data synthesis will follow a deductive and inductive approach. Findings will be presented in a descriptive format according to the review objectives.

Discussion

We will assess the extent to which vulnerability issues are included and how they are defined in the general health sector and immunization policy documents. In addition, the review will examine strategies proposed, planned and/or implemented to promote access and uptake of immunization services in Kenya.

Plain Language Summary

Plain English Summary

Vaccines offer several benefits key among them being prevention of infectious disease outbreaks and deaths. Unfortunately, not everyone enjoys these benefits partly due to avoidable differences in reaching and using vaccines. In most African countries, there have been an increase in the number of those using vaccines over the years even though there are still differences between and within countries. In a bid to ensure that no one is left behind in reaching and using vaccines, most international organizations working around vaccines have now prioritized attaining fairness in use of vaccines and this commitment is reflected in international immunization policy documents. It is therefore important to examine how this is working out at country level. That is whether countries are also working towards ensuring that everyone is vaccinated and whether this is captured in their policy documents. This review therefore seeks to understand what is being done in Kenya and Uganda to ensure that everyone is reached with vaccines by examining key health sector and immunization policy documents.

The review will focus on key health sector and immunization policy documents published in the English language from 2000 to 2023. An online search will be conducted through relevant websites such as ministry of health websites for each country. In addition, documents that cannot be accessed via online sources will be requested from relevant stakeholders in the two countries. The documents will then be screened to determine those appropriate to the review objective. Data from selected documents will be extracted using a data extraction tool, analysed and presented in a descriptive format and in line with the objectives of the review.

Keywords

Equity, immunization, vulnerability, vaccine, vaccination, Kenya, Uganda, policy document review

Revised Amendments from Version 1

One of the key changes to the review protocol is on the scope. Initially, we intended to examine how equity and vulnerability issues are framed and addressed in the health sector and immunization policy documents in Kenya and Uganda. However, we narrowed down the scope to how vulnerability issues are framed and addressed in the Kenyan policy documents in order to align the review with a primary study, which the review is part of. Therefore, the protocol has been revised to reflect this new scope.
The following revisions have been made in each section.
We have revised the title to incorporate one of the comments we received from one of the reviewers. In addition, we dropped one of the concepts, “Equity’’ and Uganda from the title because of the reasons provided above.
Abstract and Keywords: Has been revised to reflect the narrowed scope
Main body: The body has been revised to reflect the new scope. We have also revised the data synthesis section. We have dropped the framework we had initially proposed because it would no longer be relevant given the change in the scope.

See the authors' detailed response to the review by Patricia Mechael

Introduction

Vaccines are some of the most effective public health interventions with a demonstrated capacity to prevent and/or control the outbreak and spread of infectious diseases13. Improved health outcomes globally can partly be attributed to the use of vaccines which have played a significant role in the reduction of morbidity and mortality arising from life threatening infectious diseases. According to the WHO, immunization against different infectious diseases contributes to the prevention of approximately four million deaths per year globally, hence an increase in life expectancy. Moreover, disease prevention using vaccines can help to avert medical expenditures and other related costs such as loss of wages by caregivers during sickness episodes, travel time and transportation costs to seek treatment4.

In the past decades, several concerted efforts have been put in place internationally to promote access and uptake of vaccines targeting different age groups. Key among these was the establishment of the Expanded Programme on Immunization (EPI) by WHO in 1974 and the Global Alliance for Vaccines and Immunization (GAVI) in 1999. These initiatives have so far led to improved childhood vaccine coverage across the globe. However, access and uptake between countries are still characterized by inequities, especially in sub-Saharan Africa where the majority of vaccine-preventable diseases are experienced57. Additionally, immunization coverage at national and sub-national levels in most African countries has stagnated and is disparate6. WHO estimates that more than 30 million of under five years children in Africa suffer from vaccine-preventable diseases annually, out of which 500,000 die from these diseases. This is almost equivalent to 58% of the global vaccine-preventable diseases2. Moreover, many of these children haven’t received any dose of the recommended childhood vaccines (zero-dose children).

These disparities in access and uptake not only make some children vulnerable to vaccine-preventable diseases but can also potentially form hotspots for future disease outbreaks. Several reviews of published literature have been conducted to highlight vulnerabilities that influence the disparities in access and uptake of childhood vaccines8,9. For instance, in Kenya, previous studies have shown that children’s vulnerability to vaccine-related disparities is influenced by geographical, household, and mothers’ characteristics10,11. However, how these vulnerability issues are framed and addressed in grey literature, such as government policies, is lacking. Yet this understanding is not only important but also necessary for the identification of gaps and the formulation of appropriate strategies. We therefore intend to systematically review general health sector and immunisation-specific policy documents in Kenya to examine the extent to which vulnerability issues are framed and addressed generally and in the context of immunization. Specifically, the review will: (1) describe how vulnerability is conceptualized in the general health sector and immunisation-specific policy documents, and (2) examine strategies proposed in the policy documents to address vulnerability issues in general and in the context of immunization.

Methods

Inclusion criteria

The documents to be reviewed will include general health sector and immunization specific policies, guidelines and strategic plans. Only documents in the English language will be included. Publication date for inclusion will be from 2000 (to correspond with the establishment of GAVI, which has played a key role in promoting access to vaccines in most of the developing countries like Kenya and Uganda) to 2023.

Information sources

Documents to be reviewed will be retrieved from the following sources:

Search strategy

The following key words will be used for general google searches as well as the specific websites listed above: Vaccin* and/or immuniz* AND/OR routine vaccin* and/or immuniz* and/or vulnerab* AND/OR Expanded programme on immunization or EPI OR Kenya expanded programme on immunization or KEPI. In addition to the search terms listed above, documents will also be identified through the reference list of identified documents.

Study records

Data management and selection process. All documents retrieved from online sources will be exported and managed in Endnote v20 or Mendeley where duplicates will also be identified. The reviewer (EO) will manually screen the documents to identify those relevant to the review questions and that meet the eligibility criteria. The screening will be based on the title of the document, a search of terms, including vulnerability, immunization, and vaccination within the documents, and by reading through the executive summary of a document. The list of documents identified as eligible for review will then be shared with the other reviewers (PC, CJ, DM and DK). The team will then meet to discuss the appropriateness of the documents identified as eligible and a consensus will be reached on documents to be included for final review.

Data collection process and data items. Data collection will be performed by EO using a data extraction template12. Extracted data will then be shared with co-reviewers who will independently review it, after which the team will meet to discuss and resolve any disagreements. The data extraction tool will be developed using an Excel spreadsheet. Each row of the tool will capture documents identified, while the individual columns will capture the type of information to extract from the documents. Information to be extracted will include general information about the documents e.g., the full title of the document, author(s), date of publication, purpose of the document, intended users/audience and a summary of issues addressed in the document. The second category of information to be extracted will include explicit and implicit information related to vulnerability. To extract this type of data, a full text review of documents that are entirely focused on immunization will be conducted, while for documents that contain other information apart from immunization, only relevant sections will be read and data extracted, in addition to the general information about the document.

Review outcomes

The key outcomes for this review will be a description of how vulnerability issues have been framed in immunization and health sector policy documents in Kenya, strategies planned and/or implemented by the Kenyan government to address health related vulnerabilities and those specific to access and uptake of vaccines as well as gaps and opportunities in the policy documents reviewed.

Risk of bias in individual studies

Not applicable

Data synthesis

Data synthesis will follow an inductive approach where the extracted data on vulnerability will be read line by line and appropriate codes applied. Data will then be organized thematically to address the review objectives: how vulnerability issues are conceptualized/defined, aspects considered in the documents and strategies proposed to address vulnerability issues.

Meta-bias(es)

Not applicable

Confidence in cumulative evidence

Not applicable

Study status

Completion of this review is anticipated to be by September 2023. The study team is currently screening documents identified through online searches.

Conclusion

The review intends to provide an understanding of vulnerability issues in the context of health and immunization in Kenya. Specifically, it will focus on how vulnerability issues are framed in policy documents to identify gaps and opportunities that can be harnessed to address vulnerabilities that influence access and uptake of vaccines. We intend to explore the gaps identified through the review with relevant stakeholders through primary research and contribute to the improvement of the policy landscape around immunization through policy recommendations.

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Version 2
VERSION 2 PUBLISHED 24 Nov 2023
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CITE
how to cite this article
Owino EA, Mafigiri D, Kamuya D et al. Vulnerability and childhood immunization in Kenya. A systematic review of policy documents protocol. [version 2; peer review: 1 approved, 1 approved with reservations]. NIHR Open Res 2025, 3:64 (https://doi.org/10.3310/nihropenres.13449.2)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Open Peer Review

Current Reviewer Status: ?
Key to Reviewer Statuses VIEW
ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version 2
VERSION 2
PUBLISHED 27 May 2025
Revised
Views
7
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Reviewer Report 30 May 2025
Patricia Mechael, HealthEnabled, Cape Town, South Africa 
Approved
VIEWS 7
This revision is much improved. The authors have sufficiently addressed the ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Mechael P. Reviewer Report For: Vulnerability and childhood immunization in Kenya. A systematic review of policy documents protocol. [version 2; peer review: 1 approved, 1 approved with reservations]. NIHR Open Res 2025, 3:64 (https://doi.org/10.3310/nihropenres.15217.r35834)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
Version 1
VERSION 1
PUBLISHED 24 Nov 2023
Views
12
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Reviewer Report 11 May 2024
Nicholas Spencer, University of Warwick, Coventry, England, UK 
Approved with Reservations
VIEWS 12
As the authors state, equity in vaccination uptake and coverage is essential in achieving the targets of the WHO agenda 2021-2030. The proposed review aims to explore the extent to which issues of (in)equity are included in Kenyan and Ugandan ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Spencer N. Reviewer Report For: Vulnerability and childhood immunization in Kenya. A systematic review of policy documents protocol. [version 2; peer review: 1 approved, 1 approved with reservations]. NIHR Open Res 2025, 3:64 (https://doi.org/10.3310/nihropenres.14588.r31141)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
Views
11
Cite
Reviewer Report 11 May 2024
Patricia Mechael, HealthEnabled, Cape Town, South Africa 
Approved with Reservations
VIEWS 11
This proposed review of equity policies related to immunization is an important and timely piece of work. One recommendation is to not call it a "systematic review" as that has connotations of a state of evidence review based on randomized ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Mechael P. Reviewer Report For: Vulnerability and childhood immunization in Kenya. A systematic review of policy documents protocol. [version 2; peer review: 1 approved, 1 approved with reservations]. NIHR Open Res 2025, 3:64 (https://doi.org/10.3310/nihropenres.14588.r31362)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
  • Author Response 28 May 2025
    Esther Owino, Centre for Geographic Medicine Research (Coast), Kenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya
    28 May 2025
    Author Response
    Thank you very much for this useful feedback.
    We have incorporated the recommendation about the title. The revised title now reads as follows; Vulnerability and childhood immunization in Kenya: a systematic review ... Continue reading
COMMENTS ON THIS REPORT
  • Author Response 28 May 2025
    Esther Owino, Centre for Geographic Medicine Research (Coast), Kenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya
    28 May 2025
    Author Response
    Thank you very much for this useful feedback.
    We have incorporated the recommendation about the title. The revised title now reads as follows; Vulnerability and childhood immunization in Kenya: a systematic review ... Continue reading

Comments on this article Comments (0)

Version 2
VERSION 2 PUBLISHED 24 Nov 2023
Comment
Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions

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