Vaccine 31S (2013) B129–B136

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Vaccine
journal homepage: www.elsevier.com/locate/vaccine

Review

The need for targeted implementation research to improve coverage of basic

vaccines and introduction of new vaccines
Narendra K. Arora a,∗,1 , Altaf A. Lal b,1 , Joachim M. Hombach c , Jose I. Santos d ,
Zulfiqar A. Bhutta e , Samba O. Sow f,g , Brian Greenwood h
a
The INCLEN Trust International, New Delhi, India
b
Barcelona Institute for Global Health, Barcelona, Spain
c
Immunizations, Vaccines and Biologicals (IVB), WHO, Geneva, Switzerland
d
School of Medicine, Universidad Nacional Autónoma de Mexico, Mexico
e
Division of Women and Child Health, Aga Khan University Medical Center, Karachi, Pakistan
f
University of Maryland School of Medicine, Baltimore, Maryland, USA
g
Centre pour le Développement des Vaccins – Mali, Ex-Institut Marchoux, CNAM, Ministère de la Santé Bamako, Mali BP251, Mali
h
London School of Hygiene & Tropical Medicine, Keppel Street, London WC1E7HT, UK

a r t i c l e i n f o a b s t r a c t

Article history: The Decade of Vaccines Collaboration (DoVC) Research and Development (R&D) Working Group iden-
Received 20 August 2012 tified implementation research as an important step toward achieving high vaccine coverage and the
Received in revised form 22 January 2013 uptake of desirable new vaccines. The R&D Working Group noted that implementation research is highly
Accepted 25 January 2013
complex and requires participation of stakeholders from diverse backgrounds to ensure effective plan-
ning, execution, interpretation, and adoption of research outcomes. Unlike other scientific disciplines,
implementation research is highly contextual and depends on social, cultural, geographic, and economic
Keywords:
factors to make the findings useful for local, national, and regional applications. This paper presents
Implementation research
Expanded Program on Immunization
the broad framework for implementation research in support of immunization and sets out a series of
Global Vaccine Action Plan research questions developed through a Delphi process (during a DoVC-supported workshop in Sitges,
Decade of Vaccines Collaboration Spain) and a literature review.
© 2013 Elsevier Ltd. All rights reserved.

Contents

1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B129
2. What is implementation research? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B130
3. Immunization-related research in GVAP and other global initiatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B131
4. Rationale and process of developing an implementation research agenda for GVAP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B131
5. Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B135
Conflict of interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B135
Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B135
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B135

1. Introduction

Abbreviations: DoVC, Decade of Vaccines Collaboration; DTP, diphthe- Impressive gains in vaccine coverage have been made since
ria/tetanus/pertussis; EPI, Expanded Program on Immunization; GIVS, Global
Immunization Vision and Strategy; GVAP, Global Vaccine Action Plan; IVR, Initia-
the launch of the World Health Organization (WHO) Expanded
tive for Vaccine Research; NGO, nongovernment organization; R&D, Research and Program on Immunization (EPI) in 1974 [1]. However, the ben-
Development; UNICEF, United Nations Children’s Fund; WHO, World Health Orga- efits of vaccination have not yet reached many of those living
nization. in resource-limited countries, which carry the major burden of
∗ Corresponding author at: The INCLEN Trust International, F-1/5, Okhla Phase-1,
vaccine-preventable diseases [2,3]. In 2005, WHO and the United
New Delhi 110020, India. Tel.: +91 9810110376; fax: +91 11 47730001.
E-mail addresses: nkarora@inclentrust.org, narendrakumararora@gmail.com
Nations Children’s Fund (UNICEF) developed the Global Immu-
(N.K. Arora). nization Vision and Strategy (GIVS), which set a goal for all
1
Narendra K. Arora and Altaf A. Lal are joint first authors. countries to achieve 90 percent national coverage and 80 percent

0264-410X/$ – see front matter © 2013 Elsevier Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.vaccine.2013.01.058
B130 N.K. Arora et al. / Vaccine 31S (2013) B129–B136
coverage in every district for delivery of three doses of diphthe-
ria/tetanus/pertussis (DTP) vaccines to infants. This goal has not
yet been achieved universally [4]. Several new vaccines are now
being introduced into national programs, but uptake of these new
vaccines in developing countries faces significant challenges.
There are important differences between the development of
new technologies, products, and interventions for disease control
and the development of the strategies required to enhance the
uptake of these approaches within their unique target communi-
ties. The R&D Working Group of the DoVC has focused on three
research domains: (1) the R&D needs for enhancing coverage of
existing vaccines and uptake of new vaccines (short-term R&D
needs); (2) innovations in technologies for development of new
and improved vaccines (mid-term R&D needs); and (3) the basic
research required to develop new concepts for vaccine develop-
ment (long-term R&D needs) [5].
The consultations of the R&D Working Group supplemented
by a literature search inform the content of this paper. The pur-
pose of this paper is to highlight the importance of implementation
research within the Global Vaccine Action Plan (GVAP) to improve
the coverage of basic vaccines as well as the uptake of desirable
new vaccines with a particular focus on low- and middle-income
countries [5].
We used the search terms “implementation research” and
“immunization”, “vaccination”, “routine immunization”, “global
immunization”, or “immunization delivery strategies” in two
search engines (PubMed and BioMed Central). Our search returned
1027 articles, and we considered 55 as relevant for this article. We
specifically looked for review articles that had undertaken analysis
of published and gray literature on the subject.
2. What is implementation research?
Health-related implementation research is the use of science to
study practices in routine clinical care and public health systems in
order to improve the quality and equity of health care [6–9]. It also
includes the study of factors that influence health care profession-
als and organizations and the factors influencing users of health
care services, thus covering demand and supply. Implementation
research often involves impact research, which includes research
aimed at understanding what happens during the process of imple-
menting a change in policy, program, or practice, and intervention
studies, which are designed to compare different approaches to
implementing change. Introducing new vaccines and ensuring they
reach all people for whom they are intended is a challenging task,
and the science related to implementing interventions effectively,
efficiently, and with equity and high fidelity has received inade-
quate attention, particularly in African and Asian countries where
overall research capacities are limited.
The major objective of implementation research for immuniza-
tion, as discussed here, is to generate evidence that can support
countries in strengthening their routine immunization programs.
Implementation research can inform locally appropriate strategies
by identifying the bottlenecks in vaccine procurement and deliv-
ery, handling the special needs of life course immunization, mass
immunization campaigns for polio, measles, influenza, meningitis
A, or other diseases, pinpointing vaccines needed during human-
itarian emergencies such as floods or conflicts, and generating
context-specific evidence for rational policy and program decisions
[10].
Our research findings covering a wide range of topics indicate
four overarching aspects of successful implementation—referred
to in the literature as “active implementation frameworks”—to
support health programs [11,12]. After summarizing these diverse
characterizations, we propose to use them to develop a framework
for research to support national immunization programs as
described below.
The first aspect is that implementation requires well-thought-
out changes, which require repetitive, context-specific learning
in discernible stages. Implementation is a process that involves
multiple decisions, actions, and course corrections to evolve new
program models, innovations, and initiatives. Implementing a well-
constructed, well-defined, well-researched program can take two
to four years, depending on whether programs are implemented at
national or district levels [13–17].
Second, implementation drivers are the core components
required to support practice, organization, and system change.
High-fidelity and sustainable programs occur when competency
drivers, organization drivers, national systems, and leadership
drivers work in partnership.
Third, implementers should connect policy and practice to
ensure that learning from both informs decision-making and
results in continual program improvements, including devel-
opment and implementation of evidence-based policies for
deployment of vaccines and allotment of funds for procurement
and delivery of vaccines.
Fourth, implementation requires constant review and input
from local, national, and global experts to ensure a transparent
process that benefit from continuous technical innovations and
cutting-edge implementation research with regular evaluation and
impact assessments.
Thus, the complete iterative process may take several years as
the results of the implementation research become available and
the new interventions become firmly embedded within the health
system [6–8,12].
During our DoVC consultations, members of the R&D work-
ing group who comprised of discovery, development and delivery
experts, proposed several important topics for an implementation
research agenda. These include: (1) new information technology
and communication tools in immunization programs; (2) life-
course immunization, where the focus should be from infancy
to adults; (3) effective and efficient systems to retain clients and
minimize dropout; (4) strategies to identify and reach the most
disadvantaged sections of society that often comprise the lower
one-third to one-fourth of the population (based on social and
economic parameters) and are often missed by routine immuniza-
tion; (5) mapping of vulnerable communities to develop targeted
strategies for these groups; (6) establishing human resource and
capacity-building programs for immunization; and (7) developing a
matrix to assess short- and long-term outcomes and programmatic
impact.
Suggested research strategies to accomplish these agenda goals
could include: (1) social and behavioral science research to increase
confidence in a vaccine; (2) an emphasis on context-specific
research; and (3) establishing a network of Centers of Excellence
for implementation research, including provision for core funding
for such centers.
Implementation research demands an appropriate balance
between internal and external validity of its findings for scaling-up
of programs [18,19]. Implementation of an intervention requires
changes at several steps in program management and delivery that
need to be embedded into the local system to ensure acceptabil-
ity and sustainability [19]. Implementation research also requires
an interdisciplinary approach that includes social sciences (such as
anthropology and health economics), statistics, epidemiology, pol-
icy analysis, ethics, and other relevant disciplines [20]. Employing
qualitative methods helps to improve understanding of the pro-
cesses, phenomena, context, inter- and intra-organizational issues,
and perspectives of different stakeholders and for triangulating
quantitative results. Implementation research focuses on effective-
ness of the interventions in actual program settings rather than
 N.K. Arora et al. / Vaccine 31S (2013) B129–B136 B131

looking for efficacy in controlled situations. Madon et al. have will be more beneficial and expand the reach of immunization and
argued that many evidence-based innovations fail to yield results maternal and child health care services in developing countries
at the community level because their implementation is not tested, [36].
is incomplete, or is not suited for the community [21].
Targeted implementation research should have clear objectives,
3. Immunization-related research in GVAP and other global
use state-of-the-art methodologies and monitoring and have a
initiatives
finite timeline for evaluation. It is important to point out that true
demand for implementation research in relation to vaccines needs
GVAP highlights the need to improve the efficiency of immu-
to come from the implementing and funding agencies, and, to date,
nization programs and to increase coverage of basic vaccines and
few agencies have shown interest in supporting the research. The
the uptake of new vaccines. New and innovative strategies are
vaccine manufacturers fund development and vaccine efficacy and
needed to overcome the challenges posed by the need for vaccina-
effectiveness studies, but bilateral and multilateral agencies and
tion throughout life and in emergency and outbreak situations. A
the GAVI Alliance have supported only very limited research in
large number of low- and middle-income countries, some of which
this area. Implementation research requires substantial financial
have weak health systems and face problems of poor governance,
resources and time, yet this work frequently faces funding con-
are likely to want to introduce new and underused vaccines. How-
straints and poor demand from users.
ever, major questions remain as to how to scale up introduction
Information and experiences from implementation research
of these new vaccines and ensure their effective integration within
in the North and South America have strengthened technical
existing immunization programs. Research can play an important
components of and policies related to national immunization pro-
role in improving immunization programs in these settings. Care-
grams. Some noteworthy examples of this include the annual
ful characterization of system problems within a specific country
Vaccination Week (now expanded globally), the elimination of
context can generally improve the efficiency of delivery and access.
rubella and congenital rubella syndrome, measles eradication,
The strategic framework for vaccine implementation research
the introduction of vaccines against rotavirus, human papillo-
is already defined within the WHO Initiative for Vaccine Research
mavirus, and influenza, and the ProVac Initiatives [22–28]. Taken
(IVR) Strategic Plan 2010–2020 [37]. Implementation research is
together, these vaccine delivery-related initiatives have led to the
well embedded within the core work of IVR, helping to define
deployment and provision of lifesaving vaccines in this geographic
the complex interplay between technical, population behavior,
region.
and health system challenges that need to be met to enhance
The largest body of implementation research comes from the
uptake of both existing and new vaccines. IVR has also conducted
Latin America, but significant research has also been conducted
a comprehensive review of implementation research issues and
elsewhere. For instance, the study of regional inequity and vaccine
prioritization methodologies. The WHO Research for Health Strat-
uptake in Malawi revealed the presence of clusters of under-
egy adopted by the 2010 World Health Assembly builds on the
vaccinated children, leading to increased vulnerability during
Mexico Ministerial Summit (2004) and the Bamako Global Minis-
outbreaks of vaccine-preventable diseases. This study also sug-
terial Forum on Research for Health (2008), both of which reiterate
gested that there is substantial potential for political intervention
the importance of focusing on research to promote knowledge
to improve the current state of immunization [29]. An experience
translation [38]. Furthermore, one of the key areas in the WHO-
from Khartoum State, Sudan, revealed that the government must
hosted Special Program for Research and Training in Tropical
make greater efforts in funding, provision of skilled manpower and
Diseases Business Plan 2008–2013 is a focus on development and
delivery mechanism to achieve higher rates of vaccination in rural
evaluation of interventions in real-life settings [39]. The Alliance
areas [30]. The strength of childhood immunization in South Africa
for Health Policy and Systems Research at WHO has set up an
comes from having a framework for intervention that not only is
implementation research platform with the aim of addressing
strong but that requires implementation to be tailored to local
common issues and obstacles in health services delivery [40].
circumstances and accompanied by high-quality monitoring and
The proposed framework in this paper (Fig. 1) and the set of
evaluation [31]. Experiences in Mali indicate that sustained immu-
research questions (Tables 2–6) link with most of the existing ini-
nization efforts will require improvements in staffing, financing,
tiatives in implementation research, but provide a comprehensive
and delivery-related guidelines to ensure the presence of skilled
approach to determine the need for implementation research spe-
staff at the periphery [32]. In a study in Burkina Faso that investi-
cially designed for national immunization programs of developing
gated rates of coverage and determinants of complete vaccination
countries.
in rural areas, researchers found that continuity of health care ser-
vices from prenatal care to institutional delivery created families’
loyalty to health services and was closely associated with commu- 4. Rationale and process of developing an implementation
nities’ rates of child vaccination [33]. research agenda for GVAP
The parents of migrant children identified “fear of arrest” as
a key barrier for accessing childhood immunization in a study In the United States, children, adolescents, and adults are
conducted in Tak Province, Thailand [34]. An EPI intervention now routinely protected against 17 vaccine-preventable diseases
package (including an extended EPI service schedule, training for [41,42]. In comparison, despite four decades of global immuniza-
service providers on valid doses and management of side-effects, tion efforts, almost 20 million children elsewhere in the world,
a screening tool to identify immunization needs among clinic generally in countries where the basic EPI package continues to
attendants, and an EPI support group for social mobilization) was contain vaccines against only six diseases, remain unimmunized
found to dramatically improve child immunization coverage in [3]. Most of these children live in a few countries and most remain
urban slums of Dhaka, Bangladesh [35]. In a study among five outside the national health delivery system but have the highest
Asian countries (India, Nepal, Bangladesh, Indonesia, and Sri Lanka), risk of morbidity and mortality.
researchers found a high level of institutional and contextual com- Heterogeneity in vaccine coverage, which varies even between
plexity at the country level that requires a more focused response districts, is a hard-to-tackle aspect of national immunization pro-
from the global partners to address local governance challenges grams [43]. Identifying population clusters that continue to remain
in providing vaccination. This study also documented that manag- outside public health services and finding strategies to deliver ser-
ing through systems, and not being overly reliant on committees, vices to these communities are important implementation research
B132 N.K. Arora et al. / Vaccine 31S (2013) B129–B136
Fig. 1. Implementation research framework for minimizing barriers and improving
coverage of basic vaccines and boosting uptake of new vaccines.
needs in developing countries and nomadic populations. There are
several reports of the public health significance of inequities in
health access and outcomes [10]. One analysis of equity and trends
in coverage of maternal, newborn, and child health services in 54
countries between the years 1990 and 2006 found that patterns
of inequity change only gradually, if at all [44]. Across Asia, eval-
uations from China [45], India [46], Indonesia [47,48], Cambodia
[49], Vietnam [50], and Bangladesh [51] reveal persistent health
inequities in access to care and consequently poor health outcomes
for the socially disadvantaged. A systematic analysis of children
who are not vaccinated has recently been published [3]. Another
recent study of equity in maternal, newborn, and child health
interventions has revealed that community-based health services
(outreach immunization and antenatal clinics) were accessed by
all segments as compared to facility-based delivery mechanisms.
This study also indicated the need for making available trained and
skilled manpower for delivering services to the poor and excluded
segments of the population to improve equity [9].
Additional studies highlight the multi-dimensional nature of
poverty and ill health in urban slums and recommend a spectrum of
responses [52]. These range from targeted medical interventions to
capacity-building and skills transfer, infrastructure development,
and improved networking among nongovernmental organizations
(NGOs), municipal governments, and private practitioners [53].
The immunization services have traditionally focused on vac-
cination in infancy. However, within GIVS, there was a clear call
to look at immunization beyond the infant age group [4]. There
are several vaccines that are already recommended for children
and older age groups, and several vaccines in the pipeline are
directed at children, adolescents, and adults. The experiences from
the Americas deserve special mention, as here EPI programs have
transitioned into family immunization programs tackling seasonal
influenza vaccination of the elderly and high-risk adults, neonatal
tetanus immunization of women of child-bearing age, and efforts
to increase human papillomavirus vaccination of adolescent girls
[22–28].
Recent studies have shown that inactivated influenza vaccine
given to pregnant women is highly effective in preventing influenza
among these women and their infants aged less than six months
[54,55]. These results have clinical as well as public health rel-
evance, especially in developing countries with a high burden of
neonatal and infant mortality. There are several vaccines available
now or planned for the future, such as those for pertussis, group B
streptococcal disease, and respiratory syncytial virus, for which a
similar strategy may be effective in preventing disease and death
in neonates and young infants. Despite vast knowledge about vac-
cine efficacy and safety, national programs still have not embraced
large-scale uptake of these vaccines. Implementation research has
an important role in accelerating the introduction and sustained
use of vaccines in older children and adults.
Current challenges to achieving universal vaccination in
developing countries are: (1) reaching the last quartile in the
socioeconomic ladder to ensure access, coverage, and equity; (2)
accelerating uptake of new and under-utilized vaccines; and (3)
identifying the most effective delivery approaches to overcome
challenges posed by life-course immunization (in infants, adoles-
cents, pregnant women, the elderly, and others) and vaccination in
emergency and outbreak situations [5]. Different working groups
of the DoVC have identified six priority actions (Table 1) for imple-
mentation research.
We have proposed actions for implementation research listed
above framed through the five domains mentioned below, four of
which were also highlighted in a literature review by Ryman et al.
[56]:
• Immunization closer to the community (e.g., through outreach clin-
ics, specifically designed community-based delivery services),
which is expected to reduce inequities and increase acceptability
of immunization services.
• Demand for vaccination, which is expected to increase coverage
and reduce inequities.
• Services at fixed sites, which is expected to improve acceptability
of immunization services and reduce drop-outs.
• Program management, which is expected to improve efficiency,
effectiveness, and equity.
• Policy and governance, which is expected to result in rational
resource allocation, utilization, and all-around accountability in
performance and resources.
Utilization of the results of implementation research has the
potential to expedite disease control, elimination, and eradication
initiatives and result in a reduction in the demand for cura-
tive services due to decreases in prevalence and incidence of
infectious diseases. This type of research will lead to program
changes that will improve women’s and men’s health care and
allow for more integrated approaches for delivery of services. The
research also will enable countries to realize long-term net sav-
ings in their national budgets by focusing on prevention using
locally derived data for decision-making and modern delivery tech-
nologies in national immunization programs. Additionally, this
type of research has the potential of rendering vaccination more
cost-effective by targeting high-burden populations and avoiding
vaccine wastage and other inefficiencies. Implementation research
findings will also influence health systems through formation of a
better-trained workforce and improvements in other primary care
health services and social programs. Fig. 1 illustrates the suggested
framework for implementation research required for minimizing
barriers to national immunization programs; improve coverage of
basic vaccines and boosting uptake of new vaccines.
Under each domain, interventions may relate to clients/
community, providers, and/or the system. The following sections
summarize the discussions and consultations of the short-term
 N.K. Arora et al. / Vaccine 31S (2013) B129–B136 B133

Table 1
Indicative implementation research actions under the GVAP six strategic objectives [5].

GVAP strategic Implementation research actions

objective

1 1. Promote collaborations between doers and users of research.

2. Disseminate evidence of public health value of vaccines.
2 1. Conduct research to communicate benefits and availability of vaccines.
2. Conduct social research to improve the delivery of immunization services and the ability to meet the needs of diverse communities.
3. Leverage new mobile and internet-based technologies.
3 1. Recast “reaching every district” to “reaching every community” to address inequities.
2. Engage underserved and marginalized groups to develop locally tailored, targeted strategies for reducing inequities.
3. Establish a life-course approach to immunization planning and implementation to ensure equity across life span.
4. Prevent and respond to diseases during outbreaks and humanitarian crises and in conflict zones.
5. Conduct operational and social science research to identify successful strategies to reduce inequity and improve quality and delivery of
immunization.
6. Track each individual’s immunization status using information and communication technologies.
4 1. Improve quality of all immunization administrative data.
2. Develop and promote use of new technologies for collection, transmission, and analysis of immunization data.
3. Strengthen and expand disease-surveillance systems to generate information for decision-making, develop surveillance strategies to
differentiate cases due to vaccine failure from failure to vaccinate, monitoring the impact of immunization on morbidity and mortality, and
changes in disease epidemiology.
4. Ensure capacity for vaccine-safety activities, including capacity to collect and interpret safety data, with enhancement of capacity in countries
that introduce newly developed vaccines.
5 1. Evaluate funding support mechanisms on the basis of their effectiveness.
2. Explore pay-for-performance funding systems.
6 1. Use modern information and communication technologies.
2. Conduct epidemiologic, immunologic, social, and operational studies and investigations of vaccine impact to guide health economics analysis.
3. Perform operational research on improved delivery approaches for life-course immunization and for vaccination in humanitarian emergencies,
fragile states, and countries in and emerging from conflict.
4. Perform research on immunologic interference effects and optimum delivery schedules.

Table 2
Illustrative list of research needs for bringing immunization closer to communities.

Type of intervention Research needs

Community/client • Investigate benefits of providing outreach immunization services in the village with oversight/social accountability from local
interventions leadership (local self-government).
• Determine the impact and acceptance of providing immunization services in schools with dissemination of information to and
by the students.
• Investigate the added value of using local women to provide health education and track clients.
Provider interventions • Conduct mapping and barrier analysis of hard-to-reach and defaulting families by community health workers.
• Identify unvaccinated children through health teams’ home visits, outreach sessions, and other developmental programs.
System intervention • Identify geographic locations and communities that remain unvaccinated using mother/child tracking systems.
• Develop mobile-based supportive supervision of primary health care workers during outreach services.

Table 3
Illustrative list of research needs for increasing community demand for vaccination.

Type of intervention Research needs

Community/client intervention
Provider intervention
System intervention
• Investigate the impact of targeting mothers and community leaders in poor communities with information/education about
vaccination.
• Investigate the impact on vaccination coverage achieved by staff who receive sustained training and who are closely supervised
by their community.
• Determine the impact of social mobilization campaigns organized by civil society organizations/NGOs, aimed at creating
demand for immunization.
• Investigate the impact of religious groups and community influencers for promoting confidence in immunization programs.
• Develop and test locally suitable communication strategies to counter misinformation by anti-vaccine groups.
• Test the impact of “mobile messages and recalls” for improving communication about childhood vaccination with parents and
communities.
• Determine the impact of call centers for vaccine-related queries and investigate their effect on vaccine coverage.

Table 4
Illustrative list of research needs for improving services in fixed sites.

Type of intervention Research needs

Community/client • Test the usefulness of establishing a system to address grievances in health facilities.
intervention • Determine if reduced waiting time at health facilities will lead to increased demand.
• Determine whether changing clinic times for client convenience and use of mobile vaccination sites will increase coverage and uptake of
vaccines.
Provider intervention • Determine the optimum methods to sustain the skills of immunization staff after their initial training period.
• Determine whether civil society organizations, local NGOs and/or ministries of health can organize and deliver immunization services and
establish effective communication with parents/guardians.
System intervention • Determine if the provision of confidentiality and basic amenities in facilities leads to better acceptability of immunization services.
• Investigate whether follow-up actions on complaints and suggestions by the community are useful for improving immunization coverage.
• Develop practical procedures for preventing stockouts and determine their impact on vaccine coverage.
• Conduct studies aimed at identifying private providers who can deliver quality immunization services.
• Test the effectiveness of involving NGOs as part of the supervisory chain.
B134 N.K. Arora et al. / Vaccine 31S (2013) B129–B136

Table 5
Illustrative list of research needs for program management.

Type of intervention Research needs

Community/client
interventions
Provider interventions
System interventions
• Investigate the use of micro-plans (e.g., those used for polio/measles campaigns) to systematically map the clients who are missed
for routine immunization and to target them for provision of outreach services.
• Investigate the use of administrative development data for identifying poor and backward communities that need targeted
immunization programs.
• Differentiate cases due to vaccine failure versus failure to vaccinate.
• Determine if clients’ rate of use of immunization programs changes if immunization is linked to other programs, such as social
welfare schemes or civil registration.
• Determine the value of incentives such as vouchers, conditional cash transfers, or school enrollment.
• Determine the impact of low-cost, mobile phone-based job aids on the performance of health workers in poor-performing regions.
• Evaluate monitoring systems for determining the impact of supervision on performance.
• Investigate how to integrate immunization services with other primary care health interventions as a measure to strengthen the
overall health systems.
• Determine the technical and policy barriers to introducing new vaccines and strategies to overcome these.
• Determine the impact of involvement of civil society organizations to improve accountability, service delivery, and coverage.
• Determine what features can be added to medical information systems that will encourage local action by program managers.

R&D sub-group. The research questions listed in the tables below
are illustrative of some of the topics identified as warranting high
priority for action.
Immunization closer to community: Experiences in resource-
constrained communities have shown that access to and utilization
of vaccines depends on the proximity of the community to the
point of delivery of the immunization services. A key strategy for
improving vaccine coverage and reaching populations that are tra-
ditionally excluded from immunization and other primary health
care services is to involve lay health workers, community volun-
teers, and/or non-health sector workers in through targeted home
visits and outreach clinics [57,58]. Recent successes in the polio
eradication initiative are a testimony to this approach. There is a
need to develop and test tools and innovative strategies to iden-
tify children who have missed vaccination and to track dropouts
in different cultural and social contexts. Some of the available evi-
dence in this regard needs evaluation and analysis of the feasibility
of scale up in wider contexts.
Modern information and communication technology has pen-
etrated deeply into even the remotest parts of most developing
countries. Recently, for example, immunization program managers
have introduced an e-tracking system in some parts of India to
improve coverage of maternal and child health services. Table 2
provides a suggested list of research needs for bringing immuniza-
tion closer to the communities.
Demand for vaccination: Various strategies to increase the
demand for vaccination with or without changing the quantum
and type of service delivery may be required in different settings.
The Communicate to Vaccinate project, funded by the Research
Council of Norway [59], focuses on effective communication to
improve childhood vaccination uptake, address partial immuniza-
tion, strengthen routine immunization services, and increase the
use of new and underused vaccines in low- and middle-income
countries. Authors have suggested a range of interventions for use
in vaccine programs. These may operate at individual, community,
or social levels and target people in their roles as parents and com-
munity members. In the context of childhood immunization policy
and programs, communication strategies may encompass a variety
of interventions such as: (1) public information campaigns [60];
(2) education strategies that are suited to local cultures [61] and/or
accessible to those with low health literacy [62]; (3) reminder
systems for addressing missed vaccinations [63]; (4) provision of
information for parents on how to assess and manage side effects
[64]; and (5) involvement of community members in planning and
evaluating programs [65].
National programs have recruited community members, civil
society organizations, local self-government institutions/local bod-
ies, and institutions from other development sectors to help with
increasing demand for immunization services in various contexts.
Individual, family, and community behavior modulation is required
to influence demand; hence the importance of social science meth-
ods in the design of such studies [66]. There is a huge potential for
exploring and leveraging the use of mobile cell phones for shap-
ing the demand for vaccines. Research in strategic communication
and social mobilization to reach different population segments and
age groups is also required to increase community confidence in
vaccines, understand the concerns of parents and health workers
about vaccination, and counter misinformation created by anti-
vaccine groups. Table 3 provides a proposed list of research needs
for increasing community demand for vaccination.
Services at fixed sites: Provision of high-quality, responsive ser-
vices at health facilities can positively influence client behavior
and increase coverage. Primary health care centers in several low-
and middle-income countries do not consider client convenience
while providing services. Similarly, fixed health facilities often do
not offer their clients respect or dignity during service delivery or

Table 6
Illustrative list of research needs for policy and governance.

Type of intervention Research needs

Community/client • Investigate the role of civil society in improving immunization coverage.

interventions
Provider interventions
System interventions
• Determine how media awareness for benefits and risks of immunization can reduce vaccine hesitancy and increase vaccine
acceptance.
• Assess the impact of bipartisan political support, including line-item funding for immunization on national programs.
• Track national and donor funding for vaccine procurement and coverage.
• Determine the impact of provision of adequate and appropriate program staff on immunization programs.
• Determine the impact of introducing performance accountability at different levels of the delivery systems.
• Determine the impact of National Immunization Technical Advisory Groups on development of rational policies and introduction of
new vaccines.
• Determine the impact of legislation or regulations on vaccine quality and safety through national regulatory authorities.
• Determine the value of planning and executing vaccination campaigns that are aligned with other health interventions.
• Determine how medical information systems can be used effectively for local action.
• Investigate the role of completed vaccination as a prerequisite to school enrollment.
 N.K. Arora et al. / Vaccine 31S (2013) B129–B136
provide basic necessities, such as water and well-maintained toi-
lets. Multi-site studies need to determine how interventions can be
introduced that will improve services and impact vaccine coverage.
Most of the issues around improvement of services are concerned
with operational aspects of the system rather than with struc-
tural problems. Table 4 provides proposed list of research needs
for improving services in fixed sites.
Program management: Innovative management practices can
improve the quality of service and increase coverage despite lim-
itations and weaknesses of the overall health system. Routinely
collected data can be used to inform staff of their performance
and shared with the local community to obtain their feedback
for improving immunization services. Experimenting with differ-
ent strategies, including peer education and learning by doing, to
improving skills of health personnel could be useful in different
settings. This may include instituting structured mentoring by the
staff of better-performing health facilities in the area or the region.
Developing systems and using technologies that decrease the work
load of health personnel and improve supervisory methods can
not only strengthen immunization programs but also enhance the
overall health system. One of the important reasons for hesitancy
in introducing new vaccines into a national program is the con-
cern that this will overburden an already weak health system and
reduce coverage with existing antigens. Interactions between the
challenges of new vaccine introduction and the overall health sys-
tem are inadequately studied and need to be documented in real
program settings. Table 5 provides proposed research needs for
improving program management.
Policy and governance: Relevant and timely policy interventions
can lead to successful immunization programs with high cover-
age even in areas with weak and fragmented systems. Some of the
critical issues to address while translating policies into implemen-
tation are the extent and time horizon of scaling up interventions,
the absorptive capacity of the system, and planning and imple-
mentation approaches. Policy interventions also need systematic
documentation and analysis of the effectiveness of policy decisions
that are responsive to demand-side factors and private-sector real-
ities. Similarly, there is a need to generate evidence about how
transparency, performance, and a framework of resource account-
ability can facilitate access and coverage objectives.
During the last two decades, international donor agencies and
vaccine financing mechanisms have played an important role
in expanding the availability of new antigens in countries and
communities where it would not otherwise have been possible
to deliver them. How such financing innovations and interna-
tional support influence national health systems and the overall
sustainability of immunization programs are issues that need
context-specific inquiry. Table 6 provides proposed list of research
needs for improving policies and governance.
5. Conclusions
The ultimate aim of the DoVC implementation research agenda
is to create a body of knowledge generated by multiple, well-funded
Centers of Excellence in developing countries, improve immu-
nization services, and support the introduction of desirable new
vaccines. This, in turn, will result in expedited control, elimination,
and eradication of infectious diseases. Implementation research
benefits when researchers work jointly with policymakers and pro-
gram personnel. This collaboration allows all parties to prioritize
appropriate questions and adopt and use the research outcomes
to improve immunization services. The research questions iden-
tified through the DoVC consultation and a literature search could
serve as a useful guide to support a generation of new evidence that
informs the expanded reach of underutilized and desirable new
B135
vaccines. The WHO Strategic Advisory Group of Experts (SAGE) for
immunization will also monitor the progress of GVAP including the
R&D indicators.
Conflict of interest
A.A.L. served as the technical director of the DoVC and as the
coordinating guest editor of the DoVC Vaccine supplement. He and
other guest editors recused themselves from serving as editors for
this paper. N.K.A. and A.A.L. received funding support from the
DoVC to attend a DoVC R&D workshop in Sitges, Spain. Z.A.B. served
as a member of the DoVC steering committee. J.M.H., J.I.S., S.O.S. and
B.G. have declared no conflict of interest.
Acknowledgments
The authors acknowledge the contributions of the participants
of the short-term R&D sub-working group that met in Sitges,
Spain, on September 29–30, 2011. We thank Prof. David Salisbury,
Co-chair DoVC R&D Working Group, for his insights and inputs
throughout the DoVC consultations. We also thank Dr. Laura Moya
Alonso for coordinating the work of the DoVC R&D Working Group,
Dr. Maria Teresa Aguado de Ros for assistance in developing the
agenda for R&D consultation and Dr. Geeta Chhibber for assistance
in conducting a literature search for this manuscript.
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