A review of potential use cases for measles-rubella, measles-mumps-rubella, and typhoid-conjugate vaccines presented on microarray patches.

As an innovative vaccine delivery technology, vaccine microarray patches could have a meaningful impact on routine immunization coverage in low- and middle-income countries, and vaccine deployment during epidemics and pandemics. This review of the potential use cases for a subset of vaccine microarray patches in various stages of clinical development, including measles-rubella, measles-mumps-rubella, and typhoid conjugate, highlights the breadth of their applicability to support immunization service delivery and their potential scope of utilization within national immunization programs. Definition and assessment of the use cases for this novel vaccine presentation provide important insights for vaccine developers and policymakers into the strengths of the public health and commercial value propositions, and the preparatory requirements for public health systems for the future rollout of vaccine microarray patches. An in-depth understanding of use cases for vaccine microarray patches serves as a foundational input to overcoming the remaining technical, regulatory, and financial challenges. Additional efforts will help to realize the potential of vaccine microarray patches as part of the global effort to improve the coverage and equity of national immunization programs.

Accelerating the development of vaccine microarray patches for epidemic response and equitable immunization coverage requires investment in microarray patch manufacturing facilities.

INTRODUCTION: There is a need for investment in manufacturing for vaccine microarray patches (vMAPs) to accelerate vMAP development and access. vMAPs could transform vaccines deployment and reach to everyone, everywhere. AREAS COVERED: We outline vMAPs' potential benefits for epidemic preparedness and for outreach in low- and lower-middle-income countries (LMICs), share lessons learned from pandemic response, and highlight that investment in manufacturing-at-risk could accelerate vMAP development. EXPERT OPINION: Pilot manufacturing capabilities are needed to produce clinical trial material and enable emergency response. Funding vMAP manufacturing scale-up in parallel to clinical proof-of-concept studies could accelerate vMAP approval and availability. Incentives could mitigate the risks of establishing multi-vMAP manufacturing facilities early.

Vaccine innovation prioritisation strategy: Findings from three country-stakeholder consultations on vaccine product innovations.

As part of the Vaccine Innovation Prioritisation Strategy (VIPS), three immunization-stakeholder consultations were conducted between September 2018 and February 2020 to ensure that countries' needs drove the prioritization of vaccine product innovations. All consultations targeted respondents with immunization program experience. They included: (1) an online survey to identify immunization implementation barriers and desired vaccine attributes in three use settings, (2) an online survey to identify and evaluate the most important immunization challenges for ten exemplar vaccines, and (3) in-depth interviews to better understand the perceived programmatic benefits and challenges that could be addressed by nine innovations and to rank the innovations that could best address current challenges. The first consultation included responses from 442 participants in 61 countries, representing 89% of the 496 respondents who correctly completed at least one section of the online survey. For facility-based settings, missed opportunities for vaccination due to reluctance to open multidose vaccine vials was the barrier most frequently selected by respondents. In community-based (outreach) and campaign settings, limited access to immunization services due to geographic barriers was most frequently selected. Multidose presentations with preservative or single-dose presentations were most frequently selected as desired vaccine attributes for facility-based settings while improved thermostability was most frequently selected for outreach and campaign settings. The second online survey was completed by 220 respondents in 54 countries. For the exemplar vaccines, vaccine ineffectiveness or wastage due to heat or freeze exposure and missed opportunities due to multidose vial presentations were identified as the greatest vaccine-specific challenges. In-depth interviews with 84 respondents in six countries ranked microarray patches, dual-chamber delivery devices, and heat-stable/controlled temperature chain qualified liquid vaccines as the three innovations that could have the greatest impact in helping address current immunization program challenges. These findings informed the VIPS prioritization and provided broader application to designing immunization interventions to better meet country needs.

Opportunities to improve vaccination coverage in a country with a fledgling health system: Findings from an assessment of missed opportunities for vaccination among health center attendees-Timor Leste, 2016.

INTRODUCTION: Since its independence in 2002, Timor Leste has made significant strides in improving childhood vaccination coverage. However, coverage is still below national targets, and children continue to have missed opportunities for vaccination (MOV), when eligible children have contact with the health system but are not vaccinated. Timor Leste implemented the updated World Health Organization methodology for assessing MOV in 2016. METHODS: The MOV data collection included quantitative (caregiver exit interviews and health worker knowledge, attitudes, practices surveys (KAP)) and qualitative arms (focus group discussions (FGDs) with caregivers and health workers and in-depth interviews (IDIs) with health administrators). During a four-day period, health workers and caregivers with children <24 months of age attending the selected eight facilities in Dili Municipality were invited to participate. The researchers calculated the proportion of MOV and timeliness of vaccine doses among children with documented vaccination histories (i.e., from a home-based record or facility register) and thematically analyzed the qualitative data. RESULTS: Researchers conducted 365 caregiver exit interviews, 169 health worker KAP surveys, 4 FGDs with caregivers, 2 FGDs with health workers, and 2 IDIs with health administrators. Among eligible children with documented vaccination histories (n = 199), 41% missed an opportunity for vaccination. One-third of health workers (33%) believed their knowledge of immunization practices to be insufficient. Qualitative results showed vaccines were not available at all selected health facilities, and some facilities reported problems with their cold chain equipment. CONCLUSION: This study demonstrates that many children in Timor Leste miss opportunities for vaccination during health service encounters. Potential interventions to reduce MOV include training of health workers, improving availability of vaccines at more health facilities, and replacing unusable cold chain equipment. Timor Leste should continue to scale up successful MOV interventions beyond Dili Municipality to improve vaccination coverage nationally and strengthen the health system overall.

Private sector engagement and contributions to immunisation service delivery and coverage in Sudan.

For more than two decades, the private sector in the Sudan (henceforth, Sudan), including non-governmental organisations and for-profit providers, has played a key role in delivering immunisation services, especially in the conflict-affected Darfur region and the most populated Khartoum state. The agreements that the providers enter into with state governments necessitate that they are licenced; follow the national immunisation policy and reporting and supervision requirements; use the vaccines supplied by government; and offer vaccinations free-of-charge. These private providers are well integrated into the states' immunisation programmes as they take part in the Ministry of Health immunisation trainings and district review meetings and they are incorporated into annual district immunisation microplans. The purpose of this article is to describe the private sector contributions to equitable access to immunisation services and coverage, as well as key challenges, lessons learned and future considerations. Fifty-five per cent of private health facilities in Sudan (411 out of 752) provide immunisation services, with 75% (307 out of 411) based in Khartoum state and the Darfur region. In 2017, private providers administered around 16% of all third doses of pentavalent (diphtheria, pertussis, tetanus, hepatitis B and Haemophilus influenzae type b) vaccines to children. Private health providers of immunisation services have especially been critical in filling the gaps in government services in hard-to-reach or conflict-affected areas and among marginalised populations, and thus in reducing inequities in access. Through its experience in engaging the private sector, Sudan has learned the importance of regulating and licencing private facilities and incorporating them into the immunisation programme's decision-making, planning, regular evaluation and supervision system to ensure their compliance with immunisation guidelines and the overall quality of services. In moving forward, strategic engagement with the private sector will become more prominent as Sudan transitions out of donors' financial assistance with its projected income growth.

Breaking the inertia in coverage: Mainstreaming under-utilized immunization strategies in the Middle East and North Africa region.

Vaccination coverage rates have stagnated in the past several years in many middle-income countries (MICs), especially in the UNICEF Middle East and North Africa region, with political and economic turmoil as contributing factors. This paper reviews country experiences with three under-utilized strategies aimed at increasing vaccination coverage and reducing disparities between socio-economic and geographic groups in MICs. These strategies include: (1) identifying and accounting for displaced, mobile and neglected populations; (2) assessing and addressing missed opportunities for vaccination, including by expanding immunization into the second year of life and beyond; and (3) engaging effectively with the private/nongovernmental health providers in the coordination, provision and reporting of immunization services. The examples focus primarily on quality data collection, analysis, use and reporting aspects of the strategies. While data are limited, there is evidence from MICs that each of these strategies can have a positive impact on vaccination coverage, especially among marginalized populations.