Micro array patch (MAP) for the delivery of thermostable vaccines in Australia: A cost/benefit analysis

BackgroundIt is anticipated that transforming the vaccine supply chain from syringe-and-needle to thermostable vaccines enabled by Micro Array Patch (MAP) will result in reduced supply chain costs as well as reduced wastes (environmental impact) and improved safety. This paper provides a thorough cost comparison of the conventional syringe-and-needle vaccine supply chain versus the MAP vaccine supply chain for influenza vaccine delivery in Australia.ObjectiveTo determine the potential cost implications and general benefits of replacing syringe-and-needle flu vaccine with MAP-enabled thermostable flu vaccine in Australia.MethodsWe first provide a snapshot of the existing flu vaccine supply chain in Australia including its limitations and opportunities for improvement. Data/information is collected through interviewing the key stakeholders across vaccine supply chain including vaccine manufacturers, logistics providers, clinics, hospitals, and pharmacies. A cost/benefit analysis of the anticipated supply chain of the MAP-enabled vaccine will reveal the opportunities and challenges of supply chain transformation for flu vaccine delivery in Australia.FindingsOur high-level practice-informed cost/benefit analysis identifies cold chain removal as an important source of cost saving, but administrative cost savings appear to be even more significant (e.g., time saving for nurses and those involved in cold chain management). Our analysis also identifies the key benefits and limitations of vaccine supply chain transformation in Australia.ConclusionWe conclude that the benefits of moving from syringe-and-needle vaccines to thermostable MAP-delivered vaccines are beyond transportation and storage cost saving. Potential benefits through cost saving, waste reduction, and service level improvement are discussed along with various safety and wellbeing consequences as well as directions for future research in this area.     

Economic impact of thermostable vaccines

BackgroundWhile our previous work has shown that replacing existing vaccines with thermostable vaccines can relieve bottlenecks in vaccine supply chains and thus increase vaccine availability, the question remains whether this benefit would outweigh the additional cost of thermostable formulations.MethodsUsing HERMES simulation models of the vaccine supply chains for the Republic of Benin, the state of Bihar (India), and Niger, we simulated replacing different existing vaccines with thermostable formulations and determined the resulting clinical and economic impact. Costs measured included the costs of vaccines, logistics, and disease outcomes averted.ResultsReplacing a particular vaccine with a thermostable version yielded cost savings in many cases even when charging a price premium (two or three times the current vaccine price). For example, replacing the current pentavalent vaccine with a thermostable version without increasing the vaccine price saved from $366 to $10,945 per 100 members of the vaccine’s target population. Doubling the vaccine price still resulted in cost savings that ranged from $300 to $10,706, and tripling the vaccine price resulted in cost savings from $234 to $10,468. As another example, a thermostable rotavirus vaccine (RV) at its current (year) price saved between $131 and $1065. Doubling and tripling the thermostable rotavirus price resulted in cost savings ranging from $102 to $936 and $73 to $808, respectively. Switching to thermostable formulations was highly cost-effective or cost-effective in most scenarios explored.ConclusionMedical cost and productivity savings could outweigh even significant price premiums charged for thermostable formulations of vaccines, providing support for their use.     

The impact of implementing a demand forecasting system into a low-income country's supply chain

ObjectiveTo evaluate the potential impact and value of applications (e.g. adjusting ordering levels, storage capacity, transportation capacity, distribution frequency) of data from demand forecasting systems implemented in a lower-income country's vaccine supply chain with different levels of population change to urban areas.Materials and MethodsUsing our software, HERMES, we generated a detailed discrete event simulation model of Niger's entire vaccine supply chain, including every refrigerator, freezer, transport, personnel, vaccine, cost, and location. We represented the introduction of a demand forecasting system to adjust vaccine ordering that could be implemented with increasing delivery frequencies and/or additions of cold chain equipment (storage and/or transportation) across the supply chain during varying degrees of population movement.ResultsImplementing demand forecasting system with increased storage and transport frequency increased the number of successfully administered vaccine doses and lowered the logistics cost per dose up to 34%. Implementing demand forecasting system without storage/transport increases actually decreased vaccine availability in certain circumstances.DiscussionThe potential maximum gains of a demand forecasting system may only be realized if the system is implemented to both augment the supply chain cold storage and transportation. Implementation may have some impact but, in certain circumstances, may hurt delivery. Therefore, implementation of demand forecasting systems with additional storage and transport may be the better approach. Significant decreases in the logistics cost per dose with more administered vaccines support investment in these forecasting systems.ConclusionDemand forecasting systems have the potential to greatly improve vaccine demand fulfilment, and decrease logistics cost/dose when implemented with storage and transportation increases. Simulation modeling can demonstrate the potential health and economic benefits of supply chain improvements.     

The impact of making vaccines thermostable in Niger's vaccine supply chain

Objective

Determine the effects on the vaccine cold chain of making different types of World Health Organization (WHO) Expanded Program on Immunizations (EPI) vaccines thermostable.

Methods

Utilizing a detailed computational, discrete-event simulation model of the Niger vaccine supply chain, we simulated the impact of making different combinations of the six current EPI vaccines thermostable.

Findings

Making any EPI vaccine thermostable relieved existing supply chain bottlenecks (especially at the lowest levels), increased vaccine availability of all EPI vaccines, and decreased cold storage and transport capacity utilization. By far, the most substantial impact came from making the pentavalent vaccine thermostable, increasing its own vaccine availability from 87% to 97% and the vaccine availabilities of all other remaining non-thermostable EPI vaccines to over 93%. By contrast, making each of the other vaccines thermostable had considerably less effect on the remaining vaccines, failing to increase the vaccine availabilities of other vaccines to more than 89%. Making tetanus toxoid vaccine along with the pentavalent thermostable further increased the vaccine availability of all EPI vaccines by at least 1–2%.

Conclusion

Our study shows the potential benefits of making any of Niger's EPI vaccines thermostable and therefore supports further development of thermostable vaccines. Eliminating the need for refrigerators and freezers should not necessarily be the only benefit and goal of vaccine thermostability. Rather, making even a single vaccine (or some subset of the vaccines) thermostable could free up significant cold storage space for other vaccines, and thereby help alleviate supply chain bottlenecks that occur throughout the world.     

One size does not fit all: The impact of primary vaccine container size on vaccine distribution and delivery

BackgroundWhile the size and type of a vaccine container (i.e., primary container) can have many implications on the safety and convenience of a vaccination session, another important but potentially overlooked consideration is how the design of the primary container may affect the distribution of the vaccine, its resulting cost, and whether the vial is ultimately opened.MethodsUsing our HERMES software platform, we developed a simulation model of the World Health Organization Expanded Program on Immunization supply chain for the Republic of Benin and used the model to explore the effects of different primary containers for various vaccine antigens.ResultsReplacing vaccines with presentations containing fewer doses per vial reduced vaccine availability (proportion of people arriving for vaccines who are successfully immunized) by as much as 13% (from 73% at baseline) and raised logistics costs by up to $0.06 per dose administered (from $0.25 at baseline) due to increased bottlenecks, while reducing total costs by as much as $0.15 per dose administered (from $2.52 at baseline) due to lower open vial wastage. Primary containers with a greater number of doses per vial each improved vaccine availability by 19% and reduced logistics costs by $0.05 per dose administered, while reducing the total costs by up to $0.25 per dose administered. Changes in supply chain performance were more extreme in departments with greater constraints. Implementing a vial opening threshold reversed the direction of many of these effects.ConclusionsOur results show that one size may not fit all when choosing a primary vaccine container. Rather, the choice depends on characteristics of the vaccine, the vaccine supply chain, immunization session size, and goals of decision makers. In fact, the optimal vial size may vary among locations within a country. Simulation modeling can help identify tailored approaches to improve availability and efficiency.     

Re-designing the Mozambique vaccine supply chain to improve access to vaccines

IntroductionPopulations and routine childhood vaccine regimens have changed substantially since supply chains were designed in the 1980s, and introducing new vaccines during the “Decade of Vaccine” may exacerbate existing bottlenecks, further inhibiting the flow of all vaccines.MethodsWorking with the Mozambique Ministry of Health, our team implemented a new process that integrated HERMES computational simulation modeling and on-the-ground implementers to evaluate and improve the Mozambique vaccine supply chain using a system-re-design that integrated new supply chain structures, information technology, equipment, personnel, and policies.ResultsThe alternative system design raised vaccine availability (from 66% to 93% in Gaza; from 76% to 84% in Cabo Delgado) and reduced the logistics cost per dose administered (from $0.53 to $0.32 in Gaza; from $0.38 to $0.24 in Cabo Delgado) as compared to the multi-tiered system under the current EPI. The alternative system also produced higher availability at lower costs after new vaccine introductions. Since reviewing scenarios modeling deliveries every two months in the north of Gaza, the provincial directorate has decided to pilot this approach diverging from decades of policies dictating monthly deliveries.DiscussionRe-design improved not only supply chain efficacy but also efficiency, important since resources to deliver vaccines are limited. The Mozambique experience and process can serve as a model for other countries during the Decade of Vaccines. For the Decade of Vaccines, getting vaccines at affordable prices to the market is not enough. Vaccines must reach the population to be successful.     

Can thermostable vaccines help address cold-chain challenges? Results from stakeholder interviews in six low- and middle-income countries

IntroductionThis study captures the perspectives of stakeholders at multiple levels of the vaccine supply chain regarding their assessment of challenges with storing vaccines within recommended temperature ranges and their perceptions on the benefits of having vaccines with improved stability, including the potential short-term storage and transport of vaccines in a controlled-temperature chain.MethodsSemi-structured interviews were undertaken with 158 immunization stakeholders in six countries. Interviewees included national decision-makers and advisors involved in vaccine purchasing decisions, national Expanded Programme on Immunization managers, and health and logistics personnel at national, subnational, and health facility levels.ResultsChallenges with both heat and freeze-exposure of vaccines were recognized in all countries, with heat-exposure being a greater concern. Conditions leading to freeze-exposure including ice build-up due to poor refrigerator performance and improper icepack conditioning were reported by 53% and 28% of participants, respectively. Respondents were interested in vaccine products with improved heat/freeze-stability characteristics. The majority of those involved in vaccine purchasing indicated they would be willing to pay a US$0.05 premium per dose for a freeze-stable pentavalent vaccine (68%) or a heat-stable rotavirus vaccine (59%), although most (53%) preferred not to pay the premium for a heat-stable pentavalent vaccine if the increased stability required changing from a liquid to a lyophilized product. Most respondents (73%) were also interested in vaccines labeled for short-term use in a controlled-temperature chain. The majority (115/158) recognized the flexibility this would provide during outreach or should cold-chain breaks occur. Respondents were also aware that possible confusion might arise and additional training would be required if handling conditions were changed for some, but not all vaccines.ConclusionParticipating immunization stakeholders recognized the benefits of vaccine products with improved stability characteristics and of labeling vaccines for controlled-temperature chain use as a means to help address cold-chain issues in their immunization programs.     

An impact assessment of the use of aerial logistics to improve access to vaccines in the Western-North Region of Ghana

BackgroundPrevention of infectious diseases among children is crucial to improve child health and survival. However, many countries in Sub-Saharan Africa struggle to achieve vaccination targets due to supply chain challenges, which lead to vaccine shortages, stockouts, and increased costs. We evaluated the effects of aerial logistics (centralized storage and delivery by drones) on vaccine stock, stockouts, vaccination coverage and vaccine preventable outcomes in the Western North Region of Ghana.MethodsThe study combined retrospective quasi-experimental and cross-sectional designs to evaluate supply chain, programmatic, and clinical outcomes. Surveys to health providers were used to collect information from a random sample of 156 facilities, and secondary data on vaccination coverage and clinical outcomes was analyzed at the district level for the years 2017–2021.ResultsFacilities served by aerial logistics reported significant reductions in the duration of vaccine stockouts (30 %, p-value < 0.05), as well as in the frequency of missed opportunities for vaccination (44 %, p-value < 0.05). Being served by aerial logistics was associated with increased satisfaction with access to vaccines. Significant differences in vaccination coverage were found for most vaccines, in a range between 13.1 and 37.5 percentage points in vaccination coverage for served districts. Infectious diarrhea cases in children between 5 and 9 years old were reduced by 41.6 % (p-value < 0.05).ConclusionEnd-to-end aerial logistics appears as an effective tool to improve the performance of the supply chain for vaccines. The strategy potentially increases the resilience of the health system and contributes to increased vaccination coverage and higher levels of satisfaction among providers in the Western North Region of Ghana.     

Costing analysis and anthropological assessment of the vaccine supply chain system redesign in the Comé District (Benin)

ObjectiveAt the end of 2013, a pilot experiment was carried out in Comé health zone (HZ) in an attempt to optimize the vaccine supply chain. Four commune vaccine storage facilities were replaced by one central HZ facility. This study evaluated the incremental financial needs for the establishment of the new system; compared the economic cost of the supply chain in the Comé HZ before and after the system redesign; and analyzed the changes induced by the pilot project in immunization logistics management.MethodThe purposive sampling method was used to draw a sample from 37 health facilities in the zone for costing evaluation. Data on inputs and prices were collected retrospectively for 2013 and 2014. The analysis used an ingredient-based approach. In addition, 44 semi-structured interviews with health workers for anthropological analysis were completed in 2014.ResultsThe incremental financial costs amounted to US$55,148, including US$50,605 for upfront capital investment and US$4543 for ongoing recurrent costs. Annual economic cost per dose administered (including all vaccines distributed through the Expanded Program on Immunization (EPI)) in the Comé HZ increased from US$0.09 before system redesign to US$0.15 after implementation, mainly due to a high initial investment and the operational cost of HZ mobile warehouse. Interviews with health workers suggested that the redesigned system was associated with improvements in motivation and professional awareness due to training, supportive supervision, and improved work conditions.ConclusionsThe system redesign involved a considerable investment at HZ level. Benefits were found in the reduction of transportation costs to health posts (HP) and commune health center (CHC) levels, and the strengthening of health workers professional skills at all levels in Comé. The redesigned system contributed to a decrease in funding needs at HP and CHC levels. The benefits of the investment need to be examined after the introduction of new vaccines and after a longer period.     

Vaccine storage and distribution between expanded program on immunization and medical store department in Tanzania: a cost-minimization analysis

BackgroundIn 2016, the Tanzanian government shifted the vaccine supply chain responsibilities from the Medical Store Department (MSD) to the Expanded Program on Immunization (EPI) to reduce costs. However, cost estimates that informed the decision were based on invoice value of vaccines and related supplies, rather than a proper economic evaluation study. Therefore, this study aims to compare the actual storage and distribution costs of vaccines and related supplies between MSD to EPI.MethodMicro-costing approach was used to estimate resource use at MSD and EPI for the year 2018. Data were collected through a review of documents, warehouse databases, and interviews with key staff at MSD and EPI. We included both capital and recurrent costs. Microsoft Excel® was used for analysis with input data from the UNICEF forecasting tool, WHOs vaccine volume and capacity estimation tool, diesel generator calculator, and supply chain service fee estimator version 1.02.ResultsThe total vaccine storage and distribution costs were estimated to be USD 1,996,286 at MSD and USD 543,648 at EPI. Distribution and program management costs represented 41% (USD 819,288) and 38% (USD 762,968) of the total costs at MSD, while storage and distribution costs represented 43% (USD 234,423) and 34% (USD 184,620) of the total costs at EPI, respectively. The cost drivers at MSD were fuel and transport (21%), receiving and dispatch (19%) and, program management personnel cost (14%), while at EPI were storage space (20%), program management personnel cost (18%) and fuel and transport (15%).ConclusionThe storage and distribution of vaccines in Tanzania via the EPI reduced the vaccine supply chain cost to about 27% of the program costs at MSD.     

Redesigning immunization supply chains: Results from three country analyses

IntroductionImmunization supply chains (iSC) are essential for ensuring access to vaccines that prevent diseases. Guinea, Madagascar, and Niger initiated iSC system design efforts to conduct analysis of alternative supply chain scenarios to identify areas for improvement.MethodologyKey stakeholders from Ministries of Health and immunization programs identified bottlenecks in the current iSC and prioritized five general design scenarios to model in each country. Scenarios included aspects of integration, changing supply chain levels and delivery frequency, ignoring administrative boundaries, and direct delivery. Primary and secondary data were collected and cleaned. Analysis was completed using Supply Chain Guru (Madagascar and Niger) and AnyLogistix (Guinea) modeling software to build a virtual representation of the iSC physical components and operating policies.ResultsModeling results were compared using both quantitative and qualitative criteria (total operating costs, cost per dose, cold chain capacity, risk of mishandling, logistics burden on healthcare workers, feasibility to implement, and equity). Using a Stop Light Analysis for user-friendly understanding of positive, negative or minimal impact on scenarios, cost savings were realized in most scenarios in Madagascar (except using autonomous aerial vehicles); proposed scenarios in Guinea increased costs or had minimal impact; in Niger, eliminating regional tiers reduced costs. Facility level cold chain was sufficient in all countries. Effect on qualitative indicators largely depended on the scenario and country context.DiscussionSimilarities in scenarios selected were seen across the three countries. Results suggest that efficiencies can be found through changes to the iSC design, but the benefits of each scenario must be considered in the country context. Results of the analysis do not provide “the right answer” but rather options and guidance which then must be grounded in the country context and used as evidence for decision making to ensure reliable availability of vaccines.     

The potential effects of introducing microneedle patch vaccines into routine vaccine supply chains

Background

Microneedle patch (MNP) technology is designed to simplify the process of vaccine administration; however, depending on its characteristics, MNP technology may provide additional benefits beyond the point-of-use, particularly for vaccine supply chains.

Dual-chamber injection device for measles-rubella vaccine: The potential impact of introducing varying sizes of the devices in 3 countries

IntroductionBy pairing diluent with vaccines, dual-chamber vaccine injection devices simplify the process of reconstituting vaccines before administration and thus decrease associated open vial wastage and adverse events. However, since these devices are larger than current vaccine vials for lyophilized vaccines, manufacturers need guidance as to how the size of these devices may affect vaccine distribution and delivery.MethodsUsing HERMES-generated immunization supply chain models of Benin, Bihar (India), and Mozambique, we replace the routine 10-dose measles-rubella (MR) lyophilized vaccine with single-dose MR dual-chamber injection devices, ranging the volume-per-dose (5.2–26 cm³) and price-per-dose ($0.70, $1.40).ResultsAt a volume-per-dose of 5.2 cm³, a dual-chamber injection device results in similar vaccine availability, decreased open vial wastage (OVW), and similar total cost per dose administered as compared to baseline in moderately constrained supply chains. Between volumes of 7.5 cm³ and 26 cm³, these devices lead to a reduction in vaccine availability between 1% and 14% due to increases in cold chain storage utilization between 1% and 7% and increases in average peak transport utilization between 2% and 44%. At the highest volume-per-dose, 26 cm³, vaccine availability decreases between 9% and 14%. The total costs per dose administered varied between each scenario, as decreases in vaccine procurement costs were coupled with decreases in doses administered. However, introduction of a dual-chamber injection device only resulted in improved total cost per dose administered for Benin and Mozambique (at 5.2 cm³ and $0.70-per-dose) when the total number of doses administered changed <1% from baseline.ConclusionIn 3 different country supply chains, a single-dose MR dual-chamber injection device would need to be no larger than 5.2 cm³ to not significantly impair the flow of other vaccines.     

Should countries switch to using five- or ten-dose rotavirus vaccines now that they are available?

IntroductionSingle-dose rotavirus vaccines, which are used by a majority of countries, are some of the largest-sized vaccines in immunization programs, and have been shown to constrain supply chains and cause bottlenecks. Efforts have been made to reduce the size of the single-dose vaccines; however, with two-dose, five-dose and ten-dose options available, the question then is whether using multi-dose instead of single-dose rotavirus vaccines will improve vaccine availability.MethodsWe used HERMES-generated simulation models of the vaccine supply chains of the Republic of Benin, Mozambique, and Bihar, a state in India, to evaluate the operational and economic impact of implementing each of the nine different rotavirus vaccine presentations.ResultsAmong single-dose rotavirus vaccines, using Rotarix RV1 MMP (multi-monodose presentation) led to the highest rotavirus vaccine availability (49–80%) and total vaccine availability (56–79%), and decreased total costs per dose administered ($0.02-$0.10) compared to using any other single-dose rotavirus vaccine. Using two-dose ROTASIIL decreased rotavirus vaccine availability by 3–6% across each supply chain compared to Rotarix RV1 MMP, the smallest single-dose vaccine. Using a five-dose rotavirus vaccine improved rotavirus vaccine availability (52–92%) and total vaccine availability (60–85%) compared to single-dose and two-dose vaccines. Further, using the ten-dose vaccine led to the highest rotavirus vaccine availability compared to all other rotavirus vaccines in both Benin and Bihar.ConclusionOur results show that countries that implement five-dose or ten-dose rotavirus vaccines consistently reduce cold chain constraints and achieve higher rotavirus and total vaccine availability compared to using either single-dose or two-dose rotavirus vaccines.     

Maternity care provider acceptance of a future Group B Streptococcus vaccine – A qualitative study in three countries

IntroductionThere are vaccines in clinical trials that target the bacterium Group B Streptococcus (GBS). When approved, GBS vaccines will be intended for administration to pregnant women to prevent infection in their infants. The success of any vaccine will depend on its’ uptake in the population. Experience with prior maternal vaccines, e.g. influenza, Tdap and COVID-19 vaccines, teaches us that acceptance of vaccines, especially if novel, is challenging for pregnant women, and that provider recommendation is a key driver of vaccine uptake.MethodsThis study investigated attitudes of maternity care providers towards the introduction of a GBS vaccine in three countries (the United States (US), Ireland, and the Dominican Republic (DR)) with different GBS prevalence and prevention practices. Semi-structured interviews with maternity care providers were transcribed and coded for themes. The constant comparative method, and inductive theory building were used to develop conclusions.ResultsThirty-eight obstetricians, 18 general practitioners and 14 midwives participated. There was variability in provider attitudes towards a hypothetical GBS vaccine. Responses ranged from enthusiasm to doubts over the need for a vaccine. Attitudes were influenced by perceived additional benefits of a vaccine over current strategy and confidence in the safety of vaccines during pregnancy. Knowledge, experience and approaches to GBS prevention differed geographically and according to provider type, and influenced how participants assessed the risks and benefits of a GBS vaccine.ConclusionMaternity care providers are engaged in the topic of GBS management and there is opportunity to leverage attitudes and beliefs that will support a strong recommendation for a GBS vaccine. However, knowledge of GBS, and of the limitations of current prevention strategies vary among providers in different regions, and between different provider types. Targeted educational efforts with antenatal providers should focus on highlighting safety data the potential benefits of vaccination over current strategies.     

Active SMS-based influenza vaccine safety surveillance in Australian children

IntroductionAustralia’s novel, active surveillance system, AusVaxSafety, monitors the post-market safety of vaccines in near real time. We analysed cumulative surveillance data for children aged 6 months to 4 years who received seasonal influenza vaccine in 2015 and/or 2016 to determine: adverse event following immunisation (AEFI) rates by vaccine brand, age and concomitant vaccine administration.MethodsParent/carer reports of AEFI occurring within 3 days of their child receiving an influenza vaccine in sentinel immunisation clinics were solicited by Short Message Service (SMS) and/or email-based survey. Retrospective data from 2 years were combined to examine specific AEFI rates, particularly fever and medical attendance as a proxy for serious adverse events (SAE), with and without concomitant vaccine administration. As trivalent influenza vaccines (TIV) were funded in Australia’s National Immunisation Program (NIP) in 2015 and quadrivalent (QIV) in 2016, respectively, we compared their safety profiles.Results7402 children were included. Data were reported weekly through each vaccination season; no safety signals or excess of adverse events were detected. More children who received a concomitant vaccine had fever (7.5% versus 2.8%; p < .001). Meningococcal B vaccine was associated with the highest increase in AEFI rates among children receiving a specified concomitant vaccine: 30.3% reported an AEFI compared with 7.3% who received an influenza vaccine alone (p < .001). Reported fever was strongly associated with medical attendance (OR: 42.6; 95% Confidence Interval (CI): 25.6–71.0). TIV and QIV safety profiles included low and expected AEFI rates (fever: 4.3% for TIV compared with 3.2% for QIV (p = .015); injection site reaction: 1.9% for TIV compared with 3.0% for QIV (p < .001)). There was no difference in safety profile between brands.DiscussionActive participant-reported data provided timely vaccine brand-specific safety information. Our surveillance system has particular utility in monitoring the safety of influenza vaccines, given that they may vary in composition annually.     

A review of recommendations for rotavirus vaccination in Europe: Arguments for change

BackgroundMore than 10 years after the authorisation of two rotavirus vaccines of demonstrated efficacy and with a strongly positive benefit-risk profile, uptake in Europe remains low. Only 13 countries in Europe provide a fully-funded rotavirus universal mass vaccination (UMV) programme, three provide a partially-funded programme, and one provides full funding for a reduced programme targeting at-risk infants. Around 40% of countries in Europe currently have no existing recommendations for rotavirus vaccine use in children from the national government.MethodsWe provide an overview of the status of rotavirus vaccine recommendations across Europe and the factors impeding uptake. We consider the evidence for the benefits and risks of vaccination, and argue that cost-effectiveness and cost-saving benefits justify greater access to rotavirus vaccines for infants living in Europe.ResultsLack of awareness of the direct and indirect burden caused by rotavirus disease, potential cost-saving from rotavirus vaccination including considerable benefits to children, families and society, and government/insurer cost constraints all contribute to complacency at different levels of health policy in individual countries.ConclusionsMore than 10 years after their introduction, available data confirm the benefits and acceptable safety profile of infant rotavirus UMV programmes. Europe serves to gain considerably from rotavirus UMV in terms of reductions in healthcare resource utilization and related costs in both vaccinated subjects and their unvaccinated siblings through herd protection.     

From program suspension to the pandemic: A qualitative examination of Australia’s vaccine pharmacovigilance system over 10 years

BackgroundIn 2010, the Australian seasonal influenza vaccination program for children under 5 years of age was suspended due to an unexpected increase in fever and febrile convulsions causally associated with one particular influenza vaccine brand. A subsequent national review made seven recommendations to improve vaccine pharmacovigilance. Ten years on, in advance of implementing the COVID-19 immunisation program, we evaluated views on the capacity of Australia’s vaccine pharmacovigilance system to promptly detect, examine and communicate a signal.MethodsSemi-structured interviews were conducted between July and October 2020 with individuals with expertise in vaccine safety in Australia using an interview guide informed by key Australian and international frameworks. Interviews were digitally recorded and transcribed verbatim. Thematic analysis was used to code data using a deductive approach.ResultsInterviews with seventeen participants enabled six themes to be identified. Participants described improvement and significant innovation within Australia’s vaccine pharmacovigilance system over the decade since 2010, particularly through establishment of a new active, cohort event monitoring system using short message service surveys. Participants thought Australia had a good foundation for COVID-19 vaccine safety surveillance; implementation of the COVID-19 immunisation program was seen as a potential driver for ongoing enhancement through: a) improved integration of the active surveillance and spontaneous reporting systems, and; b) development of population-level active surveillance, including through data linkage. Transparent communication was considered essential to address the unprecedented challenges of COVID-19 and broader vaccine safety concerns.ConclusionsVaccine safety experts in Australia convey confidence in the innovative pharmacovigilance systems implemented over the past 10 years. While Australia has a multifaceted system incorporating both active surveillance and spontaneous reporting systems, COVID-19 vaccine implementation represents an opportunity to enhance current systems and to develop new, systematic approaches to vaccine pharmacovigilance that should make both a local and global contribution.     

Preliminary results from direct-to-facility vaccine deliveries in Kano,Nigeria

ObjectiveAs part of its vaccine supply chain redesign efforts, Kano state now pushes vaccines directly from 6 state stores to primary health centers equipped with solar refrigerators. Our objective is to describe preliminary results from the first 20 months of Kano’s direct vaccine delivery operations.MethodsThis is a retrospective review of Kano’s direct vaccine delivery program. We analyzed trends in health facility vaccine stock levels, and examined the relationship between stock-out rates and each of cascade vaccine deliveries and timeliness of deliveries. Analysis of vaccination trends was based on administrative data from 27 sentinel health facilities. Costs for both the in-sourced and out-sourced approaches were estimated using a bottoms-up model-based approach.ResultsOverall stock adequacy increased from 54% in the first delivery cycle to 68% by cycle 33. Conversely, stock-out rates decreased from 41% to 10% over the same period. Similar trends were observed in the out-sourced and in-sourced programs. Stock-out rates rose incrementally with increasing number of cascade facilities, and delays in vaccine deliveries correlated strongly with stock-out rates. Recognizing that stock availability is one of many factors contributing to vaccinations, we nonetheless compared pre- and post- direct deliveries vaccinations in sentinel facilities, and found statistically significant upward trends for 4 out of 6 antigens. 1 antigen (measles) showed an upward trend that was not statistically significant. Hepatitis b vaccinations declined during the period. Overall, there appeared to be a one-year lag between commencement of direct deliveries and the increase in number of vaccinations. Weighted average cost per delivery is US$29.8 and cost per child immunized is US$0.7 per year.ConclusionDirect vaccine delivery to health facilities in Kano, through a streamlined architecture, has resulted in decreased stock-outs and improved stock adequacy. Concurrent operation of insourced and outsourced programs has enabled Kano build in-house logistics capabilities.     

An assessment of parents’ childhood immunization beliefs,intentions, and behaviors using a smartphone panel

IntroductionIt is important to quickly identify parent beliefs, intentions, and behaviors toward childhood vaccination, especially parents of children 19 to 35 months. This paper describes parental immunization beliefs, intentions, and behaviors; assesses the relationships between beliefs and intentions regarding child immunization and actual behaviors; and assesses whether beliefs, intentions, and/or behaviors varied across demographic subgroups.MethodsA sample of parents, ages 18 and older, from a mobile panel with people residing in the U.S. were invited to answer immunization behavior, intention, and belief questions using a smartphone app that was not vaccine specific. 10,000 panel members with a child under 18 were sent invitations. 1029 surveys were completed by a respondent with a child 19 to 35 months. The survey instrument replicated many NIS questions and had similar sequencing.FindingsRespondents reported that most children received all recommended vaccines, except flu vaccine, suggesting some may not understand the immunization schedule. Demographics closely associated with immunization behaviors were respondents’ education and household income. There is strong agreement that vaccines are effective, important to community health, and the child’s health. There is concern about the number of shots received, disease prevention, and ingredient safety. Some belief remains about vaccines causing learning disabilities. Positive beliefs about the benefits of childhood vaccines and concomitant risks vary with demographics.ConclusionsThis survey provided insights into beliefs and behaviors of parents regarding childhood vaccination. It found evidence of differences in beliefs, particularly related to delaying or declining recommended childhood vaccinations. The survey was conducted in a few days and at lower cost than traditional methods. This serves as a model for health agencies where rapid results or inexpensive approaches are needed.