Durability of the deltamethrin-treated polypropylene long-lasting net LifeNet® in a pyrethroid resistance area in south western Benin: A phase III trial.

BACKGROUND: Long-lasting insecticidal bed nets (LLINs) are a key measure for preventing malaria and their evaluation is coordinated by the World Health Organization Pesticide Evaluation Scheme (WHOPES). LifeNet® was granted WHOPES time-limited interim recommendation in 2011 after successful Phase I and Phase II evaluations. Here, we evaluated the durability and community acceptance of LifeNet® in a Phase III trial from June 2014 to June 2017 in Benin rural area. METHODS: A prospective longitudinal, cluster-randomized, controlled trial with households as the unit of observation was designed to assess the performance of LifeNet® over a three-year period, using a WHOPES fully recommended LLIN (PermaNet® 2.0) as a positive control. The primary outcomes were the bioassay performance using WHO cone assays and tunnel tests, the insecticide content and physical integrity. RESULTS: At baseline, 100% of LLINs were within the tolerance limits of their target deltamethrin concentrations. By 36 months only 17.3% of LifeNet® and 8.5% of PermaNet® LLINs still were within their target deltamethrin concentrations. Despite these low rates, 100% of both LLINs meet WHO efficacy criteria (≥ 80% mortality or ≥ 95% knockdown or tunnel test criteria of ≥ 80% mortality or ≥ 90% blood-feeding inhibition) after 36 months using WHO cone bio-assays and tunnel tests. The proportion of LLINs in good physical condition was 33% for LifeNet® and 29% for PermaNet® after 36 months. After 36 M the survivorship was 21% and 26% for LifeNet® and PermaNet® respectively. Although both LLINs were well accepted by the population, complaints of side effects were significantly higher among LifeNet® users than PermaNet® ones. CONCLUSION: LifeNet® LLINs did meet WHO criteria for bio-efficacy throughout the study period and were well accepted by the population. This is an important step towards getting a full WHO recommendation for use in malaria endemic countries.

The economic impact of the switch from single- to multi-dose PCV13 vial in Benin.

BACKGROUND: Little is known on the economic implications of multi-dose 13 valent pneumococcal conjugate vaccine (PCV13) introduction in expanded program on immunization (EPI). Based on evidence of PCV13's reduced pressure on vaccine cold chain, Benin, a third world country in West Africa, introduced the multi-dose PCV13 starting in April 2018 in its EPI program in replacement of the single-dose presentation. The objective of this study was to conduct a rapid assessment of the costs and economic impact of switching from single- to multi-dose PCV13 vial in Benin. METHODS: The data collected retrospectively between January 1 and February 16, 2019 using a quantitative questionnaire was analyzed using Excel 2010 and Stata 13. Resources consumed from April 1st to September 30th, 2017 for the single-dose PCV13 and from April 1st to September 30th, 2018 for multi-dose were analyzed. For both presentations, costs analyzed included vaccines, injections supplies, waste management, cold chain, personnel (salaries and per diems), supervision and monitoring, training, social mobilization and overheads. Moreover, additional costs incurred for the introduction of multi-dose PCV13 were also collected. Costs were estimated for each presentation of PCV13 vaccine by calculating the half-year value of recurrent and capital costs, discounted at a rate of 3% for capital items. To enable comparisons, costs pertaining to 2017 were converted to 2018 equivalent values taking inflation in US$ into account. RESULTS: The economic costs of the single-dose PCV13 exceeded that of the multi-dose: US$ 3,708,795 versus US$ 3,698,795, respectively. Three cost items, including costs of vaccines, injection supplies, and cold chain appeared to be the main drivers of the observed reduction in costs of multi-dose PCV13. Moreover, the cost per infant vaccinated was lower with the single-dose PCV13 than the multi-dose, respectively US$ 6.28 versus US$ 10.92, and costs of vaccines wasted higher for the multi-dose PCV13. CONCLUSIONS: This evaluation seemed to show that the switch from single- to multi-dose PCV13 resulted in reduced economic costs of PCV13. Vaccinating more infants together with a rigorous application of vaccine open vial policy could lead to the change being more cost-effective.

Decision making process, programmatic and logistic impact of the transition from a single-dose vial to a multi-dose vial of the 13-valent pneumococcal vaccine in Benin.

BACKGROUND: Benin, a country eligible for Gavi support, changed the presentation of the 13-valent pneumococcal vaccine (PCV13) from the single-dose vial (SDV) to the multi-dose vial (MDV). The present work aims to evaluate the process of making this decision as well as programmatic and logistic impacts. METHODS: WHO protocol for post-introduction evaluation (PIE) was used. Programmatic impact was evaluated by comparing PCV13 coverage and dropout rates with a comparator vaccine administered simultaneously over similar 6-month periods prior to and after the transition. This impact was also appreciated from observation of multi-dose vial management practices during immunization sessions. Logistic impact was measured from the analysis of storage capacities, waste management and vaccine losses. RESULTS: Decision to move to PCV13 MDV was taken at EPI level. Activities planned to support this switch were partially implemented. Impact on vaccination coverage and PCV13 dropout rates in relation with the transition to PCV13 MDV was not detected. The study found that 63% of the health staff surveyed knew and applied WHO's multidose vial policy (MDVP). Vaccines opened vials were found in 83% of health facilities visited. PCV13 MDV (37%) was one of the 3 main vaccines found with open vials in health facility refrigerators. Vaccination risky practices were observed during immunization sessions in 83% of health facilities. The main risky practice was the lack of indication of the date and hour of opening vials (56%). There was a reduction of the volume occupied by vaccines at central store by 47%. Net storage volume per fully immunized child (FIC) decreased from 69.5 to 41 m3. PCV13 MDV allows for 40% reduction in the amount of waste produced by vaccination. PCV13 open vial loss rate has increased from 3 to 7%. CONCLUSION: Benin's experience in transition to an MDV presentation of PCV13 reveals the need for better preparation and planning.

Introduction of multi-dose PCV 13 vaccine in Benin: from the decision to vaccinators experience.

BACKGROUND: In 2011, Benin introduced the 13-valent pneumococcal conjugated vaccine (PCV13), in a single-dose vial, into its Expanded Programme for Immunisation (EPI) with support from Gavi. In April 2018, with the support of the Agence de Médecine Préventive Afrique (AMP) and other technical and financial partners, the single-dose vial was transitioned to a four-dose vial. Here we describe the decision-making process and the experience of the vaccinators during the change. METHODS: We carried out semi-structured, individual interviews with 61 participants individuals involved in the EPI: 7 from central level, 5 from regional level, 7 from township level and 42 from district level. The interviews were recorded and transcribed, and the information categorised, using Nvivo software, and then analysed. RESULTS: The Inter-agency Coordination Committee (ICC), the Benin National Advisory Committee for Vaccines and Vaccination, (BNACVV) and the World Health Organisation (WHO) (i.e., the traditional governance structures involved in vaccination decisions) were not involved in the decision to change to the four-dose vial for PCV13. The decision was taken by the EPI, supported by Gavi. The vaccination errors observed in the first months following the change in presentation were due to the absence of guidelines for changes in vaccine presentation and the central-level actors' perception that it was 'only a change in the vial', and therefore that the communication and training for a new vaccine were not required since the vaccine itself and its administration mode were unchanged. CONCLUSIONS: It is important that the other countries eligible for Gavi support that are about to change to the multi-dose vial PCV13 presentation learn from Benin's experience. The main lessons learned are that changes in the presentation of an established vaccine should follow the same process as the introduction of a new vaccine, and that all stakeholders involved in vaccines and vaccination should participate in the decision-making process and implementation.

End-user acceptability study of the nanopatch™; a microarray patch (MAP) for child immunization in low and middle-income countries.

A promising new delivery technology, the microarray patch (MAPs) consists of an array of small solid-coated or dissolvable needles, up to one mm in length, that administers a dry formulation of a vaccine or pharmaceutical. This study is not a real-life evaluation study but determines the anticipated acceptability of the Nanopatch™, a solid microarray patch device, in Benin, Nepal and Vietnam for vaccine delivery, and identifies factors that could improve the acceptability of the technology to increase measles immunization coverage. This study combined several evaluation methods, including simulation of vaccine administration on children and in-depth interviews with key stakeholders, healthcare workers, community health volunteers, caretakers, and community representatives. A total of 314 people participated in the study. The overall rate of total acceptability of the patch for child immunization was 92.7%. General opinions were very positive, providing clinical studies confirm that MAP administration is demonstrated to be painless, safe and effective for infectious disease prevention. The study participants were asked to consider the best strategy to introduce such vaccine delivery innovation. Firstly, delivery by skilled healthcare workers at the healthcare facilities will be preferred to establish the technology. Following this, administration by selected volunteers and outreach delivery may be possible, though under the supervision of skilled healthcare workers. This study's protocol received approval from the World Health Organization (WHO) Ethical Research Committee (ERC0002813) and the national IRB in Benin, Nepal and Vietnam.

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

OBJECTIVE: At 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. METHOD: The 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. RESULTS: The 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. CONCLUSIONS: The 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.

Professional changes induced by a redesigned immunization supply chain in the Comé Health Zone, Benin.

At the end of 2013, the Government of Benin and Agence de Médecine Préventive (AMP) launched a demonstration project in Comé Health Zone (HZ) to optimize the vaccine supply chain. A key part of the demonstration project was the creation of an "informed push model" of vaccine distribution supported by a new logistician position at the health zone (district) level. At the conclusion of the demonstration project in 2015, the authors conducted an anthropological study consisting of semi-structured interviews with 62 participants to assess how the new model changed the professional identities, roles, responsibilities, and practices of personnel involved in vaccine management during and just after the demonstration project end in Comé HZ. The study found that health workers considered the logistician as a key player in enabling them to perform their public health mission, notably by improving knowledge and practices in vaccine management, providing supportive supervision, and improving the availability of vaccines and other supplies so that immunization sessions could occur more reliably and professionally within the communities they served. The demonstration project was widely accepted among study participants. The study was approved by the Cotonou Ethics Committee (CER-ISBA No. 56 dated 09/04/2015).