Facilitating the development of urgently required combination vaccines.

The essence of a vaccine lies in its ability to elicit a set of immune responses specifically directed at a particular pathogen. Accordingly, vaccines were historically designed, developed, registered, recommended, procured, and administered as monopathogen formulations. Nonetheless, the control and elimination of an astonishing number of diseases was realised only after several once-separate vaccines were provided as combinations. Unfortunately, the current superabundance of recommended and pipeline vaccines is now at odds with the number of acceptable vaccine administrations and feasible health-care visits for vaccine recipients and health-care providers. Yet, few new combinations are in development because, in addition to the scientific and manufacturing hurdles intrinsic to coformulation, developers face a gauntlet of regulatory, policy, and commercialisation obstacles in a milieu still largely designed for monopathogen vaccines. We argue here that national policy makers and public health agencies should prospectively identify and advocate for the development of new multipathogen combination vaccines, and suggest ways to accelerate the regulatory pathways to licensure of combinations and other concrete, innovative steps to mitigate current obstacles.

Lassa fever vaccine use cases and demand: Perspectives from select West African experts.

Lassa fever (LF) is a zoonotic viral hemorrhagic disease endemic to several West African countries. Approximately 300-500,000 cases occur annually across all ages with 10-20% case fatality rates. A LF vaccine is a recognized public health priority, with several candidates entering clinical trials. However, the perspectives of regional experts regarding critical vaccine properties, ideal delivery methods, and priority target populations remain unclear. Using a mixed methods approach with a standardized questionnaire, we individually interviewed 8 West African stakeholders, each with extensive knowledge and experience of LF. They strongly favored the use of a mass, proactive campaign strategy to immunize a wide age range of people in high-risk areas, including pregnant women and health care workers. We estimated that these and other plausible delivery scenarios could result in an initial demand of anywhere from 1 to 100 million doses, with most demand coming from Nigeria. These findings may help inform LF vaccine development and deployment efforts.

Monitoring of adverse drug reactions during seasonal malaria chemoprevention campaigns in children aged 3­59 months in Burkina Faso / Surveillance des effets indésirables lors des campagnes de la chimioprévention du paludisme saisonnier chez les enfants de 3-59 mois au Burkina Faso

Introduction: Seasonal malaria chemoprevention (SMC) by mass administration of sulfadoxine pyrimethamine + amodiaquine (SPAQ) reduces the burden of malaria in children aged 3­59 months. The occurrence of adverse drug reaction (ADR) may affect the success of this intervention. There are few studies of SMC adverse event surveillance in sub-Saharan Africa, particularly in Burkina Faso, a highly endemic country. Our main objective was to characterize the ADRs reported during SMC campaigns in Burkina Faso. Secondly, we evaluated the performance of the pharmacovigilance integrated into the SMC program in order to support safe administration of SMC. Method: This was a retrospective descriptive study of SMC individual case safety reports recorded in VigiBase® in Burkina Faso from 2014 to 2021. We used the P-method for the analysis of preventable serious adverse drug reactions and WHO criteria for assessing the performance of pharmacovigilance integrated into the SMC program. Results: A total of 1,105 SMC individual case safety reports were registered in VigiBase® for 23,311,453 doses of SPAQ given between 2014 and 2021. No pharmacovigilance signal was detected. The number of serious cases was 101, of which 23 (22.8%) were preventable. In 38.1% of children, the occurrence of ADRs led to discontinuation of SMC treatment. Vomiting was the most frequently reported adverse drug reaction (48.0%). The proportion of children whose treatment was discontinued due to vomiting was 42.7%, while the proportion of treatment discontinuation for other ADRs was 32.8% (p = 0.01). The SMC program contributed at 46.2% to the national pharmacovigilance database. The reporting rate was 0.03 per 1,000 exposed children in 2021. The median completeness score of the ICSRs was 0.7 (IQR: 0.5­0.7), and the median time to register the ICSRs in VigiBase® was 204 (IQR: 143­333) days. Conclusions: Post-drug administration vomiting may interfere with the purpose of SMC. Measures to manage this adverse drug reaction should be taken to improve the success of the SMC program. Based on the information on reporting time and reporting rate, spontaneous reporting should be supported by active surveillance, including cohort event monitoring, in Burkina Faso.

Introduction: La chimioprévention du paludisme saisonnier (CPS) par l'administration en masse de la sulfadoxine-pyriméthamine + amodiaquine (SPAQ) permet de réduire le fardeau du paludisme chez les enfants de 3-59 mois. La survenue d'effets indésirables (EI) pourrait nuire au succès de cette intervention. Il existe peu d'études sur la surveillance des EI de la CPS en Afrique subsaharienne et plus particulièrement au Burkina Faso, pays de forte endémicité palustre. Notre objectif principal était de caractériser les effets indésirables notifiés au cours des campagnes CPS au Burkina Faso. Secondairement, nous avons évalué la performance de la pharmacovigilance intégrée au programme de CPS dans le but de soutenir la sécurité d'administration de la CPS. Méthodes: Nous avons réalisé une analyse rétrospective à visée descriptive des rapports d'effets indésirables de la CPS enregistrés dans VigiBase® entre le 1er janvier 2014 et le 31 décembre 2021. Nous avons utilisé la P-method pour l'analyse de l'évitabilité des effets indésirables graves et les critères de l'OMS pour évaluer la performance de la pharmacovigilance intégrée au programme de CPS. Résultats: Au total, 1 105 cas individuels de rapports de sécurité de la CPS ont été analysés dans VigiBase® pour 23 311 453 doses administrées. Aucun signal de pharmacovigilance n'a été détecté. Le nombre des cas graves était de 101, dont 23 (22,8 %) évitables. Chez 38,1 % des enfants, la survenue des EI a occasionné l'arrêt de l'administration du traitement de la CPS. Le vomissement était l'effet indésirable le plus fréquemment rapporté (48,0 %). La proportion d'enfants dont le traitement a été arrêté pour motif de vomissement était de 42,7 %, tandis que la proportion d'arrêts de traitement pour les autres EI était de 32,8 % (p=0,01). La pharmacovigilance de la CPS a contribué à 46,2 % à l'alimentation de la base de données nationale de pharmacovigilance. Le taux de notification était de 0,03 pour 1 000 enfants exposés en 2021. Le score d'exhaustivité médian des rapports était de 0,7 (P25-P75 : 0,5-0,7) et le délai médian d'enregistrement des rapports dans VigiBase® était de 204 (P25-P75 : 143-333) jours. Conclusions: Les vomissements peuvent nuire à l'objectif de la CPS. Des mesures de gestion de cet effet indésirable doivent être prises pour améliorer le succès de la CPS. Au regard des informations sur le délai de notification et le taux de notification, la notification spontanée devrait être soutenue par une surveillance active, notamment une « cohort event monitoring ¼ au Burkina Faso.

Task-Shifting Immunization Activities to Community Health Workers: A Mixed-Method Cross-Sectional Study in Sahel Region, Burkina Faso.

INTRODUCTION: Faced with the frequent disruptions to the health care system and provision of immunization services caused by terrorist attacks that began in 2015, the Sahel region in Burkina Faso initiated resilience strategies, including the task-shifting of immunization activities to community health workers (CHWs). This strategy was designed to involve more CHWs in the vaccination delivery process and ultimately to improve the performance of the health care system. STRATEGY DEVELOPMENT AND IMPLEMENTATION: The task-shifting strategy began as a pilot in Djibo health district in 2019 and then extended to all 4 districts of the Sahel region. CHWs included both personnel recruited through the Ministry of Health and Public Hygiene processes at the national level and other community members who support the operation of health facilities. They were trained on standardized immunization modules and provided with vaccines by functional health facilities teams. Implementation initiated with the administration of oral antigens by CHWs. Subsequently, their service delivery was expanded to include injectable vaccines in the context of the worsening terrorist attacks and the urgent need to protect the health of local populations affected by the security and humanitarian crisis. STRATEGY EVALUATION: The intervention was evaluated through an internal programmatic review conducted as a descriptive cross-sectional study implemented from August 1 to October 28, 2022, in the Sahel region, including a survey in Dori health district. CHWs involved in implementing the strategy were considered for interviews. Performance indicators for all antigens have shown an upward trend since the strategy's inception in 2019. CONCLUSION: The task-shifting of immunization activities to CHWs has been implemented successfully in a region seriously affected by terrorism-related insecurity. It holds the promise of maintaining or even improving performance if institutionalized and scaled up while improving the monitoring of adverse events following immunization by the CHWs.

Exploring Shigella vaccine priorities and preferences: Results from a mixed-methods study in low- and middle-income settings.

Background: Shigella is the leading bacterial cause of diarrheal mortality in children and can cause long-term effects on growth and development. No licensed Shigella vaccines currently exist but several promising candidates are in development and could be available in the next five years. Despite Shigella being a well-known public health target of the World Health Organization for decades, given current burden estimates and competing preventable disease priorities in low-income settings, whether the availability of an effective Shigella vaccine will lead to its prioritization and widespread introduction among countries at highest risk is unknown. Methods: We conducted a mixed-methods study of national stakeholders and healthcare providers in five countries in Asia and Africa and regional stakeholders in the Pan American Health Organization to identify preferences and priorities for forthcoming Shigella vaccines. Results: In our study of 89 individuals, diarrhea was the most frequently mentioned serious health concern for children under five years. Antimicrobial resistance (AMR) was more often considered very concerning than diarrhea or stunting. Shigella awareness was high but not considered a serious health concern by most stakeholders. Most participants were willing to consider adding a new vaccine to the routine immunization schedule but expressed reservations about a Shigella vaccine because of lower perceived burden relative to other preventable diseases and an already crowded schedule; interest was highest among national stakeholders in countries receiving more financial support for immunization. The priority of a Shigella vaccine rose when participants considered vaccine impacts on reducing stunting and AMR. Participants strongly preferred oral and combination vaccines compared to injectable and a single-antigen presentations, citing greater perceived community acceptability. Conclusions: This study provides a critical opportunity to hear directly from country and regional stakeholders about health priorities and preferences around new vaccines. These findings should inform ongoing Shigella vaccine development efforts and eventual vaccine introduction and implementation planning.

Surveillance des effets indésirables lors des campagnes de la chimioprévention du paludisme saisonnier chez les enfants de 3-59 mois au Burkina Faso.

INTRODUCTION: Seasonal malaria chemoprevention (SMC) by mass administration of sulfadoxine pyrimethamine + amodiaquine (SPAQ) reduces the burden of malaria in children aged 3-59 months. The occurrence of adverse drug reaction (ADR) may affect the success of this intervention. There are few studies of SMC adverse event surveillance in sub-Saharan Africa, particularly in Burkina Faso, a highly endemic country. Our main objective was to characterize the ADRs reported during SMC campaigns in Burkina Faso. Secondly, we evaluated the performance of the pharmacovigilance integrated into the SMC program in order to support safe administration of SMC. METHOD: This was a retrospective descriptive study of SMC individual case safety reports recorded in VigiBase® in Burkina Faso from 2014 to 2021. We used the P-method for the analysis of preventable serious adverse drug reactions and WHO criteria for assessing the performance of pharmacovigilance integrated into the SMC program. RESULTS: A total of 1,105 SMC individual case safety reports were registered in VigiBase® for 23,311,453 doses of SPAQ given between 2014 and 2021. No pharmacovigilance signal was detected. The number of serious cases was 101, of which 23 (22.8%) were preventable. In 38.1% of children, the occurrence of ADRs led to discontinuation of SMC treatment. Vomiting was the most frequently reported adverse drug reaction (48.0%). The proportion of children whose treatment was discontinued due to vomiting was 42.7%, while the proportion of treatment discontinuation for other ADRs was 32.8% (p = 0.01). The SMC program contributed at 46.2% to the national pharmacovigilance database. The reporting rate was 0.03 per 1,000 exposed children in 2021. The median completeness score of the ICSRs was 0.7 (IQR: 0.5-0.7), and the median time to register the ICSRs in VigiBase® was 204 (IQR: 143-333) days. CONCLUSIONS: Post-drug administration vomiting may interfere with the purpose of SMC. Measures to manage this adverse drug reaction should be taken to improve the success of the SMC program. Based on the information on reporting time and reporting rate, spontaneous reporting should be supported by active surveillance, including cohort event monitoring, in Burkina Faso.

Effects of the free healthcare policy on health services' usage by children under 5 years in Burkina Faso: a controlled interrupted time-series analysis.

OBJECTIVES: This study aimed to analyse, at national level, the effects of the free healthcare policy for children on the use of health services by children under five in Burkina Faso. We hypothesised that this policy has led to an immediate and sustained increase in the use of health services for these children in the country. SETTING: We conducted a controlled interrupted time series. Monthly data at district level, spanning from January 2013 to December 2018 and corresponding to 72 monthly data points (39 before and 33 after), were extracted from the Burkina Faso National Health Information System. The analysed dataset included data from all the 70 health districts of the country. PARTICIPANTS: The study consisted of aggregated data from children under five as the target for the policy with children aged between 5 and 14 years old as control group. INTERVENTION: The intervention was the introduction of the free healthcare policy for women and children under 5 years from April 2016. OUTCOME: The primary outcome was the monthly mean rate of health services visits by children. RESULTS: Among the children under five, the rate of visits increased of 57% (incidence rate ratio (IRR)=1.57; 95% CI 1.2 to 2.0) in the month immediately following the launching of the free healthcare policy. An increase in the rate of health facility visits of 1% (IRR=1.01; 95% CI 1.0 to 1.1) per month was also noted during postintervention. Compared with the control group, we observed an increase in the rate of visits of 2.5% (IRR=1.025; 95% CI 1.023 to 1.026) per month. CONCLUSION: Findings suggest that the free healthcare policy increased the use of health facilities for care in Burkina Faso immediately after the implementation of the policy with a small increase in the rate overtime. Strategies to maintain the policy effect over time are necessary.

Pneumococcal Carriage in Burkina Faso After 13-Valent Pneumococcal Conjugate Vaccine Introduction: Results From 2 Cross-sectional Population-Based Surveys.

BACKGROUND: Burkina Faso, a country in Africa's meningitis belt, introduced 13-valent pneumococcal conjugate vaccine (PCV13) in October 2013, with 3 primary doses given at 8, 12 and 16 weeks of age. To assess whether the new PCV13 program controlled pneumococcal carriage, we evaluated overall and serotype-specific colonization among children and adults during the first 3 years after introduction. METHODS: We conducted 2 population-based, cross-sectional, age-stratified surveys in 2015 and 2017 in the city of Bobo-Dioulasso. We used standardized questionnaires to collect sociodemographic, epidemiologic, and vaccination data. Consenting eligible participants provided nasopharyngeal (all ages) and oropharyngeal (≥5 years only) swab specimens. Swab specimens were plated onto blood agar either directly (2015) or after broth enrichment (2017). Pneumococci were serotyped by conventional multiplex polymerase chain reaction. We assessed vaccine effect by comparing the proportion of vaccine-type (VT) carriage among colonized individuals from a published baseline survey (2008) with each post-PCV survey. RESULTS: We recruited 992 (2015) and 1005 (2017) participants. Among children aged <5 years, 42.8% (2015) and 74.0% (2017) received ≥2 PCV13 doses. Among pneumococcal carriers aged <1 year, VT carriage declined from 55.8% in 2008 to 36.9% in 2017 (difference, 18.9%; 95% confidence interval, 1.9%-35.9%; P = .03); among carriers aged 1-4 years, VT carriage declined from 55.3% to 31.8% (difference, 23.5%; 6.8%-40.2%; P = .004); and among participants aged ≥5 years, no significant change was observed. CONCLUSION: Within 3 years of PCV13 implementation in Burkina Faso, we documented substantial reductions in the percentage of pneumococcal carriers with a VT among children aged <5 years, but not among persons aged ≥5 years. More time, a change in the PCV13 schedule, or both, may be needed to better control pneumococcal carriage in this setting.

Missed opportunities for vaccination among children aged 0-23 months visiting health facilities in a southwest State of Nigeria, December 2019.

BACKGROUND: Despite efforts to improve childhood immunization coverage in Nigeria, coverage has remained below the national acceptable level. In December 2019, we conducted an assessment of Missed Opportunities for Vaccination (MOV) in Ondo State, in Southwest Nigeria. The objectives were to determine the magnitude of, explore the reasons for, as well as possible solutions for reducing MOV in the State. METHODS: This was a cross-sectional study using a mixed-methods approach. We purposively selected 66 health facilities in three local government authorities, with a non-probabilistic sampling of caregivers of children 0-23 months for exit interviews, and health workers for knowledge, attitudes, and practices (KAP) surveys. Data collection was complemented with focus group discussions and in-depth interviews with caregivers and health workers. The proportion of MOV among children with documented vaccination histories were determined and thematic analysis of the qualitative data was carried out. RESULTS: 984 caregivers with children aged 0-23 months were interviewed, of which 869 were eligible for inclusion in our analysis. The prevalence of MOV was 32.8%. MOV occurred among 90.8% of children during non-vaccination visits, and 7.3% during vaccination visits. Vaccine doses recommended later in the immunization series were given in a less timely manner. Among 41.0% of health workers, they reported their vaccination knowledge was insufficient. Additionally, 57.5% were concerned about and feared adverse events following immunization. Caregivers were found to have a low awareness about vaccination, and issues related to the organization of the health system were found to contribute towards MOV. CONCLUSIONS: One in three children experienced a MOV during a health service encounter. Potential interventions to reduce MOV include training of health workers about immunization policies and practices, improving caregivers' engagement and screening of vaccination documentation by health workers during every health service encounter.

Impact of Introducing Hepatitis B Birth Dose Vaccines into the Infant Immunization Program in Burkina Faso: Study Protocol for a Stepped Wedge Cluster Randomized Trial (NéoVac Study).

To achieve global hepatitis elimination by 2030, it is critical to prevent the mother-to-child transmission (MTCT) of hepatitis B virus (HBV). Since 2009, the WHO has recommended administering hepatitis B vaccine to all neonates within 24 h of birth to prevent MTCT. However, many countries in sub-Saharan Africa only provide hepatitis B immunization at the age of 6, 10, and 14 weeks or 8, 12, and 16 weeks using a combined vaccine. To accelerate the introduction of the hepatitis B birth dose vaccine (HepB-BD) into sub-Saharan Africa, it is critical to establish to what extent the addition of HepB-BD can further reduce HBV transmission in areas where three-dose infant vaccination has been implemented. We therefore designed a study to evaluate the impact, acceptability, and cost-effectiveness of incorporating the HepB-BD into the routine immunization program in a real-life field condition in Burkina Faso, where the hepatitis B vaccination is currently scheduled at 8-12-16 weeks. Through a multidisciplinary approach combining epidemiology, anthropology, and health economics, the Neonatal Vaccination against Hepatitis B in Africa (NéoVac) study conducts a pragmatic stepped wedge cluster randomized controlled trial in rural areas of the Hauts-Bassins Region. The study was registered in ClinicalTrials.gov (identifier: NCT04029454). A health center is designated as a cluster, and the introduction of HepB-BD will be rolled out sequentially in 24 centers. Following an initial period in which no health center administers HepB-BD, one center will be randomly allocated to incorporate HepB-BD. Then, at a regular interval, another center will be randomized to cross from the control to the intervention period, until all 24 centers integrate HepB-BD. Pregnant women attending antenatal care will be systematically invited to participate. Infants born during the control period will follow the conventional immunization schedule (8-12-16 weeks), while those born in the interventional period will receive HepB-BD in addition to the routine vaccines (0-8-12-16 weeks). The primary outcome, the proportion of hepatitis B surface antigen (HBsAg) positivity in infants aged at 9 months, will be compared between children born before and after HepB-BD introduction. The study will generate data that may assist governments and stakeholders in sub-Saharan Africa to make evidence-based decisions about whether to add HepB-BD into the national immunization programs.

Pneumococcal vaccine implementation in the African meningitis belt countries: the emerging need for alternative strategies.

Introduction: Besides meningococcal disease, the African meningitis belt (AMB) region is also affected by pneumococcal disease. Most AMB countries have introduced pneumococcal conjugate vaccines (PCV) following a schedule of three primary doses without a booster or a catch-up campaign. PCV is expected to help control pneumococcal disease through both direct and indirect effects. Whether and how fast this will be achieved greatly depends on implementation strategies. Pre-PCV data from the AMB indicate high carriage rates of the pneumococcus, not only in infants but also in older children, and a risk of disease and death that spans lifetime. Post-PCV data highlight the protection of vaccinated children, but pneumococcal transmission remains important, resulting in a lack of indirect protection for unvaccinated persons.Areas covered: A non-systematic literature review focused on AMB countries. Relevant search terms were used in PubMed, and selected studies before and after PCV introduction were summarized narratively to appraise the suitability of current PCV programmatic strategies.Expert opinion: The current implementation strategy of PCV in the AMB appears suboptimal regarding the generation of indirect protection. We propose and discuss alternative programmatic strategies, including the implementation of broader age group mass campaigns, to accelerate disease control in this high transmission setting.

Assessment of missed opportunities for vaccination (MOV) in Burkina Faso using the World Health Organization's revised MOV strategy: Findings and strategic considerations to improve routine childhood immunization coverage.

BACKGROUND: Despite the remarkable achievements of the Expanded Programme on Immunization (EPI) in Burkina Faso, numerous challenges remain, including missed opportunities for vaccination (MOV) which occur when people visit a health facility with at least one vaccine due according to the national immunization schedule, are free of contraindications, and leave without receiving all due vaccine doses. In 2016, we used the revised World Health Organization's (WHO) MOV strategy to assess the extent of and reasons for MOV in Burkina Faso. METHODS: We purposively selected 27 primary health facilities (PHFs) from the eight health districts with the highest absolute numbers of children who missed the first dose of measles-rubella (MR1) in 2015. We conducted exit interviews with caregivers of children aged 0-23 months, and requested health workers to complete a self-administered knowledge, attitudes and practices (KAP) questionnaire. RESULTS: A total of 489 caregivers were interviewed, of which 411 were eligible for inclusion in our analysis. Medical consultation (35%) and vaccination (24.5%) were the most frequent reasons for visiting PHFs. Among the 73% of children eligible for vaccination, 76% of vaccination opportunities were missed. Among eligible children, the percentage with MOV was significantly higher in those aged ≥12 months and also in those attending for a reason other than vaccination. A total of 248 health workers completed the KAP questionnaire. Of these, 70% (n = 168/239) considered their knowledge on immunization to be insufficient or outdated; 83% failed to correctly identify valid contraindications to vaccination. CONCLUSION: Addressing MOV offers the potential for substantial increases in vaccine coverage and equity, and ultimately reducing the burden of vaccine-preventable diseases (VPDs). This will require the implementation of a series of interventions aimed at improving community knowledge and practices, raising health workers' awareness, and fostering the integration of immunization with other health services.

Impact of 13-valent pneumococcal conjugate vaccine on the incidence of hospitalizations for all-cause pneumonia among children aged less than 5 years in Burkina Faso: An interrupted time-series analysis.

BACKGROUND: Pneumococcal disease is a major public health concern globally and particularly in Burkina Faso, where the 13-valent pneumococcal conjugate vaccine (PCV13) was introduced nationwide into the routine immunization schedule in 2013. The aim of this study was to evaluate vaccine impact on all-cause pneumonia hospitalizations among children <5 years of age. METHODS: Hospitalization data covering a 10-year period (January 1, 2009-December 31, 2018) were collected retrospectively in four rural district hospitals, using medical records to extract data on relevant variables. Using an interrupted time-series design and segmented regression, the effectiveness and impact of PCV13 on the rates of pneumonia hospitalization were estimated. Severe acute malnutrition and unintentional injury were used as control conditions. RESULTS: Vaccine effectiveness was found to be 34% (95% confidence interval (CI) 16-49%, p=0.001), 24% (95% CI 2-41%, p=0.032), and 50% (95% CI 30-64%, p<0.001) against all-cause pneumonia among children <5 years, <2 years, and 2-4 years of age, respectively. By October 2018, PCV13 introduction had led to an absolute reduction in the pneumonia hospitalization rate of 348 cases per 100000 person-years among children <5 years of age. No decline was observed for the control conditions. CONCLUSIONS: These estimates point to a substantial public health impact of PCV13 against pneumonia hospitalization among children aged <5 years in Burkina Faso.

Quality and reliability of vaccination documentation in the routine childhood immunization program in Burkina Faso: Results from a cross-sectional survey.

INTRODUCTION: Accurate and timely vaccination data are important to the Expanded Program on Immunization (EPI) to assess individual vaccination status and to monitor performance and vaccine coverage (VC). Since 2013, Burkina Faso introduced several new vaccines into the routine childhood immunization schedule. However, sustained efforts for a timely update and alignment of immunization home-based (HBRs) and health facility-based records (FBRs) with the evolving schedule were not implemented. METHODS: In 2016-17, we conducted a 6-week cross-sectional survey in 30 health facilities (HFs) across 10 health districts (HDs), targeting children aged < 24 months and their caregivers. Data collected included sociodemographics, availability of vaccination recording fields in HBRs, and vaccination dates. We evaluated the characteristics, completion patterns, and concordance of HBRs and FBRs to determine their reliability as data sources in estimating VC. A standard HBR was defined as one that had recording fields for all recommended 17 vaccine doses of the schedule, and discordance between HBR and FBR as having different vaccination dates recorded, or vaccination information missing in one of the records. We computed proportions and concordance statistics, and used logistic regression to explore predictors of discordance. RESULTS: We recruited 619 children, including 74% (n = 458) aged 0-11 months. Half (50.6%) of HBRs were non-standard. About two-thirds (64.6%) of children were concerned with discordant information. Compared to HBRs, FBRs were generally associated with low negative predictive values (median: 0.41; IQR: 0.16-0.70). Multivariate logistic regression model showed that standard HBR was protectively associated with discordant information (OR = 0.46, 95% CI: 0.26-0.81, p = 0.010). CONCLUSION: We documented a lack of standardization of HBRs and frequent information discordance with FBRs. There is a pressing need to update and standardize vaccination recording tools and ensure their continuous availability in HFs to improve data quality in Burkina Faso.

Plaidoyer pour un renforcement du système de pharmacovigilance au Burkina Faso.

Large-scale deployment of new medicines has been observed over the last two decades in many Sub-Saharan Africa countries faced with major public health issues such as malaria and HIV/AIDS. However, some of these medicines may be responsible for varying degrees of toxicity, with adverse drug reactions leading to decreased compliance or even discontinuation of treatment. Pharmacovigilance systems therefore had to be set up in these countries, such as in Burkina Faso, West Africa, which initiated the organization of pharmacovigilance activities in 2008. Despite this progress, the systems in place have not yet achieved a sufficient level of performance to deal with drug-related health issues, highlighting the need for further actions. Pharmacovigilance in Burkina Faso can be strengthened at multiple levels: pre-service and in-service training of health workers; the establishment of active surveillance based on sentinel sites; informing the public and raising awareness; and strengthening national coordination.

Self-Report Measures in the Assessment of Antiretroviral Medication Adherence: Comparison with Medication Possession Ratio and HIV Viral Load.

BACKGROUND: Adherence is a major determinant of the effectiveness of antiretroviral therapy (ART). We determined the association between self-reported adherence (SRA) and medication possession ratio (MPR), a pharmacy-based adherence measure, and their respective associations with viral load. METHODS: Adherence to ART was assessed by MPR over 6 months and by self-report which included a question with a Likert-type scale response, a visual analogue scale (VAS), and an inquiry about the last time the patients skipped any prescribed medications. RESULTS: Taking MPR as the "gold standard," all 3 SRA measures displayed high specificity but low sensitivity. The prevalence ratio (95% confidence interval) for viral load ≥50 copies/mL was 2.19 (1.07-4.50) for MPR <90%, 1.98 (1.04-3.78) for poor/fair/good versus excellent/very good ability to take antiretroviral drugs, 1.47 (0.79-2.75) for skipping medications within the past 2 weeks, and 2.51 (1.39-4.53) for VAS <95%. CONCLUSION: These data suggest various SRA measures hold clinical value in screening for poor ART adherence.

Actions of the National Regulatory Authorities in 10 Low- and Middle-Income Countries Following Stringent Regulatory Authority Safety Alerts on Rosiglitazone.

On September 23, 2010, the US Food and Drug Administration and the European Medicines Agency issued safety alerts for medicines containing rosiglitazone. The authors monitored the actions of national regulatory authorities (NRAs) from 10 low- and middle-income countries to identify the time lag between the issuance of safety alerts by these two stringent regulatory authorities and any actions by these select NRAs. Two NRAs outside Africa took regulatory actions related to safety of rosiglitazone within 2 weeks of stringent regulatory authority safety alerts. For the 7 of the 8 African NRAs where the authors could confirm the date of regulatory action, the median time lag before some regulatory action was 43 days, although there was considerable variability in time to regulatory action. Low- and middle-income countries should create or strengthen systems for timely consideration and management of emerging safety issues for products that they have registered.

Pharmacovigilance systems in developing countries: an evaluative case study in Burkina Faso.

BACKGROUND: Burkina Faso, like other Sub-Saharan African countries, has recently experienced a large-scale deployment of new medicines for the prevention and treatment of notable diseases of public health interest, including malaria, HIV/AIDS and meningitis. This new context rendered the implementation of pharmacovigilance necessary in order to monitor and establish the safety and effectiveness of these medicines. In 2008, the Ministry of Health of Burkina Faso, West Africa, launched a formal pharmacovigilance system to respond to this need. OBJECTIVE: The aim of this study was to evaluate the early-stage pharmacovigilance system of Burkina Faso through a comprehensive and system-based approach with the prospect of identifying areas for improvements. METHODS: We conducted a descriptive cross-sectional study in Burkina Faso. Sixteen key informants from the National Drug Authority (NDA), public health programmes (PHPs) and hospitals were interviewed. Study participants were selected based on a convenience sampling in the NDA, three teaching hospitals, two regional hospitals and six PHPs. Data were collected using the Indicator-based Pharmacovigilance Assessment Tool (IPAT), a metric instrument recently designed and validated by 'Management Sciences for Health', a US non-profit organization. The evaluation also involved the collection and review of relevant pharmacovigilance-related documentation in the institutions assessed. A scoring system was used for the quantification of assessment results. RESULTS: The NDA of Burkina Faso, the institution statutorily in charge of pharmacovigilance, achieved a performance score of 70 %. The basic structures for pharmacovigilance activities were in place; however, the lack of specific laws dedicated to pharmacovigilance, the lack of national guidelines and standard operating procedures on pharmacovigilance, and the insufficient coordination of pharmacovigilance stakeholders in the country were identified as the main weaknesses. Safety data collected thus far have not led to the identification of local drug-related risks; yet, relevant external safety alerts are monitored and acted upon. In 2010, 31 marketing authorizations were modified to include new safety information; seven others were suspended and the corresponding medicines were withdrawn from the national market. In PHPs, pharmacovigilance activities were not formalized, and in hospitals, pharmacovigilance structures were still under development. CONCLUSION: Relevant interventions aimed at strengthening the legal framework and structures for pharmacovigilance activities, and improving the coordination of stakeholders countrywide, should be undertaken as soon as possible. Such an investment is necessary before the national pharmacovigilance system is able to collect its own data, generate signals, evaluate and manage local medicine-related risks and then become a genuine tool for public health.