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For many individuals from developing countries, infection with Mycobacterium tuberculosis is almost inevitable. In recent years, there has been an increase in the number of immigrants and refugees from some of these countries, and thus the proportion of these individuals among newly diagnosed cases of tuberculosis has increased. The identification of these patients and the proper management of their cases are important public health priorities. Dr. Nancy Binkin and her colleagues review the data on the epidemiology of tuberculosis in immigrants and refugees and describe the available screening and evaluation programs overseas and in this country. They also highlight the importance of maintaining and expanding health care services in this country that are appropriate and welcoming to foreign-born persons. They clearly demonstrate that the control of tuberculosis in the United States will require a coordinated effort that transcends its borders. —Wafaa El-Sadr Division of Infectious Diseases, Harlem Hospital Center, New York, New York Chair, IDSA Tuberculosis Committee The number of reported cases of tuberculosis (TB) in foreign-born persons in the United States during 1995 was 8,042, 36% of the national total. The overseas screening of immigrants and refugee visa applicants, which relies on a chest radiograph and smear microscopy, is designed to identify future U.S. residents who have active TB or who are at high risk for TB. In this commentary, we summarize current policies and review retrospective evaluations of the screening system currently in place. The system appears to detect most persons who have active TB at the time of screening. However, active TB is actually diagnosed in <15% of persons who are identified by screening as having suspected TB and who are evaluated in the United States. To improve the system, more sensitive and specific techniques as well as improved means of data transmission to state and local health departments are needed. [ABSTRACT FROM PUBLISHER]

Background: India introduced rotavirus vaccines (RVV, monovalent, Rotavac™ and pentavalent, Rotasiil™) in April 2016 with 6, 10 and 14 weeks schedule and expanded countrywide in phases. We describe the epidemiology of intussusception among children aged 2-23 months in India.Methods: The prospective surveillance at 19 nationally representative sentinel hospitals from four regions recruited children with intussusception from April 2016 to September 2017. Data on sociodemography, immunization, clinical, treatment and outcome were collected. Along with descriptive analysis, key parameters between four regions were compared using Chi-Square/Fisher's exact/Mann-Whitney U/Kruskal-Wallis tests. The pre- and post-RVV periods were compared to estimate the risk ratios.Results: Six hundred twenty-one children with intussusception from South (n = 262), East (n = 190), North (n = 136) and West (n = 33) regions were recruited. Majority (n = 465, 74.8%) were infants (40.0% aged 4-7 months) with median age 8 months (IQR 5, 13 months), predominantly males (n = 408, 65.7%) and half (n = 311, 50.0%) occurred during March-June months. A shorter interval between weaning and intussusception was observed for ragi based food (median 1 month, IQR 0-4.2 months) compared to rice (median 4 months, IQR 1-9 months) and wheat (median 3 months, IQR 1-7 months) based food (p < 0.01). Abdominal pain or excessive crying (82.8%), vomiting (72.6%), and bloody stool (58.1%) were the leading symptoms. Classical triad (abdominal pain, vomiting and bloody stool) was observed in 34.8% cases (24.4 to 45.8% across regions). 95.3% of the cases were diagnosed by ultrasound. 49.3% (10.5 to 82.4% across regions) cases were managed by reduction, 39.5% (11.5 to 71.1% across regions) cases underwent surgery and 11.1% spontaneously resolved. Eleven (1.8%) cases died. 89.1% cases met Brighton criteria level 1 and 7.6% met Level 2. RVV was received by 12 cases within 1-21 days prior to intussusception. No increase in case load (RR = 0.44; 95% CI 0.22-1.18) or case ratio (RR = 0.5; 95% CI 0.3-1.2) was observed after RVV introduction in select sites.Conclusions: Intussusception cases were observed across all sites, although there were variations in cases, presentation and mode of management. The high case load age coincided with age of the RVV third dose. The association with ragi based weaning food in intussusception needs further evaluation. [ABSTRACT FROM AUTHOR]

In this article the authors discuss the World Health Organization's Global Vaccine Safety Initiative, which is designed to increase vaccine pharmacovigilance across the globe, particularly in low and middle income countries. They are supportive of the initiative and of other global efforts to increase the safety of vaccines and decrease adverse events linked to them.

Objective: Intussusception has been linked with rotavirus vaccine (RVV) as a rare adverse reaction. In view of limited background data on intussusception in India and in preparation for RVV introduction, a surveillance network was established to document the epidemiology of intussusception cases in Indian children., Methods: Intussusception in children 2-23 months were documented at 19 nationally representative sentinel hospitals through a retrospective surveillance for 69 months (July 2010 to March 2016). For each case clinical, hospital course, treatment and outcome data were collected., Results: Among the 1588 intussusception cases, 54.5% were from South India and 66.3% were boys. The median age was 8 months (IQR 6, 12) with 34.6% aged 2-6 months. Seasonal variation with higher cases were documented during March-June period. The most common symptoms and signs were vomiting (63.4%), bloody stool (49.1%), abdominal pain (46.9%) and excessive crying (42.8%). The classical triad (vomiting, abdominal pain, and blood in stools) was observed in 25.6% cases. 96.4% cases were diagnosed by ultrasound with ileocolic location as the commonest (85.3%). Management was done by reduction (50.8%) and surgery (41.1%) and only 1% of the patients' died. 91.1% cases met Brighton criteria level 1 and 3.3% Level 2. Between 2010 and 2015, the case load and case ratio increased across all regions., Conclusion: Intussusception cases have occurred in children across all parts of the country, with low case fatality in the settings studied. The progressive rise cases could indicate an increasing awareness and availability of diagnostic facilities., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

The Vaccine Safety Net's Web Analytics Project (VSN-WAP) was launched in October 2017 to monitor the behavior of users visiting websites belonging to the VSN, a global network of websites providing science-based information on vaccine safety. Participating websites could provide web metrics in two ways: through a Google Analytics (GA) script, which automatically forwarded metrics to a central account and through manual input (MI) of a reduced subset of metrics (Sessions, Page Views, New Users, Bounce Rate, Views/Session and Average Session Duration), which were pooled with the metrics obtained through GA. Additional metrics were obtained from websites providing data through Google Analytics (Country, Age, Sex, Device). We report results from February 2018 to March 2019. In March 2019, 32 websites were participating in the project (21 through GA, 11 through MI). From February 2018 to March 2019 we recorded 22,471,535 sessions, with 38,307,349 page views. Sessions, New Users and Page views progressively increased, Views/Session, Bounce Rate and Average Session Duration remained stable. Most users were female (68%) and belonged to the 25-34 age range (37%), followed by 35-44 (22%) and 18-24 (19%). Fifty-four percent of users connected from a mobile device, 42% from a desktop and 4% from a tablet. Digital media monitoring techniques can provide insights on the characteristics of users with a specific interest in vaccines. These data can be exploited to improve the performance of websites providing information on vaccines to the general public., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020. Published by Elsevier Ltd.)

The Council for the International Organizations of Medical Sciences (CIOMS) and WHO working group on pharmacovigilance defines five cause specific AEFI which includes an immunization anxiety-related reaction. Historically this term has been used to describe a range of symptoms and signs that may arise after immunization that are related to "anxiety" about the immunization. However, the term "anxiety" does not adequately capture all the elements of this cause specific AEFI. In 2015, the Global Advisory Committee for Vaccine Safety convened an expert working group with the purpose of redefining, preventing and managing this particular AEFI. The term "Immunization Stress-Related Response" is proposed to replace the former terminology. We present a manual that redefines this AEFI and present a framework for prevention, diagnosis and management in both an individual and also when such events occur as clusters and affect multiple individuals. Since such mass events can result in cessation of immunization programmes and/or a loss of public confidence, a communication response is essential., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Vaccines are everywhere hugely successful but are also under attack. The reason for the latter is the perception by some people that vaccines are unsafe. However that may be, vaccine safety, life any other scientific subject, must be constantly studied. It was from this point of view that a meeting was organized at the Wellcome Trust in London in May 2019 to assess some aspects of vaccine safety as subjects for scientific study. The objective of the meeting was to assess what is known beyond reasonable doubt and conversely what areas need additional studies. Although the meeting could not cover all aspects of vaccine safety science, many of the most important issues were addressed by a group of about 30 experts to determine what is already known and what additional studies are merited to assess the safety of the vaccines currently in use. The meeting began with reviews of the current situation in different parts of the world, followed by reviews of specific controversial areas, including the incidence of certain conditions after vaccination and the safety of certain vaccine components. Lastly, information about the human papillomavirus vaccine was considered because its safety has been particularly challenged by vaccine opponents. The following is a summary of the meeting findings. In addition to this summary, the meeting organizers will explore opportunities to perform studies that would enlarge knowledge of vaccine safety., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020.)

Improvements in vaccine safety surveillance and investigative capacity lead to identification of rare reactions attributable to vaccination. As a result, the issue of fair compensation for those who experience vaccine injuries is gaining growing attention. Although vaccine injury compensation programmes (VICP) have been developed in a few countries for more than 50 years, no global policy guidance to guide vaccine injury compensation in all countries wishing to adopt such compensation schemes is currently available. To update the landscape analysis of no-fault compensation programmes and characterize VICP implementing countries, we conducted a survey of all 194 Member States from the World Health Organization and received feedback from 151. This analysis describes the economic and vaccine safety surveillance characteristics of Member States implementing VICPs. This analysis describes the characteristics of 25 Member States implementing a compensation programmes. Characteristics examined include economic, vaccination and safety surveillance indicators. Twenty of the 25 Member States (80%) with compensation programmes are categorized as high-income countries, 20/25 (80%) met the Global Vaccine Action Plan (GVAP) safety indicator of reporting at least ten annual reports of adverse events following immunization per 100,000 population, 21/25 (84%) met the GVAP coverage indicator by achieving greater than 90% third dose of Diphtheria, Tetanus and Pertussis vaccine (DTP3) and 17/25 (68%) assessed vaccine hesitancy in 2017. All Member States with VICP have a national immunization technical advisory group. This study identified growing interest in the implementation of no-fault compensation programs beyond high-income countries. Global policies guiding compensation should be developed for countries regardless of the maturity of their immunization programmes. RESEARCH IN CONTEXT: As a result of improved vaccine safety surveillance, World Health Organization (WHO) Member States are facing situations where known untoward serious vaccine reactions are documented, including in low- and middle-income settings. This has led to increased interest for the development of national no-fault compensation policies for vaccine injuries. As of 2010, compensation schemes for vaccine related injuries had been identified and characterized in 19 out of 194 WHO member states. All these programmes were in the industrialized world with none in low- and middle-income countries. Previous reviews have described the characteristics of the existing programmes based on the six common elements identified by Evans in 1999 with less emphasis on characteristics from countries implementing these no-fault compensation programmes. This manuscript aimed to identify predictors of countries implementing no-fault compensation programmes for vaccine injuries and update the inventory of existing programmes as part of a more comprehensive global landscape evaluation of existing programmes. This information will be useful for country self-evaluation and future compensation policy formulation as discussion to develop policies guiding the implementation of vaccine injury compensation continues to gain growing attention., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Background: Global efforts to adequately monitor safety of new vaccines for pregnant women in low and middle-income countries (LMICs) are needed. The Global Alignment of Immunization Safety Assessment in pregnancy (GAIA) project recently published case definitions based on levels of diagnostic certainty for pregnancy- and neonatal outcomes and maternal vaccination. As a preliminary step to assessing the applicability of these definitions in LMICs, WHO selected sites and conducted a feasibility assessment to evaluate their ability to identify and classify selected outcomes (preterm birth, neonatal death, neonatal invasive bloodstream infection (NI-BSI), stillbirth) and maternal vaccination., Methods: Candidate sites were initially screened using a questionnaire. For each outcome, eligible sites were asked to retrospectively identify and collect information for three individuals born in 2016. Subsequently, outcomes were classified by level of diagnostic certainty., Results: Fifty-one sites (15 countries) were screened; 32 of them (9 countries) participated in the assessment and identified 315 subjects with the outcomes of interest. Twenty-four sites (8 countries) identified at least one subject per outcome and agreed to continue participating. The majority (80%) of preterm births, neonatal deaths, and NI-BSI subjects, but only 50% of stillbirths, could be assessed for diagnostic certainty. The main reasons for not classifying stillbirths were insufficient information to distinguish between antepartum and intrapartum stillbirth (29%); or that not all data for one subject fit into a single level of diagnostic certainty (35%). Forty-nine percent of mothers were considered vaccinated, 6% not-vaccinated, and vaccination status could not be assessed in 44% of them., Discussion: GAIA case definitions for four neonatal outcomes and maternal vaccination were successfully piloted in 24 sentinel sites across four WHO regions. Our assessment found that modification of the stillbirth definition could help avoid potential misclassification. Vaccine safety monitoring in LMICs will benefit from systematic recording of all vaccinations during pregnancy., (Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.)

India has recently introduced a rotavirus vaccine under a universal immunization program. There is limited information on intussusception, an adverse event, following immunization in children from India. We are conducting sentinel surveillance for intussusception in children aged under two years at 19 hospitals. The sentinel sites' selection followed a multistage process. The surveillance combines retrospective surveillance for 69 months and prospective surveillance for 18 months. The suspected intussusception cases shall be reviewed for capturing confirmed cases and detailed data collection and classification according to Brighton Collaboration criteria. Data shall be analysed to describe epidemiology, trends, regional and seasonal variations, clinical profiles, management modalities, and outcomes of intussusception. The combination of prospective and retrospective surveillance shall be informative about the trend of intussusception over the last seven years in India. At four sites where rotavirus vaccines have been introduced, the change in intussusception trends shall be documented. The potential association with rotavirus vaccines and other vaccines shall be assessed using case-control and self-controlled case series methodology. Results are forthcoming. The results shall support the national vaccine safety surveillance effort by providing baseline estimates of intussusception for continued monitoring. The surveillance protocol and site selection processes shall inform similar vaccine-safety surveillance in India and other developing countries., Competing Interests: The authors declare no conflict of interest. The findings and conclusions in this report are those of the authors and do not necessarily represent the official positions of the World Health Organization.

Reporting of adverse events following immunization (AEFI) is a key component for functional vaccine safety monitoring system. The aim of our study is to document trends in the AEFI reporting ratio globally and across the six World Health Organization (WHO) regions. We describe the number of AEFI reports communicated each year through the World Health Organization/United Nations Children's Fund Joint Reporting Form on Immunization from 2000 to 2015. The AEFI reporting ratios (annual AEFI reports per 100,000 surviving infants) were calculated to identify WHO countries (n = 191 in 2000 and n = 194 by 2015) that met a minimal reporting ratio of 10, a target set by the Global Vaccine Action Plan for vaccine safety monitoring as a proxy measure for a functional AEFI reporting system. The number of countries reporting any AEFI fluctuated over time but with progress from 32 (17%) in 2000 to 124 (64%) in 2015. In 2015, the global average AEFI reporting ratio was 549 AEFI reports per 100,000 surviving infants. The number of countries with AEFI reporting ratios greater than 10 increased from 8 (4%) in 2000 to 81 (42%) in 2015. In 2015, 60% of countries in the WHO Region of the Americas reported at least 10 AEFI per 100,000 surviving infants, followed by 55% in European Region, 43% in Eastern Mediterranean Region, 33% in Western Pacific Region, 27% in South-East Asia Region and 21% in African Region. Overall, AEFI reporting has increased over the past sixteen years worldwide, but requires strengthening in a majority of low- and middle- income countries. The AEFI reporting ratio is useful for benchmarking and following trends over time; but does not provide information on the quality of the reporting system and does not guarantee capacity to detect and manage a vaccine safety problem at a national level. Additional efforts are required to ensure and improve data quality, AEFI reporting and surveillance of immunization safety in every country., (Copyright © 2018 World Health Organization. Published by Elsevier Ltd.. All rights reserved.)

New vaccines designed to prevent diseases endemic in low and middle-income countries (LMICs) are now being introduced without prior record of utilization in countries with robust pharmacovigilance systems. To address this deficit, our objective was to demonstrate feasibility of an international hospital-based network for the assessment of potential epidemiological associations between serious and rare adverse events and vaccines in any setting. This was done through a proof-of-concept evaluation of the risk of immune thrombocytopenic purpura (ITP) and aseptic meningitis (AM) following administration of the first dose of measles-mumps-containing vaccines using the self-controlled risk interval method in the primary analysis. The World Health Organization (WHO) selected 26 sentinel sites (49 hospitals) distributed in 16 countries of the six WHO regions. Incidence rate ratios (IRR) of 5.0 (95% CI: 2.5-9.7) for ITP following first dose of measles-containing vaccinations, and of 10.9 (95% CI: 4.2-27.8) for AM following mumps-containing vaccinations were found. The strain-specific analyses showed significantly elevated ITP risk for measles vaccines containing Schwarz (IRR: 20.7; 95% CI: 2.7-157.6), Edmonston-Zagreb (IRR: 11.1; 95% CI: 1.4-90.3), and Enders'Edmonston (IRR: 8.5; 95% CI: 1.9-38.1) strains. A significantly elevated AM risk for vaccines containing the Leningrad-Zagreb mumps strain (IRR: 10.8; 95% CI: 1.3-87.4) was also found. This proof-of-concept study has shown, for the first time, that an international hospital-based network for the investigation of rare vaccine adverse events, using common standardized procedures and with high participation of LMICs, is feasible, can produce reliable results, and has the potential to characterize differences in risk between vaccine strains. The completion of this network by adding large reference hospitals, particularly from tropical countries, and the systematic WHO-led implementation of this approach, should permit the rapid post-marketing evaluation of safety signals for serious and rare adverse events for new and existing vaccines in all settings, including LMICs., (Copyright © 2017 World Health Organization. Published by Elsevier Ltd.. All rights reserved.)

New vaccines designed to prevent diseases endemic in low and middle-income countries are being introduced without prior utilization in countries with robust vaccine pharmacovigilance systems. Our aim was to build capacity for active surveillance of vaccine adverse events in the Americas. We describe the implementation of a proof-of-concept study for the feasibility of an international collaborative hospital-based active surveillance system for vaccine safety. The study was developed and implemented in 15 sentinel sites located in seven countries of the region of the Americas, under the umbrella of the World Health Organization (WHO) Global Vaccine Safety Initiative. The study evaluated the associations between measles-mumps-rubella vaccines and two well-recognized adverse events: Immune thrombocytopenic purpura (ITP) and aseptic meningitis. The regional network contributed 63 confirmed ITP and 16 confirmed aseptic meningitis eligible cases to the global study, representing, respectively, 33% and 19% of the total cases. To ensure long-term sustainability and usefulness to investigate adverse events following new vaccine introductions in low and middle-income countries, the network needs to be strengthened with additional sites and integrated into national health systems., (Copyright © 2017 Pan American Health Organization. Published by Elsevier Ltd.. All rights reserved.)

Timely and effective evaluation of vaccine safety signals for newly developed vaccines introduced in low and middle- income countries (LMICs) is essential. The study tested the development of a global network of hospital-based sentinel sites for vaccine safety signal verification and hypothesis testing. Twenty-six sentinel sites in sixteen countries across all WHO regions participated, and 65% of the sites were from LMIC. We describe the process for the establishment and operationalization of such a network and the lessons learned in conducting a multi-country collaborative initiative. 24 out of the 26 sites successfully contributed data for the global analysis using standardised tools and procedures. Our study successfully confirmed the well-known risk estimates for the outcomes of interest. The main challenges faced by investigators were lack of adequate information in the medical records for case ascertainment and classification, and access to immunization data. The results suggest that sentinel hospitals intending to participate in vaccine safety studies strengthen their systems for discharge diagnosis coding, medical records and linkage to vaccination data. Our study confirms that a multi-country hospital-based network initiative for vaccine safety monitoring is feasible and demonstrates the validity and utility of large collaborative international studies to monitor the safety of new vaccines introduced in LMICs., (Copyright © 2017. Published by Elsevier Ltd.)

Vaccination during pregnancy is increasingly being used as an effective approach for protecting both young infants and their mothers from serious infections. Drawing conclusions from published studies in this area can be difficult because of the inability to compare vaccine trial results across different studies and settings due to the heterogeneity in the definitions of terms used to assess the safety of vaccines in pregnancy and the data collected in such studies. The guidelines proposed in this document have been developed to harmonize safety data collection in all phases of clinical trials of vaccines in pregnant women and apply to data from the mother, fetus and infant. Guidelines on the prioritization of the data to be collected is also provided to allow applicability in various geographic, cultural and resource settings, including high, middle and low-income countries., (Copyright © 2016. Published by Elsevier Ltd.)

In 1999, the Global Advisory Committee on Vaccine Safety (GACVS) was established by the World Health Organization (WHO) to provide independent scientific advice on issues relating to the safety of vaccines and immunization. Fifteen years onward, we conducted a multi-faceted review to evaluate the impact, reach and challenges facing GACVS, including the role GACVS plays in informing global, regional and WHO member state vaccine policy. The methods included measures of organizational structure, citation impact, themes approached, and a discussion by previous and current members to evaluate past, present and future challenges. Given the increasing range of data sources and the deployment of many new vaccines, the Committee is facing the complex task of identifying the best available evidence for recommendations on vaccine safety. To help meet the increased demand for public transparency in decision making, GACVS-structured methodology for evidence-based decisions is evolving. GACVS also promotes best practices and capacity building for timely and accurate risk assessment; risk communications; outreach to help countries maintain and, if needed, rebuild public trust in vaccines; and advocacy for bridging the major gaps in vaccine safety capacity globally., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Major vaccine safety controversies have arisen in several countries beginning in the last decades of 20th century. Such periodic vaccine safety controversies are unlikely to go away in the near future as more national immunization programs mature with near elimination of target vaccine-preventable diseases that result in relative greater prominence of adverse events following immunizations, both true reactions and temporally coincidental events. There are several ways in which vaccine safety capacity can be improved to potentially mitigate the impact of future vaccine safety controversies. This paper aims to take a "lifecycle" approach, examining some potential pre- and post-licensure opportunities to improve vaccine safety, in both developed (specifically U.S. and Europe) and low- and middle-income countries., (Copyright © 2015 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.)

Serious illnesses or even deaths may rarely occur after childhood vaccinations. Public health programs are faced with great challenges to establish if the events presenting after the administration of a vaccine are due to other conditions, and hence a coincidental presentation, rather than caused by the administered vaccines. Given its priority, the Global Advisory Committee for Vaccine Safety (GACVS) commissioned a group of experts to review the previously published World Health Organization (WHO) Adverse Event Following Immunization (AEFI) causality assessment methodology and aide-memoire, and to develop a standardized and user friendly tool to assist health care personnel in the processing and interpretation of data on individual events, and to assess the causality after AEFIs. We describe a tool developed for causality assessment of individual AEFIs that includes: (a) an eligibility component for the assessment that reviews the diagnosis associated with the event and identifies the administered vaccines; (b) a checklist that systematically guides users to gather available information to feed a decision algorithm; and (c) a decision support algorithm that assists the assessors to come to a classification of the individual AEFI. Final classification generated by the process includes four categories in which the event is either: (1) consistent; (2) inconsistent; or (3) indeterminate with respect of causal association; or (4) unclassifiable. Subcategories are identified to assist assessors in resulting public health decisions that can be used for action. This proposed tool should support the classification of AEFI cases in a standardized, transparent manner and to collect essential information during AEFI investigation. The algorithm should provide countries and health officials at the global level with an instrument to respond to vaccine safety alerts, and support the education, research and policy decisions on immunization safety., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Introduction: MenAfriVac is a new conjugate vaccine against Neisseria meningitidis serogroup A, the major cause of meningitis outbreaks in sub-Saharan Africa. In Niger, the MenAfriVac introduction campaign was conducted in the District of Filingue, during September 2010, targeting 392,211 individuals aged 1-29 years. We set up an enhanced spontaneous surveillance system to monitor adverse events following immunization (AEFI) during the campaign period and 42 days thereafter., Methods: All the 33 health centres of the district have been designated as surveillance units, which reported AEFIs on a daily basis to the health district headquarters. Health care workers were instructed to screen patients presenting with predefined conditions of interest and patients spontaneously presenting at units or at vaccination posts with complaints after vaccination. Cases were classified as serious (resulting in death, hospitalization or long-term disability) or minor. A National Expert Committee was established to determine if serious cases were causally associated with the vaccine., Results: In total, 356,532 vaccine doses were administered. During 61 days of monitoring, 82 suspected AEFIs were reported: 16 severe and 66 minor. The cumulative incidence was of 23.0 per 100,000 doses. Among severe cases, 14 were classified as coincidences, one urticaria complicated by respiratory distress was classified as a probable vaccine reaction, and one death was unclassifiable because post-mortem information was unavailable. The number of units that reported at least one case was 19/33 (57.6%)., Conclusions: Although these results are limited by underreporting of cases, we did not identify safety concerns with MenAfriVac. The lessons learned from this experience should be used to reinforce the national pharmacovigilance system in Niger to make it complaint with international standards. In order to do so, we recommend using a lighter system for routine; and conducting regular training and supervisory activities to increase its acceptance among local health workers., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

A new Group A meningococcal (Men A) conjugate vaccine, MenAfriVac™, was prequalified by the World Health Organization (WHO) in June 2010. Because Burkina Faso has repeatedly suffered meningitis epidemics due to Group A Neisseria meningitidis special efforts were made to conduct a country-wide campaign with the new vaccine in late 2010 and before the onset of the next epidemic meningococcal disease season beginning in January 2011. In the ensuing five months (July-November 2010) the following challenges were successfully managed: (1) doing a large safety study and registering the new vaccine in Burkina Faso; (2) developing a comprehensive communication plan; (3) strengthening the surveillance system with particular attention to improving the capacity for real-time polymerase chain reaction (PCR) testing of spinal fluid specimens; (4) improving cold chain capacity and waste disposal; (5) developing and funding a sound campaign strategy; and (6) ensuring effective collaboration across all partners. Each of these issues required specific strategies that were managed through a WHO-led consortium that included all major partners (Ministry of Health/Burkina Faso, Serum Institute of India Ltd., UNICEF, Global Alliance for Vaccines and Immunization, Meningitis Vaccine Project, CDC/Atlanta, and the Norwegian Institute of Public Health/Oslo). Biweekly teleconferences that were led by WHO ensured that problems were identified in a timely fashion. The new meningococcal A conjugate vaccine was introduced on December 6, 2010, in a national ceremony led by His Excellency Blaise Compaore, the President of Burkina Faso. The ensuing 10-day national campaign was hugely successful, and over 11.4 million Burkinabes between the ages of 1 and 29 years (100% of target population) were vaccinated. African national immunization programs are capable of achieving very high coverage for a vaccine desired by the public, introduced in a well-organized campaign, and supported at the highest political level. The Burkina Faso success augurs well for further rollout of the Men A conjugate vaccine in meningitis belt countries., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

MenAfriVac™ is a new meningococcal A conjugate vaccine developed to prevent meningitis outbreaks in Africa. It was first introduced during the last quarter of 2010 in three West African countries. We report on the monitoring of adverse events following immunization (AEFI) in Burkina Faso where more than 11 million people aged 1-29 years were vaccinated. Vaccine pharmacovigilance relied on stimulated passive AEFI surveillance countrywide and active surveillance for 12 clinical conditions in one sentinel district (Ziniaré) with 97,715 people eligible for vaccination. All AEFI occurring during the 10 days of mass campaign or the 42 subsequent days were to be notified. Serious AEFI were submitted to a national expert committee (NEC) for causality assessment. A total of 11,466,950 people were vaccinated with 1471 vaccinees reported to have experienced at least one AEFI (12.83 cases per 100,000). 1444 AEFI were minor; the most common of which were fever, headache, gastro-intestinal disorders and local reactions (2-7 cases per 100,000). Of 27 serious AEFI reported, four cases were classified by the NEC as related to vaccine (1 case per 3 million vaccinated) including one case each of exanthematous pustulosis, angioedema, bronchospasm and severe vomiting. Active surveillance identified 71 cases of the 12 conditions of interest. Convulsions, urticaria and bronchospasm were more frequently reported. Attack rates for those conditions were similar to the baseline rates recorded in the same population, over the same time period, a year earlier. With the exception of convulsions in the days following vaccination the distribution of time intervals between vaccination and the occurrence of symptoms did not reveal any temporal clustering. The monitoring of AEFI of MenAfriVac™ in Burkina Faso did not suggest special concern regarding the vaccine safety. However, reported possible hypersensitivity reactions to vaccine components would require further review to rule out any anaphylactic reaction., (Published by Elsevier Ltd.)

Since 2000, GAVI provided essential support for an unprecedented increase in the use of hepatitis B (HepB) and Haemophilus influenzae (Hib) containing vaccines in resource poor countries. This increase was supported with significant funding from international donors, intended to be time-limited. To assess the sustainability of this important expansion of the global access to vaccines, we reviewed supply chains, financial resources for procurement and decision-making in countries that introduced hepatitis B or Hib vaccines with GAVI support. During the period studied, the types of vaccine products supplied fluctuated rapidly in relationship with the number of suppliers and availability of more combination products. The price of the cheaper vaccines decreased while that of pentavalent DTwP-HepB-Hib remained stable. In average, vaccine introduction was associated with an increase of national programs budget, with new vaccines representing more than half of that increase, while the part of GAVI contributions to the budget went from 25% to 46%. Less than 20% of the vaccine introductions were decided by a national advisory body. Strengthening supply chains, adjusting funding schemes and increasing national ownership will be key to the sustained use of hepatitis B and Hib vaccines and the eventual addition of other important vaccines where they are the most needed., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

This article analyzes the performance of a Hib vaccine demand forecast developed in 2003 for 68 GAVI-supported countries between 2004 and 2007. During that period of time, corresponding to an acceleration of Hib vaccine uptake, several groups of countries were identified based on the stage of their decision-making process, perception of Hib disease burden and programme performance. Better forecast accuracy was obtained for countries having already introduced the vaccine or that were about to do so. The ability to anticipate global needs in terms of vaccine volumes was highly dependant on the actual year of introduction of a small number of very large countries.

Despite the demonstration of effectiveness and public health impact of Hib conjugate vaccines, the majority of infants from poorest countries do not yet have access to this safe and effective preventive intervention. This paper provides a descriptive analysis of the main characteristics of countries that have included Hib vaccine in their national immunization programmes before 2006. It highlights the importance of regularly analyzing the process of decision-making involved in implementation of public health interventions, in order to learn from cumulative experience and expedite the introduction of future interventions.