Last data update: Sep 23, 2024. (Total: 47723 publications since 2009)
Records 1-27 (of 27 Records) |
Query Trace: Zuber A [original query] |
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A technology-enabled multi-disciplinary team-based care model for the management of Long COVID and other fatiguing illnesses within a federally qualified health center: protocol for a two-arm, single-blind, pragmatic, quality improvement professional cluster randomized controlled trial
Godino JG , Samaniego JC , Sharp SP , Taren D , Zuber A , Armistad AJ , Dezan AM , Leyba AJ , Friedly JL , Bunnell AE , Matthews E , Miller MJ , Unger ER , Bertolli J , Hinckley A , Lin JS , Scott JD , Struminger BB , Ramers C . Trials 2023 24 (1) 524 BACKGROUND: The clinical burden of Long COVID, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), and other post-infectious fatiguing illnesses (PIFI) is increasing. There is a critical need to advance understanding of the effectiveness and sustainability of innovative approaches to clinical care of patients having these conditions. METHODS: We aim to assess the effectiveness of a Long COVID and Fatiguing Illness Recovery Program (LC&FIRP) in a two-arm, single-blind, pragmatic, quality improvement, professional cluster, randomized controlled trial in which 20 consenting clinicians across primary care clinics in a Federally Qualified Health Center system in San Diego, CA, will be randomized at a ratio of 1:1 to either participate in (1) weekly multi-disciplinary team-based case consultation and peer-to-peer sharing of emerging best practices (i.e., teleECHO (Extension for Community Healthcare Outcomes)) with monthly interactive webinars and quarterly short courses or (2) monthly interactive webinars and quarterly short courses alone (a control group); 856 patients will be assigned to participating clinicians (42 patients per clinician). Patient outcomes will be evaluated according to the study arm of their respective clinicians. Quantitative and qualitative outcomes will be measured at 3- and 6-months post-baseline for clinicians and every 3-months post assignment to a participating clinician for patients. The primary patient outcome is change in physical function measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)-29. Analyses of differences in outcomes at both the patient and clinician levels will include a linear mixed model to compare change in outcomes from baseline to each post-baseline assessment between the randomized study arms. A concurrent prospective cohort study will compare the LC&FIRP patient population to the population enrolled in a university health system. Longitudinal data analysis approaches will allow us to examine differences in outcomes between cohorts. DISCUSSION: We hypothesize that weekly teleECHO sessions with monthly interactive webinars and quarterly short courses will significantly improve clinician- and patient-level outcomes compared to the control group. This study will provide much needed evidence on the effectiveness of a technology-enabled multi-disciplinary team-based care model for the management of Long COVID, ME/CFS, and other PIFI within a federally qualified health center. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05167227 . Registered on December 22, 2021. |
Essential public health functions are not enough: fostering linkages between functions through National Public Health Institutes improves public health impact
Zuber A , Pearson J , Sebeh Y , Jarvis D , Bratton S . BMJ Glob Health 2023 8 (6) COVID-19 has highlighted the importance of essential public health functions (EPHFs) and the coordination between them. The US Centers for Disease Control and Prevention defines EPHFs as 'the public health activities that all communities should undertake'. According to multiple functional frameworks published in literature, the functions typically include workforce development, surveillance, public health research, laboratory services, health promotion, outbreak response and emergency management. National Public Health Institutes (NPHIs) are often the lead government agency responsible for execution of these functions.This paper describes how NPHIs or other health authorities can improve public health impact by enhancing the coordination of public health functions and public health actors through functional and organisational linkages. We define public health linkages as practical, replicable activities that facilitate collaboration between public health functions or organisations to improve public health. In this paper, we propose a novel typology to categorise important public health linkages and describe enablers of linkages identified through our research.Based on our research, investments in health systems should move beyond vertical approaches to developing public health capacity and place greater emphasis on strengthening the interactions between public health functions and institutions. Development of linkages and their enablers require a purposeful, proactive focus that establishes and strengthens linkages over time and cannot be developed during an outbreak or other public health emergency. |
Exploratory literature review of the role of National Public Health Institutes in COVID-19 response
Zuber A , Sebeh Y , Jarvis D , Bratton S . Emerg Infect Dis 2022 28 (13) S151-s158 To help explain the diversity of COVID-19 outcomes by country, research teams worldwide are studying national government response efforts. However, these attempts have not focused on a critical national authority that exists in half of the countries in the world: national public health institutes (NPHIs). NPHIs serve as an institutional home for public health systems and expertise and play a leading role in epidemic responses. To characterize the role of NPHIs in the COVID-19 response, we conducted a descriptive literature review that explored the research documented during March 2020-May 2021. We conducted a name-based search of 61 NPHIs in the literature, representing over half of the world's NPHIs. We identified 33 peer-reviewed and 300 gray articles for inclusion. We describe the most common NPHI-led COVID-19 activities that are documented and identify gaps in the literature. Our findings underscore the value of NPHIs for epidemic control and establish a foundation for primary research. |
Vaccine safety issues at the turn of the 21st century
Conklin L , Hviid A , Orenstein WA , Pollard AJ , Wharton M , Zuber P . BMJ Glob Health 2021 6 Global gains in vaccination coverage during the early 21st century have been threatened by the emergence of antivaccination groups that have questioned the effectiveness of vaccines to generate public distrust of vaccines and immunisation programmes. This manuscript summarises six key topics that have been at the centre of global discussions on vaccine safety during the early 21st century: thiomersal in multi-dose non-live vaccines, aluminium adjuvants used with several non-live vaccines, autism and auto-immune conditions as possible consequences of vaccination, a risk of immune overload with increasing numbers of vaccinations, and detrimental non-specific effects (NSEs) of vaccination. For each topic, we describe the hypothesis behind the public concern, the evidence reviewed by the WHO's Global Advisory Committee for Vaccine Safety (GACVS) during 1999-2019, and any significant new data that has emerged since GACVS conclusions were made. Although the scientific evidence on these issues overwhelmingly supports the safety of vaccines, communication messages to caregivers and providers need to condense and convey scientific information in an appropriate way to address concerns contributing to vaccine distrust. In addition, there is need for further studies specifically designed to address both positive and negative NSE of vaccination. The role of GACVS will be increasingly important in evaluating the evidence and engaging the global community in promoting and assuring the safety of vaccines in the decades to come as we move into an era in which we use new vaccination platforms, antigens and formulations. |
Novel vaccine safety issues and areas that would benefit from further research
Salmon DA , Lambert PH , Nohynek HM , Gee J , Parashar UD , Tate JE , Wilder-Smith A , Hartigan-Go KY , Smith PG , Zuber PLF . BMJ Glob Health 2021 6 Vaccine licensure requires a very high safety standard and vaccines routinely used are very safe. Vaccine safety monitoring prelicensure and postlicensure enables continual assessment to ensure the benefits outweigh the risks and, when safety problems arise, they are quickly identified, characterised and further problems prevented when possible. We review five vaccine safety case studies: (1) dengue vaccine and enhanced dengue disease, (2) pandemic influenza vaccine and narcolepsy, (3) rotavirus vaccine and intussusception, (4) human papillomavirus vaccine and postural orthostatic tachycardia syndrome and complex regional pain syndrome, and (5) RTS,S/adjuvant system 01 malaria vaccine and meningitis, cerebral malaria, female mortality and rebound severe malaria. These case studies were selected because they are recent and varied in the vaccine safety challenges they elucidate. Bringing these case studies together, we develop lessons learned that can be useful for addressing some of the potential safety issues that will inevitably arise with new vaccines. |
Risk of intussusception after monovalent rotavirus vaccine (Rotavac) in Indian infants: A self-controlled case series analysis
Das MK , Arora NK , Poluru R , Tate JE , Gupta B , Sharan A , Aggarwal MK , Haldar P , Parashar UD , Zuber PLF , Bonhoeffer J , Ray A , Wakhlu A , Vyas BR , Iqbal Bhat J , Goswami JK , Mathai J , Kameswari K , Bharadia L , Sankhe L , Ajayakumar MK , Mohan N , Jena PK , Sarangi R , Shad R , Debbarma SK , Shyamala J , Ratan SK , Sarkar S , Kumar V , Maure CG , Dubey AP , Gupta A , Sam CJ , Mufti GN , Trivedi H , Shad J , Lahiri K , R K , Luthra M , Behera N , P P , Rajamani G , Kumar R , Sarkar R , Santosh Kumar A , Sahoo SK , Ghosh SK , Mane S , Dash A , Charoo BA , Tripathy BB , Rajendra Prasad G , S HK , K J , Sarkar NR , Arunachalam P , Mohapatra SSG , Garge S . Vaccine 2021 39 (1) 78-84 BACKGROUND: An association between rotavirus vaccination and intussusception has been documented in post-licensure studies in some countries. We evaluated the risk of intussusception associated with monovalent rotavirus vaccine (Rotavac) administered at 6, 10 and 14 weeks of age in India. METHODS: Active prospective surveillance for intussusception was conducted at 22 hospitals across 16 states from April 2016 through September 2017. Data on demography, clinical features and vaccination were documented. Age-adjusted relative incidence for 1-7, 8-21, and 1-21 days after rotavirus vaccination in children aged 28-364 days at intussusception onset was estimated using the self-controlled case-series (SCCS) method. Only Brighton Collaboration level 1 cases were included. RESULTS: Out of 670 children aged 2-23 months with intussusception, 311 (46.4%) children were aged 28-364 days with confirmed vaccination status. Out of these, 52 intussusception cases with confirmed receipt of RVV were included in the SCCS analysis. No intussusception case was observed within 21 days of dose 1. Only one case occurred during 8-21 days after the dose 2. Post-dose 3, two cases in 1-7 days and 7 cases during 8-21 days period were observed. There was no increased risk of intussusception during 1-7 days after the doses 1 and 2 (zero cases observed) or dose 3 (relative incidence [RI], 1.71 [95% confidence interval {CI} 0.0-5.11]). Similarly, no increased risk during 8-21 days after the dose 1 (zero cases observed), dose 2 (RI, 0.71 [95% CI, 0.0-3.28]) or dose 3 (RI, 2.52 [95% CI, 0.78-5.61]). The results were similar for 1-21 day periods after the doses separately or pooled. CONCLUSIONS: The risk of intussusception during the first 21 days after any dose of rotavirus vaccine (Rotavac) was not higher among the Indian infants than the background risk, based on limited SCCS analysis of 52 children. |
Implementation and evaluation of a Project ECHO telementoring program for the Namibian HIV workforce
Bikinesi L , O'Bryan G , Roscoe C , Mekonen T , Shoopala N , Mengistu AT , Sawadogo S , Agolory S , Mutandi G , Garises V , Pati R , Tison L , Igboh L , Johnson C , Rodriguez EM , Ellerbrock T , Menzies H , Baughman AL , Brandt L , Forster N , Scott J , Wood B , Unruh KT , Arora S , Iandiorio M , Kalishman S , Zalud-Cerrato S , Lehmer J , Lee S , Mahdi MA , Spedoske S , Zuber A , Reilley B , Ramers CB , Hamunime N , O'Malley G , Struminger B . Hum Resour Health 2020 18 (1) 61 BACKGROUND: The Namibian Ministry of Health and Social Services (MoHSS) piloted the first HIV Project ECHO (Extension for Community Health Outcomes) in Africa at 10 clinical sites between 2015 and 2016. Goals of Project ECHO implementation included strengthening clinical capacity, improving professional satisfaction, and reducing isolation while addressing HIV service challenges during decentralization of antiretroviral therapy. METHODS: MoHSS conducted a mixed-methods evaluation to assess the pilot. Methods included pre/post program assessments of healthcare worker knowledge, self-efficacy, and professional satisfaction; assessment of continuing professional development (CPD) credit acquisition; and focus group discussions and in-depth interviews. Analysis compared the differences between pre/post scores descriptively. Qualitative transcripts were analyzed to extract themes and representative quotes. RESULTS: Knowledge of clinical HIV improved 17.8% overall (95% confidence interval 12.2-23.5%) and 22.3% (95% confidence interval 13.2-31.5%) for nurses. Professional satisfaction increased 30 percentage points. Most participants experienced reduced professional isolation (66%) and improved CPD credit access (57%). Qualitative findings reinforced quantitative results. Following the pilot, the Namibia MoHSS Project ECHO expanded to over 40 clinical sites by May 2019 serving more than 140 000 people living with HIV. CONCLUSIONS: Similar to other Project ECHO evaluation results in the United States of America, Namibia's Project ECHO led to the development of ongoing virtual communities of practice. The evaluation demonstrated the ability of the Namibia HIV Project ECHO to improve healthcare worker knowledge and satisfaction and decrease professional isolation. |
The science of vaccine safety: Summary of meeting at Wellcome Trust
Plotkin SA , Offit PA , DeStefano F , Larson HJ , Arora NK , Zuber PLF , Fombonne E , Sejvar J , Lambert PH , Hviid A , Halsey N , Garcon N , Peden K , Pollard AJ , Markowitz LE , Glanz J . Vaccine 2020 38 (8) 1869-1880 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. |
An approach for preparing and responding to adverse events following immunization reported after hepatitis B vaccine birth dose administration
Gidudu JF , Shaum A , Habersaat K , Wilhelm E , Woodring J , Mast E , Zuber P , Amarasinghe A , Nelson N , Kabore H , Abad N , Tohme RA . Vaccine 2019 38 (49) 7728-7740 The success of immunization programs in lowering the incidence of vaccine preventable diseases (VPDs) has led to increased public attention on potential health risks associated with vaccines. As a result, a scientifically rigorous response to investigating reported adverse events following immunization (AEFI) and effective risk communications strategies are critical to ensure public confidence in immunization. Globally, an estimated 257 million people have chronic hepatitis B virus (HBV) infection, which causes more than 686,000 premature deaths from liver cancer and cirrhosis. Hepatitis B vaccination is the most effective way to prevent mother-to-child transmission of HBV infection, especially when a timely birth dose is given within 24h of birth. However, an infant's risk of dying is highest in the neonatal period, and thus, administering HepB-BD within 24h of birth overlaps with the most fragile period in an infant's life. A working group formed in July 2016 following the publication of the case reports of the effects on vaccination coverage of media reports of infant deaths after HepB-BD administration in China and Vietnam. The goal of the working group was to create a framework and describe best practices for preparing for and responding to AEFI reported after HepB-BD administration, using existing resources. The framework includes six steps, including three preparation steps and three response steps. This document is written for national and regional immunization program staff. Prior to using the framework for preparation and response to AEFIs reported after HepB-BD administration, staff members should be familiar with how AEFI are detected, reported, and investigated in the country. The document might also be of interest to national regulatory staff members who monitor vaccine safety within the country. |
Using surveillance and economic data to make informed decisions about rotavirus vaccine introduction
Cohen AL , Aliabadi N , Serhan F , Tate JE , Zuber P , Parashar UD . Vaccine 2018 36 (51) 7755-7758 While rotavirus vaccines are available, safe, and effective, many countries are not yet widely using these vaccines. Surveillance for rotavirus disease and potential vaccine adverse events is critical for country decision making about rotavirus vaccine. This special issue shares rotavirus and intussusception disease surveillance data and rotavirus vaccine cost-effectiveness analyses from countries that have yet to introduce rotavirus vaccines into their routine infant immunization programs. The studies highlight the substantial burden of rotavirus disease and the cost-effectiveness of rotavirus vaccine in a broad set of countries without rotavirus vaccine in their routine immunization programs. |
Use of a new global indicator for vaccine safety surveillance and trends in adverse events following immunization reporting 2000-2015
Lei J , Balakrishnan MR , Gidudu JF , Zuber PLF . Vaccine 2018 36 (12) 1577-1582 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 ratiosgreater than10 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. |
Zimbabwe's Human Resources for health Information System (ZHRIS) - an assessment in the context of establishing a global standard
Waters KP , Zuber A , Simbini T , Bangani Z , Krishnamurthy RS . Int J Med Inform 2017 100 121-128 Introduction There have been numerous global calls to action to utilize human resources information systems (HRIS) to improve the availability and quality of data for strengthening the regulation and deployment of health workers. However, with no normative guidance in existence, the development of HRIS has been inconsistent and lacking in standardization, hindering the availability and use of data for health workforce planning and decision making (Riley et al., 2012). CDC and WHO partnered with the Ministry of Health in several countries to conduct HRIS functional requirements analyses and establish a Minimum Data Set (MDS) of elements essential for a global standard HRIS. As a next step, CDC advanced a study to examine the alignment of one of the HRIS it supports (in Zimbabwe) against this MDS. Method For this study, we created a new data collection and analysis tool to assess the extent to which Zimbabwe's CDC-supported HRIS was aligned with the WHO MDS. We performed systematic "gap analyses" in order to make prioritized recommendations for addressing the gaps, with the aim of improving the availability and quality of data on Zimbabwe's health workforce. Results The majority of the data elements outlined in the WHO MDS were present in the ZHRIS databases, though they were found to be missing various applicable elements. The lack of certain elements could impede functions such as health worker credential verification or equitable in-service training allocation. While the HRIS MDS treats all elements equally, our assessment revealed that not all the elements have equal significance when it comes to data utilization. Further, some of the HRIS MDS elements exceeded the current needs of regulatory bodies and the Ministry of Health and Child Care (MOHCC) in Zimbabwe. The preliminary findings of this study helped inspire the development of a more recent HRH Registry MDS subset, which is a shorter list of priority data elements recommended as a global standard for HRIS. Conclusion The field-tested assessment methodology presented here, with suggested improvements to the tool, can be used to identify absent or unaligned elements in either an HRH Registry or a full HRIS. Addressing the prioritized gaps will increase the availability of critical data in the ZHRIS and can empower the MOHCC and councils to conduct more strategic analyses, improving health workforce planning and ultimately public health outcomes in the country. |
Regulatory Advances in 11 Sub-Saharan Countries in Year 3 of the African Health Profession Regulatory Collaborative for Nurses and Midwives (ARC)
Dynes M , Tison L , Johnson C , Verani A , Zuber A , Riley PL . J Assoc Nurses AIDS Care 2016 27 (3) 285-96 Sub-Saharan Africa carries the greatest burden of the HIV pandemic. Enhancing the supply and use of human resources through policy and regulatory reform is a key action needed to improve the quality of HIV services in this region. In year 3 of the African Health Profession Regulatory Collaborative for Nurses and Midwives (ARC), a President's Emergency Plan for AIDS Relief initiative, 11 country teams of nursing and midwifery leaders ("Quads") received small grants to carry out regulatory improvement projects. Four countries advanced a full stage on the Regulatory Function Framework (RFF), a staged capability maturity model used to evaluate progress in key regulatory functions. While the remaining countries did not advance a full stage on the RFF, important gains were noted. The year-3 evaluation highlighted limitations of the ARC evaluation strategy to capture nuanced progress and provided insight into how the RFF might be adapted for future use. |
eSIP-Saude: Mozambique's novel approach for a sustainable human resources for health information system
Waters KP , Mazivila ME , Dgedge M , Necochea E , Manharlal D , Zuber A , de Faria Leao B , Bossemeyer D , Vergara AE . Hum Resour Health 2016 14 (1) 66 INTRODUCTION: Over the past decade, governments and international partners have responded to calls for health workforce data with ambitious investments in human resources information systems (HRIS). However, documentation of country experiences in the use of HRIS to improve strategic planning and management has been lacking. The purpose of this case presentation is to document for the first time Mozambique's novel approach to HRIS, sharing key success factors and contributing to the scant global knowledge base on HRIS. CASE PRESENTATION: Core components of the system are a Government of Mozambique (GOM) registry covering all workers in the GOM payroll and a "health extension" which adds health-sector-specific data to the GOM registry. Separate databases for pre-service and in-service training are integrated through a business intelligence tool. The first aim of the HRIS was to identify the following: who and where are Mozambique's health workers? As of July 2015, 95 % of countrywide health workforce deployment information was populated in the HRIS, allowing the identification of health professionals' physical working location and their pay point. HRIS data are also used to quantify chronic issues affecting the Ministry of Health (MOH) health workforce. Examples include the following: HRIS information was used to examine the deployment of nurses trained in antiretroviral therapy (ART) vis-a-vis the health facilities where ART is being provided. Such results help the MOH align specialized skill sets with service provision. Twenty-five percent of the MOH health workforce had passed the 2-year probation period but had not been updated in the MOH information systems. For future monitoring of employee status, the MOH established a system of alerts in semi-monthly reports. As of August 2014, 1046 health workers were receiving their full salary but no longer working at the facilities. The MOH is now analyzing this situation to improve the retirement process and coordination with Social Security. CONCLUSION: The Mozambican system is an important example of an HRIS built on a local platform with local staff. Notable models of strategic data use demonstrate that the system is empowering the MOH to improve health services delivery, health workforce allocation, and management. Combined with committed country leadership and ownership of the program, this suggests strong chances of sustainability and real impact on public health equity and quality. |
Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women
Jones CE , Munoz FM , Spiegel HM , Heininger U , Zuber PL , Edwards KM , Lambach P , Neels P , Kohl KS , Gidudu J , Hirschfeld S , Oleske JM , Khuri-Bulos N , Bauwens J , Eckert LO , Kochhar S , Bonhoeffer J , Heath PT . Vaccine 2016 34 (49) 5998-6006 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. |
Contributions and challenges for worldwide vaccine safety: The Global Advisory Committee on Vaccine Safety at 15 years
Asturias EJ , Wharton M , Pless R , MacDonald NE , Chen RT , Andrews N , Salisbury D , Dodoo AN , Hartigan-Go K , Zuber PL . Vaccine 2016 34 (29) 3342-9 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. |
Lessons learned from enhancing vaccine pharmacovigilance activities during PsA-TT introduction in African countries, 2010-2013
Diomande FV , Yameogo TM , Vannice KS , Preziosi MP , Viviani S , Ouandaogo CR , Keita M , Djingarey MH , Mbakuliyemo N , Akanmori BD , Sow SO , Zuber PL . Clin Infect Dis 2015 61 Suppl 5 S459-66 BACKGROUND: The rollout of the group A meningococcal vaccine, PsA-TT, in Africa's meningitis belt countries represented the first introduction of a vaccine specifically designed for this part of the world. During the first year alone, the number of people who received the vaccine through mass vaccination campaigns was several hundredfold higher than that of subjects who participated in the closely monitored clinical trials. Implementation of a system to identify rare but potentially serious vaccine reactions was therefore a high priority in the design and implementation of those campaigns. METHODS: National authorities and their technical partners set up effective vaccine pharmacovigilance systems, including conducting active surveillance projects. RESULTS: Implementation of national expert advisory groups to review serious adverse events following immunization in all countries and active monitoring of conditions of interest in 3 early-adopter countries did not identify particular concerns with the safety profile of PsA-TT, which had already provided tremendous public health benefits. CONCLUSIONS: Lessons learned from this experience will help to improve preparations for future vaccine introductions in resource-poor settings and capitalize on such efforts to advance vaccine safety systems in the future. |
Active surveillance for adverse events after a mass vaccination campaign with a group A meningococcal conjugate vaccine (PsA-TT) in Mali
Vannice KS , Keita M , Sow SO , Durbin AP , Omer SB , Moulton LH , Yameogo TM , Zuber PL , Onwuchekwa U , Sacko M , Diomande FV , Halsey NA . Clin Infect Dis 2015 61 Suppl 5 S493-500 BACKGROUND: The monovalent meningococcal A conjugate vaccine (PsA-TT, MenAfriVac) was developed for use in the "meningitis belt" of sub-Saharan Africa. Mali was 1 of 3 countries selected for early introduction. As this is a new vaccine, postlicensure surveillance is particularly important to identify and characterize possible safety issues. METHODS: The national vaccination campaign was phased from September 2010 to November 2011. We conducted postlicensure safety surveillance for PsA-TT in 40 government clinics from southern Mali serving approximately 400 000 people 1-29 years of age. We conducted analyses with individual-level data and population-level data, and we calculated rates of adverse events using the conditional exact test, a modified vaccine cohort risk interval method, and a modified self-controlled case series method for each outcome of interest, including 18 prespecified adverse events and 18 syndromic categories. RESULTS: An increased rate of clinic visits for fever within 3 days after vaccination was found using multiple methods for all age groups. Although other signals were found with some methods, complete assessment of all other prespecified outcomes and syndromic categories did not reveal that PsA-TT was consistently associated with any other health problem. CONCLUSIONS: No new safety concerns were identified in this study. These results are consistent with prelicensure data and other studies indicating that PsA-TT is safe. The approach presented could serve as a model for future active postlicensure vaccine safety monitoring associated with large-scale immunization campaigns in low-income countries. |
Enhancing vaccine safety capacity globally: a lifecycle perspective
Chen RT , Shimabukuro TT , Martin DB , Zuber PL , Weibel DM , Sturkenboom M . Vaccine 2015 33 Suppl 4 D46-54 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. |
The African Health Profession Regulatory Collaborative (ARC) at two years
McCarthy CF , Zuber A , Kelley MA , Verani AR , Riley PL . Afr J Midwifery Womens Health 2014 8 4-9 BACKGROUND: The African Health Profession Regulatory Collaborative (ARC) for nurses and midwives was created in response to the increasing reliance on shifting HIV tasks to nurses and midwives without the necessary regulation supporting this enhanced professional role. ARC APPROACH: The ARC initiative comprises regional meetings, technical assistance, and regulatory improvement grants which enhance HIV service delivery by nurses and midwives, and systematic evaluation of project impact. RESULTS: Eight of 11 countries funded by ARC advanced a full stage in regulatory capacity during their 1-year project period. Countries in ARC also demonstrated increased capacity in project management and proposal writing. DISCUSSION: The progress of country teams thus far suggests ARC is a successful model for regulation strengthening and capacity building, as well as presenting a novel approach for sustainability and country ownership. The ARC platform has been a successful vehicle for regional harmonisation of updated regulations and promises to help facilitate the enhancement of HIV service delivery by nurses and midwives. |
Roadmap for the international collaborative epidemiologic monitoring of safety and effectiveness of new high priority vaccines
Izurieta HS , Zuber P , Bonhoeffer J , Chen RT , Sankohg O , Laserson KF , Sturkenboom M , Loucq C , Weibel D , Dodd C , Black S . Vaccine 2013 31 (35) 3623-7 With the advent of new vaccines targeted to highly endemic diseases in low- and middle-income countries (LMIC) and with the expansion of vaccine manufacturing globally, there is an urgent need to establish an infrastructure to evaluate the benefit-risk profiles of vaccines in LMIC. Fortunately the usual decade(s)-long time gap between introduction of new vaccines in high and low income countries is being significantly reduced or eliminated due to initiatives such as the Global Alliance for Vaccines and Immunizations (GAVI) and the Decade of Vaccines for the implementation of the Global Vaccine Action Plan. While hoping for more rapid disease control, this time shift may potentially add risk, unless appropriate capacity for reliable and timely evaluation of vaccine benefit-risk profiles in some LMIC's are developed with external assistance from regional or global level. An ideal vaccine safety and effectiveness monitoring system should be flexible and sustainable, able to quickly detect possible vaccine-associated events, distinguish them from programmatic errors, reliably and quickly evaluate the suspected event and its association with vaccination and, if associated, determine the benefit-risk of vaccines to inform appropriate action. Based upon the demonstrated feasibility of active surveillance in LMIC as shown by the Burkina Faso assessment of meningococcal A conjugate vaccine or that of rotavirus vaccine in Mexico and Brazil, and upon the proof of concept international GBS study, we suggest a sustainable, flexible, affordable and timely international collaborative vaccine safety monitoring approach for vaccines being newly introduced. While this paper discusses only the vaccine component, the same system could also be eventually used for monitoring drug effectiveness (including the use of substandard drugs) and drug safety. |
Kenya's Health Workforce Information System: a model of impact on strategic human resources policy, planning and management
Waters KP , Zuber A , Willy RM , Kiriinya RN , Waudo AN , Oluoch T , Kimani FM , Riley PL . Int J Med Inform 2013 82 (9) 895-902 OBJECTIVE: Countries worldwide are challenged by health worker shortages, skill mix imbalances, and maldistribution. Human resources information systems (HRIS) are used to monitor and address these health workforce issues, but global understanding of such systems is minimal and baseline information regarding their scope and capability is practically non-existent. The Kenya Health Workforce Information System (KHWIS) has been identified as a promising example of a functioning HRIS. The objective of this paper is to document the impact of KHWIS data on human resources policy, planning and management. METHODS: Sources for this study included semi-structured interviews with senior officials at Kenya's Ministry of Medical Services (MOMS), Ministry of Public Health and Sanitation (MOPHS), the Department of Nursing within MOMS, the Nursing Council of Kenya, Kenya Medical Practitioners and Dentists Board, Kenya's Clinical Officers Council, and Kenya Medical Laboratory Technicians and Technologists Board. Additionally, quantitative data were extracted from KHWIS databases to supplement the interviews. Health sector policy documents were retrieved from MOMS and MOPHS websites, and reviewed to assess whether they documented any changes to policy and practice as having been impacted by KHWIS data. RESULTS: Interviews with Kenyan government and regulatory officials cited health workforce data provided by KHWIS influenced policy, regulation, and management. Policy changes include extension of Kenya's age of mandatory civil service retirement from 55 to 60 years. Data retrieved from KHWIS document increased relicensing of professional nurses, midwives, medical practitioners and dentists, and interviewees reported this improved compliance raised professional regulatory body revenues. The review of Government records revealed few references to KHWIS; however, documentation specifically cited the KHWIS as having improved the availability of human resources for health information regarding workforce planning, management, and development. CONCLUSION: KHWIS data have impacted a range of improvements in health worker regulation, human resources management, and workforce policy and planning at Kenya's ministries of health. |
Effectively introducing a new meningococcal A conjugate vaccine in Africa: the Burkina Faso experience
Djingarey MH , Barry R , Bonkoungou M , Tiendrebeogo S , Sebgo R , Kandolo D , Lingani C , Preziosi MP , Zuber PL , Perea W , Hugonnet S , Dellepiane de Rey Tolve N , Tevi-Benissan C , Clark TA , Mayer LW , Novak R , Messonier NE , Berlier M , Toboe D , Nshimirimana D , Mihigo R , Aguado T , Diomande F , Kristiansen PA , Caugant DA , Laforce FM . Vaccine 2012 30 Suppl 2 B40-5 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. |
Research priorities regarding rotavirus vaccine and intussusception: a meeting summary
Tate JE , Steele AD , Bines JE , Zuber PL , Parashar UD . Vaccine 2012 30 Suppl 1 A179-84 Currently available rotavirus vaccines have been associated with a small increased risk of intussusception ( approximately 1-2 cases per 100,000 vaccinated infants) in some populations. In response to this newly emerging data on intussusception related to current rotavirus vaccines, a group of technical experts convened by the Program for Applied Technology in Health met to review the data, establish what gaps in knowledge exist, and identify what future research is needed. This manuscript outlines the evidence that is currently available and the research agenda that was generated during this meeting. It also highlights the need for countries that are using or considering introducing the rotavirus vaccine to evaluate both the benefits and risks of vaccination. |
Impact of vaccination against Haemophilus influenzae type b with and without a booster dose on meningitis in four South American countries
Garcia S , Lagos R , Munoz A , Picon T , Rosa R , Alfonso A , Abriata G , Gentile A , Romanin V , Regueira M , Chiavetta L , Agudelo CI , Castaneda E , De la Hoz F , Higuera AB , Arce P , Cohen AL , Verani J , Zuber P , Gabastou JM , Pastor D , Flannery B , Andrus J . Vaccine 2012 30 (2) 486-92 To inform World Health Organization recommendations regarding use of Haemophilus influenzae type b (Hib) vaccines in national immunization programs, a multi-country evaluation of trends in Hib meningitis incidence and prevalence of nasopharyngeal Hib carriage was conducted in four South American countries using either a primary, three-dose immunization schedule without a booster dose or with a booster dose in the second year of life. Surveillance data suggest that high coverage of Hib conjugate vaccine sustained low incidence of Hib meningitis and low prevalence of Hib carriage whether or not a booster dose was used. |
Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines
Black S , Eskola J , Siegrist CA , Halsey N , Macdonald N , Law B , Miller E , Andrews N , Stowe J , Salmon D , Vannice K , Izurieta HS , Akhtar A , Gold M , Oselka G , Zuber P , Pfeifer D , Vellozzi C . Lancet 2009 374 (9707) 2115-22 Because of the advent of a new influenza A H1N1 strain, many countries have begun mass immunisation programmes. Awareness of the background rates of possible adverse events will be a crucial part of assessment of possible vaccine safety concerns and will help to separate legitimate safety concerns from events that are temporally associated with but not caused by vaccination. We identified background rates of selected medical events for several countries. Rates of disease events varied by age, sex, method of ascertainment, and geography. Highly visible health conditions, such as Guillain-Barre syndrome, spontaneous abortion, or even death, will occur in coincident temporal association with novel influenza vaccination. On the basis of the reviewed data, if a cohort of 10 million individuals was vaccinated in the UK, 21.5 cases of Guillain-Barre syndrome and 5.75 cases of sudden death would be expected to occur within 6 weeks of vaccination as coincident background cases. In female vaccinees in the USA, 86.3 cases of optic neuritis per 10 million population would be expected within 6 weeks of vaccination. 397 per 1 million vaccinated pregnant women would be predicted to have a spontaneous abortion within 1 day of vaccination. |
Intussusception and rotavirus vaccination: a review of the available evidence
Patel MM , Haber P , Baggs J , Zuber P , Bines JE , Parashar UD . Expert Rev Vaccines 2009 8 (11) 1555-64 Two live oral rotavirus vaccines (RotaTeq) and Rotarix) have recently been recommended by the WHO for inclusion into the national immunization programs of countries worldwide. Owing to the association of the withdrawn Rotashield vaccine with intussusception, these two new rotavirus vaccines underwent large clinical trials of over 60,000 infants each to assess safety with regard to this medical condition. For these two new vaccines, clinical trials and available postmarketing safety monitoring data do not indicate a risk of intussusception after vaccination, although a low-level risk cannot be excluded at present. We review these safety data for the new vaccines and for Rotashield to provide background information relevant for considering age recommendations for rotavirus vaccination. |
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