Introduction of new vaccines for immunization in pregnancy - Programmatic, regulatory, safety and ethical considerations

Immunizing pregnant women is a promising strategy to reduce infectious disease-related morbidity and mortality in pregnant women and their infants. Important pre-requisites for the successful introduction of new vaccines for immunization in pregnancy include political commitment and adequate financial resources: trained, committed and sufficient numbers of healthcare workers to deliver the vaccines; close integration of immunization programs with antenatal care and Maternal and Child Health services; adequate access to antenatal care by pregnant women in the country (especially in low and middle-income countries (LMIC)); and a high proportion of births occurring in health facilities (to ensure maternal and neonatal follow-up can be done). The framework needed to advance a vaccine program from product licensure to successful country-level implementation includes establishing and organizing evidence for anticipated vaccine program impact, developing supportive policies, and translating policies into local action. International and national coordination efforts, proactive planning from conception to implementation of the programs (including country-level policy making, planning, and implementation, regulatory guidance, pharmacovigilance) and country-specific and cultural factors must be taken into account during the vaccines introduction

WHO SAGE values framework for the allocation and prioritization of COVID-19 vaccination

This Values Framework offers guidance globally on the allocation of COVID-19 vaccines between countries, and to offer guidance nationally on the prioritization of groups for vaccination within countries while supply is limited. The Framework is intended to be helpful to policy makers and expert advisors at the global, regional and national level as they make allocation and prioritization decisions about COVID-19 vaccines

Immunization in pregnancy safety surveillance in low and middle-income countries- field performance and validation of novel case definitions

Background: A globally standardized approach in high and low and middle-income countries (LMIC) to actively monitor the safety of vaccines for pregnant women during development and implementation phases is critical. Brighton Collaboration’s (BC) Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project has developed globally standardized case definitions (CDs) of key obstetric and neonatal terms for the assessment of safety of vaccines in pregnancy. CDs are categorized into levels of diagnostic certainty, facilitating their use in varied settings. This study evaluates the field performance of CDs in LMIC. Methods: Data from pregnant participants of RCTs for trivalent inactivated influenza vaccine conducted at Chris Hani Baragwanath Academic Hospital, South Africa (SA) between 2011 and 2013 were reviewed retrospectively for preterm birth, stillbirth and hypertension CDs and the Gestational age assessment (GA) algorithm. Data from an ongoing pneumococcal vaccine trial (conducted at MRC Unit, The Gambia) were collected prospectively for GA. Results: For GA, 600 mother-infant dyads from Gambia and 155 mother-infant dyads from SA were reviewed. Level 2B (unsure LMP and US in 2nd trimester) was the most common level seen in Gambia (63%) and level 3B1 (unsure LMP with physical examination) in SA (43%). Preterm deliveries had similar results in SA. The pregnancy-induced hypertension definition performed well, with 96% (54/56) of cases fulfilling ‘level 1’ for ‘preeclampsia with severe features’. 24 stillbirths were identified and 21 records were reviewed; 73.3% (11/15) of the stillbirths classified as antepartum by attending physicians and 83.3% (5/6) of the intrapartum stillbirths did not fulfil the criteria for any level of certainty. Conclusion: BC CDs for neonatal and maternal outcomes (preterm and hypertension) and GA were sensitive, reliable and feasible to use in RCTs in SA and Gambia. Modifications to the stillbirth CD are required to improve its usefulness in varied settings

The use of a speaking book® to enhance vaccine knowledge among caregivers in The Gambia: A study using qualitative and quantitative methods.

OBJECTIVES: To measure the usefulness of a Speaking Book (SB) as an educational tool for enhancing knowledge, understanding and recall of key vaccine-related information among caregivers in The Gambia, as well as its acceptability and relevance as a health promotion tool for caregivers and healthcare workers. DESIGN AND SETTING: We developed a multimedia educational tool, the vaccine Speaking Book, which contained prerecorded information about vaccines provided in The Gambia's Expanded Programme on Immunization. Using qualitative and quantitative methods, we then conducted a sequential study assessing the use of this tool among caregivers andhealthcare workers in The Gambia.Participants200 caregivers attending primary healthcare centres in The Gambia for routine immunisation services for their infants, and 15 healthcare workers employed to provide immunisation services at these clinics. OUTCOME MEASURES: We calculated the median knowledge scores on vaccine-related information obtained at baseline, 1-month and 3-month follow-up visits. Wilcoxon's matched-pairs signed-rank test was used to compare the difference in the median knowledge scores between baseline and 1-month, and between baseline and 3-month follow-up visits. RESULTS: Of the 113 caregivers who participated, 104 (92%) completed all three study visits, 108 (95.6%) completed the baseline and 1-month follow-up visits, and 107 (94.7%) completed the baseline and 3-month follow-up visits. The median knowledge score increased from 6.0 (IQR 5.0-7.0) at baseline to 11.0 (IQR 8.0-14.0) at 1-month visit (p<0.001), and 15.0 (IQR 10.0-20.0) at 3-month visit (p<0.001). Qualitative results showed high acceptability and enthusiasm for the Speaking Book among both caregivers and healthcare workers. The Speaking Book was widely shared in the community and this facilitated communication with healthcare workers at the primary healthcare centres. CONCLUSIONS: Context-specific and subject-specific Speaking Books are a useful communication and educational tool to increase caregiver vaccine knowledge in low/middle-income countries

Diseases, Injuries, and Risk Factors in Child and Adolescent Health, 1990 to 2017 Findings From the Global Burden of Diseases, Injuries, and Risk Factors 2017 Study

IMPORTANCE Understanding causes and correlates of health loss among children and adolescents can identify areas of success, stagnation, and emerging threats and thereby facilitate effective improvement strategies. OBJECTIVE To estimate mortality and morbidity in children and adolescents from 1990 to 2017 by age and sex in 195 countries and territories. DESIGN, SETTING, AND PARTICIPANTS This study examined levels, trends, and spatiotemporal patterns of cause-specific mortality and nonfatal health outcomes using standardized approaches to data processing and statistical analysis. It also describes epidemiologic transitions by evaluating historical associations between disease indicators and the Socio-Demographic Index (SDI), a composite indicator of income, educational attainment, and fertility. Data collected from 1990 to 2017 on children and adolescents from birth through 19 years of age in 195 countries and territories were assessed. Data analysis occurred from January 2018 to August 2018. EXPOSURES Being under the age of 20 years between 1990 and 2017. MAIN OUTCOMES AND MEASURES Death and disability. All-cause and cause-specific deaths, disability-adjusted life years, years of life lost, and years of life lived with disability. RESULTS Child and adolescent deaths decreased 51.7% from 13.77 million (95% uncertainty interval [UI], 13.60-13.93 million) in 1990 to 6.64 million (95% UI, 6.44-6.87 million) in 2017, but in 2017, aggregate disability increased 4.7% to a total of 145 million (95% UI, 107-190 million) years lived with disability globally. Progress was uneven, and inequity increased, with low-SDI and low-middle–SDI locations experiencing 82.2% (95% UI, 81.6%-82.9%) of deaths, up from 70.9% (95% UI, 70.4%-71.4%) in 1990. The leading disaggregated causes of disability-adjusted life years in 2017 in the low-SDI quintile were neonatal disorders, lower respiratory infections, diarrhea, malaria, and congenital birth defects, whereas neonatal disorders, congenital birth defects, headache, dermatitis, and anxiety were highest-ranked in the high-SDI quintile. CONCLUSIONS AND RELEVANCE Mortality reductions over this 27-year period mean that children are more likely than ever to reach their 20th birthdays. The concomitant expansion of nonfatal health loss and epidemiological transition in children and adolescents, especially in low-SDI and middle-SDI countries, has the potential to increase already overburdened health systems, will affect the human capital potential of societies, and may influence the trajectory of socioeconomic development. Continued monitoring of child and adolescent health loss is crucial to sustain the progress of the past 27 years

Clinical trial data sharing: Here's the challenge

Objective Anonymised patient-level data from clinical research are increasingly recognised as a fundamental and valuable resource. It has value beyond the original research project and can help drive scientific research and innovations and improve patient care. To support responsible data sharing, we need to develop systems that work for all stakeholders. The members of the Independent Review Panel (IRP) for the data sharing platform Clinical Study Data Request (CSDR) describe here some summary metrics from the platform and challenge the research community on why the promised demand for data has not been observed. Summary of data From 2014 to the end of January 2019, there were a total of 473 research proposals (RPs) submitted to CSDR. Of these, 364 met initial administrative and data availability checks, and the IRP approved 291. Of the 90 research teams that had completed their analyses by January 2018, 41 reported at least one resulting publication to CSDR. Less than half of the studies ever listed on CSDR have been requested. Conclusion While acknowledging there are areas for improvement in speed of access and promotion of the platform, the total number of applications for access and the resulting publications have been low and challenge the sustainability of this model. What are the barriers for data contributors and secondary analysis researchers? If this model does not work for all, what needs to be changed? One thing is clear: that data access can realise new and unforeseen contributions to knowledge and improve patient health, but this will not be achieved unless we build sustainable models together that work for all