Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women.

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

CDC's COVID-19 International Vaccine Implementation and Evaluation Program and Lessons from Earlier Vaccine Introductions.

The US Centers for Disease Control and Prevention (CDC) supports international partners in introducing vaccines, including those against SARS-CoV-2 virus. CDC contributes to the development of global technical tools, guidance, and policy for COVID-19 vaccination and has established its COVID-19 International Vaccine Implementation and Evaluation (CIVIE) program. CIVIE supports ministries of health and their partner organizations in developing or strengthening their national capacities for the planning, implementation, and evaluation of COVID-19 vaccination programs. CIVIE's 7 priority areas for country-specific technical assistance are vaccine policy development, program planning, vaccine confidence and demand, data management and use, workforce development, vaccine safety, and evaluation. We discuss CDC's work on global COVID-19 vaccine implementation, including priorities, challenges, opportunities, and applicable lessons learned from prior experiences with Ebola, influenza, and meningococcal serogroup A conjugate vaccine introductions

Selected Major Issues in Vaccine Safety

Recent examples of the major public health benefits of vaccination include global reductions in measles mortality and record low levels of vaccine-preventable diseases in the United States. Nevertheless, real or perceived vaccine safety issues may adversely impact vaccine programs. Robust post-licensure safety monitoring which combines active and passive surveillance with use of standardized case definitions for adverse events is the scientific basis for assessing safety concerns. Emerging aspects of vaccine safety science include clinical research networks and vaccine risk communication research. Current high-profile safety issues include the introduction of 2 second-generation rotavirus vaccines, for which close monitoring of intussusception is necessary. To date, data from the US do not indicate an elevated risk associated with the licensed Merck vaccine (Rotateq®). An issue of global interest is the use of thimerosal as a preservative in multi-dose vaccine vials. Comprehensive independent reviews as well as recently published research have reaffirmed the lack of association between thimerosal and neuro-developmental disorders, including autism. Expanded use of annual influenza vaccine and pandemic planning in the developed or developing world should include plans for safety monitoring. As the number of newly licensed vaccines increases, potentially preventable vaccine administration errors and post-vaccination events such as syncope are being increasingly recognized. Primary care clinicians and others involved in giving vaccines should follow proper vaccine storage, handling and administration procedures and should participate in adverse event following immunization (AEFI) reporting systems. The Brighton Collaboration provides another outlet, which interested clinicians and researchers can participate in, increasing the global vaccine safety knowledge base. Increased knowledge of and participation in vaccine safety systems at all levels of health care systems in both developed and developing country settings will allow vaccines to maintain their excellent safety track record, as safety data is used to improve immunization practice

Optimising reporting of adverse events following immunisation by healthcare workers in Ghana: A qualitative study in four regions.

IntroductionDespite the emphasis on reporting of Adverse Events Following Immunisation (AEFIs) during didactic training sessions, especially prior to new vaccine introductions, it remains low in Ghana. We explored the factors underlying the under-reporting of AEFI by healthcare workers (HCWs) to provide guidance on appropriate interventions to increase reporting.MethodsWe conducted an exploratory descriptive in-depth study of the factors contributing to low reporting of AEFI among HCWs in four regions in Ghana. Key informant interviews (KII) were held with purposively selected individuals that are relevant to the AEFI reporting process at the district, regional, and national levels. We used KII guides to conduct in-depth interviews and used NVivo 10 qualitative software to analyse the data. Themes on factors influencing AEFI reporting were derived inductively from the data, and illustrative quotes from respondents were used to support the narratives.ResultsWe conducted 116 KIIs with the health managers, regulators and frontline HCWs and found that lack of information on reportable AEFIs and reporting structures, misunderstanding of reportable AEFIs, heavy workload, cost of reporting AEFIs, fear of blame by supervisors, lack of motivation, and inadequate feedback as factors responsible for underreporting of AEFIs. Respondents suggested that capacity building for frontline HCWs, effective supervision, the provision of motivation and feedback, simplification of reporting procedures, incentives for integrating AEFI reporting into routine monitoring and reporting, standardization of reporting procedures across regions, and developing appropriate interventions to address the fear of personal consequences would help improve AEFI reporting.ConclusionFrom the perspectives of a broad range of key informants at all levels of the vaccine safety system, we found multiple factors (both structural and behavioural), that may impact HCW reporting of AEFI in Ghana. Improvements in line with the suggestions are necessary for increased AEFI reporting in Ghana

Interviews conducted.

Interviews conducted.</p

AEFI reporting in Ghana (adapted from the Ghana FDA) [17].

AEFI reporting in Ghana (adapted from the Ghana FDA) [17].</p

Establishing vaccine pregnancy registries and active surveillance studies in low-and middle-income countries: Experience from an observational cohort surveillance project in The Gambia

Despite significant advances in child survival, infectious diseases continue to be among the leading causes of neonatal deaths. Maternal immunization is a well-recognized public health intervention to reduce vaccine-preventable disease-related morbidity and mortality in the pregnant woman, her foetus, and infant from tetanus, pertussis, seasonal influenza, and COVID-19. The development of new maternal vaccines against respiratory syncytial virus (RSV) and group B streptococcus (GBS) may significantly decrease the morbidity and mortality from these diseases in neonates and infants, 2 with the FDA approval for licensure of an RSV vaccine to be administered in pregnancy occurring in August 2023

Implementation of data triangulation and dashboard development for COVID-19 vaccine adverse event following immunisation (AEFI) data in Nigeria

Nigeria began administering COVID-19 vaccines on 5 March 2021 and is working towards the WHO’s African regional goal to fully vaccinate 70% of their eligible population by December 2022. Nigeria’s COVID-19 vaccination information system includes a surveillance system for COVID-19 adverse events following immunisation (AEFI), but as of April 2021, AEFI data were being collected and managed by multiple groups and lacked routine analysis and use for action. To fill this gap in COVID-19 vaccine safety monitoring, between April 2021 and June 2022, the US Centers for Disease Control and Prevention, in collaboration with other implementing partners led by the Institute of Human Virology Nigeria, supported the Government of Nigeria to triangulate existing COVID-19 AEFI data. This paper describes the process of implementing published draft guidelines for data triangulation for COVID-19 AEFI data in Nigeria. Here, we focus on the process of implementing data triangulation rather than analysing the results and impacts of triangulation. Work began by mapping the flow of COVID-19 AEFI data, engaging stakeholders and building a data management system to intake and store all shared data. These datasets were used to create an online dashboard with key indicators selected based on existing WHO guidelines and national guidance. The dashboard went through an iterative review before dissemination to stakeholders. This case study highlights a successful example of implementing data triangulation for rapid use of AEFI data for decision-making and emphasises the importance of stakeholder engagement and strong data governance structures to make data triangulation successful