23 research outputs found
Developing Product Label Information to Support Evidence-Informed Use of Vaccines in Pregnancy
Background: Product labelling information describing the use of vaccines in pregnancy continues to contain cautionary language even after clinical and epidemiological evidence of safety becomes available. This language raises safety concerns among healthcare providers who may hesitate to recommend vaccines during pregnancy.
Purpose: To develop clear evidence-based language about vaccine safety and effectiveness in pregnancy for inclusion in vaccine product labels.
Methods: We conducted a three-stage consensus-methods project with stakeholders, including: healthcare providers, vaccine regulators, industry representatives, and experts in public health, communication, law, ethics, and social sciences. Using qualitative and quantitative methods, we held a nominal group technique (NGT) meeting, followed by a Delphi survey, and then a consensus workshop with a subset of Delphi participants. We developed a methodological tool to analyse data for consensus.
Principal results: Stakeholders (N = 14) at the NGT meeting drafted product label statements for evaluation in the Delphi survey. Survey participants (N = 41) provided feedback on statements for five hypothetical vaccines. Workshop participants (N = 27) initiated discussions that demonstrated a lack of awareness that the regulatory purpose of product labels is to provide a scientific summary of product-specific preclinical and clinical trial data. Each stage of this project built on earlier stages until we achieved strong consensus on the language, structure, and types of data that stakeholders wanted to include in inactivated influenza vaccine (IIV) and tetanus-diphtheria-acellular pertussis (Tdap) vaccine product labels in Canada.
Conclusions: The revised statements for IIV and Tdap aligned with workshop participantsâ goals that the product label be evidence-based, with a consistent structure and language that is easily understood by healthcare providers. Emergent methods uncovered stakeholder concerns about the regulatory purpose, content, and evidence used in product labels. Involving healthcare providers in the development and regular updating of product information could prevent interpretations of that information that contribute to vaccine hesitancy
Neonatal infections: Case definition and guidelines for data collection, analysis, and presentation of immunisation safety data.
Maternal vaccination is an important area of research and requires appropriate and internationally comparable definitions and safety standards. The GAIA group, part of the Brighton Collaboration was created with the mandate of proposing standardised definitions applicable to maternal vaccine research. This study proposes international definitions for neonatal infections. The neonatal infections GAIA working group performed a literature review using Medline, EMBASE and the Cochrane collaboration and collected definitions in use in neonatal and public health networks. The common criteria derived from the extensive search formed the basis for a consensus process that resulted in three separate definitions for neonatal blood stream infections (BSI), meningitis and lower respiratory tract infections (LRTI). For each definition three levels of evidence are proposed to ensure the applicability of the definitions to different settings. Recommendations about data collection, analysis and presentation are presented and harmonized with the Brighton Collaboration and GAIA format and other existing international standards for study reporting
Neonatal seizures: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data.
Risk of seizures after immunization in children with epilepsy: a risk interval analysis
Abstract Background In children with epilepsy, fever and infection can trigger seizures. Immunization can also induce inflammation and fever, which could theoretically trigger a seizure. The risk of seizure after immunization in children with pre-existing epilepsy is not known. The study objective was to determine the risk of medically attended seizure after immunization in children with epilepsy <â7Â years of age. Methods We conducted a retrospective study of children <â7Â years of age with epilepsy in Nova Scotia, Canada from 2010 to 2014. Hospitalizations, emergency visits, unscheduled clinic visits, and telephone calls for seizures were extracted from medical records. Immunization records were obtained from family physicians and Public Health with informed consent. We conducted a risk interval analysis to estimate the relative risk (RR) of seizure during risk periods 0â14, 0â2, and 5â14Â days post-immunization versus a control period 21â83Â days post-immunization. Results There were 302 children with epilepsy who were eligible for the study. Immunization records were retrieved on 147 patients (49%), of whom 80 (54%) had one or more immunizations between the epilepsy diagnosis date and age 7Â years. These 80 children had 161 immunization visits and 197 medically attended seizures. Children with immunizations had more seizures than either those with no immunizations or those with no records (mean 2.5 versus 0.7 versus 0.9, pâ<â0.001). The risk of medically attended seizure was not increased 0â14Â days after any vaccine (RRâ=â1.1, 95% confidence interval (CI): 0.5â2.8) or 0â2Â days after inactivated vaccines (RRâ=â0.9, 95% CI: 0.1â7.1) versus 21â83Â days post-immunization. No seizure events occurred 5â14Â days after live vaccines. Conclusions Children with epilepsy do not appear to be at increased risk of medically attended seizure following immunization. These findings suggest that immunization is safe in children with epilepsy, with benefits outweighing risks
Additional file 1: of Risk of seizures after immunization in children with epilepsy: a risk interval analysis
Results of sensitivity analyses of risk interval analysis. This table presents the results of the analysis of the risk of seizure 0â14Â days after any vaccine versus 7â83Â days before immunization, the risk of seizure 0â2Â days after an inactivated vaccine versus 7â83Â days before immunization and the risk of seizure 0â3Â days after an inactivated vaccine versus 21â83Â days post-immunization. (XLSX 9 kb
Vaccine regulation should require and enforce the inclusion of pregnant and breastfeeding women in prelicensure clinical trials
Exclusion of pregnant and breastfeeding women from the pivotal randomized controlled trials for COVID-19 vaccines that led to emergency regulatory approval created gaps in data needed for vaccine policy, healthcare provider recommendations, and womenâs decisions about vaccination. We argue that such knowledge gaps increase potential for vaccine hesitancy and misinformation relating to the health of women and infants, and that these gaps in evidence are avoidable. Over several decades, ethical and scientific guidance, scholarship, and advocacy in favor of pregnant and breastfeeding womenâs participation in clinical development of vaccines has accumulated. Guidance on how to include pregnant and breastfeeding women in vaccine trials ethically and safely predates the COVID-19 pandemic but has yet to be routinely incorporated in vaccine development. We highlight the important role regulatory authorities could play in requiring that pregnant and breastfeeding women be eligible as volunteer participants in prelicensure vaccine trials for products that are expected to be used in this population. Inclusion of pregnant and breastfeeding populations in clinical trials leading to market approval or emergency use authorization should be undertaken early or concurrently at the time of trials in the general population
Effect of package insert language on health-care providers' perceptions of influenza vaccination safety during pregnancy
Is âconflict of interestâ a Misnomer? Managing interests in immunization research and evaluation
Potential conflicts of interest in vaccine research can lead to negative consequences that undermine public trust and thereby put communities at risk. However, collaborations that may give rise to potential conflicts between interests can also greatly facilitate appropriate, scientifically robust, and timely vaccine development, implementation, and evaluation. At present, policies regarding the management of potential conflicts between interests are not ideal. To optimally manage interests in vaccine research, we recommend acknowledging all forms of interests and treating them all as relevant, developing appropriate collaborations, referring to all âconflicts of interestâ simply as âinterestsâ or âdeclarations,â and promoting transparency through developing consistent reporting mechanisms