Relevant Brighton Collaboration Resources and Tools
Brighton Collaboration is working diligently to fight the coronavirus disease (COVID-19) pandemic.
The Coalition for Epidemic Preparedness Innovations (CEPI) has partnered with the Brighton Collaboration (BC), through the Task Force for Global Health (TFGH), to harmonize the safety assessment of CEPI-funded vaccines via its Safety Platform for Emergency vACcines (SPEAC) Project. SPEAC is creating resources and tools to facilitate COVID-19 vaccine safety clinical trials and pharmacovigilance. Each is described briefly below, along with a link to the specific content page for all AESI. Further information regarding availability for each AESI is provided at the content page.
To view a complete list of BC publications and related tools, please click here. Publications and related tools are organized in a Google spreadsheet that is sortable and filterable by each column. Direct clickable links to publication DOIs are provided.
BC Resources and Tools Relevant for COVID-19:
This deliverable provides guidance on the collection of safety data for COVID-19 vaccine candidates
COVID-19 AESI list: Literature Review and Quarterly Updates
Excel spreadsheet with updated citations, tabbed by AESI
Topics include regulatory approvals, risk management plans, usage recommendations, adverse events and databases. This resource is intended for public use by anyone who is interested in details about Covid-19 vaccines.
Webinars to explain and discuss relevant BC work.
2. Draft BC templates
AESI Case Definitions
2. Draft BC Case definitions
Glossary of Terms
(content summarized below)
Comprehensive guide to accompany each AESI case definition. The guides bring together CEPI-SPEAC outputs into one place for each AESI including the specific content as summarized below. In addition, the guides include brief sections on development of the various resources including background, objectives, methods, results and recommendations for use.
1. Risk Factors
Tabular presentation of known risk factors and/or causes including vaccine(s)
2. Background Rates
Tabular presentation of AESI population-based incidence (overall and by country, gender and age where known) based on systematic literature review.
3. Diagnosis, Data Analysis and Presentation
Tabular presentation that summarizes recommendations for real time investigation relevant to what is needed to meet levels of certainty as well as what would exclude an event as a case. This also captures key elements of the published case definition guidelines most relevant to the AESI as an AEFI.
4. ICD-9/10-CM, MedDRA Codes
Tabular presentations of ICD and MedDRA codes that can be used to search for and/or code AESI in research and pharmacovigilance databases as well as for administrative databases. These may also be accessed in a separate document that includes codes for several AESI (anaphylaxis, thrombocytopenia, generalized convulsion, aseptic meningitis, GBS, encephalitis, myelitis, ADEM and facial nerve palsy) and also provides a more detailed description of the methodology used to generate them.
5. Data Abstraction & Interpretation Forms
Detailed case report form for collection of clinical and laboratory case data from hospital or other collections of medical data with instructions for applying the data to determine Brighton case definition level of diagnostic certainty. It also summarizes what data are needed to meet the case definition.
6. Tabular Checklist & Level of Certainty Algorithm
Abbreviated one page form to capture key case definition criteria along with an algorithm to determine level of certainty.
7. Pictorial Level of Certainty Algorithm
Single page guide that provides a step-wise decision tree to determine case definition level of certainty. It also includes checkboxes so known case data can be captured as part of the assessment process.