We are happy to announce the release of a comprehensive Companion Guide for the Brighton Collaboration Case Definition of Single Organ Cutaneous Vasculitis (SOCV). This new resource combines a wealth of tools and guidance to standardize vaccine safety assessments and pharmacovigilance efforts worldwide.
What is a Companion Guide?
Under the CEPI-funded Safety Platform for Emergency Vaccines (SPEAC) Project, the Brighton Collaboration developed Companion Guides to enhance the harmonization of vaccine safety assessments. Since its establishment in 2000, the Brighton Collaboration has created 74 case definitions for Adverse Events Following Immunization (AEFI) and AESI, which are critical for supporting vaccine safety research throughout a vaccine’s lifecycle. Companion Guides provide a standardized global reference by consolidating SPEAC resources and tools for selected high-priority case definitions.
What’s inside the guide?
The deliverable consolidates essential SPEAC resources, including:
– ICD-9/10-CM, MedDRA, and SNOMED CT codes.
– Background incidence rates and risk factors.
– Practical guidance for real-time investigation, data collection, analysis, and reporting.
– Tools like data abstraction forms, tabular summaries of case definition criteria, and algorithms for determining levels of certainty.
Designed for diverse stakeholders, this guide aids in assessing the occurrence of SOCV, including as a potential adverse event following immunization.
What is Single Organ Cutaneous Vasculitis (SOCV)?
Single Organ Cutaneous Vasculitis (SOCV) refers to small vessel vasculitis of the skin where systemic involvement has been excluded. This terminology is based on the 2012 revised CHCC nomenclature, which recommends naming single-organ vasculitis based on the affected organ and vessel type (e.g., cutaneous small vessel vasculitis). SOCV has been identified as an Adverse Event of Special Interest (AESI) for vaccines using vesicular stomatitis virus (VSV) vectors, such as vaccines in development against Marburg Virus and Lassa Fever.
Where to find it?
This SOCV Companion Guide is now available on the SPEAC community on Zenodo, and is citable with a Digital Object Identifier (DOI)
