Quantitative vaccine safety surveillance with VigiLyze
Uppsala Monitoring Centre (UMC) is committed to supporting members of the WHO Programme for International Drug Monitoring (WHO PIDM) in their vaccine safety surveillance efforts. Just now we recognise the challenges faced by member countries given the large numbers of incoming reports of adverse events following immunisation related to COVID-19 vaccines, and understand that a case-by-case approach to signal detection may no longer be feasible.
We have made essential improvements in VigiLyze to enable statistical screening of your national subset of the WHO global database, including powerful methods for prioritisation. To use these features, it is essential that the data is shared as recommended by the WHO Safety Surveillance Manual for COVID-19 vaccines. The improvements we have made in our data management system, VigiFlow, support the required workflow and data processing, including batch sharing of data (read more about VigiFlow improvements here). If you would you like to learn how you can share data more efficiently with VigiBase, you are welcome to contact us.
Improvements in vaccine surveillance
In pharmacovigilance, statistical screening for medicines is usually done at the active ingredient-preferred term level, and all disproportionality calculations in the Quantitative work area have been provided at this level. However, for vaccines, the active ingredient level corresponds to the disease and not individual vaccines. So we introduced an active ingredient variant that supports more granular disproportionality analysis for individual vaccines.
VigiLyze now supports vaccine-specific search and analysis, including statistical signal detection, using the therapeutic scope setting. You can set your background to either drugs and vaccines, or drugs or vaccines separately. This will affect which reports are available for searches and calculations.
A pregnancy indicator algorithm has been developed to flag maternal drug exposure before or during pregnancy. The algorithm uses multiple report parameters and is available as a new filter under Patient for more focused analysis on pregnancy cases.