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Unmasking safety signals in an infodemic
WHO has been promoting fair and equitable access to appropriate, safe and efficacious new COVID-19 vaccines for all countries through its prequalification (PQ) programme and Emergency Use Listing (EUL) service, and their expedited approvals in countries through facilitated pathways. Given the accelerated development of the new COVID-19 vaccines, safety data collected and reviewed for the PQ and EUL services will be limited (number of participants, duration of follow up, population heterogeneity, disease enhancement). Further characterization of the safety profiles of each vaccine will occur post emergency use authorizations in countries, provided appropriate PV capacities and resources are in place.
Established in 1968, the WHO Programme for International Drug Monitoring (PIDM) provides a global platform for Member States to exchange safety and regulatory information on all medicines and vaccines. Vigibase is the WHO global database of individual case safety reports (ICSR), a repository of safety data maintained by the WHO Collaborating Centre, the Uppsala Monitoring Centre (UMC), on behalf of WHO and its Member States. Vigibase holds over 28 million case safety reports shared by 148 countries. The data are routinely analyzed by UMC for new signals and to study trends with known signals using a Bayesian method of disproportionality analysis and adverse event-drug pair pattern detection.
The COVID-19 pandemic has seen unprecedented public interest in the new COVID-19 vaccines and therapeutics. This has led to a phenomenal surge in spontaneous reports reaching the global database in 2021. While a good number of reports is needed when applying datamining algorithms, poor quality data can seriously undermine or hamper the detection of new signals. In particular, there is a risk of excessive background noise leading to the detection of false positives, as well as of masking effect in relation to common reactions, hindering the detection of true signals.
A workshop was organized by WHO and the UMC to take stock of current methodologies in signal detection, to understand the impact of the pandemic on signal detection and to discuss new approaches, as well as agile solutions that can serve as early warning systems and complement or enhance current signal detection practices.
To access a folder containing presentation and the recording of the WHO-UMC webinar, please use this link. The technical report is available here.
Off label use of medicines for treating COVID-19 infection
During the COVID-19 pandemic several medicines were promoted to be used for prevent and treatment of the infection. These drugs were, however, not approved to be used for this particular medical condition. The off-label use of prescription drugs is associated with more adverse drug events (ADEs) in adults than on-label use, especially when off-label indications are not backed by solid data. For additional information please visit the dedicated page.