The epidemiology, detection and impact of substandard and falsified vaccines
Presenting findings from research undertaken to better detect for substandard and falsified vaccines.
Paul Newton, on behalf of the VIE Consortium:
Substandard, including degraded, and falsified or counterfeit vaccines are a relatively neglected issue. This has been highlighted during the rapid and widespread rollout of COVID-19 vaccines. There have been multiple examples of SF vaccines, including deliberate falsification, errors and contamination during manufacture and degradation due to inappropriate storage conditions in supply chains.
There has been increasing interest in devices to screen for SF non-vaccine medicines including tablets and capsules to empower inspectors and standardise surveillance. However, there has been very limited published research focussed on repurposing or developing new devices for screening for SF vaccines.
Multiple devices will be needed to test at different supply chain levels. During the pandemic we pioneered research into the development and evaluation of screening devices with high sensitivity and specificity to detect SF vaccines: Matrix- assisted laser desorption/ionization-time-of-flight mass spectrometry (MALDI-TOF), spatially-offset Raman spectroscopy (SORS), rapid diagnostic tests (RDTs) and diverse lower cost devices.
The results provide preliminary data that these techniques could be used by national medicines regulators, international organisations, and vaccine manufacturers/distributors to screen for SF vaccines in supply chains, aligned with the WHO global ‘Prevent, Detect and Respond’ strategy. Each has specific advantages and disadvantages and we are planning a near-to-real-life evaluation and cost-effectiveness analysis to compare and better understand optimal supply chain positions. Caution is needed in the dissemination of the results to avoid inappropriate fuelling of vaccine hesitancy and avoid inappropriately providing details to criminals to enable them to bypass these technologies.
Speaker
Paul Newton, Nuffield Department of Medicine, University of Oxford
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