Development and evaluation of innovative devices for detecting falsified and substandard vaccines in supply chains

We are increasingly reliant on safe and effective vaccines to prevent infectious diseases. Over 16 billion vaccines were used in 2021 to tackle the COVID-19 pandemic and >~5 million deaths are prevented annually through immunization with vaccines for >20 other diseases.


WHO estimates that 10.5% of medical products in low- and middle-income countries are substandard or falsified (SF). Some estimate>1 million deaths/year globally. There are increasing reports of SF vaccines in supply chains, risking impaired vaccine effectiveness. Substandard (often degraded by heat) and falsified (due to fraud, aka counterfeit) vaccines are a neglected global public health problem, with minimal research to inform interventions to reduce the risk. There have been multiple examples, involving thousands of patients, both before, during and after the COVID-19 pandemic, e.g. 60,000 injected with fake vaccines in Niger in 1995 and 250,000 substandard vaccines for children distributed in China in 2018. SF vaccines risk not just ineffective disease prevention but economic and societal harms, including impaired trust in vaccines. A major challenge to mitigate SF vaccine risk is a paucity of devices/methods for SF vaccine screening. Multiple devices will be needed to test at different supply chain levels. This represents a major gap in preparing for vaccine-preventable pandemics, epidemics and multiple endemic diseases.


Over the last 5 years we have pioneered research into the development and evaluation of screening devices with high sensitivity and specificity to detect SF vaccines. These include matrix-assisted laser desorption/ionization-time-of-flight mass spectrometry (MALDI-TOF), handheld spatially offset Raman spectroscopy (SORS), and rapid diagnostic tests (RDTs). Importantly, these devices are widely available globally (e.g. SORS for airport security). We work with multiple medicines regulatory authorities, vaccine manufactures, WHO and other national and international...