Their study demonstrates the viability of SORS, which performs chemical analysis by shining a laser light into an unopened vial of the vaccine, and inspecting the light emanating from the vial to indicate the presence of different ingredients within. The research team compared genuine vaccine with liquids known to be used in falsified vaccines and were able to distinguish them without opening the vial.
The new SORS method to counter the problem of COVID-19 vaccine falsification was developed by an international consortium that included researchers from several University of Oxford departments and institutes, including MORU and IDDO’s Medicine Quality Research Group, as well as the UK's Science and Technology Facilities Council (STFC), Agilent Technologies, WHO Geneva, the Serum Institute of India, and the University of Huddersfield. The work was supported by the WHO, the Oak Foundation, and two anonymous philanthropic families.
There have been numerous instances of vaccine supply chains being infiltrated by falsified products, both for vaccines before the pandemic and for COVID-19 around the globe. Since the emergence of COVID-19 and its immunisation programs worldwide, there have been over 184 public domain reports across 48 countries of diverted and substandard or falsified COVID-19 vaccines.
Apart from endangering the public by not effectively protecting people from COVID-19, these incidences also risk undermining trust in vaccines. As such, it is critically important that we maintain integrity of supply chains by detecting falsified products rapidly and effectively.
SORS was originally invented and developed by an STFC Central Laser Facility at Harwell, Oxon, with handheld. portable SORS devices are produced by Agilent Technologies. They are used to screen for hazardous substances at airports and used widely by fire officers, military, border protection and law enforcement. Only minor modifications in sample compartment and software adaption are required to deploy SORS to identify falsified vaccines. That SORS can effectively screen for falsified vaccines without opening the vial is a major advantage in terms of speed of detection and ability to use vaccines that pass the SORS testing.
Although this study focusses only on COVID-19 vaccines, researchers say the SORS technique could also be used to authenticate other COVID-19 and non-COVID-19 vaccines, liquids, and solid medicines.
"There has been minimal research to develop and evaluate screening devices for detecting falsified vaccines in supply chains and this research suggests a viable technique for empowering inspectors to do this – more work is needed for diverse vaccines and where to place such devices in supply chains and their implementation and cost-effectiveness," said study co-author Prof Paul Newton, of the University of Oxford and Head of MORU's Medicine Quality Research Group.
-Text contributions: John Bleho, Charvy Narain, Paul Newton, and STFC comms.
Image courtesy of Vaccine.
Innovative method for rapid detection of falsified COVID-19 vaccines through unopened vials using handheld Spatially Offset Raman Spectroscopy (SORS). Mosca S, Lin Q, Stokes R, Bharucha T, Gangadharan B, Clarke R, Fernandez LG, Deats M, Walsby-Tickle J, Arman BY, Chunekar SR, Patil KD, Gairola S, Van Assche K, Dunachie S, Merchant HA, Kuwana R, Maes A, McCullagh J, Caillet C, Zitzmann N, Newton PN, Matousek P. Vaccine. 2023 Nov 13;41(47):6960-6968. doi: 10.1016/j.vaccine.2023.10.012. Epub 2023 Oct 20. PMID: 37865599.