The new method analyses the vaccine vial label and its adhesive and therefore allows the vaccine vials to be retained in the supply chain. Furthermore, the study has shown that the technique can also differentiate genuine Covid-19 vaccine liquid from falsified vaccine surrogates, using a recently published method developed using non-Covid vaccines.
The World Health Organization (WHO) estimates that 10.5% of medicines worldwide in low- and middle-income countries are substandard or are falsified (i.e. fake) medicines made by criminals. This threatens global health since the medicines and vaccines fail to prevent and treat the diseases for which they were intended, and they risk additional adverse health consequences if the ingredients used by criminals in the falsified products are harmful.
The development of vaccines against Covid-19 was a remarkable achievement marked by the supply and distribution of billions of doses worldwide. Although the vast majority of Covid-19 vaccines were genuine and efficacious, falsified vaccines, including the COVISHIELD™ vaccine, were found in Uganda, India and Myanmar. In these cases, the label on the vaccine vial had also been falsified.
The Vaccine Identify Evaluation (VIE) Collaboration are developing novel tests for detecting falsified vaccines in supply chains. The international consortium who worked on this study include representatives from:
- University of Oxford’s Nuffield Department of Medicine, Department of Biochemistry, Kavli Institute for Nanoscience Discovery and Department of Chemistry
- STFC, part of UK Research and Innovation (UKRI)
- WHO, Geneva
- Serum Institute of India
- bioMérieux, France
- University of East London
- Agilent Technologies
In this new study, researchers in the VIE team have used devices, called MALDI-ToF mass spectrometers, which are widely available throughout the world and used in hospitals for identifying bacteria. They tested the COVISHIELD™ vaccine produced by the Serum Institute of India and show for the first time that analysis of spectra from the vaccine vial label and its adhesive could be used to detect falsified vaccines – this novel method could be applied to other medicine labels.
The vaccine liquid could also be easily differentiated from a range of solutions commonly used in falsified vaccines, such as amikacin which had been used for falsified COVISHIELD™ vaccine.
VIE team leader, Professor Paul Newton of the Centre for Tropical Medicine and Global Health, University of Oxford and Head of MORU MQRG, said: "This innovative approach gives a relatively simple and accessible method for the local screening of vaccine labels and liquids for authenticity and detecting falsified vaccines when fake labels have been used. For implementation in supply chains, joined up systems for access to MALDI-ToF vaccine label and liquid reference libraries will be needed, but such libraries are already available for bacteria."
Study co-leader, Dr Bevin Gangadharan of the Department of Biochemistry and Kavli Institute for Nanoscience Discovery, University of Oxford, said: "For analysing the label, the approach is simple and involves cutting off a small piece of the label, extracting its adhesive in a solvent and then analysing the sample. For the vaccine liquid, even if criminals made up falsified vaccines using the same ingredients at the same concentration, they could still be identified due to characteristic spectral profile of an excipient which acts as an internal marker for authenticity."
Study co-leader, Professor Nicole Zitzmann of the Department of Biochemistry and Kavli Institute for Nanoscience Discovery, University of Oxford, said "We need this method to be useful everywhere in the world, and particularly in low- and middle-income countries. This is why we developed it for two different MALDI-ToF mass spectrometers, the bioMérieux VITEK® MS and the Bruker Sirius, which - between them - are available in almost every country in the world, where they are being used for clinical microbiology. A particular thank you goes to bioMérieux for all their support and the loan of their instrument for this development work."
Study co-leader, Professor James McCullagh of the Department of Chemistry, University of Oxford, said: "With an increasing global reliance on vaccines to maintain population health, and the rise in substandard and falsified vaccines, this method is both timely and addresses an important global need. I am delighted to see that our recently published method using mass spectrometry with machine learning is already being applied to innovate non-invasive detection of falsified vaccines."