Novel method to detect fake vaccines using mass spectrometry
- Falsified or 'fake' vaccines are made by criminals for financial gain and there are currently no effective devices to screen vaccine stocks in supply chains.
- Scientists have developed a first of its kind mass spectrometry method for vaccine authenticity screening using machine learning.
- The method repurposes clinical mass spectrometers already present in hospitals worldwide, making the approach feasible for global supply chain monitoring.
- The discovery offers an effective solution to the rise in counterfeit vaccines threatening public health.
Research published today in the Nature portfolio journal npj Vaccines describes a new method capable of distinguishing authentic and falsified (i.e. fake) vaccines using mass spectrometry, a technique that can identify and measure the amount of different substances in a sample based on their mass and charge. In matrix-assisted laser desorption/ionisation-mass spectrometry (MALDI-MS) the sample is ionised by placing it in a matrix material which absorbs energy from a laser. This enables large molecules to be ionised without these fragmenting, making it particularly suitable for analysing complex biological substances. A fingerprint of chemical masses for a given vaccine can be established and by using machine learning analysis the method proved effective in differentiating between a range of authentic and 'faked' vaccines previously found to have entered supply chains.
Yohan Arman using the Vitek MALDI MS system for vaccine authenticity testing
A key benefit of the novel method is that it uses clinical mass spectrometers already distributed globally for medical diagnostics and freely available open-source software for data processing and statistical analysis, giving it the potential to address the urgent need for more effective global vaccine supply chain screening.
The Zitzmann lab in the Department of Biochemistry have been working with the Department of Chemistry, the Medicines Quality Research Group (within the Nuffield Department of Medicine) and the Rutherford Appleton Laboratory (RAL) of UKRI on this project.
Professor Nicole Zitzmann , study co-leader and Professor of Virology in the Department of Biochemistry said:
"This latest research will bring the world community one step closer to being able to tell apart falsified, ineffective vaccines from the real thing, making us all safer. It has been a tremendous collaborative effort by The Vaccine Identity Evaluation (VIE) consortium , with all of us having this same important goal in mind. Bevin Gangadharan, Tehmina Bharucha, Yohan Arman and Laura Gomez Fernandez from the Department of Biochemistry all played key roles in developing this new method, which has the potential to benefit countless people at manageable cost. Our heartfelt gratitude goes to the visionary donors who match our commitment to protecting and promoting global health: two anonymous philanthropic families, the Oak Foundation, the Wellcome Trust, bioMérieux, and the Oxford Glycobiology Endowment. This research is important to our global partners, including the World Health Organisation (WHO)."
Professor James McCullagh , study co-leader and Professor of Biological Chemistry in the Department of Chemistry said:
"This method is the culmination of a number of years of collaborative research that has brought together scientists from multiple departments and divisions across the university with outside partners including Prof. Pavel Matousek at the Rutherford Appleton Laboratory at Harwell. Rebecca Clarke and John Walsby-Tickle both played key roles in the method's development in the Department of Chemistry.
We are thrilled to see the method's effectiveness and its potential for deployment into real-world vaccine authenticity screening. This is an important milestone for The VIE consortium which focusses on the development and evaluation of innovative devices for detecting falsified and substandard vaccines, supported by multiple research partners including the WHO, medicine regulatory authorities and vaccine manufacturers."
VIE project co-leader Professor Paul Newton (Professor of Tropical Medicine at the Centre for Tropical Medicine and Global Health) said:
"This innovative research provides compelling evidence that MALDI mass spectrometry techniques could be used in accessible systems for screening for vaccine falsification globally, especially in centres with hospital microbiology laboratories, enhancing public health and confidence in vaccines."
Nicole Zitzmann, Bevin Gangadharan, Tehmina Bharucha, Yohan Arman and Laura Gomez Fernandez are VIE consortium members in the Department of Biochemistry involved in this study
The global population is increasingly reliant on vaccines to maintain population health with billions of doses used annually in immunisation programs worldwide. The vast majority of vaccines are of excellent quality. However, a rise in substandard and falsified vaccines threaten global public health. Besides failing to treat the disease for which they were intended, these can have serious health consequences, including death, and reduce confidence in vaccines. Unfortunately, there is currently no global infrastructure in place to monitor supply chains using screening methods developed to identify ineffective vaccines.
In this new study, researchers developed and validated a method that was able to distinguish authentic and falsified vaccines using instruments developed for identifying bacteria in hospital microbiology laboratories. The method was based on MALDI-MS, a technique used to identify the components of a sample by giving the constituent molecules a charge then separating them. The MALDI-MS in the Zitzmann lab was a Vitek MS (bioMérieux) run by Yohan Arman and Laura Gomez. The MALDI-MS data then underwent processing using an approach established by Tehmina Bharucha with open-source software followed by statistical machine learning. This provided a reliable multi-component model which could differentiate authentic and falsified vaccines and was not reliant on a single marker or chemical constituent.
The method successfully distinguished between a range of genuine vaccines - including for influenza (flu), hepatitis B virus, and meningococcal disease - and solutions commonly used in falsified vaccines, such as saline, glucose and antibiotics. The results provide a proof-of-concept method that could be scaled to address the urgent need for global vaccine supply chain screening.
Read more in npj Vaccines: https://www.nature.com/articles/s41541-024-00946-5 and https://www.ox.ac.uk/news/2024-08-29-new-method-developed-detect-fake-va...
You can find more about our work here:
https://www.bioch.ox.ac.uk/article/vaccine-identity-evaluation-vie-in-the-zitzmann-lab
https://www.bioch.ox.ac.uk/article/advanced-laser-spectroscopy-to-detect-falsified-vaccines
https://www.bioch.ox.ac.uk/article/novel-approaches-to-identify-substandard-and-falsified-medicines
Nicole Zitzmann
28th August 2024
