Researchers from the University of Oxford, in collaboration with the Serum Institute of India and other partners, have made a breakthrough in the fight against falsified vaccines, developing a novel method that allows the detection of counterfeit vaccines without the need to open the vaccine vial. This significant advancement, published in npj Vaccines, analyzes the vial’s label and its adhesive to determine authenticity. The new technique not only keeps vaccine vials intact but also provides a non-invasive way to confirm whether the liquid inside is a genuine vaccine or a falsified substitute.
Tackling the Growing Threat of Falsified Vaccines
The issue of substandard and falsified medicines is a global concern, especially in low- and middle-income countries. The World Health Organization (WHO) estimates that approximately 10.5% of medicines worldwide are substandard or falsified, with devastating implications for public health. Falsified vaccines, in particular, pose a unique danger: they can fail to provide the protection they promise, leaving individuals vulnerable to preventable diseases. Furthermore, they may contain harmful substances that could cause serious side effects or even death.
The COVID-19 pandemic highlighted the urgency of addressing this problem, as the distribution of billions of vaccine doses brought with it an increased risk of counterfeit products entering the market. While the majority of vaccines were legitimate and effective, reports of falsified vaccines, including COVISHIELD (produced by the Serum Institute of India), surfaced in countries such as Uganda, India, and Myanmar. In these cases, the labels on the vials were found to be tampered with, raising concerns about the safety and authenticity of the vaccines being administered to the public.
The Vaccine Identify Evaluation (VIE) Collaboration
To combat this growing problem, the Vaccine Identify Evaluation (VIE) Collaboration, a group of researchers and institutions, has been working to develop methods for identifying falsified vaccines throughout the global supply chain. Their latest innovation involves the use of MALDI-ToF mass spectrometry, a technology commonly used in hospitals for bacterial identification. This technique has proven to be an effective tool in detecting counterfeit vaccines, even without opening the vial or disturbing its contents.
MALDI-ToF Mass Spectrometry: A Game-Changer for Vaccine Authentication
MALDI-ToF (Matrix-Assisted Laser Desorption/Ionization Time-of-Flight) mass spectrometry is a widely accessible technology that uses laser pulses to ionize molecules and measure their mass-to-charge ratios. The technique produces a spectral “fingerprint” that can be used to identify a wide range of substances. In the context of the new study, the VIE team has successfully adapted MALDI-ToF mass spectrometry to analyze both the vaccine label and vaccine liquid, enabling the detection of falsified products.
In their research, the VIE team focused on the COVISHIELD vaccine, examining both the label and the adhesive used to affix it to the vial. By analyzing the spectra produced by these components, they demonstrated that they could detect falsified vaccines that used counterfeit labels, even when the label itself appeared identical to the genuine product. The method was also able to differentiate genuine vaccine liquid from falsified surrogates, such as those made with common substances like amikacin, a drug sometimes used in the production of counterfeit vaccines.
How the New Method Works
The new method involves two primary components: analyzing the vaccine vial label and examining the liquid inside the vial.
- Vaccine Label Analysis: To test the authenticity of a vaccine label, researchers simply cut off a small piece of the label, extract its adhesive in a solvent, and analyze the sample using MALDI-ToF mass spectrometry. The spectral profile generated by the adhesive can be compared against reference data, allowing researchers to determine whether the label is genuine or has been tampered with.
- Vaccine Liquid Analysis: In addition to the label, the researchers also developed a method for analyzing the vaccine liquid itself. Even if counterfeiters used the same ingredients in their falsified vaccines as the genuine product, the liquid can still be identified as fake due to the unique spectral profile of the excipient—an inactive substance used as a vehicle for the active ingredients in the vaccine. This excipient acts as an “internal marker,” helping to distinguish authentic vaccine liquids from their falsified counterparts.
Accessibility and Global Application
One of the key advantages of this new method is its accessibility. The MALDI-ToF mass spectrometers used in this research are already widely available in hospitals and laboratories around the world, including in low- and middle-income countries. These devices are commonly used for clinical microbiology, making the new vaccine screening method highly adaptable for global use.
The researchers also made sure that the method would work with two different types of MALDI-ToF mass spectrometers: the bioMérieux VITEK MS and the Bruker Sirius. Between them, these devices are available in nearly every country, making this technology accessible even in resource-limited settings where the problem of falsified vaccines is most severe.
Professor Nicole Zitzmann, a co-leader of the study, emphasized the importance of ensuring that the method is usable worldwide: “We need this method to be useful everywhere, and particularly in low- and middle-income countries. This is why we developed it for two different MALDI-ToF mass spectrometers, which are available globally and widely used in clinical microbiology.”
A Step Toward Global Vaccine Security
The development of this non-invasive method is a crucial step forward in ensuring the safety and authenticity of vaccines worldwide. With the increasing global reliance on vaccines to maintain public health, the rise in substandard and falsified vaccines presents a growing threat. This innovative approach offers a practical and efficient solution for detecting counterfeit vaccines in supply chains, without compromising the integrity of the vaccine vial or the vaccine’s distribution.
As Professor James McCullagh, another co-leader of the study, noted, “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.”
The VIE team’s work marks a significant milestone in the fight against falsified vaccines. It provides a simple, accessible tool that can be used locally to identify counterfeit products and ensure the safety of vaccines before they reach vulnerable populations. This research could pave the way for the creation of global vaccine reference libraries, which could further enhance the ability to detect and prevent falsified vaccines, ensuring that the promise of vaccination remains intact for generations to come.
Conclusion
The detection of falsified vaccines is an essential issue in global public health, and the research conducted by the VIE team offers an innovative solution that could transform the way counterfeit vaccines are identified. By utilizing MALDI-ToF mass spectrometry to analyze vaccine labels and liquids, the team has developed a method that is both effective and accessible, with the potential to be applied worldwide. As the fight against substandard and falsified vaccines continues, this breakthrough technology represents a major step forward in safeguarding public health and ensuring that vaccines remain safe, effective, and available to those who need them most.
Reference: Benediktus Yohan Arman et al, Identifying falsified COVID-19 vaccines by analysing vaccine vial label and excipient profiles using MALDI-ToF mass spectrometry, npj Vaccines (2025). DOI: 10.1038/s41541-024-01051-3
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