Identifying falsified COVID-19 vaccines by analysing vaccine vial label and excipient profiles using MALDI-ToF mass spectrometry
Abstract The rapid development and worldwide distribution of COVID-19 vaccines is a remarkable achievement of biomedical research and logistical implementation. However, these developments are associated with the risk of a surge of substandard and falsified (SF) vaccines, as illustrated by the 184 i...
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Nature Portfolio
2025-01-01
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| Series: | npj Vaccines |
| Online Access: | https://doi.org/10.1038/s41541-024-01051-3 |
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| author | Benediktus Yohan Arman Rebecca Clarke Tehmina Bharucha Laura Gomez Fernandez John Walsby-Tickle Michael Deats Sara Mosca Qianqi Lin Sneha Banerjee Shrikrishna R. Chunekar Kundan D. Patil Sunil Gairola Susanna Dunachie Hamid A. Merchant Robert Stokes Rutendo Kuwana Alexandrine Maes Jean-Philippe Charrier Fay Probert Céline Caillet Pavel Matousek James McCullagh Paul N. Newton Nicole Zitzmann Bevin Gangadharan |
| author_facet | Benediktus Yohan Arman Rebecca Clarke Tehmina Bharucha Laura Gomez Fernandez John Walsby-Tickle Michael Deats Sara Mosca Qianqi Lin Sneha Banerjee Shrikrishna R. Chunekar Kundan D. Patil Sunil Gairola Susanna Dunachie Hamid A. Merchant Robert Stokes Rutendo Kuwana Alexandrine Maes Jean-Philippe Charrier Fay Probert Céline Caillet Pavel Matousek James McCullagh Paul N. Newton Nicole Zitzmann Bevin Gangadharan |
| author_sort | Benediktus Yohan Arman |
| collection | DOAJ |
| description | Abstract The rapid development and worldwide distribution of COVID-19 vaccines is a remarkable achievement of biomedical research and logistical implementation. However, these developments are associated with the risk of a surge of substandard and falsified (SF) vaccines, as illustrated by the 184 incidents with SF and diverted COVID-19 vaccines which have been reported during the pandemic in 48 countries, with a paucity of methods for their detection in supply chains. In this context, matrix-assisted laser desorption ionisation-time of flight (MALDI-ToF) mass spectrometry (MS) is globally available for fast and accurate analysis of bacteria in patient samples, offering a potentially accessible solution to identify SF vaccines. We analysed the COVISHIELD™ COVID-19 vaccine; falsified versions of which were found in India, Myanmar and Uganda. We demonstrate for the first time that analysis of spectra from the vaccine vial label and its adhesive could be used as a novel approach to detect falsified vaccines. Vials tested by this approach could be retained in the supply chain since it is non-invasive. We also assessed whether MALDI-ToF MS could be used to distinguish the COVISHIELD™ vaccine from surrogates of falsified vaccines and the effect of temperature on vaccine stability. Both polysorbate 80 and L-histidine excipients of the genuine vaccine could be detected by the presence of a unique combination of MALDI-ToF MS peaks which allowed us to distinguish between the genuine vaccines and falsified vaccine surrogates. Furthermore, even if a falsified product contained polysorbate 80 at the same concentration as used in the genuine vaccine, the characteristic spectral profile of polysorbate 80 used in genuine products is a reliable internal marker for vaccine authenticity. Our findings demonstrate that MALDI-ToF MS analysis of extracts from vial labels and the vaccine excipients themselves can be used independently to detect falsified vaccines. This approach has the potential to be integrated into the national regulatory standards and WHO’s Prevent, Detect, and Respond strategy as a novel effective tool for detecting falsified vaccines. |
| format | Article |
| id | doaj-art-bd148a3106b1418d998d79075def1147 |
| institution | Kabale University |
| issn | 2059-0105 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | npj Vaccines |
| spelling | doaj-art-bd148a3106b1418d998d79075def11472025-02-02T12:07:34ZengNature Portfolionpj Vaccines2059-01052025-01-0110111410.1038/s41541-024-01051-3Identifying falsified COVID-19 vaccines by analysing vaccine vial label and excipient profiles using MALDI-ToF mass spectrometryBenediktus Yohan Arman0Rebecca Clarke1Tehmina Bharucha2Laura Gomez Fernandez3John Walsby-Tickle4Michael Deats5Sara Mosca6Qianqi Lin7Sneha Banerjee8Shrikrishna R. Chunekar9Kundan D. Patil10Sunil Gairola11Susanna Dunachie12Hamid A. Merchant13Robert Stokes14Rutendo Kuwana15Alexandrine Maes16Jean-Philippe Charrier17Fay Probert18Céline Caillet19Pavel Matousek20James McCullagh21Paul N. Newton22Nicole Zitzmann23Bevin Gangadharan24Department of Biochemistry, University of OxfordDepartment of Chemistry, University of OxfordDepartment of Biochemistry, University of OxfordDepartment of Biochemistry, University of OxfordDepartment of Chemistry, University of OxfordMedicine Quality Research Group, NDM Centre for Global Health Research, Nuffield Department of Medicine, University of OxfordCentral Laser Facility, Research Complex at Harwell, STFC Rutherford Appleton Laboratory, UKRI, Harwell CampusCentral Laser Facility, Research Complex at Harwell, STFC Rutherford Appleton Laboratory, UKRI, Harwell CampusCentral Laser Facility, Research Complex at Harwell, STFC Rutherford Appleton Laboratory, UKRI, Harwell CampusSerum Institute of India Pvt. Ltd., 212/2, HadapsarSerum Institute of India Pvt. Ltd., 212/2, HadapsarSerum Institute of India Pvt. Ltd., 212/2, HadapsarMahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol UniversityDepartment of Bioscience, School of Health, Sport and Bioscience, University of East London, Water LaneAgilent Technologies LDA UK, Becquerel AvenueRegulation and Safety Unit, Regulation and Prequalification Department, Access to Medicines and Health Products Division, World Health Organization (WHO)Regulation and Safety Unit, Regulation and Prequalification Department, Access to Medicines and Health Products Division, World Health Organization (WHO)Department of Microbiology Research & Development, bioMérieuxDepartment of Chemistry, University of OxfordMedicine Quality Research Group, NDM Centre for Global Health Research, Nuffield Department of Medicine, University of OxfordMedicine Quality Research Group, NDM Centre for Global Health Research, Nuffield Department of Medicine, University of OxfordDepartment of Chemistry, University of OxfordMedicine Quality Research Group, NDM Centre for Global Health Research, Nuffield Department of Medicine, University of OxfordDepartment of Biochemistry, University of OxfordDepartment of Biochemistry, University of OxfordAbstract The rapid development and worldwide distribution of COVID-19 vaccines is a remarkable achievement of biomedical research and logistical implementation. However, these developments are associated with the risk of a surge of substandard and falsified (SF) vaccines, as illustrated by the 184 incidents with SF and diverted COVID-19 vaccines which have been reported during the pandemic in 48 countries, with a paucity of methods for their detection in supply chains. In this context, matrix-assisted laser desorption ionisation-time of flight (MALDI-ToF) mass spectrometry (MS) is globally available for fast and accurate analysis of bacteria in patient samples, offering a potentially accessible solution to identify SF vaccines. We analysed the COVISHIELD™ COVID-19 vaccine; falsified versions of which were found in India, Myanmar and Uganda. We demonstrate for the first time that analysis of spectra from the vaccine vial label and its adhesive could be used as a novel approach to detect falsified vaccines. Vials tested by this approach could be retained in the supply chain since it is non-invasive. We also assessed whether MALDI-ToF MS could be used to distinguish the COVISHIELD™ vaccine from surrogates of falsified vaccines and the effect of temperature on vaccine stability. Both polysorbate 80 and L-histidine excipients of the genuine vaccine could be detected by the presence of a unique combination of MALDI-ToF MS peaks which allowed us to distinguish between the genuine vaccines and falsified vaccine surrogates. Furthermore, even if a falsified product contained polysorbate 80 at the same concentration as used in the genuine vaccine, the characteristic spectral profile of polysorbate 80 used in genuine products is a reliable internal marker for vaccine authenticity. Our findings demonstrate that MALDI-ToF MS analysis of extracts from vial labels and the vaccine excipients themselves can be used independently to detect falsified vaccines. This approach has the potential to be integrated into the national regulatory standards and WHO’s Prevent, Detect, and Respond strategy as a novel effective tool for detecting falsified vaccines.https://doi.org/10.1038/s41541-024-01051-3 |
| spellingShingle | Benediktus Yohan Arman Rebecca Clarke Tehmina Bharucha Laura Gomez Fernandez John Walsby-Tickle Michael Deats Sara Mosca Qianqi Lin Sneha Banerjee Shrikrishna R. Chunekar Kundan D. Patil Sunil Gairola Susanna Dunachie Hamid A. Merchant Robert Stokes Rutendo Kuwana Alexandrine Maes Jean-Philippe Charrier Fay Probert Céline Caillet Pavel Matousek James McCullagh Paul N. Newton Nicole Zitzmann Bevin Gangadharan Identifying falsified COVID-19 vaccines by analysing vaccine vial label and excipient profiles using MALDI-ToF mass spectrometry npj Vaccines |
| title | Identifying falsified COVID-19 vaccines by analysing vaccine vial label and excipient profiles using MALDI-ToF mass spectrometry |
| title_full | Identifying falsified COVID-19 vaccines by analysing vaccine vial label and excipient profiles using MALDI-ToF mass spectrometry |
| title_fullStr | Identifying falsified COVID-19 vaccines by analysing vaccine vial label and excipient profiles using MALDI-ToF mass spectrometry |
| title_full_unstemmed | Identifying falsified COVID-19 vaccines by analysing vaccine vial label and excipient profiles using MALDI-ToF mass spectrometry |
| title_short | Identifying falsified COVID-19 vaccines by analysing vaccine vial label and excipient profiles using MALDI-ToF mass spectrometry |
| title_sort | identifying falsified covid 19 vaccines by analysing vaccine vial label and excipient profiles using maldi tof mass spectrometry |
| url | https://doi.org/10.1038/s41541-024-01051-3 |
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