Oxford team identifies fake vaccines using mass spectrometry

The new analytical method is based on matrix-assisted laser desorption/ionisation-mass spectrometry (MALDI-MS), a technique used to identify the components of a sample by giving the constituent molecules a charge and then separating them. MALDI-MS analysis is then combined with open-source machine learning, providing a reliable multi-component model that can differentiate between real and fake vaccines, and is not reliant on a single marker or chemical constituent.

Described in Nature publication npj Vaccines, the new method successfully distinguished between a range of genuine vaccines – including influenza, hepatitis B, and meningococcal disease – and solutions commonly used in falsified vaccines, such as sodium chloride.

“We are thrilled to see the method’s effectiveness and its potential for deployment into real-world vaccine authenticity screening,” said study co-lead James McCullagh, Professor of Biological Chemistry at the University of Oxford.

 “This is an important milestone for The Vaccine Identity Evaluation (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 World Health Organization (WHO), medicine regulatory authorities and vaccine manufacturers.”

Global health is increasingly reliant on vaccines, with billions of doses used annually in immunisation programs worldwide. According to the Oxford team, 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, as well as reduce confidence in vaccines.

There is also currently no global infrastructure in place to monitor supply chains using screening methods developed to identify ineffective vaccines. However, the new research, claimed to be the first study of its kind, could have wide ranging impacts for vaccine authentication, as mass spectrometry equipment is already globally available for medical diagnostics.

“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,” said study co-author Nicole Zitzmann, Professor of Virology in Oxford’s the Department of Biochemistry.

“It has been a tremendous collaborative effort, with everyone having this same important goal in mind.”