HQ Team
May 1, 2025: UK scientists at biotech company Stablepharma Ltd. have developed a tetanus-diphtheria vaccine that is completely stable at room temperature and does not need to be refrigerated or frozen, and early trials on humans have started.
The UK-based biotechnology company Stablepharma’s SPVX02 vaccine was developed with support from a UK government-backed programme.
Stablepharma’s platform converts existing approved vaccines to fridge-free versions. These are ‘thermostable.’ They can be stored for long periods at room temperature.
SPVX02 is the lead candidate fridge-free tetanus and diphtheria vaccine, supported by the National Institute for Health and Care Research (NIHR), and is being trialled at Southampton Clinical Research Facility, according to a NIHR statement.
Vaccine access
The SPVX02 vaccine has been developed with support from Innovate UK. The agency is part of UK Research and Innovation (UKRI).
Access to vaccines is limited by the international, temperature-controlled supply chain (cold chain). This cold chain is complex and costly.
It requires vast amounts of energy that lead to carbon emissions. It can also lead to significant vaccine wastage when the cold chain is compromised.
“This research will be an important step toward exploring whether this innovation could eradicate vaccine wastage and move away from the need for the cold chain,” said Professor Saul Faust from the University of Southampton, who leads the trial and is a Director of the NIHR Southampton Clinical Research Facility.
Chief Development Officer of Stablepharma, Dr Karen O’Hanlon, said it was an “important milestone towards launching the world’s first fridge-free tetanus-diphtheria vaccine.
Global use by 2027
“We have also previously demonstrated that our technology can be manufactured under commercially scalable GMP conditions, enabling a scaling-up to millions of doses per year without the need for the global cold chain,” she said.
The early trials are expected to be completed in the summer of 2025. Results will be published by the end of the year.
Early-phase clinical trials are important first steps to testing treatments in people, O’Hanlon said. They examine the safety, side effects, best dose and timing of new treatments.
Stablepharma hope the vaccine will be in use globally by 2027. Tetanus and diphtheria are serious infectious diseases. Vaccination helps protect against them.
According to the World Health Organization, about half of all vaccines are wasted around the world each year. “Despite the availability of many tools for reducing such wastage, high wastage rates are still occurring in countries.”
‘Real game-changer’
Health and Social Care Secretary Wes Streeting said:“For years, vaccines have been held back by the need to be stored in a fridge, causing endless amounts of wastage and making it difficult to deliver them to remote communities.
“We are leading the charge by pushing through the world’s first trial for fridge-free vaccines. This could be a real game changer and lifesaver worldwide, helping deliver vaccines to poorer nations, where they’re often needed the most.”
Scientists at Stablepharma have previously demonstrated that the SPVX02 vaccine remains completely stable for at least 12 months at 30°C and 40°C (climate zone IVB).
The batch in the current phase I study has a shelf life of 18 months. The trial was given the go-ahead by the Medicines and Healthcare products Regulatory Agency.
The team have also shown that SPVX02 can withstand temperature fluctuation. It remained stable and fully potent after three cycles of extreme fluctuation from -20℃ to +40℃.
Expand health coverage
The company has identified up to 60 vaccines that could be suitable for StablevaX technology.
Professor Jonathan Van-Tam, former Deputy Chief Medical Officer for England, and a member of the Stablepharma Advisory Board said the fridge-free solution could transform the entire vaccine industry.
“It could also potentially lead to wider distribution and improved uptake in areas of the world where currently the stringency of the cold chain limits deployment and uptake.
“Fridge-free vaccines could, in the future, play a major role in delivering the WHO’s ambitions for universal health coverage.”
