Health secretary Wes Streeting today (April 29) welcomed the announcement that the “world’s first trial for fridge-free vaccines” has begun at University Hospital Southampton.
Described as “an innovative vaccine that doesn’t need to be refrigerated or frozen” as it is “completely stable at room temperature”, the first participant is set to start the clinical trial this month, the NHS foundation trust said.
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Developed by Stablepharma, the tetanus-diphtheria vaccine (SPVX02) is now ready “to be trialled through a UK government-backed programme” at the National Institute for Health and Care Research (NIHR) Southampton Clinical Research Facility, it added.
“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,” Streeting said.
“But thanks to this government’s vision and our investment through the NIHR, all that could be about to change,” he said, adding that “we are leading the charge by pushing through” this vaccine.
“Lifesaver worldwide”
“This could be a real game changer and lifesaver worldwide helping deliver vaccines to poorer nations, where they’re often needed the most,” Streeting said.
He stressed that “projects like this are vital in driving growth and firmly positioning the UK as a global leader in vaccine development and research”.
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According to World Health Organization (WHO) data, “about half of all vaccines are wasted around the world each year” and access to them is limited by the “international temperature-controlled supply chain”, the trust said.
But Stablepharma’s trial aims to convert “existing approved vaccines to fridge-free versions” – which are ‘thermostable’ – allowing them to be “stored for long periods of time at room temperature”, it added.
“Shelf life of 18 months”
The clinical trial is being led by Professor Saul Faust from the University of Southampton and Stablepharma chief development officer Dr Karen O’Hanlon and the company hopes that the vaccine “will be in use globally by 2027”, the trust said.
“The phase I clinical trial is expected to complete in summer 2025 [and] results will be published by the end of the year,” it added.
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“Scientists at Stablepharma have previously demonstrated that the SPVX02 vaccine remains completely stable for at least 12 months at 30°C and 40°C,” the NHS trust said, adding that the current study batch “has a shelf life of 18 months”.
While tetanus-diphtheria is the only vaccine being trialled with the fridge-free technology at the moment, the company “has identified up to 60 vaccines” it believes could also be suitable, it added.
“Revolutionary”
O’Hanlon said that Stablepharma is “delighted to have received funding from a UK government scheme and support from NIHR” for its first clinical trial, adding that it could enable “a scaling-up to millions of doses per year without the need for the global cold chain”.
And Department of Health and Social Care (DH) chief scientific adviser Professor Lucy Chappell said that the trial “represents a crucial step in building the evidence for this game-changing development in vaccine delivery”.
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Meanwhile, England’s former deputy chief medical officer (CMO) Professor Jonathan Van-Tam said that the clinical trial could be “revolutionary for the entire vaccine industry”.
“It could also potentially lead to wider distribution and improved uptake” and “in the future, play a major role in delivering the WHO’s ambitions for universal health coverage”, he added.
