‘Revolutionary’ fridge-free vaccines to be trialled in UK
British scientists have begun the world’s first clinical trial of a vaccine that doesn’t require refrigeration, using breakthrough technology that could become a "global lifesaver."
Currently, most vaccines must be kept cold or frozen, and this "cold chain" poses a major obstacle to vaccinating people in developing nations — resulting in around half of all vaccines being discarded each year.
The UK biotech company Stablepharma, with government support, has created a new method that transforms existing vaccines into "thermostable" versions that can be stored at room temperature for extended periods.
One of these, the Stablepharma tetanus-diphtheria vaccine (SPVX02), is now undergoing human trials at University Hospital Southampton.
The trial is due to conclude by the summer, and the company aims to have the vaccine available globally by 2027 to protect children against tetanus and diphtheria.
Stablepharma has identified 60 vaccines that could potentially be converted into fridge-free forms, and said it could quickly ramp up production to manufacture "millions of doses a year."
Health secretary Wes Streeting said: “For too long, vaccines have been limited by the need for refrigeration — leading to vast amounts of waste and making it difficult to reach remote areas.
Two nurses in a clinical setting prepare a fridge-free vaccine for testing.
“But thanks to the vision of this government and our investment through the National Institute for Health and Care Research (NIHR), that could all be about to change.
“We’re leading the way with the world’s first trial of fridge-free vaccines. This could transform vaccine delivery and save lives around the globe — opening up new ways for poorer nations to get vaccines to the people who need them most.
“Britain’s strength has always been groundbreaking science, and this innovation cements our role as a global leader in vaccine research and development — helping drive growth and economic security, key parts of our Plan for Change.”
The vaccine has been shown to remain stable between -20C and 40C, with a shelf life of up to 18 months. One of the biggest hurdles to effective vaccination is the cold chain — a costly, complex global network that requires huge amounts of energy and contributes to carbon emissions.
Professor Sir Jonathan Van-Tam, former deputy chief medical officer for England and a member of Stablepharma’s advisory board, said: “If the challenges and complications of the global cold chain could be solved with a proven fridge-free solution like Stablepharma’s, it would not only revolutionise the vaccine sector but could also dramatically improve distribution and uptake in areas where maintaining the cold chain is currently impossible.
“Fridge-free vaccines could play a crucial part in advancing the WHO’s goals for universal health coverage.”
The clinical trial, focused on assessing safety and potential side effects, is being led by Professor Saul Faust from the University of Southampton alongside Dr Karen O’Hanlon, Stablepharma’s chief development officer.
Faust said: “This study is a key step in seeing whether this innovation could eliminate vaccine wastage and allow us to move beyond the cold chain.”
O’Hanlon added: “We’re thrilled to have secured funding from a UK government programme and support from NIHR for our first clinical trial. This marks an important milestone towards introducing the world’s first fridge-free tetanus-diphtheria vaccine.
“We have also shown that our technology can be produced at commercial scale under GMP [good manufacturing practice] conditions, making it possible to manufacture millions of doses annually without relying on the global cold chain.”