UK Scientists Successfully Trial First 'Fridge-Free' Vaccines in Patients
UK scientists have successfully trialled the first 'fridge-free' tetanus-diphtheria vaccine in a study of 60 volunteers, demonstrating equivalent immune responses to conventional vaccines. Developed by Stablepharma, the technology uses the sugar trehalose to stabilize the vaccine as a dry powder at room temperature for a year. This innovation aims to eliminate the 'cold chain' requirement, addressing the World Health Organization's estimate that half of all vaccines are wasted globally due to temperature failures and transport challenges.
Fridge-free vaccine trial results
▪A larger clinical trial involving 160 people is scheduled to begin in the coming months as the final stage of research for Stablepharma's "fridge-free" tetanus-diphtheria vaccine.
▪The early-stage clinical trial of the "fridge-free" tetanus-diphtheria vaccine demonstrated equivalent immune responses to conventional vaccines and was safe and well-tolerated.
▪UK scientists and the company Stablepharma successfully completed an early-stage clinical trial of a "fridge-free" tetanus-diphtheria vaccine involving 60 human volunteers.
Cold chain infrastructure challenges
▪Data from Stablepharma shows that the components of its "fridge-free" tetanus-diphtheria vaccine can survive temperature fluctuations cycling between -20 degrees Celsius and +40 degrees Celsius.
▪Traditional vaccines require strict temperature control, known as the "cold chain," during storage and transport, which is highly challenging in remote, impoverished, or conflict-affected regions.
▪The World Health Organization has set a target for vaccines to survive at temperatures of 30 degrees Celsius and 75 percent relative humidity.
Vaccine wastage statistics
▪The World Health Organization estimates that approximately half of all vaccines globally are wasted and discarded annually.
▪Global vaccine wastage is driven by multiple factors, including failures in the cold chain, damage during transport, passing expiration dates, and unused doses from multi-dose vials.
Trehalose stabilization technology
▪While the trehalose stabilization approach cannot be adapted for mRNA vaccines, it could stabilize many current vaccines and other medicines like monoclonal antibodies.
▪Stablepharma's clinical trial converted a liquid tetanus-diphtheria vaccine into a dry powder that remained stable at room temperature for a year before being reconstituted with water.
▪The "fridge-free" vaccine technology developed by Stablepharma uses the sugar trehalose, inspired by resurrection plants, to stabilize and protect the vaccine's vital components as a dry powder.
Global health access improvements
▪Professor Tuck Seng Wong of the UK-Southeast Asia Vaccine Manufacturing Research Hub noted that further research is needed on vaccine stability during regular temperature fluctuations and performance in larger, diverse groups.
▪Representatives from UNICEF and Stablepharma stated that reliable, fridge-free vaccines could expand immunization access to millions of people globally and make programs more sustainable.
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