UK scientists have announced the first successful human clinical trial of a vaccine that does not require refrigeration. Most vaccines today must be stored under strict cold or frozen conditions, yet around half are wasted annually due to temperature fluctuations that render them ineffective. In a trial involving 60 volunteers, UK pharmaceutical company Stablepharma transformed a liquid tetanus-diphtheria vaccine into a 'no-refrigeration' version by turning it into a dry powder. The powder can be stored at room temperature for up to a year and then reconstituted with water before injection. The 'cold chain'—the temperature-controlled supply chain from manufacturing to administration—is a major logistical hurdle, especially in impoverished, remote, or conflict-affected regions where refrigeration and stable electricity are scarce. The UK's National Institute for Health and Care Research (NIHR) is now testing this innovative technology, inspired by 'resurrection plants'—species that can survive extreme dehydration by producing a sugar called trehalose, which protects their cells. The research team used trehalose to dry and stabilize the tetanus-diphtheria vaccine. Professor Saul Faust, Director of the NIHR Clinical Research Facility in Southampton, told BBC that the new vaccine elicited an immune response 'comparable' to traditional vaccines and was 'safe and well-tolerated.' He added, 'This clearly has the potential to eliminate reliance on the cold chain, reduce waste, and improve vaccine accessibility.' A larger trial involving 160 participants is planned within the next few months. Because the original vaccine is already approved, it won't require the large-scale late-phase trials typical of new vaccines, making this the final stage of research. The goal is to meet World Health Organization (WHO) standards: remaining stable at 30°C and 75% relative humidity. Data also show the vaccine can withstand repeated temperature shifts between -20°C and 40°C—meaning it remains effective even after transport through cold aircraft holds and hot delivery trucks. The World Health Organization estimates that about half of all vaccines are discarded globally due to transport damage, expiration, or unused multi-dose vials, with cold chain failure being a primary cause. Professor Sir Jonathan Van-Tam, former UK Deputy Chief Medical Officer and current advisor to Stablepharma, recalled working in remote clinics: 'I remember carrying vaccines in cool boxes... walking on terrible roads, never knowing how long it would take to get from A to B, always worrying if the cold chain would hold until we injected the children.' While this method cannot yet be applied to mRNA vaccines, it could stabilize many existing vaccines and potentially extend to other refrigerated drugs like monoclonal antibodies. Professor Tuck Seng Wong, Director of the UK-Southeast Asia Vaccine Manufacturing Research Centre and not involved in the study, called it a 'very exciting' achievement and a 'major breakthrough in UK science.' However, he noted further research is needed on stability under repeated temperature fluctuations and performance in larger, more diverse populations. The findings have been published in eClinicalMedicine, part of The Lancet series. Ephrem Tekle Lemango, Deputy Director of Immunization at UNICEF, said immunization is a 'life-saving service dependent on refrigeration,' and that 'this innovation can help us reach more children with vaccines and pave the way for future no-refrigeration vaccines.' Dr. Bruce Roser, founder of Stablepharma, explained, 'Reliable and safe no-refrigeration vaccines could be a game-changer for global health—delivering life-saving vaccines to millions more people, no matter where they live, and making immunization programs more sustainable, reliable, and equitable for future generations.' This article was translated using AI, with the original in English. BBC journalists reviewed the translation before publication.

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  • Source: PR Times
  • Category: New Product
  • Organizations: Stablepharma / NIHR / UNICEF