Cold-Free Vaccine Shows Year-Long Stability in Early Human Trial
Researchers reported that an experimental tetanus-diphtheria vaccine kept its potency after a year at up to 30 °C, eliminating the need for refrigeration.
Stablepharma applied its StablevaX platform, which coats vaccine ingredients with inert substances like trehalose, to reformulate an existing tetanus-diphtheria vaccine. The resulting candidate, SPVX02, was stored at temperatures up to 30 °C for a year before being administered to 60 volunteers in the United Kingdom, none of whom had received a tetanus or diphtheria shot in the past ten years. Immunogenicity measured 28 days later matched that of participants given conventional vaccines, and the trial reported no serious side effects.
Parallel animal experiments demonstrated that the formulation retained potency for two years at 30 °C with 75 % humidity and for six months at 40 °C with the same humidity level. Researchers plan a larger study involving 160 participants to further compare safety and efficacy with the original TetaDif product. While the method cannot yet be applied to mRNA vaccines, the breakthrough could dramatically reduce cold-chain constraints for many immunizations.
Why it matters
A fridge-free vaccine could expand immunization access in regions lacking reliable refrigeration.
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