Full recovery of vaccine potency, after 7–10 months at 45°C, was shown by complete protection against supra-lethal doses of active toxins
Stablepharma’s scientific publication, which was published by the prestigious journal Vaccine (Elsevier) Volume 41, Issue 22, May 2023, has presented its fridge-free, single-dose, thermostable vaccine (STVX-01) that has been developed in a pre-filled syringe used for vaccination.
Full recovery of vaccine potency, after 7–10 months at 45°C, was shown by complete protection against supra-lethal doses of active toxins.
To prevent loss of potency, almost all vaccines require continuous refrigeration from factory to patient and must be stored in the “cold chain”. This greatly complicates both the worldwide distribution and stockpiling of vaccines but also has substantial cost implications. A large number of life-saving vaccines are discarded before their use, mainly due to storage at sub-optimum temperatures.
What is urgently needed in this globally connected World, to pre-empt the transmission of new pathogens or new waves of mutants is that in a pandemic, vaccination can be quickly extended to everyone Worldwide. This will require a technology to produce effective safe thermostable vaccines, that can be manufactured and distributed quickly and are resistant to adverse storage or transportation conditions.
Stablepharma has addressed this global unmet need by developing a simplified, thermally stable formulation of vaccine, a full dose of which is absorbed and dried in a medical sponge.
There are currently no fridge-free Tetanus or Diphtheria vaccine solutions on the marketplace
The company's novel and patented technology platform, StablevaX converts existing, approved vaccines to a fridge-free status. By creating pre-dosed and stable vaccines, it ensures safe, efficient and waste-free delivery without the need for the cold chain.
To be considered a fridge-free finished pharmaceutical product (FPP), World Health Organisation (WHO) stability guidelines specify the need for accelerated thermostability at +40°C ± 2 °C and certain humidity for a minimum period of 6 months. Based on the WHO stability guidelines, the StablevaX formulations developed for Td have not only met but exceeded the temperature requirements to be considered as a fridge-free pharmaceutical product. StablevaX patents have been issued in 14 jurisdictions including US, Europe, Japan and several emerging markets.
It has been a specific goal of many organisations responsible for delivering vaccines worldwide such as the World Health Organisation (WHO), Médecins Sans Frontières (MSF) and Coalition for Epidemic Preparedness Innovations (CEPI) to have vaccines available that do not need refrigeration in a cold chain.
Stablepharma’s R&D Team in Madrid, Spain have identified up to 60 vaccine candidates that could be suitable for StablevaX technology which will dramatically enhance the performance of existing and new vaccines.
There are currently no fridge-free Tetanus or Diphtheria vaccine solutions on the marketplace.
Read the full peer-reviewed paper here.