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Publications

A thermostable tetanus/diphtheria (Td) vaccine in the StablevaX™ pre-filled delivery system

Our scientific publication, which was published by the prestigious journal Vaccine (Elsevier) Volume 41, Issue 22, May 2023 presents our 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.

A thermostable tetanus/diphtheria (Td) vaccine in the StablevaX™ pre-filled delivery system

Chemistry of Protein Stabilisation by Trehalose, Quadrant Research Foundation

The following is a 30 year old paper written by Dr Bruce Roser (Chairman & Founder, Stablepharma Ltd) and his colleagues from the Food Research Institute in Norwich in 1994. Upon recently reviewing it, Dr Roser feels convinced that it is fundamentally one of the most important papers on the basic science of Trehalose stabilisation yet published.

A thermostable tetanus/diphtheria (Td) vaccine in the StablevaX™ pre-filled delivery system

Extraordinary Stability of Enzymes Dried in Trehalose: Simplified Molecular Biology

The following paper was written by Dr Bruce Roser (Chairman & Founder, Stablepharma Ltd) and his colleagues at Quadrant Research Institute, which was published by Nature Publishing Group in 1992. This paper highlights the most remarkable and dramatic demonstration of the high temperature, long term potency of trehalose as a stabiliser of the most well-known notoriously fragile proteins.

A thermostable tetanus/diphtheria (Td) vaccine in the StablevaX™ pre-filled delivery system

Industry Publications

Transforming Global Access to Vaccines - Unicef.org

UNICEF’s pooled procurement of vaccines has helped countries make big strides in their routine immunization efforts, and the procurement of the pentavalent vaccine stands out as a success story. The vaccine protects against diphtheria, tetanus, pertussis, hepatitis B and haemophilus influenzae type b – five potentially fatal diseases.

National Vaccine Wastage Assessment - Unicef.org

This National Vaccine Wastage Assessment by Unicef.org highlights a recent study that shows an average 16 times greater return as compared to the investment made in the National Immunization Programme, proving that immunization is one of the best cost-effective interventions for vaccine-preventable diseases.

The assessment ensured active participation of all Immunization stakeholders such as World Health Organization (WHO), United Nations Development Programme (UNDP), John Snow Inc. (JSI), Immunization Technical Support Unit (ITSU), National Cold Chain Resource Centre (NCCRC) and medical colleges. The field visit for data collection was held from 24 February to 2 March 2019

Tip of the cold chain iceberg? Vaccines worth $26 million lost - News GP

At least $25.9 million in Australian vaccines has been lost to cold chain breaches since 2014, but incomplete government statistics mean the final total could be much higher.

Economic Impact of Thermostable Vaccines – Vaccine (Elsevier 2017)

Because lifesaving vaccines should be made available to all citizens around the world, they are carefully developed and manufactured to be safe, effective and, importantly, relatively cheap to be affordable by everyone.

It is, however, widely assumed that any additional manufacturing steps necessary to stabilise vaccines, such as the StablevaX™ technology which reformulates existing approved vaccines to fridge-free status, could render them too expensive. This is the opposite of the truth. The economic benefits to low-income countries of having even a few of their vaccines stable at room temperature, thereby not requiring the refrigerated cold chain, have been authoritatively documented and reported in the following paper.  In addition, the considerable overall savings that can be achieved, even with more expensive versions are both surprising and gratifying.

The vaccine cold chain: A history

It’s been true since Edward Jenner’s day: finding a vaccine is just the first step. Getting it out into the world demands a lot more problem-solving.

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