Stablepharma's EIC Accelerator Takes the Fridge Out of Vaccines
The World Health Organization estimates that about half of the world's vaccines are wasted every year, largely because they get too warm somewhere between the factory and the arm. Stablepharma, based in Bath, reformulates existing vaccines so they do not need a fridge at all. Its lead product, SPVX02, is a thermostable version of Tetadif, a WHO-prequalified tetanus and diphtheria vaccine, made with a platform it calls StablevaX.
The EIC Accelerator selected the project, SUFFVSA40C, at its October 2024 cut-off as a grant-only award, and CORDIS records €2,499,999 from June 2025 to February 2027 to run a phase 2b trial with EU manufacturing, clinical and regulatory partners, seek EU market authorisation and extend the platform to more products. The company says StablevaX could apply to more than 60 approved vaccines.
Company file
- Legal entity
- Stablepharma Limited, 1 Queen Square, Bath
- CEO
- Özgür Tuncer
- Platform
- StablevaX, for thermostable vaccines and, the company says, small molecules, peptides and biologics
- Lead product
- SPVX02, thermostable tetanus and diphtheria vaccine
- Trial partners
- University of Southampton, University Hospital Southampton, the Medicines Evaluation Unit in Manchester, UK Health Security Agency laboratories
- Other funding
- Innovate UK; the phase I trial delivered through NIHR-funded infrastructure
- EIC project
- SUFFVSA40C, agreement 101218257, June 2025 to February 2027
The data, and who published it
On 6 August 2026 the University of Southampton announced the results of a world-first randomised phase I trial of a fridge-free tetanus and diphtheria vaccine, published in the Lancet group journal eClinicalMedicine. Sixty healthy adults took part at the NIHR clinical research facility in Southampton. The vaccine was well tolerated with no vaccine-related serious adverse events, and by day 28 every recipient had reached protective antibody levels against both tetanus and diphtheria, comparable to licensed vaccines.
The stability data is what makes it matter: at least two years at up to 30°C without losing effectiveness, with four-year testing under way, and full potency retained after three cycles between minus 20°C and plus 40°C. "Our study suggests that this vaccine can remain safe and effective without refrigeration," said Saul Faust of the University of Southampton, who led the study. That is a peer-reviewed result from a university and an NHS trust rather than a company claim, which puts Stablepharma in a small minority of this cut-off.
The published evidence
Two years at 30°C, and three trips to +40°C
From the phase I work: shelf life without refrigeration, the temperature cycling the vaccine survived, and the 60 adults in the trial. Researchers are testing whether stability holds for four years.
University of Southampton and University Hospital Southampton, 6 August 2026, on the eClinicalMedicine paper.
The trial the grant pays for
The EIC money is for the next step: a phase 2b trial, run with EU partners, to support market authorisation in Europe. The phase 2b received UK Health Research Authority approval in June 2026 and has launched, and the company expects to complete clinical development of SPVX02 by 2027. CORDIS shows no periodic report for the project.
Beyond the lead product, the company says it can reformulate other vaccines and is working with a partner on thermostabilising small-molecule oncology and anti-infective products. The platform claim, more than 60 approved vaccines, is the commercial story; one reformulated vaccine in humans is the evidence for it.
The platform claim
Sixty approved vaccines the company says it could reformulate
The project says the StablevaX platform applies to more than 60 approved vaccines; one has been through a human trial. The company also says Td vaccines are the largest human vaccine market by dose volume outside COVID-19.
CORDIS, SUFFVSA40C project summary; Stablepharma.
The plan
A phase 2b trial, EU market authorisation and distribution partners, then the same treatment for more of the 60-plus vaccines the platform could apply to.
The record so far
Peer-reviewed phase I safety and immunogenicity data, two years of stability at 30°C, a phase 2b approved and launched; no authorisation, no commercial partner and no second product in the clinic.
- Thermostability without potency lossPublishedTwo years at 30°C and three cycles to plus 40°C.
- Safety and immune response in humansPublished60 adults, all at protective antibody levels by day 28, eClinicalMedicine, August 2026.
- Phase 2b trialLaunchedHRA approval in June 2026; no results.
- EU market authorisationNot filedThe project's stated aim with EU regulatory partners.
Why this is worth €2.5 million of EU money
The cold chain is the single largest logistical cost and failure point in immunisation, and the countries where vaccination coverage is lowest are the ones where refrigeration is least reliable. The UK health minister's line at the announcement put it bluntly: children miss out "not due to a lack of vaccines, but a lack of refrigeration". A thermostable Td vaccine also has uses in rich countries: stockpiling without power, disaster response, and lower wastage in routine use. Tetanus and diphtheria is a sensible first target because, as the company says, it is the largest human vaccine market by dose volume outside the COVID-19 years.
The record
The first fridge-free vaccine through a human trial
SPVX02 is a reformulation of Tetadif, a WHO-prequalified tetanus and diphtheria vaccine, made thermostable with Stablepharma's StablevaX platform.
- Before 2025Phase I trial runA world-first randomised trial of a fridge-free tetanus and diphtheria vaccine in Southampton, supported by Innovate UK
- Jun 2025EIC project startsTwenty-one months of EIC funding, grant only, for a phase 2b trial with EU partners and EU market authorisation€2.5M
- Jun 2026Phase 2b approvedUK Health Research Authority approval for the larger trial
- Aug 2026Phase I results publishedIn eClinicalMedicine: well tolerated, and all recipients reached protective antibody levels by day 28
- 2027Clinical development to completeThe company expects to finish the SPVX02 programmePlanned
- Feb 2027EIC project endsScheduled end of the EIC projectScheduled
CORDIS; University of Southampton, 6 August 2026; HRA; NHS Southampton.
Verdict
This is one of the few projects in the cut-off with peer-reviewed human data. The claim is specific, it was tested in a randomised trial run by a university and an NHS trust, the data is peer-reviewed, and the result is unambiguous: a vaccine that does not need a fridge and brought every recipient to protective antibody levels. What remains is regulatory and commercial, a phase 2b that has only just started, no authorisation filed, and a platform claim resting on one product.
Sources
- CORDIS, SUFFVSA40C project fact sheet
- University of Southampton, fridge-free vaccine shows promise of reaching millions worldwide, 6 August 2026
- University Hospital Southampton, trial results
- Health Research Authority, fridge-free vaccine clinical trial results announced
- Manufacturing Chemist, fridge-free tetanus-diphtheria vaccine passes its first human trial
- ISRCTN registry entry for the trial
Industry
HealthBiopharmaceuticals
- Focus
- Vaccines
- Technologies
- Drug formulation
- Keywords
- Vaccines
- Cold chain
- Global health
- Clinical trials