Özgür Tuncer: Health and vaccine equity

Cold-chain dependence is not just a logistical burden, it is a primary driver of global health inequality. Following promising Phase 1 results for SPVX02, StablePharma’s chief executive discusses how thermostabilisation technology can redefine global health equity.

At the beginning of August, StablePharma announced Phase 1 clinical trial results for SPVX02, a room-temperature-stable reformulation of a licensed tetanus-diphtheria (Td) vaccine. It is hard to underestimate what a breakthrough this is. Keeping vaccines cold from the factory to the patient is one of the biggest challenges facing immunisation programmes worldwide. If, as expected, the Phase 2b trials confirm these results early next year, then this technology could help transform the way vaccines are stored and delivered around the world.

Here, Stablepharma chief executive Özgür Tuncer talks to Healthcare Today about vaccine wastage, why fridge-free vaccines are a game changer and how the technology will help health equity.

 

Let’s start with the obvious question: how big is the vaccine-wastage problem actually caused by the cold chain?

Up to 50% of all vaccines produced globally are wasted, which is a staggering figure. Put simply, we are manufacturing two vaccine doses just to get one into a patient’s arm – a massive inefficiency given the billions of doses produced worldwide every year.

While precise localised data can be difficult to pinpoint, our own studies across developed markets – including surveys of GPs and clinicians in the UK, Germany and Spain – reveal telling results. While wastage in the Western world may not reach the 50% mark seen globally, it still reaches up to 30%. Around a third of the doctors we surveyed reported frequently having to discard vaccines due to cold chain breaches or related logistics failures.

Gavi, the vaccine alliance, recently published a paper underlining that cold chain management remains one of the single greatest logistical hurdles in global healthcare. Whether in emerging markets or developed nations, temperature-sensitive vaccine wastage remains a critical, pervasive problem.

Stablepharma currently quotes WHO estimates that more than half of vaccines are wasted every year, “primarily due to failures in the logistical cold chain”. 50% of what, across which vaccines and countries, and how much is actually cold-chain failure?

To grasp the scale of the issue, one first has to understand what cold chain failure actually entails. This is not like a household fridge where you can take out a bottle of milk and put it back later without issue. Most conventional vaccines must be kept continuously within a strict two-to-eight degree Celsius range – with some requiring deep-freeze storage at minus 20 or even minus 80 degrees, as we all saw during the pandemic.

Cold chain failure occurs whenever there is a temperature deviation. Over a typical vaccine shelf life of two to three years, the probability of a temperature spike occurring somewhere along the supply chain is extremely high; maintaining an unbroken temperature window for years is a monumental logistical challenge.

Expirations create another major source of wastage, as many vaccines have relatively short shelf lives. Our technology directly addresses both hurdles. By thermostabilising – essentially fortifying – the vaccine, we eliminate the need for temperature-controlled refrigeration while simultaneously extending product shelf life beyond that of standard cold-chain products. We tackle wastage from both ends: extending viability and removing cold chain dependencies entirely.

Using dehydration for preservation is an ancient concept. For thousands of years, our ancestors knew that removing moisture preserved food, for the simple reason that where there is water, biological activity thrives. Powdered milk is a modern parallel: convert fresh milk to powder, and its shelf life expands dramatically. That is essentially what we are achieving with vaccines – converting them into a stable powder format that remains viable for extended periods without any need for refrigeration.

 

“Our technology provides genuine peace of mind by ensuring vaccine potency regardless of external conditions.”

 

 

What does a fridge-free vaccine make possible that simply improving today’s cold chain can’t? What does it mean in human terms?

There are parts of the world where, no matter how much you invest in cold chain infrastructure, reaching remote populations remains nearly impossible. Health workers are still forced to rely on insulated boxes packed with ice.

That dynamic introduces another frequently overlooked issue: freezing damage. Standard vaccines must be maintained between two and eight degrees Celsius; if they drop below freezing, the biological active ingredients degrade, and the batch is ruined. Placing vaccines directly against ice packs carries a significant risk of accidental freezing, resulting in immediate waste.

Enormous sums have been poured into improving cold chain technology – refrigeration manufacturers have built entire business models around pharma logistics. Yet equipment upgrades alone cannot make the supply chain bulletproof. Maintaining an unbroken temperature window relies heavily on human behaviour, not just hardware. Even here in the UK, we routinely hear anecdotes of clinic fridges being accidentally unplugged over a weekend. Across a multi-year shelf life, human error is almost inevitable.

Our technology provides genuine peace of mind by ensuring vaccine potency regardless of external conditions. That reliability touches on an uncomfortable question that many in the industry avoid, but as a sector disruptor, I believe needs addressing: vaccine scepticism in developing regions across Africa, Asia and Latin America.

When communities express doubt because they have seen vaccines fail to protect patients, the core issue is often not the vaccine’s design, but how it was stored. In remote settings, there is currently no way to verify whether a dose has retained its potency by the time it reaches a patient’s arm. At StablePharma, our goal is to guarantee that a vaccine administered anywhere in the world remains fully potent. That guarantee represents a fundamental shift for global immunisation.

 

Your Phase 1 results were impressive. What does that result tell you about the underlying technology – and what don’t we yet know?

The earlier trials demonstrated a great deal; the results were fantastic and confirmed that both our science and the underlying product are working as intended. The vaccine was stored at 30 degrees Celsius for up to 12 months before administration, and it performed exceptionally well in human trials.

We have now initiated our Phase 2b trial, which serves as our pivotal study. While the Phase 1 trial directionally proved that the technology functions brilliantly, it was not statistically powered to hit every endpoint required to declare full non-inferiority against the standard reference vaccine. Certain endpoints achieved statistical significance, but not all of them.

Our Phase 2b trial addresses that limitation by expanding the sample size. The trial design itself remains virtually identical to Phase 1: a two-arm study directly comparing our reformulated, thermo-stable vaccine against the original refrigerated version to prove non-inferiority, backed by fully powered statistical data.

We expect to report the top-line results from this pivotal Phase 2b study in the first quarter of next year.

 

“Millions of people continue to suffer from illnesses that are entirely preventable simply because of where they live.”

 

 

How much could removing refrigeration actually reduce the cost of delivering a vaccine?

There is compelling published pharmacoeconomic research showing that even if a thermostable vaccine were priced at three times the cost of a conventional vaccine, health systems in developing nations would still save money. That is because a massive portion of immunisation budgets is swallowed up by cold-chain logistics and product wastage.

To explore whether this issue applies to high-income regions, we partnered with IQVIA to publish a joint white paper titled The Tip of the Iceberg. There is a common assumption that thermostabilisation technology is only relevant for developing countries, but our findings in Europe prove otherwise.

Out of €31 billion spent on vaccines across Europe, €21 billion goes directly toward cold chain maintenance and absorbing wastage. The actual cost of the vaccines themselves represents just €10 billion of that total sum. The potential savings – even in advanced healthcare systems – are vast.

This brings me to a fundamental question for the broader industry: given that we now possess proven technology to create shelf-stable vaccines that eliminate waste and reach every patient, why is there not greater political and commercial determination to deploy it? Opting for lower-cost, traditional vaccine formulations is a false economy. In the long run, “cheap” proves vastly more expensive – both in financial terms and in environmental footprint.

If we were having this conversation five or ten years from now and fridge-free vaccines had become mainstream, what would have changed about the way we vaccinate people?

Ultimately, this comes down to health and vaccine equity. Millions of people continue to suffer from illnesses that are entirely preventable simply because of where they live. As the pandemic demonstrated, no population is truly safe until everyone is safe. The political impulse to close borders and isolate within national boundaries has rarely proven effective in human history, yet we saw a return to that instinct during COVID-19. Protecting global public health requires eradicating preventable diseases everywhere – and given that effective vaccines already exist, achieving that goal should be entirely within our reach.

Beyond equity, there is another industry-wide trend that deeply concerns me: the relentless pressure to drive down vaccine prices. While lowering costs is often framed as a positive move to expand access, it has rendered vaccine development commercially unattractive. Over the past five years, numerous vaccines have been withdrawn from the market simply because they were no longer financially viable for manufacturers.

By removing the massive logistical overhead of the cold chain, technologies like StablePharma’s offer a different path forward. Eliminating supply chain waste enables manufacturers to capture fair value and reinvest in research and development, restoring commercial incentives for new vaccines. As part of my work with the UK Health Security Agency (UKHSA) working group, I frequently emphasise that private industry must be given viable commercial incentives. If manufacturing remains unprofitable, companies will continue to exit the sector – leaving us with a dangerously depleted vaccine development pipeline.