Over the last century, vaccines have saved millions of lives and transformed modern medicine. Their evolution has been marked by continual scientific breakthroughs, the most recent of which is the development and delivery of mRNA vaccines, which enable a much quicker design and development time compared to traditional vaccines. mRNA vaccines have been under development since the 1970s but were first available to the public during the COVID-19 pandemic.
While the science of vaccines themselves has advanced dramatically, the delivery method has remained remarkably static. For more than 100 years, most vaccines have been administered in liquid form using a syringe and needle. This intramuscular injection method is reliable but comes with well-known drawbacks including cold-chain storage requirements, the risk of injury, needle phobia, and the need for trained healthcare professionals.
Today, researchers and companies are actively pursuing alternatives that eliminate the needle altogether. These innovations not only have the potential to improve patient experiences but also to solve major logistical challenges in global vaccine distribution. They also create opportunities for robust patent protection, an important consideration in a field with enormous commercial potential.
New Frontiers in Needle-Free Delivery
Microneedles: Painless and Flexible
One promising approach comes from Innoture, a company developing microneedle-based platforms. Their system uses tiny needles that are either coated with a vaccine or made from a dissolvable material that contains the active ingredient. When applied to the skin, these microneedles penetrate only the outermost layer before dissolving or releasing the vaccine payload.
The advantages are significant and include the process being reasonably painless, easy to administer, and highly adaptable. Innoture’s microneedle arrays are manufactured on backing plates, allowing the size, shape, and height to be customized depending on the target vaccine. The platform is not limited to vaccines but could also be used for drug delivery and diagnostics. Moreover, the design supports efficient, high-volume manufacturing, making it attractive for large-scale immunisation programs.
Solid Dose Pens: Accuracy and Convenience
aVaxziPen has developed a very different system based on solid-dose vaccines. Their innovation centres around a reusable pen and a single-use cassette that contains an individual solid vaccine dose, roughly the size of a grain of rice.
The mechanism is simple: the cassette is loaded into the pen, pressed against the skin, and the solid dose is deposited just under the surface. The dose dissolves quickly and triggers an immune response. Because the dosage form is solid, it eliminates the risk of spillage or waste, and ensures accurate, repeatable administration. After use, the cassette can be discarded, while the pen can be reused with a fresh cassette.
This system addresses multiple pain points simultaneously, including no cold-chain requirement, minimal training for administration, and improved patient comfort. For healthcare systems, the reduction in vaccine wastage alone represents a substantial advantage.
Ultrasound: Harnessing Sound Waves
At the University of Oxford, researchers are developing a method that uses ultrasound to propel vaccines into the skin. The process begins with a formulation of vaccine molecules mixed with specially designed cup-shaped protein molecules, applied topically to the skin. When ultrasound waves are directed at the site (similar to a sonogram), bubbles form within the mixture. As these bubbles collapse, they drive the vaccine molecules deeper into the skin layers. While still in its early stages, this technique has shown promising results in mice.
Particle Acceleration: Precision Through Physics
Particle Therapeutics has designed a ballistic vaccine delivery system, with their focus being on veterinary medicine. Their technology uses high-pressure helium gas to accelerate microscopic vaccine particles into the skin.
These particles must be carefully engineered such that they are strong enough to withstand the force of acceleration yet stable enough to retain their biological activity through the formulation and delivery process. The approach has been successfully tested in pigs, demonstrating a robust immune response. Through an agreement with Particle Vaccines Canada Limited, this technique is also being applied to human vaccine delivery.
The Benefits of Eliminating Needles
The appeal of needle-free delivery extends far beyond patient comfort:
- No cold chain dependence: Solid-dose or microneedle formats often do not require refrigeration, simplifying global distribution and reducing energy consumption.
- Overcoming needle phobia: Millions of people avoid vaccinations due to fear of needles. Eliminating needles could boost uptake rates significantly.
- Lower skill requirements: Many needle-free systems are designed for easy use, reducing the need for trained healthcare professionals.
- Potential reduced dose: Due to the location in the body where the vaccine is delivered, there is evidence that the same immune response can be provoked with a significantly smaller dosage compared to traditional liquid vaccine delivered into the muscle.
- Safety improvements: Removing syringes and needles eliminates risks of accidental needle-stick injuries and sharps waste disposal.
The potential impact is profound, with reduced costs, improved accessibility in low-resource settings, and enhanced public health outcomes.
Patent Protection in Needle-Free Delivery
As is evident from the above discussion, there are an incredibly broad range of approaches in developing needle-free vaccine delivery. From a patent perspective, such a variety means this is an area ripe with opportunity to obtain broad protection. Although methods of treatment of the human or animal body by surgery or therapy are excluded from patentability at the European Patent Office (EPO), apparatus and devices used to carry out these treatments are patentable. This distinction creates a valuable pathway for protecting innovations in vaccine delivery.
Companies are already pursuing comprehensive protection strategies. For example, aVaxziPen has filed patents covering:
- The solid-dose vaccine formulation itself
- The single-use cassette system
- The delivery device as a whole
These filings span major jurisdictions, including the US, Europe, China, Japan, Korea, and Australia. Such broad protection is valuable in a field with global relevance and multi-billion-dollar commercial potential.
Looking Ahead
Vaccines themselves have undergone transformative advancements in recent years. Now, attention is also being brought to how these vaccines are delivered. The wide range of approaches, from microneedles to ultrasound and particle acceleration, highlights the creativity and diversity of solutions being explored.
This variety not only offers the chance to improve public health outcomes but also presents an enormous opportunity for innovators to secure broad, valuable patent protection. Companies that successfully combine technical innovation with a robust IP strategy stand to gain a significant competitive advantage in a global market.
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