Vaccines reinvented: Vaxxas

An innovative and pain-free vaccination system, that increases efficacy and safety of vaccine delivery, is a game changer for global vaccination programs helping to eliminate infectious disease.

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CHALLENGE

Despite increasing vaccination coverage, the WHO estimates there are still 1.5 million deaths each year from vaccine-preventable diseases (VPD). This is due to a series of issues, including:

• Storage: Almost half of vaccines given in developing countries are thought to fail due to difficulties keeping the vaccine cold enough before use.
• Cost: A large dose of vaccine is needed for intramuscular injection because muscle is inefficient at producing an immune response. This increases production costs and reduces availability.
• Safety: Needles come with potential threats including needle-stick injuries to healthcare workers, particularly in HIV-endemic areas. They can also be traumatic, particularly for children, leading to needle-phobias and vaccine avoidance.
• Access: current vaccines must be administered by a healthcare professional, making it difficult to achieve adequate vaccination rates in remote regions or for people living in areas of political instability and conflict. This has tragically led to the recent re-emergence of VPDs in countries such as Iraq, South Sudan, Syria, Yemen and the Congo.

RESEARCH

Prof. Mark Kendall, who started this work at the University of Queensland (UQ), has developed a device, dubbed the HD-MAP (previously known as the Nanopatch™), that could revolutionise vaccine delivery. The HD-MAP is a one square-centimetre silicon patch covered with thousands of vaccine-coated micro-projections. These pass through the skin’s outer layer to deliver the vaccine directly to the immune cells in the skin, which are more efficient at mounting an immune response than muscle. Tests showed that only 1-2.5% of the dose currently used for influenza and polio vaccines was needed to elicit the same immune response. It is now being commericalised by spin-out Vaxxas.

Scanning electron micrograph of the Nanopatch™

Throughout its development, pre-clinical and current clinical trial phases, Prof. Kendal and Vaxxas have used microscopes at Microscopy Australia’s UQ facility to monitor the design, production and functionality of the HD-MAP. Our microscopes feature in over 20 HD-MAP publications. With success in several completed clinical trials, Vaxxas is now working on ongoing Phase I clinical studies for COVID-19 and seasonal influenza, with other studies to start soon, targeting pandemic influenza and measles–rubella. Our UQ facility was also used in the development of several vaccines by UQ researchers that are being trailed with the HD-MAP. Read more about how our facilities were used in the development and trials of a HD-MAP based dengue fever vaccine, and ongoing trials of a needle-free COVID-19 vaccine.

False coloured Scanning electron micrograph of the Nanopatch™ (yellow) in skin (orange)

IMPACT

The HD-MAP is a game changer for global vaccination programs for several reasons:

• it uses a dry vaccine that does not need to be kept cold to be effective, tackling one of the greatest barriers to delivering effective vaccinations in developing countries
• the same amount of vaccine goes much further
• it can be administered by non-health professionals, increasing access
• it is pain free and reduces the burden on needle-phobic patients
• tests showed that it’s more effective than competitor microarray patches.

Vaxxas has secured both global partnerships and investment, attracting over $35 million in initial funding along with a deal with world leading vaccine producer, Merck, for further R&D and trials. Bill & Melinda Gates Foundation have provided two grants totalling $14.25 million for preclinical development and trials for measles and rubella vaccinations.

Recently, Vaxxas opened a the 5,500m² Vaxxas Biomedical Facility, a first-of-its-kind manufacturing site designed to support the scale-up of the HD-MAP for late-stage clinical trials and first commercial products. Vaxxas currently employs 130 people in its Queensland operations, and is planning for an increase to 200 employees over the next three to five years.

A vaccine being delivered using the Nanopatch™