Vaxxas granted approval to manufacture needle-free biotech


Joseph Brookes
Senior Reporter

Promising biotech Vaxxas on Monday announced it will begin manufacturing its needle free vaccination patches in Brisbane for clinical trials after securing approval from Australian regulators.

The commercialisation milestone comes as Vaxxas is yet to announce a replacement for its founding chief executive who stepped aside earlier this year amid a disappointing funding round.

Founded in 2012 to spin out University of Queensland research that promises to replace inoculation jabs with less intrusive vaccine patches, the Brisbane-based company is one of Australia’s most promising BioTechs.

The Vaxxas HD-Map could replace needle delivery of vaccines. Image: Supplied

On Monday, the company announced it had been granted a licence by the Therapeutic Goods Administration (TGA) to manufacture its high-density microarray patch (HD-MAP) for clinical trials.

The small HD-MAP patches are made up of thousands of microscopic projections, each with a small dose of a vaccine in a dried formulation. When applied to skin, the vaccine is delivered to immune cells residing just below the surface.

Vaxxas says its tech can disrupt the multi-billion dollar market for traditional needle and syringe delivery through easier administering and stability at higher temperatures, meaning fewer cold chain challenges.

The company’s chair Sarah Meibusch said the TGA manufacturing licence marks a significant commercialisation milestone for Vaxxas.

“By reducing cold-chain requirements and enabling self-administration, this innovation addresses key barriers to vaccine access and uptake worldwide,” she said.

The patches have been trialled by more than 750 people but remain under investigation and are not available for sale anywhere in the world. But the company has been valued at more than $800 million and already runs out of state of the art facilities in Brisbane.

Earlier this year Vaxxas founding CEO David Hoey departed the role but remained with the company as a strategic adviser, following a capital raise that fell short of expectations.

The company had reportedly told investors it was seeking $100 million in the Series D round but only raised $50 million in equity and secured a new $40 million debt facility.

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