Vaxxas secures TGA licence to manufacture vaccine patch technology

Australian biotechnology company Vaxxas has announced it has been granted a licence by the Therapeutic Goods Administration (TGA) to manufacture its proprietary high-density microarray patch (HD-MAP) for clinical trials at its biomedical facility in Brisbane.

The company says the achievement strengthens Vaxxas’ leadership in next-generation vaccine delivery and follows installation of the company’s first robotic lines for aseptic (sterile) manufacture. The TGA licence provides Vaxxas with a clear competitive advantage, placing the company and its global partners in a strong position to transform vaccine delivery.

Designed to deliver all major vaccine types to the skin using a simple, easy-to-use applicator, the HD-MAP has the potential to be a universal delivery solution for vaccine self-administration.

The manufacturing licence for aseptic (sterile) production includes principles and procedures to ensure the vaccines are of the necessary high quality, as defined by the TGA and Good Manufacturing Practice (GMP) standards.

“The TGA manufacturing licence marks a significant milestone for Vaxxas as we progress toward commercialising our HD-MAP technology,” said Vaxxas Chair Sarah Meibusch. “By reducing cold-chain requirements and enabling self-administration, this innovation addresses key barriers to vaccine access and uptake worldwide.”

Vaxxas has completed six first-in-human clinical trials to date with support from global partners including SK bioscience, the US Government, the Wellcome Trust and Gates foundation to assess the potential of the Company’s HD-MAP technology to vaccinate against COVID-19, seasonal and pre-pandemic influenza, and measles and rubella.

The Vaxxas high-density microarray patch (HD-MAP) is composed of thousands of microscopic projections moulded into a small patch. Each microprojection is ‘printed’ with a small dose of vaccine in a dried formulation. When applied to the skin, the patch delivers the vaccine to the abundant immune cells that naturally reside immediately below the skin surface.

“This licence unlocks the way forward for Vaxxas to continue developing our world-leading HD-MAP technology,” said Vaxxas Chief Technology Officer Dr Angus Forster. “We are proud to contribute to Queensland’s growing biotech sector and to advance sovereign manufacturing capabilities that translate cutting-edge research to address real-world health solutions.”