Vaxxas Secures TGA Licence to Manufacture Therapeutic Goods
Milestone enables GMP manufacturing to accelerate clinical trials and transform global vaccine delivery
BRISBANE, Australia and CAMBRIDGE, Mass., Dec. 14, 2025 (GLOBE NEWSWIRE) — Australian biotechnology pioneer Vaxxas Pty Ltd, has been granted a licence by the Therapeutic Goods Administration (TGA) to manufacture the Company’s proprietary high-density microarray patch (HD-MAP) for clinical trials at its state-of-the-art biomedical facility in Brisbane.
This 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 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.
Vaxxas Chair Sarah Meibusch said, “The TGA manufacturing licence marks a significant milestone for Vaxxas as we progress toward commercialising our HD-MAP technology. By reducing cold-chain requirements and enabling self-administration, this innovation addresses key barriers to vaccine access and uptake worldwide.”
Vaxxas Chief Technology Officer Dr Angus Forster added, “This licence unlocks the way forward for Vaxxas to continue developing our world-leading HD-MAP technology. 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.”
About Vaxxas
Vaxxas is a biotechnology company pioneering HD-MAP technology for vaccine delivery. The HD-MAP has been administered to more than 750 participants across early-stage (first-in-human) clinical trials, showing strong safety, tolerability, and robust immune responses. Preclinical and clinical data demonstrate the technology’s ability to deliver all major vaccine types positioning the platform as a potential universal delivery solution. By targeting immune cells just beneath the skin, the HD-MAP has the potential to achieve stronger protection with smaller doses, while reducing cold-chain requirements and enabling self-administration.
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.
With the potential to disrupt the multibillion-dollar global vaccine market by improving access, reducing costs, and expanding vaccination coverage, Vaxxas is advancing its lead programs toward commercialisation, including the recent installation of the Company’s first robotic lines for aseptic (sterile) manufacture at its state-of-the-art biomedical facility in Brisbane.
About HD-MAP
The Vaxxas high-density microarray patch (HD-MAP) is comprised 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.
HD-MAP vaccine delivery has the potential to overcome challenges faced by traditional needle and syringe delivery of vaccines. The HD-MAP delivery of the vaccine has been shown in early clinical studies to be more stable at higher temperatures than vaccines in liquid formulations, potentially reducing the need for cold-chain storage and distribution. Previous studies have also shown the safety and tolerability of Vaxxas’ HD-MAP for use in vaccine delivery and inducing equal or greater immune responses to injected vaccines at lower doses. HD-MAP vaccines are designed to be self-administered in the future to enable home delivery.
The Vaxxas HD-MAP delivered vaccines are under investigation and available only for investigational uses. They are not available anywhere in the world for sale or purchase. As such, Vaxxas makes no claim that the vaccines are reliable, durable, dependable, safe, or effective, and makes no claim that it is superior to any other vaccine or vaccine delivery technology.
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