Australian biotechnology firm Vaxxas Pty. Ltd. has secured a Therapeutic Goods Administration (TGA) license to manufacture the company’s proprietary high-density microarray patch (HD-MAP) for clinical trials at its Brisbane-based biomedical facility.

The TGA licence provides Vaxxas with clear competitive advantage placing the company and its global partners in a strong position to transform vaccine delivery, Vaxxas bigwigs claim.

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

Designed to deliver all major vaccine types to the skin using a simple, easy-to-use applicator, the HD-MAP could potentially be a universal delivery solution for vaccine self-administration, according to the company. The manufacturing licence for aseptic (sterile) production includes principles and procedures to ensure the vaccines maintain high quality standards defined by TGA and Good Manufacturing Practice (GMP) rules.

“This license unlocks the way forward for Vaxxas to continue developing our 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,” Vaxxas Chief Technology Officer Dr. Angus Forster said.

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 U.S. government, the Wellcome Trust, and Gates foundation to assess HD-MAP’s potential to vaccinate against COVID-19, seasonal and pre-pandemic influenza, 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 commercialization, including the recent installation of the company’s first robotic lines for aseptic (sterile) manufacture at its state-of-the-art Brisbane biomedical facility.

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 for sale or purchase.