Key Takeaways
- Vaxxas has received TGA approval to manufacture its high-density microarray patch (HD-MAP) for clinical trials in Brisbane.
- The HD-MAP technology offers a potential universal vaccine delivery solution, allowing for easier self-administration.
- Vaxxas aims to enhance vaccine accessibility and reduce costs while advancing its programs toward commercialization.
TGA Approval and HD-MAP Technology
Vaxxas Pty Ltd, an Australian biotechnology leader, has been granted a manufacturing licence by the Therapeutic Goods Administration (TGA) for its high-density microarray patch (HD-MAP). This milestone allows Vaxxas to produce the patch for clinical trials at its advanced biomedical facility in Brisbane, bolstering its position in the vaccine delivery sector.
The HD-MAP is designed for simple, skin-based vaccine administration via a convenient applicator. It represents a potential universal solution for vaccine self-administration, which could dramatically improve vaccine delivery. The TGA manufacturing licence ensures compliance with high-quality standards, essential for the sterile production of vaccines.
Vaxxas Chair Sarah Meibusch emphasizes that this licence is critical for advancing HD-MAP technology towards commercialization. The innovation promises to address major barriers to vaccine access by reducing cold-chain logistics and enabling self-administered vaccines. Chief Technology Officer Dr. Angus Forster highlighted the importance of the licence in propelling the development of their technology and enhancing Queensland’s biotechnology landscape.
Vaxxas specializes in developing the HD-MAP for various vaccines, having successfully administered it to over 750 participants in early clinical trials, demonstrating strong safety, tolerability, and robust immune responses. The technology targets immune cells just beneath the skin, allowing for more effective protection with smaller doses while minimizing the need for cold storage.
The company has conducted six first-in-human trials with support from notable global partners such as SK bioscience, the US Government, Wellcome Trust, and the Gates Foundation. These trials explore the potential of HD-MAP for vaccines against COVID-19, seasonal influenza, and measles, amongst other diseases. Vaxxas envisions disrupting the multibillion-dollar vaccine market by improving accessibility and reducing associated costs, aiming to expand vaccination coverage globally.
The HD-MAP is made up of thousands of microscopic projections that deliver a small vaccine dose when applied to the skin. It has shown greater stability at elevated temperatures compared to traditional liquid vaccines, further easing storage and distribution challenges. While the technology has garnered positive results, it remains in investigational use, and Vaxxas abstains from making definitive claims about the reliability or superiority of its vaccines.
Overall, Vaxxas is progressing toward bringing its innovative HD-MAP technology to market, potentially revolutionizing vaccine delivery.
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