An Australian healthcare company has announced the opening of a new manufacturing facility that will produce needle-free vaccine patches, which they (and all needle phobes) hope will be the future of vaccination.
Vaxxas released the interim results from its phase I clinical study of the first needle-free COVID vaccine using its proprietary high-density microarray patch (HD-MAP) earlier this month.
The HD-MAP technology uses injection moulding to produce small circular patches, each with thousands of very short (~0.25mm) micro-projections – invisible to the naked eye – which deliver drugs efficiently to the high-density populations of immune cells directly beneath the surface of the skin.
A proprietary dry-coating process has been used to apply an active and stable vaccine onto the projections, which also triggers a natural immuno-cellular reaction that causes vaccine components to be rapidly trafficked to lymph nodes – eliciting a robust immune response.
Vaxxas CEO Mr David Hoey explained that the patches have now been thoroughly validated in both pre-clinical and human clinical settings and, significantly, were stable at room temperature.
“We are very encouraged by the compelling early data and rapid progress of our needle-free COVID vaccine candidate,” Mr Hoey said.
“We believe our patch-based delivery of a next generation spike protein has the potential to offer best-in-class protection against COVID along with cost-effective distribution without the need for extensive refrigeration.
“Ease of use of the HD-MAP could also enable simplified administration, potentially encompassing self-administration.”
The Phase I clinical trial assessed the safety, tolerability and immunogenicity of the HD-MAP COVID vaccine in 44 healthy adults, aged 18-50 years.
HD-MAP delivered HexaPro, a second-generation version of the spike protein used in all major US approved vaccines, which was modified to be more stable and immunogenic than its predecessor, giving potential coverage of all known SARS-CoV-2 variants.
Preclinical research by the University of QLD (UQ), published in Science Advances and Vaccine, demonstrated that the HD-MAP delivered HexaPro resulted in “enhanced virus neutralising antibody and T-cell responses against all major variants of concern when compared to needle and syringe vaccination with the same vaccine.”
The HD-MAP COVID patches were well tolerated, with no serious or severe adverse events, and an analysis from Day 28 showed that the HD-MAP delivered vaccine increased relevant antibody levels by an average of eight-fold, with the antibody response indicating a dose dependent trend.
Vaxxas’ core technology was initially developed at UQ, and the company was established as a start-up in 2011 by UQ’s commercialisation company UniQuest.
The new facility will also serve as the company’s new global headquarters and in the next three to five years, they expect the number of employees to grow from 130 to 200.
“The site will significantly increase our manufacturing capacity, creating new local, skilled jobs, while enabling Vaxxas to progress through late-stage clinical trials that will bring our first commercial vaccine products to the market,” Mr Hoey said.
“With the support of the QLD state and Australian federal governments, the Vaxxas biomedical facility will firmly position Australia at the forefront of vaccine technology innovation.”