On Jun. 2, 2021, Vaxxas announced that research demonstrated the potential of Vaxxas’ novel high-density microarray patch (HD-MAP) for vaccination against COVID-19 had been published in a manuscript posted to the preprint server BioRxiv. Using a novel SARS-CoV-2 spike subunit vaccine, this preclinical study of Vaxxasﾒ HD-MAP showed enhancement of immune response compared to vaccination by needle-and-syringe, including significantly enhanced T-cell and spike-specific antibody responses as compared to needle-and-syringe delivery. Notably, complete protection from COVID-19 by a single dose skin patch delivery using HD-MAP was shown in a lethal virus challenge in a relevant COVID-19 animal model. Comparable protection against COVID-19 was not seen with the same vaccine when delivered by needle-and-syringe, even when the spike subunit vaccine formulation included appropriate adjuvantation.

The research underlying the study was co-funded by Vaxxas and the Queensland Government and was performed in collaboration with researchers at the University of Queensland and Griffith University and led by principal investigator, David A. Muller, PhD, of the School of Chemistry and Molecular Biosciences at the University of Queensland.

For these studies, the SARS-CoV-2 spike subunit vaccine was dry-coated on the HD-MAP patch using proprietary systems and technology developed by Vaxxas. Once applied on the Vaxxas HD-MAP, the patch vaccine dose was shown to be stable for at least 30 days at 25˚C which opens up the future potential for unrefrigerated distribution and potentially the use of commercial shipping to deliver HD-MAP patches to homes and businesses for self-administration. These dry-coating technologies and potential for self-administration build upon clinical and other demonstration work being done for the United States Biomedical Advanced Research and Development Authority (BARDA) on pandemic influenza vaccination.