• Self-administration of vaccines using the Vaxxas high-density microarray patch (HD-MAP) could reduce the need for healthcare workers to administer vaccines, expanding the rate, broadening the scope, and lowering the cost of routine and pandemic vaccination.
• During a pandemic, self-administration could help to avoid populations being exposed to a given infectious disease by eliminating the need to travel to a crowded, central location such as doctor’s office or vaccination center for vaccination.
• HD-MAP vaccines also offer the potential for distribution without a cold chain, further enhancing vaccination efficiency, broadening accessibility and lowering costs.

Vaxxas, a clinical-stage biotechnology company commercializing a novel vaccination platform, today announced a publication in the journal Vaccine entitled “Vaccine microarray patch self-administration: An innovative approach to improve pandemic and routine vaccination rates.”

Vaxxas’ HD-MAP targets delivery of vaccines to the dense populations of immune cells in the skin, that then transport the vaccine directly to the lymph nodes (the central “hubs” of the immune system), potentially producing a more robust and dose-efficient immune response than vaccines injected into the muscle.

The publication outlines the potential for Vaxxas’ HD-MAP to enhance vaccine performance as well as increasing rates and acceptance of vaccination based on needle-free self-administration. The HD-MAP, upon which vaccines are ‘printed’ and dried, also provides storage and distribution benefits due to reduced cold chain requirements generally associated with vaccines delivered by needle and syringe.

The publication discusses how Vaxxas’ HD-MAP technology offers an attractive alternative for vaccine delivery during a pandemic due to its ability to alleviate the strain on healthcare systems by enabling vaccine administration by lesser-trained healthcare and community workers, guardians, or individuals themselves.

As presented in the paper’s discussion, self-vaccination using the HD-MAP could occur in various settings including vaccination hubs with supervision, at home after purchasing at a pharmacy, or via direct distribution to in-home settings via national postal systems.

Self-administration with HD-MAPs also has the potential to increase vaccine coverage and reach, while reducing labor costs and eliminating the significant waste associated with single-use needle and syringe. Self-administering vaccines, particularly in a pandemic context, could also reduce the need for personal protective equipment (and resulting waste) such as gowns, facemasks, aprons, gloves, needles, and syringes, which are typically disposed of after a single vaccination. The waste issue is significant. For example, it is estimated that the COVID-19 pandemic resulted in overwhelming levels of medical waste, generating as much as 2.6 million tons of waste per day worldwide (Andeobu et al 2022).

“Vaxxas is committed to the development and commercialization of our novel HD-MAP platform, which could deliver significant benefits by enhancing immune response and protection, as well as simplifying distribution,” said David L. Hoey, President and CEO of Vaxxas. “Our HD-MAP platform has the potential to simplify delivery and enable self-administration of vaccines, which could dramatically improve pandemic and routine vaccination, accelerate vaccination rates, increase vaccine acceptance, and reduce costs and waste associated with needle/syringe vaccination.”

This recent publication in Vaccine provides a public health and economic context to a previously-published self-administration clinical study conducted by Vaxxas with HD-MAPs (Evaluation of the self-administration potential of high-density microarray patches to human skin: A preliminary study - Human Vaccines & Immunotherapeutics, March 2023), which provided data validating the potential of Vaxxas’ high-density microarray patch (HD-MAP) to effectively deliver vaccine payloads when used by either a trained healthcare professional or self-administered by individuals with lesser or no training.

Vaxxas is advancing a robust pipeline of pre-clinical and clinical stage HD-MAP vaccine candidates and has recently concluded multiple Phase I clinical studies. The current Vaxxas pipeline targets COVID-19, seasonal and pandemic influenza, typhoid, measles and rubella, and cancer.

About HD-MAP needle-free vaccines

The Vaxxas high-density microarray patch (HD-MAP) is made up of thousands of microscopic projections attached to a small patch. On each of these solid projections sits a tiny dose of vaccine in a dried formulation. When applied to the skin, the patch delivers the respective vaccine to the abundant number of immune cells that naturally reside immediately below the skin surface.

HD-MAP vaccine delivery offers many potential benefits over more traditional ways of administering vaccines. For example, the dried form of the vaccine is more stable at higher temperatures than vaccines in liquid formulations, therefore reducing the need for cold-chain storage and distribution.

Vaxxas’ HD-MAPs have proven safe and tolerable in hundreds of trial participants to date, and have been shown to induce equal or greater immune responses to injected vaccines at lower doses. Compared with needle-and-syringe systems, they are also much easier to administer and are likely to have greater acceptability.

Ultimately, HD-MAP patches could enable a future in which vaccine patches could be mailed directly to peoples’ homes, workplaces, and schools, avoiding the delay and inconvenience of traditional needle-and-syringe vaccine scheduling and administration.

About Vaxxas

Vaxxas is a privately held biotechnology company focused on enhancing the performance of existing and next-generation vaccines with its proprietary high-density microarray patch (HD-MAP). Vaxxas is targeting initial applications in infectious diseases and oncology.

With success in several completed human clinical trials involving more than 500 participants; additional ongoing Phase I clinical studies for COVID-19 and seasonal influenza; and other vaccine studies targeting pandemic influenza, funded by the United States Biomedical Advanced Research and Development Authority (BARDA), a typhoid vaccine patch study funded by the Wellcome Trust, and a measles and rubella vaccine patch program supported by the Bill and Melinda Gates Foundation, Vaxxas’ HD-MAP vaccine delivery platform is advancing rapidly toward commercialization.

Vaxxas’ core technology was initially developed at The University of Queensland (UQ), and the company was established as a start-up in 2011 by UQ’s commercialization group UniQuest. The company was founded with the completion of an initial equity financing led by OneVentures Innovation Fund I with co-investors Brandon BioCatalyst and U.S.-based HealthCare Ventures, followed by a further financing led by OneVentures with UQ joining the most recent financing.

OneVentures Innovation Fund I and Brandon BioCatalyst are supported by the Australian Government’s Innovation Investment Fund (IIF) program. The IIF is an Australian Government venture capital initiative that provides investment capital and managerial expertise through licensed venture capital fund managers to investee companies. Learn more at www.one-ventures.com and www.brandoncapital.vc.

Caution

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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