Needle-Free Patch Technology for mRNA Vaccines Aims to End Need for Frozen Storage & Improve Access

CEPI, the Coalition for Epidemic Preparedness Innovations, and Vaxxas have recently signed a partnership agreement to advance the development of Vaxxas’ needle-free vaccine-patch delivery technology in a project that could end the need for frozen storage of mRNA vaccines. CEPI will provide up to $4.3 million (AUD6.4 million) for preclinical testing of Vaxxas’ platform — a needle-free, high-density microarray patch (HD-MAP) to assess its stability, safety, and immunogenicity and to evaluate its potential as a rapid-response technology for heat-stable, dried-formulation mRNA vaccines.

This project is the first to be announced as part of CEPI’s January 2022 call for proposals, aimed at improving thermostability of — and thereby improving equitable access to — a variety of new vaccine platforms. This call forms part of CEPI’s wider strategic goal of harnessing innovative technologies to improve the speed, scale and access of vaccine development and manufacturing in response to epidemic and pandemic threats.

HD-MAPs are made up of thousands of microscopic points attached to a small patch. Each of these micro-projections contains a tiny dose of vaccine in a dried formulation. When applied to the skin, the patch delivers vaccine to the abundant immune cells immediately below the skin surface.

HD-MAP vaccine delivery offers many potential advantages 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. 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.

CEPI and Vaxxas are committed to enabling global equitable access to the vaccines they develop including those incorporating patch technology. Under the terms of the funding agreement, Vaxxas has committed to achieving equitable access to the outputs of this project including prioritization of supply for low-income and middle-income countries (LMICs), production of vaccine volumes required to meet public health needs, with affordable pricing, and the potential technology transfer to LMIC manufacturers in line with CEPI’s Equitable Access Policy.

Jane Halton, Chair of CEPI, said “As we have witnessed with COVID-19, equitable access to vaccines must be at the heart of any effective pandemic response. This is a guiding principle for all of CEPI’s investments. Combining Vaxxas’ vaccine-patch technology with the speed and effectiveness of mRNA vaccines could produce a tool that is not only suited as a rapid-response platform for use against unknown pathogens, but could also serve as an additional means to get life-saving vaccines to the most vulnerable populations around the world.”

Richard Hatchett, CEO of CEPI, added “The advances in mRNA vaccine technology were critical to the global response to COVID-19. One of the major challenges the world faced in getting these life-saving vaccines to vulnerable populations was the need to store them at very low temperatures. One possible way to improve access to mRNA vaccines in future would be to adapt their formulation so that they could be delivered using microarray patches. This removes the need for frozen storage, allows for easier distribution and safe delivery with accurate dosing. These qualities make this technology particularly promising as a platform for rapid delivery of vaccines in an outbreak situation, particularly in harder to reach regions.”

David Hoey, Vaxxas Chief Executive Officer, also added “Earning this significant funding from one of the world leaders in vaccine development is a great honor, and validates the benefits offered by Vaxxas’ HD-MAP vaccine platform in the fight against global epidemic and pandemic threats. In addition to providing an opportunity to get life-saving vaccines for infectious diseases that have a disproportionate impact on the most vulnerable populations around the world, the advanced development of HD-MAP delivery of mRNA vaccines could also prove very beneficial for the development of Vaxxas’ internal pipeline across a number of diseases, including Covid-19.”

CEPI is an innovative partnership between public, private, philanthropic, and civil organizations, launched in 2017, to develop vaccines against future epidemics. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need.

Prior to COVID-19, CEPI’s work focused on developing vaccines against Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever virus and Chikungunya virus – it has over 20 vaccine candidates against these pathogens in development. CEPI has also invested in new platform technologies for rapid vaccine development against unknown pathogens (Disease X).

CEPI has played a central role in the global response to COVID-19, supporting the development of the world’s largest portfolio of vaccines against SARS-CoV-2 and its variants with a focus on speed, scale and access, as well as co-leading COVAX, the global initiative to deliver fair and equitable access to COVID-19 vaccines. CEPI is also the world’s leading funder of R&D for broadly protective coronavirus vaccines which could protect against future variants of COVID-19 as well as other coronaviruses with epidemic and pandemic potential.

CEPI has embarked upon an ambitious US$3.5bn five-year plan – called CEPI 2.0 – to dramatically reduce or even eliminate the future risk of pandemics and epidemics. Central to the plan is CEPI’s goal – supported by the G7 and G20 – to compress the time taken to develop safe, effective, globally accessible vaccines against new threats to just 100 days. Achieving this 100 Days Mission would give the world a fighting chance of containing a future outbreak before it spreads to become a global pandemic. Read the plan at endpandemics.cepi.net/.

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 disease and oncology.

In addition to a Phase I clinical study of a COVID-19 vaccine candidate patch, Vaxxas is performing demonstration work in preparation for clinical evaluation under contract with the United States Biomedical Advanced Research and Development Authority (BARDA) on pandemic vaccination solutions.

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 company UniQuest. The company was founded with the completion of an initial equity financing led by OneVentures Innovation Fund I with co-investors Brandon Capital Partners, Brandon BioCatalyst, and US-based HealthCare Ventures, followed by a further financing led by OneVentures. 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. For more information, visit www.one-ventures.com and www.brandoncapital.vc.