Needle-free future: Tackling vaccine delivery challenges

Vaxxas is a privately held biotech focused on enhancing the performance of existing and next-generation vaccines with a proprietary high-density microarray patch (HD-MAP). Its core technology was initially developed at The University of Queensland (UQ), Australia, and the company was established as a start-up in 2011 by UQ’s commercialization company, UniQuest.

The US$4.3m agreement 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. The 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.

Vaxxas said its vaccine-delivery platform could improve access to mRNA vaccines by removing the need for frozen storage, enabling easier distribution, and offering accurate and safe dosing with minimal waste.

The CEPI financing will go towards preclinical testing of the needle-free vaccine-patch technology delivery, to assess its stability, safety, and immunogenicity and to evaluate its potential as a rapid-response technology for heat-stable, dried-formulation mRNA vaccines.

HD-MAP vaccine delivery offers many potential advantages over more traditional ways of administering vaccines, claims Vaxxas. “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.”​

Supplying LMICs ​

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.

Richard Hatchett, CEO of CEPI, said: “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.”​

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, noted David Hoey, CEO of Vaxxas.

Rmping up manufacturing capabilities

The company also recently completed ​​a financing round, announcing in December 2022 that it had raised US$23m (A$34m) in new funds, which would be directed at advancing multiple vaccine programs in the clinic and ramping up manufacturing capabilities towards commercial scale. Vaxxas has its development headquarters in Brisbane, Australia and its commercialization focus in the US in Cambridge, Massachusetts.

It is currently undertaking a Phase I clinical study​​ of a COVID-19 vaccine candidate patch and is also performing demonstration work in preparation for clinical evaluation under contract with the US Biomedical Advanced Research and Development Authority (BARDA) on pandemic vaccination solutions.