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1 Jun 2020

Scaling up for unprecedented global vaccine manufacturing

Vaxxas announces Merck (known as MSD outside the US and Canada) milestone and Harro Höfliger manufacturing alliance.

Vaxxas has announced two developments relating to its novel high-density microarray patch (HD-MAP), which uses an ultra-high density array of projections — invisible to the naked human eye — applied to the skin to rapidly deliver any vaccine to the abundant immune cells immediately below the skin surface.

Vaxxas HD-MAP could be a game-changing technology for vaccine delivery in pandemic situations such as COVID-19 or influenza because it makes it possible to vaccinate up to six times more people using the same amount of vaccine — each patch uses a percentage of the vaccine dose needed by conventional delivery approaches.

Merck has exercised its option to utilize Vaxxas’ proprietary HD-MAP) platform for an unidentified vaccine candidate. The company also retains an option to license the HD-MAP technology for two additional vaccines.

Vaxxas will receive $12 million (A$18 million) in a combination of equity funding and option fees associated with the agreement. In addition, the company is eligible to receive future option, development, and commercial milestone payments.

In a separate agreement, Vaxxas and Harro Höfliger, a leader in sterile processing and scale-up of new pharmaceutical products, technologies and devices, will develop the world’s first high-throughput aseptic line for vaccine-HD-MAP production.

Single, aseptic-based lines will have a targeted throughput of up to 5 million vaccine products/week. Initial efforts are focused on a pilot line operating in 2021 to be used to support late-stage clinical studies.

"A major challenge in commercializing microarray patches — like Vaxxas’ HD-MAP — for vaccination is the ability to manufacture at industrially relevant scale while meeting stringent sterility and quality standards. Our novel device design along with our innovative vaccine coating and quality verification technologies are an excellent fit for integration with Harro Höfliger’s aseptic process automation platforms. Adopting a modular approach, it will be possible to achieve an output of tens-of-millions of vaccine-HD-MAP products per week,” said David L. Hoey, President and CEO of Vaxxas.

For routine infectious disease more than 750 million vaccinations are administered worldwide each year by needle/syringe. In the case of pandemic response, billions of vaccinations may need to occur in a variety of settings. Vaxxas’ HD-MAP has the potential to create new needle-free vaccine products with enhanced immune response and designed for improved safety, storage, and distribution logistics to extend the reach of vaccines and improve vaccination efficiency and effectiveness.

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