Clinical results of Vaxxas needle free vaccine technology

Vaxxas announced positive interim results from a Phase I human clinical trial with the first needle-free COVID-19 vaccine candidate delivered using its proprietary high-density microarray patch (HD-MAP) technology.


The COVID-19 vaccine involves HD-MAP delivery of HexaPro, a second-generation version of the spike protein used in all major U.S. approved COVID-19 vaccines, which was modified to be more stable and immunogenic than its predecessor, giving potential coverage of all known SARS-CoV-2 variants.

The HD-MAP COVID-19 vaccine patches were well tolerated, with no serious or severe adverse events. Analysis of samples from day 28 show the HD-MAP COVID-19 vaccine increased relevant antibody levels by 8-fold on average, and the antibody responses indicated a dose-dependent trend.

“We are very encouraged by the compelling early data and rapid progress of our needle-free COVID-19 vaccine candidate,” said Vaxxas chief executive officer David L. Hoey.

“We believe our patch-based delivery of a next-generation spike protein has the potential to offer best-in-class protection against COVID-19 along with cost-effective distribution without the need for extensive refrigeration.”

Vaxxas’ proprietary HD-MAP technology platform utilises an ultra-high-density array of projections – invisible to the naked human eye – applied to the skin as a patch sitting inside a small applicator device.

When applied to the skin, the patch delivers the vaccine to the abundant immune cells immediately below the skin surface. This approach can enhance the efficiency and effectiveness of the resulting immune responses of vaccines.

Vaxxas today also announced the appointment of Dr Rochelle Chaiken, as chief medical officer. Dr Chaiken joins Vaxxas following a 23-year career at Pfizer, bringing extensive experience designing and executing late-stage clinical trials and successfully launching new products in markets.

“We are delighted to welcome Rochelle to the Vaxxas team as our chief medical officer. This is a pivotal time for the business as we advance our vaccine patch technology through multiple development programs with respective vaccines and partners,” said Hoey.

“Dr Chaiken’s extensive track record as a global senior leader in the biopharmaceutical industry, significant experience managing late-stage clinical trials, and successfully launching new products in markets, will be incredibly valuable to us.”



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