Fear of Needles Resolved with Pain-less Microarray Patch
A clinical-stage biotechnology company commercializing a novel vaccination platform announced a potential solution for millions afraid of needles.
This vaccine innovation is essential as researchers estimate that fear of needles affects up to 25% of adults and may lead to many people skipping standard vaccinations.
Vaxxas confirmed today it initiated a Phase I clinical trial with the first needle-free inactivated seasonal influenza vaccine quadrivalent (IIV4) candidate delivered using the Company's proprietary high-density microarray patch (HD-MAP) technology.
Vaxxas's Chief Executive Officer, David L. Hoey, stated in a press release on February 10, 2023, "Vaccine delivered via an HD-MAP patch is easy to use and can be self-administered.
"It can simplify distribution by removing or reducing the need for refrigeration; and avoids needles."
The Phase I clinical trial will assess the safety, tolerability, and immunogenicity of the inactivated influenza vaccine quadrivalent (IIV4) candidate in participants who have not received a flu shot within the last six months and have received no vaccines of any kind for at least thirty days before participating in the study.
In contrast to current flu shots given by needle and syringe, which must be stored under refrigerated conditions, Vaxxas has shown that the influenza vaccine on the HD-MAP can be kept at temperatures up to 40°C, for at least 12 months, without losing effectiveness.
These thermostability benefits of an HD-MAP influenza vaccine have the potential to enable broader flu shot distribution at a lower cost.
During the 2022-2023 flu season in the U.S., over 171 million flu shots were distributed.
"All factors that could improve access to, and acceptability of, current influenza vaccines, offering greater protection each season to communities around the globe."
"We are excited by the potential of our needle-free, seasonal flu patch development program. This clinical trial builds upon our compelling body of data from clinical and preclinical studies using flu vaccines," Mr. Hoey added.
In addition to this seasonal IIV4/HD-MAP Phase I clinical trial, Vaxxas is preparing for the clinical evaluation of a pandemic influenza vaccine under contract with the U.S. Biomedical Advanced Research and Development Authority.
In 2022, the Company also initiated a Phase I clinical study of the first COVID-19 vaccine candidate delivered using its HD-MAP technology.
Vaxxas has completed three human clinical studies with its HD-MAP, demonstrating safety and enhanced immune response of vaccine administration by HD-MAP.
The Company's proprietary HD-MAP technology platform utilizes an ultra-high-density array of projections that is invisible to the naked human eye and 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 novel approach could enhance the efficiency and effectiveness of the resulting immune responses of vaccines.
Ease of use of the HD-MAP could enable simplified administration, potentially encompassing self-administration.
To create the quadrivalent influenza vaccine patch candidate, Vaxxas' HD-MAP is coated with a commercially available inactivated quadrivalent influenza vaccine and integrated into a single-use applicator, ready-for-vaccination.
The influenza vaccine candidate delivered by Vaxxas' HD-MAP in this study is a commercially available undisclosed IIV4.
In laboratory testing published in PLoS Med (Mar. 2020), Vaxxas' HD-MAP-delivered vaccines have been shown to be stable and remain active when stored and transported at room temperature and demonstrate greater safety and protection, along with a potential for a lower dose when compared to needle and syringe delivery of vaccine antigens, including influenza as well as measles/rubella.
Additional influenza news for the 2023 flu season is posted at PrecisionVaccinations.com/Flu.