The U.S. Department of Health and Human Services (HHS) is supporting the development of a patch could administer vaccines without traditional needles. Under an approximately $22 million, 3-year agreement between the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS, and Vaxxas, the company will conduct U.S. and Australian Phase I trials to evaluate the safety and efficacy of an easy-to-use, high-density micro-array patch (HD-MAP) and other development activities for the patch.
“Protecting health and saving lives in public health emergencies such as pandemics often requires rapid, widespread vaccination among large groups of people, which poses multiple logistics challenges,” said BARDA Acting Director Gary Disbrow, Ph.D. “Imagine placing a patch on your arm or leg instead of having to go to a clinic or doctor’s office to get a shot. Not only would needle-free technology simplify vaccination logistics and potentially lower costs, but a self-administered patch also may improve vaccination rates.”
Micro-array patch technology has the potential to reduce the amount of vaccine required, which would help healthcare professionals provide vaccine to more people. Patch technology also has the potential to offer a room-temperature-stable alternative to the cold chain required for some traditional vaccines, reducing the need for refrigeration in transport and storage, and could possibly be provided directly to consumers for self-administration.
The Phase I clinical trial, expected to start in 2022, will include more than 400 adult volunteers using unadjuvanted and adjuvanted influenza vaccines. By using pre-pandemic influenza vaccines for the clinical trials, the company can more easily determine the baseline immune response and safety of the micro-array technology, as well as the usability and acceptability of the technology.
HD-MAP is the latest next-generation technology to receive BARDA development support and part of a growing pandemic preparedness and response portfolio.