The U.S. National Institutes of Health (NIH) has granted the Biotech company Vaxxas Pty. Ltd. of Australia a worldwide license to a respiratory syncytial virus (RSV) antigen known as DS2. The license will allow for the firm to create the first needle-free and room-temperature stable RSV vaccine using a novel and “cutting edge” high-density microarray patch (HD-MAP). The DS2 antigen was developed at the NIH’s Vaccine Research Center and is designed to elicit a stronger and durable immune response than the currently approved DS-Cav1.1
Vaxxas’ HD-MAP technology is a needle-free vaccine consisting of thousands of tiny projections on a small patch. Each of the micro projections is coated with a dried vaccine formulation. The patch is applied to the skin then delivers the vaccine to immune cells located just beneath the skin’s surface.
The needle-free vaccine platform has gone through five Phase I clinical trials including a second-generation COVID-19 biologic candidate, as well as microarray versions of vaccines for influenza, measles, and rubella. Vaxxas plans to advance its HD-MAP RSV vaccine to a Phase I clinical study after completing preclinical development.1
Goal of Needle-Free Vaccine Developers is Increased Uptake and Accessibility
Developers of needle-free vaccines such as HD-MAP believe the skin patch delivery system could lead to more people accepting vaccines. The plan is for vaccines to be delivered directly to homes, workplaces, and schools and for people to administer the patch vaccines to themselves, which would lead to increased vaccine uptake and accessibility.2
Gates Foundation, U.S. Government Grant Millions to Accelerate Needle-Free Vaccine Development
In November of 2023, the Bill and Melinda Gates Foundation granted $23.6 million to the Micron Biomedical, Inc. of Atlanta to fund the first ever mass production of needle-free vaccine technology. The company is developing a microarray version of the measles-rubella vaccine indicated for children as young as nine months old once it is approved following additional clinical studies.
According to Centers for Disease Control and Prevention (CDC) scientist James Goodson, the technology “could help overcome some of the most substantial barriers to eradicating measles and rubella globally.” Micron says that its microarray technology “allows a community health worker to vaccinate a child within minutes by applying the technology to the skin and pressing a button that confirms administration.”3
U.S. health agencies like the CDC and NIH, along with the Department of Defense (DoD) have also granted money to various developers of needle-free vaccines. In 2023, the NIH gave two separate $3 million grants to Orlance, Inc. of Seattle and DoD granted $5.5 million to Lumen Bioscience, Inc. also of Seattle.3
In May of 2023, Micron announced successful phase one and two data from the first-ever clinical trial of MAP technology in Gambian children, including infants as young as nine months old.4
Officials at the Vaccine Alliance Gavi believe the COVID pandemic “reinvigorated interest and investment in the MAP technology,” seemingly fueling funding, urgency, and fast tracking of the new needle free vaccine technology.3
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1 Business Wire. Vaxxas licenses next-generation vaccine for respiratory syncytial virus (RSV) from the United Stations National Institutes of Health (NIH). Oct. 28, 2024.
2 Synapse. Vaxxas acquires next-gen RSV vaccine from NIH. Nov. 1, 2024
3 Cáceres M. Needle-free vaccines pushed by Gates Foundation, U.S. government. The Vaccine Reaction Dec. 4, 2023.
4 Rigby J. No more needles? Gates Foundation funds patch-style vaccine technology. Reuters Nov. 16, 2023.