Composed of hundreds of microscopic projections shaped into a tiny patch, the HD-MAP vaccine technology offers self-administered needle-free vaccine delivery method. Applied to the skin, the patch sends the vaccination to the many immune cells under the skin surface.

Vaxxas new patent’s claims includes company’s proprietary printhead system that accurately and consistently dispenses a dried formulation of vaccine onto the HD-MAP microprojections in small doses. 

“The printhead system has been specifically designed to coat the HD-MAP with vaccines in an aseptic environment that complies with government regulations for clinical and commercial manufacturing of vaccines,” Dr. Scott Fry, Vaxxas Chief Operating Officer, said. “This is a critical phase of our manufacturing process. It enables us to coat the HD-MAP at high speed and in a consistent manner to achieve large volumes without compromising the quality of the end product.”

“The precision by which the printhead system coats the vaccine onto each microprojection is quite incredible, and a significant achievement by our team of engineers,” Dr. Fry said. “It’s great to have this recognised and covered by the U.S. patent office.”

This new U.S. patent issuance increases Vaxxas’ growing international intellectual property portfolio of 43 issued patents and supports the company’s exclusive right to produce and market its patented vaccination technology in the United States, Europe, Asia, and Australia.

More broadly, Vaxxas’ patent portfolio addresses all notable proprietary features of the company’s vaccine delivery platform and products, including the manufacture and use of the HD-MAP vaccine technology and novel applicator device; vaccine formulations; and methods for formulating, loading and coating vaccines on HD-MAP technology.

“Vaxxas is aiming to transform the vaccine market by improving the performance of vaccines and reducing the economic and logistical challenges typically associated with needle-and-syringe vaccination,” David Hoey, Vaxxas Chief Executive Officer, said. “The breadth of our patent portfolio protects our exclusive use of the technologies necessary to achieve this goal, as well as freely manufacture and sell our products at commercial scale and in a safe and regulatory compliant manner.”

From its worldwide headquarters and cutting-edge biomedical facility in Brisbane, Vaxxas is ramping up production and distribution of the world’s first commercially available vaccine patches.

Vaxxas’ HD-MAP vaccine technology has finished five successful Phase I clinical trials with vaccines addressing some of the world’s most pressing health issues including COVID-19, flu, and measles and rubella involving more than 500 individuals.

With money from the United States Biomedical Advanced Research and Development Authority (BARDA), Vaxxas has lately finished enrolling 258 people in a U.S. IND-enabled Phase I clinical trial for a pre-pandemic influenza vaccination.  Results from the trial are anticipated in June of this year.V

The findings suggest that one booster shot of an mRNA vaccine, in addition to the less expensive but less effective inactivated vaccines, is adequate to attain the ‘gold-standard’ immune reaction calculated after three doses of an mRNA vaccine, says Karolinska Institutet’s Department of Biosciences and Nutrition’s professor Qiang Pan Hammarström. Even in resource-poor countries, which would probably be a great investment to defend against severe COVID-19.

A total of 175 healthy volunteers with varied vaccination histories participated in the study. After immunisation and booster doses with an immobilised vaccine (Sinovac/Sinopharm), mRNA vaccine (Pfizer-BioNTech/Moderna), or a blend of both, the researchers looked for antibody and memory B and T cell responses against SARS-CoV-2.

The findings revealed that giving an mRNA vaccine booster shot to people who had already gotten two doses of inactivated vaccine significantly increased the levels of nullifying antibodies and memory B and T cells targeted towards SARS-CoV-2 variants of concern, particularly Omicron. The levels were much greater than those seen in people who received three doses of inactivated vaccination and were comparable to that seen in those who received three doses of mRNA vaccine or a booster of mRNA vaccine after a natural illness.

Since nearly half of the COVID-19 vaccine doses supplied worldwide are inactivated shots, an enhanced mRNA booster technique could help billions of people in their fight against developing variations of worry, explains Qiang Pan Hammarström. A wider usage of mRNA booster doses could also help China overcome its current restrictions. The small number of participants in the trial is a restriction; just 16 people were vaccinated with 2 doses of inactivated vaccine accompanied by an mRNA vaccine boost. Moreover, the study participants’ median age was 36, which is lower than the global average population. So, the results need to be confirmed by large-scale longitudinal studies with people of different ages.

Now, the researchers will look at how the heterologous vaccination method affects new strains of the SARS-CoV-2 virus. They will see for the first time if this vaccination method can negate the two developing Omicron subvariants BA.4 and BA.5, which are at the root of the recent COVID-19 outbreak in South Africa, adds Qiang Pan Hammarström.

The research was conducted by Karolinska Institutet as part of the ATAC research consortium, which was financed by the European Commission in response to the COVID-19 outbreak. Policlinico San Matteo in Pavia (Italy), The Institute for Research in Biomedicine (Switzerland), the European Commission’s Joint Research Centre and Technische Universitaet Braunschweig (Germany), are all members of the group. The study was also made possible by partnerships involving Shahid Beheshti University of Medical Sciences (Iran), Peking University Health Science Center (China), Stockholm University (Sweden), and Tehran University of Medical Sciences (Iran). The Swedish Research Council and the Knut and Alice Wallenberg Foundation also contributed to the discovery. There are no conflicting interests declared by the researchers.