BioProcess Insider Interview: Michael Schrader, Chief Executive Officer and Cofounder, Vaxess Technologies

Millie Nelson, Editor, BioProcess Insider (left); Michael Schrader, Chief Executive Officer and Cofounder, Vaxess Technologies (right).

The COVID-19 pandemic highlighted an increasing demand for in-home healthcare. Schrader discussed the potential of a service that allows people to self-administer vaccines and how such a program can improve treatment for patients around the world. The Vaxess patch system is designed to enable patients to receive critical medicines without visiting a clinic.

Patients apply a Vaxess adhesive patch to the skin for five minutes, enabling microneedles to deliver a vaccine or therapy. The needles dissolve in a user’s interstitial fluid, leaving behind microparticles under the skin to deliver medicine continuously over a two-week period. The patches are shelf stable, requiring no refrigeration for storage. Their design also enables disposal without requiring a sharps container. The Bill and Melinda Gates Foundation has provided funding for Vaxess’s patch system because of its potential to improve global accessibility to vaccines. Schrader hopes that the patch will help to eradicate diseases that have been pushed to the brink (e.g., poliomyelitis and measles), but he also emphasizes that the Vaxess technology can be used in the future to deliver hormones and other therapies.

Schrader said that his company has establish its own good manufacturing practice (GMP) production facility. Vaxess observed the difficulties faced by other medical-device companies and designed its patch system accordingly. First, it had to figure out how to deliver doses consistently to all patients, which the company did by precision-engineering the printing process for its patch design. Second, Vaxess had to account for differences in patients’ skin based on age, tissue structure, and hair content. Designing a patch that consistently delivered material efficiently across skin types proved to be a key obstacle, one that has challenged other companies in the past. Finally, the company had to ensure quality and ease of use for customers by fine-tuning the applicator, instructions, system design, and ordering process.

The patch has undergone phase 1 clinical testing for dermal delivery of a seasonal influenza vaccine. Products were mailed to subjects’ homes for self-administration. Schrader said that immune responses observed during the trial were consistent with those produced by commercially available flu vaccines and even showed two improvements over traditional clinical administration. Durability of protection was significantly better for patients using the Vaxess patch, meaning that protection did not fall off at the end of the season for those who applied the vaccine early. Second, and more surprising was a dramatic reduction in side effects, including flu-like symptoms often experienced by patients after clinical administration. Scientists at Vaxess believe that both improvements are attributable to the patch’s slow-release system. Phase 2 development work is underway with a full trial planned for 2024.

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