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Vaxxas Advances Revolutionary Needle-Free Vaccine Patch in Largest HD-MAP Clinical Trial

• Vaxxas has completed enrollment for a groundbreaking clinical trial of their High-Density Microarray Patch (HD-MAP) technology, testing both adjuvanted and adjuvant-free vaccine formulations for enhanced delivery.

• Previous clinical studies demonstrated HD-MAP technology achieved comparable immune responses using just one-sixth of traditional vaccine doses, potentially revolutionizing vaccine administration.

• Research suggests implementing HD-MAP technology for just 10% of COVID-19 vaccinations could have reduced the pandemic duration by 150 days and prevented 16.4 million cases in the US.

Vaxxas has reached a significant milestone in advancing needle-free vaccine delivery with the completion of enrollment for its largest clinical trial of the High-Density Microarray Patch (HD-MAP) technology. The study will evaluate both adjuvanted and adjuvant-free vaccine formulations, marking a crucial step toward revolutionizing vaccine administration.

Promising Technology with Proven Results

David L. Hoey, Vaxxas CEO and President, highlighted the technology's potential, stating, "In our prior clinical studies for seasonal influenza, we've demonstrated comparable immune responses to traditional vaccination with as little as one-sixth of the vaccine with no adjuvant by delivering the vaccine directly to the immune cells just below the skin surface."
The trial's dual-arm design, testing both adjuvanted and adjuvant-free formulations, could expand the technology's applications across various infectious diseases. Success in either arm would represent a significant advancement in vaccine delivery methods.

Revolutionary Impact on Pandemic Response

The significance of HD-MAP technology extends beyond individual vaccination experiences. According to research by the Avalere Group, implementing HD-MAP technology for just 10% of COVID-19 vaccinations could have:
  • Shortened the pandemic by up to 150 days
  • Prevented 16.4 million cases
  • Avoided 200,000 deaths
  • Reduced economic impact by over $500 billion

Advanced Design and Benefits

The HD-MAP system consists of thousands of microscopic projections on a small patch, each coated with dried vaccine formulation. This innovative design offers several advantages:
  • Enhanced stability at higher temperatures, reducing cold-chain requirements
  • Simplified administration process
  • Proven safety and tolerability in hundreds of trial participants
  • Potential for direct distribution to homes, workplaces, and schools

Clinical Trial Outlook

The trial represents a critical evaluation of Vaxxas's technology, with initial results expected in the first half of 2025. The study builds on previous successful trials involving over 500 participants, including pandemic influenza studies funded by the Biomedical Advanced Research and Development Authority (BARDA).

Potential Public Health Impact

The development of HD-MAP technology could transform vaccine distribution and administration globally. The ability to ship vaccine patches directly to various locations could eliminate many current logistical challenges and improve vaccination rates through easier access and administration.
The technology's potential to reduce vaccine doses while maintaining efficacy could also address global vaccine supply challenges and improve cost-effectiveness of vaccination programs. If successful, this advancement could mark a new era in vaccine delivery, making immunization more accessible and efficient worldwide.
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