Dynavax Technologies Corporation has secured exclusive worldwide rights to develop and commercialize Vaxart's investigational oral COVID-19 vaccine through a licensing agreement announced November 5, 2025. The deal includes a $25 million upfront payment and $5 million equity investment, positioning Dynavax to potentially transform COVID-19 vaccination with needle-free delivery.
The collaboration centers on Vaxart's oral vaccine candidate, which uses the company's proprietary VAAST (Vector-Adjuvant-Antigen Standardized Technology) platform to deliver vaccines in room-temperature stable pills. Unlike traditional injectable vaccines, the oral approach is designed to induce mucosal immunity at respiratory tract entry points, potentially reducing infection, transmission and disease severity.
"COVID-19 continues to cause significant levels of severe illness, hospitalization, and death each year. Vaxart's oral vaccine candidate represents what we believe is a differentiated and potentially transformative approach to improve protection, and reduce local and systemic adverse events with needle-free delivery," said Ryan Spencer, Chief Executive Officer of Dynavax.
Phase 2b Trial Design and Timeline
Vaxart is currently conducting a randomized, double-blind, multi-center Phase 2b trial comparing its oral COVID-19 vaccine candidate against an FDA-approved mRNA COVID-19 injectable vaccine in adults previously immunized against COVID-19. The trial has completed enrollment of approximately 5,400 participants, with topline data results expected in late 2026.
The primary endpoint measures the relative efficacy of Vaxart's candidate compared to the mRNA comparator for preventing symptomatic disease. The primary efficacy analysis will be performed once all participants have either discontinued or completed a 12-month post-vaccination visit. Over this follow-up period, the trial will also assess safety and tolerability while measuring both systemic and mucosal immunogenicity.
The ongoing Phase 2b trial is funded under a contract between Vaxart and Advanced Technology International, supported by BARDA (the U.S. Biomedical Advanced Research and Development Authority) as part of Project NextGen.
Strategic Partnership Structure
Under the licensing agreement terms, Vaxart retains full operational and financial responsibility for the oral COVID-19 vaccine program through completion of the Phase 2b clinical trial and subsequent End of Phase 2 (EOP2) meeting with the FDA. After receiving Phase 2b data, Dynavax has the right—but not obligation—to elect whether to assume future clinical development.
"The agreement provides us with an exclusive license to a novel program while limiting our overall committed financial obligations. This gives Dynavax the opportunity to evaluate Phase 2b data before further committing to invest in late-stage development," Spencer explained.
If Dynavax elects to proceed after reviewing Phase 2b results, the company will pay an additional $50 million to Vaxart. Should Dynavax choose not to continue, the license agreement will terminate.
Potential Financial Terms
The collaboration could generate substantial payments for Vaxart if Dynavax advances the program. Beyond the initial $30 million in upfront payments and equity investment, Vaxart may receive up to $195 million in potential regulatory milestone payments and up to $425 million in potential net sales milestone payments. The agreement also includes tiered royalties at rates in the low-to-mid teens on potential future net sales of oral COVID-19 vaccines.
Technology Platform Advantages
Vaxart's oral vaccine candidates are designed to generate broad and durable immune responses, including systemic, mucosal, and T cell responses, which may enhance protection against infectious diseases like COVID-19. The pill format eliminates needle-stick injury risks and could significantly improve vaccine access, compliance, and global distribution by removing cold chain storage requirements.
"This agreement provides a clear and well-funded path forward for our oral vaccine platform in COVID-19," said Steven Lo, Chief Executive Officer of Vaxart. "Dynavax's investment and late-stage expertise provide critical support for our technology."
The collaboration aligns with Dynavax's strategy to build a diversified vaccine portfolio while complementing the growth trajectory of its commercial hepatitis B vaccine HEPLISAV-B. Dynavax also markets CpG 1018 adjuvant, currently used in HEPLISAV-B and multiple adjuvanted COVID-19 vaccines.
