We recently Zoomed with the management team at Vaxart (VXRT) to catch up and get a feel for the upcoming Phase II COVID-19 oral vaccine development, notes John McCamant, editor of The Medical technology Stock Letter — and a participant in The Interactive MoneyShow Virtual Expo on Oct. 5-7. Register here for free.

The dose ranging portion of the Phase II trial is expected to begin shortly. VXRT could announce data within a few months after dosing as they will be able to track the trial results real time as they reveal themselves using the open-label design.

The Phase II trial will almost certainly enroll patients who need a booster shot after receiving the mRNA vaccine from either Moderna (MRNA) or Pfizer (PFE). The first portion of Phase II is expected to occur in the U.S. with the second portion expanding to overseas with SE Asia and Africa being likely candidate locations.

The company is preparing for their next stage of growth and the upcoming Phase II COVID-19 vaccine development program by creating both an eight-member Scientific and Clinical Advisory Board and adding a new Director to their Board. 

The Advisory Board, whose first meeting occurred on July 24, 2021, is composed of medical and health care professionals who are vaccine, research, and academic experts in immunology, microbiology, and infectious diseases.

In our view, two of the new SAB members are clearly outstanding and represent a true coup for VXRT to attract such preeminent leaders in their fields.

Dr. Marion Pepper (Ph.D.  Associate Professor, Immunology  University of Washington) is a world renown expert in T-cells which may be one of the key advantages for VXRT’s oral vaccine.

And Dr. Ralph Baric (Ph.D.  Professor, Department of Epidemiology, Microbiology, and Immunology, Gillings School of Global Public Health University of North Carolina) is one of the world’s leading experts on corona viruses.

VXRT has also added Dr. Julie Cherrington to the Vaxart Board of Directors. Dr. Cherrington’s background in virology and immunology and her record as the CEO of multiple companies makes her a great fit for the company.

The second half of 2021 holds significant promise for VXRT as the Phase II data has the potential to transform the company from an interesting “story stock” to a major player in COVID-19 vaccine development space.  The booster data could be huge if the vaccine can protect against the Delta variant. 

In our view, the recent noravirus data where VXRT demonstrated the ability to boost the immune response in patients who had previously received the VXRT vaccine candidate bodes well for the upcoming booster data in COVID-19. 

Importantly, the company has also made progress on the manufacturing front with an announcement expected by year end on the progress. VXRT has the potential to be both a major player and part of the long-term vaccine solution.

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