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Vaxart's oral COVID-19 tablet vaccine to enter clinical trials - BioPharma-Reporter.com

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The California-headquartered biotech, which develops oral vaccines administered by tablet rather than injection, says a COVID-19 vaccine in this form would be ‘significantly’ easier and cheaper to store and distribute as it does not require a refrigerated cold chain like most injectable vaccines. 

Having obtained the green light from the U.S. Food and Drug Administration (FDA) in its IND application, announced yesterday, enrolment for the Phase 1 clinical trial will begin this month with results anticipated in early 2021. It is the first oral tablet vaccine for COVID-19 to reach human clinical trials. 

Vaxart’s COVID-19 vaccine is using the same platform technology as its more advanced influenza vaccine program, which released topline data from a Phase 2 challenge study earlier this year.

‘We made the strategic decision to pivot our focus to COVID-19’

Vaxart's focus is on developing tablet versions of currently marketed vaccines, as well as designing recombinant vaccines for new indications. All are based on its oral Vector-Adjuvant platform, VAAST.

Development programs include tablet vaccines for norovirus, seasonal influenza, and respiratory syncytial virus (RSV). The company has also a development program for a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immune-oncology indication.

At the start of this year, Vaxart started working on its coronavirus vaccine.

“In January,we felt a “call to duty” and made the strategic decision to pivot our focus to combatting COVID-19 using our proprietary vector platform,”​ Vaxart’s chief scientific officer, Sean Tucker Ph.D., told BioPharma-Reporter.

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