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Monday, September 14, 2020

-= Vaxart (VXRT) : The FDA cleares IND application for oral COVID-19 vaccine candidate

FDA completed its review of the Company's IND application for its Phase 1 clinical trial evaluating its oral COVID-19 vaccine candidate 

  • The Phase 1, open-label, dose-ranging study will be conducted in healthy adults ages 18 to 55 years old. The study's primary objective is to examine the safety and reactogenicity of two-doses of the vaccine. Secondary objectives include immunogenicity, duration of immune response and occurrence of symptomatic COVID-19.
  • Vaxart is conducting a SARS-CoV-2 challenge study in hamsters to provide efficacy data and insights into the optimal dose regimen of our vaccine candidate. Results from this study, which began in early August, are expected mid-October.
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