Vaxart announced that it has begun recruiting subjects for its Phase II COVID-19 oral tablet vaccine clinical trial. Vaxart expects to begin dosing the first of 96 U.S. subjects, split evenly between COVID-19 naïve and mRNA vaccinated subjects, later this month.
The company's Phase II COVID-19 program will also include countries outside of the United States, starting with a trial in India that is expected to begin later this year.
"Phase II is an extremely important milestone in the development of the first and only COVID-19 oral tablet vaccine that has reached this phase of development," said Vaxart Chief Executive Officer, Andrei Floroiu.
"An oral vaccine has the potential to dramatically impact the world's response to the COVID-19 pandemic and to improve global public health. It can be easier and faster to administer than injectables and can help mitigate vaccine hesitancy, as many of those unwilling to get vaccinated by needle would take an oral tablet vaccine," Floroiu said.
"We're very excited to start Phase II trials of our S-only vaccine candidate because in our nonhuman primate studies, our S-only vaccine produced much higher serum antibody levels than the S+N construct did," said Dr. Sean Tucker, Vaxart's founder and Chief Scientific Officer.
"Vaxart's new trials will generate key data that will allow us to compare the S-only and S+N vaccine candidates and help us decide on the best development path forward for our COVID-19 vaccine program, particularly in the face of emerging variant strains," added Dr. Tucker.
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