On Oct. 26, 2021, Vaxart announced that it has dosed the first subject in its Phase II COVID-19 oral tablet vaccine clinical trial, the only Phase II trial of an oral tablet COVID-19 vaccine underway in the world.

Vaxart expects to enroll 96 subjects at four sites in the United States in the first part of its Phase II trial. The U.S. trial will be followed by an international trial involving a larger pool of subjects. The U.S. portion of the trial will be a randomized open-label dose and age escalation lead-in segment in naïve and previously vaccinated subjects, to be followed by an international placebo-controlled efficacy trial. The full data set from the U.S. trial is expected in Q1 2022.

Vaxart has recently brought online its own GMP manufacturing facility and is now producing vaccines at two GMP plants in parallel. This allowed the company to manufacture all of the COVID-19 vaccine oral tablets for the clinical trials planned to start in 2021, and to start manufacturing vaccines for its upcoming norovirus Phase II trials.

A Duke University-led study published earlier this month showed that Vaxart’s vaccine candidate reduced the airborne transmission of SARS-CoV-2 virus in an animal model and suggested the vaccine candidate would support superior mucosal protection.

The study’s findings, published by bioRxiv, are consistent with those from Vaxart’s Phase II human flu challenge study published in 2020. The flu study showed Vaxart’s oral tablet flu vaccine was better at reducing shedding than the injectable flu vaccine competitor. The Duke and flu studies’ data support the thesis that mucosal vaccines may offer better protection than injectable vaccines against airborne viruses.