Oral COVID-19 Vaccine Could Activate both Systemic and Mucosal Immunity for Protection against Coronavirus

Vaxart, Inc. (South San Francisco, CA, USA) has further advanced its oral COVID-19 vaccine candidate towards the clinic by filing its Investigational New Drug (IND) application with the US Food and Drug Administration (FDA).

Vaxart develops oral tablet vaccines designed to generate mucosal and systemic immune responses that protect against a wide range of infectious diseases and has the potential to provide sterilizing immunity for diseases such as COVID-19. Vaxart believes that a room temperature stable tablet vaccine is easier to distribute, store and administer than injectable vaccines and may provide significantly faster response to a pandemic than injectable vaccines, enabling a greater portion of the population to be protected. The company’s development programs include oral tablet vaccines that are designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV).


Recently, Vaxart’s oral COVID-19 vaccine was selected to participate in a non-human primate (NHP) challenge study, organized and funded by Operation Warp Speed, a new national program aiming to provide substantial quantities of safe, effective vaccine for Americans by January 2021.

“We are very excited to reach this important milestone in advancing our oral COVID-19 vaccine candidate towards the clinic,” said Andrei Floroiu, chief executive officer of Vaxart. “We expect our upcoming Phase I study to generate data that will further differentiate our oral vaccine from injectable vaccines by substantiating the importance of activating both systemic and mucosal immunity in protecting against COVID-19. We believe that this mechanistic benefit combined with the significant advantages of oral administration to the patient while eliminating the need for cold chain distribution, could make our COVID-19 vaccine an ideal candidate for successful mass vaccination campaigns globally.”

“Filing the IND is the first major step of many we are taking to advance our oral vaccine in the prevention of COVID-19,” said Sean Tucker, Ph.D., chief scientific officer of Vaxart. “We are excited to be moving this project toward clinical trials, and potentially demonstrating similarly potent mucosal and systemic immune responses like we have seen with our other vaccine candidates using the same oral tablet vaccine platform.”

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