FDA Clears IND Application for S-Only Oral Tablet COVID-19 Vaccine Candidate

California-based Vaxart, Inc. announced today that the U.S. FDA had cleared Vaxart's Investigational New Drug application for an S-only oral tablet SARS-CoV-2 vaccine candidate, Vaxart COVID-19 Oral Vaccine (VXA-CoV2-1).

This vaccine triggers mucosal immune responses in humans. Mucosal immunity is believed to be the first defense against airborne viruses, such as coronavirus and flu. It may also be important in reducing viral shedding and preventing transmission.

Additionally, Vaxart COVID-19 Oral Vaccine targets both the spike protein (S) and nucleoprotein (N).

"This is great news because it allows us to move forward with our first S-only vaccine construct," stated Andrei Floroiu, Vaxart's CEO, in a press release.

"As we said at the end of the first quarter, we will explore multiple S-only constructs in clinical trials alongside the S+N construct that has already completed its Phase I trial."

"Together, the S-only and S+N constructs are part of our unique oral tablet COVID-19 vaccine candidate portfolio, which we believe could make a significant contribution to the fight against COVID-19 globally."

Vaxart announced in February 2021 that it had completed a Phase 1 clinical trial for its oral S+N COVID-19 vaccine.  The results from that study found that the investigational oral vaccine triggered multiple immune responses against SARS-CoV-2 antigens while reaching primary and secondary endpoints of safety and immunogenicity, respectively.

The Phase II clinical trial with the S-only construct is expected to start in 2021.

Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are administered using convenient room temperature-stable tablets that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury.