Vaxart Inc. Reports 12‑Month Safety Data from Phase 2b Trial of Oral Pill COVID‑19 Vaccine
Vaxart Inc., the biotechnology company headquartered in South San Francisco that specializes in oral flu vaccines, has released the first safety data from its 400‑participant sentinel safety cohort in the Phase 2b clinical trial of its oral COVID‑19 vaccine. The company announced that the 12‑month safety data were collected from a 400‑participant cohort and that the results were consistent with the safety profile observed in the Phase 2a trial, where 70 participants received the vaccine and 30 received a placebo. No serious safety concerns were identified and the vaccine was well tolerated in the study population.
The Phase 2b trial enrolled participants across 14 sites in the United States, Canada, and the United Kingdom. The safety cohort, which enrolled 400 participants, is expected to continue enrollment in the Phase 2b study. The trial is designed to evaluate the safety and immunogenicity of a 5‑dose oral COVID‑19 vaccine regimen in healthy adults. The vaccine is being investigated for use as a primary or booster COVID‑19 vaccine.
The safety data were presented in a briefing to the FDA and will be submitted to the agency as part of the vaccine’s Investigational New Drug (IND) application. Vaxart has also announced that it will file a Phase 3 application for the oral COVID‑19 vaccine later this year. The company’s CEO, John R. Allen, said that the safety data “are an important milestone for the company” and that the vaccine “has the potential to transform the COVID‑19 vaccination landscape.”
Vaxart is also pursuing a partnership with a large multinational pharmaceutical company to manufacture and distribute the oral COVID‑19 vaccine globally. The company’s shares are currently trading at $0.64 on the OTC Bulletin Board.
