Vaxart dosed the first patient in the 10,000-participant phase of its Phase 2b clinical trial for its oral COVID-19 vaccine candidate. This trial will compare the efficacy, safety, and immunogenicity of Vaxart’s oral vaccine against an existing mRNA vaccine in previously vaccinated adults. The trial’s continuation follows a positive safety review of a smaller initial cohort by an independent Data Safety Monitoring Board.
This advancement is crucial due to the potential for a more accessible COVID-19 vaccine. An oral pill format could simplify distribution and administration, particularly in areas with limited healthcare infrastructure. This could broaden vaccine coverage and contribute to controlling the virus’s spread globally. Additionally, the trial investigates the vaccine’s effectiveness as a booster, which is important for maintaining long-term immunity against evolving COVID-19 variants.
The trial is funded by the U.S. government’s Project NextGen initiative through BARDA and NIAID, with an award value of up to $460.7 million. This funding underscores the government’s interest in developing next-generation COVID-19 vaccines. The trial’s design, comparing the oral vaccine to an established mRNA vaccine, will provide valuable comparative data on efficacy and safety.
The progress of this large-scale trial represents a significant milestone for Vaxart and the potential development of more accessible vaccine options. Positive results could pave the way for regulatory approval and widespread availability of an oral COVID-19 vaccine, potentially reshaping the vaccination landscape and the fight against the pandemic.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
