In June 2024 Vaxart announced that it has received a project award valued at up to $453 million to conduct a Phase IIb comparative study to evaluate Vaxart’s oral pill COVID-19 vaccine candidate against an FDA-approved mRNA vaccine comparator. The funding will be provided in two parts, with approximately $65.7 million available immediately; this will be followed by $387.2 million when Vaxart and BARDA have established that the study can proceed.
The vaccine and the trial
Vaxart’s oral pill vaccine “holds the promise of longer protection from infection, broader protection against virus variants, and a greater reduction in virus transmission than the first-generation injectable vaccines”. The vaccine triggers “strong” IgA and T-cell responses. It is designed to be room temperature-stable to facilitate global distribution with “wide public acceptance, minimal cost, and maximum speed”.
The Phase IIb trial is a double-blind, multi-centre, randomised, comparator-controlled study to determine the relative efficacy, safety, and immunogenicity of the oral pill candidate against an approved mRNA injectable vaccine in adults who have previously been immunised against COVID-19 infection. The study will enrol around 10,000 healthy adults.
A next-generation approach
Dr James F. Cummings, Vaxart’s Chief Medical Officer, is “grateful to BARDA for this funding”, which will enable Vaxart’s pursuit of a Phase IIb trial for the COVID-19 oral pill vaccine candidate.
“This trial will evaluate whether our oral pill vaccine candidate compares favourably against an approved mRNA injectable vaccine. We are excited to explore the results of this head-to-head comparison. Previous research showed that our earlier COVID-19 vaccine constructs triggered long-lasting immune responses and induced a cross-reactive immunogenic response against all tested SARS-CoV-2 variants.”
Vaxart’s Chief Executive Officer, Steven Lo, commented that “vaccine delivery has relied primarily on injection for more than 150 years”.
“This funding from BARDA will assist us in determining whether we can bring a transformational, next-generation approach to global vaccination. We believe our oral pill vaccine platform can better meet societal needs not just for COVID-19, which now in the endemic phase, but for other infectious diseases that present significant endemic and pandemic threats.”
We look forward to hearing more about this oral vaccination strategy from Vaxart at the Congress in Barcelona this October; get your tickets to join us here and don’t forget to subscribe for more updates.
