VXA-CoV2-1 - (XBB)

July 06, 2026: Vaxart, Inc. (OTCQX: VXRT) reported topline 12‑month data from the ~400-participant sentinel safety cohort of its Phase 2b trial of an oral pill COVID-19 vaccine candidate versus an approved mRNA vaccine comparator. In the dosed sentinel cohort (201 oral; 199 mRNA), no vaccine-related serious adverse events and no sustained Grade 3 or higher adverse events were reported in either arm.

Common adverse events differed by route: oral vaccine—malaise/fatigue (20.9%), headache (18.9%), anorexia (10.0%), with <10% for other AEs; mRNA— injection site pain (60.3%), tenderness (40.2%), malaise/fatigue (35.2%), myalgia (33.2%), headache (28.6%), with several other AEs at 10–15%.

As an efficacy measure, symptomatic COVID occurred in 33 oral vs 30 mRNA participants; asymptomatic cases were 12 vs 12. The company noted the sentinel cohort was not powered for comparative efficacy.

Upcoming catalyst: topline data from the complete Phase 2b study (sentinel cohort plus ~5,000-participant main cohort targeting KP.2) are anticipated in 2027; the main cohort is designed to support statistical comparisons of safety and relative efficacy. The program is funded under Project NextGen, with an award valued up to $344.8 million via the RRPV Consortium.