Vaxart, Inc. (VXRT) disclosed interim safety results from the 400‑participant sentinel cohort of its Phase 2b trial, which evaluated its oral COVID‑19 vaccine against an approved mRNA vaccine.
The trial included 201 participants receiving Vaxart’s oral pill formulation and 199 participants receiving an injectable mRNA vaccine specific to the XBB SARS‑CoV‑2 variant. No serious adverse events related to vaccination, nor any persistent Grade 3 or higher toxicities, were observed in either group.
The most frequent adverse events among oral pill recipients were fatigue/malaise (20.9%), headache (18.9%), and loss of appetite (10.0%). Less than 10% reported any additional side effects.
In the mRNA arm, injection‑site pain (60.3%), tenderness (40.2%), fatigue/malaise (35.2%), muscle pain (33.2%), and headache (28.6%) were more common, while chills, nausea, and diarrhea each affected 10–15% of participants.
Symptomatic infections occurred in 33 participants in the oral pill group and 30 in the mRNA group, with 12 asymptomatic cases reported in each arm. The sentinel cohort was not designed to evaluate comparative efficacy.
Full study data, encompassing roughly 5,000 participants in the primary cohort, are projected for release in 2027. This cohort will enable statistical comparison of safety and efficacy between the oral pill and mRNA vaccines.
