Vaxart’s Oral COVID-19 Pill Shows Strong Safety Profile in Phase 2b Trial — Vaxart, Inc.

Event summary

Vaxart reported topline 12-month safety data from a 400-participant sentinel cohort in its Phase 2b trial for an oral COVID-19 vaccine, showing no serious adverse events.
The study compared Vaxart’s oral pill (201 participants) against an approved mRNA vaccine (199 participants), with both arms showing favorable safety profiles.
Common side effects in the oral pill group were milder than those in the mRNA group, including malaise/fatigue (20.9%), headache (18.9%), and anorexia (10.0%).
Full trial results, including efficacy data from approximately 5,400 participants, are expected in 2027.
The study is funded under Project NextGen by BARDA and NIAID, with a potential award value of up to $344.8 million.

The big picture

Vaxart’s Phase 2b trial results reinforce the growing interest in oral vaccine delivery, a sector poised to disrupt traditional injectable formulations. The strong safety data from this early cohort could accelerate adoption of pill-based vaccines, particularly if efficacy matches expectations. With significant government funding backing its development, Vaxart is well-positioned to challenge established players in the COVID-19 vaccine space.

What we're watching

Execution Risk: Whether Vaxart can sustain this safety profile in the larger main cohort and meet anticipated timelines for full trial results.
Regulatory Pathway: How regulatory authorities will interpret these early safety data when assessing the oral vaccine’s potential approval.
Market Differentiation: The pace at which Vaxart can position its oral pill as a viable alternative to injectable mRNA vaccines in a competitive market.