Vaxart's COVID-19 Vaccine Trial Halted as BARDA Shifts Focus

Vaxart, a biotechnology company developing an oral COVID-19 vaccine, has encountered a significant setback in its clinical trial program following a stop work order from the U.S. government. This development comes amid broader changes in federal funding priorities for vaccine research.

BARDA Contract Suspension

Vaxart recently announced that it received a stop work order from Advanced Technology International (ATI), effectively halting most activities under a contract funded by the Biomedical Advanced Research and Development Authority (BARDA). The order impacts a major phase 2b trial of Vaxart's oral COVID-19 vaccine candidate, which had already enrolled approximately 5,000 of its planned 10,000 participants.

Steven Lo, Vaxart's CEO, stated, "At this time, Vaxart has not been provided with any further details, including the reason for the stop work order, but we're actively seeking more information." The company is permitted to continue per protocol follow-up of participants who have already been dosed in the study.

Funding Fluctuations and Regulatory Whiplash

The stop work order is the latest in a series of abrupt changes affecting Vaxart's government-funded research:

• February 7, 2025: BARDA committed an additional $105.9 million to the phase 2b study, increasing the total available funding to $240.1 million, with a potential ceiling of $460.7 million.
• February 21, 2025: ATI instructed Vaxart to halt work under the contract, except for follow-up on a 400-person cohort.
• April 24, 2025: The stop work order was lifted, allowing Vaxart to resume incurring costs and begin screening for the 10,000-subject study.

This back-and-forth has created uncertainty for the company and its vaccine development program.

Broader Context of Vaccine Funding Shifts

The suspension of Vaxart's trial coincides with a broader shift in U.S. government funding priorities for vaccine development. On the same day as Vaxart's stop work order, the Department of Health and Human Services (HHS) announced it would be winding down mRNA vaccine development supported by BARDA.

While Vaxart's vaccine candidate is not mRNA-based, the company's phase 2b trial does use an mRNA vaccine as a control. This connection to mRNA technology may have played a role in the funding decision, although the exact reasons remain unclear.

The changes in BARDA's funding approach have affected other biotechnology companies as well, with some experiencing grant cancellations despite not working on mRNA vaccines or even vaccine projects at all.

As the pharmaceutical industry adapts to these shifting priorities, companies like Vaxart are left seeking answers and reevaluating their development strategies in a rapidly changing funding landscape.