Vaxart is actively seeking more information about why it was told to stop work under a federally funded COVID-19 vaccine contract.
Last week, the company said it received a stop work order from Advanced Technology International (ATI), a nonprofit that manages research initiatives. The order ended most work under a Biomedical Advanced Research and Development Authority (BARDA) contract that was supporting a major 10,000-subject phase 2b trial of Vaxart’s oral COVID-19 vaccine candidate. Vaxart is uncertain why ATI pulled the plug.
“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,” Vaxart’s CEO Steven Lo said in an emailed statement to Fierce Biotech.
Lo said the company had enrolled about 5,000 participants in the phase 2b study when it received the stop work order. Vaxart can continue per protocol follow-up of participants that it has already dosed. The company said the last meeting of the independent data safety monitoring board, which took place July 14, found the study could proceed without modification.
As Lo noted, Vaxart received the stop work order on the same day that the U.S. Department of Health and Human Services (HHS) said it is winding down mRNA vaccine development supported by BARDA. Vaxart was not named in the HHS notice and is not developing a mRNA vaccine. The company’s phase 2b trial uses a mRNA vaccine as the control.
Asked about the reasoning for the order, a HHS spokesperson sent Fierce a link to the press release about BARDA winding down mRNA vaccine development. Fierce previously reported on another biotech's grant cancellation cited as part of the federal mRNA vaccine rollback, though the project doesn’t use mRNA and is not a vaccine.
The stop order extends a series of whiplash changes in the government’s handling of the contract with Vaxart. Feb. 7, the government committed a further $105.9 million to the phase 2b study, resulting in an increase in the amount available for payment to $240.1 million. The total estimated ceiling for funding was approximately $460.7 million.
On Feb. 21, ATI told Vaxart to stop work under the contract, with the exception of per protocol follow-up for a 400-person cohort. Things changed again April 24, when ATI wrote to Vaxart to lift the stop work order. The letter cleared Vaxart to resume incurring costs under the contract. Vaxart said the BARDA subsequently cleared it to start screening for the 10,000-subject study.
Editor's note: This story has been updated at 12 p.m. ET to reflect the correct total funding amount.