HHS Lifts Stop Work Order on Vaxart's COVID-19 Vaccine Trial, Resuming 10,000-Participant Study

The Department of Health and Human Services (HHS) has lifted a stop work order on Vaxart's phase 2b trial for an investigational COVID-19 oral vaccine, allowing the biotech company to resume its plans for a 10,000-person study. This development marks a significant turn of events for the South San Francisco-based firm, which had previously been forced to halt operations and reduce its workforce due to the unexpected government directive.

Trial Resumption and Funding

The lifted order, communicated to Vaxart through documents filed with the Securities and Exchange Commission (SEC) on April 24, enables the company to reactivate field sites and begin screening participants for enrollment. The study, which compares Vaxart's oral vaccine candidate to an approved mRNA COVID-19 vaccine in previously immunized adults, is being funded by up to $460.7 million awarded under the Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases' Project NextGen initiative.

A Vaxart spokesperson confirmed that the government continues to finance the trial, stating, "Vaxart thanks the U.S. Department of Health and Human Services for its thorough review of our COVID-19 oral vaccine candidate and looks forward to continuing its collaboration with HHS and other government partners."

Impact on Vaxart and Market Response

The reversal of the stop work order has had a significant impact on Vaxart's financial outlook. Over the five days following the announcement, the company's stock rose nearly 38%, opening at 43 cents per share compared to 33 cents at market open on April 22.

The biotech is now evaluating its cost structure and remains committed to ensuring the success of both the COVID-19 trial and its ongoing norovirus program. This positive turn of events comes after a challenging period for Vaxart, which had previously laid off 10% of its workforce in response to the initial stop work order issued in February.

Broader Industry Context

The decision to resume Vaxart's trial comes amid a complex landscape for COVID-19 vaccine development. While the pandemic's acute phase has subsided in many regions, the need for innovative vaccine technologies remains relevant. Vaxart's oral vaccine candidate represents a potential breakthrough in vaccine administration, offering a more convenient alternative to injectable formulations.

However, the pharmaceutical industry continues to face challenges in vaccine development and distribution. The stop work order issued to Vaxart was not an isolated incident, as evidenced by a similar directive given to GeoVax Labs for their COVID-19 vaccine program. These events highlight the evolving nature of government support for vaccine research and development in the post-pandemic era.

As the industry navigates these changes, companies like Vaxart are adapting their strategies to ensure continued progress in vaccine development while managing financial and operational uncertainties. The resumption of Vaxart's trial signifies a renewed focus on exploring diverse vaccine technologies to enhance global preparedness for future infectious disease threats.