While Vaxart can proceed with its study, fellow COVID-19 vaccine developers GeoVax and Novavax continue to be hamstrung by various regulatory roadblocks.
The Department of Health and Human Services lifted its stop order of Vaxart’s COVID-19 vaccine trial, allowing the biotech to continue screening patients for enrollment into the study, Vaxart announced in an SEC filing on Monday.
HHS first froze Vaxart’s trial in February, putting in limbo the biotech’s multi-billion-dollar contract with the government, signed under President Joe Biden, for the development of an oral COVID-19 vaccine. At the time, HHS said the pause was to give federal authorities time to evaluate the company’s initial findings.
With the stop order lifted, Vaxart can now resume “incurring costs, participating in meetings, and communicating” with collaborators, including the government, regarding the vaccine project, as per the SEC document. The company can now also reactivate its field sites and proceed with assessing potential participants for inclusion in the study’s 10,000-patient portion.
Under the terms of the lift order, HHS is also requiring Vaxart to engage in further discussions with the Biomedical Advanced Research and Development Authority (BARDA) regarding “costs, timelines, and regulatory pathway agreement.” The biotech has since held a virtual meeting with BARDA to discuss its dosing plans for the study.
While Vaxart can now proceed with its vaccine study, the COVID-19 space remains fraught. GeoVax, which is also developing a COVID-19 shot with government support, was also slapped with an HHS stop work order earlier this month. GeoVax is studying its multi-antigen injection GEO-CM04S1 under Project NextGen, a $5-billion initiative under Biden, focused on funding next-generation vaccines and therapies.
GEO-CM04S1 is currently in Phase IIb development and has so far shown an encouraging profile as a primary and booster shot, even in patients who had previously shown substandard response to currently approved vaccines.
At the same time, the FDA on April 1 missed its decision deadline for Novavax’s COVID-19 shot. Last week, the company revealed that the FDA has asked it for a postmarketing commitment, with an eye toward generating additional clinical data for the vaccine. Novavax believes its investigational vaccine is “approvable,” according to a press release at the time.
Beyond COVID-19, the broader vaccines market is also in a precarious position as health authorities sow skepticism toward the platform. Earlier this month, for instance, HHS Secretary Robert F. Kennedy suggested that vaccine complications are much more common than is understood, especially since “we don’t have a surveillance system that functions.”
Kennedy is currently proposing changes to the Vaccines Adverse Event Reporting System to find the alleged “contribution” of vaccines to particular health outcomes that he has yet to spell out.
