GeoVax was using its HHS contract to develop its next-generation multi-antigen COVID-19 vaccine, which is in Phase IIb development.
The Department of Health and Human Services has issued a Stop Work Order for GeoVax’s investigational COVID-19 vaccine GEO-CM04S1, which the Atlanta biotech was developing under a government-sponsored initiative.
According to GeoVax, the Biomedical Advanced Research and Development Authority (BARDA) has decided to withdraw its funding for the biotech, originally granted under Project NextGen, a $5 billion effort started under the Biden administration to support the development of next-generation vaccines and therapies.
GeoVax was using its Project NextGen award to run a Phase IIb trial for GEO-CM04S1, a multi-antigen shot designed to elicit “broader, more durable” COVID-19 protection, according to the biotech’s Wednesday announcement of the order. The contract termination took effect on April 11.
GeoVax CEO David Dodd, in a statement, called the HHS’s Stop Work Order “disappointing and surprising,” though he nevertheless affirmed the biotech’s “commitment” to developing GEO-CM04S1. According to the company, the investigational shot has so far shown promise as both a primary vaccine and as a booster, eliciting encouraging immune response and durability even in patients who are inadequately protected by currently approved vaccines.
GeoVax has fully enrolled its healthy-adult trial to test GEO-CM04S1 as a booster and expects a readout in the first half of the year. Studies in immunocompromised patients—one in adults with a specific blood cancer and another in patients who had received stem cell or CAR T treatments—are currently enrolling participants.
“Our clinical momentum is strong in support of our ongoing Phase 2 GEO-CM04S1 programs,” Dodd said.
GeoVax isn’t the first biotech to lose HHS funding for a vaccine study. In February, the government likewise slapped Vaxart with a Stop Work Order, pausing a multibillion-dollar contract for the study of an oral COVID-19 vaccine.
Since Robert F. Kennedy Jr. passed the Senate vote in February despite a documented history of vaccine skepticism, the HHS has seen several high-profile disruptions in terms of vaccine policy. Among these are two cancelled or postponed meetings for vaccine advisors and a suspended study for BioNTech’s malaria shot.
Things seemed to be looking up, however, when Kennedy earlier this month publicly expressed his support for immunization amid the current U.S. measles outbreak. “The most effective way to prevent the spread of measles is the MMR vaccine,” he wrote on X at the time.
However, last week, he said during an interview with CBS News that certain single-antigen vaccines “have never worked.”
