The Department of Health and Human Services (HHS) has withdrawn funding for GeoVax's next-generation COVID-19 vaccine candidate, GEO-CM04S1, halting development work that was supported through the Biden administration's $5 billion Project NextGen initiative.
According to GeoVax's announcement on Wednesday, BARDA (Biomedical Advanced Research and Development Authority) issued a Stop Work Order effective April 11, terminating the contract that was supporting the company's Phase IIb clinical trial. GeoVax CEO David Dodd described the decision as "disappointing and surprising" but affirmed the company's commitment to continuing development of the vaccine candidate.
Vaccine Development Status
GEO-CM04S1 is a multi-antigen vaccine designed to elicit broader and more durable protection against COVID-19 compared to currently available options. The vaccine has shown promising results in early trials, demonstrating potential as both a primary vaccine and as a booster shot.
The company has fully enrolled its healthy-adult trial testing GEO-CM04S1 as a booster, with results expected in the first half of this year. Additionally, two studies focused on immunocompromised patients are currently enrolling participants:
- A trial for adults with specific blood cancers
- A study involving patients who have received stem cell or CAR T treatments
"Our clinical momentum is strong in support of our ongoing Phase 2 GEO-CM04S1 programs," Dodd stated, indicating the company's intention to proceed despite the funding loss.
Pattern of Funding Terminations
GeoVax is not alone in facing sudden funding cuts. In February, HHS issued a similar Stop Work Order to Vaxart, pausing a multibillion-dollar contract for the study of an oral COVID-19 vaccine. More recently, Endpoints News reported that CastleVax also received a stop work order for its Project NextGen award.
These terminations come amid several disruptions in vaccine policy since Robert F. Kennedy Jr. passed Senate confirmation in February, despite his documented history of vaccine skepticism. Other disruptions have included:
- Two cancelled or postponed meetings for vaccine advisors
- A suspended study for BioNTech's malaria shot
Broader Implications for Vaccine Development
The series of funding terminations raises questions about the future of next-generation vaccine development in the United States. Project NextGen was established specifically to support advanced vaccine and therapeutic candidates that could address evolving variants and provide better protection for vulnerable populations.
GeoVax's vaccine candidate was particularly notable for its potential to protect immunocompromised patients, who often show inadequate responses to currently approved vaccines. The ongoing trials in patients with blood cancers and those who have received stem cell or CAR T treatments represent important research for these vulnerable populations.
Industry Response
The pharmaceutical industry is closely watching these developments, particularly as they coincide with other significant shifts in the healthcare landscape. Some pharmaceutical companies have recently announced major investments in US-based manufacturing, with Roche pledging $50 billion over five years and Regeneron partnering with Fujifilm to invest more than $3 billion to double their US manufacturing capability.
These investments come as companies navigate an uncertain regulatory environment and potential tariffs on pharmaceuticals, suggesting a strategic pivot toward domestic production and development.
Looking Forward
Despite the funding setback, GeoVax maintains that clinical development of GEO-CM04S1 will continue. The company's focus on vulnerable populations, particularly those who are immunocompromised, addresses an important unmet need in COVID-19 protection.
The outcome of GeoVax's ongoing trials could provide valuable data on alternative approaches to COVID-19 vaccination, especially for those who remain at high risk despite current vaccination options. However, without government funding, the timeline and scope of these development efforts may be significantly impacted.
