Updated IDSA Guidelines Highlight COVID-19 Vaccine Gaps for Immunocompromised, Align with GeoVax's GEO-CM04S1 Clinical Data

The Infectious Diseases Society of America's updated COVID-19 vaccination guidelines highlight significant limitations in current vaccine protection for immunocompromised individuals, reinforcing the need for alternative approaches like GeoVax's GEO-CM04S1 vaccine. The IDSA guidance, issued October 17, 2025, concluded that existing COVID-19 vaccines provide only moderate and short-lived protection for immunocompromised patients, with effectiveness against hospitalization ranging from 33% to 56% and waning within two months. The panel specifically called for new vaccine strategies tailored to vulnerable populations, including cancer patients, transplant recipients, and individuals receiving immunosuppressive therapies.

GeoVax's recently presented Phase 2 clinical data for GEO-CM04S1, first reported at the World Vaccine Congress Europe 2025, demonstrate alignment with these recommendations. Interim results from ongoing Phase 2 studies showed robust T-cell responses to both Spike and Nucleocapsid antigens that exceeded responses seen with mRNA boosters. The vaccine also demonstrated broad, cross-variant immunity including activity against Omicron subvariants, along with a favorable safety profile characterized by only mild-to-moderate adverse events such as injection site reactions, fatigue, and myalgia, with no vaccine-related serious adverse events reported.

David A. Dodd, Chairman & CEO of GeoVax, emphasized the significance of these findings. Immunocompromised Americans represent one in eight adults, including cancer patients, transplant recipients, people with autoimmune disease, and those living with HIV. Yet mainstream vaccine approaches, heavily centered on mRNA, continue to leave them without durable protection. The convergence of IDSA guidelines and clinical findings underscores GEO-CM04S1's potential to address one of the most critical gaps in COVID-19 prevention.

GEO-CM04S1 represents a multi-antigen, Modified Vaccinia Ankara-based COVID-19 vaccine designed specifically to elicit both antibody and T-cell immune responses. This dual-pathway activation is particularly important for patients who often fail to mount sufficient antibody responses with current mRNA vaccines. The vaccine's multi-antigen breadth, targeting both Spike and Nucleocapsid proteins, provides broader immunologic coverage intended to remain relevant as the virus continues to evolve. Ongoing trials include Phase 2 studies as a primary vaccine for immunocompromised individuals, including post-transplant and hematologic cancer patients, and as a booster for patients with chronic lymphocytic leukemia.

In patients with hematologic malignancies post-transplant or CAR-T therapy, breakthrough infections were mild-to-moderate, underscoring the vaccine's protective potential in highly vulnerable groups. While mRNA vaccines were pivotal in the early pandemic response, their limitations in durability, breadth, and performance in immunocompromised populations highlight the risks of relying on a single platform. GEO-CM04S1 demonstrates how multi-antigen, T-cell-driven approaches can better protect high-risk populations and strengthen pandemic preparedness. For more information about the current status of clinical trials and other updates, visit https://www.geovax.com.