Vaxart

The Department of Health and Human Services issued a stop work order on August 5, 2025, halting Vaxart's Phase IIb trial for VXA-CoV2-3.3, an oral COVID-19 vaccine that had enrolled approximately 5,000 of its targeted 10,000 participants.

Avacta Group plc has appointed David Liebowitz, M.D., Ph.D. as Chief Medical Officer to lead clinical strategy and execution for its targeted cancer therapy pipeline.

• The Department of Health and Human Services has issued a Stop Work Order for GeoVax's investigational COVID-19 vaccine GEO-CM04S1, withdrawing funding previously granted under Project NextGen. • GeoVax's vaccine candidate was designed to provide broader and more durable COVID-19 protection, showing promise in both primary vaccination and as a booster, particularly for immunocompromised patients. • This termination follows similar funding cuts to other biotechs including Vaxart and CastleVax, raising questions about shifting priorities in vaccine development under the current HHS leadership.

Phase 1b trial results published in Science Translational Medicine demonstrate strong and durable antibody responses to Vaxart's oral norovirus vaccine in elderly adults, despite age-related immune challenges.

Vaxart's Phase 2b trial of its oral COVID-19 vaccine candidate received a favorable review from the independent Data Safety Monitoring Board (DSMB).

Vaxart's Phase 2b COVID-19 oral vaccine trial is set to expand to 10,000 participants, pending FDA review of safety data and BARDA approval.

Moderna's mRNA-1403 vaccine demonstrated strong antibody responses against prevalent norovirus genotypes in early-phase trials, utilizing similar technology to their COVID and RSV vaccines.

Healthcare workers experienced a 45% reduction in ongoing COVID-19 symptoms after receiving subsequent doses of the original monovalent vaccine, highlighting the protective benefits of booster shots.

Moderna's mRNA-1403 norovirus vaccine has entered a pivotal Phase 3 trial, evaluating its efficacy, safety, and immunogenicity in adults.

• Vaxart completed two Phase 2 clinical studies for its oral norovirus vaccine candidate, establishing proof of concept for both respiratory and GI viruses. • A $9.27 million contract from BARDA will support preparations for a Phase 2b clinical trial evaluating Vaxart's oral COVID-19 vaccine candidate against an approved mRNA vaccine. • Preclinical data demonstrated Vaxart's COVID-19 vaccine candidate's potential to protect against multiple SARS-CoV-2 variants by eliciting strong antibody responses and reducing viral shedding. • Vaxart anticipates meeting with the FDA in Q2 2024 to discuss data on potential correlates of protection for its norovirus vaccine and the path forward for the program.