Influenza is a major cause of morbidity and mortality in the U.S. and worldwide. However, currently marketed vaccines have suboptimal efficacy and only 47% of eligible U.S. citizens were vaccinated in 2016-2017. Vaxart believes its tablet vaccine has the potential to improve the protective efficacy of currently available influenza vaccines and increase flu vaccination rates.
Vaxart completed Phase 1 trials for an H1N1 influenza A strain and for an influenza B strain, demonstrating safety and immune responses that correlate with protection from influenza.
Vaxart was awarded a $13.98 million Advanced Development Contract by the Office of Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response. The two-year contract was awarded under a Broad Agency Announcement issued to support the advanced development of more effective and universal influenza vaccines to improve seasonal and pandemic influenza preparedness. In April 2017, the contract was increased to $15.7 million and the term was extended by 6 months. The contract primarily funded a Phase 2 challenge study in human volunteers, designed to evaluate whether the Vaxart tablet vaccine offers broader and more durable protection than currently marketed injectable vaccines.
On October 26, 2017, Vaxart announced that, in healthy volunteers experimentally infected with H1 influenza, its H1 influenza oral tablet vaccine resulted in a 39% reduction in clinical disease relative to placebo, compared to a 27% reduction by the active comparator, the market-leading injectable quadrivalent influenza vaccine. The Vaxart tablet vaccine also showed a favorable safety profile, indistinguishable from placebo.
In July 2019, Vaxart announced that it has entered into a research collaboration agreement with Janssen Vaccines & Prevention B.V. (Janssen) to evaluate Vaxart’s proprietary oral vaccine platform for the Janssen universal influenza vaccine program. Under the agreement Vaxart will produce an oral vaccine containing certain proprietary antigens from Janssen, and test the product in a pre-clinical challenge model. Upon completion of the study Janssen will have an exclusive option to negotiate an exclusive worldwide license to the Vaxart technology encompassing the Janssen antigens.
This work was funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201500034C.
• Vaxart data on file.
• Frequently Asked Flu Questions 2017-2018 Influenza Season. U.S. Centers for Disease Control and Prevention. Updated December 2017. www.cdc.gov/flu/about/season/flu-season-2017-2018.htm#effectiveness. Accessed November 2017.
• Flu Vaccination Coverage, United States, 2016-17 Influenza Season. U.S. Centers for Disease Control and Prevention. Updated September 2017. www.cdc.gov/flu/fluvaxview/coverage-1617estimates.htm. Accessed November 2017.