Favorable DSMB Review for Vaxart
Vaxart, Inc. announced that an independent DSMB, which conducted a planned review of the 30-day safety data from a sentinel cohort of 400 participants in its COVID-19 Phase IIb trial, has recommended that the study continue without any modifications
“We are pleased with the DSMB recommendation, an important step forward in conducting our head-to-head study versus an mRNA comparator,” said Dr. James F. Cummings, Vaxart’s Chief Medical Officer. “We look forward to the next steps of review of the safety data by the FDA and approval from BARDA before advancing the Phase IIb trial to the second part that will measure both safety and efficacy.”
The FDA is reviewing the 30-day safety data from the sentinel cohort, and, upon favorable review as well as BARDA’s approval, the study will progress by enrolling approximately 10,000 participants. The trial will strive to enroll participants in line with U.S. demographics, as well as including at least 25% over the age of 65.
The Phase IIb trial is a double-blind, multi-center, randomized, comparator-controlled study to determine the relative efficacy, safety, and immunogenicity of Vaxart’s oral pill COVID-19 vaccine candidate (VXA-CoV2-1) compared to an approved mRNA COVID-19 injectable vaccine, in adults previously immunized against COVID-19 infection.
Funding for this award was received under Project NextGen, a $5 billion initiative led by BARDA and the National Institute of Allergy and Infectious Diseases (NIAID) to accelerate and streamline the development of the next generation of innovative COVID-19 vaccines, therapeutics, and enablers. Vaxart’s project award through the Rapid Response Partnership Vehicle (RRPV) is valued at up to $460.7 million. This project has been funded with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); BARDA, under Other Transaction (OT) number 75A50123D00005.
As a pioneer of oral vaccines, Vaxart was the first U.S. company to complete a Phase II clinical trial of an oral vaccine for COVID-19.
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