YAHOO! NEWS – Multiple vaccine projects have been paused by the Department of Health and Human Services Secretary Robert F. Kennedy Jr.
Kennedy paused a multimillion-dollar project to create a new Covid-19 vaccine in pill form on Tuesday, and the Food and Drug Administration canceled an advisory committee meeting on updating next season’s flu vaccine, an advisory committee said Wednesday.
The Covid project was a $460 million contract with Vaxart to develop a new Covid vaccine in pill form, with 10,000 people scheduled to begin clinical trials on Monday. Of that, $240 million was reportedly already authorized for the preliminary study.
“While it is crucial that the Department [of] Health and Human Services support pandemic preparedness, four years of the Biden administration’s failed oversight have made it necessary to review agreements for vaccine production, including Vaxart’s,” Kennedy said, according to Fox News.
“I look forward to working with Vaxart and medical experts to ensure this work produces safe, effective, and fiscal-minded vaccine technology,” Kennedy added …
BACKGROUND:
Vaxart Highlights Progress of COVID-19, Norovirus and Influenza Programs, January 14, 2025
COVID-19 Phase 2b study poised to initiate 10,000 participant portion of trial pending U.S. Food and Drug Administration (FDA) review of sentinel cohort 30-day safety data
SOUTH SAN FRANCISCO, Calif., Jan. 14, 2025 (GLOBE NEWSWIRE) — Vaxart, Inc. (Nasdaq: VXRT) today provided business updates as the Company continues to advance its oral pill vaccine platform.
“We continue to execute on our lead COVID-19 and norovirus programs as evidenced by the advancement of both programs toward key milestones,” said Steven Lo, Vaxart’s Chief Executive Officer.
“Starting with our COVID-19 program, we believe that the favorable review of the 30-day sentinel cohort safety data of our Phase 2b trial by an independent DSMB has us well-positioned to initiate the 10,000-participant portion of the trial following a positive review from the FDA as well as approval from BARDA to proceed.”
“Regarding our norovirus program, after a thorough review of the constructive feedback from the FDA on our GI.1 norovirus candidate, discussions with advisors and infectious disease experts, and promising preclinical data on our second-generation constructs, we believe that performing a Phase 1 trial substantially improves our chance of success.
The trial will compare the second-generation constructs to our first-generation constructs, providing us with supporting data to rapidly proceed with the best candidate,” added Mr. Lo.
“We proved efficacy against a robust controlled human infection using our first-generation norovirus construct and identified important immune markers that track with norovirus protection,” said James F. Cummings, MD, Vaxart’s Chief Medical Officer. “Our second-generation constructs induced stronger immune responses in preclinical models. As a result, our next clinical study will evaluate these next generation constructs head-to-head against our first-generation constructs to verify this robust response.”
“Through the tireless work of our dedicated team, we are now prepared to advance our two lead programs. At the same time, we will explore value creating partnerships and non-dilutive funding options to sustain our continued momentum and extend our cash runway,” concluded Mr. Lo.
COVID-19 Program Developments
An independent Data and Safety Monitoring Board (DSMB) recommended the continuation of the Phase 2b study. The DSMB reviewed 30-day safety data of the sentinel cohort of a Phase 2b clinical trial evaluating Vaxart’s oral pill COVID-19 vaccine candidate against an approved mRNA vaccine comparator.
The FDA is reviewing the 30-day safety data from the sentinel cohort, and, upon favorable review, the study will progress following the Biomedical Advanced Research and Development Authority’s (BARDA’s) approval to the second part of the trial by enrolling approximately 10,000 participants.
The primary efficacy analysis will be performed when all participants have either discontinued or completed a study visit 12 months post-vaccination.
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 …
