Vaxart Wins BARDA-Funded $453M Award for Phase 2b Study of Oral COVID-19 Vaccine

Vaxart, Inc., a South San Francisco-based biotechnology company listed on Nasdaq as VXRT, announced on June 13, 2024, that it has secured a project award worth up to $453 million through the Rapid Response Partnership Vehicle (RRPV). This consortium is funded by the Biomedical Advanced Research and Development Authority (BARDA), which operates under the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS).

The funding will support a Phase 2b study, comparing Vaxart’s next-generation oral COVID-19 vaccine to an FDA-approved mRNA vaccine. This oral vaccine candidate, produced under Good Manufacturing Practice (GMP) standards, is based on preclinical data indicating higher potency than previous iterations of Vaxart’s COVID-19 vaccines.

The award will be disbursed in two parts: an immediate $65.7 million to kickstart the study, with the remaining $387.2 million allocated based on further agreements between Vaxart and BARDA. Vaxart aims to begin enrolling participants as early as summer 2024, with an interim analysis of the vaccine's efficacy against the mRNA comparator expected by the first quarter of 2025.

Dr. James F. Cummings, Vaxart’s Chief Medical Officer, expressed gratitude for BARDA’s support, emphasizing that the Phase 2b trial will assess whether the oral pill can match or surpass the effectiveness of an injectable mRNA vaccine. Previous studies have shown Vaxart's oral vaccine candidates elicited lasting immune responses and cross-reactive immunogenic responses against various SARS-CoV-2 variants.

Steven Lo, Vaxart’s CEO, highlighted the historical reliance on injectable vaccines for over 150 years and noted that BARDA’s funding could pave the way for a transformative approach to global vaccination. He stated that the oral pill vaccine platform might cater better to societal needs, addressing not only COVID-19 but other significant endemic and pandemic threats.

Previously, Vaxart became the first U.S. company to complete a Phase 2 clinical trial for an oral COVID-19 vaccine. These trials demonstrated that Vaxart’s vaccine candidates produced strong mucosal IgA responses, boosted immune responses to existing COVID-19 vaccines, increased neutralizing antibodies against the Omicron variant, and showed a benign tolerability profile.

The funding for this initiative is part of Project NextGen, a $5 billion HHS project aimed at developing new vaccines and therapeutics that offer broader and more durable protection against COVID-19 compared to first-generation vaccines.

The upcoming Phase 2b trial will be a double-blind, multi-center, randomized, comparator-controlled study. It aims to evaluate the efficacy, safety, and immunogenicity of Vaxart’s oral COVID-19 vaccine against an approved mRNA vaccine in adults previously immunized against COVID-19. The trial plans to enroll around 10,000 healthy adults aged 18 and older in the U.S., with 5,000 participants receiving Vaxart’s oral vaccine and the other 5,000 receiving an mRNA comparator. At least 25% of the participants will be aged 65 or older.

The study will measure outcomes such as symptomatic and asymptomatic disease efficacy, immune system responses, and adverse event incidence. The primary endpoint is the relative efficacy of Vaxart’s oral vaccine compared to the mRNA comparator in preventing symptomatic disease. This primary analysis will take place after all participants have either completed or discontinued a study visit 12 months post-vaccination. An independent Data and Safety Monitoring Board (DSMB) will monitor the safety data of the participants.

Vaxart continues to leverage its proprietary oral vaccine technology to develop a range of vaccines, including those targeting coronavirus, norovirus, influenza, and human papillomavirus (HPV). The company holds broad domestic and international patents on its vaccine delivery platform.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!