Vaxart Receives BARDA Approval to Initiate Dosing in 10,000-Participant Portion of Phase 2b COVID-19 Trial
Vaxart (NASDAQ: VXRT) has received BARDA approval to begin dosing in the 10,000-participant portion of its Phase 2b clinical trial for its oral pill COVID-19 vaccine candidate. The double-blind, multi-center study will compare the efficacy, safety, and immunogenicity of Vaxart's oral vaccine to an approved mRNA COVID-19 vaccine in previously vaccinated adults.
The company expects to dose the first patient in Q2 2025. The trial is funded through Project NextGen, a $5 billion BARDA and NIAID initiative, with Vaxart's project award valued at up to $460.7 million through the Rapid Response Partnership Vehicle (RRPV) Consortium.
Vaxart (NASDAQ: VXRT) ha ottenuto l'approvazione dalla BARDA per iniziare la somministrazione nella fase del suo studio clinico di Fase 2b che coinvolge 10.000 partecipanti, relativo al suo vaccino orale contro il COVID-19. Lo studio, in doppio cieco e multicentrico, confronterà l'efficacia, la sicurezza e l'immunogenicità del vaccino orale di Vaxart con un vaccino mRNA contro il COVID-19 già approvato, in adulti precedentemente vaccinati.
L'azienda prevede di somministrare la prima dose nel secondo trimestre del 2025. La sperimentazione è finanziata tramite il Project NextGen, un'iniziativa da 5 miliardi di dollari di BARDA e NIAID, con un finanziamento a Vaxart del valore fino a 460,7 milioni di dollari attraverso il consorzio Rapid Response Partnership Vehicle (RRPV).
Vaxart (NASDAQ: VXRT) ha recibido la aprobación de BARDA para comenzar la administración en la parte de 10,000 participantes de su ensayo clínico de Fase 2b para su vacuna oral contra el COVID-19. El estudio, doble ciego y multicéntrico, comparará la eficacia, seguridad e inmunogenicidad de la vacuna oral de Vaxart con una vacuna de ARNm contra el COVID-19 aprobada previamente en adultos ya vacunados.
La compañía espera administrar la primera dosis en el segundo trimestre de 2025. El ensayo está financiado a través del Proyecto NextGen, una iniciativa de 5 mil millones de dólares de BARDA y NIAID, con un premio para Vaxart valorado en hasta 460.7 millones de dólares mediante el Consorcio Rapid Response Partnership Vehicle (RRPV).
Vaxart (NASDAQ: VXRT)는 BARDA로부터 10,000명 참가자를 대상으로 하는 2b상 임상 시험 투여 승인을 받았습니다. 이 연구는 경구용 COVID-19 백신 후보로, 이중 맹검 다기관 연구에서 이전에 백신을 접종받은 성인을 대상으로 Vaxart의 경구 백신과 승인된 mRNA COVID-19 백신의 효능, 안전성 및 면역원성을 비교할 예정입니다.
회사는 2025년 2분기에 첫 환자 투여를 계획하고 있습니다. 이 임상 시험은 BARDA와 NIAID의 50억 달러 규모 프로젝트인 Project NextGen을 통해 자금이 지원되며, Vaxart의 프로젝트 수상금은 Rapid Response Partnership Vehicle (RRPV) 컨소시엄을 통해 최대 4억 6,070만 달러에 달합니다.
Vaxart (NASDAQ: VXRT) a reçu l'approbation de BARDA pour commencer l'administration dans la partie de son essai clinique de phase 2b comprenant 10 000 participants pour son candidat vaccin oral contre la COVID-19. Cette étude en double aveugle et multicentrique comparera l'efficacité, la sécurité et l'immunogénicité du vaccin oral de Vaxart à un vaccin COVID-19 à ARNm approuvé chez des adultes déjà vaccinés.
L'entreprise prévoit d'administrer la première dose au 2e trimestre 2025. L'essai est financé dans le cadre du Project NextGen, une initiative de 5 milliards de dollars de BARDA et NIAID, avec une subvention pour Vaxart pouvant atteindre 460,7 millions de dollars via le consortium Rapid Response Partnership Vehicle (RRPV).
Vaxart (NASDAQ: VXRT) hat die Genehmigung von BARDA erhalten, mit der Dosierung im Teil mit 10.000 Teilnehmern seiner Phase-2b-Studie für seinen oralen COVID-19-Impfstoffkandidaten zu beginnen. Die doppelblinde, multizentrische Studie wird die Wirksamkeit, Sicherheit und Immunogenität von Vaxarts oralem Impfstoff mit einem zugelassenen mRNA-COVID-19-Impfstoff bei zuvor geimpften Erwachsenen vergleichen.
Das Unternehmen plant, den ersten Patienten im 2. Quartal 2025 zu dosieren. Die Studie wird im Rahmen von Project NextGen finanziert, einer 5-Milliarden-Dollar-Initiative von BARDA und NIAID, wobei der Projektzuschuss für Vaxart bis zu 460,7 Millionen US-Dollar über das Rapid Response Partnership Vehicle (RRPV) Konsortium beträgt.
- Secured BARDA approval for large-scale 10,000-participant trial phase
- Received substantial funding of up to $460.7 million through Project NextGen
- Trial compares directly with approved mRNA vaccines, potentially demonstrating competitive advantages
- Results from the trial are still pending and success is not guaranteed
- Timeline for potential market entry remains uncertain
Insights
BARDA approval for Vaxart's 10,000-participant COVID vaccine trial marks major development milestone with significant government backing.
Vaxart's announcement represents a significant clinical development milestone for their oral pill COVID-19 vaccine candidate. Securing BARDA approval to proceed with the 10,000-participant portion of their Phase 2b trial demonstrates regulatory confidence in their program's progress and safety profile to date.
The double-blind, comparator-controlled study design is particularly notable as it will directly compare Vaxart's oral vaccine against an approved mRNA COVID-19 vaccine. This head-to-head comparison in previously vaccinated adults will provide critical data on relative efficacy, safety, and immunogenicity between these fundamentally different vaccine platforms.
The $460.7 million potential funding through Project NextGen represents substantial financial backing and validates the government's interest in alternative vaccine delivery methods. Oral vaccines could address several limitations of injectable vaccines, including cold-chain requirements, needle phobia, and administration complexity.
With dosing expected to begin in Q2 2025, Vaxart is entering a capital-intensive phase of development. This large-scale trial's execution will require significant operational capabilities across multiple trial sites. The BARDA funding critically supports this expansion of their clinical program, potentially accelerating their path to potential regulatory submission if results prove favorable.
While this progress is encouraging, investors should recognize that successful completion of the trial and subsequent regulatory approval remain key milestones ahead for Vaxart before any commercial opportunity materializes for this candidate.
SOUTH SAN FRANCISCO, Calif., May 15, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced that it has received approval from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), to initiate dosing in the 10,000-participant portion of its ongoing Phase 2b clinical trial evaluating its oral pill COVID-19 vaccine candidate.
“We are pleased to receive BARDA approval to move forward with dosing in this large-scale study and expect to dose the first patient in this cohort in the second quarter of 2025,” said Steven Lo, Chief Executive Officer of Vaxart. “We are deeply grateful for the continued support of our government partners at HHS and BARDA, whose collaboration is critical to advancing our clinical development program.”
The Phase 2b trial is a double-blind, multi-center, randomized, comparator-controlled study. It is designed to evaluate the relative efficacy, safety, and immunogenicity of Vaxart's oral COVID-19 vaccine candidate compared to an approved mRNA COVID-19 vaccine in adults who have previously been vaccinated against COVID-19.
Funding for this award was received under Project NextGen, a
About Vaxart
Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using pills that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxart’s development programs currently include pill vaccines designed to protect against coronavirus, norovirus and influenza, as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart's strategy, prospects, plans and objectives, funding milestones, the results of the FDA’s review of any trials, studies, or data, results from clinical trials and the timing of such results and such trials, commercialization agreements and licenses, and beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as “should,” “believe,” “could,” “potential,” “will,” “expected,” “anticipate,” “plan,” and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart’s ability to complete the Phase 1 trial of its oral bivalent norovirus vaccine; Vaxart's ability to develop and commercialize its product candidates, including its vaccine booster products; Vaxart's expectations regarding clinical results and trial data, including their design, and the timing of such trials and of receiving and reporting such clinical results and trial data; Vaxart’s expectations regarding timing of enrollment in studies; and Vaxart's expectations with respect to the effectiveness of its product candidates and the potential of its vaccine pill platform. Vaxart may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in the forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations, and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Vaxart makes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement, and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates, and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart's product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxart's product candidates may not achieve broad market acceptance; that a Vaxart collaborator may not attain development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart's or its partners' control; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state, and foreign regulations; that Vaxart may not be able to obtain, maintain, and enforce necessary patent and other intellectual property protection; that Vaxart's capital resources may be inadequate; Vaxart's ability to resolve pending legal matters; Vaxart's ability to obtain sufficient capital to fund its operations on terms acceptable to Vaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the "Risk Factors" sections of Vaxart's Quarterly and Annual Reports filed with the U.S. Securities and Exchange Commission. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law.
Contact
Vaxart Media and Investor Relations
Matt Steinberg
FINN Partners
IR@vaxart.com
(646) 871-8481
This press release was published by a CLEAR® Verified individual.
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