Vaxart

Vaxart, Inc. is an American biotechnology company focused on the discovery and development of orally administered vaccines delivered in temperature-stable tablets. Its platform is intended to provide an alternative to conventional injected vaccines while potentially stimulating systemic, mucosal, and T-cell immune responses. The company’s approach uses enteric-coated tablets designed to protect vaccine material from degradation in the stomach and release it in the small intestine, where the intestinal immune system can be activated. This delivery model is intended to address several practical limitations associated with injectable vaccination, including needle aversion, the need for trained personnel, cold-chain requirements, and the logistical complexity of mass immunization campaigns. The company was founded in California in 2004 by Sean Tucker under the name West Coast Biologicals, Inc. It reincorporated in Delaware and adopted the Vaxart name in July 2007. Vaxart’s technology is based on recombinant vaccines using adenovirus type 5 as a vector. The vector carries genetic instructions for selected antigens to mucosal epithelial cells, with the objective of producing immune protection at both the site where some pathogens enter the body and throughout the wider immune system. Vaxart has referred to the broader platform as VAAST, or Vector-Adjuvant-Antigen Standardized Technology. Vaxart has pursued vaccines for infectious diseases as well as therapeutic applications involving chronic viral infections and cancer. Its development programs have included seasonal influenza, norovirus, respiratory syncytial virus, human papillomavirus, and COVID-19. The influenza program supplied early clinical evidence for the tablet approach. In a Phase 1 study, an oral influenza candidate was reported to be well tolerated and to produce neutralizing antibody responses. Subsequent Phase 2 work, including a human challenge study, indicated that the tablet vaccine could reduce clinical disease and performed favorably against an injectable comparator in that study. These results supported the company’s broader effort to develop vaccines that generate mucosal as well as systemic immunity. The COVID-19 pandemic brought Vaxart’s oral delivery strategy increased attention. The company began planning a tablet COVID-19 vaccine program in early 2020 and reported immune responses in animal studies later that year. Its subsequent development work has focused on candidates intended to provide broader protection across variants and to stimulate immunity in the respiratory mucosa. In 2024, Vaxart received a $9.27 million award from the Biomedical Advanced Research and Development Authority under Project NextGen to support preparation for a large Phase 2b trial of an XBB COVID-19 tablet vaccine candidate. The planned study was designed to compare the candidate with an approved messenger RNA vaccine and involve approximately 10,000 participants. Norovirus has become another central program. Vaxart has developed bivalent and monovalent oral candidates aimed at major norovirus genogroups, including GI and GII. Because norovirus infects the gastrointestinal tract, an orally delivered vaccine capable of inducing intestinal antibodies could offer a biologically relevant form of protection. The company reported positive results from a Phase 2 dose-ranging study of a bivalent candidate in 2023 and from a Phase 2 challenge study of a monovalent candidate, although these findings remained clinical-development results rather than evidence of an approved product. A Gates Foundation-supported maternal and infant study examined whether vaccination of lactating mothers could produce antibodies in breast milk and potentially transfer protection to infants. Vaxart has no marketed vaccine listed in the supplied source material. It remains a development-stage biotechnology company whose commercial prospects depend on clinical efficacy, safety, regulatory approval, manufact…

Vaxart originated in California in 2004 as West Coast Biologicals, Inc., founded by Sean Tucker. The company was established around the concept that vaccines could be delivered through the gastrointestinal tract rather than by injection. It later reincorporated in Delaware and changed its corporate name to Vaxart, Inc. in July 2007. The company’s central scientific proposition is that an orally administered vaccine can activate immune defenses at mucosal surfaces while also producing systemic immunity. Vaxart developed enteric-coated tablets intended to survive the acidic environment of the stomach and release vaccine material in the small intestine. Its recombinant approach uses an adenovirus type 5 vector to deliver antigen-related genetic material to intestinal epithelial cells. The company has described this technology platform as VAAST, or Vector-Adjuvant-Antigen Standardized Technology. Vaxart’s initial clinical work included an oral influenza program. A Phase 1 study reported tolerability and neutralizing antibody responses. In a later Phase 2 program, the VXA-A1.1 candidate was evaluated against an established injectable influenza vaccine. A 2018 human challenge study reported a 39 percent reduction in clinical disease compared with placebo for the oral candidate, versus a 27 percent reduction for the injectable comparator in that study. These results helped establish influenza as an important proof of concept for the company’s delivery platform. The company has also pursued vaccines for norovirus, respiratory syncytial virus, human papillomavirus, COVID-19, and other infectious or therapeutic indications. Its norovirus program has included candidates directed at GI and GII genogroups. The oral route is particularly relevant to norovirus because the pathogen infects the gastrointestinal tract. In 2022, Vaxart received support from the Bill & Melinda Gates Foundation for work involving breastfeeding mothers and infants. The related program investigated whether maternal vaccination could induce antibodies in breast milk and potentially provide infants with passive protection. During 2023, Vaxart reported positive topline results from a bivalent Phase 2 dose-ranging study and a monovalent Phase 2 challenge study. Vaxart entered COVID-19 vaccine development in early 2020. The company’s tablet candidate was intended to offer advantages in administration and distribution while potentially inducing respiratory mucosal immunity. Animal studies reported in 2020 showed immune responses, and the program subsequently progressed into human clinical development. In January 2024, BARDA awarded Vaxart $9.27 million through Project NextGen to prepare a Phase 2b study of an XBB candidate. The proposed study was expected to enroll about 10,000 people and compare the oral candidate with an approved messenger RNA vaccine. A data-safety review of an initial participant cohort supported continuation without modification, as described in the supplied reference material. A major corporate turning point occurred on February 13, 2018, when Vaxart completed a reverse merger with Aviragen Therapeutics, Inc. Following the transaction, Vaxart became a wholly owned subsidiary of Aviragen, and the public company continued under the Vaxart name. The transaction provided a public-company structure for continued vaccine development. The company’s profile also became connected to legal disputes involving statements about COVID-19 development and government programs. A Delaware stockholder derivative action filed in 2021 alleged insider trading and breaches of fiduciary duty by executives; the case was dismissed in early 2024. A separate federal securities class action alleged that investors were misled about Vaxart’s involvement in Operation Warp Speed. The supplied material states that the class was certified in December 2024 and that Vaxart was dismissed from the action later that year. Vaxart denied the allegations. Throughout its history, the company has remained focused on converting its oral vaccine technology into approved products, but its candidates remain subject to clinical, regulatory, manufacturing, and financing risks.

1. 2024BARDA funds preparation for a Phase 2b COVID-19 study

   A $9.27 million BARDA award under Project NextGen supported preparation for a large comparative trial of an XBB tablet candidate.

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2. 2023Norovirus clinical studies report positive topline findings

   Vaxart announced positive topline results from a bivalent dose-ranging study and a monovalent challenge study.

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3. 2022Gates Foundation supports a maternal and infant norovirus study

   The foundation supported research into breast-milk antibodies and potential infant protection associated with maternal norovirus vaccination.

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4. 2020Vaxart enters COVID-19 vaccine development

   The company announced an oral tablet COVID-19 vaccine program and reported immune responses in animal studies later in the year.

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5. 2018Vaxart completes reverse merger with Aviragen

   The February 13 reverse merger made Vaxart a wholly owned subsidiary of Aviragen Therapeutics, with the combined public company continuing under the Vaxart name.

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6. 2018Influenza challenge study reports positive comparative results

   A Phase 2 challenge study reported lower clinical disease in the oral-vaccine group than in the placebo group and a numerically stronger result than the injectable comparator.

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7. 2015Oral influenza vaccine reaches Phase 1 evidence

   A Phase 1 study of an oral influenza candidate reported tolerability and neutralizing antibody responses.

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8. 2007The company adopts the Vaxart name

   After reincorporating in Delaware, the company changed its name to Vaxart, Inc. in July.

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9. 2004West Coast Biologicals is founded

   Sean Tucker founded the company in California under the name West Coast Biologicals, Inc.

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A development-stage vaccine biotechnology company differentiated by temperature-stable, orally administered tablet vaccines designed to stimulate mucosal, systemic, and T-cell immunity.

• VAAST platformVaccine-delivery platform

  Vaxart’s VAAST platform combines an adenovirus type 5 recombinant vector with antigen designs and oral, enteric-coated tablet delivery. The platform is intended to expose intestinal mucosal tissue to vaccine antigens, supporting mucosal and systemic immune responses without an intramuscular injection. It has been applied across infectious-disease and therapeutic vaccine programs.

• Oral influenza vaccineSeasonal influenza vaccine candidate

  Vaxart’s influenza program used an orally administered tablet designed to generate immune responses against influenza. Clinical studies reported tolerability, neutralizing antibodies, protection against viral shedding, and reduced clinical disease in a challenge setting. The program served as an important clinical proof of concept for the company’s tablet-based vaccine technology.

• Oral COVID-19 vaccine candidatesCOVID-19 vaccine candidate2020

  Vaxart’s COVID-19 program is intended to produce a temperature-stable tablet vaccine that may stimulate respiratory mucosal immunity as well as systemic responses. The company has developed candidates against circulating SARS-CoV-2 variants, including an XBB candidate supported by BARDA funding for planned Phase 2b development.

• Norovirus vaccine candidatesNorovirus vaccine candidate

  The norovirus program includes bivalent and monovalent oral tablet candidates targeting major genogroups such as GI and GII. The program seeks to generate intestinal antibodies against a pathogen that primarily infects the gastrointestinal tract. Vaxart has reported results from dose-ranging, challenge, and maternal-infant studies.

• Therapeutic vaccine programsTherapeutic vaccine candidate

  Vaxart has explored therapeutic applications of its platform beyond preventive infectious-disease vaccines, including candidates directed at chronic viral infections and human papillomavirus-related disease or cancer. These programs aim to use systemic and T-cell responses as part of treatment-oriented immune interventions.

• 2024Advance an XBB COVID-19 tablet candidate with BARDA supportProduct launch

  Vaxart sought to test whether an oral vaccine could provide broader or more durable protection than existing injected products.

  What changed. BARDA awarded $9.27 million under Project NextGen to support preparation for a Phase 2b study of the XBB candidate.

  Aftermath. The proposed study was designed to compare the tablet candidate with an approved mRNA vaccine in approximately 10,000 participants.

  BARDA award. $9.27 million (2024)

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• 2020Enter COVID-19 vaccine developmentProduct launch

  The COVID-19 pandemic created demand for vaccines that could be administered and distributed more easily and that might provide mucosal protection.

  What changed. Vaxart initiated development of an oral tablet COVID-19 vaccine candidate.

  Aftermath. The program progressed into clinical development and later received BARDA support for planned Phase 2b work.

  Source
• 2018Complete reverse merger with Aviragen TherapeuticsM&A

  Vaxart used a reverse merger to obtain a public-company structure and continue development of its vaccine platform.

  What changed. On February 13, Vaxart merged with Aviragen Therapeutics and became its wholly owned subsidiary; the combined company retained the Vaxart name.

  Aftermath. Vaxart continued as the operating biotechnology business within the public company.

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• 2007Adopt an oral tablet vaccine strategyStrategy

  The company sought to address limitations of injectable vaccines, including needle use, cold-chain dependence, and mass-administration logistics.

  What changed. Vaxart developed enteric-coated recombinant vaccine tablets using an adenovirus-based delivery system.

  Aftermath. The oral tablet platform became the foundation for the company’s influenza, norovirus, COVID-19, and therapeutic vaccine programs.

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• 2021Stockholder derivative litigation over alleged insider tradingControversy

  Shareholders filed a Delaware Court of Chancery action alleging that Vaxart executives breached fiduciary duties and engaged in insider trading connected with statements about the company’s vaccine work. The case was dismissed in early 2024, according to the supplied reference material.

  Source
• 2020Securities litigation concerning Operation Warp Speed statementsControversy

  A federal securities class action alleged that investors were misled about Vaxart’s involvement in Operation Warp Speed. The supplied material states that the class was certified in December 2024 and that Vaxart was dismissed from the case later that year. The company denied the allegations.

  Source

• 2024Vaxart receives BARDA support for a Phase 2b COVID-19 trial

  BARDA awarded Vaxart $9.27 million under Project NextGen to support preparation for a large Phase 2b comparison of an XBB oral vaccine candidate with an approved mRNA vaccine.

  Product launchOther
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• 2023Vaxart reports positive norovirus Phase 2 findings

  Vaxart announced positive topline results from a dose-ranging study of a bivalent norovirus vaccine and a challenge study of a monovalent candidate.

  Product generation
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• 2020Vaxart begins development of an oral COVID-19 vaccine

  Vaxart announced plans to develop a tablet-based COVID-19 vaccine and subsequently initiated its program.

  Product launch
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• 2020Vaxart reports preclinical immune responses for its COVID-19 candidate

  The company reported immune responses in laboratory animals studying its oral COVID-19 vaccine candidate.

  Product generation
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