VXA CoV2 1
Alternative Names: Corona virus vaccine - VAXART; COVID-19 (SARS-CoV-2) E1-/E3-deleted replication defective recombinant adenovirus 5 with dsRNA adjuvant oral tablet vaccine; Non replicating Ad5 adjuvanted oral tableted vaccine; Oral SARS-CoV2 vaccine; Oral Tableted Ad5 COVID-19 Vaccine; SARS-CoV2 vaccine - VAXART; VXA-CoV2-1Latest Information Update: 28 Oct 2023
At a glance
- Originator Vaxart
- Class COVID-19 vaccines; Viral vaccines; Virus-like particle vaccines
- Mechanism of Action Immunostimulants
-
Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- No development reported COVID 2019 infections
Most Recent Events
- 28 Oct 2023 No recent reports of development identified for phase-I development in COVID-2019-infections(In the elderly, Prevention, In adults) in USA (PO, Tablet)
- 20 Jul 2022 Updated immunogenicity data from a phase I trial in COVID-2019 infections released by Vaxart
- 24 Feb 2022 Pharmacodynamic data from a preclinical trial in COVID-2019 infections released by Vaxart
Development Overview
Introduction
VXA CoV2 1 is a non-replicating Ad5 vector adjuvanted oral tableted vaccine, being developed by Vaxart, in collaboration with Emergent BioSolutions, for the prevention of COVID-2019 infections. The vaccine consists of both S and N proteins and expresses SARS-CoV-2 antigen and dsRNA adjuvant. Vaxart has utilised its proprietary Vector-Adjuvant-Antigen Standardized Technolog (VAAST™) platform. Phase II clinical development is underway in the US.
VAAST™ platform uses of a non-replicating chimeric adenovirus-5 (Ad5) vector as a delivery vehicle, and a vaccine adjuvant. Direct delivery of the vaccines into the gut using the Ad5 vector is expected to avoid neutralisation of the vaccine by immune cells based in the blood or muscle tissue. Potential advantages of the oral vaccines over injected vaccines include ease of administration, stability at ambient temperatures, reduced distribution costs, reduced medical waste and risk of needle-stick injury associated with injectable vaccines, and increased safety over other vaccines that contain killed or attenuated virus strains.
As at October 2023, no recent reports of development had been identified for phase-I development in COVID-2019-infections (In the elderly, Prevention, In adults) in USA (PO, Tablet).
Company Agreements
In October 2020, KindredBio announced expansion of its previous manufacturing agreement with Vaxart for Vaxart's oral vaccine candidate for COVID-2019. Under the terms of the expanded agreement, KindredBio's California plant will be responsible for scaling the COVID-2019 clinical trial material into mid-size bioreactors and the Kansas plant will be responsible for manufacturing at 2000L scale in its single use bioreactors.
In May 2020, Kindred Biosciences entered into an agreement with Vaxart for the manufacture of Vaxart's oral vaccine candidate for COVID-19. Under the terms of the agreement, KindredBio will provide manufacturing services from its biological development and cGMP manufacturing facility in Burlingame, CA. KindredBio will produce the candidate vaccine bulk drug substance under Good Manufacturing Practices, and provide it to Vaxart to be formulated into an oral tablet. KindredBio will manufacture the vaccine for clinical trials beginning in the second half of 2020. [1] [2]
In June 2020, Vaxart announced that it has signed a Memorandum of Understanding with Attwill Medical Solutions Sterilflow, LP (AMS) for lyophilization development and large scale manufacturing including tableting and enteric coating for COVID-19 vaccine. As per the terms of agreement, AMS will assign dedicated resources and equipment for the scale up and commercial production of the vaccine upon entering a formal agreement to enable the large scale manufacturing and ultimate supply of our COVID-19 vaccine for the US, Europe and other countries in need. [3]
In March 2020, Vaxart signed a development agreement with Emergent BioSolutions for the former's COVID-2019 candidate. Development services are to begin immediately and upon Vaxart’s election, Emergent is expected to produce bulk cGMP vaccine for a planned phase I trial. [4]
Key Development Milestones
In February 2022, Vaxart announced its intention to initiate additional clinical trials in COVID-2019 infections in 2022, that may highlight the advantages of triggering mucosal immunity. The company also plans to initiate two studies to test the cross reactivity of the candidate against the Omicron SARS-CoV-2 variant, in March 2022. First study will test the activity of VXA CoV2 1 against Omicron in patients who were already vaccinated in a phase II trial. In second study, the candidate will be assessed against an Omicron specific vaccine candidate developed by Vaxart, in an animal Omicron challege [5]
As of April 2021, Vaxart completed a phase I trial of VXA CoV2 1 which met its primary and secondary endpoints of safety in healthy volunteers (NCT04563702; VXA-COV2-101). The company initiated the trial in September 2020, to determine the safety and immunogenicity of an adenoviral-vector based vaccine (VXA-CoV2-1) expressing a SARS-CoV-2 antigen and dsRNA adjuvant administered orally to healthy adult volunteers. Vaxart announced dosing of first patient in this study in October 2020. In November 2020, the open-label trial completed enrolment of 48 patients in the US [6] [7] [8] [9] [10] . In September 2020, US FDA approved IND application of oral COVID-19 vaccine for phase I trial [11] . In August 2020, Vaxart filed an IND with the US FDA for its COVID-19 vaccine [12] . In April 2021, Vaxart reported immunogenicity data from the study. In February 2021, preliminary results were released from the trial by Vaxart [13] [14] . In July 2022, the company released updated immunogenicity data from the trial [15] .
In February 2022, Vaxart announced the preclinical study data demonstrating the strong-cross reactive mucosal and systemic immune responses in non-human primates [16] .
In December 2021, Vaxart reported that it plans to test the cross-reactivity of VXA CoV2 1 against omicron variant in two different studies. In the first study, the activity of the vaccine will be tested against omicron by analyzing mucosal and serum samples from patients to whom the vaccine was administered in the phase II trials. The second study will assess the vaccine in comparison to an omicron-specific vaccine candidate, being developed by Vaxart [17] .
In November 2021, Vaxart announced preclinical data from hamster challenge study in prevention of COVID-2019 infections [18] .
In November 2020, preclinical data from hamster challenge study demonstrating significant viral load reduction and strong antibody responses were released by Vaxart [8] [19] .
In October 2020, results from preclinical studies were released by Vaxart. The study evaluated the systemic weight for five days before animals were assessed for lung disease [20] [21] .
In August 2020, Vaxart initiated SARS-CoV-2 challenge study in hamsters. This study will provide efficacy data and optimal dose regimen about the COVID-19 vaccine [11] .
In June 2020, Vaxart announced that the COVID-19 vaccine has been selected by the US Government's Operation Warp Speed to participate in a non-human primate (NHP) challenge study [22]
In May 2020, Vaxart announced that it has chosen the lead candidate for cGMP manufacturing and clinical testing based on the magnitude and the breadth of the immune response [23] .
In March 2020, Vaxart had produced five COVID-19 vaccine candidates for testing in its preclinical models. Each of the COVID-19 vaccine constructs is based on a different coronavirus antigen combination, and Vaxart expects to advance the best performing vaccine to manufacturing for further clinical trials. Positive preclinical data were released by Vaxart in April 2020 [24] [25] [26] .
Patent Information
As at October 2021, Vaxart filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists [27] [28]
In June 2011, Vaxart was issued US patent No. 7 879 602, which covers the company's oral-delivery platform technology [29]
Drug Properties & Chemical Synopsis
- Route of administration PO
- Formulation Tablet
- Class COVID-19 vaccines, Viral vaccines, Virus-like particle vaccines
- Mechanism of Action Immunostimulants
-
WHO ATC code
J07B-X (Other viral vaccines)
-
EPhMRA code
J7A9 (Other specified single component)
Biomarker
| Drug Name | Biomarker Name | Biomarker Function |
|---|---|---|
| VXA CoV2 1 | ACE2 | Outcome Measure |
| AMH | Detailed Description, Outcome Measure | |
| Apolipoprotein H antibodies | Eligibility Criteria | |
| B-cell lymphoma 2 (Bcl-2) | Arm Group Description | |
| B-lymphocyte antigen CD19 | Arm Group Label | |
| B-lymphocyte antigen CD20 | Arm Group Description, Brief Title, Official Title | |
| Bilirubin | Eligibility Criteria | |
| C-reactive protein (CRP) | Brief Summary, Detailed Description, Eligibility Criteria, Outcome Measure | |
| C1QL1 | Outcome Measure | |
| Calprotectin | Detailed Description | |
| Cardiac Troponin I | Eligibility Criteria, Outcome Measure | |
| CGA | Eligibility Criteria | |
| chorionic gonadotropin beta subunit 5 | Eligibility Criteria | |
| corticotropin releasing hormone | Outcome Measure | |
| Cytokeratin 20 | Arm Group Description | |
| D-dimer | Eligibility Criteria | |
| D-Urobilinogen | Eligibility Criteria | |
| Estradiol-17beta 3-sulfate | Outcome Measure | |
| Ferritin | Eligibility Criteria, Outcome Measure | |
| Ferrocytochrome | Eligibility Criteria | |
| Fibrinogen | Eligibility Criteria | |
| FSH | Eligibility Criteria | |
| fuzzy planar cell polarity protein | Outcome Measure | |
| GNPTAB | Eligibility Criteria | |
| Gut Microbiome | Brief Title, Official Title | |
| heat shock 27kDa protein 3 | Outcome Measure | |
| hypertrichosis 2 (generalized, congenital) | Eligibility Criteria | |
| immunoglobulin heavy constant epsilon | Outcome Measure | |
| Insulin | Brief Summary, Outcome Measure | |
| Interferon alpha (IFN-alpha) | Outcome Measure | |
| Interferon Gamma (IFNg) | Brief Summary, Detailed Description, Outcome Measure | |
| Interleukin-2 (IL-2) | Outcome Measure | |
| Interleukin-4 (IL-4) | Outcome Measure | |
| Interleukin-5 (IL-5) | Outcome Measure | |
| Interleukin-6 (IL-6) | Eligibility Criteria, Outcome Measure | |
| KRT88P | Eligibility Criteria | |
| L-Lactic acid | Eligibility Criteria | |
| microcephaly with spastic diplegia (Paine syndrome) | Outcome Measure | |
| mutated in colorectal cancers | Brief Summary | |
| PCNA | Arm Group Label | |
| PD-1/CD279 | Eligibility Criteria, Outcome Measure | |
| PD-L1/CD274 | Brief Title, Eligibility Criteria, Official Title, Outcome Measure | |
| Phosphonoacetate | Outcome Measure | |
| Progesterone | Brief Summary, Detailed Description, Outcome Measure | |
| Protein S | Outcome Measure | |
| protein tyrosine phosphatase, non-receptor type 6 | Eligibility Criteria | |
| Protoporphyrin IX | Eligibility Criteria | |
| PYD and CARD domain containing | Outcome Measure | |
| pyrroline-5-carboxylate reductase 1 | Outcome Measure | |
| RBP4 | Outcome Measure | |
| serine peptidase inhibitor, Kunitz type 1 | Outcome Measure | |
| serine racemase | Outcome Measure | |
| seryl-tRNA synthetase | Brief Summary, Detailed Description, Eligibility Criteria, Outcome Measure | |
| Soluble transferrin receptor | Outcome Measure | |
| STS | Outcome Measure | |
| suppression of tumorigenicity 14 (colon carcinoma) | Outcome Measure | |
| T-box 1 | Eligibility Criteria | |
| T-Cell differentiation antigen CD8 | Detailed Description, Outcome Measure | |
| T-cell surface antigen CD4 | Detailed Description, Eligibility Criteria, Outcome Measure | |
| TF | Outcome Measure | |
| Thromboxane | Outcome Measure | |
| Toll-Like Receptor 4 (TLR4) | Outcome Measure | |
| Tumor necrosis factor alpha (TNF-alpha) | Outcome Measure | |
| Vitamin A | Outcome Measure | |
| vitronectin | Arm Group Description, Arm Group Label, Detailed Description, Official Title, Outcome Measure | |
| Y Chromosome | Eligibility Criteria | |
| zinc finger protein 415 | Arm Group Description |
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| COVID 2019 infections | - | In adults, In the elderly, Prevention | No development reported (I) | USA | PO / Tablet | Vaxart | 28 Oct 2023 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Vaxart | Originator | USA |
| Vaxart | Owner | USA |
| Emergent BioSolutions | Collaborator | USA |
| Duke University | Collaborator | USA |
Scientific Summary
Adverse Events
Pharmacodynamics
In hamsters, oral administration of the recombinant adenoviral vaccine, with doses given at 0 and 4 weeks, demonstrated that all unvaccinated animals lost at least 8% of their body weight, and all showed evidence of lung disease as measured by relative weight gain in the lungs. By contrast, all animals vaccinated with two doses of the oral vaccine maintained or gained body weight by the end of the experiment, a statistically significant result (p<0.001). Additionally, these animals were protected against the lung weight gain seen in the unvaccinated animals (p<0.001). For unvaccinated animals, lung weight as a percentage of body weight was approximately twice that of the animals that received two oral doses of the vaccine [20] . In hamster challenge study, significant reduction in lung viral load of 4-5 logs in hamsters that received two oral vaccine doses, as compared to non-vaccinated animals was observed. Oral vaccination protected as well as intranasal vaccination, against intranasal challenge with respect to key indicators: protection from weight loss, protection from increase in lung weight, viral load reduction, and induction of serum IgG antibodies, demonstrating that mucosal protection by both routes of administration was comparable [19] [8] .
Preclinical data from hamster challenge study demonstrated protection against systemic weight loss, lung weight gain and showed a 4-5 log reduction in lung viral load. Both oral and intranasal delivery of VXA CoV2 1 showed similar protection against intranasal viral challenge. Comparable mucosal protection by nasal and oral routes was observed [32] [8]
Results from preclinical study showed that, in hamster transmission study, COVID-19 vaccine reduced the airborne transmission of SARS-CoV-2 virus in a hamster model. Vaccinated hamsters had no significant loss of weight over the 5 days post challenge, while unvaccinated hamsters lost up to 10% of their body weight. Lung weight, which can be an indirect measure of lung inflammation, was significantly lower in double-vaccinated hamsters compared with unvaccinated animals.5 days post challenge, double-vaccinated hamsters had a greater than 4 log reduction in viral load and had no detectable infectious virus in their lungs [18] .
In preclinical research with non-human primates, VXA CoV2 1 induced the strongest antibody response with significant nasal IgA and serum IgG responses against multiple variants. Cross-reactivity occurred with the vaccine, causing antibodies to all four major variants of concern explored, with a more than 1,000-fold increase in IgA [16] .
Immunogenicity
Summary
Oral administration of COVID-19 vaccine in animal models demonstrated statistically significant antibody responses in comparison to the control. IgG anti-SARS CoV-2 antibodies were observed in serum two weeks following first vaccination. Robust response was observed after both the first and second dose, with a clear boosting effect after the second dose. In all vaccinated groups, antibody responses were statistically significant (p < 0.002), with median ELISA IgG antibody titers more than 10 000 compared to a median titer of 1 in the untreated controls indicating a larger than 10 000 fold increase [24] [25] .
Preclinical studies showed immunisation with the vaccine candidate induced IgA response in the lungs of animals, indicating a mucosal immune response. There were neutralising antibodies in the lungs at a very high percentage of the total antibody response. Vaccine expressing full length S and N proteins induced IgG responses in a dose-dependent manner. At both high and low doses, antigen-specific CD4+ and CD8+ T cells were induced. Only low levels of IL-4 production were observed with vaccine administration, suggesting little risk of vaccine- dependent disease enhancement [21] .
In hamster challenge model, potent induction of antibody response, with serum IgG antibody titers above 10,000 in hamsters that received two oral vaccine doses was observed [19] .
Updated data from a phase I trial, demonstrated broad cross-reactive mucosal IgA responses for at least 6 months in most responders, and up to one year in a subset of them following a single dose VXA CoV2 1, in healthy volunteers. Nasal samples collected reported at least a 1.5-fold increase in SARS-CoV-2-specific secretory IgA compared with pre-vaccination levels, in 46% of subjects. In a separate study, nasal and saliva samples showed that 50% of the vaccinated subjects had more neutralizing activity [15] . Earlier results induced high percentage of CD8+ T cells against the viral Spike (S) protein and Nucleoprotein (N) proteins which could potentially induced cross-reactive immune response against SARS-CoV-2 viruses as well as diverse endemic coronaviruses such as 229E, NL63, HKU1, and OC43. The vaccine also induced specific IgA antibodies in the mucosa. The vaccine also induced B cell response with increase in plasmablast cells and upregulation of mucosal homing receptors as well as increase in proinflammatory Th1 cytokines. IgA antibodies were detected in serum and/or nasal swab samples in 100% of 2 dose subjects. The vaccine did not induced neutralising antibodies in serum and IgG antibodies in most participants [13] [14] [9] . IgA levels in saliva and nasal samples were assessed 29 days post-vaccination. More than half (54%) of subjects had at least a two-fold increase in IgA antibodies in either their saliva or nasal samples. Responses were similar for both S and N protein as well as for the receptor-binding domain. It also showed an increase in cross-reactive IgA that bound to spike proteins from the Middle East respiratory syndrome coronavirus (MERS-CoV) and SARS-CoV-1 along with the four endemic strains of coronavirus as well as [31] .
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 31 Dec 2022 | Trial Update | Vaxart plans clinical trials in COVID-2019 infections (prevention) (PO, Tablet) in 2022 [5] | 07 Mar 2022 |
| 31 Mar 2022 | Trial Update | Vaxart plans two studies in COVID-2019 infections, to test cross-reactivity against omicron variant in March 2022 [5] | 07 Mar 2022 |
| 30 Sep 2020 | Trial Update | Vaxart plans a phase I trial for COVID-2019 infections (In volunteers, Prevention) in USA in September 2020 (PO) (700320031) [11] | 09 Oct 2020 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 28 Oct 2023 | Phase Change - No development reported | No recent reports of development identified for phase-I development in COVID-2019-infections(In the elderly, Prevention, In adults) in USA (PO, Tablet) Updated 28 Oct 2023 |
| 20 Jul 2022 | Scientific Update | Updated immunogenicity data from a phase I trial in COVID-2019 infections released by Vaxart [15] Updated 22 Jul 2022 |
| 24 Feb 2022 | Scientific Update | Pharmacodynamic data from a preclinical trial in COVID-2019 infections released by Vaxart [16] Updated 07 Mar 2022 |
| 24 Feb 2022 | Trial Update | Vaxart plans clinical trials in COVID-2019 infections (prevention) (PO, Tablet) in 2022 [5] Updated 07 Mar 2022 |
| 24 Feb 2022 | Trial Update | Vaxart plans two studies in COVID-2019 infections, to test cross-reactivity against omicron variant in March 2022 [5] Updated 07 Mar 2022 |
| 17 Jan 2022 | Biomarker Update | Biomarkers information updated Updated 20 Jan 2022 |
| 16 Nov 2021 | Scientific Update | Pharmacodynamic data from a preclinical trial in COVID-2019 infections released by Vaxart [18] Updated 26 Nov 2021 |
| 06 Oct 2021 | Patent Information | Vaxart files for patent protection for proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists in USA and other countries [27] [28] Updated 01 Nov 2023 |
| 03 May 2021 | Scientific Update | Immunogenicity data from a phase I trial in COVID-2019 infections released by Vaxart [13] Updated 07 May 2021 |
| 22 Apr 2021 | Trial Update | Vaxart completes its phase I VXA CoV2 1 clinical trial in COVID-2019 infections (Prevention, In adults, In the elderly) in USA (PO) before April 2021 [6] Updated 27 Apr 2021 |
| 03 Feb 2021 | Scientific Update | Preliminary immunogenicity and adverse events data from a phase I trial in COVID-2019 infections released by Vaxart [14] Updated 05 Feb 2021 |
| 03 Feb 2021 | Trial Update | Vaxart plans a clinical trial for COVID-2019 infections (Treatment-experienced) (PO) [14] Updated 05 Feb 2021 |
| 03 Feb 2021 | Trial Update | Vaxart plans phase II trials for COVID-2019 infections (PO) [14] Updated 05 Feb 2021 |
| 12 Nov 2020 | Scientific Update | Pharmacodynamics and immunogenicity data from preclinical trials in COVID-2019 infections released by Vaxart [8] [19] Updated 21 Nov 2020 |
| 11 Nov 2020 | Trial Update | Vaxart completes enrolment in its phase I clinical trial in COVID-2019 infections (Prevention, In adults, In the elderly) in USA (PO) (NCT04563702) [8] Updated 21 Nov 2020 |
| 14 Oct 2020 | Scientific Update | Pharmacodynamics data from preclinical trials in COVID-2019 infections released by Vaxart [20] Updated 19 Oct 2020 |
| 29 Sep 2020 | Phase Change - I | Phase-I clinical trials in COVID-2019 infections (Prevention, In adults, In the elderly) in USA (PO) (NCT04563702) Updated 29 Sep 2020 |
| 14 Sep 2020 | Trial Update | Vaxart plans a phase I trial for COVID-2019 infections (In volunteers, Prevention) in USA in September 2020 (PO) [11] Updated 09 Oct 2020 |
| 14 Sep 2020 | Regulatory Status | US FDA approves IND application for COVID-19 vaccine in COVID-2019 infections (Prevention) [11] Updated 16 Sep 2020 |
| 08 Sep 2020 | Scientific Update | Immunogenicity data from preclinical studies from COVID-2019 infections (Prevention) released by Vaxart [21] Updated 11 Sep 2020 |
| 10 Aug 2020 | Regulatory Status | Vaxart files an IND application with the US FDA for COVID-2019 infections (Prevention) [12] Updated 12 Aug 2020 |
| 30 Jun 2020 | Licensing Status | Vaxart signs a Memorandum of Understanding with Attwill Medical Solutions for lyophilization development and large scale manufacturing for COVID-19 vaccine [3] Updated 30 Jun 2020 |
| 26 Jun 2020 | Regulatory Status | The US Government selects Vaxart's COVID-19 Vaccine for the Operation Warp Speed [22] Updated 16 Sep 2020 |
| 21 Apr 2020 | Scientific Update | Immunogenicity data from a preclinical data in COVID-19 infections released by Vaxart [25] [24] Updated 23 Apr 2020 |
| 19 Mar 2020 | Licensing Status | Vaxart signs development services agreement with Emergent BioSolutions for COVID-2019 vaccine development [4] Updated 24 Mar 2020 |
| 19 Mar 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections (Prevention) in USA (PO) [30] Updated 23 Mar 2020 |
| 07 Jun 2011 | Patent Information | Vaxart has patent protection for company′s oral-delivery platform technology in USA [29] Updated 01 Nov 2023 |
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Vaxart, Inc. Signs Memorandum of Understanding with Attwill Medical Solutions Sterilflow, LP.
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A Phase 1 Open-Label, Dose-Ranging Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Vaccine (VXA-CoV2-1) Expressing a SARS-CoV-2 Antigen and dsRNA Adjuvant Administered Orally to Healthy Adult Volunteers VXA-CoV2-1.1-S Boost Substudy: Boost at 1 Year Post Initial Vaccination With an Adenoviral-Vector Based Vaccine VXA-CoV2-1.1-S Expressing a SARS-CoV-2 S Protein in a Subset of Subjects
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