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Data published in bioRxiv confirmed previous results suggesting that mucosal vaccines may further reduce transmission of airborne viruses such as COVID-19 and influenza than injectable vaccines.
Mucosal vaccines may protect not only vaccinated animals, but unvaccinated animals, study suggests
SOUTH SAN FRANCISCO, California, October 7, 2021 / PRNewswire / – A duke universityA supervised study published in bioRxiv showed that the investigational oral tablet vaccine from Vaxart, Inc. (NASDAQ: VXRT) reduced airborne transmission of the SARS-CoV-2 virus in an animal model.
These results are consistent with those from Vaxart’s Phase II human influenza study, which showed that Vaxart’s oral tablet vaccine reduced shedding better than injectable influenza vaccine.
One limitation of currently approved injected COVID-19 vaccines is that airborne transmission occurs in people who have received them. The preclinical study also demonstrated that Vaxart’s oral vaccine platform induces robust systemic and mucosal responses.
Researchers vaccinated hamsters orally or intranasally with Vaxart’s vaccine candidate S only, then exposed them to significant levels of COVID-19 virus to promote the vaccine’s breakthrough. Vaccinated hamsters quickly cleared the infectious virus in the nose and lungs. Prior to clearing the infection, the vaccinated hamsters were exposed to unvaccinated hamsters by aerosol. Mucosal vaccinated hamsters infected fewer hamsters and created less severe clinical symptoms than unvaccinated hamsters.
“These results show that our vaccine candidate can reduce the transmission of SARS-CoV-2, even with breakthrough infection in vaccinated subjects,” said Dr. Sean tucker, lead author of the study and scientific director of Vaxart.
“Existing injected vaccines do not always protect against viral shedding and transmission to others. A vaccine that reduces shedding and reduces the likelihood of infection could make a big difference in protecting life and public health, especially given the large number of unvaccinated people. This study used the same vaccine candidate that Vaxart is using in its development of an oral tablet vaccine, ”added Dr. Tucker.
Earlier this week, Vaxart initiated the recruitment for a global Phase II clinical trial of its COVID-19 oral tablet vaccine candidate, which targets the viral spike (S) protein of SARS-CoV-2.
“Vaxart previously published data from a human influenza challenge study which demonstrated that our oral influenza vaccine candidate inhibited viral RNA excretion better than injectable vaccines. The reported data provide further evidence that our oral vaccine could offer both an easier and more attractive mode of administration and potentially superior protection against respiratory viruses, ”said Andrei Floroiu, CEO of Vaxart.
The mucosal surface of the upper respiratory tract is the initial site of SARS-CoV-2 replication and the primary site of infection. Vaccines that induce robust mucosal immune responses may have the greatest impact in reducing the transmission of SARS-CoV-2. Approved COVID-19 vaccines, all of which are given by intramuscular injection, stimulate systemic immune responses but have minimal effects on mucosal immunity.
About the study
The study used a hamster infection and aerosol transmission system to investigate the potential impact of oral vaccination on the transmission of SARS-CoV-2 to uninfected individuals.
The animals received oral, intranasal or intramuscular vaccines targeting the S protein, and a control group received a mock vaccine (four animals per group). These index hamsters were then infected intranasally with a high titer of SARS-CoV-2 to reproduce a post-vaccination breakthrough infection.
One day after viral challenge, index hamsters were placed upstream of unvaccinated hamsters in a chamber that allowed movement of aerosols but not direct contact with other animals or the litter or feeding receptacles used by d ‘other animals. Index animals were assessed for antibodies for systemic (IgG) and mucosal (IgA) immunity; all animals were assessed for viral titers and body weight and lung weight (indicators of SARS-CoV-2 infection).
Main conclusions
The main findings of the study include:
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Oral and intranasal vaccination against S protein induced strong systemic and mucosal antibody responses.
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Oral and intranasal vaccination accelerated the clearance of SARS-CoV-2 RNA and protected animals against disease.
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Oral and intranasal vaccination limited the transmission of SARS-CoV-2 to unvaccinated animals.
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Taken together, these data demonstrate that oral immunization against SARS-CoV-2 S protein resulted in reduced disease and decreased transmission of SARS-CoV-2 in a hamster model.
About Vaxart
Vaxart is a clinical stage biotechnology company developing a range of recombinant oral vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using tablets that can be stored and shipped unrefrigerated and eliminate the risk of needlestick injury. Vaxart believes that its proprietary tablet vaccine delivery platform is suitable for the delivery of 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 tablet vaccines designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine against human papillomavirus (HPV), the first indication in immuno-oncology for Vaxart. Vaxart has filed extensive national and international patent applications covering its proprietary technology and designs for oral vaccination using adenoviruses 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 fact, included in this press release regarding Vaxart’s strategy, prospects, plans and objectives, results of preclinical and clinical trials, marketing agreements and licenses, and management’s beliefs and expectations are forward-looking statements. These forward-looking statements may be accompanied by words such as “should”, “believe”, “could”, “potential”, “will”, “expected”, “plan” and other words and terms with similar meanings. Examples of such statements include, but are not limited to, statements relating to Vaxart’s ability to develop and market its product candidates, including its vaccine booster products; Vaxart’s expectations regarding clinical results and trial data; and Vaxart’s expectations with respect to the effectiveness of its product candidates. Vaxart may not actually carry out the plans, achieve the intentions or meet the expectations or projections disclosed in the forward-looking statements, and you should not place undue reliance on such 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 Vaxart’s forward-looking statements, including inherent research and development uncertainties, including the ability to achieve expected clinical goals, start dates and / or completion of clinical trials, regulatory submission dates, regulatory approval dates and / or launch dates, as well as the possibility of new adverse clinical data and other analyzes of existing clinical data; the risk that clinical trial data may be subject to different interpretations and evaluations by regulatory authorities; whether regulatory authorities will be satisfied with the design and results of 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-US regulatory authorities; that, although approved by the FDA or non-US regulatory authorities, Vaxart’s product candidates may not be widely accepted in the market; that a Vaxart employee may not reach the development and commercial stages; that Vaxart or its partners may experience manufacturing problems and delays due to events under or beyond the control of Vaxart or its partners; production difficulties, especially in increasing initial production, including difficulties with production costs and yields, quality control, including stability of the candidate product and quality assurance testing, shortages of skilled 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 the necessary patents and other intellectual property protections; whereas Vaxart’s capital resources may be insufficient; Vaxart’s ability to resolve outstanding legal issues; Vaxart’s ability to obtain sufficient capital to finance its operations on terms acceptable to Vaxart, if applicable; the impact of government health care proposals and policies; competitive factors; and other risks described in the “Risk Factors” sections of Vaxart’s quarterly and annual reports filed with the SEC. Vaxart assumes no obligation to update forward-looking statements, except as required by law.
Contacts
Vaxart press relations
Marc sir
Vaxart, Inc.
[email protected]
(203) 517-8957
Investor Relations
[email protected]
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SOURCE Vaxart, Inc.
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