Vaxart announces publication of peer-reviewed journal article showing potential clinical and economic value of norovirus vaccine

• A computer simulation model has shown that a norovirus vaccine costing up to $ 1,300 can still be a savings for children under 5.

• The model also showed that a norovirus vaccine costing $ 100 can save the elderly.

SOUTH SAN FRANCISCO, Calif., January 27, 2021 (GLOBE NEWSWIRE) – Vaxart, Inc., (NASDAQ: VXRT), a clinical-stage biotechnology company developing oral vaccines that are administered by pill rather than by injection, including a Program of norovirus ready for phase 2, health economics results published in the American Journal of Preventive Medicine. Computer modeling simulating norovirus infection and transmission in a community setting has shown that a potential norovirus vaccine can prevent symptomatic cases and lead to cost savings. The study found, among other things, that vaccination against norovirus can reduce the economic burden of the virus and is cost effective even though it costs $ 500 per course when vaccinating children under 5 and older adults, a much higher value than previously estimated. The manuscript entitled “Potential Clinical and Economic Value of Norovirus Vaccination in the Community Setting” is available Here.

“This study highlights the fact that norovirus is highly contagious and can lead to a lack of school and work, with productivity losses that can add up,” said Bruce Y. Lee, MD, MBA, lead author of the study, professor of health policy and management at the City University of New York (CUNY) and executive director of research in informatics, informatics and public health operations (PHICOR). “The preschool age population may be particularly vulnerable due to the high social mix leading to further spread of the virus, and the older adult population may be vulnerable to more severe disease and subsequently experience high rates of outpatient consultations and hospitalizations. ”

The PHICOR team has developed a computer simulation model of different segments of the American population and the spread of norovirus in order to better understand the value of vaccinating children <5 years and adults ≥ 65 years against norovirus. The model simulated the spread of norovirus, subsequent clinical outcomes (eg, Symptoms, hospitalization, death) and associated costs (eg, Direct medical costs, lost productivity), as well as vaccination.

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Main conclusions:

• Even with 25% vaccine efficacy and 10% vaccine coverage, a norovirus vaccine could reduce symptomatic cases in a community by 7.7% relative.

• For preschoolers, the cost of immunization could go up to $ 1,300 while providing savings and up to $ 1,600 while remaining cost effective.

• Vaccinating children under 5 had a significantly greater benefit than vaccinating older adults, as children under 5 contribute significantly to the spread of norovirus. However, vaccinating the elderly can still be cost effective or economical.

• In older adults, the cost of vaccination could be as high as $ 100 while providing savings and up to $ 165 while remaining cost effective.

“These important findings confirm our view of the significant potential clinical and economic benefit of a norovirus vaccine,” said Andrei Floroiu, CEO of Vaxart. “The significantly higher cost levels resulting from this analysis significantly increase our view of the value creation potential of our oral norovirus tablet vaccine. We are very pleased to advance our norovirus program with the three clinical trials that we plan to start in 2021 and look forward to confirming the efficacy and tolerability profile suggested by the very encouraging data from our previous Phase 1 studies. .

Norovirus is the leading cause of acute viral gastroenteritis in all age groups in the United States. However, there are no approved vaccines against noroviruses. Each year, on average, norovirus causes 19 to 21 million cases of acute gastroenteritis and leads to 56,000 to 71,000 hospitalizations and 570 to 800 deaths, mainly in young children and the elderly.

Vaxart, Inc. supported the PHICOR research team.

About PHICOR

Since 2007, PHICOR’s team of scientists and experts in medicine, public health and communication research and develop computer systems and approaches, methods (e.g. artificial intelligence (AI), learning automatic, data science), models and tools to help a wide range of decision-makers tackle various health and public health issues. PHICOR helps local, state and federal governments respond to threats from infectious diseases, ranging from influenza to Ebola to Zika virus and the current COVID-19 pandemic. For example, during the 2009 H1N1 influenza pandemic, the PHICOR team was integrated with the US Department of Health and Human Services (HHS) to help with the national response. This included working with the Department of Homeland Security (DHS) and the Centers for Disease Control and Prevention (CDC).

About Vaxart

Vaxart is a clinical stage biotechnology company developing a line of recombinant oral vaccines based on its proprietary delivery platform. Vaxart investigational vaccines are designed to be administered using tablets that can be stored and shipped unrefrigerated and eliminate the risk of needle stick injury. Vaxart believes that its patented tablet vaccine distribution platform is suitable for delivering recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Its 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 immuno-indication. oncology from Vaxart. Vaxart has filed extensive national and international patents covering its proprietary technology and its creations for oral vaccination using adenoviruses and TLR3 agonists.

Note regarding forward-looking statements

This press release contains forward-looking statements that involve important 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, 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 having similar meanings. Examples of such statements include, but are not limited to, statements relating to the potential clinical and economic value of a norovirus vaccine in a community setting; Vaxart’s ability to develop and market its vaccine candidates and preclinical or clinical results and test data; Vaxart’s expectations for the benefits it believes its oral vaccine platform can offer over injectable alternatives; and Vaxart’s expectations regarding the effectiveness of its products or 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 the uncertainties inherent in research and development, including the ability to meet expected clinical criteria, start dates and / or completion of clinical or preclinical trials. studies, 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 data from clinical trials and preclinical studies may be subject to different interpretations and assessments 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 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 development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events under or beyond the control of Vaxart or its partners, including the recent outbreak of COVID-19; production difficulties, particularly in increasing initial production, including difficulties with production costs and yields, quality control, including stability of the candidate product and quality assurance testing, lack of qualified personnel or key raw materials, and adherence to strictly enforced federal, state rules. and foreign regulations; that Vaxart may not be able to obtain, maintain and enforce the necessary patent and other intellectual property protection; whereas Vaxart’s capital resources may be insufficient; Vaxart’s ability to obtain sufficient capital to finance its operations on terms acceptable to Vaxart, if at all; 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.

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