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

• A computer simulation model showed that a norovirus vaccine costing up to $ 1,300 can still save on children under 5

• The model also showed that a $ 100 norovirus vaccine can be cost-effective for older adults

SOUTH SAN FRANCISCO, Calif., January 27, 2021 (GLOBE NEWSWIRE) – Vaxart, Inc., (NASDAQ: VXRT), a clinical biotechnology company that develops oral vaccines administered by tablet instead of injection, including a Program of phase 2 ready norovirus, today announced the economic results of health care published in the American Journal of Preventative Medicine. Computer modeling that simulates norovirus infection and transmission in a community setting has shown that a potential norovirus vaccine can prevent symptomatic cases and result in cost savings. The study found, among other things, that vaccination against norovirus can reduce the economic burden of the virus and is economical even if it costs $ 500 per course to vaccinate children under 5 and older adults, a much higher value than than previously estimated. The manuscript entitled, “Potential clinical and economic value of norovirus vaccination in the community environment” can be accessed on here.

“This study highlights the fact that norovirus is highly contagious and can lead to absences from classes and work, with productivity losses that can increase,” said Bruce Y. Lee, MD, MBA, senior author of the study, Professor of City University of New York Health Policy and Administration (CUNY) and executive director of Public Health Informatics, Computational, and Operations Research (PHICOR). “The population of pre-school age can be particularly vulnerable due to the great social mix that leads to a greater spread of the virus, and the elderly population can be susceptible to more serious diseases and, subsequently, present high rates of outpatient consultations and hospitalizations” .

The PHICOR team developed a computer simulation model for different segments of the US population and the spread of norovirus to better understand the value of vaccinating children <5 and adults ≥65 years of age against norovirus. The model simulated the spread of norovirus, subsequent clinical results (for example, symptoms, hospitalization, death) and associated costs (for example, direct doctors, loss of productivity), as well as vaccination.

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Main conclusions:

• Even with a vaccine effectiveness of 25% and vaccination coverage of 10%, a norovirus vaccine could decrease symptomatic cases in a community by about 7.7%.

• In pre-school children, the cost of vaccination can be as high as $ 1,300 and still provide cost savings and as high as $ 1,600 and still be economical.

• Vaccination of children <5 years of age had a substantially greater benefit compared to vaccination of older adults, as children under 5 years of age contribute considerably to the spread of norovirus. However, vaccinating the elderly can still be economical or economical.

• In older adults, the cost of vaccination can be as high as $ 100 and still provide cost savings and as high as $ 165 and still be economical.

“These important findings confirm our vision of the significant potential clinical and economic benefit of a norovirus vaccine,” said Andrei Floroiu, executive director of Vaxart. “The significantly higher cost levels of this analysis significantly increase our view of the value-creating potential of our oral norovirus tablet vaccine. We are excited to advance our norovirus program with the three clinical trials that we hope to start in 2021 and hope to confirm the effectiveness 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 for norovirus. 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 among older children and adults.

Vaxart, Inc. supported the PHICOR research team.

About PHICOR

Since 2007, PHICOR’s team of scientists and specialists in medicine, public health and communication has been researching and developing computational systems and approaches, methods (for example, artificial intelligence (AI), machine learning, data science), models and tools to help the wide range of decision makers address various health and public health issues. PHICOR helps local, state and federal governments to respond to threats from infectious diseases ranging from influenza to Ebola to Zika and the current COVID-19 pandemic. For example, during the 2009 H1N1 flu pandemic, the PHICOR team was incorporated into the US Department of Health and Human Services (HHS) to assist in 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 biotechnology company that develops a variety of oral recombinant vaccines based on its proprietary distribution platform. Vaxart experimental vaccines are designed to be administered in tablets that can be stored and shipped without refrigeration and eliminate the risk of injury with needles. Vaxart believes its proprietary tablet vaccine delivery platform is suitable for delivering recombinant vaccines, positioning the company to develop oral versions of vaccines currently on the market 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 for human papillomavirus (HPV), Vaxart’s first immuno-oncological indication. Vaxart has registered broad national and international patents covering its technology and proprietary creations for oral vaccination using adenovirus and TLR3 agonists.

Note on forward-looking statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, except statements of historical facts, included in this press release about Vaxart’s strategy, perspectives, plans and objectives, results of preclinical and clinical studies, marketing agreements and licenses, management’s beliefs and expectations are statements prospective. These forward-looking statements may be accompanied by words such as “should”, “believe”, “could”, “potential”, “will”, “expected”, “plan” and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements regarding 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 pre-clinical or clinical results and trial data; Vaxart’s expectations regarding the advantages 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 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 may differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Several important factors may 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 expected clinical outcomes, start dates and / or completion of clinical trials or pre-clinical studies, regulatory submission dates, regulatory approval dates and / or launch dates, as well as the possibility of unfavorable new clinical data and additional analysis of existing clinical data; the risk that data from clinical and pre-clinical studies are 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 that affect the labeling, manufacturing processes and safety that may affect the availability or commercial potential of any candidate product, including the possibility that Vaxart candidate products will not be approved by the FDA or non-US regulatory authorities ; that, even if approved by the FDA or non-US regulatory authorities, Vaxart’s candidate products may not gain wide acceptance in the market; that a Vaxart employee cannot reach development and commercial milestones; that Vaxart or its partners may experience manufacturing problems and delays due to events within or outside the control of Vaxart or its partners, including the recent outbreak of COVID-19; difficulties in production, particularly in increasing initial production, including difficulties with production costs and yields, quality control, including stability of the candidate product and quality assurance tests, shortage of qualified personnel or essential raw materials and compliance with standards strictly enforced federal and state laws, and foreign regulations; that Vaxart may not be able to obtain, maintain and enforce the necessary patent and other intellectual property protections; that Vaxart’s capital resources may be inadequate; Vaxart’s ability to raise sufficient capital to finance its operations on terms acceptable to Vaxart, if applicable; the impact of government health 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 any forward-looking statements, except as required by law.

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