Vaxart announces publication of peer-reviewed journal article demonstrating potential clinical and economic value of Nasdaq Norovirus vaccine: VXRT

• A computer simulation model showed that a norovirus vaccine that costs as much as $ 1,300 can still save costs in children under 5
• The model also showed that a $ 100 norovirus vaccine could save costs in older adults

SOUTH SAN FRANCISCO, Calif., January 27, 2021 (GLOBE NEWSWIRE) – Vaxart, Inc., (NASDAQ: VXRT), a clinical-grade biotechnology company developing tablet-administered oral vaccines rather than injectables , including its Phase 2 Norovirus Completion Program, announced today the economic results of health care published in the American Journal of Preventive Medicine. Computer modeling simulating norovirus infection or transmission in a community setting has shown that norovirus vaccination may be able to avoid symbolic issues and achieve cost savings. The study found, among other things, that norovirus vaccination can reduce the economic burden of the virus and is cost-effective even when it costs $ 500 per course when vaccinating minors 5 and older adults, much higher value than previously thought. The manuscript is entitled “Clinical and Economic Value of the Norovirus Vaccination in a Community Setting”. here.

“This study highlights that norovirus is highly contagious and can lead to loss of school and work, with potential loss of productivity,” said Bruce Y. Lee, MD, MBA, lead author of the study, Professor of Health Policy and Governance at New York City University (CUNY), and executive director of Public Health Information Research, Computing, and Functionality (PHICOR). “Pre-school age populations can be particularly vulnerable to heavy social mixing leading to increased spread of the virus, and the older adult population may be susceptible to more serious disease and beyond. there will be high levels of patient and hospital visits. ”

The PHICOR team developed a computer simulation model of different segments of the U.S. population and norovirus distribution to better understand the vaccine value of children <5 and ≥65-year-old adults against norovirus. The model simulated norovirus transmission, subsequent clinical outcomes (e.g., symptoms, hospitalization, death) and associated costs (e.g., direct medical, loss of productivity), as well as vaccination.

Key Results:

• Even with 25% vaccine efficacy and 10% vaccine coverage, norovirus vaccination could reduce symptomatic cases in a community by 7.7% relative.
• In preschool-aged children, the cost of the vaccine could be as high as $ 1,300 and provide cost savings and as high as $ 1,600 while still being cost-effective.
• Vaccination of children <5 years had a significantly higher benefit compared to older adult vaccines in that children under 5 years of age contribute significantly to the spread of norovirus. However, vaccination of older adults can be cost effective or cost saving.
• In older adults, the cost of the vaccine can be as high as $ 100 and still provide cost savings and as high as $ 165 and still be cost – effective.

“These important decisions confirm our view of the potential clinical and economic benefits of norovirus vaccines,” said Andrei Floroiu, Vaxart chief executive. “The significantly higher cost levels from this analysis significantly increase our perception of the value-creating potential of our oral norovirus tablet vaccine. We are very excited to advance our norovirus program with the three clinical trials we plan to begin in 2021 and look forward to confirming the efficacy and tolerance profile suggested by the data. very encouraging from our previous Stage 1 inspections. “

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

Thug Vaxart, Inc. support for the PHICOR research team.

About PHICOR

Since 2007, the PHICOR team of scientists and medical, public health and communications experts has been studying and developing computer systems and procedures, methods (e.g., artificial intelligence (AI), machine learning, science data), models, and tools to help a wide range of decision-makers address a number of public health and health issues. PHICOR helps local, state and federal governments deal with infectious disease threats, ranging from influenza to Ebola to Zika to the widespread COVID-19 pandemic. For example, during the 2009 H1N1 flu pandemic, the PHICOR team was rooted in the U.S. 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).

Mu Vaxart

Vaxart is a clinical-grade biotechnology company developing a range of oral oral vaccines based on its proprietary delivery platform. Vaxart surveillance vaccines are designed to be administered using records that can be stored and disposed of without cooling and eliminate the risk of needlestick injury. Vaxart believes its platform-based vaccine delivery platform is fitted to deliver recombinant vaccines, positioning the company to develop oral versions of vaccines currently marketed and to re-vaccinate design a petition for new tokens. Its current development programs include schedule vaccines designed to protect against coronavirus, norovirus, seasonal flu and respiratory syncytial virus (RSV), as well as therapeutic vaccines for human papillomavirus (HPV). ), Vaxart’s first sign of immuno-oncology. Vaxart has filed extensive domestic and international patents covering its proprietary technology and formulations for oral vaccines using adenovirus and TLR3 agonists.

Note on forward – looking statements

This press release contains forward-looking statements that include major risks and uncertainties. All statements, as well as statements of historical facts, included in this press release contain Vaxart’s strategy, expectations, plans and objectives, results from preclinical and clinical trials, commercial agreements and licenses , beliefs and regulatory expectations of the forward-looking statements. These positive statements may be accompanied by words such as “should,” “believe,” “could,” “ability,” “will,” “expectation,” “plan” and other similar words and conditions sense. Examples of such statements include, but are not limited to, statements related to the potential clinical and economic value of norovirus vaccines in a community setting; Vaxart’s ability to develop and commercialize its vaccine candidates and preclinical or clinical results and test data; What Vaxart expects in terms of the benefits it believes its oral vaccination platform could offer over injectable options; and Vaxart’s expectations regarding the effectiveness of its products or product candidates. Vaxart may not actually fulfill the plans, fulfill the intentions or meet the expectations or projections published in the forward-looking statements and you should not rely on very much in line with these positive statements. Actual results or events may differ significantly from the plans, intentions, expectations and projections disclosed in the forward-looking statements. A variety of important factors that could cause real results or events could be quite different from the advanced statements that Vaxart makes, including uncertainties that are inherent in research and development, including ability to meet expected clinical points, start and / or end dates for clinical trials or preclinical studies, regulatory submission dates, regulatory approval dates and / or heads launch date, as well as the potential of unfavorable new clinical data and further analysis of existing clinical data; the risk of clinical trial and preclinical examination data being subject to various interpretations and assessments by regulatory authorities; whether regulatory authorities are satisfied with the design and results of the clinical trials; decisions by regulatory authorities affecting labeling, manufacturing processes, and safety that may affect the accessibility or commercial viability of any product applicant, including the possibility that Vaxart product applicants may not be approved by the FDA or regulatory authorities outside the United States; , even if approved by the FDA or regulatory authorities outside the U.S., Vaxart product applicants may not achieve general market acceptance; a Vaxart colleague may not reach development and commercial milestones; Vaxart or its partners may have manufacturing issues and delays as a result of events within, or outside the control of, Vaxart or its partners, including the revolution from recent release of COVID-19; difficulties in production, especially in increasing original production, including problems with production and production costs, quality control, including product candidate stability and quality assurance testing, staff shortages with certification or main raw materials, and compliance with federal, state strict, state. , and foreign regulations; Vaxart may not be able to obtain, maintain and enforce patent protection and other necessary intellectual property; Vaxart’s capital resources may be inadequate; Vaxart’s ability to raise sufficient capital to fund its activities 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 accepts no responsibility for updating forward-looking statements, except as required by law.

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