Vaxart, Inc., (NASDAQ: VXRT), a clinical-stage biotechnology
company developing oral recombinant vaccines that are administered
by tablet rather than by injection, and has a Phase 2 ready
norovirus vaccine program, today announced that a new study was
published in the Journal of Infectious Diseases today, which
concluded that norovirus gastroenteritis costs the United States an
estimated median of $10.6 billion each year. In particular,
norovirus outbreaks that are widely publicized are only the tip of
the iceberg and constitute less than 10% of all the costs. The vast
majority of the costs come from sporadic cases in the community.
These results came from a computational model
that simulated the course of a norovirus infection and quantified
its clinical and economic burden in the United States. Each person
with a norovirus infection had probabilities of seeking medical
care (e.g., outpatient or ambulatory care visits), hospitalization,
and death. Costs included care required (e.g., hospitalization) and
missed days of school and work.
“Although norovirus tends to get highlighted by
the news media during outbreaks, it’s the cases of norovirus in the
community that are contributing to the bulk of the costs,”
commented Bruce Y. Lee, MD, MBA, senior author of the study,
Professor of Health Policy and Management at the City University of
New York (CUNY), and executive director of the Public Health
Informatics, Computational, and Operations Research (PHICOR). “As
our study shows, the costs of these individual cases can add up
substantially. This gives a sense of how much an effective vaccine
could save employers and the economy.”
A previous study estimated that norovirus cost
society $60.3 billion worldwide each year and subdivided this
estimate by the respective World Health Organization region, with
the Americas having the highest cost at $23.5 billion.
Even though norovirus infections occur
year-round, the results from the new study show that over 50% of
the total costs are incurred during winter. This suggests that any
policies or interventions to prevent norovirus should be
implemented before or escalated during the winter months.
In addition, productivity losses accounted for
89% of total costs, offering a sense of how much norovirus may be
costing employers. Dr. Lee added, “Since our study demonstrated
that the majority of norovirus-related costs may be productivity
losses, claims data and other measures of medical costs may
substantially underestimate the total cost of norovirus.”
Vaxart, Inc. supported the PHICOR’s research
team to model the course of a norovirus infection using empirical
data. The results from this study provide a vast array of analyzed
and raw data to underpin the medical need and advance the company’s
development of its tableted norovirus vaccine.
About PHICOR
Since 2007, the PHICOR (Public Health
Informatics, Computational, and Operation Research) team has been
developing and utilizing computer models to help a wide range
of organizations and local, state, and federal governments respond
to infectious disease threats, ranging from the flu
to Ebola to Zika. For example, during the 2009 H1N1 flu pandemic,
the PHICOR team was embedded 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).
About Vaxart
Vaxart is a clinical-stage biotechnology company
focused on developing oral tablet vaccines designed to generate
mucosal and systemic immune responses that protect against a wide
range of infectious diseases and has the potential to provide
sterilizing immunity for diseases such as COVID-19. Vaxart believes
that a room temperature stable tablet vaccine is easier to
distribute, store and administer than injectable vaccines and may
provide significantly faster response to a pandemic than injectable
vaccines, enabling a greater portion of the population to be
protected. Vaxart’s development programs include oral tablet
vaccines that are designed to protect against coronavirus,
norovirus, seasonal influenza and respiratory syncytial virus
(RSV), as well as a therapeutic vaccine for human papillomavirus
(HPV). For more information, please visit www.vaxart.com.
Forward-Looking Statements
This press release contains forward-looking
statements that involve substantial risks and uncertainties. All
statements, other than statements of historical facts, included in
this press release regarding Vaxart’s strategy, prospects, plans
and objectives, results from pre-clinical and clinical trials,
commercialization agreements and licenses, beliefs and expectations
of management are forward-looking statements. These forward-looking
statements may be accompanied by such words 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 relating to potential policies
or interventions to prevent norovirus. 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 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 the forward-looking statements that Vaxart makes, including
uncertainties inherent in research and development, including the
ability to meet anticipated clinical endpoints, commencement and/or
completion dates for clinical trials, regulatory submission dates,
regulatory approval dates and/or launch dates, as well as the
possibility of unfavorable new clinical data and further analyses
of existing clinical data; the risk that clinical trial data are
subject to differing interpretations and assessments by regulatory
authorities; whether regulatory authorities will be satisfied with
the design of and results from the 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-U.S. regulatory authorities; that, even if approved by the FDA
or non-U.S. regulatory authorities, Vaxart’s product candidates may
not achieve broad market acceptance; that a Vaxart collaborator may
not attain development and commercial milestones; that Vaxart may
experience manufacturing issues and delays due to events within, or
outside of, Vaxart’s control, including the recent outbreak of
COVID-19; that Vaxart may not be able to obtain, maintain and
enforce necessary patent and other intellectual property
protection; that Vaxart’s capital resources may be inadequate;
Vaxart’s ability to obtain sufficient capital to fund its
operations on terms acceptable to Vaxart, if at all; the impact of
government healthcare 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
does not assume any obligation to update any forward-looking
statements, except as required by law.
Contacts
Brant Biehn Vaxart, Inc. 650 550 3500
IR@vaxart.com
Bruce Y. Lee, MD, MBAHealth Policy and
Management at the City University of New York
(CUNY)Public Health Informatics, Computational, and
Operations Research (PHICOR) BruceLeeMDMBA@gmail.com
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