- New Phase 3 PREVENT-19 data reinforce the Novavax COVID-19
vaccine's benefits as an adult booster in both younger and older
adults, and with varying time intervals for the booster
dose
- Phase 1/2 trial data show COVID-19-Influenza Combination
vaccine candidate induced antibody and T-cell responses against
SARS-CoV-2 and homologous and heterologous influenza
strains
GAITHERSBURG, Md., Oct. 20,
2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq:
NVAX), a biotechnology company dedicated to developing and
commercializing next-generation vaccines for serious infectious
diseases, will present new data from the Phase 3 PREVENT-19 trial
evaluating its protein-based COVID-19 vaccine (NVX-CoV2373) as a
booster in adults, including a breakdown by age and by booster dose
interval (8 and 11 months) at IDWeek 2022, October 20 to 22, 2022. Novavax will also present
data from the first Phase 1/2 COVID-19-Influenza Combination
(CIC) vaccine dose-finding trial.
"At IDWeek 2022, we will share additional insights on the
Novavax COVID-19 vaccine as an adult booster dose and show how we
are further developing our portfolio with data from the first
COVID-19-Influenza Combination vaccine candidate," said
Gregory Glenn, M.D., President,
Research and Development, Novavax.
New data will be presented from the PREVENT-19 trial, including
an evaluation of the effect of age (18 to 64 years, and ≥ 65 years)
and schedule on boosted immunologic response. These data showed
that following a booster dose, anti-spike antibody and neutralizing
responses for the original prototype strain increased significantly
relative to pre-boost levels, regardless of the dosing regimen or
age group across adult participants. Antibody responses against the
more recent Omicron variants, including BA.1, BA.2, and BA.5,
approximated those associated with protection in the PREVENT-19
trial. These data will be presented in addition to data shared
earlier in the month.
In addition to the data presentations, Novavax is sponsoring a
Learning Lounge session, "Using Behavioral Science to Help
Understand Vaccine Hesitancy." As a Mentorship Champion of the
Infectious Diseases Society of America (IDSA) Foundation, Novavax
will also host the Mentorship Luncheon at IDWeek.
"Having a mentoring relationship is one of the main reasons that
medical students and residents choose to pursue a career path in
infectious diseases," said Stephen E.
Peeler, IDSA Foundation, Executive Director. "That is why we
are grateful to Novavax for their generous commitment to our
growing mentorship program."
Novavax presentations during IDWeek 2022:
Author
|
Presentation
title
|
Details
|
Áñez, G
|
Safety and
Immunogenicity of a
Booster Dose of Novavax
COVID-19 Vaccine,
Adjuvanted (NVX-
CoV2373) in Adults from
the PREVENT-19 Trial in
the United States
|
Late-breaking Oral
Presentation
October 20,
2022
1:45 - 3:00pm
(EDT)
|
Shinde, V
|
Safety and
Immunogenicity of COVID
Influenza Combination
Vaccine
|
Poster
Presentation
October 22,
2022
12:15 – 1:30pm
(EDT)
|
Graves, C
Wolynn, T
Wright, W
|
Using Behavioral
Science
to Help Understand
Vaccine Hesitancy,
Presented by Novavax
|
Learning Lounge Session
October 22,
2022
10:15 – 11:00am
(EDT)
|
For more information, visit the IDWeek 2022 website.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a
biotechnology company that promotes improved health globally
through the discovery, development, and commercialization of
innovative vaccines to prevent serious infectious diseases. The
company's proprietary recombinant technology platform harnesses the
power and speed of genetic engineering to efficiently produce
highly immunogenic nanoparticles designed to address urgent global
health needs. The Novavax COVID-19 vaccine has received
authorization from multiple regulatory authorities globally,
including the U.S. Food and Drug Administration, the European
Commission, and the World Health Organization. The vaccine is
currently under review by multiple regulatory agencies worldwide,
including for additional populations and indications such as
adolescents and as a booster. In addition to its COVID-19 vaccine,
Novavax is also currently evaluating its CIC vaccine candidate in a
Phase 1/2 clinical trial, its quadrivalent influenza
investigational vaccine candidate, and an Omicron strain-based
vaccine (NVX-CoV2515) as well as a bivalent format Omicron-based /
original strain-based vaccine. These vaccine candidates incorporate
Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the
immune response and stimulate high levels of neutralizing
antibodies.
For more information, visit www.novavax.com and
connect with us on LinkedIn.
Forward-Looking Statements
Statements herein relating
to the future of Novavax, its operating plans and prospects, its
partnerships, the timing of clinical trial results, the
ongoing development of NVX-CoV2373, including NVX-CoV2515, a
bivalent Omicron-based / original strain based vaccine, the CIC
and the quadrivalent influenza investigational candidates the
scope, timing and outcome of future regulatory filings and actions,
including additional worldwide authorizations of NVX-CoV2373
for use in adults and adolescents, and as a booster, the potential
impact and reach of Novavax and NVX-CoV2373 in addressing vaccine
access, controlling the pandemic and protecting populations, the
efficacy, safety intended utilization, and the expected
administration of NVX-CoV2373 are forward-looking statements.
Novavax cautions that these forward-looking statements are subject
to numerous risks and uncertainties that could cause actual results
to differ materially from those expressed or implied by such
statements. These risks and uncertainties include, without
limitation, challenges satisfying, alone or together with partners,
various safety, efficacy, and product characterization
requirements, including those related to process qualification and
assay validation, necessary to satisfy applicable regulatory
authorities; difficulty obtaining scarce raw materials and
supplies; resource constraints, including human capital and
manufacturing capacity, on the ability of Novavax to pursue planned
regulatory pathways; unanticipated challenges or delays in
conducting clinical trials; challenges meeting contractual
requirements under agreements with multiple commercial,
governmental, and other entities; and those other risk factors
identified in the "Risk Factors" and "Management's Discussion and
Analysis of Financial Condition and Results of Operations" sections
of Novavax' Annual Report on Form 10-K for the year ended
December 31, 2021 and subsequent
Quarterly Reports on Form 10-Q, as filed with the Securities and
Exchange Commission (SEC). We caution investors not to place
considerable reliance on forward-looking statements contained in
this press release. You are encouraged to read our filings with the
SEC, available at www.sec.gov and www.novavax.com,
for a discussion of these and other risks and uncertainties. The
forward-looking statements in this press release speak only as of
the date of this document, and we undertake no obligation to update
or revise any of the statements. Our business is subject to
substantial risks and uncertainties, including those referenced
above. Investors, potential investors, and others should give
careful consideration to these risks and uncertainties.
Contacts:
Investors
Erika Schultz | 240-268-2022
ir@novavax.com
Media
Ali Chartan or Giovanna Chandler | 202-709-5563
media@novavax.com
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SOURCE Novavax, Inc.