- Both vaccine candidates induced robust immune responses
across all antigens tested
- No new safety signals were observed and both vaccine
candidates were well tolerated consistent with past trials
- Novavax continues to pursue partnering opportunities to
advance further development of these programs
GAITHERSBURG, Md., June 11,
2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq:
NVAX) today announced results of the initial cohort of its
COVID-19-Influenza Combination (CIC) and stand-alone trivalent
hemagglutinin nanoparticle seasonal influenza (tNIV) Phase 3
trial that showed both the CIC and flu vaccine candidates induced
immune responses similar to licensed comparators
Nuvaxovid® and Fluzone HD, respectively. This cohort was
designed to provide descriptive data on three flu
strains (H1N1, H3N2, B) and SARS-CoV-2 (COVID-19) to inform a
future registrational Phase 3 program.
"Both our combination and stand-alone flu vaccine candidates
induced robust immune responses and were well tolerated," said
Ruxandra Draghia-Akli, MD, PhD,
Executive Vice President and Head of Research and Development,
Novavax. "This data set adds to findings from our Phase 2
trial and will help inform discussions with potential
partners."
Both stand-alone flu and CIC vaccine candidates induced robust
immune responses to the vaccine strains (2.4-5.7-fold over
baseline). Both vaccine candidates were well tolerated and saw
reactogenicity comparable to authorized comparators. Nearly all
(>98%) solicited adverse events were mild or moderate in
severity.
This descriptive trial was designed to evaluate the safety
and immunogenicity of the CIC and stand-alone flu vaccine
candidates compared to Nuvaxovid and Fluzone HD in
approximately 2,000 adults aged 65 and older. This trial was
not adequately powered to demonstrate statistical significance.
These results build on previous Phase 2 data.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) tackles
some of the world's most pressing health challenges with its
scientific expertise in vaccines and its proven technology
platform, including protein-based nanoparticles and its
Matrix-M® adjuvant. The Company's growth strategy seeks
to optimize its existing partnerships and expand access to its
proven technology platform via research and development innovation,
organic portfolio expansion in infectious disease and beyond, and
forging new partnerships and collaborations with other companies.
Please visit novavax.com and LinkedIn for more
information.
Forward-Looking Statements
Statements herein relating to the future of Novavax, its operating
plans and prospects, its partnerships, and the potential for its
CIC and stand-alone influenza vaccine to be used with a partner in
a registrational Phase 3 program, 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 pursuing additional partnership
opportunities; challenges satisfying, alone or together with
partners, various safety, efficacy, and product characterization
requirements, including those related to process qualification,
assay validation and stability testing, necessary to satisfy
applicable regulatory authorities; challenges or delays in
conducting clinical trials or studies for its product candidates;
challenges or delays in obtaining regulatory authorization for its
product candidates, including for future COVID-19 variant strain
changes, its CIC vaccine candidate, its stand-alone influenza
vaccine candidate or other product candidates; manufacturing,
distribution or export delays or challenges; Novavax's substantial
dependence on Serum Institute of India Pvt. Ltd. and Serum Life
Sciences Limited for co-formulation and filling Novavax's COVID-19
vaccine and the impact of any delays or disruptions in their
operations; difficulty obtaining scarce raw materials and supplies
including for its proprietary adjuvant; resource constraints,
including human capital and manufacturing capacity; constraints on
Novavax's ability to pursue planned regulatory pathways, alone or
with partners; challenges in implementing its global restructuring
and cost reduction plan; challenges in obtaining commercial
adoption and market acceptance of its updated COVID-19 vaccine or
any COVID-19 variant strain containing formulation, or for its CIC
vaccine candidate and stand-alone influenza vaccine candidate or
other product candidates; challenges meeting contractual
requirements under agreements with multiple commercial,
governmental, and other entities, including requirements to deliver
doses that may require Novavax to refund portions of upfront and
other payments previously received or result in reduced future
payments pursuant to such agreements and challenges in amending or
terminating such agreements; challenges related to the seasonality
of vaccinations against COVID-19; challenges related to the demand
for vaccinations against COVID-19 or influenza; challenges in
identifying and successfully pursuing innovation expansion
opportunities; Novavax's expectations as to expenses and cash needs
may prove not to be correct for reasons such as changes in plans or
actual events being different than its assumptions; 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's Annual Report on Form 10-K for
the year ended December 31, 2024, 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
Luis Sanay, CFA
240-268-2022
ir@novavax.com
Media
Giovanna Chandler
202-709-5563
media@novavax.com
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SOURCE Novavax, Inc.
