GAITHERSBURG, Md., Oct. 18,
2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq:
NVAX), a global company advancing protein-based vaccines with its
Matrix-M™ adjuvant, today announced that
Singapore's Health Sciences
Authority (HSA) has granted full approval for Novavax's prototype
COVID-19 vaccine Nuvaxovid™ (NVX-CoV2373) for active immunization
to prevent COVID-19 in individuals aged 12 and older. The
Singapore Ministry of Health has included Nuvaxovid in the National
Vaccination Programme as a protein-based non-mRNA option for
COVID-19 prevention.
"Today's full approval of our prototype vaccine will enable us
to file for approval of our updated protein-based non-mRNA
COVID-19 vaccine in the coming weeks," said John C. Jacobs, President and Chief Executive
Officer, Novavax. "We continue to work closely with HSA to ensure a
protein-based vaccine is part of the portfolio for Singaporeans to
protect themselves against COVID-19."
For the 2023-2024 vaccination season, Novavax has developed
an updated COVID-19 vaccine which has been authorized for use in
the U.S. The updated vaccine induces neutralizing antibody
responses against currently circulating variants XBB.1.5, XBB.1.16,
XBB.2.3, BA.2.86, EG.5.1, FL.1.5.1 and
XBB.1.16.6. Additional non-clinical data demonstrated that
Novavax's vaccine induced CD4+ polyfunctional cellular (T-cell)
responses against EG.5.1 and XBB.1.16.6. These data indicate
Novavax's vaccine can stimulate both arms of the immune system and
may induce a broad response against currently circulating
variants.1,2
In clinical trials, the most common adverse reactions associated
with Novavax's prototype COVID-19 vaccine (NVX-CoV2373)
included headache, nausea or vomiting, muscle pain, joint pain,
injection site tenderness, injection site pain, fatigue and
malaise.
Trade Name Use
The trade name Nuvaxovid™ has not been
approved by the U.S. Food and Drug Administration.
About Nuvaxovid™ (NVX-CoV2373)
NVX-CoV2373 is a
protein-based vaccine made by creating copies of the surface spike
protein of SARS-CoV-2 that causes COVID-19. With Novavax's unique
recombinant nanoparticle technology, the non-infectious spike
protein serves as the antigen that primes the immune system to
recognize the virus, while Novavax's Matrix-M adjuvant enhances and
broadens the immune response. The vaccine is packaged as a
ready-to-use liquid formulation and is stored at 2° to 8°C,
enabling the use of existing vaccine supply and cold chain
channels.
About the PREVENT-19 Phase 3 Trial
The PRE-fusion
protein subunit Vaccine Efficacy Novavax Trial COVID-19
(PREVENT-19) was a randomized, placebo-controlled, observer-blinded
Phase 3 trial conducted in the U.S. and Mexico to evaluate the efficacy and safety of
NVX-CoV2373 as a primary series and as a booster in adults and
adolescents to prevent SARS-CoV-2 infection. As a primary series,
the primary endpoint was the first occurrence of polymerase chain
reaction (PCR)-confirmed symptomatic (mild, moderate, or severe)
COVID-19 with onset at least seven days after the second dose in
29,960 adult participants aged 18 and older at baseline without
protocol violations prior to illness. A secondary endpoint was the
prevention of PCR-confirmed, symptomatic moderate or severe
COVID-19. Full results of the trial were published in The New
England Journal of Medicine.
About Matrix-M™ Adjuvant
When added to vaccines,
Novavax's patented saponin-based Matrix-M adjuvant enhances the
immune system response, making it broader and more durable. The
Matrix-M adjuvant stimulates the entry of antigen-presenting cells
at the injection site and enhances antigen presentation in local
lymph nodes.
About Novavax
Novavax, Inc. (Nasdaq: NVAX)
promotes improved health by discovering, developing and
commercializing innovative vaccines to help protect against serious
infectious diseases. Novavax, a global company based in
Gaithersburg, Md., U.S., offers a
differentiated vaccine platform that combines a recombinant protein
approach, innovative nanoparticle technology and Novavax's patented
Matrix-M adjuvant to enhance the immune response. Focused on the
world's most urgent health challenges, Novavax is currently
evaluating vaccines for COVID-19, influenza and COVID-19 and
influenza combined. 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, the
scope, timing and outcome of future regulatory filings and actions,
including its coordination with HSA, 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; resource constraints, including human capital and
manufacturing capacity, on the ability of Novavax to pursue planned
regulatory pathways; challenges or delays in obtaining regulatory
authorization for its product candidates, including its updated XBB
version of its COVID-19 vaccine in time for the fall 2023
vaccination season or for future COVID-19 variant strain changes;
challenges or delays in clinical trials; manufacturing,
distribution or export delays or challenges; Novavax's exclusive
dependence on Serum Institute of India Pvt. Ltd. for
co-formulation; 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, 2022 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
240-720-7804
media@novavax.com
References
- Wherry EJ, Barouch DH. T cell immunity to COVID-19
vaccines. Science. 2022;377(6608):821-822.
doi:10.1126/science.add2897.
- Markov PV, Ghafari M, Beer
M, et al. The evolution of SARS-CoV-2.
Nat Rev Microbiol. 2023;21(6):361-379.
doi:10.1038/s41579-023-00878-2.
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