- Novavax's updated protein-based non-mRNA COVID-19 vaccine
will be available in Canada for
individuals aged 12 and older in the coming days
GAITHERSBURG, Md., Dec. 5, 2023
/CNW/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing
protein-based vaccines with its Matrix-M™ adjuvant,
today announced that Health Canada has granted expanded
authorization for Nuvaxovid™ XBB.1.5 Vaccine (Recombinant protein,
Adjuvanted) (NVX-CoV2601) for active immunization to prevent
COVID-19 caused by SARS-CoV-2 in individuals aged 12 and
older. The Public Health Agency of Canada's National Advisory Committee on
Immunization recommended XBB COVID-19 vaccines that target more
recent, immune-evasive variants of the virus.1
"Today's expanded authorization will support the Canadian
government's strong commitment to provide its citizens with
effective options, such as our protein-based non-mRNA vaccine, in
the campaign against currently circulating COVID-19 variants," said
John C. Jacobs, President and Chief
Executive Officer, Novavax. "We look forward to helping to
protect Canadians in time for the upcoming holiday season and,
pending vaccine batch release, have doses in market for access
across the country."
The expanded authorization was based on non-clinical
data showing that Novavax's COVID-19 vaccine induced
functional immune responses against XBB.1.5, XBB.1.16 and XBB.2.3
variants. Additional non-clinical data demonstrated that Novavax's
vaccine induced neutralizing antibody responses to subvariants
BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6 as well as 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.2,3
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.
Novavax's updated COVID-19 vaccine is also authorized in the
U.S., the European Union and by the WHO, and is under
review in other markets.
Trade Name in the U.S.
The trade name
Nuvaxovid™ has not been approved by the U.S. Food and
Drug Administration.
About Nuvaxovid™ XBB.1.5 2023-2024 Formula
(NVX-CoV2601)
NVX-CoV2601 is an updated version of
Novavax's prototype COVID-19 vaccine (NVX-CoV2373) formulated to
target the Omicron XBB.1.5 subvariant. It 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 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 the availability of its updated XBB version of its
Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula)
(NVX-CoV2601) and the timing of vaccine batch release, delivery,
and distribution of its vaccine 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; 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 filling and the impact of any delays or disruptions in their
operations on the delivery of customer orders; challenges in
obtaining commercial adoption of our updated protein-based non-mRNA
XBB COVID-19 vaccine, NVX-CoV2373 or any COVID-19 variant
strain-containing formulation; 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'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
- Public Health Agency of Canada. An Advisory Committee Statement (ACS)
National Advisory Committee on Immunization (NACI) – Guidance on
the use of COVID-19 vaccines in the fall of 2023. July 11, 2023.
https://www.canada.ca/content/dam/phac-aspc/documents/services/publications/vaccines-immunization/national-advisory-committee-immunization-guidance-use-covid-19-vaccines-fall-2023/statement.pdf.
- 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.
- Wherry EJ, Barouch DH. T cell immunity to COVID-19 vaccines.
Science. 2022;377(6608):821-822.
doi:10.1126/science.add2897.
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SOURCE NOVAVAX, INC