- Novavax's COVID-19 vaccine would be the only protein-based
option available in Canada, if
authorized
- Novavax's filing is aligned with NACI, U.S. FDA, EMA and WHO
recommendations on vaccine composition
GAITHERSBURG, Md., July 2, 2024
/CNW/ -- Novavax, Inc. (Nasdaq: NVAX), a global company
advancing protein-based vaccines with its Matrix-M™
adjuvant, announced that it has filed for authorization with
Health Canada for its 2024-2025 Formula COVID-19 vaccine
(NVX-CoV2705) for individuals aged 12 and older. The submission
follows the National Advisory Committee on Immunization (NACI)
guidance to use the latest selected strain and the guidance from
the U.S. Food and Drug Administration (FDA), European Medicines
Agency (EMA) and World Health Organization
(WHO).1-4
"Novavax is working closely with Health Canada to have an
updated protein-based COVID-19 vaccine option approved for all
eligible Canadians this fall," said John C.
Jacobs, President and Chief Executive Officer, Novavax. "Our
updated COVID-19 vaccine is active against JN.1, KP.2 and KP.3, in
addition to other JN.1 sublineage strains."
Nonclinical data have demonstrated that Novavax's updated
COVID-19 vaccine induces broad neutralization responses to JN.1
lineage viruses, including those containing the F456L and R346T
mutations, to "FLiRT" variants and to "FLuQE" variants such as
KP.3.4-6 Novavax's vaccine also produces conserved
polyfunctional, Th1-biased CD4+ T cell responses to a wide range of
JN.1 lineage variants.4 These responses indicate that
Novavax's vaccine technology induces broadly neutralizing responses
against multiple variant strains, including responses to
circulating forward drift variants.
Novavax intends to have its vaccine available in Canada for immediate release
post-authorization, should public health programs choose to provide
this option. Novavax has filed with the U.S. FDA and EMA,
and is working with other regulatory authorities globally on
authorization or approval of its updated COVID-19 vaccine.
About the Novavax COVID-19 2024-2025 Formula
(NVX-CoV2705)
NVX-CoV2705 is an updated version of Novavax's
prototype COVID-19 vaccine (NVX-CoV2373) formulated to target the
JN.1 variant. 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.7 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. The Company's
portfolio includes its COVID-19 vaccine and its pipeline includes a
vaccine for influenza and COVID-19 and influenza combined. In
addition, Novavax's adjuvant is included in the University of Oxford and Serum Institute of
India's R21/Matrix-M malaria
vaccine. 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
immunogenic response of its vaccine technology against variant
strains and the scope, timing and outcome of future regulatory
filings and actions, including any Health Canada, EMA or FDA
recommendations, the timing of its delivery for a JN.1
protein-based COVID-19 vaccine this fall, 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, antigenic drift or shift in the SARS-CoV2 spike
protein, 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 a
JN.1 protein-based COVID-19 vaccine 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;
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,
2023, 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
Giovanna Chandler
240-720-7804
media@novavax.com
References
- Public Health Agency of Canada. Guidance on the use of COVID-19
vaccines during the fall of 2024. May 5,
2024. Available
at: https://www.canada.ca/en/public-health/services/publications/vaccines-immunization/national-advisory-committee-immunization-guidance-covid-19-vaccines-fall-2024
- U.S. Food and Drug Administration. Updated COVID-19 Vaccines
for Use in the United States
Beginning in Fall 2024. June 13,
2024. Available at:
https://www.fda.gov/vaccines-blood-biologics/updated-covid-19-vaccines-use-united-states-beginning-fall-2024
- European Medicines Agency. ETF recommends updating
COVID-19 vaccines to target new JN.1 variant. April 30, 2024. Available
at: https://www.ema.europa.eu/en/news/etf-recommends-updating-covid-19-vaccines-target-new-jn1-variant
- World Health Organization. Statement on the antigen composition
of COVID-19 vaccines. April 26, 2024.
Available
at: https://www.who.int/news/item/26-04-2024-statement-on-the-antigen-composition-of-covid-19-vaccines
- U.S. Centers for Disease Control and Prevention. Variant
Proportions [Data set]. In COVID Data Tracker. 2024. Available at:
https://covid.cdc.gov/covid-data-tracker/#variant-proportions
- Focosi D, Spezia PG, Gueli F, Maggi F. The Era of the FLips:
How Spike Mutations L455F and F456L (and A475V) Are Shaping
SARS-CoV-2 Evolution. Viruses. 2023;16(1):3. Published 2023
Dec 19. doi:10.3390/v16010003.
- Stertman L, Palm AE, Zarnegar B, et al. The Matrix-M™ adjuvant:
A critical component of vaccines for the 21st century. Hum
Vaccin Immunother. 2023;19(1):2189885.
doi:10.1080/21645515.2023.2189885.
SOURCE Novavax, Inc.