- Novavax's JN.1 COVID-19 vaccine is active against current
circulating strains, including KP.2 and KP.3
GAITHERSBURG, Md., June 24,
2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a
global company advancing protein-based vaccines with its Matrix-M™
adjuvant, today announced that it has filed for a type II variation
of existing Marketing Authorization with the European Medicines
Agency (EMA) for its JN.1 COVID-19 vaccine (NVX-CoV2705) for
individuals aged 12 and older. The submission is in line with
guidance from EMA and the World Health Organization to target
the JN.1 lineage this fall.1,2
"Novavax is working closely with European markets seeking to
offer a protein-based alternative to mRNA this fall for COVID-19
vaccination," said John C. Jacobs,
President and Chief Executive Officer, Novavax. "Our updated
COVID-19 vaccine is active against current circulating strains,
including KP.2 and KP.3."
Nonclinical data have demonstrated that Novavax's JN.1 COVID-19
vaccine induces broad neutralization responses to JN.1 lineage
viruses, including those containing the F456L and R346T mutations,
and to "FLiRT" and "FLuQE" variants.2-4 Novavax's
vaccine also produces conserved polyfunctional, Th1-biased CD4+ T
cell responses to a range of JN.1 lineage variants.2
Novavax's JN.1 COVID-19 vaccine targets the "parent strain" of KP.2
and KP.3.2
Novavax intends to have its vaccine in unit-dose vials available
for distribution in the European Union for immediate release
post-approval. Novavax has also filed with the U.S. Food and
Drug Administration (FDA) and is working with other regulatory
authorities globally on authorization or approval of its JN.1
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. 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 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 EMA or FDA recommendations, the
intention to be ready to deliver 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
- 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.
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SOURCE Novavax, Inc.