- Novavax's updated JN.1 COVID-19 vaccine is
active against current circulating strains, including KP.2 and
KP.3
- Novavax's JN.1 COVID-19 vaccine would be the only
protein-based option available in the U.S.
- Novavax's filing is aligned with FDA, EMA and WHO
global recommendations on vaccine composition
- Novavax intends to have its vaccine in pre-filled
syringes available in the U.S. for immediate release
post-authorization and following recommendation by the U.S.
CDC
GAITHERSBURG,
Md., June 14, 2024
/PRNewswire/ -- Novavax, Inc.
(Nasdaq: NVAX), a global company advancing protein-based vaccines
with its Matrix-M™ adjuvant, today announced that it
has submitted an amendment to its Emergency Use Authorization to
the U.S. Food and Drug Administration (FDA) for its updated
JN.1 COVID-19 vaccine (NVX-CoV2705) for
individuals aged 12 and older. The submission is in
line with guidance from the U.S. FDA, European
Medicines Agency (EMA) and the World Health
Organization (WHO) to target the JN.1
lineage this fall.1-3
Novavax's JN.1 vaccine has
demonstrated broad cross-neutralizing antibodies
against multiple variant strains, including KP.2 and KP.3,
indicating the potential to protect against forward drift variants.
As discussed at the recent FDA Vaccines and Related Biological
Products Advisory Committee meeting, there is a public health
benefit to target JN.1, the parent strain of the most common
currently circulating variants.
"Novavax is committed to
having a protein-based COVID-19 option available at the start of
the vaccination season, which is critical because research suggests
that providing vaccine choice, along with healthcare provider
recommendations, may help improve vaccination rates,"
said John C. Jacobs,
President and Chief Executive Officer, Novavax.
Nonclinical data have
demonstrated that Novavax's JN.1 vaccine induces broad
neutralization responses to JN.1 lineage
viruses including those containing the F456L and R346T mutations,
and to "FLiRT" and "FLuQE" variants.2,4,5
Novavax's vaccine also produces conserved polyfunctional,
Th1-biased CD4+ T cell responses to a range of JN.1 lineage
variants.2 Novavax's updated JN.1 COVID-19 vaccine
targets the "parent strain" of KP.2 and
KP.3.2
Novavax intends to have doses in the U.S.
for distribution by mid-August. Upon FDA authorization and U.S.
Centers for Disease Control and Prevention (CDC) recommendation,
Novavax is preparing to promptly deliver to U.S. customers.
Novavax is also 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 FDA or CDC recommendations, the
intention to be ready to deliver a JN.1 protein-based non-mRNA
COVID-19 vaccine by mid-August, 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 its product candidates, including an JN.1
protein-based non-mRNA 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;
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,
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
- 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
- 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
- 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
- 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.