- Doses of Novavax's 2024-2025 Formula COVID-19 vaccine now
available at thousands of locations nationwide
- Novavax's updated vaccine is the only protein-based option
available in the U.S. this fall for individuals aged 12 and
older
GAITHERSBURG, Md., Sept. 13,
2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq:
NVAX), a global company advancing protein-based vaccines with its
Matrix-M™ adjuvant, today announced that doses of the Novavax
COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705) to
prevent COVID-19 in individuals aged 12 and older are in stock
at major pharmacy retailers across the U.S.
Through agreements with pharmacies, Novavax's updated vaccine is
expected to be widely available in locations including, but not
limited to, CVS Pharmacy, Rite Aid, Walgreens, Costco, Publix,
Sam's Club, Kroger, Meijer, hundreds of other regional grocers and
thousands of independent pharmacies. Novavax's updated vaccine
received Emergency Use Authorization (EUA) on August 30, 2024 from the U.S. Food and Drug
Administration (FDA).
"We have worked hard to ensure greater ease of access for
consumers this vaccination season by more than doubling the number
of locations stocking our vaccine compared to last year and
offering a more convenient presentation in a pre-filled syringe,"
said John C. Jacobs, President and
Chief Executive Officer, Novavax. "Our vaccine targets JN.1, the
'parent strain' of those currently circulating, and our vaccine has
demonstrated cross-reactivity against JN.1 lineage viruses,
including KP.2.3, KP.3, KP.3.1.1 and LB.1.1"
Novavax's vaccine is the only protein-based option available in
the U.S. this fall and is in pre-filled syringe presentation. Doses
of Novavax's vaccine can be located on
us.novavaxcovidvaccine.com.
AUTHORIZED USE IN THE U.S.
Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) has not
been approved or licensed by the FDA but has been authorized for
emergency use by the FDA, under an EUA to prevent Coronavirus
Disease 2019 (COVID-19) for use in individuals 12 years of age and
older. Refer to the full Fact Sheet for information about
the Novavax COVID-19 Vaccine, Adjuvanted.
The EUA of this product will remain in effect for the duration
of the COVID-19 EUA declaration justifying emergency use of the
product, unless the authorization is revoked sooner.
VACCINE AUTHORIZATION (U.S.)
Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) is
indicated for active immunization to prevent coronavirus disease
2019 (COVID-19) caused by severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and
older.
IMPORTANT SAFETY INFORMATION
Contraindications
- Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to
individuals with a known history of a severe allergic reaction
(e.g., anaphylaxis) to any component of the Novavax COVID-19
Vaccine, Adjuvanted.
Warnings and Precautions
- Management of Acute Allergic Reactions: Appropriate
medical treatment must be immediately available to manage potential
anaphylactic reactions following administration of the Novavax
COVID-19 Vaccine, Adjuvanted.
- Myocarditis and Pericarditis: Clinical trials data
provide evidence for increased risks of myocarditis and
pericarditis following administration of Novavax COVID-19 Vaccine,
Adjuvanted.
- Syncope (fainting): may occur in association with
administration of injectable vaccines. Procedures should be in
place to avoid injury from fainting.
- Altered Immunocompetence: Immunocompromised persons,
including individuals receiving immunosuppressant therapy, may have
a diminished immune response to the Novavax COVID-19 Vaccine,
Adjuvanted.
- Limitations of Vaccine Effectiveness: The Novavax
COVID-19 Vaccine, Adjuvanted may not protect all vaccine
recipients.
Adverse Reactions
Solicited adverse reactions
included: Injection site pain/tenderness, fatigue/malaise, muscle
pain, headache, joint pain, nausea/vomiting, injection site
redness, injection site swelling and fever.
Reporting Adverse Events and Vaccine Administration
Errors
The vaccination provider is responsible for mandatory reporting
of certain adverse events to the Vaccine Adverse Event Reporting
System (VAERS) online at https://vaers.hhs.gov/reportevent.html, by
calling 1-800-822-7967 or send an email to info@vaers.org.
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.2 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 the plan to be ready to deliver
a JN.1 protein-based non-mRNA COVID-19 vaccine, and the extent
of the availability of its vaccine at various locations, 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;
retail customer stocking strategies; warehouse order fulfilment
execution, 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. 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
- 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.
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SOURCE Novavax, Inc.