- Novavax expects pre-filled syringes will be broadly
available in thousands of locations across the U.S.
- Novavax's vaccine is the only protein-based option
available in the U.S. for use in individuals aged 12 and older to
prevent COVID-19
GAITHERSBURG, Md., Aug. 30, 2024 /PRNewswire/ -- Novavax, Inc.
(Nasdaq: NVAX), a global company advancing protein-based vaccines
with its Matrix-M™ adjuvant, today announced the Novavax
COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705) has
received Emergency Use Authorization (EUA) from the U.S. Food and
Drug Administration (FDA) for active immunization to prevent
COVID-19 in individuals aged 12 and older. Novavax's vaccine
is included in the recommendations issued by the U.S. Centers for
Disease Control and Prevention (CDC) on June
27, 2024.
Pre-filled syringes of the vaccine will be available in
thousands of locations, including retail and independent pharmacies
and regional grocers, following the Center for Biologics Evaluation
and Research release of vaccine batches.
"Today's authorization enables Novavax to launch our updated
COVID-19 vaccine in the U.S. in pre-filled syringes, and we have
worked hard to ensure consumers have access in thousands of
locations nationwide," said John C.
Jacobs, President and Chief Executive Officer, Novavax. "Our
updated vaccine targets JN.1, the 'parent strain' of currently
circulating variants, and has shown robust cross-reactivity against
JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and
LB.1."
In June, the CDC's Advisory Committee on Immunization Practices
voted unanimously in favor of a universal recommendation for the
use of 2024-2025 COVID-19 vaccines authorized under EUA or approved
by Biologics License Application in individuals aged six months and
older, regardless of specific viral strains.1 As
discussed at the June 2024 U.S. 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.2,3 Novavax filed for JN.1 in line with
guidance from the U.S. FDA, European Medicines Agency (EMA) and the
World Health Organization to target the JN.1 lineage this
fall.2,4,5
The EUA was based on non-clinical data that showed Novavax's
updated vaccine provides protection and cross-reactivity against
JN.1 and numerous JN.1 lineage viruses, including KP.2.3, KP.3,
KP.3.1.1 and LB.1.1 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.
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.3 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
COVID-19-Influenza Combination and stand-alone influenza vaccine
candidates. 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
expectation to have pre-filled syringes broadly available in
thousands of locations in the U.S., 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-CoV-2 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
- 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.
- U.S. Food and Drug Administration. Vaccines and Related
Biological Products Advisory Committee June
5, 2024 Meeting Summary Minutes. June
5, 2024. Available at:
https://www.fda.gov/media/180732/download.
- U.S. Centers for Disease Control and Prevention. CDC Recommends
Updated 2024-2025 COVID-19 and Flu Vaccines for Fall/Winter Virus
Season. June 27, 2024. Available at:
https://www.cdc.gov/media/releases/2024/s-t0627-vaccine-recommendations.html.
- European Medicines Agency. EMA confirms its recommendation
to update the antigenic composition of authorised COVID-19 vaccines
for 2024-2025. July 19, 2024.
Available at:
https://www.ema.europa.eu/en/documents/other/ema-confirms-its-recommendation-update-antigenic-composition-authorised-covid-19-vaccines-2024-2025_en.pdf.
- 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.
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