GAITHERSBURG, Md., Oct. 9, 2024
/PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company
advancing protein-based vaccines with its Matrix-M™ adjuvant, today
announced that the European Commission granted Marketing
Authorization for Novavax's updated 2024-2025 Nuvaxovid™ COVID-19
Vaccine (recombinant, adjuvanted) (NVX-CoV2705), dispersion for
injection, for use in individuals aged 12 and older for the
prevention of COVID-19 in the European Union (EU). This
decision follows the positive opinion from the Committee for
Medicinal Products for Human Use of the European Medicines Agency
(EMA).
Authorization was based on non-clinical data that showed
Novavax's updated vaccine provides 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.
Novavax's vaccine is also authorized for use in the U.S., and is
in line with guidance from the U.S. Food and Drug Administration
(FDA), EMA and the World Health Organization to target the
JN.1 lineage this fall.2-5
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 Emergency Use Authorization
(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 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 including JN.1 lineage viruses, and the scope, timing and
outcome of future regulatory filings and actions, including any EMA
or FDA recommendations, the expectation to have unit dose vials
available in select European countries this fall season, 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
Luis Sanay, CFA
240-268-2022
ir@novavax.com
Media
Giovanna Chandler
240-720-7804
media@novavax.com
References
- Kaku Y, Uriu K, Okumura K; Genotype to Phenotype Japan
(G2P-Japan) Consortium, Ito J,
Sato K. Virological characteristics of the SARS-CoV-2 KP.3.1.1
variant. Lancet Infect Dis. 2024;24(10):e609.
doi:10.1016/S1473-3099(24)00505-X
- U.S. Centers for Disease Control and Prevention. Interim
Clinical Considerations for Use of COVID-19 Vaccines in
the United States. September 6, 2024. Available
at: https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html.
- 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.
- 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.
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SOURCE Novavax, Inc.