Novavax's Updated 2024-2025 Nuvaxovid™ COVID-19 Vaccine Receives Authorization in the EU

Rhea-AI Summary

Novavax announced that the European Commission has granted Marketing Authorization for its updated 2024-2025 Nuvaxovid™ COVID-19 Vaccine for individuals aged 12 and older in the European Union. The authorization follows a positive opinion from the EMA's Committee for Medicinal Products for Human Use. Non-clinical data showed the updated vaccine provides cross-reactivity against JN.1 and numerous JN.1 lineage viruses.

The vaccine is also authorized for use in the U.S. under an Emergency Use Authorization. Common adverse reactions include headache, nausea, muscle pain, joint pain, injection site tenderness, fatigue, and malaise. The vaccine is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years and older.

Positive

• Marketing Authorization granted for updated 2024-2025 Nuvaxovid™ COVID-19 Vaccine in the EU
• Vaccine shows cross-reactivity against JN.1 and numerous JN.1 lineage viruses
• Authorization for use in individuals aged 12 and older
• Also authorized for use in the U.S. under Emergency Use Authorization

Negative

• Potential risks of myocarditis and pericarditis following vaccine administration
• Possible limitations in vaccine effectiveness for all recipients
• Various adverse reactions reported, including injection site pain and fatigue

Insights

Vaccine Development Expert

The authorization of Novavax's updated COVID-19 vaccine in the EU is a significant milestone for the company. This approval demonstrates the vaccine's ability to target newer variants, particularly the JN.1 lineage, which is important for ongoing pandemic management. The cross-reactivity against multiple JN.1 sub-variants suggests broad protection, potentially enhancing the vaccine's appeal in a competitive market.

From an investor perspective, this authorization could lead to increased revenue streams for Novavax in the EU market. However, it's important to note that the vaccine landscape remains competitive, with mRNA vaccines still dominating. Novavax's protein-based approach might appeal to those seeking alternatives, but market penetration will depend on distribution capabilities and public health recommendations.

The alignment with FDA, EMA and WHO guidance on targeting JN.1 lineage positions Novavax favorably for potential global contracts. Investors should monitor uptake rates and any post-authorization safety data as key indicators of the vaccine's long-term market potential.

Financial Analyst

Novavax's EU authorization for its updated COVID-19 vaccine is a positive development for the company's financial outlook. With a market cap of $2.15 billion, this news could potentially drive stock price appreciation if it translates into significant sales.

Key financial considerations include:

• Potential revenue boost from EU sales, which could improve Novavax's cash position
• Reduced R&D expenses as the vaccine moves from development to commercialization
• Possible economies of scale in production as demand increases

However, investors should be cautious about overestimating impact. The COVID-19 vaccine market is maturing, with potentially lower margins than in previous years. Novavax's ability to capture market share from established mRNA vaccines will be important for financial performance.

Monitor upcoming quarterly reports for concrete evidence of how this authorization translates into revenue growth and profitability. The company's cash burn rate and ability to secure additional contracts will be key metrics to watch.

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

1. 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
2. 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.
3. 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.
4. 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.
5. 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.

FAQ

What is the new authorization for Novavax's COVID-19 vaccine (NVAX) in the EU?

The European Commission granted Marketing Authorization for Novavax's updated 2024-2025 Nuvaxovid™ COVID-19 Vaccine for use in individuals aged 12 and older in the European Union.

What viruses does Novavax's updated COVID-19 vaccine (NVAX) show cross-reactivity against?

Non-clinical data showed that 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.

What are the common side effects of Novavax's COVID-19 vaccine (NVAX)?

Common adverse reactions include headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue, and malaise.

Is Novavax's updated COVID-19 vaccine (NVAX) authorized in the United States?

Yes, Novavax's vaccine is authorized for emergency use in the U.S. under an Emergency Use Authorization (EUA) for individuals 12 years of age and older.