Novavax Submits Application to European Medicines Agency for Updated Protein-based 2024-2025 Formula COVID-19 Vaccine

Rhea-AI Summary

Novavax (Nasdaq: NVAX) announced it has submitted a type II variation application to the European Medicines Agency (EMA) for its updated JN.1 COVID-19 vaccine (NVX-CoV2705), intended for individuals aged 12 and older. The vaccine is designed to address current circulating strains, including KP.2 and KP.3. This submission follows EMA and WHO guidance to target the JN.1 lineage this fall.

Nonclinical data indicate the vaccine induces broad neutralization responses to various JN.1 lineage viruses, including mutations F456L and R346T, and variants like

Insights

Medical Research Analyst

Novavax's application to the European Medicines Agency (EMA) for its updated JN.1 COVID-19 vaccine is a significant development in the vaccine landscape. The JN.1 vaccine targets current circulating strains, including KP.2 and KP.3. This is important because it suggests a proactive approach to ensure the vaccine's relevance against evolving virus strains.

From a scientific perspective, the nonclinical data showing broad neutralization responses and Th1-biased CD4+ T cell responses are promising. Neutralizing antibodies are critical for immediate defense against the virus, while Th1-biased responses indicate that the vaccine might offer longer-lasting immunity.

For retail investors, understanding the scientific efficacy is key. The vaccine's ability to target specific mutations like F456L and R346T and variants like "FLiRT" and "FLuQE," suggests it could be a robust option as the virus continues to mutate. However, clinical efficacy data in real-world settings will be important to confirm these findings.

Market Research Analyst

Novavax seeking EMA approval for its JN.1 COVID-19 vaccine presents a notable opportunity in the European market. This region has shown high acceptance of varied COVID-19 vaccines, creating a favorable environment for Novavax to gain market share. Importantly, the vaccine offers a protein-based alternative to mRNA vaccines, potentially appealing to those hesitant about mRNA technology.

The company's immediate distribution plans post-approval could ensure a quick market entry, providing a competitive edge. This strategic move might bolster Novavax's market position and revenue, particularly as new COVID-19 variants emerge. However, the market response and actual uptake will depend significantly on regulatory timelines and comparative efficacy data from real-world use.

Financial Analyst

From a financial perspective, Novavax's filing with the EMA is an encouraging step. If approved, it could lead to increased revenue and market valuation, particularly if the vaccine demonstrates strong uptake in the European Union. The company's strategy to have unit-dose vials ready for immediate release post-approval is a practical move to capitalize on the demand swiftly.

However, there are financial risks to consider. The successful commercialization of the JN.1 vaccine will depend on various factors, including competition from other vaccine manufacturers, regulatory approvals in different regions and public perception. Additionally, while filing with the U.S. FDA and other global regulators is positive, any delays or rejections could impact the financial outlook.

For investors, the potential benefits seem substantial, but it is critical to monitor the regulatory outcomes and market acceptance closely.

• Novavax's JN.1 COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3

GAITHERSBURG, Md., June 24, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that it has filed for a type II variation of existing Marketing Authorization with the European Medicines Agency (EMA) for its JN.1 COVID-19 vaccine (NVX-CoV2705) for individuals aged 12 and older. The submission is in line with guidance from EMA and the World Health Organization to target the JN.1 lineage this fall.^1,2

"Novavax is working closely with European markets seeking to offer a protein-based alternative to mRNA this fall for COVID-19 vaccination," said John C. Jacobs, President and Chief Executive Officer, Novavax. "Our updated COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3."

Nonclinical data have demonstrated that Novavax's JN.1 COVID-19 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 Novavax's vaccine also produces conserved polyfunctional, Th1-biased CD4+ T cell responses to a range of JN.1 lineage variants.² Novavax's JN.1 COVID-19 vaccine targets the "parent strain" of KP.2 and KP.3.² 

Novavax intends to have its vaccine in unit-dose vials available for distribution in the European Union for immediate release post-approval. Novavax has also filed with the U.S. Food and Drug Administration (FDA) and is 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 EMA or FDA recommendations, the intention to be ready to deliver a JN.1 protein-based COVID-19 vaccine this fall, 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 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

1. 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
2. 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
3. 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
4. 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.