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Novavax Submits Application to U.S. FDA for Updated Protein-based 2024-2025 Formula COVID-19 Vaccine

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Novavax has submitted an amendment for Emergency Use Authorization to the U.S. FDA for its updated JN.1 COVID-19 vaccine, NVX-CoV2705, for ages 12 and older. This protein-based vaccine targets the JN.1 lineage, effective against strains like KP.2 and KP.3. The submission aligns with global recommendations from the FDA, EMA, and WHO. Novavax plans to distribute pre-filled syringes in the U.S. by mid-August, pending authorization and CDC recommendation. Preclinical data indicates broad neutralization and robust immune responses. The vaccine uses Novavax's recombinant nanoparticle technology and Matrix-M adjuvant.

Positive
  • Submission for Emergency Use Authorization aligns with global recommendations.
  • Targets JN.1 lineage, effective against KP.2 and KP.3 variants.
  • Preclinical data shows broad neutralization and robust immune responses.
  • Ready-to-use liquid formulation enables easy distribution.
  • Prepared for immediate release post-authorization and CDC recommendation.
  • Plans to distribute in the U.S. by mid-August.
Negative
  • Success dependent on FDA authorization and CDC recommendation.
  • Potential delays may affect mid-August distribution goal.
  • No clinical trial data on efficacy mentioned, only preclinical data.
  • Reliance on continued demand for COVID-19 vaccines could impact financial outlook.

Novavax's updated protein-based COVID-19 vaccine could be a significant addition to the current vaccine landscape. The vaccine targets the JN.1 lineage, which is a parent strain of prevalent circulating variants like KP.2 and KP.3. This targeted approach addresses the ongoing evolution and mutation of the virus, potentially providing better protection against forward drift variants.

Furthermore, the use of Novavax's Matrix-M adjuvant enhances the immune response, ensuring a broad and durable immunity. The adjuvant works by stimulating antigen-presenting cells and improving antigen presentation in lymph nodes, which are critical for a robust immune response. This makes the vaccine a promising candidate in boosting vaccination rates, particularly among those who prefer protein-based vaccines over mRNA alternatives.

Having the vaccine pre-filled in syringes and stored at 2°C to 8°C simplifies distribution and administration, potentially increasing vaccination rates. However, the successful uptake will depend on timely authorization by the FDA and recommendations from the CDC.

The introduction of Novavax's updated COVID-19 vaccine into the market aligns with global health authorities' recommendations and highlights the company's strategic positioning. The ability to offer the only protein-based option in the U.S. fills a unique niche, potentially attracting individuals hesitant towards mRNA vaccines. This could enhance Novavax’s market share in the competitive vaccine market.

However, market success will rely heavily on the timely authorization of the vaccine and subsequent endorsement by healthcare providers. The company must also ensure an efficient distribution network to meet the mid-August target for availability. Any delays or supply chain disruptions could affect market performance and investor confidence.

Investors should note that while the immediate impact may hinge on regulatory approvals, the long-term outlook appears favorable given the vaccine’s broader applicability and potential market demand.

  • Novavax's updated JN.1 COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3
  • Novavax's JN.1 COVID-19 vaccine would be the only protein-based option available in the U.S.
  • Novavax's filing is aligned with FDA, EMA and WHO global recommendations on vaccine composition
  • Novavax intends to have its vaccine in pre-filled syringes available in the U.S. for immediate release post-authorization and following recommendation by the U.S. CDC

GAITHERSBURG, Md., June 14, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that it has submitted an amendment to its Emergency Use Authorization to the U.S. Food and Drug Administration (FDA) for its updated JN.1 COVID-19 vaccine (NVX-CoV2705) for individuals aged 12 and older. The submission is in line with guidance from the U.S. FDA, European Medicines Agency (EMA) and the World Health Organization (WHO) to target the JN.1 lineage this fall.1-3 

Novavax's JN.1 vaccine has demonstrated broad cross-neutralizing antibodies against multiple variant strains, including KP.2 and KP.3, indicating the potential to protect against forward drift variants. As discussed at the recent 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.

"Novavax is committed to having a protein-based COVID-19 option available at the start of the vaccination season, which is critical because research suggests that providing vaccine choice, along with healthcare provider recommendations, may help improve vaccination rates," said John C. Jacobs, President and Chief Executive Officer, Novavax.

Nonclinical data have demonstrated that Novavax's JN.1 vaccine induces broad neutralization responses to JN.1 lineage viruses including those containing the F456L and R346T mutations, and to "FLiRT" and "FLuQE" variants.2,4,5 Novavax's vaccine also produces conserved polyfunctional, Th1-biased CD4+ T cell responses to a range of JN.1 lineage variants.2 Novavax's updated JN.1 COVID-19 vaccine targets the "parent strain" of KP.2 and KP.3.2

Novavax intends to have doses in the U.S. for distribution by mid-August. Upon FDA authorization and U.S. Centers for Disease Control and Prevention (CDC) recommendation, Novavax is preparing to promptly deliver to U.S. customers. Novavax is also 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 FDA or CDC recommendations, the intention to be ready to deliver a JN.1 protein-based non-mRNA COVID-19 vaccine by mid-August, 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; 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

  1. U.S. Food and Drug Administration. Updated COVID-19 Vaccines for Use in the United States Beginning in Fall 2024. June 13, 2024. Available at: https://www.fda.gov/vaccines-blood-biologics/updated-covid-19-vaccines-use-united-states-beginning-fall-2024
  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. 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
  4. 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
  5. 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.

Novavax logo (PRNewsfoto/NOVAVAX, INC)

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SOURCE Novavax, Inc.

FAQ

What has Novavax submitted to the FDA for NVAX?

Novavax has submitted an amendment for Emergency Use Authorization for its JN.1 COVID-19 vaccine (NVX-CoV2705) targeting individuals aged 12 and older.

When will Novavax's updated COVID-19 vaccine be available?

Novavax plans to have its JN.1 COVID-19 vaccine available in pre-filled syringes in the U.S. by mid-August, pending FDA authorization and CDC recommendation.

What variants is Novavax's JN.1 COVID-19 vaccine effective against?

Novavax's JN.1 COVID-19 vaccine is designed to be effective against the JN.1 lineage, including variants KP.2 and KP.3.

What is unique about Novavax's JN.1 COVID-19 vaccine?

The JN.1 COVID-19 vaccine is the only protein-based option available in the U.S., utilizing Novavax's recombinant nanoparticle technology and Matrix-M adjuvant.

What are the storage requirements for Novavax's updated COVID-19 vaccine?

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.

Novavax, Inc.

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