- 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 United States
- Novavax’s dossier complies with global recommendations from the FDA, EMA and WHO on vaccine composition
- Novavax intends to make its vaccine available in pre-filled syringes in the United States for immediate release upon authorization and in accordance with US CDC recommendations.
GAITHERSBURG, Maryland., June 14, 2024/PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, announced today that it has submitted an amendment to its Emergency Use Authorization to the United States Food and Drug Administration (FDA) for its updated JN.1. COVID-19 vaccine (NVX-CoV2705) for people aged 12 and over. The submission complies with US FDA guidelines, European Medicines Agency (EMA) and World Health Organization (WHO) to target the JN.1 line this fall.1-3
Novavax’s JN.1 vaccine demonstrated broad cross-neutralizing antibodies against several variant strains, including KP.2 and KP.3, indicating the potential for protection 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 targeting JN.1, the parent strain of the most common currently circulating variants.
“Novavax is committed to offering a protein-based COVID-19 option early in the vaccination season, which is critical as research suggests that vaccine choice, along with recommendations from healthcare providers, can help improve vaccination rates.,” said John C. Jacobs, President and CEO, Novavax.
NOTclinical data demonstrated that Novavax’s JN.1 vaccine induces broad neutralization responses to John.1 lineage viruses, including those containing F456L and R346T mutations, and “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 United States for distribution by mid-July. Following FDA approval and recommendation from the US Centers for Disease Control and Prevention (CDC), Novavax is preparing to quickly deliver to US customers. Novavax is also working with other regulatory authorities around the world on authorization or approval of its JN.1 COVID-19 vaccine.
About Novavax COVID-19 Formula 2024-2025 (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. Using Novavax’s unique recombinant nanoparticle technology, the non-infectious spike protein serves as an antigen that prepares 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 between 2° and 8°C, allowing use of existing vaccine supply circuits and cold chain.
About Matrix-M™ Admixture
When added to vaccines, Novavax’s patented saponin-based Matrix-M adjuvant enhances the immune system’s response, making it broader and more durable. 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, Maryland., USA, offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax’s patented Matrix-M adjuvant to enhance immune response. The Company’s portfolio includes its COVID-19 vaccine and its pipeline includes a combination COVID-19 and influenza vaccine. Additionally, Novavax adjuvant is included in the University of Oxford and the Serum Institute of India Malaria vaccine R21/Matrix-M. Please visit novavax.com And LinkedIn for more information.
Forward-looking statements
The statements contained 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 results of future filings and actions regulatory requirements, including any recommendations from the FDA or CDC, the intention to be ready to deliver a JN.1 protein-based mRNA-free 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, but are not limited to, antigenic drift or shift of the SARS-CoV2 spike protein, challenges meeting, alone or with partners, various requirements for safety, efficacy and product characterization, including those related to process qualification and test validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on Novavax’s ability to pursue planned regulatory pathways; difficulties or delays in obtaining regulatory approval for its product candidates, including a JN.1 protein-based mRNA-free COVID-19 vaccine or for future changes in COVID-19 variant strains 19; challenges or delays in clinical trials; delays or difficulties in manufacturing, distribution or export; Novavax’s sole reliance on Serum Institute of India Pvt. Ltd. for co-formulation and filling and the impact of any delay or interruption of their operations on the delivery of customer orders; difficulties in meeting contractual requirements under agreements with multiple commercial, governmental and other entities; and 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 then-ended fiscal year. 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 significant reliance on the forward-looking statements contained in this press release. We encourage you to read our SEC filings, available at www.sec.gov And www.novavax.comfor a discussion of these and other risks and uncertainties. The forward-looking statements contained in this press release speak only as of the date hereof, and we undertake no obligation to update or revise these statements. Our business is subject to significant risks and uncertainties, including those discussed above. Investors, potential investors and others should pay particular attention to these risks and uncertainties.
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The references
- US Food and Drug Administration. Updated COVID-19 vaccines for use in United States From fall 2024. June 13, 2024. Available at: https://www.fda.gov/vaccines-blood-biologics/updated-covid-19-vaccines-use-united-states-beginning-fall-2024
- World Health Organization. Statement on the antigenic 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 the 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
- US Centers for Disease Control and Prevention. Proportions of variants (dataset). In tracking COVID data. 2024. Available on: https://covid.cdc.gov/covid-data-tracker/#variant-proportions
- Focosi D, Spezia PG, Gueli F, Maggi F. The era of FLips: how Spike mutations L455F and F456L (and A475V) shape the evolution of SARS-CoV-2. Virus. 2023;16(1):3. Published December 19, 2023. doi:10.3390/v16010003.
SOURCE Novavax, Inc.