GAITHERSBURG, Md. , June 14, 2024 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a global corporation promoting protein-based vaccines with its Matrix-M adjuvant, announced today that it has submitted an amendment to its emergency plan. Regulations. Use authorization from the U. S. Food and Drug Administration. The U. S. Food and Drug Administration (FDA) for its updated JN. 1 COVID-19 vaccine (NVX-CoV2705) for Americans 12 years of age and older. The submission complies with U. S. FDA standards. The U. S. , EMA, and global standards. Health Organization (WHO) standards will focus on the JN. 1 lineage this fall. 1-3
Novavax’s JN. 1 vaccine demonstrated broad cross-neutralization antibodies against several variant strains, adding KP. 2 and KP. 3, indicating the possibility of coverage against direct drift variants. As discussed at the recent meeting of the Advisory Committee on Vaccines and Related Biologics, there is a potential for the public to benefit from targeting JN. 1, the original strain of most of the most common variants circulating recently.
“Novavax is committed to providing a protein-based option against COVID-19 early in the vaccination season, which is critical because studies suggest that providing vaccine selection, as well as recommendations from healthcare providers, can help vaccination rates,” said John C. Jacobs, President and CEO of Novavax.
Non-clinical knowledge has shown that the Novavax JN. 1 vaccine induces broad neutralization responses against viruses of the JN. 1 lineage, adding those containing the F456L and R346T mutations, as well as the “FLiRT” and “FLuQE” variants. 2,4,5 The Novavax vaccine also produces conserved responses of polyfunctional, Th1-biased CD4 T cells to a diversity of variants of the JN lineage. 1. 1. 2 Novavax’s updated JN. 1 COVID-19 vaccine targets the “stock ” of KP. 2 and KP. 3. 2
Novavax intends to have doses in the U. S. For distribution until mid-August. After FDA clearance and advice from the U. S. Centers for Disease Control and Prevention (CDC), the U. S. Department of Disease Control and Prevention (CDC) has been approved by the U. S. Food and Drug Administration (CDC). In the U. S. , Novavax is preparing to make temporary deliveries to its U. S. customers. U. S. It also collaborates with other regulatory governments around the world on the authorization or approval of its JN. 1 COVID-19 vaccine.
About Novavax COVID-19 2024-2025 Formula (NVX-CoV2705) NVX-CoV2705 is an updated edition of Novavax’s COVID-19 vaccine prototype (NVX-CoV2373) formulated to target the JN. 1 variant. It is a protein-based vaccine. A vaccine made by creating copies of the SARS-CoV-2 surface spike protein that causes COVID-19. Using Novavax’s unique recombinant nanoparticle technology, the non-infectious spike protein serves as an antigen that prepares the immune formula to recognize the virus, while Novavax’s spike protein Matrix-M adjuvant complements and amplifies the immune response. The vaccine is packaged in ready-to-use liquid formulas and stored between 2° and 8°C, allowing the use of the existing vaccine origin chains and the bloodless chain.
About the Matrix-M adjuvant? When added to vaccines, Novavax’s patented saponin-based Matrix-M adjuvant complements the immune system’s response, making it broader and longer-lasting. The Matrix-M adjuvant stimulates the access of antigen-presenting cells to the injection and improves antigen presentation in local areas. lymph nodes.
About Novavax Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing cutting-edge vaccines to help protect against serious infectious diseases. Novavax, a global company founded in Gaithersburg, Maryland, USA, offers a vaccine platform that combines a recombinant protein approach, cutting-edge nanoparticle technology, and Novavax’s proprietary Matrix-M adjuvant for immune response. The company’s portfolio includes its COVID-19 vaccine and its portfolio includes a mixed COVID-19 vaccine and influenza vaccine. In addition, Novavax’s adjuvant is included in the R21/Matrix-M malaria vaccine from the University of Oxford and the Serum Institute of India. Visit novavax. com and LinkedIn for more information.
Forward-Looking Statements Statements contained herein relating to Novavax’s long-term future, operating plans and prospects, the immunogenicity of its vaccine generation against variant strains, and the scope, timing and effects of regulatory filings and actions to long-term, adding any FDA or CDC recommendations, the goal of being in a position to administer a non-mRNA COVID-19 vaccine based on JN. 1 protein by mid-August, are forward-looking statements. Array Novavax cautions that such forward-looking statements are subject to threats and uncertainties that may cause actual effects to differ materially from those expressed or implied by such statements. These threats and uncertainties include, among others, antigenic drift or the change of the SARS-CoV2 spike protein, demanding situations that meet, alone or with partners, various requirements for safety, efficacy and product characterization, in addition to those related with the qualification of the procedure. and check validation, mandatory to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and fabrics; resource limitations, human capital addition and production capacity, to Novavax’s ability to pursue expected regulatory pathways; difficulties or delays in obtaining regulatory approval for its product candidates, adding a non-mRNA COVID-19 vaccine based on JN. 1 protein or for long-term adjustments to variant strains of COVID-19 19; demanding situations or delays in clinical trials; delays or difficulties in production, distribution or export; Novavax’s sole dependence on Serum Institute of India Pvt. Limited. Ltd. for the co-formulation and filling and the effect of any delay or interruption of its operations in the delivery of visitor orders; difficulties in meeting contractual needs under agreements with multiple commercial, governmental and other entities; and other known threat points 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 upcoming quarterly reports on Form 10. -Q, 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. com, for a discussion of those and other threats and uncertainties. The forward-looking statements contained in this press release speak only as of the date hereof and we undertake no legal responsibility to update or revise such statements. Our business is subject to significant threats and uncertainties, in addition to those discussed above. Investors, potential investors and others deserve to pay close attention to those threats and uncertainties.
Contacts: Investors Erika Schultz 240-268-2022 [email protected]
Giovanna Chandler Media 240-720-7804 [email protected]
References
SOURCE Novavax, Inc.