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Novavax’s latest protein-based, mRNA-free COVID-19 vaccine will be available in Canada for Americans ages 12 and older in the coming days.
GAITHERSBURG, Md. , Dec. 5, 2023 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a global corporation advancing protein-based vaccines with its Matrix-M™ adjuvant, announced today that Health Canada has granted an expanded authorization. . for Nuvaxovid™ XBB. 1. 5 (recombinant, adjuvanted protein) vaccine (NVX-CoV2601) for active immunization to save COVID-19 caused by SARS-CoV-2 in Americans 12 years of age and older. The Public Health Agency of Canada’s National Advisory Committee on Immunization has XBB COVID-19 vaccines that target newer immune variants of the virus. 1
“Today’s expanded authorization reflects the Canadian government’s strong commitment to providing its citizens with effective options, such as our mRNA-free protein-based vaccine, in the crusade against the COVID-19 variants circulating lately,” said John C. Jacobs, President and Chief Executive Officer of Novavax. ” We hope to help protect Canadians in time for the upcoming holiday season and, pending the rollout of vaccine batches, bring doses to market so they are available across the country.
The expanded authorization was based on non-clinical data showing that Novavax’s COVID-19 vaccine induced functional immune responses against XBB.1.5, XBB.1.16 and XBB.2.3 variants. Additional non-clinical data demonstrated that Novavax’s vaccine induced neutralizing antibody responses to subvariants BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6 as well as CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6. These data indicate Novavax’s vaccine can stimulate both arms of the immune system and may induce a broad response against currently circulating variants.2,3
In clinical trials, the most common adverse reactions related to Novavax’s COVID-19 vaccine prototype (NVX-CoV2373) included headache, nausea or vomiting, muscle pain, joint pain, tenderness when injecting, injection pain, fatigue, and malaise.
Novavax’s updated COVID-19 vaccine is also legal in the United States, the European Union and through the WHO, and is under review in other markets.
The industrial call Nuvaxovid™ has been approved through the U. S. Food and Drug Administration. U. S.
About Nuvaxovid™ XBB. 1. 5 2023-2024 (NVX-CoV2601)NVX-CoV2601 is an updated edition of Novavax’s COVID-19 vaccine prototype (NVX-CoV2373) formulated to target the Omicron XBB. 1. 5 subvariant. It is a protein-vaccine based on 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 primes the immune formula to recognize the virus, while Novavax’s 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 existing vaccine origin chains and the bloodless chain.
When added to vaccines, Novavax’s patented saponin-based Matrix-M™ adjuvant supplements the immune system’s response, making it broader and more sustainable. The Matrix-M adjuvant stimulates the access of antigen-presenting cells at injection and improves antigen presentation in local lymph nodes.
About NovavaxNovavax, 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 headquartered in Gaithersburg, Maryland, USA, is a global company based in Gaithersburg, Maryland, USA. The U. S. Vaccine Offering a Differentiated Vaccine Platform that combines a recombinant protein approach, cutting-edge nanoparticle technology and Novavax’s proprietary Matrix-M adjuvant for immune response. Focused on the world’s most pressing health challenges, Novavax is recently comparing COVID-19, influenza, and COVID-19 vaccines. and influenza combined. Visit novavax. com and LinkedIn to learn more.
Forward-Looking StatementsStatements herein relating to the future of Novavax, its operating plans and prospects, the scope, timing and outcome of future regulatory filings and actions, including the availability of its updated XBB version of its Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) and the timing of vaccine batch release, delivery, and distribution of its vaccine 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, 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 its updated XBB version of its COVID-19 vaccine in time for the fall 2023 vaccination season 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 in obtaining commercial adoption of our updated protein-based non-mRNA XBB COVID-19 vaccine, NVX-CoV2373 or any COVID-19 variant strain-containing formulation; 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, 2022 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:InvestorsErika Schultz240-268-2022ir@novavax. com
MediaAli Chartan240-720-7804media@novavax. com
References
Public Health Agency of Canada. Advisory Committee (ACC) Statement National Advisory Committee on Immunization (NACI) – Guidance on the use of COVID-19 vaccines in the fall of 2023. July 11, 2023. https://www. canada. ca /content/dam/phac-aspc/documents/services/publications/vaccines-immunization/national-advisory-committee-immunization-guidance-use-covid-19-vaccines-fall-2023/statement. pdf.
Markov PV, Ghafari M, Beer M et al. The evolution of SARS-CoV-2. Nat Rev Microbiol. 2023; 21(6):361-379. com what I:10. 1038/s41579-023-00878-2.
Wherry EJ and Barouch DH. T-cell immunity to COVID-19 vaccines. Science. 2022; 377(6608):821-822. com what I:10. 1126/science. add2897.
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