The vaccine is packaged as a ready-to-use liquid formula and stored between 2° and 8° Celsius, allowing the use of existing vaccine source channels and bloodless chain. The use of the vaccine should be in accordance with official recommendations.
Novavax has established partnerships for the manufacture, marketing and distribution of NVX-CoV2373 worldwide. The existing approvals leverage Novavax’s production partnership with the Serum Institute of India, the world’s largest vaccine manufacturer by volume. These will later be supplemented with knowledge of other production sites. Novavax’s global supply chain.
About the Matrix-M Adjuvant Novavax’s patented saponin-based Matrix-M™ adjuvant demonstrated a potent and well-tolerated effect by stimulating the access of antigen-presenting cells at the injection site and antigen presentation in local lymph nodes, thereby stimulating the immune response.
About Novavax Novavax, Inc. (Nasdaq: NVAX) is a biogeneration company that advances advanced global fitness through the discovery, progression and commercialization of cutting-edge vaccines to save you from serious infectious diseases. The company’s proprietary recombinant generation platform harnesses the power and speed of genetic engineering to successfully produce highly immunogenic nanoparticles designed to address urgent global fitness needs. The Novavax COVID-19 vaccine has gained approval from multiple regulatory governments around the world, including the US FDA, the European Commission, and the World Health Organization. The vaccine is currently being reviewed through various regulatory agencies around the world, and is being added for other indications and populations, such as adolescents and as a booster. In addition to its COVID-19 vaccine, Novavax is also recently comparing its combined COVID-19 influenza vaccine (CIC) candidate in a Phase 1/2 clinical trial, its investigational quadrivalent influenza vaccine candidate, and a strain-based vaccine. Omicron (NVX-CoV2515), as well as an Omicron-based/parent-based bivalent vaccine. These vaccine candidates incorporate Novavax’s proprietary saponin-based Matrix-M adjuvant for the immune reaction and stimulate the highest levels of neutralizing antibodies.
Forward-Looking Statements Detailed statements regarding Novavax’s long-term, business plans and prospects, partnerships, timing of clinical trial effects, continued progression of NVX-CoV2373, NVX-CoV2515, and a bivalent vaccine based on the Omicron/Original strain, the CIC vaccine candidate, adding Novavax’s plans to initiate a Phase 3 trial in 2024, an investigational quadrivalent influenza vaccine candidate, scope, timing and effects of submissions and actions Long-term regulatory requirements, adding Novavax’s plans to supplement existing authorizations with information from other production sites in Novavax’s global supply chain, plus global authorizations of NVX-CoV2373 for use in adults and adolescents, and as a reminder, the potential impact and success of Novavax and NVX-CoV2373 on access to vaccines, expansion of vaccination rates, control l The pandemic and protective persons, efficacy, safety, intended use, and intended management of NVX-CoV2373 and the CIC vaccine candidate are forward-looking statements. 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, but are not limited to, difficulties in assembly, alone or with partners, various safety, efficacy, and product characterization needs, as well as the likes of qualification and validation procedures. testing, as required to satisfy applicable regulatory authorities; difficulty in obtaining scarce raw materials and supplies; resource constraints, adding human capital and production capacity, on Novavax’s ability to adhere to expected regulatory pathways; unforeseen difficulties or delays in conducting clinical trials; difficulties in assembling control needs under agreements with multiple commercial, governmental and other entities; and other known threat items 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 fiscal year ended December 31, 2021 and upcoming quarterly reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place significant reliance on any forward-looking statements contained in this press release. We invite you to read our SEC filings, available at www. sec. gov and www. novavax. com, for a discussion of these and other threats and uncertainties. Forward-looking statements contained in this press release speak only as of the date hereof, and we do not assume any legal responsibility to update or revise any forward-looking statements. Our business is subject to really extensive threats and uncertainties, in addition to those discussed above. Investors, potential investors and others deserve to pay special attention to these threats and uncertainties.
contacts:InvestorsErika Schultz | 240-268-2022ir@novavax. com
MediaAli Chartan or Giovanna Chandler| 202-709-5563media@novavax. com
SOURCE Novavax, Inc.