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. Statements herein relating to the future of Novavax, its operating plans and prospects, the ongoing development of NVX-CoV2373 and other Novavax vaccine product candidates, timing of future regulatory filings and actions, and the role that Novavax may play in helping control the COVID-19 pandemic are forward-looking statements. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.įor more information, visit and connect with us on Twitter and LinkedIn.
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NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. The company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. The vaccination regimen calls for two 0.5 ml doses (5 microgram antigen and 50 microgram Matrix-M adjuvant) given intramuscularly 21 days apart. Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. In addition to the submission for WHO EUL, SII and Novavax last month completed the submission of modules required by regulatory agencies in India, Indonesia and the Philippines for the initiation of review of the vaccine, including preclinical, clinical, and chemistry, manufacturing and controls (CMC) data. The grant of EUL by the WHO is a prerequisite for exports to numerous countries participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies. "It represents another major milestone in Novavax' transformation into a commercial global vaccine company and reinforces the value of global collaboration and need for multiple approaches to help control the pandemic." Erck, President and Chief Executive Officer, Novavax. "Today's submission of our protein-based COVID-19 vaccine to WHO for emergency use listing is a significant step on the path to accelerating access and more equitable distribution to countries in great need around the world," said Stanley C. The submission to WHO is based on the companies' previous regulatory submission to the Drugs Controller General of India (DCGI). (SII), today announced a regulatory submission to the World Health Organization (WHO) for emergency use listing (EUL) of Novavax' recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, with its partner, Serum Institute of India Pvt. Novavax and Serum Institute of India file regulatory submission for World Health Organization Emergency Use Listing of Novavax' recombinant nanoparticle protein-based COVID-19 vaccine
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