GAITHERSBURG, MD., September 23, 2021 / CNW / – Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to the development and commercialization of next-generation vaccines against serious infectious diseases, with its partner, the Serum Institute of India Pvt. Ltd. (SII), today announced a regulatory submission to the World Health Organization (WHO) for the Emergency Use List (EUL) of Novavax’s recombinant protein nanoparticle COVID-19 vaccine candidate with Matrix-M ™ adjuvant. The submission to WHO is based on the previous regulatory submission of companies to the Comptroller General of Medicines of India (DCGI).
“Today’s submission of our protein-based COVID-19 vaccine to WHO for emergency use is an important step on the road to accelerated access and distribution fairer to the countries in great need of it in the world ”, declared Stanley C. erck, President and Chief Executive Officer, Novavax. “It represents another important step in the transformation of Novavax into a global commercial vaccine company and reinforces the value of global collaboration and the need for multiple approaches to help control the pandemic. “
The granting of EUL by WHO is a prerequisite for exports to many countries participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies. In addition to the submission for the WHO EUL, SII and Novavax last month completed the submission of modules required by regulatory bodies in India, Indonesia and The Philippines for the initiation of the vaccine review, including preclinical, clinical and chemical, manufacturing and control (CMC) data.
NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a UK trial that demonstrated 96.4% efficacy against the original viral strain, 86.3% against the Alpha variant (B.1.1 .7) and an overall efficiency of 89.7%; and the PREVENT-19 trial in the United States and Mexico which demonstrated 100% protection against moderate and severe disease and an overall efficacy of 90.4%. It was generally well tolerated and elicited a strong antibody response.
NVX-CoV2373 is a protein-based vaccine candidate designed from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’s recombinant nanoparticle technology to generate an antigen derived from the coronavirus spike (S) protein and is formulated with the patented Matrix-M ™ adjuvant based on saponin from Novavax to improve the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate or cause COVID-19.
Novavax’s COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination schedule requires two doses of 0.5 ml (5 micrograms of antigen and 50 micrograms of Matrix-M adjuvant) administered intramuscularly 21 days apart. The vaccine is stored between 2 ° and 8 ° Celsius, which allows the use of the vaccine supply and existing cold chain channels.
About Matrix-M ™ Adjuvant
Novavax’s patented saponin-based Matrix-M ™ adjuvant has been shown to have a potent and well-tolerated effect by stimulating entry of antigen-presenting cells into the injection site and improving antigen presentation in the injection site. local lymph nodes, thereby strengthening the immune response.
Novavax, Inc. (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. The company’s proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to meet urgent global health needs. Novavax is conducting advanced clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu ™, its quadrivalent nanoparticle influenza vaccine, has met all of the primary goals of its pivotal Phase 3 clinical trial in the elderly and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax’s proprietary saponin-based Matrix-M ™ adjuvant to enhance immune response and stimulate high levels of neutralizing antibodies.
For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.
These statements regarding the future of Novavax, its operating plans and prospects, the ongoing development of NVX-CoV2373 and other Novavax vaccine candidates, the timing of future filings and regulatory actions, and the role that Novavax may playing to help control the COVID-19 pandemic are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties which could cause actual results to differ materially from those expressed or implied by these statements. These risks and uncertainties include the challenges of meeting, alone or with partners, various safety, efficacy and product characterization requirements, including those related to process qualification and test validation, necessary to meet applicable regulatory authorities; difficulty in obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on Novavax’s ability to follow planned regulatory pathways; challenges in meeting contractual requirements under agreements with multiple commercial, government and other entities; and the other risk factors identified in the “Risk factors” and “Management’s analysis and analysis of the financial position and operating results” sections of Novavax’s annual report on Form 10-K for the financial year ended December 31, 2020 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 any 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 these and other risks and uncertainties. The forward-looking statements contained in this press release speak only as of the date of this document, and we assume no obligation to update or revise any such statements. Our business is subject to significant risks and uncertainties, including those mentioned above. Investors, potential investors and others should carefully consider these risks and uncertainties.
Erika Schultz | 240-268-2022
Alexandra Roy | 617-221-9197
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Laura Keenan Lindsey | 202-709-7521
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SOURCE Novavax, Inc.
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