GAITHERSBURG, MD., November 24, 2021 / PRNewswire / – Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to the development and commercialization of next-generation vaccines against serious infectious diseases, today announced its submission to the Singapore Health Sciences Authority (HSA) for the provisional authorization of its COVID-19 vaccine under the special access road in the event of a pandemic (PSAR).
“Today’s filing reinforces our continued commitment to provide our COVID-19 vaccine, based on a proven and well-understood vaccine platform, to help end the pandemic,” said Stanley C. erck, President and Chief Executive Officer, Novavax. “Each new submission to the market marks further progress in delivering our vaccine globally, which we believe could help overcome key barriers to global immunization, including global distribution challenges and reluctance. vis-à-vis the vaccine. “
Novavax has submitted the request for regulatory review by the HSA of NVX-CoV2373, the company’s COVID-19 vaccine based on recombinant nanoparticles with the adjuvant Matrix-M ™. The dossier includes clinical data from two pivotal Phase 3 clinical trials: PREVENT-19, which included 30,000 participants in the United States and Mexico and demonstrated 100% protection against moderate and severe disease and 90.4% efficacy; and a trial of 15,000 participants in the UK which demonstrated an efficacy of 96.4% against the original viral strain, 86.3% against the Alpha variant (B.1.1.7) and an overall efficacy of 89 , 7%. In both trials, NVX-CoV2373 demonstrated a reassuring safety and tolerability profile.
Novavax and Serum Institute of India Pvt. Ltd. (SII) recently received emergency use authorization (EUA) for the vaccine in Indonesia and the Philippines, and the companies have filed an India EUA Application and Emergency Use List (EUL) with the World Health Organization (WHO). Novavax also announced regulatory filings for its vaccine in the UK, Australia, New Zealand, Canada, the European Union and with the WHO. In addition, Novavax and SK bioscience announced a Biologics License Application (BLA) submission to the MFDS in South Korea. Novavax plans to submit the complete package to the US FDA by the end of the year.
The chemistry, manufacturing and controls (CMC) dataset submitted to the HSA and other global regulatory agencies is based on Novavax’s manufacturing partnership with SII, the largest vaccine manufacturer in the world. world in volume. It will then be supplemented with data from additional manufacturing sites in Novavax’s global supply chain.
About NVX-CoV2373 Phase 3 Trials
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 Matrix-M ™ adjuvant patented saponin from Novavax to improve the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains a 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 existing vaccine supply and 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 harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to meet urgent global health needs. NVX-CoV2373, the company’s COVID-19 vaccine, received emergency use authorization in Indonesia and The Philippines and has been subject to regulatory clearance in several markets around the world. NanoFlu ™, the company’s quadrivalent nanoparticle influenza vaccine, met all of the primary goals of its pivotal Phase 3 clinical trial in the elderly. Novavax is currently evaluating a COVID-NanoFlu combination vaccine in a Phase 1/2 clinical trial, which combines the company’s NVX-CoV2373 and NanoFlu vaccine candidates. These vaccine candidates incorporate Novavax’s proprietary saponin-based Matrix-M ™ adjuvant to enhance immune response and stimulate high levels of neutralizing antibodies.
The following statements concerning the future of Novavax, its operating plans and prospects, its partnerships, the ongoing development of NVX-CoV2373, the scope, timing and results of future regulatory filings and actions, the role that Novavax can play to help end the COVID-19 pandemic, Novavax’s plans to deliver a COVID-19 vaccine to people around the world, and Novavax’s plan to complete CMC data submitted to the HSA and to other global regulatory agencies with data from additional manufacturing sites around the world of Novavax. supply chain 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 discussion and analysis of the financial position and operating results” sections of Novavax’s annual report on Form 10-K for the fiscal 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 substantial 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
Alison Chartan | 240-720-7804
Laura Keenan Lindsey | 202-709-7521
View original content to download multimedia:https://www.prnewswire.com/news-releases/novavax-files-for-interim-authorization-of-covid-19-vaccine-in-singapore-301431572.html
SOURCE Novavax, Inc.