Decision of the European Commission on the conditional marketing authorization expected soon
Upon approval, Nuvaxovid ™ (also known as NVX-CoV2373) will be the first protein-based COVID-19 vaccine available in Europe
GAITHERSBURG, MD., 20 December 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 that the European Medicines Agency ( EMA) recommended the granting of conditional marketing authorization for Novavax’s COVID-19 vaccine (also known as NVX-CoV2373) to prevent COVID-19 in people aged 18 and over. After authorization, NVX-CoV2373 will be marketed in the European Union (EU) under the vaccine name Nuvaxovid ™ COVID-19 (recombinant, with adjuvant).
“Novavax appreciates the positive opinion of the CHMP regarding our vaccine, and we look forward to a decision from the European Commission”, said Stanley C. erck, President and Chief Executive Officer, Novavax. “A Commission authorization would deliver the first protein-based vaccine to the EU at a critical time when we believe having a choice of vaccines will lead to increased immunization.”
The EMA recommendation follows a positive opinion from the CHMP based on an expedited review of all manufacturing, preclinical and clinical trial data submitted by the company, with the conclusion that the vaccine meets the strict criteria set by the EU in terms of efficiency, safety and quality. . This included data from two pivotal Phase 3 clinical trials: PREVENT-19, which enrolled nearly 30,000 participants in the United States and Mexico, and achieved an overall efficiency of 90.4%, the results of which were published in the New England Journal of Medicine (NEJM)); and a trial with over 14,000 participants in the UK that achieved an overall efficacy of 89.7%, the results of which have also been published in NEJM. In both trials, NVX-CoV2373 demonstrated high efficacy and a reassuring safety and tolerability profile.
Novavax and the European Commission announcement an Advance Purchase Agreement (APA) for up to 200 million doses of Novavax’s COVID-19 vaccine in August 2021. This dossier is based on Novavax’s manufacturing partnership with the Serum Institute of India (SII), the world’s largest vaccine manufacturer by volume, which will supply the initial doses for the EU. It will then be supplemented with data from additional manufacturing sites in Novavax’s global supply chain.
Novavax and SII recently received Emergency Use Authorization (EUA) in Indonesia and the Philippines, where it will be marketed by SII under the trade name Covovax ™. The companies also received an emergency use list for Covovax from the World Health Organization. The vaccine is also currently under review by several regulatory agencies around the world, and the company plans to submit its full chemistry, manufacturing, and controls (CMC) data set to the US Food and Drug Administration (FDA). United by the end of the year.
The use of the brand name Nuvaxovid ™ has not yet been approved in the United States by the FDA.
Authorization in the United States
NVX-CoV2373 has not been approved for use in the United States and the trade name Nuvaxovid has not yet been approved by the United States FDA.
NVX-CoV2373 is a protein-based vaccine 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 mcg of antigen and 50 mcg 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.
Novavax has established partnerships for the manufacture, marketing and distribution of NVX-CoV2373 around the world.
About the Phase 3 trials of NVX-CoV2373
NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials.
A UK trial with 14,039 participants was designed as a randomized, placebo-controlled, observer-blind study and achieved an overall efficacy of 89.7%. The primary endpoint was based on the first onset of symptomatic COVID-19 (mild, moderate or severe) confirmed by PCR with onset at least 7 days after the second study vaccination in serologically negative adult participants (SARS -CoV-2) at the start. .
PREVENT-19, a trial in the United States and Mexico which recruited nearly 30,000 participants, achieved an overall efficiency of 90.4%. It was designed as a randomized, placebo-controlled, blinded 2: 1 study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373. The primary endpoint of PREVENT-19 was the first occurrence of symptomatic COVID-19 (mild, moderate, or severe) confirmed by PCR with onset at least 7 days after the second dose in serologically negative adult participants (SARS-CoV -2) at baseline. The criterion for statistical success included a lower limit of 95% CI> 30%. The key secondary endpoint is prevention of COVID-19 confirmed by PCR, moderate or severe symptomatic. Both endpoints were evaluated at least seven days after the second study vaccination in volunteers who had not previously been infected with SARS-CoV-2. It was generally well tolerated and elicited a strong antibody response in both studies.
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, has 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. These vaccine candidates incorporate Novavax’s proprietary saponin-based Matrix-M ™ adjuvant to enhance immune response and stimulate high levels of neutralizing antibodies.
These statements regarding the future of Novavax, its operating plans and prospects, its partnerships, the ongoing development of NVX-CoV2373, the potential of a conditional marketing authorization for NVX-CoV2373 to increase the vaccination and the scope, timing and results of future regulatory filings and actions, including Novavax’s plans to complete the conditional marketing authorization submitted to the EMA and, by the end of the year, to submit a complete CMC data dossier to the US FDA 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 substantial risks and uncertainties, including those mentioned above. Investors, potential investors and others should carefully consider these risks and uncertainties.
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SOURCE Novavax, Inc.